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LifeGLOBAL REACH, LOCAL KNOWLEDGE Sciences www.lslawmag.com Lawyer Patents are not the way to fix drug pricing issues Bob Stoll of Drinker Biddle & Reath LLP explains why drug pricing bills may not be the answer to public concern over pharmaceutical costs
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Trademark Front co Front elcome to the first issue of our new publication, new our of the first issue elcome to The field of life sciences is a fast-moving and heavily regulated sector. sector. regulated and heavily fast-moving is a sciences life of The field controversial, highly them some of subject areas, of wide range a It covers For information publicationsFor on our sister please visit www.patentlawyermagazine.com r. We sincerely hope you enjoy our first issue and look forward to receiving your receiving to forward first issue and look our enjoy you hope sincerely We r. Matt Seex Editor The Life Sciences The Life in this debut issue of can be found this and much, much more All Elsewhere, we have an update on CBD regulation in Europe, plant patent plant Europe, in regulation CBD on update an have we Elsewhere, For this, our inaugural issue, the topic at the forefront of our minds is our of at the forefront issue, the topic inaugural this, our For Almost any discussion of life sciences in a legal context involves a consideration a consideration involves context sciences in a legal life discussion of Almost any Mission statement Lawyer Sciences The Life It features globally. knowledge disseminating and expanding by industry which contain expertise, of fields their of people at the top by written articles examined judgments are and opinion. Important but analysis just the facts not articles. feature in longer reviewed issues are in case studies and topical Lawye feedback. protection in Mexico, and the protection of inventions in India. inventions of and the protection in Mexico, protection pharmaceuticals. Bob Stoll of Drinker Biddle tells us why patents are not the way to way the not are patents why us Biddle tells Drinker of pharmaceuticals. Bob Stoll GCRoberts fix drug pricing issues. MacKenna or is opening the door whether asks James And industry. the pharmaceutical abuse litigation for closing on market look at the impact of Marks & Clerk Singapore of Tim Headley and Kinnaird scheme on generic drug approval. linkage patent Singapore’s of intellectual property. To that end, To property. intellectual of and guest experts property science and intellectual life international of a panel by on the most information up-to-date provide we that ensure will who writers, developments. international important and many of which will prove to be of critical importance to the human race as a race the human importance to critical be of to prove will which of and many and uncertain future. a strange like what can feel into move we whole, no less, as CRISPR examples, few but a to give by, opportunities offered The possibilities and therapeutic medicine, and personalized crops, gene editing, genetically-modified provoke. that these topics debates ethical the are but so too far-reaching, are CBD, jurisdictions across present sciences continue to surprise, then, that the life no It’s challenges. and regulatory legal complex with uniquely the globe Editor’s welcome W age 3 Page :19 08 – [email protected] 1 22/1/20 t :Layou int CTC Legal Media Whilst every effort has been made to ensure that the to ensure has been made effort Whilst every neither is correct, contained in this journal information can Media Legal CTC or contributors the editor, omissions or errors any for responsibility any accept therefrom. consequences resulting any for or The 2020, and contributors. Media Legal © CTC the under protected are journal this of contents Kingdom, the Berne the United of law copyright Convention. Copyright the Universal and Convention be in may the journal of unauthorised copying Any be will Infringers law. and criminal civil both of breach prosecuted. THE LIFE SCIENCES LAWYER Issue 1 2020 Editor Matt Seex [email protected] Publishing Director Chris Dooley [email protected] Enquiries Advertising Naz Hassan (Publishing Executive) Katie Kerr [email protected] Executive) (Publishing Carter Dael [email protected] Enquiries Subscription [email protected] Enquiries Accounts [email protected] Published by: Ltd, Media Legal CTC Kingsnorth, Way, 23 Hedgers TN23 3GN Kent Ashford, 7112 8862 (0)20 +44 Tel: 0365 7084 (0)20 +44 Fax: by: Design and Repro Design and Printing Solutions Ltd Wilson Industrial Joseph Unit 45C, 3PS CT5 Whitstable, Kent Estate, by: Printed Geerings Print Ltd, Chart Road, House, Wood Cobbs TN23 1EP Kent Ashford, CTC Legal Media CTC Legal lcome_pr s we or’ Edit Contents:Layout 1 16/1/20 10:49 Page 4 Contents:Layout 1 20/1/20 10:18 Page 5 CONTENTS ContentsIssue 1 2020
6 Meet the editorial board 17 The CBD regulatory Meet our Editorial Board members who help landscape in Portugal determine the direction of this magazine. and in the EU Ricardo Costa Macedo and Diana Mâncio da 7 News Costa of Caiado Guerreiro look at Portugal’s Challenge to HIV drug patent extension, approach to CBD. Shanks v Unilever, "pay-for-delay", and more. 32 21 Singapore’s patent-linkage scheme and its effects on 38 Protection of plant 50 A case analysis of patent 10 COVER STORY Patents are marketing approval for inventions in Mexico invalidation of Ticagrelor not the way to fix drug generic drugs Janett Lumbreras, Senior Associate, Uhthoff, in China pricing issues James Kinnaird, Partner, and Tim Headley, Gomez Vega & Uhthoff S.C, looks in detail at Xiaofeng Tang, Managing Partner and Bob Stoll of Drinker Biddle & Reath LLP Associate, Marks & Clerk Singapore, discuss an increasingly important area of IP protection. Patent Attorney at Beijing Geach Intellectual explains why drug pricing bills may not be the aims and operation of Singapore’s Property Law Office, looks at a recent the answer to public concern over patent-linkage scheme. 42 Doing justice to chemical invalidation case in China concerning pharmaceutical costs. a blood-thinning medication. 24 Understanding the patents inventive step for pharma Vladimir Biriulin, Partner and Head of Legal 54 Announcing the birth of 14 Life sciences meets Practice at Gorodissky & Partners, discusses competition law and bio-pharma inventions the application of term extensions to SMAS INTELLECTUAL patented chemical compounds. MacKenna Roberts, General Counsel and in India PROPERTY’s sister DPO to Choice Telemed Ltd, asks whether Rajeev Kumar and Pankaj Musyuni of company “BAIANAT courts will become an accepted forum to LexOrbis discuss the importance of the 46 Functionally-claimed INTELLECTUAL challenge exploitative drug pricing practices inventive step and the ways of establishing it. antibody patent – the in the pharmaceutical industry, and explains PROPERTY” why it matters. 28 Understanding the state of Amgen v Sanofi case Shadya Ahmed Awad of SMAS-IP details uncertainty of life sciences Osamu Yamamoto, patent attorney and some recent developments at her firm, patents partner at Yuasa and Hara, examines recent and highlights the challenges posed by an Japanese drug patent litigation. ever-changing IP landscape. 10 David G. Rosenbaum, founder and chairman of Rosenbaum IP, discusses the difficulties and uncertainty facing those who wish to register patents in the life science sector. 42 32 Plant protection in Europe: seeds of discord? Dr Penny Gilbert, Partner, and Dr William Hillson, Associate, Powell Gilbert LLP look at the tensions and controversies caused by the thorny issue of European plant patents. 35 Precision medicine in Taiwan Mr. Yu-Li Tsai and Mr. Lu-Fa Tsai of Deep & Far Taiwan look at a recent memorandum of understanding between the Taiwanese National Health Research Institutes and Swiss healthcare giant Roche.
4 THE LIFE SCIENCES LAWYER CTC Legal Media CTC Legal Media THE LIFE SCIENCES LAWYER 5 NEWS 7 THE LIFE SCIENCES LAWYER While it is too early to say what effect say to early While it is too The matter now lies with the USPTO lies now The matter The letter continues, “If Gilead’s continues, “If The letter this surprising decision will have on the have will this surprising decision inventor employee of field wider what compensation, the success of as a hopeless regarded observers many many that the prospect case raises by be brought now will cases more seeking additional disgruntled inventors compensation.” Appeal upholding the first instance Appeal The £24 million. of valuation judge’s Court which the Supreme main issue such a sum whether was decide had to when be called ‘outstanding’, could truly the immense annual to compared a multinational of and profits revenue Although the Unilever. like corporation that due regard legislation provides of and nature the size should be paid to a whether when deciding the employer a this is not ‘outstanding’, benefit is be but just one aspect to deciding factor account, alongside others. into taken to went therefore this appeal The crux of be it should weight much relative how is picture overall when the afforded, mixed. and, by extension, the Trump the extension, and, by itself. Administration monopoly is allowed to continue, it will continue, it to is allowed monopoly suffer Americans while a profit reap was behavior Gilead’s needlessly. Corporate and amoral. deceitful by be rewarded misconduct must not extending through government the U.S on monopoly a government-granted of tens worth this medicine that is likely dollars”. billions of differentiated from existing drugs”. existing from differentiated Although exactly how much money how Although exactly Upending expectations, the Supreme the Upending expectations, Professor Shank’s inventions generated inventions Shank’s Professor was the parties, it by disputed hotly was a produced they that ground common of with the Court Unilever, for profit large Court … [found] that Professor Shanks that Professor Court … [found] £2 million in additional entitled to was his former compensation from his and above over Unilever, employer, was when he earnings regular research their by employed previously rule The normal arm. and development an employee where is that law UK under job their as part of invent to is employed that arise inventions any description, be the will employment during their However, employer. their of property has been of an invention where employer, to their benefit’ ‘outstanding for apply to entitled is inventor the with the compensation, additional legislation setting out the rules and when such establishing for procedures compensation is owed. additional fewer still are appealed all the way to way the appealed all are still fewer court. highest country’s the predecessor, Truvada (which was also was (which Truvada predecessor, which, it has been Gilead, and made by patients’ alleged, caused damage to despite bones and kidneys) teeth, “was successor Truvada’s that knowing Sanders and Ocasio- be safer”. to likely that Gilead had been contend Cortez carry would that Descovy years for aware its fulfil to health risks, but “failed fewer disclose its true reason obligation to legal … [Truvada] of halting the development for USPTO the because it told the USPTO” to development Truvada ceased that it only be to “unlikely was it because only age 7 Page :09 10 that has surprised many, and Senator Bernie Sanders have and Senator The pair are demanding that the are The pair “The decision had been eagerly Bethan Hopewell, Partner at IP law at IP Partner Bethan Hopewell, After a thirteen-year legal battle for legal a thirteen-year After Whilst working for a Unilever subsidiary a Unilever for working Whilst CTC Legal Media CTC Legal Ocasio-Cortez and Ocasio-Cortez HIV challenge Sanders extension drug patent OCASIO- ALEXANDRIA REPRESENTATIVE CORTEZ and Patent US the to letter open an written accusing US Office (USPTO) Trademark giant Gilead Sciences Inc pharmaceutical its actions over misconduct” “corporate of its anti-HIV of the development to relating drug “Descovy”. against Unilever Shanks triumphs anticipated, as few cases of this type cases of as few anticipated, settled (most are trial it to make ever judgment) and come to they before firm Powell Gilbert, comments: Powell firm compensation, Professor Shanks has compensation, Professor in the Supreme victory achieved finally winning a £2 million payout. Court, in the 1980s, Professor Shanks invented in the 1980s, Professor – the electrochemical technology measuring for – (ECFD) device fill capillary in blood samples. glucose levels that Unilever been told having However, the company his invention, owned it and made millions from patented Professor world. the licensing it around or payment any receive Shanks did not salary. his usual compensation beyond IN A DECISION A IN by the contrary decisions to earlier given the and Court High the Office, Patent the Ian Shanks Appeal, Professor Court of Court his case in the Supreme won has Unilever. employer, against his former USPTO reject Gilead’s request for a for request Gilead’s reject USPTO allege They the drug. for extension patent delayed intentionally Gilead that to order the medication in developing its by generated profit maximize News 1 16/1/20 t Layou news: LSL The Law The Law CTC Legal Media CTC Legal Smart Machines.. and Michael Pears - Partner Pears Michael Clarkson Potter biotechnological of wide range handles a Michael the in expertise and has particular subject matter applications patent of prosecution and drafting gene stability, protein concerning immunotherapy, and drug delivery, metabolic profiling, therapy, also managed the has He technologies. assay portfolios, patent global several of prosecution Canada, China, Australia, including applications in and the US. Japan India, Malcolm Dowden - Legal Director, Director, - Legal Malcolm Dowden Bond Dickinson Womble at Director Legal a is Dowden Malcolm Womble Bond Dickinson, firm law transatlantic in the chapter the EU/UK of and is the author book new Association's American Bar Intelligence Artificial of LL.M, Dynowski Piotr & Bird Bird and practice, the IP co-head of is Partner, Piotr He is office. Warsaw at the practice TMT head of litigation lawyers and patent the leading IP one of in Poland. Bob Stoll - Partner, - Partner, Bob Stoll LLP & Reath Biddle Drinker LLP & Reath Biddle at Drinker Bob is a partner Group. Property the Intellectual of and Co-Chair a three- to appointed was he 2013, of In October was Council, Advisory on the CAFC term year in 2016, term three-year another for reappointed three- an additional in 2019 for and reappointed on the Board serving is currently He term. year Property American Intellectual the for Directors of Association. Law detailed on this page. of international patent experts. patent international of Members of our editorial board are board editorial our of Members is advised by a distinguished panel a distinguished panel is advised by The Life Sciences Lawyer Magazine Sciences Lawyer The Life age 6 Page :23 10 thank the editorial board for their time and support. their for board thank the editorial Osamu Yamamoto Osamu Japan & Hara, Yuasa and a attorney, is a patent Yamamoto Osamu He and Hara. Yuasa of managing partner of in the fields in patents specializes & pharmaceuticals. biotechnology Vitor Fidalgo Vitor International Inventa and Patent Trademark Palmela Fidalgo is a Vítor and is the matters, IP in all specialized Attorney, International. Inventa at Director IP Noel Courage - Partner, - Partner, Courage Noel LLP & Parr Bereskin of and licensing the patenting on focuses Noel He inventions. and mechanical chemical biotech, and validity patent opinions on provides infringement. MacKenna Roberts - General Counsel and DPO, Counsel - General Roberts MacKenna Ltd Telemed Choice litigation and regulatory sciences is a life MacKenna practice, in private worked who has lawyer and Counsel in-house as General academia and is an MacKenna Ltd. Telemed Choice DPO to assisting clients in adviser strategic experienced at the innovation medical of the commercialization and gene medicine, specializing in cell of frontiers and genetic testing engineering, therapies/tissue technologies. health digital
THE LIFE SCIENCES LAWYER The Life Sciences Lawyer Magazine wishes to take this opportunity to to this opportunity take wishes to Magazine Sciences Lawyer The Life
Matthew Rodgers - Senior Patent Attorney, Attorney, Patent - Senior Rodgers Matthew Scientific Boston to due diligence relating aspects of advises on IP Matthew field, devices in the medical acquisitions and product company and and academic collaborations company aspects of IP the US and UK. He R&D units in both for portfolios manages IP and biotechnology chemistry to relating in areas worked has freedom ensure to strategies developing products and natural through way clearing the families, product new for operate to oppositions and managing litigation risk. MEET THE EDITORIAL BOARD EDITORIAL THE MEET 6
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NEWS NEWS California stops pharmaceutical Organizations demand African “pay-for-delay” pharmaceutical patent reform CALIFORNIA HAS INTRODUCED a pioneering new law designed to stop A COLLECTIVE OF more than ninety organizations has called The price of medicines in these countries determines whether large pharmaceutical companies for urgent reform of the Harare Protocol of the African Regional the government will be able to provide treatment for these settling claims of patent infringement by Intellectual Property Organization (ARIPO) in order to ensure diseases to its people or not. When medicines are unaffordable, generic drug manufacturers by paying that people across Africa have access to affordable medicines. people pay with their lives”. those manufacturers to delay launching The organizations are demanding that Ministers representing According, to the group, ARIPO has, to date, failed to utilize their products – the so-called “pay-for- ARIPO Member States — change how they grant medicinal many of the key public health safeguards allowed under delay” practice. patents, in order to promote cheaper, generic competition. international law and championed by national and regional bodies California hopes that Bill AB 824 will, ARIPO is a regional mechanism that administers the filing, throughout Africa. in effect, block pharmaceutical examination, and grant of pharmaceutical patents for 18 African Instead, the organizations claim that ARIPO continues to grant companies from keeping cheaper countries that have signed up to the Harare Protocol. The unworthy pharmaceutical patents, making certain medicines generic medicines off the market. In Protocol sets out the rules for the administration of patents, unaffordable to patients and governments. doing so, it is hoped that prescription utility models and industrial designs. Says Allan Maleche of the Kenya Legal and Ethical Issues drug costs will be significantly lowered. “To combat growing epidemics such as drug-resistant Network on HIV and AIDS (KELIN): According to the Federal Trade tuberculosis, diabetes and cancer — where a single drug can “Now is the time for urgent action. This is not just about legal Commission, “pay-for-delay” deals cost Gavin Newsom, “California will use our saving treatments”. cost hundreds or thousands of dollars to treat just one person — technicalities — ARIPO’s decisions affect the lives of many consumers and taxpayers $3.5 billion in market power and our moral power to With plans for similar legislation ARIPO’s rules for granting patents, laid out in the ‘Harare people living across the region. higher drug costs every year. The bill take on big drug companies and prevent underway at a federal level, it is expected Protocol’, must be changed in order to facilitate access to more In particular, we call on Ministers and Heads of Patent Offices prohibits such agreements between them from keeping affordable generic that this first step by California will mark affordable generics, rather than granting undeserving patent attending the ARIPO Governing Body meetings in Liberia to branded and generic drug drugs out of the hands of people who the beginning of a new battle between monopolies to multinational pharmaceutical companies,” said ensure that ARIPO establishes a credible and transparent manufacturers by making them need them. Competition in the the powerful pharmaceutical industry Lotti Rutter from Health GAP, a global HIV advocacy ‘TRIPS Flexibilities Working Group’ to discuss and develop anticompetitive by presumption. pharmaceutical industry helps lower and legislators seeking to reduce the organisation, “ARIPO Member States have some of the highest proposals to implement public health safeguards in the Harare According to California Governor prices for Californians who rely on life- cost of medicines for all US citizens. burdens of disease in the world. Protocol, including those recommended by civil society.
