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GLOBAL REACH, LOCAL KNOWLEDGE www.patentlawyermagazine.com January / February 2021 Approaches to patenting alloys before the Russian and the Eurasian offices

DLE ID EA M S T Law firm RANKINGS A N D A A F R I C Anatoly Nistuk and Mikhail Samsonov, of Gorodissky & Partners, examine the patenting of alloys through history and give an evaluation of both the RUPTO and the EAPO approach to patenting.

Pharmaceutical Ben Hoopes, HP Women patent Page 20 in IP litigation Leadership Page 15 Page 35

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Turing Fea The Life Sciencepg 45 IPC Renew - Preparing for Launch 2 - 240x340.pdf 3 23/06/2019 12:07:44 EDITOR’S WELCOME

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AL KNOWLEDGE GLOBALGLOBAL REACH,REACH, LOCALLOC KNOWLEDGE January / February 2021 www.patentlawyermagazine.com Approaches to patenting alloys before the Russian and the Eurasian patent offices Editor’s

LE DD EA I S M T Law firm RANKINGS A N D A A F R I C welcome Anatoly Nistuk and Mikhail Samsonov, of Gorodissky & Partners, examine the patenting of alloys through history and give an evaluation of both the RUPTO and the EAPO approach to patenting. Ben Hoopes, HP Women in IP Pharmaceutical Page 20 Leadership patent Page 35 hat features should define the of a solution? litigation Page 15 A question Gorodissky & Partners experts examine in FEATURING LAWYER THE LIFE SCIENCESPG 45

23/02/2021 11:56 relation to alloys in our cover story this issue, with close dd 1 W examination of the treatment of alloys through time and what is THE PATENT LAWYER needed to successfully patent an alloy at both the RUPTO and EAPO. Issue 52 This issue also sees an interesting introduction to patent litigation has cleared the tower with examples from recent Chinese pharmaceutical cases, including a Editor case concerning chronic obstructive pulmonary disease. Tang Xiaofeng, Faye Waters “Continually push further and without being limited by convention, [email protected] Beijing Geach, offers advice on to prove that the ‘truly special’ can be done, regardless of whether it re-examination and non-obviousness Publishing Director is absolutely necessary to do so. Without a drive towards such based on personal experience. C Chris Dooley things, the world would solely be functional.” [email protected] From here we meet Benjamin M We meet Advertising Enquiries Hoopes, HP’s Patent Counsel, for an Y The imminent launch of IPC Renew, by IP Centrum, marks the final “ Benjamin CM few weeks of the renewals industry as we’ve all known it to date. Katie Kerr (Publishing Executive) interview in which we discuss his [email protected] MY Hoopes, management of the Inkjet Print Head After five years of the most intense service development Subscription Enquiries CY portfolio, the qualities he looks for in programme imaginable, we are proud to finally introduce to the [email protected] HP’s Patent CMY his outside counsel, and his vision for world’s greatest IP formalities professionals, the future of renewals. Accounts Enquiries K the development of 3D printing. [email protected] Counsel. We would like to give special thanks Published by: to Dumont for their sponsorship of this CTC Legal Media Ltd, 23 Hedgers Way, Kingsnorth, issues Women in IP Leadership Follow the launch: @ipcentrum Ashford, Kent TN23 3GN segment. The interviews” in this issue discuss the importance of Tel: +44 (0)20 7112 8862 mentoring with Rachael Lodge of Foga Daley, and the exacerbated Sign up for early access: www.ipcentrum.com/renewals Fax: +44 (0)20 7084 0365 effects COVID-19 has had on the challenges women face with Design and Repro by: Karen Taylor of Anaqua. Design and Printing Solutions Ltd This plus The Life Sciences Lawyer, including articles on telemedicine, Unit 45C, Joseph Wilson Industrial Estate, Whitstable, Kent CT5 3PS health data and AI. Printed by: What developments do you think will be fundamental for IP in 2021? Pureprint Group, Crowson House, Get in touch and let us know. Bolton Close, Bellbrook Park, Uckfield, I hope you enjoy the issue. East Sussex TN22 1PH Whilst every effort has been made to ensure that the information contained in this journal is correct, neither the editor, contributors or CTC Legal Media can accept any responsibility for any errors or omissions or for any consequences resulting therefrom. © CTC Legal Media 2020, and contributors. The Faye Waters, Editor contents of this journal are protected under the copyright law of the , the Berne LAUNCH SEQUENCE Convention and the Universal Copyright Convention. Any unauthorised copying of the journal may be in START UP MIGRATION TEST OK PINST 1 P2 PARTNER ONBOARDING CINST 1 CAUTO 1 P2 CLIENT ONBOARDING EPV MIGRATION breach of both civil and criminal law. Infringers will Mission statement be prosecuted. The Patent Lawyer educates and informs professionals working in the industry by PROD ENV P1 PARTNER ONBOARDING PAUTO 1 G2 PR SEPARATION P1 CLIENT ONBOARDING G2 CR SEPARATION G2 SHUT DOWN ISSN 2051-3690 disseminating and expanding knowledge globally. It features articles written by people at the top of their fields of expertise, which contain not just the facts but analysis and opinion. Important judgments are examined in case studies and topical issues are reviewed in longer feature articles. All of this and the top news stories are brought to [email protected] CTC Legal Media your desk via the printed magazine or the website www.patentlawyermagazine.com +44 (0) 207 186 1800 www.ipcentrum.com CTC Legal Media THE PATENT LAWYER 3

Editor's welcome_TPL52_v1_ONLINE.indd 3 26/02/2021 08:51 CONTENTS January / February 2021 The 24 Life Sciences Contents Lawyer 46 Meet the Editorial Board Meet our Editorial Board members who help 6 Meet the Editorial Board determine the direction of this magazine. Meet our Editorial Board members who help 20 determine the direction of this magazine. 47 Editor’s Welcome 9 Cover Story: 48 Cover Story: Approaches to patenting A Portuguese and alloys before the European perspective Russian and the on telemedicine and Eurasian patent offices e-health Anatoly Nistuk and Mikhail Samsonov, of Gorodissky Ricardo Costa Macedo and Diana Mâncio da & Partners, examine the patenting of alloys through Costa, of Caiado Guerreiro, Sociedade de history and give an evaluation of both the RUPTO and Advogados, discuss the needed reinvention the EAPO approach to patenting. of medical care and how it is redefining the relationship between healthcare services 15 Introduction to and providers and patients. comment on typical 20 An interview with HP’s 52 Health data in the UK: Chinese pharmaceutical Patent Counsel, What’s next for 2021? patent litigation case Benjamin Hoopes Jaspreet Takhar, Senior Associate at Tang Xiaofeng, Patent Attorney of Beijing Geach Baker McKenzie, suggests what Brexit and Benjamin Hoopes talks with The Patent Lawyer’s 24 IP strategy: what to Intellectual Property Law Office, gives an overview NHS information governance will mean Editor, Faye Waters, about his experience in the of recent rulings concerning reexamination decision consider when for data transfers, sharing, and use in 2021. and non-obviousness with comment based on IP field, his work as patent counsel, and the collaborating personal experience. technologies of the future. Christian Wende, Partner at DTS, provides 55 The use of Artificial a concise list of strategies that, in his experience, Intelligence in life lead to successful practice. sciences and the 9 protection of IP rights 29 Rankings: Janett Lumbreras, Senior Associate, Uhthoff, Middle East & Africa Gomez Vega & Uhthoff S.C, discusses types Ten of the best law firms from each of the top of protection available for protecting AI Middle East & Africa jurisdictions, including Egypt, innovations in the field with an explanation Nigeria and UAE. and a for and against approach. 60 Functional claiming in 35 Women in IP life science inventions Leadership: in India An interview: inspirations, Manisha Singh & Pradeep Kumar Kamal, of experiences, and ideas LexOrbis, look to the USPTO, EPC, and EPO for equality. for examples and guidelines of the use of Featuring: Rachael Lodge: functional claiming to offer guidance for its Associate, Foga Daley & use in Indi where the practice is still unsettled. Karen Taylor: General Manager Asia Paci c, Anaqua. Sponsored by Dumont 65 Directory of services An A to Z list of the international law firms who provide IP related services.

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Contents_TPL52_v1.indd 4 23/02/2021 13:22 Contents_TPL52_v2.indd 5 25/02/2021 11:59 MEET THE EDITORIAL BOARD

Ken Adamo – IP Attorney USA Simon de Banke – Founder & CEO, Ken has extensive trial experience as lead IP Centrum counsel before state and federal courts and the Simon de Banke is founder and CEO of the US International Trade Commission. high-tech-focused IP Services disruptor IP Centrum.

Dr Saiful Khan – Potter Clarkson Enrique A. Diaz – Goodrich Riquelme Saiful is a Partner and Board Member at Potter Enrique is head of the Industrial and Intellectual Clarkson who practises in both the Electronics Property Department. He currently manages the & Computing Group and the Design & prosecution of over 3500 and more Group. than 1000 per year.

Osamu Yamamoto – Yuasa & Hara, Mark Durrant – Director of Marketing and Osamu Yamamoto is a patent attorney, Communications, Marconi Group and a managing partner of Yuasa and Hara. Mark spent thirteen years at Nokia, most He specializes in patents in the fields of recently as Director of Communications for Nokia biotechnology & pharmaceuticals. Technologies, He is now Director of Marketing and Communications at Marconi Group.

Pravin Anand – Anand & Anand, India Eric Su – HongFangLaw, Pravin Anand, managing partner of Anand Eric Su is founding partner at HongFangLaw and Anand, is an and a patent and and studied law at the East China University of attorney. Politics and Law and chemical engineering at the North University of China.

Noel Courage – Partner, Sergio Olivares Jr. – Olivares, Mexico Bereskin & Parr LLP Sergio Olivares leads the multi-award winning Noel Courage is a partner and patent attorney patent practice at the law firm Olivares and is at Bereskin & Parr LLP, working in its Toronto widely recognized as one of Mexico’s leading office. His practice focuses on patenting and patent attorneys. licensing of life sciences inventions.

Stefan Schohe – Boehmert & Boehmert Dr. Claudia Tapia – Ericsson, Stefan is partner at Boehmert & Boehmert. He Claudia is Director of IPR Policy & Legal mainly works in the fields of IT and physics, with Academic Research at Ericsson. She is Chair a focus on litigious issues. of 4iP Council and vice chair of the Patent and Technology Licensing of LESI.

Caitlin Heard – Partner, CMS Valery Medvedev – Gorodissky & Caitlin’s principal area of expertise is Partners, multi-jurisdictional patent litigation. She has Valery is the Managing Partner and in charge of acted on a number of high-profile disputes the largest IP practice in Russia. He is a Russian across a range of technical areas. and Eurasian Patent Attorney.

Vitor Fidalgo – Lecturer at the Eugene Goryunov – Partner, University of Lisbon Faculty of Law Haynes and Boone Vitor is also Legal Director at Inventa International, Eugene Goryunov is a partner in the Intellectual implementing the best IP strategies and Property Practice Group in the Chicago office enhancing the profitability of assets. of Haynes and Boone and an experienced trial lawyer.

David Harper – Cedar White Bradley Maria Zamkova – Fenix Legal KB, David is a Partner at CWB, and heads up its Sweden regional Patent and IP Disputes teams. With over Maria has a Master of Industrial Design and is 12 years of Middle East experience, David has a a patent and . She is an wealth of regional experience in advising on all expert in European Patents. aspects of intellectual property law.

The Patent Lawyer would like to thank the Editorial Board for their time and support.

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Editorial Board_TPL52_v2.indd 6 23/02/2021 10:17 KT Patent FP.indd 1 05/02/2020 14:35 PATENTING ALLOYS 9 23/02/2021 10:30 Accordingly, for for Accordingly, 1 THE PATENT LAWYER Izobretatelstva. Patentnaya Okhrana Sovetskogo Eksporta [Main Inventive Act Issues. Patent Protection of the Soviet Export], Vneshtorgizdat, ; p. 202. For example, in the 30s of the last century in the last century in the 30s of example, For “properties of a concept rise to gave This provision

Kheyfets, I. Ya. (1935). Osnovnye Problemy example, if “stainless” steel had paramagnetic paramagnetic had steel “stainless” if example, examination patent during intensity varying with a in the initial objects such as alloys technical of again USSR period and it is gaining adherents the Russian of in practice particularly nowadays, Office (RUPTO). Trademark and Patent 1 been unambiguously recognized to be patentable to recognized been unambiguously been as such, but at the same time it has should features what set of discussed persistently solution classified as “alloy”. define a patentable be to considered not was the USSR, an alloy technical valuable “specifically if patentable use are scope of new that determine properties alloy”. in a known discovered be considered not would such an alloy properties, be patentable. to that can be detected alloy” a known to inherent applied was concept This person. skilled a by Mikhail Samsonov Anatoly Nistuk treatise treatise

been historically historically been chemicals, “alloys” chemicals, “alloys” aving come into the life of people people of life the into come aving were civilization, alloys of at the dawn the important to becoming increasingly Anatoly Nistuk and Mikhail Samsonov, of Gorodissky & Partners, examineAnatoly Nistuk and Mikhail history and give an evaluation of both thethe patenting of alloys through to patenting. RUPTO and the EAPO approach By the time of establishing patent systems at systems establishing patent the time of By for such restrictions Despite point that by about 1550, at the time the about 1550, at the point that by and have own their of a category into allocated “De re metallica” was written by Georgius by written was metallica” “De re CTC Legal Media Approaches to Approaches before alloys patenting and the Russian the offices patent Eurasian H “leading a for a precondition were they Agricola, lifestyle”. civilized were alloys the 20th century, the beginning of mankind that it allowed important for so already compounds chemical of the fate avoid them to solutions at that time as unprotectable recognized one example As nature. of based on the laws the USSR Article 3 of such recognizing, of Technical and on Inventions Regulations be 9, 1931 may April dated Improvements “Invention which: to according here, mentioned new for issued be shall patents and certificates food, medicinal, manufacturing methods of substances obtained other and any flavouring, the for means, but not chemical through substances themselves.” as a patent subject-matter have have subject-matter patent a as Gorodissky_TPL52_v5.indd 9 30/04/2019 15:39 Gorodissky_FP.indd 1 PATENTING ALLOYS PATENTING ALLOYS