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8 THE LIFE SCIENCES LAWYER CTC Legal Media CTC Legal Media THE LIFE SCIENCES LAWYER 9 DRUG PRICING 11 THE LIFE SCIENCES LAWYER Résumé Bob Stoll at team on the Patent Bob is a partner and Co-Chair LLP & Reath Biddle Drinker In Group. Property the Intellectual of by appointed, was 2013, he of October term a three-year to Judge Rader, Chief was Council, Advisory on the CAFC term three-year another for reappointed and Prost, Judge Sharon Chief in 2016 by in 2019 for reappointed is also He term. three-year an additional on (2018-2021) term serving a three-year American the for Directors of the Board As Association. Law Property Intellectual for Commissioner USPTO the former in the instrumental was he Patents, legislation, landmark patent passage of and lauded for Act, America Invents the pendency reduce patent to his efforts has spent He quality. patent and improve the intellectual improving his career and educating the system property and public, applicants, corporations of the criticality on governments foreign economic growth to property intellectual and job creation. ” The most likely for provisions addressing drug pricing through are patents in contained a couple of bills that already have seen some action. “ age 11 Page :40 10 H.R. 3991, attempts to address something recognizes heartbeat a with everyone Almost way the bills pricing drug patent these are But so. think I don’t “Product hopping” arguments fail to CTC Legal Media CTC Legal drug application or biosimilar biological product biological biosimilar or application drug license application. subsequent innovation that This would extent the would time release of the active include component or the reformulation of the delivery. an intravenous from administration product to an oral called “patent thicketing”. Patent thicketing is require would that patents overlapping of web a a licensee to take many licenses to be able to clear a potential conflict. Thewould bill cap at 20 the number of biologic patents drug a manufacturer brand-name infringer. litigation against a biosimilar can assert in that we shouldn’t keep life-saving drugs from prevent not should Affordability need. in anyone Americans from getting life-saving medicines. drug-prices that consensus large a is there And States. high in the United too are go? to acknowledge that innovation does not is treatment in stop useful ingredient active an when 16/1/20 1 t 2:Layou ll_v Sto Bob CTC Legal Media CTC Legal H.R. 5133 would establish that “product-hopping” that establish would 5133 H.R. One such potential ornament has enthralled and confirmedby the Senateto vest them with the necessary authority to invalidate patents. associated problems constitutional the However, with their appointment by Commerce the can be remedied Secretary by having of PTAB is who director, USPTO the by reviewed decisions the by confirmed and President the by appointed viable is alternative Another Senate. to establish a small panel constitutional requirements to review all PTAB of judges would solutions proposed the of Either decisions. who meet work to cure the problem. The the need for a fixto this problem is to likely result in legislation that a become and Congress the through move could for other legislation “Christmas to referred Tree” bill. on a moving as “ornaments” is anti-competitive behavior in violation of the describes bill The Act. Commission Trade Federal incrementally of practice a as hopping” “product a reformulating drug after receiving notice that new abbreviated an submitted has applicant an both both the public and the Hill bills, of series a in above resulted has and issues all patent other which have high betting odds for quick action; some which patents pricing drug to relate these prices. drug high to contributor main a are claim The most provisions likely for addressing drug pricing through patents are contained couple of in bills that a have already seen some recently Committee Judiciary House The action. for Prescriptions Affordable the 5133, H.R. moved of Act Competition Promoting Through Patients Prescriptions Affordable the 3991, H.R. and 2019, for Patients Through Improvements Patent Litigation Act to of 2019. The bills contain the provisions that are intended to to access help increasing by prices drug reduce prescription products. generic and biosimilar ” Affordability not should prevent Americans getting from life-saving medicines. Bob Stoll “ case Athena age 10 Page :39 10 of the Athena case Athena the en banc of
Anthrex Inc. v. Smith & Nephew Smith & Nephew v. Inc. Anthrex THE LIFE SCIENCES LAWYER here here is broad consensus in community that the the patent system could patent be by improved both markedly legislative
may not be the answer to public concern over pharmaceutical costs. pharmaceutical over concern public to be the answer not may Bob Stoll of Drinker Biddle & Reath LLP explains why drug pricing bills why explains LLP Biddle & Reath Drinker of Bob Stoll It is possible that we may see legislation that fixes and the enactment of rules to better protect better to rules of enactment the and fixes innovation in the biotech and pharmaceutical industries. However, very little in the patent way legislation of is expected any time in decisions soon. important had have we While
Diagnostic Inc v Mayo Collaborative Services Collaborative Mayo v Diagnostic Inc focused on claims on certainty from we far methods, are the larger relating to question of patent subject The matter eligibility. diagnostic rehearing a for denial this Circuit Federal the for Appeals of Court the at summer resulted in eight separate opinions, all of which sought the to confusion added collectively, but eligibility, clarity on subject applicability of the matter subject matter eligibility test and distress to those who must without operate action for call clarion a with Even guidelines. clear by the judges for a usable standard, unlikely to see we a are legislative remedy soon. The clamber in the patent community legislative to obtain relief application by lower courts from of patent subject matter the ineligibility tests emanating lack the overcome easily not from will overly-broad Court Supreme the of consensus on any proposed language for a sure is agreement of lack The solution. legislative to doom any Congressional action on patent this term. eligibility would cure the with “constitutionality problem” The judges. (PTAB) Board Appeal and Trial Patent recent which process, Review Partes Inter the upended way inexpensive relatively and quick a as used is and Patent States United at patents invalidate to Trademark Office (USPTO). The case held that President the by appointed be must judges PTAB T drug pricing issues pricing drug the only way to fix to way only the Patents are not not are Patents DRUG PRICING DRUG 10
16/1/20 1 t 2:Layou ll_v Sto Bob Bob Stoll_v2:Layout 1 16/1/20 10:40 Page 12
DRUG PRICING
developed. The different phases of trials for the original drug innovations. Capping the ability of a branded company to use are extremely expensive and can take years to complete. Most the patents in its portfolio denies the company the ability to drugs fail and never come to market. But for those that are assert valid patents against competitors and violates the successful, innovative improvements during that period can concept that in exchange for providing the public with the Since 1992 …… provide for a more efficacious product or reduce side-effects information on how to make and use the invention, the inventor or any number of other developments. As a society, we want to will be provided with a limited period to exclude others from encourage developers to continue to improve their products making and using the invention. toward a better treatment. Patented drugs, like other patented It is critically important that we reduce drug costs in the innovations, are protected for a limited time, and, after United States but using the patent system to do so would have expiration of that period, are in the public domain freely many unintended consequences. The United States is by far available for any company to manufacture. There are special the most innovative country in the world in the development of rules that allow companies to bring generic versions to market new drugs and biosimilars. There must be significant early. But the problem might be that the patented investigation into what effects bills such as these would have improvements made on the original drug are so significant that on research and development in this country for investment in the original drug or its generic version are significantly less the next cures for cancer and other diseases. We are already desirable than the improved drug. hearing about research and venture capital moving overseas YU-LI TSAI LU-FA TSAI “Patent thicketing” is a different issue. In this case, patentees because of our recent treatment of diagnostic methods related seek several patents which overlap with the original invention to patent subject matter eligibility. Do we want to further harm and form a web, or “thicket”, of interwoven protection. But it the impetus that is driving our drug research? And what are should be recognized that each element in this family of foreign countries going to do when we limit enforcement in the patents must each be novel to receive a full term. If a family United States for drug-related patents? Will they consider member is obvious over an earlier invention with a common further limitations on the patents of our drug companies in their inventor and the same entity, the USPTO will require a terminal countries? disclaimer, so that the term of the obvious over the original We might create a research spiral as efforts flow into other drug modification does not extend beyond the term of the areas where returns on investment are more certain; and original invention. Patents that are not obvious over the we might lose our leadership in the innovation of healthcare originally patented drug or process have a presumption of products and cures. validity and do not have a reduced term as they are new Are these bills on drug “product hopping” and “patent thicketing” the proverbial “camel’s nose under the tent”? There are significantly fewer patents associated with the development of a drug than those related to a telecom innovation. Smart phones and standards like 5G can have hundreds of patents associated with them. Will the bills we are reviewing now spill over into other industries? High drug prices in the US are caused by a complex group of players, including providers, insurers, doctors, drug companies among others. Fixing the problem is critical, but the solution is not properly tied to patents. Society should distribute the § Quality | Reliable | Invaluable § burden of making sure that life-saving drugs are available to all. The costs of drug development are enormous, and most efforts are not successful. We want to continue to stimulate IP Right Prosecution & Litigation research in the next cures by providing funds and a collaborative atmosphere to undertake the research to find Corporate Legal & Consulting them. It does not make sense to hurt innovation by limiting the enforcement of patents. IP Value-Added Services Our patent system is so important that its basis is found in the Constitution. It has driven our economic expansion Focus: Patents, Trademarks, Copyrights, Trade Secrets, Unfair Competition for two centuries and led to job creation and economic growth. Before we tinker with it, we should do some research to Licensing, Counseling, Litigation, Transaction understand what the drug patent pricing changes would likely Territories: Taiwan, Mainland China, Hong Kong, and Macau do to the system and to our leadership in a critical area of human endeavor. Fields: Mechanics, Chemistry, Pharmacy, Biology, Electronics, Optics, Telecommunications, and Computer Sciences Contact: Drinker Biddle & Reath LLP + Address: 1500 K Street, NW, Suite 1100, Address: 13th Floor, 27, Sec. 3, Chung San N. Road, Taipei, Taiwan Washington, DC 20005 Telephone: 886-2-25856688 Email: [email protected] Tel: 202-230-5716 Fax: 886-2-25989900/25978989 } E-mail: [email protected] 12 THE LIFE SCIENCES LAWYER CTC Legal Media ß Web site: http://www.deepnfar.com.tw
Deep & Far FP.indd 1 16/01/2020 10:44 COMPETITION LAW 15 was were Latvian case in 2017. United United Brands Pfizer and Flynn due to the economic THE LIFE SCIENCES LAWYER Latvian Latvian Copyright case was handed down after the CMA’s the after down handed was case but found it “persuasive” but and it found “eminently “persuasive” Pfizer and Flynn, In In finding unfairness, thefound CMA the price Second, the opinion and decision in the the in decision and opinion the Second, The CAT criticized the cost-plus analysis for prices the that find not did CAT the Importantly, significantTwo pointsto note inregardto the be decided on a case-by-case basis. basis. on a case-by-case be decided so- a applied CMA the pricing, drug of complexity called analysis. “cost-plus” The CMA compared reference with medicine the of price and cost the products of portfolio a across sales” of “return a to used in the yielding PPRS a scheme, benchmark the compared it which against 6% of margin profit drugs. the target for margin to be unfair “in itself” because reasonable relationship between the economic there was no see not did CMA The drug. the of price and value did It limb. second the to continue to necessary it note for “completeness” costs lower much at drug the anyway supply to continued that Pfizer in other Member regimes regulatory and provided States no justification that had for these differences. Given thewasdisparity so different large, the CMA noted differences. such basis could justify objective that it is unlikely an CAT decision CAT The CAT agreed with markets narrowly to find that both defining the dominant within it However, overturned their how respective markets. That is to say that the “multiple by methodology” adopted not was proposed Wahl AG approach the ECJ but endorsed nonetheless by the CAT. acknowledged The that CAT the opinion did not have the same authoritative decision weight as the sensible”. applied in reaching its findings. applied in reaching competition. market of notion “idealized” an being The felt CAT the CMA should have established other to reference by range or price benchmark a economic methodologies likely not could it although competition, market normal to apply in suggest one that would clearly. In particular, have it felt the CMA should provided not this the of price higher the comparing dismissed have tablets with the capsules despite agreeing that the tablet form cannot be substituted for product. the a comparator capsules, so it is not were but not that “excessive” the single method sufficient. not and incorrect was CMA the by used This finding is directin contrast todecisions. the Aspen decision: CAT’s Firstly, the basis for overturning the findingCMA’s ofwas “unfair” and“excessive” largely adopted from the European General Wahl’s Attorney opinion as opposed to the ECJ decision in the Copyright ” Public pressure has led to regulators expand the toolbox. legal “ United In suggests (“Aspen”) (“Aspen”) and its age 15 Page :54 10 United United Brands United United Brands. Aspen Aspen Pharmacare the European Court of Justice (ECJ) It set out a two-stage analytical framework: is After After a three-year investigation, in 2016, the On appeal, in 2018, the findingwas in part set conjoined to leave granted Appeal of Court The CTC Legal Media CTC Legal CMA approach CMA In reaching its test legal the applied CAT and decisions, CMA the complex, both lengthy and from the leading case, Brands, confirmed that it isfor unlawful a dominant firm to charge a price which is because excessive it value economic the to relation reasonable “no has of the product supplied”, under what TFEU. Article 102 is now price A “unfair”. it is so, if and, “excessive” price the when compared or in itself either be “unfair” may to competing products. one appropriate methodology in establishing an economic benchmark is a determination of cost of amount ‘the revealing thereby price selling and analysis. price-cost so-called a margin’, profit the The Court emphasized should and suitable more be may methodologies that other possible approach in the Italian excessive pricing decisions pricing excessive Italian the in approach against investigation. Commission pending European Flynn and Pfizer form capsule a of seller the was Pfizer case, this In of an epilepsy treatment, phenytoin sold previously under the brand Epanutin. sodium, Pfizer the authorization sell its to marketing transferred drug in the UK to Flynn without its associated trademark, effectively the drug “genericizing” so that it falls outside the “debranding” pricing branded drugs, scheme voluntary the for and Pharmaceutical Price (PPRS). Regulations Pfizer Scheme drug same the sell exclusively and manufacturer continued 780-1,600%) (between increase price a at Flynn to to be and Flynn then supplied it wholesalers onto and the sole pharmacies at increase) an 2,300-2,600% (between price increased even more with dramatically the NHS 50 to 2012 in million 2 from increased expenditure a captive market. million in The 2013 with 10mg packs increasing from NHS £2.83 to per £67.50 pack, much to the chagrin of Health. the Department of CMA found dominance unfair for both Pfizer and Flynn, pricing ordering almost of fines imposing and prices lower to them and abuse £90 million. of (CAT) Tribunal Authority Competition the by aside for having misapplied the relevant legal and test remanded the matter back to to be reconsidered. the The CMA CAT’s judgment was which hasto multiple the a CMA significant blow pricing investigations. ongoing excessive imminently. appeals and its decision is expected 1 16/1/20 t Layou erts: Rob enna McK CTC Legal Media CTC Legal with the European to to set the parameters Pfizer and Flynn , has taken center stage center taken has , Flynn and Pfizer Of particular interest will be to compare the UK the compare to be will interest particular Of Whether competition law is the correct remedy correct the is law competition Whether Potential legal turning points ahead legal Potential and UK in EU a divergence for approaches case, The having been heard before the English Court of Appeal in 2019. November Its judgment is much anticipated internationally unfair regulate may jurisprudence judicial how for will It courtroom. the in pricing drug excessive and also impact conduct by competition agencies in and EU. ongoing cases in the UK a string of approach in raising prices by up to 1,600% (from approximately (from 1,600% to up by prices raising £4.46 when branded to £258 per pack). An EU example includes authority the Danish sanctioning of price the increasing for Pharma, CD distributor, competition the the drug pharmaceutical Syntocinon, given to women case a submitted also has It 2000%. by during childbirth, to the Danish economic crime. state prosecutor for serious for excessive pricing is but controversial public appetite is fueled by outrage when old drugs This become almost article expensive overnight. examines the evolution of unfair and excessive pricing law in the pharmaceutical while sector it shape will that decisions seminal of brink the on is its development. ” Résumé Roberts MacKenna who lawyer litigation and regulatory sciences is a life MacKenna academia and, most recently, practice, in private worked has Ltd, Telemed Choice and DPO to Counsel in-house as General trials. that supports clinical imaging company a medical clients assisting adviser strategic is an experienced MacKenna at the frontiers innovation medical of in the commercialization and gene therapies/tissue medicine, specializing in cell of health technologies. and digital engineering, genetic testing Courts are extremely not cautious become to tantamount a price to regulator. MacKenna Roberts MacKenna “ age 14 Page :54 10
ntitrust regulators targeted pharmaceutical companies worldwide for have investigation of alleged anticompetitive
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pricing practices in the pharmaceutical industry, and explains why it matters. why and explains industry, in the pharmaceutical pricing practices whether courts will become an accepted forum to challenge exploitative drug exploitative challenge to forum become an accepted will courts whether MacKenna Roberts, General Counsel and DPO to Choice Telemed Ltd, asks Ltd, Telemed Choice and DPO to Counsel General Roberts, MacKenna Traditionally, Traditionally, these investigations have As the dynamics of pharmaceutical markets for basis legal unusual previously a 2013, Since These cases are triggered by exploitative
competition competition law Life sciences meets sciences Life COMPETITION LAWCOMPETITION 14 scrutinized scrutinized alleged anti-competitive collusion around “pay for delay” to market agreements between branded drug manufacturers and the manufacturers of generic drugs. These abuse of market claims are pursued in contravention of the of Functioning the on Treaty the of 101 Article European Union (TFEU) and Chapter I 1998. Act Competition of the shift from blockbusters to rare disease “orphan” designations and pharmacogenetics, therapies are more specificsubstitutable and competitors. less Meanwhile, likely prices increasingly exceed production have to costs. Public pressure has led regulators to expand the legal toolbox and attempt alternative ways to hold pharmaceutical companies legally accountable drug pricing practices. exploitative for market abuse litigation prevalent: the prohibition of “unfair purchase or has become CA II Chapter and TFEU 102 (Article prices” selling more 1998). Its application to drug pricing has been keenly contested and courts are reluctant in this manner. in markets intervene to behaviors often combined with exclusionary or include investigations Recent conduct. deceptive 12,000% price hikes for packs of hydrocortisone prompting 2016) March £88.00 to 2008 April (£0.70 three separate investigations into Actavis and others. Concordia investigated for buying International the license to a hypo- and has it de-branding Liothyronine, drug, thyroidism been practices. practices. The ensuing litigation has spotlighted industry practices to secure market dominance and profitmargins. In the UK alone during 2019, eleven investigations and Competition the by ongoing were companies into (CMA). Authority Markets pharmaceutical A
1 16/1/20 t Layou erts: Rob enna McK CBD 17 THE LIFE SCIENCES LAWYER He is considered by Chambers and by is considered He Diana Mâncio da Costa is a Junior Lawyer Junior Diana Mâncio da Costa is a of She is a member at Caiado Guerreiro. and Life Property the Intellectual Caiado Sciences department of legal and she has provided Guerreiro, aspects of various assistance regarding and health sector, the pharmaceutical advice on the of including the provision and products medical of advertising services, home care devices, medical medical new aspects of regulatory and drug prescription. products practice her She has also concentrated Intellectual of on the enforcement rights in these sectors. Property Résumés Costa Macedo Ricardo Macedo joined Caiado Costa Ricardo in 2000 and has been a Guerreiro heads the since 2006. He partner sciences life and property intellectual covers the firm. His practice of groups and non- contentious of wide range a and trademark patent, contentious rights, such as trade IP-related other in competition, unfair and secrets in the pharmaceutical, home particular sectors. and insurance food care, in knowledge vast he has Moreover, in these sectors. matters regulatory in field” in their Partners as a “leader IP. of the area Diana Mâncio da Costa Diana Mâncio da Costa Ricardo Costa Macedo Ricardo age 17 Page :04 11 ll ll across the world, Cannabidiol (CBD) the products is on interest the in rise, which is the attested by millions of Ricardo Costa Macedo and Diana Mâncio da Costa of Caiado Guerreiro look Guerreiro Caiado Costa Macedo and Diana Mâncio da Costa of Ricardo CBD. to approach at Portugal’s According According to the INFARMED (the Portuguese The question remains as to how CBD should In Europe and elsewhere, the legal cannabis CBD, CBD, which is a non-psychoactive chemical CTC Legal Media CTC Legal Drug Authority), Drug Authority), the intent of enacting regulation on cannabis was to enhance the availability of medical treatments based on the cannabis plant. The INFARMED is responsible for guaranteeing that these products meet requirements concerning their quality all and safety. the mandatory Pursuant to this, the chain, production entire from CBD as a medical product CBD as a medical In Portugal, Law of use the for 33/2018, framework legislative the approved of 18 July on based substances and preparations 2019, products, the cannabis plant for medicinal purposes. This step significant a as perceived is approval recent to encourage scientific andinvestments in pharmaceutical this area. namely 8/2019, Decree-Law of Further 15 January, has legislation, detailed the legal regime applicable to these products. medical The CBD regulatory CBD The in Portugal landscape EU in the and be handled from a point and regulatory view, of doubts arise as to these how CBD products can in the EU and in Portugal. be marketed industry is rapidly developing and an exponential an and developing rapidly is industry in growth this area is expected in the upcoming years. Various EU countries have passed new legislation on the matter, Portugal being one of those countries. compound from the cannabis food from plant, products, of number a in incorporated can be and cosmetics. products medicinal to searches searches being made online each month about CBD. Also, shops selling locations. various in mushrooms like up springing CBD products are A 16/1/20 t 1 ayou V2:L ado_ Cai CTC Legal Media CTC Legal a price regulator. AG regulator. price a However, However, the awaited determination on the He He also expressed concern for the legal Some argue this prosecution will detract Conclusion Despite the economic complexity of bringing unfair and excessive pricing claims in the sciences life sector, it is unlikely to stem the tide. pricing excessive of complaints been have There for by, example, Biogen in Belgium and Italy for its orphan muscular drug spinal Spinraza to treat Future cases, atrophy. are therefore, anticipated be would law EU of application the on clarity and alike. and regulators industry by welcome with authorities competition for required calculus proof of burden its discharge to resources limited this which with enthusiasm the influence will likely It remains litigation is pursued in future. of strand to be seen if the UK will diverge in its approach jurisdictional offer to serve may which EU the from on door the close or open either that preferences case law. of body this emerging Market intervention debate intervention Market debate jurisprudence a litigation, this of heart the At cautious extremely are Courts rumble. to continues to tantamount become to not Wahl, like many sceptics, cautioned against price tendency a for concern his discussing interventions, false towards positives. He warned of the greater commerce than rulings in errors correct to difficulty in the market. errors for correct to uncertainty for dominant firms to be assess when able a to price might be deemed to excessive and the be need not to set the threshold is pricing Drug price. benchmark the to close too a result of opaque and factors often commercial wider algorithms, highly complex economic policies. reimbursement an in medicines innovative of R&D into investment industry that suffers high exceedingly attrition costly rates and and lengthy market. Others pipelines argue that social policy dictates to and access distort abuses market when remedy a negatively impact public health while relying heavily on public investment. Indeed, the OECD Competition Committee convened hearings on “Excessive Prices in Pharmaceutical in Markets” 2018. November across across Europe, this contrast could divergence demark a in approach to and EU. in the UK pricing cases exploitative drug ” Contact: MacKenna Roberts, General Counsel and DPO Counsel General Roberts, Contact: MacKenna Telemedicine Choice 0961 957 796 +44 Direct: 151 382 7979 +44 Tel: https://www.choicetelemed.co.uk/ Website: At the heart At this of litigation, a jurisprudence debate rumbles. “ prima facie prima “Companies Pfizer and Flynn. and Flynn. Pfizer age 16 Page :54 10 te te prices of cancer