As a remark, it is worth noting that initially it Although, in our opinion, this issue was not computer-implemented algorithm, for example considered as their prevailing specific features. involved exactly discovery of specifically valuable supertopical at that time due to the fact that the using an artificial intelligence, which the RUPTO Moreover, a purpose of creating new alloys, technical properties of a known alloy, and the problem of a variety of alloys and development has recently attempted to implement. excluding purely theoretical studies, is precisely use of said provision was limited to this case. At “What set of the art was levelled by the fact that the role It is the alloys that, due to their initial special “The the implementation of their certain functionality the same time, it remained unclear how to classify of characteristics of alloys in the claims was position, have been fully affected by these changes through unique properties. the case when specific valuable properties of of features assumed by a purpose and properties of the in approaches, which is why today, in the case of properties At the same time, according to the regulations the alloy were obtained purposefully as a result of should alloys, which allowed skilled persons to define the RUPTO and the Eurasian Patent Office (EAPO), of an alloy applied by the RUPTO, an “alloy” is assumed to inventive activities, selection of a certain ratio of alloy new technical solutions so as to distinguish them “alloys” again have to prove their right to be fully exist outside the environment. components from known ranges, and relevant define a from those previously known.2 classified as a result of intellectual activity and are a In our opinion, an alloy property defined by a process operations to manufacture the alloy. The reappearance of market competition at to be defined by sufficient combinations of features measurable or calculable quantitative parameter Numerous alloys, new requests, and new pertinent patentable the end of the 20th century in Russia resulted in that fully define the proposed technical solution. consequence is nothing but a measure of interaction with arts requiring suitable materials demanded a solution significant social changes, which affected all areas Although, in modern practice of the RUPTO and of its the environment, therefore, by excluding the constant improvement of the patent system as including the RUPTO. So, comparing to the USSR the EAPO, alloys are considered to be “substances” environment from consideration, the alloy to alloy patenting regulations. classified times, where the examination goal consisted in (see paragraph 47.10 of the Requirements3 and qualitative cannot be fully defined. In the Soviet times, the prevailing general as “alloy”. identifying new technical solutions for the benefit of paragraph 2.5.6.3 of the Eurasian Rules4), which and An examiner, being a skilled person having approach provided that a “general” solution did all state-owned collaborating enterprises, today the certainly corresponds to the existing definitions technical knowledge in the art to which the not discredit novelty of particular “implementations”; Office’s functions are shifting towards providing of alloys (for example, according to the definition quantitative subject-matter belongs (for example, metal moreover, skilled persons theoretically studied services in granting a patent to competing market given by the Encyclopaedia Britannica, “Alloy is industry for alloys), can step back not only from and discussed a possibility to extend the concept players. a metallic substance composed of two or more composition. formal consideration of a virtual object, but also of so-called “selection inventions” to alloys. This goal setting has resulted in a review of the elements, as either a compound or a solution)”. should see it in reality, interacting with the ” private existing practice and statutory provisions However, in practice, there is a situation when environment, that is, he or she may consider the taking as the basis a reduction in the processing the “alloy” as a substance is unambiguously alloy as the claimed subject-matter in the whole time and an increase in the scope of services subclassified as a “composition”, while there are variety of its features and properties, which is Résumés provided. restrictions imposed on it as to the features ” completely excluded when implementing the Anatoly Nistuk, Ph.D, Russian & Eurasian Patent Attorney, As a result, for example, the statement that used to define the alloy. formalized algorithm for comparing features Gorodissky & Partners (Moscow) the properties of an alloy are a consequence of currently proposed in the regulatory documents Anatoly holds an engineer diploma in physics and and PhD its qualitative and quantitative composition The most important of such restrictions is that of the RUPTO. from the Lomonosov Moscow State University of Fine Chemical chosen randomly has first appeared in the “to define a composition, it is not allowed to use In all fairness, it should be mentioned that the Technology, trained in an international IP firm and worked in R&D sector. recommendations for patent examination of an information that is not directly related to the described approach so far is only read in Since 2002 he has been working at Gorodissky & Partners, where he applications for inventions and utility models. composition itself as the composition features” regulatory documents, but it has not taken a counsels Russian and foreign clients on forming patent protection Accordingly, no evidence of an advance in the art, (see paragraph 39.3 of the Requirements* and dominant role when conducting the patent strategy of inventions and utility models in the spheres of: mining and when narrowing the known range, was required paragraph 2.5.4.4 of the Rules**); in both cases, examination by the RUPTO where examiners, processing of uranium and rare metal ores, production of basic and a solution was considered as disclosed if it such composition features are called, inter alia, “a due to their experience and practice, are still inorganic chemical products, electrolysis of aluminum, forging, could be obtained by a random search of quantitative (measurable or calculable) parameter guided by a rational approach to consideration pressing, stamping and rolling, powder metallurgy, manufacture of pointwise values out of the known ranges. It started that defines one or more properties of the of these subject-matters such as alloys. equipment for welding, surface heat and hot spraying with gases, to smoothly drift to adopting the provision that a composition”. It should also be noted that the existing tools chemical sources of power, semi-conductor components and others. general disclosure discredits novelty of all Direct adherence to the listed provisions of both the RUPTO and the EAPO make it He has a considerable experience of oppositions and appeals before particular forms covered by it, which is reflected results in paradoxical conclusions that: possible to consider any claimed solution, the Russian and Eurasian Patent Offices. He is a frequent speaker of in the regulatory documents effective today. 1. The properties of the composition defined taking into account the purpose and to the Russian and international events, an author of numerous articles. To achieve the goals set, an approach to by measurable or calculable quantitative extent of disclosure and examples given in the [email protected] ultimate formalization of the patent examination parameters should be considered as not description of the invention, through which it is has been proposed, backing off the technical nature directly related to the composition; quite possible to exclude unprotectable Mikhail Samsonov, PhD, Russian and Eurasian Patent Attorney, of the claimed invention, replacing it with formal 2. The alloys as compositions for patenting solutions but at the same time consider the Gorodissky & Partners (Moscow) reading of the features, and discarding those purposes cannot be defined by a claimed solution, in particular the alloy, as a Mikhail Samsonov holds an engineer diploma and PhD from the National features that require high technical competence measurable or calculable quantitative whole, that is, also considering its unique University of Science and Technology «MISIS», trained in The University in making a decision. In other words, according parameter defining one or more of its properties being defined, among other things, of Resources (Freiberg, Germany) and international IP firms. Worked in to an approach by the RUPTO, an “alloy” is assumed properties, since such a parameter by the parameters reflecting their properties. R&D sector and in industry before joining Gorodissky & Partners in 2004. to exist outside the environment, that is, to be represents an information not directly 2 The issue is discussed in At Gorodissky & Partners, Mikhail advises foreign and Russian an attribute of the virtual space, and projections related to the composition. more detail in our previous Further, let us turn your attention to differences article: The Patent Lawyer, companies and research institutes on patenting strategy issues having into reality reflect only its gist and are inherent in the approaches of the RUPTO and the EAPO Gorodissky:Layout 1 specialties in mining and processing of ores, production of metals and to it in the whole variety of manifestations. In other words, an alloy being a patent 13/11/19 13:22 to the subject-matter expressed as an “alloy” alloys, production of industrial gases, manufacture of machinery and In fact, it appears as a slightly modified revival subject-matter cannot be defined by any of its 3 The Requirements for and considered essentially as a composition. equipment for metallurgy, manufacture of iron and steel pipes, surface of the afore-mentioned century-old concept properties which may be exemplified by strength, Application Documents for The mentioned provisions of paragraph 39.3 heat treatment and thermal spraying, powder metallurgy, recycling of that an alloy is non-patentable in case of a hardness, conductivity, magnetic properties, or Issuing an Invention Patent of the Requirements* and paragraph 2.5.4.4 of secondary raw materials, metallic and non-ferrous metallic waste and “discovery of specifically valuable technical any other measurable or calculable parameters. at the RUPTO. (subsequent the Rules** differ significantly in that the RUPTO scrap. properties in the known alloy”. At the same time, the approach actually references *) approach does not allow use of a measurable or 4 Rules for Compiling, Filing, Mikhail represents clients before the Russian PTO, Eurasian PTO, emerging at the RUPTO to consider alloys as calculable quantitative parameter defining one or and Considering Eurasian courts, in objection cases against patent grant, court cases on The main idea behind such formalization is patent subject-matters distinguishes from the Applications at the EAPO. more properties of the composition as a distinctive infringement etc. [email protected] creating completely unbiased patent examination historical approach according to which it is the (subsequently references feature of the composition. Whereas, according by delegating comparison of features to a properties of alloys that have always been with **) to the EAPO approach, such a feature is not

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Time scale Admissible features of composition (alloy) Differences

USSR and 1. Qualitative formulation (ingredients) Russia until 2. Quantitative formulation (content of ingredients) December 15, 3. Structure of composition 2018 4. Structure of ingredients 5. Physical, chemical and other characteristics 6. Preparation method features (for compositions of non-established or unknown formulation)

Since 1. Qualitative formulation (ingredients) Physical, chemical and other characteristics December 15, 2. Quantitative formulation (content of ingredients) and method features are not admissible 2018 in Russia 3. Structure of composition features if they are distinctive features over 4. Structure of ingredients the . 5. Preparation method features (for compositions of non-established or unknown formulation)

Since January 1. Qualitative formulation (ingredients) It is not admissible to use features of a 01, 2012 in 2. Quantitative formulation (content of ingredients) composition that are not directly related to EAPO 3. Structural characteristics the composition (for example, conditions 4. Preparation method features (for compositions of and modes of using the composition in any non-established or unknown formulation) process, method); quantitative parameter (measurable or calculable) defining one or more properties of the composition, if this parameter is used as the only feature defining the composition in an independent claim.

Table 1

allowed only if it is used as the only feature However, the purpose “for high-temperature a novelty over D1. based on the “broader — narrower” or “narrower defining the composition in an independent corrosive medium” of the alloy has been found As we can see from this specific example, the — broader” principle. However, these provisions claim. by the RUPTO to be an inadmissible feature EAPO’s approach to patentability assessment of have disappeared from the new Guidelines for The formal reading of these provisions makes related to the “use conditions” of the alloy in a alloys is actually much more loyal to applicants Patent Examination of Invention Applications at it possible to conclude that the approaches of high temperature corrosive medium. than that of the RUPTO. the RUPTO dated 2018. the RUPTO and the EAPO are similar. Feature (a) has been found to be an inadmissible Another important difference in the approaches Therefore, the broad application of the However, essentially, the EAPO’s approach is feature related to a calculable quantitative of the RUPTO and the EAPO appears during arguments based on the “selection invention” actually more loyal to applicants and makes it parameter (inadmissible calculable parameter). patentability assessment of selection inventions. concept in favour of patentability of selective possible to define alloys through a combination Feature (b) has been found to be an inadmissible Thus, on the one hand, pursuant to paragraph compositions in general and selective alloys or of their properties as used historically and is feature related to a measurable parameter 78 of the Rules for Compiling, Filing and glasses in particular has in fact become consistent with the common sense and the gist (inadmissible measurable parameter). Considering of Inventions Application Documents unlawful and virtually impossible. of developing and creating alloys and their Feature (c) has been found to be an inadmissible as used by the RUPTO, the concept of “selection improvements. feature related to a technical effect (inadmissible invention” is used in assessment of only an Let us consider this using a specific example Let us consider one specific example of technical effect). inventive step and only individual chemical of patent examination of a claimed getter alloy patent examination of a claimed alloy at the The rest alloy features defining the amounts compounds, but not in assessment of any other at the RUPTO. Independent claim 1 recites: RUPTO. In independent claim 1, an iron-based of X, Y, and Z of the elements A, B, and C, technical solutions, such as compositions, 1. A getter alloy consisting of: alloy (steel) has been claimed in the following respectively, have been found to be disclosed devices, and methods. Has in fact (a) element A in amount X form: in the prior art, i.e. in a known document D1. The Recommendations for Patent Examination “ (b) element B in amount Y “1. Iron-based alloy for high-temperature “It is possible As a result, the alloy claimed in independent of Invention Applications dated 2009 and become (c) one or more optional additional corrosive medium, comprising: claim 1 has been rejected by the RUPTO as previously effective at the RUPTO have provided element in amount Z - element A in amount X to fully having no novelty over the document D1. for in paragraph 9.1.12 that: “Methods for unlawful (d) element C the balance. - element B in amount Y automate However, if the EAPO’s approach was applied assessment of compliance of selection inventions and - element C in amount Z to this claimed alloy, then, since neither the with the inventive step condition are generally At the same time, both a ternary getter alloy wherein the patent feature of the purpose of the alloy nor the the same as the methods for the inventive step virtually with elements A+B+C and a quaternary getter (a) a ratio of X + 2Y – 3Z > 10 features (a), (b), and (c) of the alloy are the only assessment of other chemical compounds impossible. alloy with elements A+B+C + an additional element (b) having a mechanical strength of S, and examination. features of the alloy in independent claim 1, all having an established structure”. In addition, have been identified in document D1, known (c) allowing for pitting corrosion resistance these features would be considered to be paragraph 13 of these Recommendations has from the prior art, however, the ternary alloy has of a rolled product.” admissible and, as a result, the claimed alloy provided methods for patentability assessment only been formally covered by the claims of would most likely be found by the EAPO to have of an invention correlated with a known solution document D1, but has not been disclosed in the

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23/02/2021 10:49 15 THE PATENT LAWYER He has been engaged in He is good at solving inventiveness Résumé Attorney Patent Xiaofeng, Tang Mr. Tang specializes in patent litigation, patent invalidation, and strategy, covering various technical fields such as pharmaceutical chemistry, formulation, biotechnology, and polymer. issue and insufficient disclosure issue and is skilled in obtaining patent rights and defending patents against invalidation attacks. pharmaceutical patent attorney for nearly 30 years handling more than 2500 patent applications at home and abroad, and easily recognize examiner’s errors. He is familiar with inventive examination standards in US, EPO and JP, and easily communicate with foreign patent . Sometimes foreign lawyers really don’t know know don’t really lawyers foreign Sometimes how to appropriately respond to Chinese puzzling to respond appropriately to how sufficient, not are reasons because the patentees’ judgment. judicial wrong due to and some are the correct due to course, some are Of should patentees judgment and applicants or lost the lawsuit. have Official Actions or preliminary judicial decisions. judicial preliminary or Actions Official applicants or for reasons many be may There because Some are a lawsuit. lose to patentees the for subtle too are Actions the Official are some defects, overcome to applicants ” Tang Xiaofeng Can’t Can’t confirm or whether not the compound of the application indeed has a longer duration of activity. “ may have known that it is not that it is not known have may proportion of the invalidated cases invalidated the of proportion hina’s huge and growing pharmaceutical pharmaceutical huge and growing hina’s applications patent has attracted market Some important world. the over all from Tang Xiaofeng, Patent Attorney of Beijing Geach Intellectual Property LawTang Xiaofeng, Patent Attorney of recent rulings concerning reexaminationOffice, gives an overview with comment based on personal experience.decision and non-obviousness Patent litigation mainly includes infringement includes litigation mainly Patent Patent lawyers with Chinese pharmaceutical with Chinese pharmaceutical lawyers Patent easy to obtain patent protection in China. Even if if in China. Even protection patent obtain to easy on challenged is it if granted, is patent the the validity, inventions are not allowed, and some allowed and some allowed allowed, not are inventions infringement challenged because of are patents patent of number large a in resulting issue, litigation cases. litigation. Relative litigation and administrative technical other in cases infringement patent to for fields than pharmaceuticals, it is easier be infringement to patent pharmaceutical lies in a lawsuit win to and the key determined, and questioning evidence. providing obtaining, the most litigation, patent pharmaceutical For important and difficult litigations are litigations, administrative patent pharmaceutical or decision reexamination originating from whether is hit critical which decision, invalidation involving mainly patentable, is invention the issue and insufficient disclosure inventiveness infringement patent issue. Pharmaceutical the patent leads to litigation generally the accused by challenge initiated invalidation which bring about pharmaceutical infringer, litigation. administrative patent CTC Legal Media C is very high. Some invaluable pharmaceutical pharmaceutical high. Some invaluable very is some or been granted, not have inventions involving invalid been declared have patents granted three-to- the last in Only disputes. infringement pharmaceutical branded of dozens years four proceedings. invalidation begun patents Introduction to and to Introduction comment on typical pharmaceutical Chinese litigation case patent patent practice patent Beijing Geach_TPL52_v6.indd 15 23/02/2021 10:31 CTC Legal Media

7 Taking into account all the above, we can see see can we above, the all account into Taking Contact & Partners Gorodissky 25, bldg 3, Str., B. Spasskaya 129090, Russia Moscow (495) 937-6116 Tel: +7 www.gorodissky.com [email protected] similar to the EPO’s criteria. the EPO’s to similar that the approaches to patentability assessment patentability to that the approaches are EAPO the and RUPTO the at alloys of along but, changing and improving, constantly that the RUPTO’s stated with that, it can be patentability alloy the to drifting are approaches the at as back far as used methods assessment while the EAPO’s 20th century, the beginning of to and loyal advanced more are approaches on focused generally applicants, are the of with the approaches harmonization such as the EPO, offices patent leading world’s in this innovations aimed at stimulating and are field. long-established technical ” Maria A. Serova in the Russian magazine “Patents and Licenses”, No. 1, 2017, pages 58-69. E. Ignatov and Maria A. Serova recently published in the Russian magazine “Patent Attorneys”: “Patentability Assessment of Inventions related to ‘Composition’ Subject- matter”, Part I in No. 3, 2018, pages 42-51 and Part II in No. 4, 2018, pages 29-39; “Particulars of Filing and Examination of Divisional Applications for Inventions at the Eurasian Patent Office” No. 1, 2020, pages 48-58; and “Once again about Selection Inventions” No. 2, 2020, pages 34-43). (see page 67). Michael E. Ignatov and the articles of Michael (see 5 6 7 Known Known from the prior art. “

6 t’s arguments that the arguments t’s of selection inventions, selection inventions, of says literally as follows: “The subject- as follows: literally says 5

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However, despite of such non-disclosure in in such non-disclosure of despite However, When considering the corresponding selection Understanding the importance of patentability criteria for selection inventions quite quite selection inventions for criteria patentability 14 Eurasian Rules** so as to clearly prescribe specific prescribe clearly to as so Rules** Eurasian matters of such inventions (i.e. selection inventions) inventions) (i.e. selection such inventions of matters chemical (individual products can be both compounds, compositions) and methods.” PATENTING ALLOYS PATENTING description of D1, while the quaternary alloy has has alloy quaternary the while D1, of description experimental the in details in described been D1. of in the description given examples an by has been found alloy D1, the ternary D1 from be known to RUPTO the of examiner same the At novelty. no having therefore, and, taken has not the RUPTO of time, the examiner account the applican into and that the is selective alloy claimed getter D1 is in fact from known allegedly alloy ternary D1, therefore, of disclosed in the description not implement art could not a person skilled in this D1 on the claims of only based such alloy preparation on data experimental any without which such alloy, of methods and properties the between agreement the social means that as detailed information obtain seeking to society further for inventions as possible about new holder, in the art and the D1 patent progress the for protection patent who has received without disclosing any alloy ternary complied been data on it, has not experimental the applicant has been forced a result, As with. of limit the claimed composition excessively to A+B+C so as to with elements alloy the ternary is that alloy ternary the from a difference ensure the claims of from known formally only D1. document Office (EPO), at the European the claimed of the selectivity the contrary, to and the has been observed alloy getter been considered document D1, although having not to found been has examiner, EPO the by of step inventive the and novelty the discredit a and, as a result, alloy the claimed getter containing the claim shown patent European granted. has been above specifically innovations, stimulate to inventions arts, well-studied and in the long-developed an demonstrated recently often has EAPO the the European to similar generally approach the confirms general, in and, approach patentability conceptual invention” “selection that the term despite even Rules**. used in the Eurasian explicitly yet is not the article titled “Patent one example, As at the Chemistry in Inventions of Examination heads of published by Office” Patent Eurasian and Chemistry the EAPO Department of Medicine Moreover, the EAPO is considering a possibility the EAPO is considering a possibility Moreover, the of provisions change the regulatory to Gorodissky_TPL52_v5.indd 14 CHINESE PHARMACEUTICAL PATENTS CHINESE PHARMACEUTICAL PATENTS

satisfied with the reexamination decision and activity. Therefore, the purpose of the present In this case, compared with the compound disclosed filed an administrative lawsuit with Beijing First invention is to provide a betamimetic, which in example 4 of D1, the distinguishing technical Intermediate People’s Court of PRC, which plays a therapeutic effect in the treatment of feature is that the position of hydroxyl in benz- however upheld the decision. Boehringer refused COPD, has a long active period, and can be “Synthetized oxazine ring structure is different: the hydroxyl to accept the Court’s administrative judgment used to prepare medicaments with a longer group of the compound of formula 1a in claim 1 and appealed to Beijing Higher People’s Court. duration of activity. The other objective is to a false is in position 6, while that of the compound However, the appeal was rejected, and the original provide such a betamimetic, which are not only conclusion. disclosed in Example 4 of D1 is in position 5. For judgment was upheld. Based on the above- exceptionally potent but are also characterized the compounds of general formula 1 disclosed in mentioned parent application, the applicant by a high degree of selectivity with respect to D1, although the position of the hydroxyl group filed two divisional applications with application the β2-adreno-receptor. Examples 1-35 prepared on the benzene ring of the benzoxazine ring is not numbers 2009102663272 and 2010100046971. some specific compounds and provided some limited, those skilled in the art can reasonably The two divisional applications were still rejected examples of drug preparations, but the ” determine that the hydroxyl group can and can by the Patent Office on the grounds of insufficient experimental data on the activity of the only be at position 5, 6 or 7 of the benzoxazine disclosure of the specification and lack of compound and the experimental data on the ring. In the case that the range of choices is so inventiveness respectively, and the Patent active action period and selectivity were not limited, it can be concluded that the compound Reexamination Board maintained two rejection recorded in the description. Therefore, those of general formula 1 clearly indicates that the decisions. The applicant sued to Beijing skilled in the art still can’t confirm whether or hydroxyl group may be at position 6. In addition, Intellectual Property Court and then appealed to not the compound of the application indeed has those skilled in the art know that the conventional Beijing Higher People’s Court separately, which a longer duration of activity and its activity or position change of hydroxyl group usually has ended in upholding the reexamination decisions. selectivity is superior to D1. Therefore, the little impact on the activity of the compound. Lastly, the petitioner appealed to the Supreme collegiate bench believes that based on the Therefore, in the case that D1 has given the People’s Court for retrial. After retrial, the Supreme above distinguishing features, the technical technical indication that the hydroxyl group can People’s Court made two decisions to reject the problem actually solved by the invention is to be in the position of 6 and only limited selection Boehringer ‘s petitions for retrial. This national obtain a betamimetic with similar structure, is needed, it is easy for those skilled in the art to phase application triggered eight independent which can be used for the treatment of COPD. think of modifying the hydroxyl group from oral hearings. This paper will discuss the litigation The D1 discloses the corresponding general position 5 to position 6 on the basis of example cases about the former divisional application formula I: 4 of D1, so as to obtain the compound in claim 1 only. of the application. Therefore, claim 1 has no prominent substantive features compared with Reexamination decision D1, and thus is obvious. Claim 1 claims a compound of formula Ia: (2) Can the supplementary experimental data The author takes the following Administrative submitted by Boehringer prove that the Ruling of Supreme People’s Court of the PRC patent application has the alleged (2018) Supreme Court Xing Shen No. 3961 technical effect? between Boehringer Ingelheim Pharma GmbH Boehringer has submitted supplementary &co.KG (hereinafter referred to as Boehringer) experimental data to prove that claim 1 of the and the State Intellectual Property Office as an Where R1 is R2 selected from application has achieved extremely strong example, which is the only case involving medicines “It is difficult Reference document 1 (D1) discloses a effect and highly selective technical effect on among 50 typical intellectual property cases in betamimetic, which can be used to treat COPD. β�2-adrenoceptor compared with D1, so it has Chinese courts in 2019. Its family applications for a person The compound of example 4 is specifically inventiveness. In this regard, the court considers have been allowed in many countries and skilled in disclosed: (Observations on inventiveness of claim1 in that the evidence on the case cannot prove that regions, and the drug-Olodaterol involved has this paragraph are substantially the same as the patent application has achieved the above- been sold in more than 30 countries. This is a the art to those given by Supreme Court, and the mentioned unexpected technical effect, and difficult and interesting case, involving the reasonably observations together with observations on the main reasons are as follows� typical legal issues during Chinese pharma- claims 2-4 are overlooked in order to save paper First of all, in the field of medicinal chemistry ceutical patent practice, which has a very typical determine space.) to which the application belongs, its research significance in the Chinese pharmaceutical Both the court of first instance and the court foundation is experimental science, and its patent litigation cases. the of second instance upheld the view of the predictability is relatively low. The realization of objective The difference between the compound of reexamination decision. technical solutions or the existence of technical Brief of the case formula Ia in pending claim 1 of the application effects largely depends on the verification and The international application PCT / EP2003 / existence and the compound in example 4 of D1 lies in the Supreme Court Decision support of experimental data. The condition that 012565 of Boehringer entered Chinese national of the position of hydroxyl in the benzoxazine ring During the retrial proceeding alone, the retrial the supplementary experimental data can be phase with title of a novel medicament for the structure: the hydroxyl group of formula Ia in petitioner submitted 21 new evidences to the accepted is that it can only be used as treatment of chronic obstructive pulmonary technical claim 1 is at position 6 of benzoxazine ring, while Supreme Court to prove the technical effect in reinforcement evidence to further prove the disease. The parent application was rejected the hydroxyl group of compound 4 in example 4 the specification and the commercial success technical effect disclosed in application document. by the Patent Office on the ground that the effect. of D1 is at position 5 of benzoxazine ring. of the claimed compound. Secondly, if a person skilled in the art is specification was not sufficiently disclosed and According to the description, for drug unable to reasonably determine the technical was still maintained rejection by the Patent treatment of diseases it is often desirable to (1) Is the patent application involved in the effect which is merely claimed or asserted in Reexamination Board. Boehringer was not ” prepare medicaments with a longer duration of case obvious relative to D1? the application document but is not confirmed 16 THE PATENT LAWYER CTC Legal Media CTC Legal Media THE PATENT LAWYER 17

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features and the commercial success, can it be deduced reversely, that the technical solution of the invention is not obvious, so that the invention , has inventiveness. The evidence submitted by Boehringer Don t gamble cannot prove that the patent application has achieved commercial success. The technical solution of claim 1 of the application is obvious over D1, and the existing evidence cannot prove that the application has with your IP rights achieved unexpected technical effect or obtained commercial success.

Comments Individual opinion possibly differs even in respect to the same question. The applicant has made so many efforts but has not yet been able to persuade the reexamination board or the courts successfully. In the author’s opinion, the present invention absolutely has inventiveness, and it is much easier to elucidate the inventiveness of the present invention than to demonstrate its inventiveness by many evidences, and even hitherto there is an opportunity to overturn the case. The conflicting opinions of the plaintiff Since 1950, provides by qualitative or quantitative experimental data (appellant, petitioner) and the defendant Modiano & Partners or other objective basis, it cannot be proved by (appellee, respondent) interacted and supplementary experimental data. synthesized a false conclusion. It is often said highly specialized assistance on all facets Finally, although the specification of the that asking the right question is often equal to application does record the technical effect of solving the problem. Due to the limited space of of Intellectual Property Law, “it is not only extremely powerful but also highly the paper, the author will not comment on the selective in terms of β� 2-adrenoceptor”, and the specific reasons in detail. It is worth mentioning ǁŝƚŚŽǀĞƌϭϮϬWĂƚĞŶƚͲdƌĂĚĞŵĂƌŬƩŽƌŶĞLJƐ͕ technical effect is not disclosed in D1, there is no that the author has handled a much more qualitative or quantitative experimental data on difficult patent case than this one and is waiting the technical effect in the description, and there for judicial decision of the Intellectual Property serving more than 6,000 clients worldwide. is nothing else to confirm. It is difficult for a Court of the Supreme Court. The author has person skilled in the art to reasonably determine clearly explained to the judges the reasons why the objective existence of the technical effect at the present invention is non-obvious. the date of application based on the contents Some applicants or patentees may be disclosed in the description and the common puzzled on why their invaluable inventions knowledge in the art based on their knowledge cannot be protected in China. Here, the author level and cognitive ability. In this case, it is not suggests that they should pay more attention possible to prove that the patent application has for choice of their litigation strategies and first achieved unexpected technical effects consider whether or not selective defense is compared with D1 based on the supplementary sufficient, rigorous, and appropriate. If others experimental data submitted by Boehringer. cannot refute their arguments, the patents will � be inevitably established. (3) �Whether the patent application has That the achieved commercial success “ When the petitioner alleges that the invention technical Contact ƵƌŽƉĞĂŶWĂƚĞŶƚĂŶĚdƌĂĚĞŵĂƌŬƩŽƌŶĞLJƐ has achieved commercial success, it shall be solution Beijing Geach Intellectual Property examined whether the relevant evidence can Law Office MUNICH MILAN LUGANO prove that the technical solution of the invention of the Room 525, Building B, Fucheng Mansion has achieved commercial success and whether No. 98 Beilishi Street Jia, Xicheng District the commercial success of the invention stems invention is Beijing 100037, P. R. China from distinguishing technical features of the not obvious. Tel: +86-10-68318129 invention from the prior art, rather than other [email protected] factors. Only when there is a direct causal www.geach.com.cn relationship between the distinguishing technical www.modiano.com [email protected] 18 THE PATENT LAWYER ” CTC Legal Media

Beijing Geach_TPL52_v6.indd 18 23/02/2021 10:50 Modiano FP.indd 1 16/12/2020 10:59 BENJAMIN HOOPES OF HP 23/02/2021 13:17 21 THE PATENT LAWYER Do you use outside counsel at HP? you use outside counsel Do what circumstances? And under team isn’t very big We do. Our in-house amount of IP we develop compared with the rely quite a bit on outside and protect, so we do patent applications are counsel. Most of our so we have outside drafted by outside counsel, world. If a patent is drafted counsel around the that by outside counsel in the US, then typically that and handle prosecution the do will counsel similar side of things in their jurisdiction. This is for European and Asian firms as well. when you use do What parameters firms and which law deciding on use? to outside counsel we There definitely are different criteria that firms which on depends it Personally, at. look are easy to deal with. If you keep my paralegal happy, you are in a good place! How does this problem exist if it is outside of of if it is outside this problem exist How does their solution? If of their product, or the context more bit little a problem that understand we broadly capture it’s easier for us to broadly then are proposing. that solution that they ” We have have We outside counsel around the world. “

The process includes getting this IP captured, captured, IP this getting The process includes CTC Legal Media When working with R&D groups on with R&D groups working When portfolio, patent HP’s developing innovation? you identify do how process? your is What in place to help make We have a formal process very IP-savvy engineers who know what they are very IP-savvy engineers which developmentslooking for and understand really this so – IP protectable potentially are helps. very this gives the opportunity for me to work closely with the engineers to ensure everything what is is captured properly, then we review decide being proposed by the engineers and when I whether or not to file on it. Personally, the help and try I what capture, IP approach for easy it’s – problem the is on focus engineers the engineers to think of their solution within on, four walls of the product they are working getting so one of the exercises we go through is them to think of the problem more generally. sure we are capturing the IP that is developed sure we are capturing program a for instance, groups. For R&D our by have check points where or project we will have meetings with the we will check in and we will discuss what is engineers and where have a lot of excellent, being developed. We Ben Hoopes interview_TPL52_v3.indd 21 23/02/2021 11:02 CTC Legal Media There are also opportunities to move within There are also opportunities to move within asking you to incorporate business considerations, limited asking you to provide counsel in view of all that resources, and so our job is to juggle based and come out with the optimal solution on all circumstances. I suppose I was tempted kind and seduced by the opportunity to do this the of work. HP itself, although we are not proud young kid on the block anymore, is very of its culture, which kicked off Silicon Valley by the way. And the combination of this work and the HP culture is such that I really enjoy working here. with HP you been long have How the you to what attracted and company? I joined in January 2017. HP is very proud of their culture and their openness. As an attorney, we are given the opportunity to thrive in our position. We are given the space to accept our role and carry the mantle forward and really grow and progress as attorneys. We are given opportunities to take on projects that could potentially be outside of our typical role – these are really valuable growth opportunities. HP, within legal you can go from patent had have we transactions, IP to development attorneys that have moved outside of legal to business roles as well. There are definitely unique and special opportunities here. experiences, in-house counsel had a unique unique a had counsel in-house experiences, have to perspective. When you’re in-house you that balance a lot of business and legal risks worry necessarily doesn’t counsel outside want to about. In the private practice world, you to minimize all risk; in-house (while still needing executives you have business risk) minimize ” We have have We a formal process in place to help make are sure we capturing the IP that is developed. Benjamin Hoopes “

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the technologies of the future. about his experience in the IP field, his work as patent counsel, andabout his experience in the Benjamin Hoopes talks with The Patent Lawyer’s Editor, Faye Waters,Benjamin Hoopes talks with After my electrical engineering degree, I went I degree, engineering electrical my After After graduation I went into private practice at 20 In addition to finding that I wasn’t suited to In addition to finding that I wasn’t suited to contentious litigation, I felt that, based on my in-house previous with attorneys to exposure What made you decide to make the you decide to What made in-house counsel? change to former in-house attorneys at large tech companies, and that opened my eyes to that path. When the opportunity with HP presented itself, I jumped at it. Since joining HP I have managed the Inkjet Printer patent portfolio, and now I manage the Inkjet Print Head portfolio. I started out with an interest in science, and that I started out with an interest in science, and initially interest in science and engineering – pushed me towards aerospace engineering and because I was too tall and near sighted I university, At astronaut! an be couldn’t thus switched to electrical engineering. A professor more I mentioned patent law to me and the of idea the liked I more the it about thought patent law. Can you describe your pathway into into pathway your describe you Can role? current your and to IP Benjamin HoopesBenjamin HP’s Patent Counsel, Patent HP’s An interview with An interview BENJAMIN HOOPES OF HP OF HOOPES BENJAMIN on to law school and I got my Juris Doctorate. on to law school and I got my Juris Doctorate. property intellectual emphasizing courses took I law because I knew that was the path I wanted a for clerked I school law at While take. to couple of IP boutique firms and did some patent prosecution work. business complex did an IP boutique firm and to suited wasn’t I realised I there While litigation. contentious litigation. So that’s when I began focusing my practice on patent preparation and prosecution. I lateralled to another firm where we had quite a few attorneys who had been Ben Hoopes interview_TPL52_v3.indd 20 BENJAMIN HOOPES OF HP

I do prefer to use firms that are familiar with with my own, so I think it is a good fit. But this is MEXICO and used to the technology, and that I like their my experience. work product, too. If it is less time and work for me to review and correct application drafts, all One area “ What future technology are you the better. As long as firms check those boxes, I do my best to spread the work around the where most looking forward to using? firms that we do work with, as there are many. HP are One area where HP are innovating is in 3D innovating printing, we have these new 3D printers – built Out of those you have handled, on HP Multi Jet Fusion technology – where we Industrial and what case have you found most is in are using our inkjet technology and we can print one pass at a time and build up 3D objects quite interesting during your career? 3D printing. quickly. Intellectual Property I have had the opportunity over the last few So, when I think about 3D printing, if we years to work on a few projects that were compare it to the way that the word processor particularly meaningful for me and that I felt would made 2D printing so much more mainstream have a large impact in their own technology where in the home and the office environment realm. The group of engineers I have worked ” we can easily draft a document and print it out, Litigation with on these projects are very good, and what I am looking forward to a time, and I think we they do well is focusing on customer needs. are seeing a trend, when the barrier of entry for That focus on customer problems helps me, 3D modelling is going down. We have a little as a patent attorney, get on the same page as fused filament 3D printer at home, so my Licensing the engineers. We can discuss and strategize 13-year-old son is actually really good at our decisions and approaches for protecting Tinkercad™ and getting in there and building the intellectual property. So, for me, the learning these models really quickly – it blows my mind! Enforcement is really that ability to come to the table with the But I am looking forward to that barrier continuing engineers with almost childlike eyes, and to lower so that anyone could model something, willingness to view those things and get as test it, print it, really with relative ease. I don’t excited as the engineers are about the ideas, think this is that far off. Entertainment and think about what the customer’s problem is, really opens the doors to pursue broad and Where do you take inspiration and Sport Law powerful patents. And these aspects are what from? make a case exciting for me. Professionally, I definitely have had many Do you miss your role in the private professors, engineers, and lawyers with whom Copyrights practice environment? I’ve crossed their paths and I am very admirative and appreciative of what they have done. One thing comes to mind that I don’t necessarily I mentioned earlier my former partner, he is a miss. I don’t miss the stress of never having an brilliant man, and I am very much in awe of his off button to my work life. At my last firm, a legal and technical knowledge – he is a good Enrique A. Diaz [email protected] (5255) 5525 1422 partner, who I actually adore - he is amazing and example of someone that I look up to and as a great person -would send me these strings of someone who inspires me. increasingly stress-inducing emails late in the Here at HP, we have many some giants in the Jaime Delgado [email protected] (5255) 5207 5324 evening or at the weekend. I would regularly be legal field on our team, and I am very inspired by sitting with my family for dinner and I would what they accomplish day in and day out. receive a notification ding on my phone, a ding Then personally, my parents and my wife are Juan Carlos Suarez [email protected] (5255) 5207 9261 that was connected to my work emails, and all all very hard-working people and I definitely of a sudden my heart rate would increase, and look up to them and find inspiration in everything Guillermo Sosa [email protected] (5255) 5207 7561 I would feel the stress growing as more they do. notifications would come in. And I would have to get up from the table to try and resolve We are living in a very exciting time in which whatever it may have been that was occurring. technology plays an ever-increasing role in our e-mail: [email protected] I certainly don’t miss that side of things. lives, and so, as attorneys working closely with I suppose that is one of the trade-offs for innovators, and often as innovators ourselves, website: www.goodrichriquelme.com going in-house, there are lifestyle advantages we have opportunities to use that technology to (though, I have noted that the off button help transform people’s lives and help becomes more difficult to press as you advance transform things for the better and I think it is a Paseo de la Reforma 265, M2 through the corporate hierarchy). It isn’t the special and unique time to do just that. To step panacea for all private practice ills, going in- up to the plate and take a swing at that, to do all Col. y Del. Cuauhtemoc, 06500 Mexico, D.F. house. I think I am fortunate to have found a that we can to protect our client’s interests is Tel. (5255) 5533 0040, Fax. (5255) 5207 3150 company with values that are closely aligned very special and worthwhile.