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Aspen’s Aspen’s anticompetitive conduct Both the AGCM and administrative appeal has Aspen whether investigating now is EC The The administrative appeal of the Aspen case Depending on the Court Appeal of ruling and Ultimately, the Ultimately, decision CAT requires multiple Aspen Aspen In the EU, the situation has potentially evolved agency competition Italian the 2016, In differently. (AGCM) fined Aspen Pharmadominance for to artificially infla abusing its medicines it licensed The from GlaxoSmithKline. decision was upheld on appeal. In the 2017, EC commenced proceedings against Aspen unjustified “price gouging” for stating: encompassed its price negotiation It conduct. sought to re-classified have so its as which to escapefor drugs, the pull to leukemia regulatedthreatened It controls. price treatments there is no alternative treatment, from market 1,500%) approximately (of increase price a unless drug the in shortage a caused Aspen agreed. was agreed. were its demands and eventually supply the on pricing excessive and unfair found tribunal basis that the price defended Aspen costs. increase manufacturing increased did not bring to reflect was increase price the for reason the that Italian drug prices into alignment with European and insufficient be to held was reason This prices. the only justificationsfor a price increase could be: R&D costs, innovation costs or increases in distribution costs. or manufacturing unfairly priced these same cancer drugs across Europe. found that the cost-plus analysis to calculate a profitstark in is This marginpricing. excessive of determination was sufficient decision in the CAT’s to contrast to make a the EC’s Aspen investigation into unfair pricing convincing convincing argument that pricing is approach, fair. This if upheld by the significantly increases the Court evidentiary burdenof of Appeal, allocated costs and time the increasing CMA, the investigations. to resources limited from should be pharmaceuticals to ensure that keep they making rewarded for them into the future. But when a producing price of a drug this these percent, hundred goes suddenly up several by look at”. is something the Commission may economic methodologies to be utilized before pricing. determining Also, “excessive” unfairness must be found only if all possible under both arguments separate limbs the of test been have non-comparator but similar including considered, either limb drugs. could CAT, For be relied on to account must analysis overall but unfairness, find any evaluate must and limbs both for decision, so it was not within the contemplation the CMA. of COMPETITION LAWCOMPETITION 16
1 16/1/20 t Layou erts: Rob enna McK CBD 19 THE LIFE SCIENCES LAWYER In this it regard, should be noted that the entity As As for the regulatory framework of food Accordingly, Accordingly, a recent German decision that intends to bring the product to the market will market the to product the bring to intends that have to make a choice between marketing it as a medical product or as food or food supplement. INFARMED, the by clarified already as and such, As if we are dealing with a product that has been be will the cannabis plant and that from extracted purposes, used medical then for will said product be subject to the INFARMED’s supervision. The as used products the to applies reasoning inverse the within fall will which supplements, food or food the DGAV. of responsibility scope of containing CBD in acknowledged that the competent authority for Portugal, it and Quality Food (the DGAV the is matters these should be Agency). Nevertheless, Safety there has been a struggle in determining competent authority to handle which matters related one is with cannabis. In this sense, the be distinction to the attributed be to purpose the on relies here made medical a be will it if instance, for product, the to supplement. and food food vs. product confirmedthat products containing CBD will be theby classified competent authorities as either a prescription-only medicine or a novel food, meaning they shall not concerns safety be additional without public general marketed to the being followed. and research CBD in cosmetics cosmetics in CBD When reflecting on the recent interest for CBD products, one should take increased into use account of CBD the in cosmetic products. ” Relevant concerns are also raised regarding the legal framework food of containing CBD. “ age 19 Page :04 11 a non-controlled substance non-controlled a It could be argued that the set footnote to be CTC Legal Media CTC Legal included in the Convention does not concretely the status since CBD, legal alter of this cannabis component was already not scheduled in the case the Nevertheless, conventions. international bring to footnote simple this for made be should due CBD, surrounding regime legal the to clarity as consignation its to under the referred conventions. As a matter of though this component in is listed not even fact, the schedules of the 1961, 1971 or 1988 United Nations International Drug Control Conventions, CBD that is produced as an extract of cannabis remains included in Schedule general, In prohibited. is such, as I and, Convention of the 1961 into translate likely most will modifications these a development of the distribution of medical whole. as a cannabis products This leads to the conclusion that there may be a may This the leads conclusion to that there specifically designed be to regime legal different CBD. for CBD containing Food The Food Catalogue Novel states that extracts of containing products derived and L. sativa cannabis cannabinoids are considered novel foods. The Catalogue lists foods that were not significantly consumed within the Union, prior to 15 May 1997, thus requiring further authorization before they are sold and marketed risk assessment within the EU. Even though and this Catalogue is not legally binding, it is still considered relevant for national authorities. As such, producers willing to the follow to have will CBD with products food sell 2015/2283. (EU) Regulation in out set process due 16/1/20 t 1 ayou V2:L ado_ Cai measured be be CTC Legal Media CTC Legal THCCOOH THCCOOH will be component to component - Crude or purified separated oil separated purified or Crude - - separate raw or purified resin - Seeds not intended for sowing - flowering or fruiting leaves and distribution, importation, exportation, cultivation, cultivation, production, manufacture, use, flowering matter of the Cannabissativa L. extracted, been has resin no which from plant its designation. whatever Cannabis the Cannabis plant. from obtained oil Cannabis the Cannabis plant. from obtained Cannabis L7. Cannabis sativa Cannabis • • • substance a as THC lists II-B Table Additionally, Ghebreyesus’ Tedros Mr. of implementation The Likewise, Article 81 of the Portuguese Road • For For the purpose of exploring the legal subject to control. As INFARMED’s for CBD, it is not possible to find ato reference this cannabis component neither in 15/93 Decree-Law nor in As such, the the question UN arises Convention. regarding the legal classification of CBD as a prohibited substance or not, particularly since the in regulated) (and foreseen specifically is THC legislation. abovementioned recommendations may have less cannabis Portugal, in all, far-reaching of First Portugal. in effects I-C (thus, IV is and listed only not in Table in Table not being subject to the strictest form of control). As for the remaining of proposal not including preparations containing recommendations, the 0.2% than more no with cannabidiol predominantly THC in the international drug conventions control will certainly have a tremendous effect inpharmaceutical industry. In fact, not scheduling a the are they that determines Tables these in substance including control, international strict to subject not and supply. production their the purpose of for Traffic Code foresees general a prohibition of driving under the psychotropic influence substances. of Nevertheless, narcotic drug-screening the or tests that will be performed, aimed at detecting whether the driver has concentration value of cannabinoids equal to or a than greater the concentration of 50 ng/ml, do a as CBD foresee not transit, transit, acquisition, sale, delivery and holding of in listed preparations and substances plants, the following the lists I-C Table such, As IV. to I Tables substances: wholesale, framework of this cannabis component in Portugal, in component cannabis this of framework Decree-Law 15/93, of 22 January, on the fight against drugs, enacted as a result of the United Narcotic In Traffic Illicit Against Convention Nations Drugs And Psychotropic Substances of 1988, should be considered. This piece of legislation made it clear competent authority to supervise the that activities the INFARMED of is the (indeed, THC, and 11-OH-THC the searched substances), possibly due to its classification as a non-intoxicating substance. ” In Europe and elsewhere, the legal cannabis is industry rapidly developing and an exponential in this growth is area in expected the upcoming years. “ "Preparations containing "Preparations age 18 Page :04 11
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Due to the of novelty the legal framework of As As for the availability of these medical The insertion of a substance both on Schedule on both substance a of insertion The medical cannabis in Portugal, there are still some still are there Portugal, in cannabis medical essential questions that for remain unanswered, instance, the legal classification of one of the components of an thought extensive cannabis, have to (CBD), Cannabidiol the well-known safe, and therapeutic properties range a of fairly tolerable and non-addicting (THC), cannabidiol use. unlike Tetrahydrocannabinol Moreover, does not portrait any (relevant) intoxicating or psychotropic effect in humans. Consequently, consumers and industries, not only in Portugal attention paying are level, European a at also but CBD. utilizations of the many to CBD 18 Upcoming changes in the CBD of classification The winds may be classification of changing CBD. regarding In a public24 the letter, January dated 2019 from the the Director-General of United Nations' World Health Organization (WHO), Mr. Tedros Ghebreyesus, to the United Nations António Secretary-General, Mr. Guterres, there is 1961 the of context a the in cannabis of classification recommendation to Single review Convention on the Narcotic removing towards oriented are recommendations Drugs. These cannabis and cannabis resin from Schedule IV of the mentioned Convention, removing cannabis adding and I Schedule from tinctures and extracts a footnote on cannabis and cannabis Schedule I in the lines of: resin in and cannabidiol than not more 0.2% predominantly of the are not delta-9-tetrahydrocannabinol under control." international I and Schedule IV is considered as to of the control be level restrictive applied. Indeed, most both in indicated currently is (plant) cannabis the of Convention Single UN the of IV and I Schedule 1961. Consequently, removing the indication of letter the in suggested as IV, Table from cannabis from Mr. Tedros Ghebreyesus, would present itself as a game changer in the legal framework cannabis. of products, products, they may only pharmacies, upon medical prescription, issued be dispensed in a important Another by physician. remark to be made is that closed a is there on INFARMED, the of 11/CD/2019 account of Resolution n. list of appropriate for the prescription therapeutic of cannabis- based products, indications substances and preparations deemed for medicinal purposes. periodically revised, and such This revision will be list based will on the evolution be of the technical and in this field. scientific knowledge cultivation cultivation of the plant to INFARMED. the by be controlled shall distribution, its preparation and
16/1/20 t 1 ayou V2:L ado_ Cai PATENT-LINKAGE IN SINGAPORE 21 THE LIFE SCIENCES LAWYER Tim Headley (UK) and European Tim is a Chartered He 2018. in qualifying Attorney, Patent his for Honors with a First-Class graduated the Sciences from MSci in Natural joining Cambridge. Before of University at a worked Tim Marks & Clerk Singapore, Attorney Patent UK London-based leading ranging from clients for working firm companies pharmaceutical multinational patent in specializes Tim start-ups. local to and has chemistry to relating matters to relating patents in experience particular molecule pharmaceuticals and small handling Tim has experience polymers. the of all covering families patent large world. around the offices IP major Résumés Kinnaird James Patent Registered is a Singapore James (UK) and European Chartered Attorney, and has been in practice Attorney, Patent holds a BSc in Chemistry since 2005. He and a PhD Glasgow of the University from the University from Chemistry in Organic in the specializes James Cambridge. of polymers/materials, chemistry, of fields wearable and pharmaceuticals, textiles joining the patent Before technology. conducted James profession, at Columbia research postdoctoral as a medicinal worked and University as an He is listed Pfizer. chemist for work his from derived patents on inventor and Pfizer. Columbia University at both Tim Headley James Kinnaird James age 21 Page :08 11 the launch of the generic version); the generic the launch of product. the therapeutic to relating ingapore’s ingapore’s stated ambition is to be an IP- hub for South-East Asia and part of this plan involves a robust patent-linkage (a) (a) (to consent given has owner patent the (b) or is invalid; the patent (c) acts be infringed by not will the patent The consequence of filinga declaration that James Kinnaird, Partner, and Tim Headley, Associate, Marks & Clerk Associate, Tim Headley, and Partner, Kinnaird, James patent-linkage Singapore’s of the aims and operation discuss Singapore, scheme. An applicant for approval of any drug must contains false information include a fine and/or important is it so months, 12 to up of imprisonment and any list diligently to competitor generic a for all patents (including process patents) that may launch. wish to they the product to be relevant scheme that was originally introduced to meet its meet to introduced originally was that scheme obligations under the US-Singapore free-trade agreement. This patent-linkage scheme allows approval the halt) (or delay to proprietor patent the scheme the addition, In drug. generic a for process looking company a on burden significant a places Singapore, in drug a of version generic a launch to and failure to comply could result in criminal sanctions. CTC Legal Media CTC Legal declare to the HSA whether there are any patents any are there whether HSA the to declare The question. in product the to relate that force in that: the HSA to applicant must also declare The marketing approval The process is marketing approval governed by the Singapore Health Sciences Authority (HSA), Products) (Therapeutic Products Health the under Regulations 2016 (TPR), which also sets out the applicant’s obligations under the patent-linkage scheme and provides legal basis for regulatory data exclusivity. Singapore’s patent-linkage Singapore’s on its effects and scheme for approval marketing drugs generic approval The marketing system and “patent-linkage” in Singapore S 16/1/20 t 1 ayou k:L Cler ks & Mar CTC Legal Media CTC Legal The legal framework surrounding CBD is A push regulation for of CBD products seems Portugal in particular, having passed across the word in relation to cannabis and CBD. CBD. and cannabis to relation in word the across currently in a grey state, being that some CBD the with products, medicinal as used are products associated marketing authorization and clinical be regarded may products other whereas testing, cosmetics. supplements or & food as food medicinal, of sectors the that being order, in be to food and cosmetic products will most the legislation of the harmonization benefit from likely will as regimes, regulatory puzzling less from and patients and consumers. and cannabis medicinal on legislation interesting having attracted a number of companies and start-ups in this would sector, certainly benefit which to as clarity and regulation CBD clear from what in this domain. for is responsible authority +351 21 371 70 00 70 21 371 +351 Contact: Caiado Guerreiro Tel: [email protected] Email: [email protected] age 20 Page :05 11
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Conclusions WHO The the on made recommendation the by rescheduling of cannabis and cannabis-related be may Convention Single UN the in substances an important ties which framework, cannabis step the on discussion to enhance up with the the momentum that legal is currently felt especially especially with the recommendations modifications for the to UN Convention. be introduced in the Regulation Regulation (EU) No. 1223/2009 (the substances Cosmetics of list a II Annex in contains Regulation) prohibited in cosmetic products. Entry 306 of this list includes any substance to referred I in Tables 1961, of Drugs Narcotic on Convention the of II and in which cannabis is included. Once again, the question is raised regarding the use of CBD in cosmetic products, since CBD mentioned is in not the directly UN Single European Convention. The Commission source, its of irrespective such, as (CBD) “Cannabidiol has is not clarified listed in the Schedules of that the Convention on Narcotic Drugs. it 1961 However, shall be Single prohibited from use in cosmetic products (II/306), if it is prepared as an extract or tincture or resin of Convention”. Single the with accordance in Cannabis Future developments may also be looming, CBD 20
16/1/20 t 1 ayou V2:L ado_ Cai PATENT-LINKAGE IN SINGAPORE 23 THE LIFE SCIENCES LAWYER fringed, and the innovator can bring 77 Robinson Road, #17-00 Robinson 77, 77, Robinson #17-00 Road, 77 Robinson [email protected] +65 6227 8986 Patent Term Patent Extensions Term (PTEs) and Adjustments (PTAs) are Singapore has a data-exclusivity provision in the TPR of 5 years 5 of TPR the in provision data-exclusivity a has Singapore Singapore 068896 Singapore Contact: Marks & Clerk Singapore Address: Email: Tel: available available in Singapore to hard typically are PTEs and However, law. patent US of provisions are based HSA the on to attributable delays only because Singapore in the obtain equivalent are when considered determining whether there has been an “undue delay” in granting the MA. Given that the HSA usually first the unless unlikely is PTE quickly, approval marketing grants is possible are obtained in PTAs Singapore. approval marketing by or Office Patent Singapore the by prosecution in delays to due USPTO). the (e.g. scheme similar a has that office patent foreign a The latter may be easier examination to obtain grant of to a patent in Singapore, but it obtain is if Adjustment the that way the to due former one the obtain to difficult uses modified Office. Patent the Singapore by is calculated from from the date of the original which marketing approval, means the based drug generic a for approval grant not will HSA the that original test data without of approval the originator company. least at guarantees and available automatically is protection This companies. innovator period for a short monopoly Other methods to delay generic entry to the to entry generic delay methods to Other market Three further options are available to delay market entry of generics onto the Singapore though market- one only of these process. approval marketing the to relates Conclusion As is evident from the above, the patent-linkage scheme is generally favourable to innovator companies generic because competitor is required to inform the the innovator of any patents that might be in proceedings (and hence the delay) before they are sure that there is an infringement. This highlights formulation, dosage the regime and process patents in importance Singapore, of each of which could be used contrast, to In patent. product original an delay of expiry the generic after market entry to the there is a heavy burden on generics companies to declare all can to comply generic Failure to their product. patents relevant criminal even and revoked being authorisation marketing to lead people responsible. the sanctions for “infringes “infringes a patent As a result, and while not while and result, a As ancelled if he can obtain a the patents; and the patents; t, even when no infringement had infringement no when even t, age 23 Page :09 11 claim could only be based on a past “has to declare the patents and then state, It is for the Singapore authorities to decide whether decide to authorities Singapore the for is It patents, DHA had filed a declaration containing a containing declaration a filed had DHA patents, would order such an (obtaining falsehood material marketing the granted for apply enable Millennium to be revoked); to approval would had been registered products which their infringement of constitute (i) the of existence the declare to failing that by order an (ii) for the acts of performance that DHA’s a declaration (iii) infringing the patents. from DHA restrain to an injunction Thus, the message to generics companies is clear: declare all declare clear: is companies generics to message the Thus, More More generally, the Court of Appeal noted that a generic Rather, it considers whether an act authorised by a marketing a by authorised act an whether considers it Rather, The Court of Appeal disagreed. The In disagreed. Appeal Court decision, their opined of they The first instance decision held that reference the to the DHA applied to have these claims struck out. As they had not had they As out. struck claims these have to applied DHA Millennium applied to the High Court for a number of remedies, of number a for Court High the to applied Millennium CTC Legal Media CTC Legal patents patents which could be considered relevant to your product not will you that sure are you where even processes), (including infringe them. among several possibilities, that the patents are invalid or will not will or invalid possibilities, that are the patents among several infringed…” be on the proprietor. must be served notice company company cannot omit a process patent from their declaration a Instead, process. different a use to intend they because simply generic company approval would infringe a patent, irrespective of whether the act the whether of irrespective patent, a infringe would approval gets patentee a that means this Whether not. or place taken has a second chance at using TPR, the noted that they a proprietor who does not take action when made aware of an application for marketing approval risks the market being flooded now is no abuse in the proprietor “There with cheap generic products: wanting to have the registration c matters”. specified the on determination necessarily agreeing that Millennium’s case would ultimately succeed at full trial, they deemed that out. be struck should not Millennium’s claims that the TPR is not necessarily concerned with proving actual a patent. infringement of Patents Patents Act meant that a was it basis, this On occurred). not had (which infringement of act deemed impossible for claims (ii) and (iii) to succeed, and they were struck out. The first instance court concluded that the to reference the Patents Act should be interpreted in this way window 45-day the missed who proprietor a otherwise because to bring would proceedings have another opportunity after the gran authorisation’s marketing occurred. been notified by a on claim their DHA,based they Instead, above. discussed provisions Millennium could person interested any allows rely which not TPR, the in provision different on the to apply for cancellation of the marketing if approval doing an act authorised by the marketing approval Act”. the Patents under including: meant that Millennium was not served notice that DHA had applied for marketing and approval were not able to halt the DHA TPR. the under litigation commencing by process approval asserted that they did not use the processes disclosed in the their declare to need no was there that accordingly and patents, the HSA. to existence 16/1/20 t 1 ayou k:L Cler ks & Mar This “…it can be “…it CTC Legal Media CTC Legal the Patents Act, the Act, the Patents court t the Patents Act requires an [2018] SGHC 149 (first instance) ommitted ommitted before infringement Millennium Pharmaceuticals, Inc. v Millennium Pharmaceuticals (Millennium) are the proprietor of proprietor the are (Millennium) Pharmaceuticals Millennium Drug Australia (DHA) Houses obtained of approval marketing AstraZeneca AstraZeneca argued that did they not believe that the Sanofi While mere belief of infringement would probably not be proceedings start can patentee the above, the from clear is As What constitutes a “relevant” patent patent a “relevant” What constitutes that must be disclosed? patent a when and approval marketing to relating issues Certain is relevant are dealt with in Pte Ltd Drug Australia Houses of and the subsequent appeal [2019] SGCA 31. The full trial has not has trial full The 31. SGCA [2019] appeal subsequent the and applications to relate judgements these of both and heard, been out certain claims. strike to Singapore patent nos. SG 151322 and SG 182998 (the patents), both of which relate to processes for the manufacture of the drug bortezomib. anti-cancer Although the containing bortezomib. a product for in Singapore never was process application DHA’s of part as filed declaration made the available, concluded Appeal Court that, of of existence the declare not did Respondent the that implied fairly Authority…”. Sciences Health the to patents two Appellant’s the under under the Medicines Act for a declaration that the ‘993 patent injunction an sought and product, Sanofi’s by infringed be would to restrain Sanofi from performing acts thatwould infringe the ‘993 patent. AstraZeneca chose the Medicines Act as the basis for their suit due to concerns tha infringing act to have been c requires only Act Medicines the contrast, In begin. can proceedings that a prospect of future infringement needs to be established launch the in result would approval (i.e. succeed to case their for of an infringing product). The court approved the use of the in this context. Act the Medicines of provisions product fell outside the scope of the patent. This is because AstraZeneca did not believe it possible to produce a stable formulation of rosuvastatin that outside fell their patent claims. They also argued that their reasonable application given to the that marketing the on stay 30-month the from benefit court to proceedings they was only evidence the of all had obtain to possible not was it that and approval 45 days to in this time-frame, bring especially as Sanofi had not disclosed full details of their product. Sanofi soughtto have the claim struck out on the basis that AstraZeneca were infringement. of evidence unable to provide sufficient to proceedings bring under scenario this cover to intended was Act Medicines the that held and so the of information level in provided the initial claim was Sanofi’s of respect in discovery sought AstraZeneca acceptable. to information this needed it that basis the on products, specific Sanofi and granted was Discovery infringement. assess properly had to disclose the composition of place. in put were their provisions confidentiality appropriate product, although without a clear idea of whether the product will infringe the be need to will evidence further in question. However, patent(s) obtained during the proceedings, which could be through the voluntary sharing of information by the generic infringement or to by discovery. This exclude appears to be a balanced approach, given the short period patentee to start of proceedings under the TPR the (or formerly, time available to the Act). Medicines AstraZenaca [2012] SGHC 16. “inorganic “inorganic salt in which the osuvastatin and a stabiliser. They stabiliser. a and osuvastatin age 22 Page :09 11 , as set out in the patent claims. patent , as set out in the