22 THE PATENT LAWYER CTC Legal Media

Ben Hoopes interview_TPL52_v3.indd 22 23/02/2021 11:03 IP STRATEGY

23/02/2021 11:12 25 THE PATENT LAWYER so give it to him Résumé at DTS Partner Wende, Christian Christian is a German and European Patent Attorney. He has a Master’s Degree (Dipl.-Ing.) in Mechanical Engineering of the Technical University of Munich (TUM) and earned a PhD for his work in the field of liver dialysis. At TUM, he is Adjunct Professor for Patent Law. He is co-author of a Design Commentary for German and European Design Law. He advises clients in IP prosecution and litigation, but also M&A, and he is specialized in IP for Medical Technology. Further, he is very active in IP Due Diligence for inter alia large VC Funds and listed companies. This does mean for the external counsel that counsel the external mean for This does In my practice, I do not accept such “no- accept I do not practice, In my done in the specific, what is The decision, 4. is seeking counsel, Your client attorneys young from especially seen, I have colleagues senior from but also and associates Due Diligences performing was when I (especially to the best of your knowledge you have to try to to try to have you knowledge your the best of to and what can happen of estimate a clear give know You happen. normally will think you what develop. will things can and in most cases how the and explain and anticipate “forecast” to Try is needed on the This information scenarios. wants he not or whether decide side to client’s with the matter. pursue to on the buyer’s side), that in difficult situations that in difficult situations side), on the buyer’s a with client the confront to tendency a is there explanations and a lengthy options of plurality are they problems legal (huge) what kind of of is given. recommendation clear No facing. members and team my I encourage counsel”. the to provided is always that counsel care take with the deal to how know to want They client. the point, they to be a bit more to situation. Or in were would do we what we if want to know more have we situations most In shoes. their the legal about and knowledge experience counsels, should as external we, situation and about, is all technology what the client’s know similar or is done in parallel or was what suggest to situations, and use that knowledge do. what to side. course, on the client’s of remains, ” This helps to streamline the whole process of drafting and for approval filing. “

is a regular touchpoint. It is especially especially is It touchpoint. regular a is I am aware of several discussions where where discussions several of aware am I There is some truth in this and it is very polemic, very is it and this in truth some is There What does this mean in M&A? – At some some At – M&A? in What does this mean mutual a have is that? It is important to Why important for the external counsel to understand to counsel external the important for it is counsel the internal needs. For the client’s the external whether get a feeling, to necessary Trust job. do the person to is the “right” counsel when it gets the grow only it can is the key; grow. to chance just discovered were problems legal accidental for ideas Or chat. to time was there because were because the inventors “born” were patents the of in front counsel with the external standing good give So break. coffee a on machine coffee it. worth it is develop, to things room CTC Legal Media presentation of your argument is lengthy and and is lengthy argument your of presentation understand, how to problematic you, for even, in vote and the judges understand then can more the them, convince to want You favor? your 3. Expectation Management when the outcome arise, will can and Huge problems quite can develop matters that clients know years, And an important than expected. differently impacts on the negative avoid to measure is that among the collaborators relationship a matter of about the outcome expectations possible of in the range be kept should always in place warranties also no are There outcomes. is It guaranteed. be cannot that outcomes for no statement is absolutely there also bad if about possible outcomes. 2. Talk with each other been calls have regular and/or Meetings Regular if develop This can only be achieved. goals to there of a matter is not as expected. When I started When I started as expected. is not a matter of me said to mentors my one of in IP, career my then outcome has a positive the matter that if the fact due to was claim that it will the clients be decided otherwise could not that the matter the – and if matter the because of was and it blame. is to is bad then the attorney outcome the over experience hand, in my on the other language you need to transport your argument, argument, your transport need to you language to others it be for will problematic the more going down. chances are your and so follow findings to your report to have will you point the all in interested really not is who someone, this but work, Diligence Due your of details are there whether understand person needs to even or nature financial of serious risks, either the to sharp be to necessary is Then, it worse. get will you otherwise risks, real points that form will consider points to lost in details and the real be transported. not be important. to proven and used be to methods about understanding DTS_TPL52_v3.indd 25 23/02/2021 11:12 CTC Legal Media So, one important aspect of quality in IP is that that is IP in quality of aspect important one So, in simple and communicate to Thus, try Some examples: drafting What does this mean in prosecution, specification and claims. They do not like ambiguities, like do not They specification and claims. with times many confronted are although they this. What does this mean in litigation? understands, involved that everybody sure Make your sure Make what is going on in the dispute. your If understood. well be can arguments litigate one day the patent, judges will understand will judges the patent, one day litigate worldwide, judges patent to listen you If better. what for protection you grant willing to are they that sure make So, please invented. have you patent your from can get this information they They did not need complex words and long and long words need complex did not They opinion – And this is – at least in my sentences. subjects. all for true basically and communicate someone can explain way. in an understandable matters complex accept understandable language. Do not true is this and understand not do you anything counsel external the for also but client the for the same is “on that everybody sure side. Make and implementing on work cannot You page”. people the involved if strategy maintaining an IP not counsel) are and external internal (e.g. talking about the same thing. understandable Use – application? patent a of and complex. abstract overly language. Be not Patent not are Inventors sentences. short Use under- The more Attorneys. Patent or Agents the language is, the standable and readable will the draft of the approval and faster better whole process the streamline This helps to be. you if And filing. for approval and drafting of ” How can you you can How to manage lost not get in details, a clear keep on the view big picture? Christian Wende “

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P strategy matters. Strategy is important and Strategy matters. strategy P their for a strategy have claims to everybody you? Do Really? IP. you assess it? in his experience, lead to successful practice.in his experience, lead to Christian Wende, Partner at DTS, provides a concise list of strategies that,Christian Wende, Partner From my experience in the IP profession I had profession in the IP experience my From pieces of summary is a subjective This report But even in incredibly difficult matters, it is it is difficult matters, in incredibly But even a simple example: of way this by explain to I try How can you implement an IP strategy in strategy implement an IP you can How business? daily get lost in not manage to you can How on the big picture? view a clear details, keep the most with some of work the chance to including worldwide, professionals IP renowned counsels. counsels but also internal external some years the and over practice Also, in daily crucial me that are to things became apparent be to crucial which are and be successful to in collaborating. successful my in successful be to proven have which the complete have claim to I do not practice. a successful implementing for and best recipe that doubts serious have also I and strategy is such a thing as a “best and one-fits-all- there strategy”. 24 IP matters are complex and sometimes also and sometimes also complex are matters IP This is true for understand. difficult to very litigation and last but but also for prosecution, and the transactions least also in M&A not Due Diligence. IP respective scenarios or complex explain possible to words. in simple subject-matter complex or teacher favorite your remember you when you made they university, or school in lecturer simple in matters understand the most complex examples. analogies or of way and by words 1. Quality matters – but how can

I

collaborating

to consider when consider to IP strategy: what strategy: IP IP STRATEGY IP DTS_TPL52_v3.indd 24 IP STRATEGY IP STRATEGY

5. Visualize your cases and topics the points that really matter and that you are know that litigation is easily started, but ended choice to negotiate a good commercial solution, - at some point of time you will really concerned with. And expect clear with difficulties? because this might be faster than the way up to have to show and report it questions and be prepared to provide clear And, as I am more active in the transaction the Supreme Court. To explain this point in a “visualized” manner, Trust is the answers. business and in IP Due Diligence, I can tell you Lesson “ “ 7. No surprises – talk about I would like to refer to one of my cases, which that investors do not like (or shall I say “they hate really impressed me: key; it can 6. Patience matters – impatience it”) legal uncertainty and unnecessary litigation. learnt: budgets In a Due Diligence review we had to check the only grow can be very expensive We want to see clear and certain conditions. In make things Last but not least: give a (preliminary) price tag Freedom to Operate (FTO) analysis of the target “This can’t be. They have to be stopped – a DD, and from the buyer’s perspective, we do for what you are intending to do as external company and we were acting on the buyer’s when it gets immediately. We need to take action.” not really care if you believe that you can win a visible, it is counsel. Or as internal counsel, or internal side. the chance When I hear this, I ask myself if the person litigation. We also understand that this needs to possible. responsible person, ask for a cost estimate. The The FTO findings were presented in perfectly really knows what this means? To take action be done from time to time and in most cases we external counsel has the experience, how much and professionally prepared slide deck, explained to grow. means starting a journey, which might lead agree with the findings, that there are good time and effort will be spent – under normal in all details and in a videoconference between through several instances, courts, offices and at chances to win the litigation. But we see legal circumstances. So why not at least give or ask two continents (and this was before the some point will end up in a final instance. uncertainty and not legal certainty. And legal for a rough estimate? It is possible. And it is pandemic). Lesson learnt: make things visible, it To set this clear: I am not against litigating, this uncertainty is less worth the legal certainty. If ” helpful for everybody. is possible. And then you can even do it in a has to be done if there is no other solution. there is no certainty, we simply reduce the offer video conference. ” But here we are: “If there is no other solution!” by the financial risk that we estimate or a part of It is clear that fancy slides do not outweigh I am aware of several cases, where impatience the purchases price is put into an escrow substance, but in this case slide deck and or the ego of the persons in charge has driven a account (with the risk for the seller that it will substance matched. And this is how it should be. case into unnecessary litigation, starting with a never be released). And this is really very Thus: have both – the usual detailed analysis warning letter, followed by a counter-warning expensive. Contact and comments and memorandums, which go letter and then you end up in proceedings to the Thus, my recommendation is that you better DTS Patent and Trademark Attorneys into details, give the arguments etc., but also merits, which no one really wanted. But, as you think twice whether you need start litigation and Marstallstraße 8, 80539 Munich, media, which allow a fast way to digest the are there now, and the other side is to blame for “to take action”. Germany content and a slide deck is a good way to it, you must win it. Yes there are cases when you really need to Tel: +49 89 219996-0 transport your key findings. It is possible to I am not complaining about this because as an take action, especially when your sales team [email protected] break down the key findings to the few points external counsel you just do the job. But I sometimes reports that the sales are going down because www.dts-law.com that really matter. Take your time and think of ask myself whether the decisionmakers really of copycats. But sometimes it is the better

    

26 THE PATENT LAWYER CTC Legal Media CTC Legal Media THE PATENT LAWYER 27

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Patent Power 50 Advert_FINAL.indd 1 23/02/2021 13:46 THE MIDDLE EAST AND AFRICA PATENT RANKINGS 2021 23/02/2021 11:15 31 THE PATENT LAWYER      Lebanon Nigeria Kenya Morocco SPACE TO FILL SPACE TO FILL Abu-Ghazaleh Intellectual Property (AGIP) Alem & Associates Baianat IP Cedar White Bradley NASSER & ASSOCIATES LAW OFFICE Obeid Law Firm Raphaël & Associés Saba IP Sader & Associates United Trademark & Patent Services CTC Legal Media Aluko & Oyebode ǼLEX Adeniji Kazeem & Co Allan & Ogunkeye Banwo & Ighodalo G. Elias & co Jackson Etti & Edu O Kayode & Co Olajide Oyewole LLP Stillwaters Law Firm Anjarwalla & Khanna Anjarwalla (Coulson Harney) Bowmans CFL Harrison & Mathews Dentons Hamilton ENSafrica Advocates Gikera & Vadgama Advocates(IKM) Iseme, Kamau & Maema Kaplan & Stratton MMC Asafo & Co Simba & Simba Abu-Ghazaleh Intellectual Property (AGIP) Baianat IP Cedar White Bradley CMS Francis Lefebvre Maroc HHH Avocats IB for IP Kettani Law Firm NJQ & Associates Saba IP United Trademark & Patent Services TPL52 rankings - Africa_v3.indd 31 23/02/2021 11:15 CTC Legal Media Israel Cameroon SPACE TO FILL Adin Liss Pyernik Dr Shlomo Cohen & Co Ehrlich Group Gilat Bareket & Co Liad Whatstein & Co Luthi + Webb Meitar Law Offices Pearl Cohen Zedek Latzer Baratz S. Horowitz & Co Soroker Agmon Nordman Akkum, Akkum & Associates LLP & Associates Akkum, Akkum Cabinet ISIS D. Moukouri & Partners Etah-Nan & Co Forchak IP & Co. Henry, Samuelson Ngu & Co Law Firm Firm Nico Halle & Co. Law Patimark SCP Global Africa IP Egypt

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Abu Ghazaleh Intellectual Property Baianat IP Cedar White Bradley Eldib & Co Hassouna & Abou Ali Helmy Hamza & Partners (Baker McKenzie) Ibrachy & Dermarkar Maddock & Bright IP Law Office Saba IP Shalakany Throughout the next few pages, you will view a comprehensiveThroughout the next law firmslist of the 10 most well-respected Middle from the country and company order.East and Africa, in alphabetical from a multifaceted methodology,Our focused list is derived industry research and feedback fromwhich uses months of esteemed connections around theour readers, clients, and world. All firms but are are ranked top 10 in their jurisdiction to avoid bias. displayed alphabetically 30 THE MIDDLE EAST AND AFRICA PATENT RANKINGS 2021 RANKINGS PATENT AFRICA AND EAST MIDDLE THE TPL52 rankings - Africa_v3.indd 30 THE MIDDLE EAST AND AFRICA PATENT RANKINGS 2021 23/02/2021 11:16 33 it Contact Us Contact THE PATENT LAWYER +971 4 3816888 Tel: www.cwblegal.com 'XEDL8QLWHG$UDE(PLUDWHV (PDLl: GXEDL#FZEOHJDOFRP %XUM$O6DODP6KHLNK=D\HG5RDG 0DLQ2IÀFH&HGDU:KLWH%UDGOH\,3//& &UHDWH3URWHFW(QIRUFH For many local and international entities, entities, local and international For many handling choice for is the preferred BSA IP issueslegal and and outside inside in acting experience of years With UAE. IP significant most region’s the some of are interests your ensure cases, we or type the sector Whatever protected. property: intellectual of it, create You protect we’ll touch in Get & Partner Suboh, BSA Munir Property Intellectual Head of 5555 4 528 +971 [email protected] bsabh.com &:% LVDspecialist 0(1$ UHJLRQ Middle East WKHMiddle SURYLGLQJ ,3ÀUP DQG1RUWK$IULFD UAE Tunisia SPACE TO FILL SPACE TO FILL SPACE TO VHUYLFHVWKURXJKRXW LQWHOOHFWXDOSURSHUW\ CTC Legal Media Abu-Ghazaleh Intellectual Property Al Tamimi & Company Baianant IP Bird & Bird (MEA) BSA Ahmad Bin Hezeem & Associates Cedar White Bradley Clyde & Co Gowling WLG Rouse Saba IP Abu-Ghazaleh Intellectual Property (AGIP) Intellectual Property Abu-Ghazaleh Firm Achour Law Baianat IP Ellouze Cabinet Donia Hedda Cedar White Bradley El Heni Gide Loyrette Nouel JURISMED & Conseils Kammoun Kallel Avocats Tunisiens La Centrale Des Avocats TPL52 rankings - Africa_v3.indd 33 25/02/2021 15:23 CTC Legal Media Magazine. Magazine. Tanzania Saudi Arabia SPACE TO FILL SPACE TO FILL The Patent Lawyer of Lawyer The Patent March/April 2021 issue 2021 March/April Rankings to appear in the in the appear to Rankings North and Central America America Central and North A&K Tanzania ABC Attorneys Afrilex Associates Alin Law Care Bowmans Eden Law Chambers FB Attorneys Lex Globe IP NexLaw Advocates Vemma Consult Attorneys Adams & Adams Brian Bacon ENSafrica Hahn & Hahn KISCH IP Rademeyer Attorneys Smit & Van Wyk Spoor & Fisher Von Seidels Webber Wentzel Abu-Ghazaleh Intellectual Property Al Ajaleen Law Firm & Intellectual Property Al Hadaf (Saba IP) Al-Otaishan IP Al Tamimi & Company Baianat IP Cedar White Bradley Clyde & Co Sutherland) AlDhabaan and Partners (Eversheds Kadasa IP

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23/02/2021 13:57 39 THE PATENT LAWYER People might be tired of the phrase People might be tired of the phrase I would love to see more representation for Sometimes during IP related group meetings Friends would joke that based on my diverse Friends would joke that based on my diverse unfortunately, sometimes opposition from other generally interested in the cause of equality and equality of cause the in interested generally women. “representation matters” but it can’t be said enough; representation does matter and the more my circle expands the more I understand that. women and women of color in particular. In Jamaica, what I have found is that the IP community is generally female dominated, but it’s that realise I scale global a on look I when not the same. And this is not to say there are not women in the field, but that the level of representation is not what it should be. I’ve found myself looking around and thinking… globally be to supposed is that group a for inclusive, how is it that I’m the only black person here? It’s something that has struck me more so often promote others ahead of themselves others ahead so often promote everyone for doors opening of aim the with involved. career aspirations? What are your future that know don’t I day! every that myself ask I I have so many thoughts I can say right now, do. But I know that I love about what I want to to continue in this field and this field and I want work in it. be recognized for my you like to see in the What changes would equality and diversity IP industry regarding in the next five years? was I was raised to never believe that anything or the out of my reach because of my gender many color of my skin. Growing up I had so in a female role models to look up to, and one country where our motto is “Out of many, races, people”, these women were of various were religions, classes, background, but all and experiences my understood that women women that I could relate to. race or family I could point to any person of any they ethnicity and say “That’s my cousin” and would believe me. As I got older and stepped raised outside of the familiar background I was raised in, I started to realize not everyone was the the same way or held the same views and it more my circle expanded, the more jarring thing became. Even as the circle expands one are that remains common globally is that there so many different types of issues that women if every face, particularly in the workplace, even country has its own unique set of issues. Issues range from sexism, racism, colourism, classism, sexual harassment, balancing personal and professional life and career advancement, and, ” I was raised I was to never that believe anything out of was reach my because of gender my or the color skin. of my “

group I’ve met so group I’ve met so Women’s IP Today and that opportunity Here in Jamaica, like many places, the law the law like many places, Here in Jamaica, I’ve had experiences where potential clients The two partners at my firm are very willing to In the Women’s IP Today A very personal challenge is that I like to be A very personal challenge is that I like The more I volunteered and got involved in CTC Legal Media do it to the very best of your ability, not not ability, the very best of your do it to halfheartedly. of more is This very saturated. getting is market to doing different things. a reason to be open close-minded to IP and I was initially very it. Even when I had thought I wouldn’t practise would tell me there’s no an interest, people of law – not knowing how market for that area convinced so was I But Jamaica. in is it important with stuck I so do, to wanted I what was this that well for me. it – it has worked out you faced? And how What challenges have them? have you overcome far is I think one of the biggest challenges so just being a young woman. they can talk to – is a male lawyer ask if there lawyer.some would just prefer to deal with a male see me I’ve also had experiences where clients their and think I’m just too young to be handling typesmatters. That said, I’ve learned not to let those of comments make me doubt my own capabilities encouraged to make presentations, teach courses come in the four years I’ve been practicing. I think many wonderful women in that group who are or join other committees and my name gets put put gets name my and committees other join or out there. A lot of these types of positions and opportunities came from volunteering to be have involved and it opened doors I wouldn’t even imagined for myself. pass opportunities to me – and push me to do things I wouldn’t otherwise, in the long run I am grateful for this. I’m a part of a non-profit group called only came about thanks to one of the partners who introduced me to the group. I appreciate that they take that step back to enable me to move forward. and it is great to prove this perception wrong. and it is great to prove this perception wrong. don’t good at anything I try as soon as I try it and set for like failing or falling short of a mark I’ve myself. It’s a challenge that I think is constantly ongoing but I’ve learned, and am still learning, try and that it’s ok not to be great at everything I there are lessons in failure. What would you consider to be your greatest achievement in your career so far? I have That’s a tough one. I would say how far I have progressed quite a bit in the field in a short space of time and I do feel very proud of that. Being featured in this issue is also a major highlight for me! various committees, the more I’d be invited or Women in IP_Rachel Lodge_v4.indd 39 23/02/2021 13:56 in applying CTC Legal Media there and volunteer your there and volunteer your attractive for when I would yourself 100% to everything you do, if you’re going to do something start practising. I believe oooooo i ggggg u bbbbbb l more mmmm p oooooo iii cccccc t ttt ssssssss eeeeeeeee aaaaaaa aaaaa

eeeeeeee IIIIII mmmmmmm ititititiit nnnn ggggggg s s s s s wwwwwwww rk rk rk rrrr rtrrtrrtrtrtrt r n amamamamamaaaa hththh aaaaaaaaa o my knowledge base to make myselfmmmmmmmm ppppppp dididddddiddd hh k mmmmmmmmm many of them are free, to increase yyy e wwwwww a ononononon IIIIII cocococococcoco courses and resources online, and courses and resources online, and thththththth ulululululululu lelelellelele ururururururururuuu y onononononoono gg IIIIII I would go out of my way to find I would go out of my way to find mmm toto inin mememememememmememmm enenenenenenee mm IIIII nknknknknknkn sssss d,d,d,d,dd,d,dd, JaJaJaJaJaJaJaJa Jamaican Intellectual Property Office. imimimimim r s w w ww w w IIII I did an unpaid internship at the the at internship an unpaid did I rmrmrmrmrm o My advice is don’t be afraid to put My advice is don’t be afraid to put MyMyMyMyMMyMyMMyM dddd popopopopopoppopo tttttt s ss s ss s ugugugug is is is is iis sssss trtrtrtrtr nnnnnnnn titittttittt time. Before I worked at Foga Daley, time. Before I worked at Foga Daley, i riririririr wo wwo wo wo asasasasasasasasasasasasasaaa e y y y w www w w aaa -t-t-t-t-t hihihihihihihi ssssssssss yourself out yoyoyoyoyoyoyyoyoyoyyoyoyo fifififififfi ssssss aa ododod e.e.e.e.e.ee.e lalalala eee ttttttt aiaiaiaiai nenenenenene aa owow o th th th tth t i yyyyyy rrrtrrtrtrtrtrtrtrtrtrtrtr e e e ee hahahhahahahahhah u hohohohohohoho our ex IIIIII wawawawwawaw ff f f fff ddddddd eee pepepepepep aaaaaaaa rtrtrtrtrt dadad mmm now I am a full-time Associate. nonononononono ttttttt aiaiaiaaiai aaaaaaa e susususususu h IIII y x veveveveveveve lelelelelele ooooooo e r knknkn ooooo P P PPP PPPPPPP th th th tth IIII s part-time while I was still in law school, and papapapapapapapapapapa rtrtrtrtrtrtrt IIII y y yyyy rererererere e.ee.e.e.e.eee tttttt exexexexexex cececececececec oooo e e e eee IPIPIPII urururururuu fffffff asasasasasasas lolo lll e iifif ililil pp o o oo ooooo lllllll w w w w w Daley as a summer intern, went on to work Daley as a summer intern, went on to work DaDaDaDaDaDaDaD tetetetetete ppppppp ntntntntntntn eererere ipipipiip dddddddd I I I love sports and music, and I like the touch I love sports and music, and I like the touch ttttt e e e e eee eeee aaatatatatataataaa eaeaeaeaeaeeaeaea wwwwwww hhh nnn r e hh rom hh hhh hhhhhhhh ttt tt while I was learning and by the end of that intern- while I was learning and by the end of thatwhwhwhww course, ship I thought I might as well take the shshshshshsh nonononononono done now knowing the law inside out. Having ththth more. the IP module I found that I loved it even thththt aspect that IP has on everything, IP touches all versatile a such is law IP because think ofofofofofofofoo I life. of arararararaa and area of law it always keeps me engaged enenenenen entertained, I never get bored with it. How have How have you found the pathway to your current posit current position? And can you offer advice f from your experience? ItItItItIt It was a strong sense of determination that got IP many have don’t We position. me me me me me me mm this to me cececececcec centred firms in Jamaica, but I was determined and certain that this area of law was what I wantedananananananan to pursue. I would offer to volunteer my time for totototototo ththththththth the experience. I started at the law firm Foga eveveveve it it it What inspired your career? What inspired your friends, I didn’t want to be Unlike some of my age but with some a lawyer from a young encouragement from some mentors, I decided it to pursue a law degree with no idea where at would take me. One year I did an internship my there, was I time the entire for where, firm a IP but nothing me gave attorney supervising and work. IP was an optional course at school course, the taking in interest no had initially I library so during my internship I had to go to the apply every day to learn the material and then area the with love in fell I just work. the to it ” I appreciate I appreciate that they that take to back step me enable to move forward. “

achael obtained her Bachelor’s Degree Bachelor’s her obtained achael the West of in Law from the University Norman the attending before Indies THE PATENT LAWYER

An interview: inspirations, experiences, and ideas for equality. inspirations, experiences, An interview: Manley Law School. During her studies, Rachael at the interned in a few positions including Foga Jamaican Intellectual Property Office and Daley where she now is an Associate. Rachael is involved with many associations, including as a INTA, and is being recognized by many rising star in the field.

38 R

Associate, Foga Daley Foga Associate, Rachael Lodge: Rachael WOMEN IN IP LEADERSHIP IN IP WOMEN Women in IP_Rachel Lodge_v4.indd 38 WOMEN IN IP LEADERSHIP 25/02/2021 15:32 41 my standing THE PATENT LAWYER I’ve also always been keen on developing developing on keen been always I’ve also Having lived in eight countries, I enjoy Having lived in eight countries, I enjoy In this role, it was essential to stay on top of In this role, it was essential to stay on top the Around this time, I got to experience o commission works with commercial potential, o commission works with commercial potential, their needs to work with development teams to build solutions that drive client growth. and using my language skills. Soon after starting at role a accepted I publishing, legal in out Thomson Reuters International as they were undertaking a wide globalization program for Westlaw – their flagship online legal research Holland, Germany, solution. I worked in London, enjoying time with clients and really under Belgium, Switzerland, and Japan. It was a fantastic opportunity for me to work with some incredibly products, new establish help and people smart businesses and teams across the world. I later to work joined LexisNexis and moved to on multiple new business initiatives across Asia. immersing myself in other cultures and learning has allowed me to new languages. My career experience times and relocate numerous different ways of doing business in many we places. I’m always intrigued by how much produce. As Publisher, I gained fantastic experience in new product development which became attending conferences and seminars, meeting lawyers and judges and visiting universities. IP!) and legal trends and emerging sectors (like t filling a need in the market. beginning of digitization for the legal publishing book a still am I good! was timing My industry. lover, but building and launching Scotland’s a big first commercial legal online service was of the moment! It’s been fascinating to be part data, big to print from evolved it’s as industry time, I AI and workflow automation. At the and was unaware that my love for technology innovation were part of my path to the IP industry and would play an important part in my current role as General Manager Asia Pacific at Anaqua – passion, and I soon was immersed in the market,passion, and I soon was immersed in the publisher for an editorial role. It was the same publisher for an editorial most of the Scots law publisher who produced student! After freelancing books I read as a secured a full-time job as through schooling, I Editor and quickly moved into commissioning, titles to advising the publishing house on which ” aren studied Law in Scotland before before Scotland in Law studied aren in the legal beginning her career industry. information and software An interview: inspirations, experiences, and ideas for equality inspirations, experiences, An interview: But it all started when I went home to to But it all started when I went home So that was a huge lesson for me lesson for me a huge So that was in humility and trust. CTC Legal Media Karen Taylor: General Manager Manager General Taylor: Karen Asia Pacific, Anaqua K From there she has developed her career over career her developed there she has From now is and regions and businesses multiple a General Manager Asia Pacific for Anaqua, and innovation of provider world-leading intellectual property management solutions.. What inspired your career? in law A number of factors. My keen interest and legal trends, my fascination with innovative, market-changing technology, my international outlook and appreciation of different cultures. Edinburgh to finish writing up my master’s a legal thesis. I heard about an opportunity with “ Women in IP_Karen Taylor_v3.indd 41 23/02/2021 13:58 THE PATENT LAWYER Sponsored by Sponsored

In terms of what can be done to continue to I also think the more female role models we I do want to see better representation across representation better see to want do I and other similar organisations similar other and Today IP Women’s will play big role. These groups are all about empowering and pursuing the interests been I’ve workplace. the in women professional of a part of Women’s IP Today for only months and a already I’ve met few so many women selflessly and mentored, encouraged, have who pushed me forward giving me a platform to be keep to chance a me giving and heard and seen paying it forward to others. Every month we’ve had the opportunity to meet, share difficulties we’ve faced in the workplace, triumphs, and been have sessions These experiences. overall particularly amazing for me as it has given me the opportunity to see that we are not alone in some of these struggles and bounce ideas off advocate to continue can we how on other each for the cause. I think the group is example a of how we perfect can reach these goals for female equality. definitely outnumbered! Within our environment definitely outnumbered! Within our environment I have had interns that have told me that they decided to intern with our firm based on how many women work at this firm. Some of them and advances sexual with experiences bad had different obstacles based on their gender at other places. There are some people that will take advantage of their senior position, when they see a young woman coming profession, into and incorrectly the use their position openly Speaking mentorship. of guise the under about these issues is in involved a is everyone if come only can change start and genuine advocating for equality and speaking against any form of inequality when it appears. out advance women’s equality, I think groups like speaking out and putting forward our colleagues our forward putting and out speaking whenever we can. have, the better. Within my firm, there are five attorneys, two female partners, two female associates and one male associate – he is since we’ve started spending more time on like Zoom. online platforms the board, and not as handouts because the for forward someone putting be not should it so are There forward. somebody putting of sake in colour of women and women qualified many the field and I think this needs to be properly represented. empowerment of How do you think the and expanded in women can be continued the IP sector? I think that we have roles to play individually in ” CTC Legal Media

40 “Out of“Out one many, people”. WOMEN IN IP LEADERSHIP IN IP WOMEN “ Women in IP_Rachel Lodge_v4.indd 40 WOMEN IN IP LEADERSHIP 25/02/2021 15:33 43 ” THE PATENT LAWYER Think about Think candidates in terms of potential not just experience. “

for but To drive diversity more generally, I think all all think I generally, more diversity drive To About ten years ago, when I first worked in Japan, In the longer term, I’m aiming for a ‘portfolio’ In the longer term, I’m aiming for a ‘portfolio’ the same rules that would apply in any industry I think that setting some rules of engagement, of rules some setting that think I down the most rewarding thing I’ve ever done. ever I’ve thing rewarding most the down over the many other achievements There are excitement of I’m grateful for, like the years that the chance to be a new product, but launching growth story is a true part of such an amazing Tokyo office in 2016 with a joy. We opened our expanded rapidly since team of four and we’ve the and team APAC our of proud really I’m then. together to develop our way we’ve all worked to and contribute client community Anaqua across the region. growth and innovation career aspirations? What are your future do. already I what of more do to like would I progress. In terms of changes, I would say do more building a strong pipeline of future female leaders. apply to IP: define ‘talent’ more broadly, encourage more creativity and imagination in your organization There is so much more to come for Anaqua in Asia There is so much more manyPacific. It’s an extremely dynamic region with global of the world’s leading IP asset owners and young work. I enjoy mentoring the next generation of a 50/50 industry. Within Anaqua, our Executive has brands. I definitely still have a lot to do here! brands. I definitely still have a lot to do here! career with a mix of commercial and volunteer that. leaders and want to devote more time to the What changes would you like to see in IP industry regarding equality and diversity in the next five years? many I’ve been pleasantly surprised by how the IP women there are in senior positions in globegender balance and our teams across the and are all very diverse in terms of nationalities we backgrounds. Within our Japan office I think speak at least ten different languages between us and everyone is multi-lingual! in the I rarely met women in senior positions legal industry. There has been a shift since then and the IP industry is one of the drivers of that of whatever is working and keep the focus on about where you get your talent from. I know a lot of people are wary of targets and quotas, example 50/50 candidate short lists, can be example 50/50 candidate short lists, can be beneficial. It forces people to look more widely in the market and think about candidates in terms of potential not just experience. Some of the best people I’ve ever hired had no industry experience, but they had the right core skills and values and they’ve been very successful. How do you think the empowerment of women can be continued and expanded in the IP sector? The IP sector encompasses so many areas –

When my husband got a job offer in Hong When my husband got a job offer in Hong The industry is at an inflection point in terms After the birth of my third child in Hong Kong, After the birth of my third child in Hong Kong, CTC Legal Media benefitted me hugely was doing a lot of ‘startups’ me hugely was doing benefitted of building a business – strategy, market research,of building a business organizational structure, investment proposals, and partnerships. This product development means you have to type of ‘startup’ experience effectively with diverse learn fast and work It’s been a natural functions and people. management role. Of pathway to a general expert in everything, but I course, I can’t be an view across the whole enjoy having that broad with clients, partners and business and working colleagues to deliver results. back Kong, we jumped at the chance to move I to Asia. It’s such a diverse and dynamic region. worked with LexisNexis in Asia in various business in the Asia region, building teams and businesses. My role leverages so many elements of my past experience and I can help our team and clients navigate this next phase in the digitization of legal work and innovation management. of technology and working practices. COVID-19 is accelerating those changes. A lot of business in Asia is still done using paper, hankos and chops (physically stamping paper documents), even fax! Enabling teams to work remotely is turbocharging the transition from these working practices to hosted solutions, remote access and collaboration, e-signature tools etc. Having been in the industry since the days of dusty libraries with gold embossed leather-bound tomes until now with data analytics and visualization, AI and RPA, I’m really excited to see what this next phase will bring and how embrace and adapt will industry the rapidly these new ways of working. greatest your be to consider you would What achievement in your career so far? Building the Anaqua APAC business is hands within Thomson Reuters and LexisNexis, for LexisNexis, for Reuters and within Thomson markets via moving into new example ventures. In this development or joint greenfield to many key elements way, I gained exposure roles. development and product development My experience of digital product development I was and online business models meant that the able to help many of our businesses across region with their print to digital transformation. The role gave me exposure to a much broader range of countries, for example India, Malaysia, a good Singapore, China and Taiwan which laid foundation for me in my current role. next about think to starting again once was I up! steps and the Anaqua opportunity popped many Working at Anaqua has brought together - about passionate most I’m things the of growth technology, data and analytics, driving Women in IP_Karen Taylor_v3.indd 43