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If the generic company applies for marketing authorisation in marketing applies the for If generic company approval marketing the patentee, the to notice of service Upon The procedure above can lead to uncertainty for both the This case was decided under the old Medicines Act, which (Sanofi) forSanofi-Aventis sought certain marketing approval days. 45 in make to decisions important two had AstraZeneca days 45 specified the within court the to applied AstraZeneca the last 18-months of the patent’s life, with an indication that the that indication an with life, patent’s the of 18-months last the the then expired, has patent the after dated be should approval other any In unabated. continue will process approval marketing case where the existence of a patent is declared and patentee has not consented to the marketing authorisation application, the HSA will issue a notice requiring the generic company to notice serve on the applied stating patentee, have for that they approval. marketing process is halted for a period of 45 days to allow time for the obtain to or approval the block to court the to apply to patentee no If infringed. be would and valid is patent the that declaration a application to the court is made during the 45-day period, the process the continues marketing approval unabated. However, (total 30-months to up for suspended be will process registration delay of up to 31.5 months) if the proposed This registration. delay in proceedings is patentee intended to challenges the provide sufficienttime forthe courts to considerthe facts and arrive at a conclusion. In the unlikely event that a decision has not been reached by the courts within 30 months, the generic company can then continue with the process while approvals awaiting the conclusion of the court case. If the concludes court in case the favour of the generic company in within the stay the overturn court to to can apply months, then they 30- will generic the then wins, patentee the if However, proceedings. need to wait until closer to the expiration date of the patent product. their register trying to before should example, For patentee. the as well as company, generics whether determine cannot they if court the to apply patentee the the within patent their of scope the within falls product generic a 45-day period? On the other hand, does a generics company will they when patent process a of existence the declare to have manufacture the drug by a differentprocess? Both of these issues are discussed below with reference Singapore. to case law in was replaced by the TPR in 2016. However, the provisions of the of provisions the However, 2016. in TPR the by replaced was Act Medicines relied upon that were identical to are essentially those in the TPR and so it appears highly that likely the same TPR. the under occur would outcome r comprising tablets film-coated declared that the products would not infringe AstraZeneca’s Singapore Patent No. SG 89993 (‘993) because their proposed composition did not comprise an cation is multivalent” First, did they have sufficient basis to apply to the court when Sanofi’s whether know to enough information did have not they they should what Secondly, t? paten their infringe would product Act? Medicines the or Act Patents the – “infringement” for on rely AB v Sanofi-Aventis Singapore Pte Ltd Pte Singapore Sanofi-Aventis v AB Can a patentee use the patent-linkage scheme generic when competitor they are unsure to of infringement? This block a in Court High Singapore the by considered was issue Identity of generic product unclear generic product of Identity PATENT-LINKAGE IN SINGAPORE IN PATENT-LINKAGE 22
16/1/20 t 1 ayou k:L Cler ks & Mar FLASH 25 THE LIFE SCIENCES LAWYER Pankaj Musyuni Pankaj is an advocate He at LexOrbis. Associate is a Managing Pankaj holds a He agent. India, and a patent of Council with the Bar registered regularly science and management. He in pharmaceutical master’s has in- management. He and portfolio strategy advises clients on IP and framework, and regulatory law patent of knowledge depth and advisory prosecution filing, drafting, in patent experience extensive chemical, pharmaceutical of the field pertaining to – especially matters talks at articles and delivered several has authored He and start-ups. landscape, and the regulatory practice, law on patent forums various research. clinical Résumés Kumar Rajeev He LexOrbis. at team Science Patents the leads and Partner a is Rajeev science and has extensive in pharmaceutical degree holds a master’s in the versed well is He practice. patent aspects of in all experience for strategy formulating at skilled and law patent of intricacies area practice His particular portfolios. and managing patent developing writing legal oppositions, litigation, prosecutions, includes drafting, chemical, of in the fields opinions and advising clients, particularly His and gas inventions. and oil pharmaceutical, biotechnological and varieties plant of the protection to also extends experience Authority. Biodiversity the National from approvals necessary obtaining and and practice, law articles on patent several has authored He developments. on patent comments frequently “the same A A similar Bishwanath “Had the document the “Had F. Roche Hoffmann-La F. “…whether “…whether the alleged M/s. Bishwanath Prasad RFA(OS) 92/2012, wherein 92/2012, RFA(OS) age 25 Page :12 11 in other words, the obvious to words, in other case (supra) (supra) case F. Roche Hoffmann-La v.Ltd.F. Cipla Bishwanath wherein the wherein Court on relied the Though usually adopted by the examiners, it is it examiners, the by adopted usually Though Whilst looking for the judicial interpretation CTC Legal Media CTC Legal pertinent to understand that while applying the hindsight approach it is essential to understand that one must avoid the approach as laid down the in regarding regarding the applications in India, there are only a handful of inventiveness cases, and only one by of the Hon’ble Supreme Court in patent the case of Industries. Metal Hindustan M/s. v. Shyam Radhey The Court stated that minor modification in the any to obvious it make would invention patented available knowledge the on based worker skilled at the date of the patent. About “inventive step” the Supreme Court laid down principles that need the to be kept in mind. For the following determination, several forms of the question have been suggested was what of track the of out much so lies discovery a to itself suggest to naturally not as before known person thinking on the subject, it must not be the obvious or natural known”; suggestion previously of what patent the that check to tested been was has test try in question lacked Court High Delhi the inventive by used been has approach step. A similar in the case of Ltd., case (supra) case and observed that read be cannot art) the in skilled ordinarily (person the in qualities other exist to has there that mean to person the of nature un-imaginary like person said qualities...”. distinct having person of kind other any or example of such an invention would be the case the be would invention an such of example an purification is enantiomer obtained by whereby consideration the Similarly, mixture. racemic a of for “obvious inventions pharma/bio-pharma for to misunderstood try” approach despite the is fact expected largely outcome in product that and formulation the technology development is the unpredictable. Additionally, and inherently as interpreted are inventions formulation obvious concerning choosing excipients and the assuming that variable not is again which predictable, be would efficacy the result for experiments. without conducting possible been placed in draftsman the (or engineer as distinguished hands from a of with the common general artisan), endowed mere a competent knowledge at the ‘priority who date’, was faced with the problem solved by without knowledge the of the patent would invention, patentee but have arrived was interpretation held in at the Cipla v. Ltd. Anr. & Ltd. invention”. the High Court held that, while conducting an inquiry into impermissible; the legal conclusion obviousness, must be reached on the basis of facts gleaned from the hindsight is 16/1/20 1 t s:Layou Orbi Lex CTC Legal Media CTC Legal Whilst examining these inventions, the Indian conjugates; pure forms; particle size; complexes, size; particle forms; pure conjugates; isomers, and Also, mixtures thereof. claims may be drafted kits, for selection inventions, process or method, and inventions. product-by-process Since these inventions have different stylesof claims to the cover nature of the invention, the obviousness issue is usually checked by evaluating by checked usually is issue obviousness the combined prior arts and checking what a skilled person would extract from the available knowledge and its In interpretation. general, the invention must be considered as person a of ability the a beyond is it whether whole check to perform. skilled in the art to examiners usually check various factors, reasonable the approach, hindsight not the to limited expectation of success, and “obvious factor to apart try” from the technical advancement, which is generally considered in the form identification of of problema and its solution, or unexpected results obtained by the proposed approach hindsight the of application The invention. by the examiner is common in such inventions to polymorph a the relates where new invention or a novel formulation with varying excipients, and different modessustained- of delayed-release, as such mechanisms delivery release or etc. in release are question. It is the assumed by and obvious are inventions these that examiners to the Contrary can retrospectively. be prepared said assumption, developing a new product or formulation is not the fact based on remains mere theory; intensive that experimentation are trial also required in and error getting and a useful a invention. Further, reasonable the in examined usually is success of expectation or teaching any having not art prior the of context the in invention present the attempt to motivation absence of undue experiments. A classic Pankaj Musyuni Pankaj Rajeev Kumar Rajeev age 24 Page :11 11
THE LIFE SCIENCES LAWYER he Indian important an has industry pharmaceutical pharmaceutical and bio- position in providing medical and
inventive step and the ways of establishing it. of ways and the step inventive Rajeev Kumar and Pankaj Musyuni of LexOrbis discuss the importance of the discuss the importance of LexOrbis of Musyuni and Pankaj Kumar Rajeev In India, patent protection is available subject Claims in pharma/bio-pharma inventions are alternative alternative therapies worldwide. Both sectors have the potential advanced and cost-effective supplies globally to provide and to work in parallel to the provide an optimum most solution. ongoing Additionally, research in the pharma/bio-pharma sector for combating to to the establishment patentability criteria of novelty, inventive step, of the and capability of pre-requisite industrial application for any invention, whether product or process. Among these criteria, establishing an step inventive is a must invention the that implies which benchmark not simply be development of an what obvious the Consequently, said criteria is are much harder and already alternate available. to comply with, and exist to establish the right balance, promoting inventions and and avoiding undesirable ensure monopolies To inventions. for unworthy rewarding patent real this, India adopted a Section under step 2(1)(ja) of assessing inventive peculiar definition for the Patents Act, inventions whereby are judged technological the of establishment the on based both. or significance, economic advancement, usually directed to new cover chemical entities, compositions/formulations, technology-based dosage combinations, specific as such inventions forms, new forms of known substances such as salts, ethers and esters; polymorphs; solvates, including hydrates; clathrates; stereoisomers; enantiomers; metabolites and pro-drugs;
diseases is vital for public health and, subsequently, and, health public for vital is diseases patent protection is equally important for the researchers. inventions in India inventions pharma and bio-pharma and pharma inventive step for step inventive Understanding the Understanding INVENTIVE STEP INVENTIVE 24 T
16/1/20 1 t s:Layou Orbi Lex LexOrbis:Layout 1 16/1/20 11:12 Page 26
INVENTIVE STEP
prior art and should not include knowledge gleaned from patent non-obviousness of a pharma/bio-pharma invention. In general, disclosure. Teachings in the prior art document have to be the identification of a problem and providing a solution can be considered as a whole. Teachings away from the patent claim the invention wherein the inventive step resides in the are treated as non-obvious. To inquire into obviousness, two-fold identification of a previously unappreciated and unrecognized inquiry is required i.e. motivation to select and motivation to problem. While the solution to the problem might be obvious modify. once the problem has been identified, the invention might In addition, the test for obviousness has been precisely dealt nonetheless be nonobvious if, upon examination, it is identified with in case of Hoechst v. Unichem Laboratories and Ors, wherein that the invention would have been obvious to a person skilled the Bombay High Court held that “... an invention usually involves in the art before the inventor identified the problem. three stages, (1) the definition of the problem to be solved, or the Though the patents are subject to the territorial regime, it is difficulty to be overcome, (2) the choice of the general principle to also essential to have them consistent with public health be applied in solving the problem overcoming the difficulty; and (3) strategies and the economy. Patents are considered a the choice of the particular means to be used... merit in any one of fundamental incentive to innovative activities in the pharma and these stages, or in the whole combined, may support the invention, bio-pharma sectors; hence they need to be safeguarded. Of late, and it is, therefore, probably more important to consider the India has been witnessing an increase in patent enforcement advance in knowledge due to the inventor rather than to examine activities and patent filings. As evident from the annual report of in detail the variations from the former product”. In another 2017-18 published by the Office of the Controller General of important matter of F. Hoffmann-La Roche Ltd & ANR versus Cipla Patents, Designs, Trademarks and Geographical Indications, RFA (OS) Nos.92/2012 & 103/2012, the Court identified some India, there was an increase of 5.3% in the overall filing of patent steps to determine obviousness/lack of inventive steps to be applications. That said, the report further indicated that the total conducted, which include: number of patents granted during the year was 13,045. Out of (1) to identify an ordinary person skilled in the art; the total granted patents, 3,318 patents were granted to (2) to identify the inventive concept embodied in the patent; applications relating to chemicals, 773 to pharmaceuticals, and (3) to impute to a normal skilled but unimaginative ordinary 505 to the biotech domain. Further, along with various initiatives, person skilled in the art what was common general the Indian Patent Office continually works to reduce the backlog knowledge in the art at the priority date; and expediate the examination procedure. (4) to identify the differences, if any, between the matter cited Upon a random analysis of the decision issued by the Patent and the alleged invention, and ascertain whether the Office, it appears that analysis of the inventive step for differences are ordinary application of law or involve pharma/bio-pharma inventions is primarily subjective. One various different steps requiring multiple, theoretical and major reason for different opinions would be the differing subject practical applications; and matter expertise of the examiners. Sometimes, the data (5) to decide whether those differences, viewed in the disclosed and presented in the specification is the primary knowledge of alleged invention, constituted steps which reason for biased interpretation. would have been obvious to the ordinary person skilled in While understanding that inventive step is the most common the art, and thus rule out a hindsight approach. issue raised in prosecution and litigation, assessing inventive Among other examples in a judicial context, whilst analyzing step, examining the prior arts, identifying the differential features, the inventive step, another famous case for the test of and defining the skilled person are the primary concerns for obviousness was decided by the Intellectual Property Appellate examiners and patent practitioners which are still open for wide Board in Enercon vs Aloys Wobben ORA/08/2009/PT/CH, Oder and varied interpretation. Going forward, more clarity, and refined No. 123 of 2013. In particular, paragraph 43 of the decision tests on the assessment of the inventive step are expected, as explains that that the "coherent thread leading from the prior art the number of cases filed and decided in this regard increases. to the obviousness" or, in other words, "the reasonable expectation of success embedded in the prior art which motivates the skilled person to reach to the invention, is the most crucial determining factor in ascertaining inventive step". In India, the evaluation of the technical advancement of patent applications is somewhat clear, focusing on exhibiting technical advancement of the claimed invention and consideration of economic advantages or advancements alone or together. Although factors such as reducing the manufacturing costs, operational costs and maintenance costs involved in any product Contact: LexOrbis development or employed process are also essential, they are Address: 709-710 Tolstoy House, 15-17 Tolstoy Marg, influential in the case of a proposed invention that is technically New Delhi -110001 weak when comparing with prior arts. Additionally, the outcome Pankaj Musyuni of the invention as an unexpected result is helpful even when it Email: [email protected] might appear that it would have been obvious to choose the Tel: +91 8750597345 combination of excipients at the time of invention. Further, Rajeev Kumar an invention is not obvious if it produces results that would not Email: [email protected] have been expected before the researcher started testing Tel: +91 9911758776 the invention. Such results will often be the basis for the
26 THE LIFE SCIENCES LAWYER CTC Legal Media
LexOrbis FP.indd 1 21/01/2020 16:02 LIFE SCIENCES PATENTS 29 THE LIFE SCIENCES LAWYER procurement, product development, product procurement, jurisdiction over patent appeals in the United States, addressed claims directed to “[a] pair of single-stranded DNA primers for determination of a nucleotide sequence of a BRCA1 gene a by polymerase chain reaction … wherein the use of said primers in a polymerase in results the chain synthesis having or part DNA all of reaction of the sequence of the The BRCA1 gene”. Court found that the claimed primers are “necessarily strands DNA of ends the to identical structurally … found in nature” and held the patent claims to cover patent ineligible subject matter. BRCA1- and In BRCA2-Based re Hereditary Cancer 2014). Cir. (Fed. 755 F.3d Litig., 774 Patent Test Résumé G. Rosenbaum David practice law property intellectual an extensive has developed David 500 Fortune to start-ups from clientele wide spectrum of a representing rights intellectual in corporations in counsels clients litigation. He and strategic handling transactions and supervises due diligence and matters property intellectual complex and strategic and acquisition licensing, mergers for positioning reviews value building and enhancing of with the result all development, product has represented Rosenbaum assets. Mr. property intellectual clients’ of applications patent a thousand domestic and foreign over well clients in $1.7 over companies in generating represented and has successfully licensing and litigation activities. acquisition, merger, from value Billion in Dunn, A., BioPharma Dive, Dunn, 13, 2018. August United States Patent and Patent States United Office, Patent Trademark Monitoring Technology to 1/1/1992 Report Team 12/31/2013. Id. United States Patent and Patent States United Office,Patent Trademark Monitoring Technology to 1/1/1996 Report Team 12/31/2015. 4 1 2 3 age 29 Page :17 11 569 U.S. 576 (2013), the U.S. Supreme U.S. the (2013), 576 U.S. 569 [comprising the BRCA1 and BRCA2 Association for Molecular Pathology v. Myriad v. Pathology Molecular for Association In Applying Applying the reasoning of the Myriad Court, CTC Legal Media CTC Legal set forth in SEQ ID No. 2”. 569 U.S. at 584. The Court The 584. at U.S. 569 2”. No. ID SEQ in forth set to drawn were claims concluded that the patent ineligible subject matter under 35 U.S.C. §101, finding that “thenucleotides location order and of the human growth human hormone, growth erythropoietin and the the at appear patents matter of Composition like. heart of the controversy and eligible in subject the matter biotechnology concerning patent fields. pharmaceutical the United States Court of Appeal for the Federal the for Appeal of Court States United the Circuit, the appellate court having exclusive genes] existed in nature before Myriad found them. … Myriad’s principal uncovering the contribution precise was location and sequence genetic of the BRCA1 and BRCA2 genes separating … that gene genetic material is not an from act 569 of invention”. its surrounding U.S. at 590-91. Other claims directed to BRCA be to patent found were in contrast, were, cDNA eligible subject matter because they related to “creation of a cDNA results sequence in an from exons-only molecule mRNA that is at 594-95. not 569 U.S. occurring” naturally Genetics, Inc. claims patent of patentability the evaluated Court a BRCA1 coding for DNA isolated “an to directed sequence acid amino the has which polypeptide, 16/1/20 t 1 ayou L baum: Rosen CTC Legal Media CTC Legal . 4 Life Life sciences companies are faced with a hose derived from combining different genetic underpinning the growth technologies. The lifeblood of life pre-revenue of life sciences sciences companies is dependent typically is capital Investment capital. typically investment portfolio patent the of scope and nature the upon capital The investment the company. by created supports the and which, research development, the enhance that inventions new creates turns in patent portfolio and enterprise value sciences Life have industries typically company. of the research on spending of percentage highest the example, For revenue. total of and development in 2016, the pharmaceutical and biotechnology on revenue of 15% approximately spent industries minefield of uncertainty increasing R&D with expenditures patents. This protecting in their Composition of matter matter Composition of claims patent matter of compositions to directed claims Patent including vaccines, or drugs for filed generally are t insulin, to pertaining patents are Examples material. research and development. In 2017, pharmaceutical 2017, In development. and research companies alone spent 21.4% of and development revenue research on changes of been the result has largely uncertainty matter subject patent-eligible of landscape the in in the United States. In the United States, patent subject matter eligibility of life science-related into called been has §101 U.S.C. 35 under patents question by certain decisions from the United of decisions follow-on and Court Supreme States the United States Court subject patent surrounding Issues Circuit. Federal of Appeals for the matter eligibility have primarily affectedpatents having composition of matter and/or method claims. ” The enterprise of value for patents sciences life companies be cannot understated. David G. Rosenbaum David “ , 1 , and 2 age 28 Page :16 11 . In the biotechnology field, alone, 3 hile most of us think of patents as covering mechanical items such as items, electrical engines, combustion
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difficulties and uncertainty facing those who wish to register patents in the patents register to wish who those facing difficulties and uncertainty sector. science life David G. Rosenbaum, founder and chairman of Rosenbaum IP, discusses the IP, Rosenbaum and chairman of founder G. Rosenbaum, David The enterprise value of patents for life sciences life for patents of value enterprise The More recently, More from recently, 1992 to 2015, the United patents patents granted in the United States grew at a a is which 2000, to 1990 from year per 15% of rate 300% growth rate when compared to during grants patent the overall in rate 5% growth annual the same period. companies cannot be understated. Simply put, patents are the driving economic force such as integrated circuits, or chemicals, such as such chemicals, or circuits, integrated as such polymers, they also cover a wide spectrum of science Life sciences. life of field the in inventions is a broad field encompassing, among others, biotechnology, pharmaceuticals, biomedical technologies, life processing, food cosmeceuticals, nutraceuticals, systems devices, biomedical technologies, environmental technologies, cell engineering, biomedical imaging biomedical and proteomics genetics, neuroscience, biology, tissue engineering. biotechnology inventions have been sought for Patents pertaining over 150 years. For to example, on 29 July 1873, method yeast-making his patented Pasteur Louis the 1969, June 26 On Office. Patent French the at Fabrik Soda & Anilin Badische company fledgling 210,992 210,992 patents on medical devices manufacturing cotton-based textiles. Subsequently textiles. cotton-based manufacturing BASF obtained patents for the well. as blue and eosin dyes, methylene syntheses of States Patent and Trademark 166,189 patents Office on biotechnology inventions issued (BASF) filed a British patent for a synthetic process synthetic a for patent British a filed (BASF) for producing the red dye alizarin, a red derived from dye the madder plant root, for use in life sciences patents life state of uncertainty of uncertainty of state Understanding the Understanding LIFE SCIENCES PATENTS SCIENCES LIFE 28 82,238 patents on nucleotide and amino acid sequences W
16/1/20 t 1 ayou L baum: Rosen LIFE SCIENCES PATENTS 31 Contact: nancing state state of uncertainty in THE LIFE SCIENCES LAWYER Direct Tel. 847-770-6010 Tel. Direct ce Opposition Appeal Board. [email protected] [email protected] It is clear that patent law reform on this issue is issue this on reform law patent that clear is It evaluating evaluating what patent applications to file, how to frame claims in those patent applications, evaluate the validity of already issued patents under the current framework, and assess how affects eligibility patent of framework current the strategy. enforcement patent any both both underway and garnering a high degree of momentum. the For time those being, however, of us in the Life Sciences, account must for the present continue to on a draft bill introduced by Senators Chris Coons Chris Senators by introduced bill draft a on part as 2019, May in (R-NC) Tillis Thom and (D-DE) The law. patent U.S. reform to effort bipartisan a of draft bill, which has bipartisan support, came after months of discussions with stakeholders, inventors individual and representatives, industry patent surrounding law patent clarify to aim who eligibility. subject matter David G. Rosenbaum, Founder & Chairman 847-770-6010 1480 Techny Road, Northbrook, Illinois 60062 USA Northbrook, Road, Techny 1480 [email protected] 2019 Revised Patent Subject Patent 2019 Revised Guidance Eligibility Matter 50, 2019) and Reg. (84 Fed. 2019 Update: the October Eligibility, Subject Matter https://www.uspto.gov/site s/default/files/documents/ peg_oct_2019_update.pdf. Contact: David G. Rosenbaum, Rosenbaum IP, P.C. IP, Rosenbaum G. Rosenbaum, Contact: David Address: Email: Tel: Direct See, Comments of the See, Comments of Research Pharmaceutical of and Manufacturers America (PhRMA), www.uspto.gov/sites/defaul t/files/documents/commen at ts_PHRMA_Jan182017.pdf citing Endo 5-6, Actavis, v. Pharmaceuticals Del. Nov. (D. Inc., No. 14-1381, No. 2018-1054 aff’d, 2015), 17, 2019). Cir. (Fed. rm having a speciality in life sciences technologies. Our focus is 5 6 ce Opposition Division and European Patent Offi ce Opposition Division and European rm have prepared, or prosecuted thousands of domestic and foreign patent applications, patent applications, thousands of domestic and foreign or prosecuted rm have prepared, age 31 Page :17 11 rm’s practice is client outcome oriented. In addition to its transactional intellectual property practice, the practice is client outcome oriented. In addition to its transactional intellectual property rm’s Address Road, 1480 Techny IL 60062 Northbrook, [email protected] 847-770-6000 Tel: rounds, merger and acquisition, licensing or litigation awards. merger and acquisition, licensing or litigation awards. rounds, The fi competition and unfair trade secret patent, trademark, copyright, clients in numerous Firm has represented clients in post-grant opposition proceedings litigation in State and Federal courts and successfully represented Patent Offi the European before Rosenbaum IP, P.C. is an intellectual property fi is an intellectual property P.C. Rosenbaum IP, estates. intellectual property developing our client’s on building enhanced enterprise value through therapeutics, medical devices, Life sciences technology competencies include pharmaceuticals, diagnostics, plant cellular biology, genetic engineering, microbiology, biomaterials, genomics, proteomics, biotechnology, fermentation, medical imaging, and pharmacology, neuroscience, molecular biology, immunology, breeding, biomedical science. Members of the fi rights, intellectual property and enforced competitive activity, monitored plans, implemented IP strategic growth fi in market value through that our clients have achieved over $1.7 Billion (USD) all with the result CTC Legal Media CTC Legal claim may integrate a judicial exception (a law of law (a exception judicial a integrate may claim into idea) abstract or phenomena natural nature, a practical application by applying or using it to effecta particular treatment foror a prophylaxis disease or medical consideration. By allowing patent applicants to claim a combination of a it of application practical a and exception judicial to a particular treatment or Guidance prophylaxis, the is consideration espoused by consistent the Mayo Court, as with discussed above. the second What lies ahead? directive offers Guidance the while Unfortunately, applications patent examining examiner patent to consistent with the surrounding patent eligibility, it does nothing to current either that reform jurisprudence jurisprudence or the statutory framework for determining patent Concerted eligibility. and largely cooperative effortsare being made by industry, the legal community, Trademark and Patent U.S. the and legislature the Office to address the uncertainty interjected by matter subject patent on decisions judicial recent eligibility. The Senate Patent of State “The about hearings held recently Judiciary Committee Eligibility in America”, focusing centered hearings The 101. § U.S.C. 35 to reforms on potential 16/1/20 t 1 ayou L baum: Rosen CTC Legal Media CTC Legal ). In response to 6 es, or substances that do that substances or es, natural natural correlations into e of how a compound is tment tment claims could be at risk courts have fueled concerns of . 5 Step 1. Is the claim directed to a process, machine, manufacture machine, process, a to directed claim the Is 1. Step With respect to diagnostic method claims that only include Step Step 2. Step two is a two-part analysis to whether determine Step 2A. Is the claim directed to a law of nature, natural Step 2B. Are any element or combination of elements in the As it relates to method claims, the new Guidance includes a the Mayo decision, patent examiners have been directed to whether a claim consider patent-eligible subject covers matter analysis: a three-step §101 employing 35 U.S.C. under the “claims inform a relevant audience about certain laws of routine, well-understood, of consist steps additional any nature; conventional activity already not are steps the engaged that believe we reasons these in For … community by the scientific sufficient transform to unpatentable at 79-80. 566 U.S. those regularities” of applications patentable steps for identifying a characteristic or disease ineligible. patent uniformly in almost be to these a found have courts patient, method claims, Treatment particularly those including method that theory the on well as risk at are treatment, pharmaceutical of all treatments are based upon have step, diagnosis a without or a with whether claims, treatment law of nature. Method of but some better, district fared court decisions such found have claims ineligible or, at least, “directed to” matter. In ineligible the process, subject these some in the pharmaceutical pharmaceutical method industry of trea who fear nearly because, all at some level, all treatments are based on natural phenomenon of of composition of matter? If the answer is no, the claim is not is answer the If rejected. be should and eligible patent deemed 2. step to proceeds the analysis yes, a claim that is to directed additional a recites exception judicial elements that constitute significantly more than the judicial exception, i.e., claim significantly more than a law nature, of natural phenomenon or abstract idea. As it relates to the Life phenomenon include natural or naturally nature Sciences, of laws occurring principles, such as physical, chemical or biological substanc occurring naturally principals, not have different characteristicsmarkedly comparedto what DNA, a these include, an isolated of Examples occurs in nature. correlation that is the consequenc metabolized, or a chemical principle water. elements and underlying fatty between the union patent deemed is claim the no, If idea? abstract or phenomenon, based patentability for continue should examination and eligible directed are Examiners the yes, If grounds. statutory other upon 2B. Step to proceed to significantly to amounts claim the that ensure to sufficient claim more than the judicial exception? If no, the claim is deemed patent ineligible. If yes, the claim qualifies as eligible subject matter and patentability of the claim is determined on other grounds. statutory “treatment/prophylaxis” consideration under which a patent Recent efforts to clarify to clarify efforts Recent eligibility subject-matter The United States Patent and Trademark Office has recently the conundrum eligibility by created subject-matter addressed Courts and made effortsto clarify subject matter eligibilityfor patent examination purposes (the “Guidance” ations of certain metabolites in 566 U.S. 66 (2012) evaluated the age 30 Page :17 11 United States Supreme Court in Mayo Collaborative Mayo in Court Supreme States United
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The Mayo Court extended their analysis to address the In 2012, the 2012, In to qualify as patent-eligible processes that apply natural laws....” natural apply that processes patent-eligible as qualify to that process a describe not did claims subject the that finding In apply natural laws, the Court held that the that held claims Court were Mayo The also standard. this meet to failing as invalid statements of the correlations to allow the processes they describe they processes the allow to correlations the of statements 6-thioguanine to a subject with such disorder; and (b) determining and (b) with such disorder; a subject 6-thioguanine to that recited further and subject; said in 6-thioguanine of level the per pmol 230 about than less is 6-thioguanine of level the where 8×108 red blood cells, this indicates a need to increase amount of the the drug being administered and where the level is greater than about 400 pmol per 8×108 red blood cells, In administered. this being amount the decrease to need a indicates to directed being as invalid were issue at claims the that finding the nature, of law a to pertaining matter subject ineligible patent Court found that the claims “set forth laws of nature - namely, relationships between concentr the blood and the that likelihood a dosage a of thiopurine drug will prove ineffectiveor consequence of cause the ways in which thiopurine compounds are harm … 566 U.S. processes”. the natural metabolized – by body entirely The relation is a at 77. question whether the patent claims “add enough to their validity validity of patent claims directed to methods of therapeutic optimizing efficacyfor treatment of comprising: disorder gastrointestinal (a) administering the drug an immune-mediated Patent claims that are directed to methods or processes relate to relate processes or methods to directed are that claims Patent the steps by which something is manipulated, example, pertain a claim process may For synthesized, purified.or extracted to a method which by a gene is extracted or manipulated or a administered. or which a drug is synthesized by process Servs. v. Prometheus Labs Inc. Method patent claims patent Method LIFE SCIENCES PATENTS SCIENCES LIFE 30
16/1/20 t 1 ayou L baum: Rosen PLANT PROTECTION 33 THE LIFE SCIENCES LAWYER Résumés Gilbert Penny Dr a London- Gilbert LLP, Powell of Partner Gilbert is a founding Penny Dr in has a degree Penny firm. law Property based specialist Intellectual University. Oxford from Biology in Molecular and DPhil Biochemistry sciences and represents litigation in the life in patent She specializes and Supreme Appeal Court, Court of Patents the UK clients before in referrals clients in CJEU and EFTA Court. She has also represented in advising on multi- experience of wealth SPCs. She has a to relation litigation strategy. jurisdictional William Hillson Dr William Gilbert LLP. at Powell Associate William Hillson is an Dr Birmingham of the University from a BSc in Biochemistry obtained as qualifying before University Oxford from in Immunology and a DPhil litigation patent includes multi-jurisdictional His experience a solicitor. and validity / SPC patent including sciences sector, in the life management. lifecycle patent on and advising infringement analysis age 33 Page :09 11 A A coalition of anti-GMO organizations had CTC Legal Media CTC Legal argued argued that it should be subject to stringent The CJEU’s decision on gene The CJEU’s or evolution editing – natural mutation? aberrant an One of the biggest risks of codifying restrictions on new technologies in legal texts is that they circumvented be (or inadequate rendered be may entirely) by subsequent as technology, alternative avenues are opened developments up in by new discoveries. The highest CJEU court) recently had to grapple with one (the EU’s decide to asked was It C-528/16. case in issue such whether modern gene editing techniques (such within encompassed be should CRISPR/Cas9) as the EU’s stringent restrictions on Genetically originally were which (GMOs), Modified Organisms designed to regulate the older “transgenesis” techniques involving the another. to one organism from genetic material direct transfer of 22/1/20 1 t t:Layou er & Gilb ll Powe CTC Legal Media CTC Legal This development has not gone unchallenged, gone not has development This II and most recently in Syngenta (dark green These peppers). concerned the of interpretation of patenting the prohibits which EPC, 53(b) Article not (though varieties animal or plant multicellular biological “essentially as well as micro-organisms) processes”, language which is mirrored in the EU’s own Biotech Directive. The EU (and most that assumed years many for had commentators) this meant that the products of such processes, as well as the processes themselves, could not be following the patented. decision However, in different, a taken has EPO the II, Broccoli/Tomato which in approach, the literal more are products patentable, but the maintained if for processes wordplay, mere not is distinction are not. This liberalizing significantly of effect the have would it European patentability rules by obtained an organism of the patenting principle) allowing (in cross-breeding. conventional by with the EPO being censured by the European the Parliament from and, in part due pressure to European Commission, changing its own interpretive rules to explicitly rule out the patenting the out rule explicitly to rules interpretive processes”, biological “essentially of products of only for their rule change incompatible with itself the EPC to by the be EPO’s own held tribunals. The EPO President’s latest appeal can be seen as an attempt to reverse this decision and bring the EPO interpretation preferred of Article 53(b). If it fails, into line with amend to be would recourse remaining only the the EU’s the wording of the EPC Conference a require would it that itself, given prospect a challenging of the EPC’s members (which include countries that are not members of the EU) and a vote by reasons, these For favor. in them of quarters three review Board’s Enlarged EPO the of outcome the of the issue may future. the foreseeable for argument be the final straw in the Dr Penny Gilbert Penny Dr Hillson William Dr In and age 32 Page :22 11 ty ty rights and the safety
THE LIFE SCIENCES LAWYER urope urope has long relationship towards the had biotechnology an sector, at times seeming to give with one ambivalent
LLP look at the tensions and controversies caused by the thorny issue of the thorny caused by and controversies look at the tensions LLP rights. IP plant European Dr Penny Gilbert, Partner, and Dr William Hillson, Associate, Powell Gilbert Powell Associate, Hillson, William and Dr Gilbert, Partner, Penny Dr The controversy stems from a series of hand and take with the other. In a continent where continent a In other. the with take and hand many countries take pride in their agricultural traditions and there is frequently a deeply felt national and production food between connection recent years the debate over the proper scope of scope proper the over debate the years recent plant patents, plant varie of new gene editing technologies have all found all have technologies editing gene new of their way before European courts. While both have liberalizers and restrictionists biotechnology scored important recent victories, as we shall certain. from far remains outcome see, the final While the European Union (EU) and the European the and (EU) Union European the While origins their have both (EPO) Organization Patent harmonization, European of project common a in they remain separate organizations and do not always see eye-to-eye. Rarely has this been more starkly illustrated than in controversy over the patenting the of “products of ongoing essentially biological processes”, seen the recently President of the which EPO take the has extraordinary step of appealing to the highest EPO’s tribunal against a decision taken by its one a serious is situation The officers. judicial own for the agricultural and biotechnology sectors – of provision key a is stake at ultimately is what for EPO’s the (EPC), Convention Patent European the “constitution” and governing treaty for patents Europe. much of throughout decisions the patentability by vegetable-related Broccoli/Tomato cases joined the in starting EPO, How a tomato divided the EU a tomato How and the EPO identity, the issue of intellectual property protection property intellectual of issue the identity, for innovations in plant modification discord? Europe: seeds of seeds Europe: Plant protection in protection Plant PLANT PROTECTION 32 cultivation cultivation have particularly proven contentious. E
16/1/20 1 t t:Layou er & Gilb ll Powe PRECISION MEDICINE IN TAIWAN 35 THE LIFE SCIENCES LAWYER Mr. Lu-Fa Tsai Lu-Fa Mr. an attorney-at-law Tsai, Lu-Fa Mr. Law the Department of from graduated (NTU), University Taiwan National of Taiwan. in school which is the best law he in business law, the interest Out of of Law of Institute the Graduate attended the LL.B. had obtained he NTU after his LL.M. degree and received degree he before year One years. three after he institute, the graduate from graduated has Tsai Mr. examination. passed the bar the from also gained an LL.M. degree of the University of Law of Faculty study of The field in Germany. Göttingen economic is international this degree of Germany, he came back from After law. Attorneys-at- he joined the Deep & Far at lawyer as a partner working is He Law. the firm currently. Résumés Tsai Yu-Li Mr. Bachelor’s a received Tsai Yu-Li Mr. Electrical the Department of from degree Taiwan the National of Engineering degree (NTU) and a Master’s University of Institute the Graduate from He NTU. of Communication Engineering from degree Master’s an IP also received Center Pierce and the Franklin UNH Law the Right after Property. Intellectual for to he had an opportunity graduation, a for Inc. in Delaware InterDigital, for work majoring is concurrently short period. He Tong Chiao in National master a law the received Tsai Mr. University. Attorney Patent Taiwan of qualification also passed He Agent. and China Patent US and Examination. Mr. Lu-Fa Tsai Lu-Fa Mr. Mr. Yu-Li Tsai Yu-Li Mr. in ” work age 35 Page :31 11 iming at supporting the medicine National trend in Taiwan, the precision Health Research Institutes and Roche Mr. Yu-Li Tsai and Mr. Lu-Fa Tsai of Deep & Far Taiwan look at a recent Taiwan Deep & Far of Tsai Lu-Fa and Mr. Tsai Yu-Li Mr. Health National Taiwanese the between understanding of memorandum giant Roche. healthcare and Swiss Institutes Research The MOU was signed by President Liang, In the future, Roche will devote their resources their devote will Roche future, the In signed a memorandum of understanding (MOU) understanding of memorandum a signed on 14 November will 2019. cooperate to The genomic promote two comprehensive profiling, parties establish and mechanisms, medication medical establish personalized a national health and medical gene database, etc., so as to accelerate Taiwan’s biotechnology and the medical industry integration of market. the international into Geng Yi of the Institutes Ling and of Yan General Manager Xu, National Health Minister of witness the in Taiwan, Research Pharma Roche Chen, Shi Zhong of the Ministry of Health and and Vice Welfare President Ron Park of Global Pharma. Roche of Healthcare Personalized CTC Legal Media CTC Legal with the National Health Research Institutes The two parties will cooperate to cooperate will parties The two genomic comprehensive promote personalized establish profiling, medication mechanisms, and medical health and a national establish gene database. medical to to supporting specific will and profiling, genomic comprehensive cancer patients via Precision medicine Precision Taiwan in the following four directions: four the following A “ 16/1/20 t 1 ayou ar: L d F eep an Deep CTC Legal Media CTC Legal Perhaps due to this greater flexibility, there has there flexibility, greater this to due Perhaps “research exemption” in patent law, is broader in is in broader patent law, exemption” “research scope. been surprisingly little case law from the CJEU on the limits of PVRs, decision making in its C-176/18 eagerly upcoming anticipated. The case a whether concerns farmer the question of who purchased and planted clementine tree saplings that were, at the time, the subject of a PVR application subsequently trees. those from fruits the selling infringed by PVR granted the The EU do acts such that is CJEU the to Advocate recommendation General’s (non-binding) The future – a need for root and root – a need for The future reform? branch As the above cases illustrate, developments in food- (especially plants to applied biotechnology bearing crops) remain in with intertwining Europe, broader controversy an area of concerns about food security, globalization and intense be will there that likely seems It power. corporate further legal challenges and, most likely, durable a the before legislation modernized for need it But issues. these on reached be can consensus is worth remembering that in such situations, there is only so much that the law can achieve. The questions we technology should of or should not and allow, what the developments proper extent of the privileges in granted to ethical, and political, deeply are developers, their ones and it is ultimately in the court of public resolution. find their will opinion that they not infringe the PVR. First, because the legislative the because First, PVR. the infringe not history of the provisions show that the drafters did not intend the growing and harvesting of fruits to require authorization from the right- holder. Secondly, and more because the monopoly controversially, protection of the PVR only takes effectafter it has been granted (with the holder being entitled only to after-the-fact application the while done acts for compensation was pending). Although the CJEU often follows not is this General, Advocate the of reasoning the always the case (a notable exception was the gene editing case discussed above), and it is to long- some provide will CJEU the that hoped be overdue clarification as to the scope of these rights. important but often-overlooked ” Powell Gilbert LLP Powell [email protected] Email: Email: Contact: [email protected] The issue of The issue intellectual property protection for innovations in plant modification and cultivation proven have particularly contentious. “ age 34 Page :24 11
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To To the shock of many observers, the CJEU Forbidden fruit and Forbidden rights variety plant In the shadows of debates over plant the patenting, it headline-generating is sometimes operates, EU the that fact the of sight lose to easy unlike many areas of the world, a standalone intellectual property right cultivars, known as to a Plant Variety Right (PVR). protect plant Representing a differentmodel of incentivizing of some avoid potentially could which innovation, system, patent the regarding raised concerns the PVRs provide rights monopoly - have could they wish something probably many patentees over a new plant variety for following up to grant, 30 years rather application. there However, is a than catch – unlike following patents, PVRs allow explicitly the the cultivation of protected varieties in order to varieties develop new – conceptually similar to an the various types exception of which, while regulation, regulation, even though the edited organisms produced were in many cases indistinguishable naturally. occurred have could that mutations from The government French argued that, instead, it should be classed under an exemption to the regulations as a form of itself “mutagenesis”, a originally was that provision outdated somewhat techniques random wholly encompass to drafted of inducing mutations such therefore was CJEU The as DNA. treating chemically irradiating or put in the position of having to technology within place one of two legal a categories, new neither of which CRISPR in mind. like systems had been designed with the that holding groups, anti-GMO the with sided for used be only could exemption “mutagenesis” safety proven with technologies long-established records. What is most extraordinary about this judgment is that it assessment of the scientificevidence about was the not based on relative risk of the any new, targeted gene editing methods versus older random techniques, but approach “precautionary” generalized a on rather which presumes that all new developments biotechnology are potentially harmful unless highest EU’s the is CJEU the As otherwise. proven constitutional court, this represents a decisive and potentially long-term restrictionists, which victory is to likely chill investment for GMO or even force researchers activities to elsewhere conduct (leaving their aside concerns about whether the decision will even practical be enforceable, given that many gene-edited organisms cannot be distinguished from natural mutants). Of course, the given the but amended, be could itself regulation Directive on this GMO plate, EU’s the on currently tasks other many time soon. happen any to seems unlikely PLANT PROTECTION 34