25/02/2021 15:32 THE PATENT LAWYER One other challenge that stands out to me is One other challenge that stands out to me One of the many things I enjoy at Anaqua is One of the many things I enjoy at Anaqua Another challenge I’ve faced throughout my tools at our disposal to foster remote collaboration. than when I first started out, so it’s definitely much work and mentoring. I go to seminars and lectures. When you’re working across time-zones, getting Senior Executives in and America. One in Europe and Senior Executives sleepless nights recall having a few time I do content Japanese our get to deadline a when was Based looming. was platform global our onto of our progress to on any numeric assessment going were we way no simply was there date, I had tried and failed to to make that deadline. team to send batches persuade the Japanese (because of course that’s as they became ready have done ‘our way’). what we would normally impossible. Eventually They insisted that was 30th is deadline the ‘Karen me to said they the exact date!] - August [yes I still remember content on the 30th of you will have your and us.’ I spoke to our CEO August. Please trust know not did really I that point at that him told cross what else to do and we would just have to content our fingers. Needless to say, 100% of the the doton format perfect to close in delivered was for me on 30th August. So that was a huge lesson need to in humility and trust. Sometimes you just thing! get out of the way and let people do their being not comfortable and too getting I’ve sufficiently challenged in my role. What done at times like that is focus more on personal signed development and community work. I’ve up to courses, sat on boards, done volunteer the balance right between flexibility and setting boundaries is tricky. Luckily for me, Anaqua has a truly global mindset and, being a technology the of focused organization, we make good use Distributed workforces are more the norm now easier to manage than in those early days! How have you found the pathway to your current position? what role, current my to pathway my of terms In Meeting people from different industries gives Meeting people from different industries It’s ideas. new and fresh perspective a me important to do that anyway. Exposing yourself in to new things can make you more effective the your current role as well as laying groundwork for the next phase of your career. that we do so much. There’s always something going on: new initiatives, new people, new things and fast paced really It’s acquisitions. change all the time. My colleagues are all recognized experts in their field. We support each other and challenge ourselves to deliver more. That teamwork and energy inspires me. career is being ‘remote’ from head office. It’s important to make the effort to reach out to colleagues and have those ‘water cooler’ chats.

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As mentioned earlier, Japan was one particular Japan is philosophically completely different. Japan is philosophically completely different. I’m not sure I have overcome them all if I’m being I’m not sure I have overcome them all honest. We always have challenges and that’s what makes life interesting! country that defined my career, but, along with the privilege of working there, came some nail- biting moments—and it was one of the biggest challenges of my career to serve as the link between two very different cultures. I had to take what our Japanese team were telling me and then ‘translate’ that into something that would provide reassurance on our progress for and fascinating to observe a completely differen excellent delivers which one and working of way as business card etiquette. There is a completely concerns sharing thoughts and ideas, expressing or suggestions. There is a Japanese expression the ‘to read the air’ – it’s a little bit like reading So room, but it goes much deeper than that. nuances many are There unspoken. is much tasks and subtleties. Planning and execution of line. is highly iterative – it’s a spiral not a straight from but target, the reach will eventually You of the outside, without a deep understanding in what is going on, it can feel like you’re going project circles. Coming from a very ‘Western’ management tradition of milestone plans, start and finish dates, strict resource allocation etc., I had to throw everything I thought I knew out the window and start again. It was really humbling Anaqua, looking at what we need to do differently Anaqua, looking at what underpinning common fundamental a still is there what is different. Understanding those differencesthose Understanding is different. what internationally. success commercial to critical is or language, it’s about translation It’s not just people think and work. This about knowing how focus for me within continues to be a major results. The Japanese commitment to quality (I a 100% pacento’ ‘hayaku expression the hear lot!) is unwavering. What challenges have you faced? And how have you overcome them? in the APAC region and why. in the APAC region and country that Was there one particular defined your career? changer for me both Japan really was a game Having worked personally and professionally. countries and often across several European European offices and been a bridge between US headquarters, I did have some understanding butof the differences between various cultures, express information, process people how in themselves, and organize themselves. (I know It’s not just about knowing the language such a little bit, I’m not fluent) or cultural norms different approach to planning, teamwork, have in common across jurisdictions as well as well as jurisdictions across common in have ” CTC Legal Media

42 And it was was And it one of the biggest of challenges career to my serve as the link between verytwo different cultures. WOMEN IN IP LEADERSHIP IN IP WOMEN “ Women in IP_Karen Taylor_v3.indd 42 WOMEN IN IP LEADERSHIP The Issue 1 2021

science, R&D, engineering, law, commercial culture that is still very reliant on face-to-face management, branding. I would say go back to interactions and paper documentation. the start. Support STEAM initiatives from early We worked with our clients to adapt to the “I feel that years education onwards and create programs changes and successfully brought on several that appeal equally to girls and boys. Champion major new clients via remote collaboration, 2021 is the study of subjects critical to future innovation where, normally, we would have spent a like data science and system design where substantial amount of time onsite. As our LifeGLOBAL REACH, LOCAL KNOWLEDGE Sciences the year women are generally under-represented and business continued to grow, we also had many we really www.lslawmag.com Lawyer improve access for girls and women via new team members join us. Recruiting, onboarding, shouldn’t be targeted scholarships and internships. training and supporting new people remotely When I was at school, we were generally requires additional planning and communication, surprised steered towards traditional subjects like law or but it’s definitely worth the investment - and medicine. Most of the roles I’ve had throughout we’ve had some great results from our efforts. by anything my career didn’t even exist then! We should Another big challenge was marketing! anymore! encourage the next generation to think outside Usually there are numerous events, which the the box in terms of the types of skills we will IP industry as a whole relies on for networking need more of in the future in areas like AI. and deal-making. We transitioned many ‘in- A Portuguese Companies in the IP sector could be very person’ activities to online, often at short notice influential here working hand in hand with – and the positive response to our digital events educational institutions. showed what is possible with good organization, ” In terms of empowering women currently engaging speakers and great technology. and European in the IP sector, the impact of the COVID-19 The urgency of digital transformation is one pandemic has exacerbated the challenges many of the key learnings for me from leading a team working women already face. This is not unique during a pandemic. From schooling to to the IP industry of course, however there have healthcare, from business to family life, that been some specific impacts. For example, the shift to digital has been accelerated. perspective number of scientific papers published by At work, it’s been great to see how Anaqua female researchers has dropped 20% in the past has helped our clients. As a hosted solution with year. There are many ways private companies, all users and outside counsel working together universities and governments could get that on a shared, secure platform, we’ve enabled number back up again, including being more clients to get their jobs done without needing to on telemedicine flexible around when, where and how work go into a physical office. Our local and global gets done. That’s a lot of innovation being lost. support teams help solve issues remotely Necessity is the mother of invention. The constraints without going onto client sites. Seeing such imposed by the pandemic can be embraced as innovation and collaboration in action has been and e-health an opportunity to find smarter ways of working. really gratifying. This is a chance to reconfigure the work / life From a personal point of view, the pandemic continuum and help expand women’s has taught me about resilience in the face of participation in the innovation economy. continuous upheaval! Many of us are working longer hours than ever, while supporting home- How has the COVID-19 pandemic affected schooling or caring for relatives. Dealing with the way you manage your work life and constant change and uncertainty whilst trying home life? to maintain a semblance of normality at work I think for everyone, it has brought many new and at home requires enormous amounts of Ricardo Costa Macedo and Diana Mâncio da Costa, of Caiado Guerreiro, Sociedade challenges. Logistically, it wasn’t too difficult for mental and physical energy. me to adapt to managing remotely, as you do a As business leaders, we have to pace de Advogados, discuss the needed reinvention of medical care and how it is lot of that naturally in a regional role. But ourselves. Getting through this pandemic is working from home was dramatically different, definitely a marathon not a sprint. We have to redefining the relationship between healthcare services providers and patients. with three children and on video calls all day. It manage for the long haul - driving our requires maximum flexibility to manage what is businesses forward, while helping our teams to basically a double schedule. This is a challenge set reasonable parameters for themselves and Health Functional for working parents everywhere and we just working with them to ruthlessly prioritise the Data Claiming have to do the best we can. critical from the ‘nice to have’. Page 52 Page 60 In Japan, Anaqua already had a flexi-work I’m a natural born planner, but I’m getting policy and everyone was set up for remote better at ‘expecting the unexpected’ and Sponsored by access to collaboration tools and systems as a making sure I am ready to handle the surprises matter of course; so, again, the shift to work I know will be thrown our way. I feel that 2021 is from home wasn’t too difficult logistically. The the year we really shouldn’t be surprised by real challenges came from finding new ways to anything anymore! 2. AI & deliver results in a work environment and IP rights Page 55

44 THE PATENT LAWYER CTC Legal Media

Women in IP_Karen Taylor_v3.indd 44 25/02/2021 15:33 Front cover_LSL121_v1.indd 1 23/02/2021 13:29 MEET THE EDITORIAL BOARD EDITOR’S WELCOME MacKenna Roberts - General Counsel and DPO, Bob Stoll - Partner, Drinker Biddle & Reath LLP Choice Telemed Ltd Bob is a partner at Drinker Biddle & Reath LLP and MacKenna is a life sciences litigation and regulatory lawyer Co-Chair of the Intellectual Property Group. In October of The Issue 1 2021 who has worked in private practice, academia and in-house as 2013, he was appointed to a three-year term on the CAFC General Counsel and DPO to Choice Telemed Ltd. MacKenna Advisory Council, was reappointed for another three-year LifeGLOBAL REACH, LOCAL KNOWLEDGE SciencesLawyer is an experienced strategic adviser assisting clients in the term in 2016, and reappointed in 2019 for an additional www.lslawmag.com commercialization of medical innovation at the frontiers of three-year term. He is currently serving on the Board of medicine, specializing in cell and gene therapies/tissue Directors for the American Intellectual Property Law engineering, genetic testing and digital health technologies. Association. A Portuguese and European Editor’s perspective Vitor Fidalgo – Lecturer at the Dr. Janita Good - Head of the UK Life Sciences on telemedicine University of Lisbon Faculty of Law sector group, Fieldfisher and e-health Vitor is also Legal Director at Inventa International, Dr. Good has almost two decades’ experience advising welcome implementing the best IP strategies and enhancing the clients on a variety of corporate deals, such as M&A

profitability of assets. transactions, venture investments and joint ventures. Ricardo Costa Macedo and Diana Mâncio da Costa, of Caiado Guerreiro, Sociedade She also has an M.Phil. in Biochemistry from the de Advogados, discuss the needed reinvention of medical care and how it is redefining the relationship between healthcare services providers and patients. Functional University of Oxford. Claiming Health Page 60 Data n the world we currently find ourselves in, it is no surprise that Page 52

AI & 2. IP rights there has been an increased urgency for telemedicine and Page 55

23/02/2021 13:29 e-health. Experts from Caiado Guerreiro, Sociedade de dd 1 I Janett Lumbreras - Senior Associate, Uhthoff Osamu Yamamoto - Advogados, discuss, in our cover story, the need for the reinvention Janett has a Pharmaceutical Chemistry-Biology Degree Yuasa & Hara, Japan from UNAM, Diplomats in Access to Worldwide Scientific Osamu Yamamoto is a patent attorney, and a managing THETHE LIFELIFE SCIENCES of medical care. This conversation explores a Portuguese and and Technological Information and in Industrial and partner of Yuasa and Hara. He specializes in patents in EU perspective on what telemedicine means for health care, Intellectual Property Law from UNAM. She is a Senior the fields of biotechnology & pharmaceuticals. LAWYER Associate at Uhthoff, working with patent matters for more including technological developments, patient information, and than 20 years. She is an active member of AMPPI, AIPLA Issue 1 2021 and CNQFBM. the relationship between health service and patient. Editor Developing further from this Faye Waters [email protected] conversation, we look at health data Noel Courage - Partner, Dr Penny Gilbert - Partner, Powell Gilbert LLP Publishing Director and its transfer, sharing and usage – Bereskin & Parr LLP Dr Penny Gilbert is a founding Partner of Powell Gilbert Chris Dooley Noel Courage is a partner and patent attorney LLP. Penny has a degree in Biochemistry and DPhil in this time from a UK perspective from [email protected] at Bereskin & Parr LLP, in its Toronto office. Molecular Biology from Oxford University. She Increased Baker McKenzie. In light of both Brexit His practice focuses on patenting and licensing of life specializes in patent litigation in the life sciences and Advertising Enquiries sciences inventions. represents clients before the UK Patents Court, Court of “ and the NHS information governance, Appeal and Supreme Court. She has a wealth of Katie Kerr (Publishing Executive) urgency for experience in advising on multi-jurisdictional litigation [email protected] this article discusses the partnership strategy. Subscription Enquiries telemedicine between the NHS and the private [email protected] and e-health. sector, the national opt-out deadline, Accounts Enquiries Matthew Rodgers - Senior Patent Attorney, Malcolm Dowden - Legal Director, and the code of practise for record [email protected] Boston Scientific Womble Bond Dickinson management. Matthew advises on IP aspects of due diligence relating to Malcolm Dowden is a Legal Director at transatlantic law Published by: company and product acquisitions in the medical devices firm Womble Bond Dickinson, and is the author of the CTC Legal Media Ltd, Then, a look to AI and the types field, IP aspects of company and academic collaborations EU/UK chapter in the American Bar Association’s new and manages IP portfolios for R&D units in the US and book The Law of Artificial Intelligence and Smart 23 Hedgers Way, Kingsnorth, of protection available for related UK. He has worked in chemistry, Biotechnology and natural Machines.. Ashford, Kent TN23 3GN ” inventions. This article provides an overview of the fields of products developing strategies to ensure freedom to operate, Tel: +44 (0)20 7112 8862 clearing through oppositions and managing litigation risk. Fax: +44 (0)20 7084 0365 application, the regulatory challenges one may face, and a Design and Repro by: comparative approach to available protection pathways. Design and Printing Solutions Ltd Piotr Dynowski LL.M - Michael Pears - Partner, Potter Clarkson LexOrbis offer an informative discussion on functional claiming, Unit 45C, Joseph Wilson Industrial Bird & Bird Michael handles a wide range of biotechnological looking to both the USPTO, EPC, and EPO for guidance and Piotr is Partner, co-head of the IP practice, and head of subject matter and has particular expertise in the drafting Estate, Whitstable, Kent CT5 3PS TMT practice at the Warsaw office. He is one of the and prosecution of patent applications concerning Printed by: examples, and explain what this can offer to life sciences leading IP and patent litigation lawyers in Poland. immunotherapy, protein stability, gene therapy, metabolic profiling, drug delivery, and assay technologies. He has Pureprint Group, Crowson House, inventions in the field in the Indian legal system. also managed the prosecution of several global patent Bolton Close, Bellbrook Park, Uckfield, Enjoy the issue. portfolios, including applications in Australia, Canada, East Sussex TN22 1PH China, India, Japan and the US. Whilst every effort has been made to ensure that the information contained in this journal is correct, neither the editor, contributors or CTC Legal Media can Zaraihan Shaari – Partner, Marie Manley, Sidley Austin LLP accept any responsibility for any errors or omissions Shearn Delamore & Co, Malaysia Marie advises bio/pharmaceutical companies on contentious or for any consequences resulting therefrom. © CTC Legal Media 2020, and contributors. The Zaraihan is a Partner in the IP and Healthcare & Life Sciences Practice Groups, and non-contentious regulatory and competition issues; contents of this journal are protected under the Faye Waters handling a wide range of life sciences subject matters ranging from represents them in litigation before the EU and English copyright law of the United Kingdom, the Berne pharmaceuticals to pesticides and plant biotechnology. She drafts patent Courts, and before the regulatory authorities. Marie has Editor Convention and the Universal Copyright Convention. extensive experience in coordinating multi-jurisdictional specifications, handles patent prosecution, represents clients in patent Any unauthorised copying of the journal may be in litigation. Marie is the Chairperson of the Legal Community at litigations, advises on licensing and technology transfer, and advises on breach of both civil and criminal law. Infringers will be legislations governing the life sciences. DIA and the co-author of “Navigating European prosecuted. Pharmaceutical Law”, Oxford University Press, 2015. Mission statement The Life Sciences Lawyer educates and informs professionals working in the industry by disseminating and expanding knowledge globally. It features The Life Sciences Lawyer Magazine wishes to take this opportunity articles written by people at the top of their fields of expertise, which contain to thank the editorial board for their time and support. CTC Legal Media not just the facts but analysis and opinion. Important judgments are examined in case studies and topical issues are reviewed in longer feature articles.