16/1/20 1 t t:Layou er & Gilb ll Powe PRECISION MEDICINE IN TAIWAN 37 THE LIFE SCIENCES LAWYER Sheng, the subsequent combination of Deep & Far Taiwan Far Deep & www.deepnfar.com.tw 13th Fl., No. 27, Sec. 3, Chung San N. Rd., Sec. 3, Chung San N. Rd., 27, 13th Fl., No. [email protected] +886 2 2598 9900 +886 2 2585 6688 #8187 Cellseed, a listing company in Tokyo, first licensed overseas first licensed Tokyo, in Cellseed, a listing company Hu, The Li-San, chairman indicated of that MetaTech, with The chairman of CellSeed, Mr. Hashimoto, indicated that that indicated Yuan-Kun, Du, Hospital, E-DA the of dean The Taipei 104, Taiwan, R.O.C. Taiwan, 104, Taipei Contact: Attorney-at-law and Partner Tsai, Lu-Fa Address: Tel: Fax: Email: Website: regenerative therapy for brachial plexus or spinal cord injury. cord spinal or plexus brachial for therapy regenerative the cell sheet technology for esophageal cancer and knee cartilage to two MetaTech years ago, and joint-founded Ri year. Sheng this respect to the future development of nerve cell sheets of Ri nerve the of development the on concentrated be will it Sheng, cell sheets applied to the peripheral nervous system at the initial stage, whose indications include radial joint syndrome, stroke hemiplegia etc. The development of the nerve cell sheets applied long-term to the central goal will nervous which system, are used be to treat syndromes such as the spinal cord injury. of manufacture technology cell sheets, it can contract with Ri As MetaTech sheets. cell of the manufacture Sheng for owns the complete CellSeed has successfully developed products which obtained seven the marketing approval cell from the sheet Japanese PMDA. With the progress of laws and regulation in and Ri Sheng will combine Taiwan, the strengths of MetaTech CellSeed and integrate communities in Japan and in to Taiwan jointly the develop new power clinic applications of cell sheet engineering of to regenerative the to promoted be also will applications clinic new The medicine. academic the regions in Asia other than Taiwan so as to satisfy more needs. with unsatisfying medical markets potential he has been devoted to precise blood rehabilitation for the vessel past 30 years and and has achieved a dozen neural for therapy new a providing of purposes the for breakthroughs patients with spinal cord injury. The chances of success for brachial plexus rehabilitation were only 10% in the past. They are now raised to 85% by means of Du’s operation skill, but 15% of patients are still unable to Du recover. anticipates that with Ri cooperating by the hopeless. help bring hope to will medicine and science ed with other combination other with ed tment of liver cancer. liver of tment age 37 Page :32 11 At At present, the research on anti-cancer drugs is a global Chen, Rui-Lou, Song, has Taiwan that indicated An-Li Zheng, The first case where a Japanese enterpriseinvested in There is a chance that the Regenerative Medicine Act will The paid-in Ri of capital Sheng is NT$13 million. focus will It Zheng, An-Li indicated that compar that indicated An-Li Zheng, CTC Legal Media CTC Legal standard standard The therapy. research shows that the combination therapy can not only extend life, but also defer the influence the disease progression. caused by life of on the quality liver advanced for Only keen. is competition the wherein activity of results the trial, on are combination drug of types six cancer, which will be published consecutively next year, or the year drugs targeted the after that indicated An-Li Zheng, next. after of the standard therapy emerged, only two types of targeted the in line first the on used solely be to able proven have drugs tried challenge to this, people but have no Many years. recent new drug or new therapy which has for challenge first the was successfully This drugs. targeted surpassed traditional the combination first-line the for used were drugs immunotherapy and it has succeeded. cancer, liver advanced of therapy drugs, the PD-1 inhibitor have time this published anti-angiogenesis the of of drug targeted the immunotherapy and the anti-angiogenesis the of drug targeted This advantage. price a is an old drug (20 years), whose patent protection period is market, to come to about are biosimilars its and expire, to about inhibitor PD-1 The present. at combination cheapest the is it so of the immunotherapy is awaiting the US Administration’s Food and approval Drug and is expected the trea guidelines for international to rewrite the Ding-Xin and other international experts research. He is in the mood in for “standing on the shoulders of liver disease giants” to make an effortto the transfer research paradigmto drugs The new price of treatment. cancer liver of the research will fall in 10 or 20 years, but in the absence of the present research, there will be fewer options in the research cannot future, stop. He predicted that so with the progress in the in the carriage rate the decrease cancer, liver of the treatment of Hepatitis B and the eradication of Hepatitis C, liver cancer would gradually cease to be the “national years. 30 disease” within biotech in Taiwan: CellSeed and MetaTech formed a Ri Sheng company, venture joint come into force CellSeed next company, Japanese A year, Taiwan. in invest which to companies will encourage foreign (AP) Inc. Inc. (CellSeed), MetaTech company, and a Taiwanese announced (MetaTech), on 6 December 2019 that they had (Ri Inc.” Biotech Cell Sheng “Ri called company a founded jointly Sheng) and retain the former deputy dean of the Academia Sinca, Wang, Hui-Jun, to be Sheng. Ri by the owned be will future chairman. the in developed The technology cell sheet The patented technology can be commercial operation. This licensed is the first and time that aJapanese used for enterprise invested in the fieldTaiwan.of It cell therapy in is expected that the joint venture will lead the trend with the Act. Medicine Regenerative implementation of on the research and development of clinic various types of cell sheets. The first task isto application with cooperate of the dean It will of use Hospital, the Du, Yuan-Kun. nerve E-DA and combine the unique operation sheets cell MetaTech from skill created by Mr. Du (Du’s operation skill) to form a 16/1/20 t 1 ayou ar: L d F eep an Deep CTC Legal Media CTC Legal A breakthrough for the treatment of advanced of treatment the for breakthrough A The ESMO Asia 2019 Congress was held in The chief host for the global research who An- Zheng, Mr. by held trial clinical Phase The of comparison and tracking long-term a After create new opportunities for the future of Taiwan’s of future the for opportunities new create industry. medicine and biotech precision liver cancer after conducted 11 by team a Taiwanese shocked the years: how community international research Singapore from 22-24 November 2019. There therapy latest the for publication research a was of advanced liver There was cancer. no empty seat at the venue and the audience crowded outside of the venue, which made the speaker himself unable to enter the venue. The reason research the that was sensation great a such for results to be i.e. years, it 11 after a breakthrough represented published by was the found that speaker targeted if the surpass will effect the combination, two drugs are used greatly. therapy the standard drug of by was almost unable to squeeze into the venue was the University dean of the Taiwan National An-Li, Zheng, was Mr. the Cancer Center, same who the drug published person of the targeted standard therapy 11 years ago. At this historic moment, it is showed that not Taiwan only the global pioneer for liver cancer and prevention position key the in firmly stands also but control, of adapting guidelines in the the aspect of treatment of liver international cancer. treatment Li received a total of 501 liver cancer patients whose lesions the could not be Part ablated. of drug targeted the used solely first-line patients’ of the standard therapy (sorafenib), and part of the patients used by combination the PD-L1 inhibitor of the (atezolizumab) immunotherapy and the targeted drug of the antiangiogenesis (bevacizumab). the two groups, it was found that the effectof better. obviously was treatment combination the The median of the survival standard therapy is 13.2 months, periods and some of of the still are the combination therapy the patients of alive. It can be said that the survival periods of the combination median therapy is of the still undetermined. In the aspect of the side effect, the rate of reaction for having the patients serious of the adverse combination therapy is only 5%, which is 1% lower than the and and information science to create a environment for cancer patients, clinicians and quality medical overall care. It is hoped that the close cooperation between both parties will not only become an important model of international cooperation, but industry-academia also jointly drive the development of Taiwan’s medical testing and new drug research industry, and ” There is a There that chance Regenerative Act Medicine come will force into next year, which will encourage foreign companies in invest to Taiwan. “ age 36 Page :31 11 THE LIFE SCIENCES LAWYER
profiling or popularization of the related the of popularization or profiling the kind, including accelerating of testing and the and regulations laws of the review to benefits, so as health insurance of study medicine in precision meet the demand of the future; help cancer medication mechanism to the use to chances the get patients genetic for treatment corresponding mutations; sustainable of gene database in the nature other with it integrate to and development with the health databases national to and public, the of consent informed for norms the relevant formulate and industrial subsequent data release application; and and examination for as a reference health of and payment registration benefits. insurance
The National Health Research Institutes look Through this collaboration, the National Health National the collaboration, this Through
Research Research Institutes have demonstrated their longstanding capacity for both basic medicine Roche’s combine can They research. clinical and leading advantages in medicine, biology (1) genomic comprehensive promote to (2) medical personalized establish the to (3) health and medical establish a national to (4) evidence real-world the use of promote to to joint forward ofefforts both sidesto improve the quality of medical care for cancer patients medical personalized Taiwan’s create jointly and ecosystem. PRECISION MEDICINE IN TAIWAN MEDICINE PRECISION 36 16/1/20 t 1 ayou ar: L d F
eep an Deep PLANT INVENTIONS IN MEXICO 39 or product or product inventions, the inventions, that patents are available are that patents THE LIFE SCIENCES LAWYER , animal, or plant human, animal, or protect egarding plants. It states that: plants. It states egarding , whether a whether , invention any , provided that such exclusion is not is that such exclusion , provided treatment of humans or animals; humans or of treatment plants of the production for processes biological and than non-biological animals, other processes. microbiological than microorganisms. However, consistent with paragraph consistent However, than microorganisms. that confirms 3, each Party paragraph 1 and subject to are that inventions for least at available are patents plants. from derived patents available for for available patents that the provided technology, of fields , in all process and is capable step, an inventive involves is new, invention application. industrial of confirms Party each 1, paragraph new the following: one of claimed as at least inventions for a known using methods of new product, a known uses of product. using a known of processes new or product, patentability from exclude may Party A prevention within their territory of the commercial of territory within their prevention public order protect to which is necessary of exploitation to including morality, or or nature to serious prejudice avoid to health or or life the environment its by is prohibited the exploitation because made merely patentability: from also exclude may Party A law. (a) the methods for and surgical diagnostic, therapeutic, (b)and essentially than microorganisms, animals other Résumé Lumbreras Janett Degree, Chemistry-Biology has a Pharmaceutical Janett (UNAM), de Mexico Autonoma Nacional Universidad from to Access 1996, and has Diplomas in City, Mexico from Information Technological Scientific and Worldwide (UNAM), de México Autonoma Nacional Universidad from Law Property and Intellectual 2003; Industrial (UNAM), de México Autonoma Nacional Universidad Plant of System the UPOV to 2005; and Introduction from Convention the UPOV under Protection Variety Lumbreras Janett 2007. Academy, Worldwide WIPO Vega & Uhthoff, Gomez at Uhthoff, practice began her in 2000. She is an active department in the Patents S.C. of the Protection for Association the Mexican of member American Intellectual (AMPPI); the Property Intellectual College of (AIPLA); National Association Law Property A.C. Chemists Biologists, Mexico, Pharmaceutical in Chemistry, are Areas practice Her A.C.). (CNQFBM, and Biotechnology. Pharmacy, 4. plants other patentability from exclude also may Party A USMCA (United States-Mexico-Canada States-Mexico-Canada (United USMCA Agreement) The recent Agreement between United States, Mexico, and Canada includes in its Article r 20.F.1 matter subject patentable the considerations for 1. make shall 3 and 4, each Party paragraphs Subject to 2.with 3 and 4 and consistent paragraphs Subject to 3. practice Mexican In Mexico, plant protection could be requested via a patent grain, countries must grant patents grant must countries in the context of TRIPS has tered tered into force granting a from patentability: from “plant” “plant” cattle, minerals, mineral waters, beer, waters, mineral cattle, minerals, age 39 Page :37 11 system and flour. plants or animals, other than non-biological or than non-biological animals, other plants or procedures. microbiological Industrial property shall be understood in the broadest sense in the broadest be understood shall property Industrial but proper, and commerce industry to only not apply and shall all industries and to and extractive agricultural to likewise wines, example, , for products natural or manufactured fruit, leaf, tobacco flowers, However, Members shall However, provide for the protection of plant - and microorganisms, plants and animals except - of the production for procedures biological essentially The scope of the term The rights are granted to varieties that are new, distinct, Wild/natural Wild/natural species that were not improved by man are The Paris Convention does not regulate the exclusions of The main international legal framework considered for The TRIPS Agreement in Article 27 paragraph 3.b states that varieties either by patents, by means patents, by an varieties sui of by either effective generis a combination thereof. by or system uniform/homogeneous, and stable. uniform/homogeneous, been extended to include protection of mushrooms; bacteria plants, and viruses are not algae, included within this and scope, however. excluded from protection. protection. from excluded patentable matter. However, Article 1, Section 3 states that: states Article 1, Section 3 However, matter. patentable CTC Legal Media CTC Legal patenting plants in Mexico includes the following: includes plants in Mexico patenting also exclude may Members Sui generis system protection specific a have varieties plant that known is It established the by the Convention for International Protection 1961, December 2 on Paris in signed Plants, of Varieties New of Agreement This 1991. in and 1978 in 1972, in amended successively creates the Paris Union on (UPOV) Plant Varieties and obliges of basis the on Thus, varieties. plant protect to States signatory the 1978 Act of this Agreement, in October 1996, the Federal Plant Variety Law in Mexico en breeder's right to those who obtain a plant provided variety, stability and homogeneity, distinction, novelty, the meets it that requirements. should be clarified to which means: This creations. their protecting the of way appropriate innovators which would be the of the two would must requirements be complied with, and what is the scope of be the best protection in each case? The option table (left) can help to for see the forms. legal both them, between differences which Paris Convention The Convention of the Paris which is is Mexico a 1883 party, of of (CPU), Property Industrial Union for the Protection of an instrument that harmonizes intellectual property rights worldwide. Aspects Related TRIPS (Trade Rights) Property Intellectual of Section 5 of Part II of the TRIPS Agreement that stipulates section is This Patents. dedicated to for inventions (of products and technology, provided that processes) the inventions are in new, involve an all fields application. industrial capable of and are activity, inventive of 1 16/1/20 t :Layou off Uhth for CTC Legal Media CTC Legal not improved by improved not manipulation, t varieties protection, it 15 years minimum years 15 PLANT VARIETIES PLANT - novelty, - stability - should be there (seeds) Certification Service (SNICS) on Law Federal propagation material material propagation Plant Varieties Plant It is in our hands to establish a strong and and commercialization inventions, of have become topics biotechnological of debate in several forums. Nevertheless, this should not hinder the advancement of science, specifically biotechnology. of the field suitable legal framework effects side and that benefits the between equilibrium maintains an of new plant-related creations, while protecting at the same time the rights of innovators in this matter. International legal framework framework legal International plants in Mexico patenting between the interrelationship of view then, in Now plant patents and plan variety, and variety, must be a genetic there manipulation protection from result of an essentially an essentially of result method, biological no genetic - be a plant must not - purposes, practical for - species wild/natural excluded man are years 20 claims PLANT PATENTS PATENTS PLANT - novelty, - and step, inventive - applicability industrial - -- and distinctiveness, uniformity, be the must not Mexican Institute of Institute Mexican (IMPI) Property Industrial Inspection and Seed National Industrial Mexican Law Property DIFFERENCES BETWEEN PLANT PATENTS AND PLANT VARIETIES AND PLANT PATENTS DIFFERENCES BETWEEN PLANT SCOPE VALIDITY REQUIREMENTS EXCEPTIONS GOVERNMENT LEGISLATION OFFICE Janett Lumbreras Janett age 38 Page :37 11
THE LIFE SCIENCES LAWYER he development of it made has engineering, genetic particular biotechnology, in possible to design and subsequently crops or related wild varieties that pollinate varieties wild related or crops etc.; wind, insects, birds, by to resistance pests, to plants resistant viruses is indirectly diseases and generated; plants, with herbicide-tolerant example, use larger to free might feel farmers other get rid of herbicides to amounts of species; and that of example species, for of existence butterfly. the monarch would reduce the use of, and expenditure the use of, reduce would also mean would which on pesticides, and impact; less environmental and species. natural than those of adverse climate conditions; climate adverse
- biodiversity; loss of - conventional genes to displacement of -by making efficiency: antibiotic reduced - contamination, for chemical increased - the abilities threaten insecticidal increased the with along issues, relevant other and These - requirements; nutrient lower -which certain pests, to seed-resistance - performance; photosynthetic increased - products; agricultural of quality improved - characteristics nutritional with greater food when plants some new created, are However, - other or drought to resistance improved Janett Lumbreras, Senior Associate, Uhthoff, Gomez Vega & Uhthoff S.C, Vega & Uhthoff Gomez Uhthoff, Associate, Senior Lumbreras, Janett protection. IP of area important at an increasingly looks in detail disadvantages may arise: may disadvantages moral and ethical dimensions of the protection create create new plant varieties traditional instead techniques, of such using as well-known the that possible crossing is it While selection. and crossing or selection techniques cannot qualify created varieties plant new protection, patent for by genetic engineering likelihood that can new plant varieties increase requirements meet of novelty and the inventive the activity. Some advantages of the new plants are following: the
inventions in Mexico inventions Protection of plant of Protection PLANTMEXICO IN INVENTIONS 38 T
1 16/1/20 t :Layou off Uhth PLANT INVENTIONS IN MEXICO 41 @uhthofflawmx THE LIFE SCIENCES LAWYER Uhthoff, Gomez Vega & Uhthoff S.C. Uhthoff Vega & Gomez Uhthoff, www.uhthoff.com.mx Hamburgo 260 col. Juárez 06600, Juárez 260 col. Hamburgo [email protected] 52 (55) 55 33 50 60 ext. 1141 52 (55) 55 33 50 60 ext. www.uhthoff.com.mx Otherwise, the exclusion of sexual crossing and selection Mexico City Mexico Contact: Address: Tel: Email: Website: processes processes from patentability could be simply by circumvented pertain which adding to do the steps and not crossing properly the with dealing steps upstream either being process, selection preparation of the plant(s) to be crossed or downstream steps the from resulting plant the of treatment further the with dealing genetic for case the be will This process. selection and crossing engineering techniques applied to plants which differ conventional from breeding techniques, as through they the deliberate insertion modificationand/or of one work or primarily genes in a plant. more genome of the plant produced, so that modification the of that trait introduction is not the or result of the mixingof the process that then crossing, sexual for chosen plants the of genes not is consequently, and, breeding plant the of realm the leaves excluded This from patentability. principle applies where only the additional step is performed within the steps of sexually crossing and selection, independently from the repetitions. number of uhthoff, gomez vega & uhthoff, s.c. & uhthoff, gomez vega uhthoff,
uhthoff, gómez vega & uhthoff, s.c. & uhthoff, gómez vega uhthoff, Uhthoff.
& (a) specific plantvarieties and plant age 41 Page :40 09 uhthofflawmx start-up TO A COMPANY WITH YEARS IN THE A COMPANY TO start-up Method for providing a Solanum lycopersicum plant lycopersicum a Solanum providing for Method comprises said method yield, with improved introducing plant lycopersicum said Solanum the genome of into at least the promoter or the SP3D and SP3 gene, another pennelli or Solanum of sequence thereof, consisting of the group from species selected Solanum Solanum chmielewskii, neorickii, Solanum Solanum parviflorum, Solanum chilense, Solanum peruvianum. and Solanum pimpinellifolium NEEDS IN UHTHOFF, GÓMEZ VEGA NEEDS IN UHTHOFF, comprising crossing plants A (transgenic) and B (wild), and and B (wild), (transgenic) A plants comprising crossing X. marker having selecting progeny method). biological claiming the essentially rescue. embryo without claiming the method. method , YOU WILL FIND SOLUTIONS TO YOUR LEGAL WILL FIND SOLUTIONS TO YOUR MARKET, YOU Now, if Now, a process of sexual crossing and selection includes FROM A CTC Legal Media CTC Legal within it an additional step of a which nature, itself technical by introduces a trait into the genome or modifies traita in the 2. plant. a into trait (transgenic) X an of Introgression 3.X trait plants having of the production for Method 4. (without genetic markers new by plant characterized A 5. of the step comprising plant breeding for Methods 6. biological an essentially by the plant obtained Parts of Conclusion Plant variety protection of patents; and (b) plants at a co-existed generic more have level, decades in Mexico. for 1 17/1/20 t :Layou off Uhth ; CTC Legal Media CTC Legal crossing and selection crossing plant that comprises the FIS the comprises that plant orn plant that comprises in its in comprises that plant orn resistant plants. resistant the plants that contain the characteristic the contain that plants the propagating crossing corn plants; wild with FRI8017 c) comprises crossing plants A and B, and selecting the A plants comprises crossing X. that has the marker progeny plants resistant glyphosate obtaining for Method comprising: a) b) by these plants reproducing inserted genome the 5-enolpiruvil-3-fosfoshikimato inserted 4. ID NO. SEQ. from gene synthase chloroplast. gene of Selaginella. 1) of ID NO. gene (SEQ ID SEQ comprising the sequence of vector a introducing NO: 1. said nucleotide wherein claim 1, of cassette expression nucleic a heterologous to linked sequence is operably interest. acid of and B (transgenic) A plants comprising crossing X. with Marker progeny and selecting (transgenic), X. trait having means, due to lack of reproducibility. lack of means, due to and selection. crossing of steps A A plant variety is not patentable even if it is genetically modified. However, if it is described as a whole plant, it could be could it plant, whole a as described is it if However, modified. patented. 1. that X trait plants that have of the production for Method Examples of patentable claims patentable of Examples 1. c resistant glyphosate A 2. SHS modified plant comprising the mutated genetically A 3. monocot drought-resistant A 4. by X trait plant having a (transgenic) producing of Method 5. the genome its into incorporated stably having plant A 6. X with character plants of the production for Method 7. select a plant ID NO: 1 to SEQ the nucleic acid of of Use claims excluded of Examples patentability from What is excluded? 1. chemical or physical by modified plants Genetically 2. which contain animals plants or methods for Breeding 3. plants, etc. animals or of breeding Marker-assisted . “essentially biological “essentially which serves to enable to serves which there there is an indispensable for the production of plants of production the for a trait into the plant genome or genome plant the into trait a both both the method and the plant age 40 Page :37 11 step of a technical nature technical a of step “step of a technical nature” a technical of and “step essentially biological processes for obtaining, for processes biological essentially and animals; plants and propagating reproducing, and varieties. plant
THE LIFE SCIENCES LAWYER step step of a technical nature essentially biological process biological essentially into plants or animals, etc. plants or into modifications without introduction of exogenous genetic exogenous of without introduction modifications material. genetic material (transgenic plants). (transgenic genetic material II. in nature; as found material and genetic biological III. breeds; animal IV. and the living parts constituting it; the human body V. I.
For a better understanding of the exceptions of Article 16, it is it 16, Article of exceptions the of understanding better a For An In a For example, For if the process contains crossing and selection necessary to define some crucial terms as terms crucial some define to necessary processes” encompasses a method which contains or consists of the steps the of consists or contains which method a encompasses of sexually crossing the whole genomes subsequently of selecting plants plants. and method the of if Such even process biological essentially an considered a method would be a contains also 3. traits new introducing engineering methods for Genetic 2. genetic directed by modified plants Genetically What can be protected? 1. exogenous of introduction by modified plants Genetically Protection of plants by patent plants by of Protection Article states in 16 Law thereof Property The Industrial Mexican that inventions that are the new, result of an inventive activity, be application, and patentable, shall in industrial susceptible of except: this Law, of the terms according according to the Mexican Legislation of 1991, and via a plant variety based on the Plant Varieties Law based on UPOV 1978 which was established in 1996 varieties. for the protection of plant the that so produced, plant the of genome the in trait a modifies the of result the not was trait that of modification or introduction mixing of the genes of the plants chosen for sexual crossing, exception patentability the under fall not would method the then Article 16. of PLANTMEXICO IN INVENTIONS or or assist the performance of the technical a of steps step additional an contains of method the if sexually crossing. However, introduces itself by which nature, human intervention, without which the final result would propagation and production of be process a example, For different. of transgenic plants is a step of a technical nature even if it includes traditional biological production stages. of plants and A animals that includes process at least technical one for step, the which cannot intervention of man and be that has a decisive impact on the final carried out exception. within this patentability fall not without will result, the steps, and an additional stage of a technical nature (genetic engineering) that induces a trait of interest in the genome or modifies the trait in the obtained plant, in such away that this introduction or modificationof thefeatureof interest is not the result of sexual crossing, obtained through it would not be excluded and could be patentable. 40
1 16/1/20 t :Layou off Uhth CHEMICAL PATENTS 43 THE LIFE SCIENCES LAWYER terest covers enforcement covers terest without indicating specifically fficient strategy of company fficient strategy rights, unfair competition, parallel competition, unfair rights, ties, conventions, agreements and the agreements ties, conventions, In this connection, the patent office concluded office patent the connection, this In identical identical to the compound disclosed in Claim 1. The marketing authorization indicates that the a in the medicine is Sofosbuvir, ingredient active S-stereoisomer of or compound same the gives claim the meantime, propionic acid. its In stereoisomer the meant. are what stereoisomers that Sofosbuvir represents a particular stereoisomer particular a represents Sofosbuvir that characterized in Claim 1 and it is not identical to the active ingredient given in authorization. the Because this, term of of extension marketing be allowed. 2651892 cannot No patent of Résumé Biriulin Vladimir legislation, IP and foreign Russian Biriulin advises clients on Mr. trea IP including international transfer, technology implementation in Russia, their peculiarities of e and elaborating licensing, copyrights in His particular intangible assets protection. owners’ IP and infringement of import and litigation. possible and cceptable age 43 Page :49 11 medicine Sofosbuvir. The patent The Sofosbuvir. medicine ers Isopropyl ers Ester Isopropyl of Propionic Acid The patent office refused to accept that It noted that marketing authorization had been The company argued that the disputed After that the company initiated a court initiated action that the company After explanation, explanation, arguing that the active ingredient shown in the marketing authorization is not alternative alternative of the claimed compounds because Claim 1 cov is alternative This stereoisomer. its or (Sofosbuvir) patent. the of specification the by supported fully CTC Legal Media CTC Legal obtained for the for obtained that determined officehave the should scope of protection according to independent Claim done not 1 was This medicine. that to corresponds by the patent office. The companyargued that Sofosbuvir completely falls within the scope of a as 1 Claim independent decision of the patent office is in contravention of contravention in is office patent the of decision Code (see above). the Civil Article 1363(2) of at IP court against the patent office seeking to overturn the negative decision of the No СИП-740/2018). (case office patent In June 2018, Gilead Pharmasset LLS applied to the patent officewith request a extend The to refused. the was but patent the of validity of term applicant filed a complaintto the patentoffice again. refused was against that decision but 16/1/20 t 1 Layou ky: diss Goro CTC Legal Media CTC Legal ombination of ingredients of ombination 2651892 dated 24 April 2018. April 24 dated 2651892 The The procedure for patent term extension is period the for extended be shall term said The be to is term of extension the for request The This extension provision proved to be quite Gilead Pharmasset LLS, a US company, for the use of which the first marketing authorization marketing first the which of use the for was obtained. The said product is an composition/c a or agent active trials clinical undergone has that product the of use in Russia. for and is permitted Article regulated by 1363(2) of the Civil Code. It for application an of date filing the from “If reads: to relating an invention a the for patent grant of the agrochemical, an or pesticide, a medicine, a the to approval, statutory a requires which of use date of granting the first marketing approval the of duration the passed, years five than more exclusive right to the respective invention and extended be shall right this certifying patent the federal the by holder patent the of request upon property”. intellectual for authority executive from the date of filing the patent application until the date authorization of minus yearsfive butfor not more issue of years. than five first marketing during the the period owner patent made of by validity of the patent before expiration of six months from the when date the first marketing authorization was obtained or from the date of grant of the patent depending on which term later. expires workable and hundreds extended without of a hitch. patents There have published were a been number of articles on extension of part most the for though country, this in patents they make it known that extension is possible and describe the procedure of how the patent owner may obtain extension. Sometimes the to worthwhile is It smooth. that not is procedure the of one by encountered snag a at look a have owners. patent No patent obtained ” This extension provision to proved be quite and workable of hundreds were patents extended without a hitch. Vladimir Biriulin Vladimir “ age 42 Page :49 11 uration uration of a patent has concern each Ever of long country. individual been a the in invented Brunelleschi Filippo since
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discusses the application of term extensions to patented chemical patented to extensions term application of discusses the compounds Vladimir Biriulin, Partner and Head of Legal Practice at Gorodissky & Partners, at Gorodissky Practice Legal of and Head Biriulin, Partner Vladimir This becomes a new patent with the revised To To meet this challenge, some countries In accordance with the amended patent As time went on, it became clear, however, that however, clear, became it on, went time As
by a supplementary patent granted with the claims the with granted patent supplementary a by containing the combination of the features of the patented invention product which for the marketing authorization characterizing the has been issued. claims and with the restricted scope of rights. The claims will characterize a specific product
chemical patents chemical Doing justice to justice Doing CHEMICAL PATENTS CHEMICAL 42 introduced a “patent term extension”. In introduced a Russia, “patent term extension”. this took place in provision 2003 was and retained the versions in of relevant the all patent law. subsequent became The part of the Civil Code as patent its Part IV in law 2008. In 2014, complemented in the that a supplementary patent relevant provision period extension the was covering issued be should patent. the existing an attachment to of instead legislation, a patent term extension is certified 15th century a barge with for years three for privilege hoisting exclusive an secured gear and the use of same, the validity term of varied until widely, patents TRIPs the WTO’s in modern set and laws national harmonize to sought times the term Article years. of twenty 33 of the TRIPs protection of term "The that provided Agreement available [for patents] shall not end before the expiration of a period of twenty years counted streamlined agreement This date". filing the from countries. in many patents of the duration and agrochemicals pharmaceuticals, for inventions pesticides were an unloved child of intellectual The property. said patented chemical products need to obtain before they approval regulatory can go to the market. This may take years, thus putting and patent the of duration the shortening field. in the chemical patents at a disadvantage D
16/1/20 t 1 Layou ky: diss Goro Gorodissky:Layout 1 16/1/20 11:49 Page 44
CHEMICAL PATENTS
In addition to that, the patent office argued that as the active ingredient of the pharmaceutical S-stereoisomer covered by the scope of Claim 1 and it may refer to the whole claim as well as to is not specifically disclosed in the specification; a specific combination of features if the claim the specification does not show that the Those rules contains several combinations of features compound was really produced and that it “ (alternatives) and only one of the combinations possesses the same activity that would allow the were not shown in the feature corresponds to the active use as intended. ingredient. The IP court examined the arguments of both respected by There is a similar approach demonstrated by sides and stated that the patent office’s decision the Presidium of IP court in case No СИП- is not based on law. According to the IP court the the patent 155/2014. Different interpretation of the scope of protection of the invention according to regulations would entail unjustified impingement Claim 1 extends to any stereoisomer of the office. of rights of the patent owners because, as was composition, including to Sofosbuvir which is a mentioned above, there are no limitations for that S-stereoisomer. In fact, the scope of protection in the law. covers S- as well as R-stereoisomers. Another ground of refusal put forward by the The company did not ask for extension of all ” patent office was that the patent office indicated possible alternatives in Claim 1 but only in respect that S-stereoisomer mentioned in Claim 1 is not of a specific S-stereoisomer of compound, i.e. in disclosed, i.e. the specification does not show respect of Sofosbuvir. The patent office does not that the compound was indeed obtained and deny that the combination of features proposed possesses the activity allowing it to use as by the company is identical to the chemical claimed. formula of Sofosbuvir. The patent office does not The court did not agree with this statement deny that the combination of features proposed either. Contrary to assertions of the patent office by the company is identical to the chemical isopropyl ester of propionic acid is disclosed in formula of Sofosbuvir. the specification, there is information to the effect Thus, Sofosbuvir falls within the scope of that such composition was obtained and protection of the invention in Claim 1, specifically possesses the claimed activity. in the part of the feature termed as “or its Obtainment of such derivatives (stereoisomers) stereoisomer” as its admissible alternative. is a standard procedure; it is evident for the The law does not impose limitations on the person skilled in the art that they maintain their extension of patents’ validity in respect of patent properties and activity. Hence, obtainment of claims if these claims are constructed with the such derivatives without mentioning a specific use of alternative concepts. Also, requirements example is a necessary and sufficient condition to the patent documents provide that one for that group of compositions to be protected. independent claim may characterize several The IP court put forward several other inventions-variants if they differ only by the arguments proving that the decision of the patent features expressed as alternatives. office was not based on law and regulations and Furthermore, Rule 46 of Patent Regulations obliged the patent office to reconsider its provides that when a group of inventions is being decision and extend the validity term of the examined patentability is checked in respect invention and issue a supplementary patent. of each invention. If a claim contains a feature The above case is very much demonstrative of expressed by several alternatives each the skills of the judges of the IP court. The rules combination of features should be checked. From allow the court to engage experts in complicated this it follows that one claim may contain one cases however in this case the judges showed combination of features or several combinations. that they themselves are competent enough to There are other rules that echo the above examine complex chemical cases. citations and all of them teach that a claim may be expressed through alternatives and each alternative may represent a separate combination of features of the invention. Those rules were not respected by the patent office. The specification of the patent reads that there are two possible stereoisomers: S-stereoisomer as well as R-stereoisomer which is reflected in Claim 1 by the words “or its stereoisomer”. Hence, the combination of features defining Contact: Gorodissky & Partners Ltd. the scope of protection characterizing a Email: [email protected] compound or a group of compounds described Tel: +7 495 937 6116 by general structural formula should be the same
44 THE LIFE SCIENCES LAWYER CTC Legal Media
Tahtadjiev_FP.indd 1 06/01/2020 11:11 ANTIBODY PATENTS 47 and competitive and antibodies competitive THE LIFE SCIENCES LAWYER Also at issue and under dispute is inventive Sanofibrought the case to the IPHC in an As for enablement and support requirements, As for inventive step, the IPHC judged that it with them, as well as the significant findings by Amgen that interactions between PCSK9 and LDLR substantially occur at the domain EGFa of the LDLR and at a specific small region in the the PCSK9. domain of catalytic a wide variety of structures; which is at odds with the with odds at is which structures; of variety wide a detailed description in the specification in which there are disclosed only a very limited number of monoclonal antibodies. In both asserted cases, that the Amgen specification includes detailed descriptions of how monoclonal antibody having the recited functions, to obtain monoclonal obtained the of effectiveness the of and the claimed antibody for reducing LDL cholesterol assertion. JPO dismissed Sanofi’s The serum, etc. level in step. Sanofi cited Lagace et al. (J. Clin.states which Invest., pp.2995-3005), No.11, Vol.116, (2006), of binding neutralizes that antibody an of use that PCSK9 to the LDLR protein may be pursued as a possible treatment for hypercholesterolemia, and discloses a purified anti-PCSK9 polyclonal the of invention the that asserted Sanofi antibody. at arrived easily been have could patents Amgen from Lagace et al. in view of common technical Again, in the art at the time. available knowledge assertion. JPO dismissed Sanofi’s the JPO. the by issued decisions the nullify to attempt The IPHC handed down decisions in both cases on 27 December 2018 (Hei 29 10225, Gyo-ke Hei in decisions JPO the upholding 10226), Gro-ke 29 Amgen. of favor the IPHC decisions state supported and enabled fully is invention claimed that the corrected by the disclosure in the specification, since the specification includes a detailedexplanation of as antibody, claimed the obtaining for process the well as evidenced facts monoclonal that antibodies a number functions, having 15 monoclonal antibodies in Patent 1, of the the of use by section example the in isolated were recited described in the specification. process would have been difficult for a person skilled in the art to arrive The al. et Lagace of disclosure the at from antibody the claimed monoclonal Court took into account difficultiesin obtaining the antibodies reference which were isolated by tailored somewhat and modified the with Amgen method in consideration of usefulness of antibodies the reference Infringement lawsuit and appealed Infringement lawsuit IPHC Decision H29 court, District Tokyo the at instance first the In request Amgen’s admitting decision a 16468, (Wa) was issued on January 17 2019. in Subsequently, the appeal case at the IPHC, H31 (Ne) 10014, ” The existence a patent of with merely functional will features a constitute tremendous to obstacle who those develop subsequent antibody products. “ age 47 Page :00 12 The corrected claims of each of the cases are support As for and enablement in requirements, CTC Legal Media CTC Legal Claim 1 of the maintained Patent 1 the maintained Patent Claim 1 of as follows: reads Claim 1: An isolated which monoclonal antibody, can neutralize binding of protein, and which is competitive for binding PCSK9 to and LDLR chain heavy a including antibody the with PCSK9 variable region consisting of sequence shown an as SEQ ID No. amino 49, and a light acid an amino acid consisting of region variable chain 23. ID No. as SEQ sequence shown 2 the maintained Patent Claim 1 of as follows: reads Claim 1: An isolated which monoclonal antibody, can neutralize binding of protein, and which is competitive for binding PCSK9 to and LDLR chain heavy a including antibody the with PCSK9 variable region consisting of sequence shown an as SEQ ID No. amino 67, and a light acid an amino acid consisting of region variable chain 12. ID No. as SEQ sequence shown essentially the same, with the exception of the recited amino acid sequences of the reference are claims corrected the that note of is It antibody. directed only to functional features; (i) whereby neutralized; is protein LDLR and PCSK9 of binding PCSK9 to binding for competition whereby (ii) and with the reference antibody for is included is definition structural no that means attained. This antibody. a claimed monoclonal both cases Sanofi asserted that the descriptions in each corrected Claim functional or 1 characterizing definitions, and amounted as a to result the mere claimed invention having antibodies monoclonal of number enormous encompasses an 1 16/1/20 t :Layou _V2 HARA & YUASA CTC Legal Media CTC Legal case Sanofi filed invalidation trials at the JPO against JPO the at trials invalidation filed Sanofi The JPO handed down decisions maintaining In the following a summary of the key features the key of a summary In the following Invalidation Trials and appealed Trials Invalidation IPHC Decision The specification Amgen the of patents includes named antibodies reference two of disclosure the 21B12 and 31H4; the claims of the first divisional patent JP 5705288 (Patent 1) recites reference antibody 21B12, and the claims of the second divisional patent JP 5906333 (Patent 2) recites 31H4. antibody reference 18 on 2016-800004, No. Trial Invalidation 1, Patent January 2016, and against Patent 2, Invalidation trial No. 2016-800066, on 31 May 2016. In both cases, the reasons for invalidation asserted by Sanofiwere each based on groundsof lackof step. support, enablement, and inventive the Amgen 2017. August (amended) claims, on 10 patents based on corrected the implications of that invention antibody pioneer a for right patent obtaining a and enforcing is claimed with functional features. On the other hand, it is apparent readily that the existence of a patent with merely functional constitute a features tremendous obstacle to those who will products. subsequent antibody develop the cases is elucidated. of Résumé Yamamoto Osamu Section of the Chemical of is the acting Chief Yamamoto Osamu experience in of years He has 19 the firm. Division of the Patent patent drafting including patents, on focusing property, intellectual expert opinions, providing Actions, with Office applications, dealing and trials invalidation in rights patent attacking or defending oppositions, and infringement litigation. Osamu Yamamoto Osamu age 46 Page :59 11 fringement of fringement the of patents. hile it is the relating to small-molecule drugs can case that inventions be sufficientlyprotected with claims
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Osamu Yamamoto, patent attorney and partner at Yuasa and Hara, examines Hara, and Yuasa at and partner attorney patent Yamamoto, Osamu litigation. drug patent Japanese recent Amgen has developed the humanized anti- Sanofideveloped and produced different a Sanofi filed patent invalidation trials against In invalidation cases, the JPO and the IP High Amgen v Sanofi v Amgen antibody patent – the patent antibody Functionally-claimed ANTIBODY PATENTS ANTIBODY 46 These cases merit of close consideration view in based on their chemical structure, the same does same the structure, chemical their on based not necessarily hold sufficient obtain to possible be not may it Namely, true for biomedicines. on based claims with biomedicine a for protection a chemical structure. This importance, issue and a is great deal of of attention has great been paid to different approaches in obtaining patents due to shifts following biomedicines around centered litigation in patent dispute and drugs. molecular small for saturation market the and “evolocumab” antibody monoclonal PCSK9 drug “Repatha®” Amgen’s hypercholesterolemia. treating containing for antibody the monoclonal 5,906,333, JP and each 5,705,288 of JP two patents, against antibody "monoclonal a to directed is which proprotein convertase subtilisin/kexin these products. cover (PCSK9)”, type 9 humanized anti-PCSK9 monoclonal containing “Praluent®” drug the and antibody “alirocumab” the monoclonal hypercholesterolemia. antibody for Amgen’s two patents at the Japan Patent Office treating (JPO) in 2016. Amgen filed a patent infringement seeking 2017 in Court District Tokyo the at lawsuit an injunction etc. against Sanofi’s One activity. of the strongly contested issues patentability requirements was are met, even if “whether the claimed monoclonal antibodies are defined only features”. functional their by patents. the two of validity Court (IPHC) admitted Further, in the infringement case, District Court and the the IPHC admitted validity of Tokyo the two patents and in W
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ANTIBODY PATENTS
A conference presented by the Healthcare and Life Sciences a decision rejecting Sanofi’s request was issued Comments Law Committee, the Intellectual Property and Entertainment Law on 30 October 2019. Despite the limited procedures available for the Committee and the Technology Law Committee It was not contested between the parties that production of monoclonal antibodies, the Sanofi’s products are encompassed by the literal structure of obtainable monoclonal antibodies is scope of the Amgen patents. diverse. This means that a sequence and structure Sanofi asserted that a scope of claims should of a monoclonal antibody that has the same be limited to that which is actually enabled, and function or characteristics will differ greatly even as such the claimed antibody should be limited if a monoclonal antibody is produced by 8th Annual to those concretely disclosed in each of the two a similar animal immunization method. specifications, or to those having a substitution of While it is the case that functionally defined one or more amino acids at specifically defined claims tend to cover a huge number of un- sites; and Sanofi’s products do not fall within this isolated monoclonal antibodies, it is also the case World Life Sciences scope. that where technical significance of an invention Follow us However, both the Tokyo District Court and the over prior arts is considerable and monoclonal @IBAevents IPHC dismissed Sanofi’s assertion, and stating antibodies having the recited functions can be Conference #IBALifeSci that considering the disclosure of the obtained without under burden, such an specifications a scope of the claims which is approach should be admitted in pursuit of enabled for a person skilled in the art is not a patent. From this viewpoint, the above cases are limited to those asserted by Sanofi. Consequently, worthy of exhaustive consideration. the both courts judged that Sanofi’s activities 5–6 June 2020, Paris, France constitute infringement of Amgen’s patents. Contact: Osamu Yamamoto As for validity of patents, as in the above Address: Section 206, New-Otemachi Building, 2-1, Topics include: invalidation cases, the Tokyo District Court Otemachi 2-chome, Chiyoda-ku, Tokyo 100-0004, Japan • IP and regulatory tendencies & opportunities for health & agricultural products rejected Sanofi’s assertion. The IPHC handed Email: [email protected] down a decision dismissing Sanofi’s appeal Tel: +81 3 3270 6641 • Market access, pricing & transparency stating essentially the same reasons as those Fax: +81 3 3246 0233 stated in the decisions handed down by the IPHC Website: http://www.yuasa-hara.co.jp/ • Shortages of medicines and solutions in the invalidation cases. • Digitalisation of medical devices & interactions with other industries • Artifi cial intelligence, ethics & data governance • New approaches in M&A and fi nancing deals in life sciences • Compliance and globalisation of practices • Litigation & new resolution tools • Brexit & its impact on healthcare & life sciences businesses