46 THE LIFE SCIENCES LAWYER CTC Legal Media CTC Legal Media THE LIFE SCIENCES LAWYER 47

Editorial board_LSL4_v3.indd 46 25/02/2021 11:46 Editor's welcome_print_v2_LSL121.indd 47 26/02/2021 08:52 TELEMEDICINE AND E-HEALTH 23/02/2021 14:11 49 THE LIFE SCIENCES LAWYER Mr. Macedo graduated from the Faculty of Law of the Catholic Ms. Costa graduated from the Faculty of Law of the Catholic University of Lisbon, in 1998. He undertook postgraduate studies in Information Society Law, at the Faculty of Law of the University of Lisbon, in 2000, and in Commercial Law, at the College of Law, London, in 2003. at Caiado Guerreiro Lawyer Junior da Costa, Diana Mâncio Ms. Diana Mâncio da Costa has been collaborating with Caiado Guerreiro since 2018 and is a member of the Intellectual Property and Life Sciences groups. Ms. Costa has been focusing her practice on the pharmaceutical and health sectors, in relation to which she covers a wide range of matters. University of Oporto, in 2017, and concluded her Masters of Laws (L.L.M.) in Globalisation and Law – Commercial and Corporate Law at the Faculty of Law of the University of Maastricht, in 2018. Mr. Macedo’s practice covers a wide range of contentious and non-contentious patent, trademark and other Intellectual Property related rights, such as trade secrets and unfair competition, in particular in the pharmaceutical, home care, food and insurance sectors. Résumés at Caiado Guerreiro, Partner and Costa Macedo, Lawyer Ricardo Sciences groups and Life Property Intellectual of Head

Moreover, the Directive establishes objectives establishes objectives the Directive Moreover, e-health when addressing Nonetheless, A coherent set of rules to govern telemedicine telemedicine govern rules to set of coherent A onsideration, such as the EU legislation on Data such as onsideration, CTC Legal Media goal of connecting national authorities responsible authorities responsible connecting national of goal States. the Member by designated eHealth for concerning the application of Said Directive, is healthcare, rights in cross-border patients’ framework the regulatory for relevant considered the EU. by e-health provided of the preparation such as network, said eHeath for and the need matters guidelines on different of in the States Member to the support for facilitate will that measures of development health. data in cross-border of transferability significant other are there services at an EU level, the Council of 9 March 2011, establishes the the establishes 2011, March 9 of Council the and the support, cooperation, need for States Member among information of exchange with within network, working the a voluntary and e-health services in all EU Member States States Member EU all in services e-health and Protection, E-commerce, Medical Devices, Devices, Medical E-commerce, Protection, Identification and Electronic Rights Consumers’ Systems. and Information Network of and Security legal instruments that should be taken in in instruments that should be taken legal c Caiado_LSL4_v4.indd 49 23/02/2021 14:10 CTC Legal Media Article 14 (1), on “eHealth”, of the Directive the Directive of Article 14 (1), on “eHealth”, Such technological advances however are not not are however advances Such technological complex a rather services form Telemedicine in the interest great The EU has shown may serve to alleviate the heavy financial burden burden financial the heavy alleviate to serve may the stimulate to public health systems, of (due the EU regions of economic development for allow and to innovation) the technological to medical cross-border to access easier an EU citizens. assistance by Parliament and of the European of 2011/24/EU necessarily being followed by the development the development by being followed necessarily The framework. regulatory an adequate of is actually telemedicine legislation surrounding issued only countries have as delayed, quite of as it is the case recommendations, general Paper the Green with the publication of the EU Health. on Mobile interconnected, multiple aspects are where web, reimbursement. to data sensitive patients’ from legislators national for hard is it Consequently, encompass will that framework up a general draw to the use of from emerging factors the numerous services. telemedicine Notes on the EU perspective on telemedicine Union has the last decades, the European For as e-health and telemedicine been perceiving healthcare. of quality better towards steps as these e-health platforms, of development medical devices but also in the way patients patients way the in also but devices medical interact. and doctors Diana Mâncio da Costa Ricardo Costa Macedo of healthcare healthcare of face-to-face patient face-to-face

THE LIFE SCIENCES LAWYER

n the context of the COVID-19 pandemic pandemic the COVID-19 of n the context with that came problems and the numerous be cancelled and to visits had it, outpatient providers and patients. care and how it is redefining the relationship between healthcare servicescare and how it is redefining Sociedade de Advogados, discuss the needed reinvention of medicalSociedade de Advogados, Ricardo Costa Macedo and Diana Mâncio da Costa, of Caiado Guerreiro,Ricardo Costa Macedo and In fact, technology has been an essential part has been an essential technology In fact, not and e-health are Although telemedicine E-health and telemedicine are having having are and telemedicine E-health patients faced the fear of visiting hospitals and of fear the patients faced had simply care Medical practices. physicians’ in already and technology reinvented; be to be a to proved e-health for programs motion 48 may be defined as the use of information information be defined as the use of may E-Health health, for (ICT) technologies communication and as the provision and telemedicine The concepts of E-Health and Telemedicine true ally of healthcare systems all over the world. the over all systems healthcare of true ally challenges the face to adopted the strategy of at a time this pandemic, especially posed by real facing are health systems when national services to healthcare difficulties in providing citizens. their them to has brought wave a new concepts, new being that the the debate, of the epicentre here are use them to urge the recent of effects stay. to

I e-health on telemedicine and on telemedicine European perspective European A Portuguese andPortuguese A TELEMEDICINE AND E-HEALTH AND TELEMEDICINE services where traditional services where traditional - doctor interaction is replaced by over distance over by is replaced interaction - doctor ICT. use of through interaction it is As an undeniable impact on healthcare. the developments the technologic expected, widespread also witnessing are has been world of the realm to only not area, medical the to Caiado_LSL4_v4.indd 48 TELEMEDICINE AND E-HEALTH 23/02/2021 14:12 51 THE LIFE SCIENCES LAWYER Notwithstanding, there is room to say that the say to is room there Notwithstanding, not conceive to be hard may Such regulation even scenario, and the Portuguese for As been In addition, legislation has already e-health and for holds What the future to us require will telemedicine and E-health Contact de Sociedade Caiado Guerreiro, RL SP, Advogados, Castilho, 39, 15º, 1250-068 Lisbon, Rua Portugal 00 70 + 351 21 371 Tel. 01 70 351 21 371 Fax. / [email protected] [email protected] www.caiadoguerreiro.com care. care. for those dealing with e-health services and its services and its with e-health dealing those for applications. insufficient is still framework regulatory EU current manner, in a detailed and coherent regulate, to e-health and telemedicine. the phenomenon of internal retain because EU Member-States only to related matters in competences relevant such but also because some topics, healthcare difficult to prove may liability, as medical address. already were there stroke, pandemic the before will that programs in large investment signs of in the country, telemedicine enhance the use of them. being one of the PENTS program telemedicine of use the promote to enacted has Association Medical the Portuguese and telemedicine the use of specific guidelines for services. though and even unknown, is still telemedicine of use intense the in changes recent the on a choice of based not were e-health services imposed by instead and patients, but doctors conceive to hard pandemic, it is the COVID-19 without these care medical of the future services. healthcare between the relationship redefine setting a new and patients, services providers rights patients’ of the protection for measure and systems information health public and liability medical addressing even potentially within an emerge issues that may and other medical of provision of environment international ” It is hard It is hard to conceive the future of medical care without these services. “ services services Moreover, Moreover, the contact between patients the contact between Subsequently, and with the intent of of with the intent and Subsequently, Lastly, it should be noted that the Regulation that the Regulation be noted it should Lastly, Medical with the Portuguese In accordance the fact should be paid to attention Particular Even if telemedicine should not replace the the replace should not telemedicine if Even of use the perspective, regulatory EU an From specific no is there although sense, this In after they ensure that the system used and its that the system ensure they after namely secrecy, the medical users guarantee names and other of the encryption through data. identifying reinforcing the implementation of the strategy strategy the of the implementation reinforcing physicians should only use telemedicine should only physicians CTC Legal Media for a Telemedicine Network in the National Health Health in the National Network Telemedicine a for of 8445/2014, No. Dispatch Service (NHS), was it published. In said Dispatch, was June, 30 access to the general for established the need the technologic considering telemedicine, institutions and the aim of the capacities of and care medical to the accessibility increasing the of capacity maximizing the installed the NHS. institutions of 21 of 707/2016, (Regulation Ethics Medical of the use of regulates extensively July) services. telemedicine some aspects that should are there Association, when considering telemedicine in mind be kept patient- the for respect the as such services, the the independence of relationship, doctor and opinion and the confidentiality doctor’s confidence. mutual said by provided framework that the regulatory the allow to appears only Association Medical are when the conditions e-health services use of and doctors had not been fully recognized until until recognized fully been had not and doctors pandemic started. the COVID-19 the overrule medicine, nor so-called standard and doctor contact between a personal need of the practice allowing that by patient, it remains a from acts and health procedures medical of countries battling is helping distance telemedicine in the health the biggest problems some of difficult the ageing population or such as sector in some regions. care medical access to as generally e-health services is regarded available, already instruments legal in regulated the EU legislation on Data Protection as is the case of Devices. and on Medical be could it EU, the in e-health for legislation that rules of set a already is there that argued in designing a future role a relevant play will e-health services the use of for framework general guidance provides and that the same already similar to the ones of a face-to-face consultation a face-to-face the ones of to similar has sufficient knowledge when the doctor and the patient. situation of the clinical of Closing notes it seems that new, is not Although telemedicine facilitate to its potential Caiado_LSL4_v4.indd 51

23/02/2021 14:11 CTC Legal Media Since the 90’s, Portugal has been developing has been developing Portugal Since the 90’s, e-Health. Plan for Strategic PENTS is the National for framework legislative the to regard In PENTS is also a solution for the problems the problems for PENTS is also a solution provision of telemedicine services to NHS NHS services to telemedicine of provision users. use of electronic means for the rendering of of rendering the for means electronic of use services. healthcare with the e-health, to approach a revolutionary PENTS of launch the being development latest in 2019. some isolation of the geographical by generated and the difficult access to locations in Portugal group remote the for allowing also healthcare, professionals. various of collaboration that noted be should it Portugal, in telemedicine of 3571/2013, No. in 2013, Dispatch already determined published. Said Dispatch was 6 March, Its goal is to set a strategy for the enhancement enhancement the for strategy a set to is goal Its in care health electronic and technologic of regards program innovative This Portugal. the to respond to e-health as an opportunity that is gradually a society challenges posed by aging. the of and establishments services that the intensify should (NHS) Service Health National and communication information the use of the and guarantee promote to technologies ” The EU The EU has been committed to providing funding and platforms. “

ommitted to providing funding funding providing to ommitted or the collaboration of EU members of the collaboration or

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An example of the enhancement of said said of enhancement the of example An Commission Implementing recently, More 50 Portugal: Embracing Telemedicine Portugal: Embracing Telemedicine pandemic came COVID-19 the current before Well healthcare applications and in tackling the problems, the tackling in and applications healthcare Decision (EU) 2020/1023 of 15 July 2020 regarding July 15 of Decision (EU) 2020/1023 collaboration is the “eHealth Digital Service Service Digital “eHealth is the collaboration electronic two that is introducing Infrastructure” EU countries: health services in all cross-border and the Patients Summaries, the ePrescription in Portugal. available already which are of both a matter undertaken internally by Member States, States, Member by internally undertaken a matter been c the EU has may be hard to accomplish. In any case, and even In any accomplish. to be hard may TELEMEDICINE AND E-HEALTH AND TELEMEDICINE and platforms f and platforms for instance related with data protection, that that protection, data with related instance for pose. may said services being already were programs ambitious about, the aiming at expanding put in place in Portugal, the cross-border exchange of data between between data of exchange the cross-border mobile warning and tracing contact national the combatting to regard with applications may This published. was pandemic COVID-19 as a sign that the EU is interested be perceived for the needed regulation in proposing though the development of eHealth solutions is eHealth of development though the on this matter. on this matter. Caiado_LSL4_v4.indd 50 HEALTH DATA 23/02/2021 13:05 53 The Agreement did The Agreement On Christmas Eve Eve On Christmas The revised version version The revised 8 THE LIFE SCIENCES LAWYER Code of Practice Code of personal data personal Despite only being a few years old, the Code years being a few only Despite UK to EEA data transfers: transfers: data EEA to UK Contact McKenzie Baker 6JA, EC4V London Bridge Street, 100 New Kingdom United 1000 20 7919 +44 Tel: [email protected] www.bakermckenzie.com/en The Records Management Code of Practice Practice Management Code of The Records with working people what out sets (Code) (2016) must do to in England in NHS organisations or on The Code focuses manage records. correctly an by retained be should records long how NHS data. It is of in possession organisation and requirements based on the legal the by published practice best professional 2016. in Alliance Governance Information A the GDPR). pre-dates (it out-of-date is already Management Records a new consultation for a so concluded, recently 2020 Practice of Code works. is in the version new not address transfers of personal data from the data from personal of transfers address not can also EEA, but these transfers the to UK the transition after without safeguards continue designated has already period because the UK an adequate as providing states member EEA the data for personal of protection of level can This designation GDPR. the UK purposes of time. at any withdrawn be 5. Management Records New Cooperation Agreement (Agreement) in principle,in (Agreement) Agreement Cooperation data for present Christmas one was there and data personal of transfer the lawyers: protection without continue may UK the to the EEA from clauses) contractual standard (e.g. safeguards months. four period of a 2021 for January 1 from a by extended automatically be will period This the EU nor the UK neither if months two further the UK This is on the condition that objects. will The period GDPR. the UK apply continues to adopts Commission European the if earlier end the UK. to decision in relation an adequacy 4. of transfers UK to and EEA Brexit transfers: data UK to EEA and Trade a concluded EU the and UK the of the code will be published once NHSX have have published once NHSX be will code the of the code. and updated the responses analysed code the new until valid is still version The 2016 has been finalised. ” information-governance/ health-and-care- information-governance- panel/minutes/ 2020-09-15/ transparency/regdoc/ rep/1/2020/EN/COM- 2020-857-F1-EN-ANNEX- 1-PART-1.PDF services/national-data- opt-out information-governance/ guidance/ information-governance/ guidance/records- management-code/ information-governance/ health-and-care- information-governance- panel/minutes/ 2020-09-15/ information-governance/ guidance/data-sharing- agreement-template/ ?utm_source=twitter&utm_ medium=social&utm_ campaign=ig_staff information-governance/ health-and-care- information-governance- panel/ minutes/2020-09-15/ https://digital.nhs.uk/ https://www.nhsx.nhs.uk/ https://www.nhsx.nhs.uk/ https://www.nhsx.nhs.uk/ https://ec.europa.eu/ https://www.nhsx.nhs.uk/ https://www.nhsx.nhs.uk/ https://www.nhsx.nhs.uk/ Once data Once is truly anonymized, it will not fall within the scope of the GDPR. 4 5 6 7 8 1 2 3 “

of the last Panel the last Panel of 4 is a service allowing is a service allowing 6 A dedicated working working dedicated A 5 “the issue around how the 31 March 2021 31 March Once data is truly anonymised, it will not fall fall not will it anonymised, is truly Once data All health and care organisations that process that process organisations health and care All deadline had been extended The original Often, data considered ‘anonymised’ for for ‘anonymised’ data considered Often, up on this picked have appears to The Panel meeting identifies health and care pseudonymised data - if it should be treated as sector would confidential patient handle information and what CTC Legal Media easier to use. However, anonymisation under the under anonymisation use. However, to easier planning. The information includes that collected The information planning. within the scope of the GDPR and it becomes becomes it and GDPR the of scope the within This is more being identified. an individual lead to safeguards are required to ensure pseudonymised data is not re-identified.” in the course of publicly funded, commissioned publicly in the course of as care, health and adult social coordinated or The in NHS settings. given care as private well where apply does not opt-out data national care. a patient’s for data is shared as a controller information care health and social opt-out with the national must be compliant 2021. 31 March by policy to organisations enable health and care to outbreak. COVID-19 the on resources their focus there must ensure In-scope organisations a patient’s facilitate in place to systems are that patient’s ensure to and processes opt-out and planning research used for data is not purposes. GDPR is a high bar and very difficult to achieve achieve to difficult very and high bar GDPR is a personal removing It involves in practice. that may and indirect, direct identifiers, both of understanding stringent than the traditional of duty the common law under ‘anonymisation’ as it applies in the healthcare confidentiality sector. ‘pseudony- is actually purposes confidentiality GDPR purposes. Pseudonymised data for mised’ identifiers key where include data data may and the data can no longer been removed have the without a specific individual to be attributed such (and information additional of use and separately kept is information additional and organisational certain technical subject to an non-attribution to ensure to measures is that pseudony- takeaway The key individual). the to subject data personal still is data mised GDPR. anonymisation for on the thresholds discrepancy of duty law common the and GDPR the under The minutes confidentiality. group is being set up to discuss this, so watch watch discuss this, so is being set up to group developments. further for this space 3. deadline: data opt-out National data opt-out The national confidential their out of opt NHS patients to and research used for being patient information Baker McKenzie_LSL4_v3.indd 53