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IBA FP.indd 1 20/01/2020 11:06 PATENT INVALIDATION 51 Markush claim includes claim Markush Markush THE LIFE SCIENCES LAWYER relating to patent infringement, patent to relating his practice on patent prosecution, on patent his practice In view In view of the error in the First judgment and According to According teaching the of evidence overall the sued decision on the determination of the 1 claim between features technical distinguishing and the reference document, which affects directly the determination on whether claim 1 1, those skilled in the skeleton part art of evidence 1, including will carbonyl, think that the is a chemical structure pharmacological activity. Once any part unit of the that large a is it produces whether changed, been has skeleton part such as the ring structure or a small part such as the carbonyl group, it is impossible to predict whether the same drug activity can be retained, so it is impossible to predict whether the technical effecthave art the in skilled those case, this of In achieved. evidence 1 canno technical be motivation at all to and 1 evidence of 86 example in group carbonyl remove the replace it with other groups. It is wrong that the invalidation decision find thatof 86 compound of substituent R corresponding replacing the evidence 1 from C(O)NH2 to OCH2CH2OH is a person, skilled a of means technical conventional and it is also improper to maintain the original it. judgment, and the court correct an an unalterable skeleton part and a changeable Markush element. In solution the of evidence overall 1, technical connected with the cyclopentane at the the upper carbonyl group left corner belongs to the unalterable skeleton, rather than the changeable variable group. The Reexamination Board has carbonyl incorporated which the belongs to skeleton part into the the variable group, which is unalterable skilled those of cognition general the to contrary in the art and belongs to the fact-finding error, it. and the court has corrected claim. As we all know, the know, all we As claim. Therefore, Therefore, it is a conventional choice for those skilled in the art to replace 4-chloro- on the 4- chlorophenyl of example the to respect With 3,4-difluoro-. 86 with 1 evidence compound of distinguishing feature (2), the example compound 86 disclosed of in evidence 1 shall understood be in the overall technical solution of evidence 1. Claim 1 in evidence 1 is a ” Résumé Tang Xiaofeng Office and Law IP Beijing GEACH of partner is a founding Tang Xiaofeng As a Office. Property Intellectual largest at China's worked then before in experience of years than twenty with more attorney seasoned patent sciences, he concentrates life fields such as technical various covering validation, litigation and among devices, medical chemistry, pharmaceuticals, biotechnology, advice legal also provides He others. strategy. and validation There is There no doubt that the invalidation decision and the first trial decision wrong. are “ 3 is 2 -alkyl OH in 2 is butyl is 2 1-8 CH cycloalkyl 2 is C 3-8 2 ; R 3 OH, or for substituent for or OH, 2 in example 86. in example age 51 Page :53 10 2 CH 2 cycloalkyl cycloalkyl group optionally on formula (I) structure can be 3-8 2 alkyl which is substituted by one or more one or by which is substituted alkyl -alkyl -alkyl or C 1-6 The compound of amended claim 1 differ from differ 1 claim amended of compound The Distinguishing technical features found by the by found features Distinguishing technical Wherein, Wherein, X is OH or NHR (1), feature technical distinguishing above the For According to the court of second instance, with instance, second of court the to According 1-6 the compound of present the in 3,4-difluoro phenyl; on substituent example 86 in: patent in instead 4-chloro of 86; example (2) the (1) the R substituent on cyclopentane; OCH invalidation examination written decision examination invalidation and by as follows: instance are First judgement of C(O)NH of claim1 instead hydroxyl groups. hydroxyl substituted by phenyl; Most preferably R preferably Most phenyl; by substituted or 2-phenylcyclopropyl, recited in description); R description); in recited 2-phenylcyclopropyl, or CTC Legal Media CTC Legal optionally substituted by aryl, or C aryl, or by substituted optionally optionally substituted by one or more phenyl, skilled in the art to modify the structure of a parent a of structure the modify to art the in skilled compound. This kind of belongs group to the technical means conventional of replacement 7 3, 4, 5 or The evidences those skilled in the art. submitted by the petitioner also this prove and said group replacement has not achieved any unexpected technical effect. Therefore, it obvious for those skilled in the art is to obtain the technical solution of claim 1 general common on with combination in 1 evidence the basis of knowledge in the art, so claim 1 possesses no inventiveness. fluorinated (1), feature distinguishing the to regard of forms common are compounds chlorinated or halogen substitution in the art, and mono- or multi- substitution of halogen is easy to choose when halogenated. Moreover, evidence 1 has disclosed in claim 1 and the description that the phenyl of the compound can substituted by be one optionally or more halogen atoms. and optional phenyl is further optionally substituted optionally further is phenyl optional and by one or more halogen atoms R (Preferably is C Patent II. Opinions of Board Reexamination and the Courts technical the that holds Board Reexamination The problem actually solved claim by 1 is to provide different with compound pyrimidine [4,5-d] triazolo substituent. substituent, halogen are chloro- and fluoro- both and evidence 1 also discloses that the phenyl contained in R matter no (2), feature technical distinguishing above OCH substituent the for C(O)NH2,in the compounds, design they are of widely used by pharmaceutical those optionally optionally replaced by one or atoms halogen more the of substitution the and halogen atoms, group conventional the to belongs phenyl the on substitution by those skilled in the art; for the C 20/1/20 t 1 ayou h:L Geac ng Beiji or a bond; or 2 CH CTC Legal Media CTC Legal 2 of example 86 on July 2, 1998 July 86 on example of is a phenyl group, optionally substituted by R is XOH, where X is CH, OCH X where XOH, R is Evidence 1 (WO98 / 28300 A1) disclosed the Compounds of formula (I) of Evidence 1 Evidence (I) of formula Compounds of Compound of example 86 1 Evidence of 2 Wherein: R compounds of formula compound (I) below and the one or more fluorine atoms; more one or in China Xiaofeng Tang Xiaofeng age 50 Page :06 12
THE LIFE SCIENCES LAWYER antiplatelet antiplatelet aggregation drug developed clopidogrel, with Compared AstraZeneca. by icagrelor is the first triazolo [4,5-d] pyrimidine [4,5-d] triazolo first the is icagrelor
Intellectual Property Law Office, looks at a recent invalidation case in China in case invalidation recent a at looks Office, Law Property Intellectual medication. blood-thinning a concerning Xiaofeng Tang, Managing Partner and Patent Attorney at Beijing Geach Beijing at Attorney Patent and Partner Managing Tang, Xiaofeng Shenzhen salubris Pharmaceuticals Co., Ltd. Ticagrelor has faster effect, stronger inhibition of inhibition stronger effect, faster has Ticagrelor reduce significantly can and aggregation, platelet myocardial death, cardiovascular of incidence the and stroke. infarction filed requesta for invalidation of the Chinese invention patent Zl99815926.3 of AstraZeneca Reexamination Patent the and Ltd, Co, (Sweden) Board made patent declaring invalidation 2017, October 10 on 33591 No. examination decision that the patent was invalidated. After that, the administrative judgment of Beijing Intellectual Property Court upheld the invalidation decision of the Reexamination Board. On 24 December 2018, the Beijing Higher People's Court issued the second trial decision (2018) No. 6345, which trial first the and decision invalidation the revoked During the invalidation procedure, granted claim granted procedure, invalidation the During 1 is limited to a specific compound (I): formula general the following compounds of from the I. Basic case decision. The decision. case has had influence an extensive on the issue of compound patent inventiveness is also a huge controversy. in China, but there Ticagrelor patent invalidation of invalidation patent A case analysis of analysis case A PATENT INVALIDATION PATENT 50 T
16/1/20 t 1 ayou h:L Geac ng Beiji PATENT INVALIDATION 53 THE LIFE SCIENCES LAWYER of paragraph of Article 3, 26 Chinese of patent law. art, those skilled in based on the prior Moreover, the art cannot expect that the compound in the patent has high metabolic patentee stability, will so not be the technical allowed effect of to the metabolic prove stability not the confirmed in the original description method and data. submitting the experimental by now Conclusion V. or right patent a maintain to order in summary, In skillfully to need parties the patent, a invalidate to manipulate the complexities of patent laws and regulations and the experience the with combination in technologies practical intricacies of as so litigation patent and prosecution patent on to safeguard their respective legitimate rights the maximum extent. to and interests http://www.geach.com.cn Room 525, Building B, Fucheng Mansion, No. 98 Beilishi Street, Mansion, No. 525, Building B, Fucheng Room [email protected] +86-10-68314219 +86-10-68318129 ÛJia, Xicheng District, Beijing 100037, P. R. China P. Xicheng District, Beijing 100037, ÛJia, Contact: Beijing Geach Intellectual Property Law Office Law Property Contact: Beijing Geach Intellectual Address: Tel: Fax: Email: Website: age 53 Page :02 11 drug finally marketed. drug finally on on the of patent protection not not raise and hear the facts and antagonist activity in WO9905143. 2T antagonist activity WO9905143. of It can be It is clearly recorded on page 2 of the 2T However, the description However, does not provide any pharmacological experiments to technical prove effect, let the alone experimental data. Therefore, the description is provision the to conform not does and disclosed not sufficiently specificationof the patent that the compounds of the patent have unexpected high metabolic stability and high with compared bioavailability the triazolo [4,5-d] pyrimidine compounds with P seen that the technical problem to be solved in this patent is to provide compounds with high rather bioavailability, high and stability metabolic than P Ticagrelor- the specific the Ticagrelor- CTC Legal Media CTC Legal limitation of the claim 1 to the specific compound has no adverse effect in patent on the defects Analysis IV. It is the author’s opinion that there is a potential is it and patent, the in issue dislosure insubstantive very possible for the patent to be invalidated in Certainly, China reasons. as following the of result the Patent Reexamination Committee and the Courts shall reasons reasons that have not been put forward by the petitioner. invalidation 22/1/20 t 1 ayou h:L Geac ng Beiji the with the 2 CTC Legal Media CTC Legal OH in this patent and the OH. 2 2 in evidence 1 can be replaced be can 1 evidence in 2 CH CH 2 2 compound of claim 1 is not close to close not is 1 claim of compound certain therapeutic use. Therefore, use. therapeutic certain OH OH in the patent belong to different of of compound 86 in evidence 1 and 2 2 CH 2 Therefore, Therefore, the Invalidation Decision and the In addition, in terms of structure, the compound the structure, of terms in addition, In The invalidation decision takes the compound the takes decision invalidation The Court Decisions are not convincing, and the 86 of evidence 1 as the starting point, violates the which whole teaching of evidence 1; the decision ignores the technical effect of the inventiveness of claim 1 should be recognized, and recognized, be should 1 claim of inventiveness it is not necessary to require that patent has unexpected effect.On the other hand, the present there is no clear and objective criterion to judge whether the two structure of compounds is close illustration to according if Even not. or other each to of the Guideline, "for part core basic same the compounds have must they structure, with similar "have prerequisite speaking, logically ring", basic or the same basic core part or basic ring" is only a necessary condition for identifying "compounds with similar structure", rather than condition. compounds Therefore, with "the a same sufficient not be in similar may part basic basic or ring" core basic part or "basic core term Moreover, structure. ambiguity scope of concept controversial a is ring" in a specific case. the compound of evidence 1 in structure and has has and novelty invention is completely non-obvious over evidence over non-obvious completely is invention knowledge general common with combination in 1 in the art. In fact, assuming that the scope of claim 1 had not been limited during invalidity although inventive, also is 1 claim proceeding, substituent OCH invention when reformulating the technical problem technical the reformulating when invention actually solved by claim 1 relative to evidence 1 and thus violates three-step process and the logic of inventiveness assessment; decision and does not the demonstrate that there technical motivation is in prior art for person to replace a substituent C(O)NH skilled OCH kinds of groups pharmaceutical with chemistry. different The properties substituent fact OCH in that the C(O)NH substituent necessarily not does 7 or 5 4, 3, evidence in equally this in equally replaced be also can they that mean there case. exist two Moreover, at differences the same time between the both. That the Court of choice conventional a as it regard instance second those for skilled in the art to replace on 4-chloro- the 4-chlorophenyl of preferable the violates 3,4-difluoro with 1 evidence the compound 86 basis. factual the lacks and 1 evidence of teaching in the Apparently, of of claim 1 in distinguishing the patent features has the in skilled person A 1. the evidence in 86 compound compared above two with field of the pharmaceutical chemistry directly can recognize that the corresponding R-substituent C(O)NH ” It is author’s It opinion that is a there substantive in the defect patent. “ that both assessment assessment of age 52 Page :06 11 the second trial court
THE LIFE SCIENCES LAWYER
At At was that not process a time, three-step there The examination of this patent shall be Under Under these circumstances, in theory, both evidence 1 and the present invention are specific are invention present the and 1 evidence compounds without general formula structure, applicable. this method is not Patent the and 1992 Law Patent the by governed 1993. Guideline Examination PATENT INVALIDATION PATENT 52 in the guideline assessing for but inventiveness, provision special is There concept. non-obvious a the for assessment of compound inventiveness, the whether structure depends on which mainly of compound is compound. A compound novel that is not close close to to the that known compound in structure of and has known certain use or effect can be considered to be unexpected have to it requiring without inventive use or effect; compounds close to known the compounds in structure must have unexpected effect. use or TSM method in US and three-step process in EPO can be used to determine invention whether is the obvious or not. decision The invalidation applied made but provision special the with combination three-step mistake process in determination in not. or is obvious invention on whether the questionable, because the unalterable concept of skeleton introduced by There There is no doubt that the invalidation decision the Although wrong. are decision trial first the and correct, is decision trial second the of conclusion the way of judgment and argumentation is also III. Comments on inventiveness inventiveness III. Comments on is not related to the general possesses possesses Reexamination Board shall, on the basis of inventiveness, the modified determination of the the distinguishing technical features, make a new decision on the Patent invalidation. for the request of examination compound inventiveness. Assuming
22/1/20 t 1 ayou h:L Geac ng Beiji BAIANAT INTELLECTUAL PROPERTY 55 the major change is . are are one of our emerging various excellent services in excellent various : THE LIFE SCIENCES LAWYER will offer new methods of work of methods new offer will and relevant government authorities. authorities. government relevant and the process of work” of the process Baianat Intellectual Property Baianat Intellectual Property Property Baianat Intellectual Baianat Intellectual Property Baianat Intellectual Shadya Awad has the bachelor’s degree in chemical degree has the bachelor’s Awad Shadya Science and of University Jordan engineering from than with more expert is a patent Shadya Technology. field. She manages in the IP experience of years 20 the for & Registration and Design Prosecution Patent of countries, is in charge Africa and North Middle East a is and Level International the on Filings Foreign Patent Shadya process. translation & legal specialist in patent Legal & Patent the of establishment the in participated wide expertise the to Departments referring Translation and manages translation; & legal Technical in the with and concluding agreements and surveys proposals worldwide. Patents especially IP, of clients in the field to responses in preparing professional is highly Shadya providing to patents, relation actions in the office patents, of opinion in the field and legal technical patent for search patent conducting preliminary specification patent in drafting applications, professional and international the local to and claims according in several is a member Shadya requirements. AIPPI, PTMG and GRUR. such as organizations Résumé Awad Ahmed Shadya Our responsibility is to protect the intangible of Intellectual of the intangible protect is to responsibility Our assets the legal of the highest standards uphold pledge is to Our profession an existing service in of possibilities is finding new motto Our experience a better deliver to order and the right protection grant will team our on field, Online or consultation Services: Intelligence Conducting the appropriate search and analysis, matching In Baianat Intellectual Property Intellectual Baianat In This challenging move has been adopted to satisfy the In Innovation Innovation and IP Consulting Moreover, in Baianat Intellectual Property we are focusing on focusing are we Property in Baianat Intellectual Moreover, ADVERTORIAL: Baianat Intellectual Property Intellectual Baianat ADVERTORIAL: clients consistent with the highest standards of integrity and professionalism. existing existing expectations, whilst moving technology, making, as always, the forward interest of our clients the to embrace change. our of cornerstone e-services the of path fast the follow to client the to services and in the region exploiting the richness of the data we own and innovative offer to resources and artificial human engaging new clients. our solutions to before the competitive courts competitive the before G G G G G the field of intellectual property, based on the outstanding legal outstanding the on based property, intellectual of field the expertise through the in-house legal advisors will be provided. “digitalizing all “digitalizing Management & IP Consulting including the combination of: Management & IP services and are key to achieving our business goals by focusing by goals business our achieving to key are and services results. financial clients’ on maximizing our the as of Competition Analysis, IP Analysis, Competition Researches, IP Auditing, social for Watch Online medias and E-commerce for besides the trainings Government several signed have we agencies with in addition to MOU Advice; the Legal and Registration rights; IP of Maintenance services; Watch Brand Licensing and of Drafting agreements; Franchising & legal Certified Patent services; translation types all Search; Market litigation and legal of in respect proceedings age 55 Page :59 10 is proud to have more experts, more have to proud is provides an extensive range an extensive provides Patent Due Diligence & FTO; Patent will deliver more comprehensive more deliver will such important news regarding “Baianat Intellectual Property” Baianat Intellectual Property Intellectual Baianat Baianat Intellectual Property Baianat Intellectual We are We delighted to share transformation significant a undergone have businesses Our The decision to open such a new entity is a response to our qualified staffing, IP experts, patent counsels, and legal assistants legal and counsels, patent experts, IP staffing, qualified or paralegals who are well organized for each assigned tasks according to the complexity of the legal effective matter manner in orderin a developto cost- our services solutionsto different and offer with our clients our collectiveto objective provide superior, cost-effective legal services our to valued Customs Recordals; and Patent & Legal Translation. & Legal and Patent Recordals; Customs of top-notch services that include, but not limited to, limited that include, but not services top-notch of designs and industrial copyrights, patents, trademarks, of Border Measures; and Seizure Action domain names; Raid Anti-Counterfeiting and Counseling; Auditing IP Measures; Portfolio Trademark Analysis; Competition Measures; ; Drafting Management; Patent clients’ clients’ and partners’ demands and in requirements the region. While SMAS-IP is taking in charge enforcement and litigation. Property Intellectual Baianat services. IP and new CTC Legal Media CTC Legal birth of our new entity October 2019 and how such will news serve our valued clients better. and we have been working since then resources. on human and artificial new services and engaging developing our 1 21/1/20 t :Layou l_v2 oria ver t ad SMAS , who has CTC Legal Media CTC Legal Baianat Intellectual Property Today; on behalf Today; of Al Mr. Nedal the Kharouf, CEO CEO of been the General Manager of SMAS-IP for over years. 25 Mr. Nedal Al Kharouf, CEO of Baianat IP of CEO Kharouf, Al Nedal Mr. ” Baianat Intellectual will Property the follow path fast the of e-services in the region. Shadya Ahmed Awad Ahmed Shadya “ have age 54 Page :59 10 in addition to the Tunisia, UAE (Dubai, Abu- (Dubai, UAE Tunisia, Palestine, (West Bank, Kurdistan, Kurdistan, Kuwait, Lebanon,
THE LIFE SCIENCES LAWYER aianat Intellectual Property recently recently launched as a new sister entity with close affiliations ourto SMAS
Intellectual Property, and highlights the challenges posed by by and highlights the challenges posed Property, Intellectual landscape. IP an ever-challenging Shadya Ahmed Awad details some recent developments at SMAS at SMAS developments details some recent Awad Ahmed Shadya Libya, Libya, Morocco, Oman, Intellectual Property Intellectual which Group Property is one of the in Firms Property Intellectual leading and largest the in operating Africa North and East Middle the team IP solid a with years 50 than more for field IP and solid practice and experience of managed the having Intellectual Property Rights of a International and local prominent of volume huge clients through evaluating, litigating such rights protecting and with the and one competent are which departments Property Intellectual of our firmof figures growth started in Kingdom of Saudi Arabia then expanded Middle through East and the North Africa region (Bahrain, Egypt, Jordan, Iraq, increasing increasing network representatives of worldwide and offices has network of a associates and and large agents best to work in of scope its to add local that jurisdictions multiple world. the around all interests its clients' serve Gaza Strip), Saudi Arabia Qatar, Jeddah, (Riyadh, Syria, Sudan, Dammam),
SMAS Intellectual Property Property Intellectual SMAS sister company of of company sister Property” – the new new – the Property” of “Baianat Intellectual “Baianat of Announcing the birth the birth Announcing ADVERTORIAL: Baianat Intellectual Property Intellectual Baianat ADVERTORIAL: 54 Dhabi), Yemen, and Turkey); B
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adoption of the IT tools to shift data to the cloud, and the early digital transformation management developing new capabilities, all will have the positive effect of AI, Digitalization and Automation. In conclusion, IP-interested parties must ensure that the people working in the field are able to realize the benefits and improvements of such digitalization and automation under the new working style with the best preparation and implementation in order to face the AI and automation. Now is the time to pause thinking which skills, competencies, capabilities, and tools are needed for the future. Only when reaching the positive disposition and way of thinking among all interested parties involved, a successful new digital way of working can be achieved. the business issues with the direction of the competitive landscape and then the intellectual property strategy to Can machine-created Inventions in IP acquire support the business goals a property right? G Strategy Services: Assessment of the company vision and Intellectual Property Protection is critical to aiding the mission against the intelligence obtained suiting the IP development of innovation and it is essential for economic tactics in order to develop a data-driven IP strategy. advancement. Without protection of ideas, businesses and Thereafter the implementation plan of portfolio projects, individuals would not reap the full benefits of their inventions and which may include a balance of IP creation, IP monetization, would focus less on research and development, and this may and intelligence investments. disincentivize people from manufacturing the products and G Management Services: Developing methods and providing the services that the market relies on. Human progress capabilities to align the IP strategy and business strategy, would ultimately suffer. working with clients to establish IP processes and Intellectual Property rights are valuable assets for your management criteria creating new IP and methods for IP business and IP rights is very important because they can: monetization. G keep your business away from competitors G Creation Services: creation of a strategic IP portfolio using G be invested or licensed, providing important revenues best invention creation processes. Strengthen, invent, and G present something new and different; and document IP business. G constitute an essential part of your marketing or branding Humans are able to build towering and durable buildings that can withstand stronger weather and meet the high safety standards. Humans possess the excellence for the production of AI systems, then they use machine-algorithms and cloud- computing to sort through many options, yielding solutions that human alone could not have designed. Humans believe that what intelligent machines are doing is just the execution of a program or algorithm which is produced by a human itself. As such, the Human should be given any intellectual property rights that flow. AI-based machines will become more human-like – more capable of learning, more complicated and more intelligent in The Future of Intellectual Property finding complex solutions. Such machines will become better at • Data-driven IP making decisions that have very important to our business. The development of Artificial Intelligence (AI), Digitalization Therefore, if we want to protect the value of intelligence, we and Automation, namely the advanced data-driven digital must recognize AI as being capable of owning intellectual technology will obviously positively affect the IP practices in the property. future, and it will be the propellent force of the digital economy. That doesn’t mean that Machine-Created Inventions in IP will By adopting the advanced digital technologies including AI, render Humans obsolete. On the contrary, when the problems new fruitful services will be developed through the manipulation are getting bigger and more difficult, humans have to be of data by assessing the value of the intellectual property rights increasingly augmented to solve them. with the aid of algorithms minimizing the costs for IPR owners. Concurrently, the implementation of AI necessitates the access of greater quantities of data in the presence of many complex policies of making the data available in the digital economy, let alone that the systems will became more complicated and Contact: BAIANAT INTELLECTUAL PROPERTY creative in view of placing machine-created inventions in IP. Tel:+962 6 554 1772 However, the strong business will support this digital Fax: +962 6 552 2748 transformation by focusing on cost and innovation. In addition, Email: [email protected]; [email protected] the quick and proper selection of cloud provider with the
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