23/02/2021 13:05 3 CTC Legal Media The DSA template template The DSA 2 intersection of data privacy and the data privacy of intersection confidentiality of duty common law private sector private These partnerships will continue to be an be an continue to will These partnerships 2020 saw NHSX publish a Data Sharing publish a Data Sharing NHSX 2020 saw is a useful tool for companies collaborating with companies collaborating for tool is a useful (as data use and access to organisations NHS DSA The purposes). other of host a for as well and NHS organisation the relevant encourages to risks related key consider to its counter-party confidentiality. medical and privacy data the out set to need will parties the Crucially, special data (and any which personal basis on are data, such as health data) of categories the GDPR and the common both under shared confidentiality. of duty law expect We the NHS in 2021. for focus of area continue to will such as NHSX organisations demonstrating on focussing guidance issue the NHS in these for value compliance and partnerships. 2. and the (messy) Anonymisation NHSX’s Health and Care Information Governance Information and Care Health NHSX’s driven healthcare technology. These partnerships technology. healthcare driven media of spot-light the under come to continue scrutinising are Commentators government. and common the and privacy data with compliance NHS organisations confidentiality. of duty law the what is in it for asking, increasingly are in these deals? public sector template. (DSA) Agreement 5 topics on the horizon for 2021 1. the NHS and the Partnerships between of in the number seen an explosion have We the NHS and the private between collaborations is sector The private years. in recent sector and using datasets from accessing increasingly data- develop to NHS organisations various Panel (Panel) informs NHS priorities for new new NHS priorities for informs (Panel) Panel their In guidance. governance information highlighted Panel the 2020, of meeting last focus. of as an area pseudonymisation ” Data sharingData between the private and public sector will be a hot topic. Jaspreet Takhar “

NHS supplemental laws laws NHS supplemental 1

THE LIFE SCIENCES LAWYER 020 was a big year for health data in the for year a big was 020 and COVID-19, Brexit of year UK. In the So key. was governance information

Résumé Associate Senior Takhar, Jaspreet Jaspreet advises market-leading tech and healthcare companies on issues at the cutting-edge of digital health. She focuses on the development and regulation of healthcare technology. This includes assessing how digital health solutions can comply with the legal framework for data privacy, medical research and medical devices / pharmaceuticals. Jaspreet also advises clients on accessing and using patient data, innovative collaborations with hospitals, and the use and regulation of AI in the healthcare space. and use in 2021. and NHS information governance will mean for data transfers, sharing, mean for data transfers, governance will and NHS information Jaspreet Takhar, Senior Associate at Baker McKenzie, suggests what Brexit McKenzie, suggests Senior Associate at Baker Jaspreet Takhar, Health data in 2020 health for developments some key 2020 saw period transition With the Brexit data in the UK. the with comply must organisations over, now (UK law national into incorporated is it as GDPR also 2020, NHSX the end of Towards GDPR). governance information new brand a launched NHS for shop’ a ‘one-stop portal, providing guidance. policies and

final decision on the status of transfers of personal of transfers decision on the status of final 2 52

What’s next for 2021? for next What’s Health data in the UK:the in data Health HEALTH DATA HEALTH data from the EEA to the UK, post-Brexit. Data UK, post-Brexit. the to the EEA data from the private between sharing collaborations topic. be a hot continue to will and public sector NHS enhance to continue will NHSX Finally, including requirements, governance information and records Data Opt-Out the National guidance. management what does 2021 have in store? We anticipate a anticipate We in store? what does 2021 have and guidance have traditionally been difficult to been difficult to traditionally and guidance have NHS for news welcome is this so navigate, a was there Finally, suppliers and collaborators. and confidentiality, on medical focus renewed made some updates Data Guardian the National Principles. the Caldicott to Baker McKenzie_LSL4_v3.indd 52 AI IPR IN LIFE SCIENCES

23/02/2021 13:08 55 THE LIFE SCIENCES LAWYER Résumé Associate - Senior Lumbreras Janett Janett has been Senior Associate at Uhthoff, Gomez Vega & Uhthoff in the Patent Department. She has a Pharmaceutical Chemistry-Biology Degree, Diplomat in Access to Worldwide Scientific and Technological Information and Industrial and Intellectual Property Law from Universidad Nacional Autonoma de Mexico (UNAM). She is an active member of AMPPI, AIPLA, CNQFBM and drug discovery. and drug discovery. There are numerous areas where the life- the where areas numerous are There Scientists are integrating research data, lab data, research integrating Scientists are especially in the context of Big Data. Given their their Big Data. Given of in the context especially nature, interdisciplinary and highly complexity AI for ample opportunities sciences provide life ways. of variety in a impact R&D efforts to Some today. AI effectively uses science industry the following: them are of • , research, Pharmaceutical • drug development: Accelerating and clinical data, in combination with new with new data, in combination and clinical media and social (e.g., sources information the drug development across wearables) the drug of a holistic picture spectrum, creating to ways Improving candidate. development time allows and mine data in real acquire ” Janett Lumbreras Visual Visual perception, speech recognition, decision- and making, translation between languages. “

decision- rtificial Intelligence (AI) is transforming (AI) is transforming Intelligence rtificial making by industry the life-sciences biological massive from discoveries computer computer systems able to perform tasks Janett Lumbreras, Senior Associate, Uhthoff, Gomez Vega & Uhthoff S.C,Janett Lumbreras, Senior available for protecting AI innovations indiscusses types of protection and a for and against approach. the field with an explanation Artificial Intelligence involves a number of of a number involves Intelligence Artificial Artificial Intelligence originates from computer computer from originates Intelligence Artificial data using machine learning, integrating clinical clinical integrating data using machine learning, different and genomic data of records drug or medicine new discovering kinds, types, cell classes of identifying new targets, clinical customizing carrying out diagnostics, or medicine. in precision procedures CTC Legal Media The use of Artificial Artificial of use The in life Intelligence the and sciences rights IP of protection considerable degree of connection among them, of degree considerable Fields of applications in life sciences briefly to important is it continuing, Before is. It is defined Intelligence Artificial what explain as normally requiring human intelligence such as visual perception, speech recognition, languages. between making, and translation approaches of wide range a science and covers machines to of enhance the ability to intended decisions and accurate data-driven make AI scientific fields, In many events. of predictions and integrated, considered is being increasingly A machine learning, primarily technologies, different deep learning, neural networks, natural language natural networks, deep learning, neural but the core technology is machine learning. So, technology but the core in could fall technology bearing in mind that this some under patentability of the exception new consider to legislation, it is necessary Thus, several rights. the IP protect to regulations when protecting aspects should be considered it. protect to and choosing how this technology processing, and computer vision. There is a is a There vision. and computer processing, Uhthoff_LSL4_v4.indd 55 AI IPR IN LIFE SCIENCES AI IPR IN LIFE SCIENCES

scientists to use AI and machine learning to Machine learning is a term that refers to the 1. Detectability. If detecting when a competitor • infringement is hard to detect. make better decisions faster, which will accelerate ability of AI algorithms to learn and develop uses an invention is hard, then the value of • the lifecycle of the invention is short. the product development and scale-up process. without being explicitly programmed. patenting that invention is diminished because • the filing behavior of the competition is not “Then the Life sciences companies are likely to begin it will be difficult to know that the patent is being “There is a active. • Epidemiology and clinical investigations. experimenting further with AI in their workflows infringed. This may be the case with innovative Trade secret protection can be very cost- • In silico modeling and simulation of value of in the coming years, but they face challenges in training algorithms for ML systems—it is perhaps possibility effective since there are no official fees to pay. molecular systems and organisms. patenting AI adoption due to strict regulations. possible to detect that the ML system is being that it is However, there are management and administrative • Designing clinical trials: used, but hard to detect how it was trained. This costs to businesses since comprehensive policies Artificial Intelligence can design clinical trials, that The regulatory challenge might suggest the trade secret route for such harder to and procedures are needed to track and secure estimating the ideal sample size, and invention is Artificial Intelligence and Machine Learning (AI/ technology. gain patent trade secrets. implementing them remotely on participants ML) involves new computing technologies, and 2. Reverse Engineering. If it is easy to reverse Trade secrets offer a degree of protection in across a wider geographical area. This, in turn, diminished. vast amounts of training data that pose new engineer the invention or hard to keep it secret protection circumstances where patenting is not the best reduces the cost and increases the odds of regulatory challenges such as: (e.g., due to desire to publish or visibility of the approach. obtaining relevant and accurate data. • Determining the accountability for providers invention in the product), then the patent route for If the technology needs to be known by several of AI/ML-based solutions and assigning may be preferable. individual entities, such as software contractors, customers, • Introducing robotic surgery: liability for harm caused by the “black box” Trade secrets offer a degree of protection in and a large number of employees, then it may A new field that is garnering a considerable ” of an AI/ML process. circumstances where patenting is not the best new drugs not be practical to be kept secret and trade amount of interest. Nowadays, surgeries can be • Assuring the quality and safety of products approach. found using secret protection is not suitable. performed in previously inaccessible places. or therapies developed using AI/ML. Keeping part of an invention secret is an option Once trained, a robot will be competent enough • Guaranteeing that the data and/or if: the AI Protection by Patent to perform each operation consistently and algorithms used in AI/ML solutions are not • time is needed to generate more These inventions must comply also with the accurately. The consistency and accuracy of the biased against underserved populations. experimental data to ensure optimal scope algorithm. requirements of novelty, inventive step, and surgery will be irrespective of the duration of • Ensuring that the AI/ML solutions of protection. industrial applicability to be patented. If claims the surgery. It is touted to be superior when developed are sustainable and • the invention could not be described in a relate to a method involving the use of technical compared to human performance, which will environmentally friendly, and that the reproducible way without disclosing training means, for instance a computer or a device, the predictably decline with time. recommendations are not in conflict with data that should remain secret. subject matter in its entirety is of a technical societal priorities such as social justice. • patent case law is not favorable in terms of ” nature and is patentable as an invention. The • Developing the next-generation of • Protecting the privacy of patients and their patent eligibility. question, then, is whether the invention satisfies radiology tools: data. Existing patient privacy rules do not, The current diagnostics processes rely on either for example, protect patient data when it is invasive techniques or information gathered from shared and used by technical or consumer radiological images. This includes data from CT marketing organizations rather than scans, X-rays, or MRI machines. AI-based radiology healthcare providers. tools will enable clinicians to gain a more Thus, international and national legislations precise and detailed understanding of how a must be adapted or must be created to regulate disease progresses by performing virtual biopsies. the safe use and protection of the AI-related IP rights. • Telemedicine: Unavailability or dearth of trained professionals Protection of Artificial Intelligence such as radiologists or ultrasound technicians innovations in life sciences can considerably limit access to life-saving care. A substantial investment in building and This is commonly observed in emergent and deploying machine learning (ML) technology – developing parts of the world. The AI-powered the most active area of AI technology being tool “Telemedicine,” which equips patients to developed today – warrants carefully considering tackle and prevent certain health concerns, has how to protect the resulting intellectual property become popular in such regions. The health rights, but there are challenges in doing so. care start-up “WeDoctor” can independently Several aspects should be considered when conduct eleven diagnostic tests and upload protecting this technology and choosing how it data for consultation in an automated fashion. is to be protected, which would be with a patent or with trade secret protection. • Clinical Trials: Clinical Internet of Things refers to the ability of Trade Secret protection patients to wear mobile devices and sensors Protecting by Trade Secret, there is no time limit that will capture and provide a stream of quality, on trade secret protection so long as the subject nearly real-time data to researchers. AI is matter is kept secret, and there are no eligibility, the technology those researchers will use to novelty, or obviousness bars to clear. There is, analyze the data and look for information, however, no recourse for independent discovery insights, or patterns. It has been defined as by a competitor. Important factors to consider machines being able to perform “smart” tasks when weighing trade secret and patent protection that are characteristic of human intelligence. include:

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other requirements of patentability, in particular filings grew at an annualized rate of over 50% Overall number of patent References novelty and inventive step. from 2014 to 2017. applications by Patent Office 1. https://www.researchgate.net/ The evaluation of the inventive step, widely Machine learning is the dominant AI technique The greatest number of patent applications are publication/328139493_Artificial_ considered the more problematic requirement, disclosed in patents. Nevertheless, according to filed in the patent offices of U.S. and China, intelligence_in_clinical_development_and_ assesses whether the mathematical method the field of application the main fields are the followed by Japan, while WIPO and the EPO are regulatory_affairs_-_Preparing_for_the_ contributes to producing a technical effect that following: also often used. future serves a technical purpose. For example, an 2. https://www.clinicalleader.com/doc/ X-ray apparatus providing a genotype estimate • Transportation industries (15 percent of all ways-ai-is-transforming-the-life-sciences- based on an analysis of DNA samples or an AI-related patents), already-0001 automated system providing a medical diagnosis • Telecommunications (15 percent), 3. https://www.clinicalleader.com/doc/ by processing physiological measurements. • Life and medical sciences (12 percent). novartis-turns-to-digital-technologies-for- Some examples of potentially patentable • Transportation, agriculture, and computing clinical-trials-0004 aspects of an ML system are: in government are growing industries, with 4. https://www.journals.elsevier.com/ • New ML model: in deploying ML annual growth rates of at least 30 percent artificial-intelligence-in-the-life-sciences technology, a new model may have been between 2013 and 2016. 5. https://www.enago.com/academy/big- developed (e.g., new neural network 10-ways-artificial-intelligence- architecture). Claiming novel aspects of the Patent families for application transforming-life-sciences/ model will help to address novelty and field categories and 6. https://emerj.com/ai-sector-overviews/ inventive step challenges. sub-categories artificial-intelligence-in-life-sciences/ • Training an ML model: innovative ways of 7. https://www.cognizant.com/whitepapers/ generating training data and/or a new ai-regulation-is-coming-to-life-sciences- training algorithm may be claimed. For three-steps-to-take-now-codex5980.pdf example, when there is insufficient training 8. https://www.mondaq.com/unitedstates/ data, it may be augmented by synthesizing patent/894530/strategies-for-patenting- new training data from old training data or artificial-intelligence-innovations-in-the- other sources, and such data augmentation life-sciences techniques may be innovative and, thus, the 9. https://www.nlo.eu/sites/nlo_corp/ focus of patent claims. files/2020-06/NLO%20Life%20 • Organizing an ML model: how an ML model Sciences%202020.pdf is integrated into an application may provide 10. https://www.wipo.int/wipo_magazine/ a novelty and inventive step hook. Claims en/2019/01/article_0001.html focusing on integration and deployment 11. https://www.wipo.int/publications/en/ should go beyond merely displaying the details.jsp?id=4386 model’s output and focus on what the output is used to achieve. For example, applying an ML system to medical images may result in instructions to take more images with different settings because the ones obtained are unsatisfactory. Other examples include choosing among different next steps in a control system, customizing a patient’s treatment, or updating a clinical trial. When an ML system is deployed in Conclusions conjunction with a specialized device (e.g., AI is expected to revolutionize processes across an imaging device, a sequencing device), a wide range of fields. It is foreseen that AI will rather than merely a computer, claims could also affect intellectual property rights, in focus on how the ML system is integrated particular patent rights and their management. with the device. This is likely to be a two-way process: on the • By publishing a patent application about an one hand, AI developments will affect and be AI algorithm for finding new drugs, there is a incorporated into IP rights management; on the possibility that it is harder to gain patent other hand, IP policies and practices will interact protection for individual new drugs found with the strategy of managing innovation in AI. using the AI algorithm. This is because the In addition, as AI develops, some of the Contact new drugs are arguably obvious since the AI “IP policies and practices will interact questions that are currently discussed only Uhthoff, Gomez Vega & Uhthoff S.C algorithm is known. hypothetically may become real issues. These Hamburgo 260 col. Juárez 06600 with the strategy of managing include the inventorship of AI, patent- and more Mexico City Filing of AI Patent applications innovation in AI. generally IP-rights infringement by AI. Such Tel: +52 (55) 55 33 50 60 ext. 1141 The number of AI-based patent filings has questions may call for related regulation or a [email protected] increased rapidly in recent years, particularly in certain interpretation of existing regulations to www.uhthoff.com.mx the and Asia. Even in Europe, patent cover possible gaps and answer related questions.

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Uhthoff_LSL4_v4.indd 58 23/02/2021 13:08 Uhthoff_LSL4_v4.indd 59 23/02/2021 13:08 FUNCTIONAL CLAIMING . 25/02/2021 12:02 61 viz. The Patents THE LIFE SCIENCES LAWYER 9 Résumés Partner Singh, Managing Ms. Manisha the is a founder and Manisha Singh LexOrbis. She Managing Partner of all practice overviews and supervises is known and groups at the firm. Manisha expertise on respected for her deep of all prosecution and enforcement for strategizing and forms of IP rights and trademarks, managing global patents, of large global and designs portfolios She is known and domestic companies. and negotiation for her sharp litigation non-IP litigations skills for both IP and and dispute resolution. She has represented a number of companies in large number of intellectual property litigations with a focus on patent litigations covering all technical fields – particularly pharmaceuticals, telecommunications, and mechanics. [email protected] Kamal, Ph.D., Kumar Pradeep Managing Associate Pradeep Kumar Kamal is an Indian patent attorney at LexOrbis. He holds a doctorate degree in biomedical science and has a rich professional experience in academia, scientific research, and patent practice in India. He handles techno- legal aspects of patenting and contentious IP matters. [email protected] Indian patent law and practice on functional on functional and practice law Indian patent connected to existing legal sources legal existing to connected Office Patent of Manual amended), (as 1970 Act, for Guidelines different and Procedure, Practice judicial and Applications Patent of Examination recognize to fail which either of all precedents, The leeway. provide claiming or functional under provided invention definition of statutory (as 1970 Act, Patents the of 2(1)(j) Section or product means a new amended) “‘invention’ claiming is an unsettled one with no jurisprudence with one unsettled an claiming is only defined in terms of a ‘result to be achieved’ achieved’ be to a ‘result of defined in terms only of satisfaction contingent to accepted, are the formulate possible to conditions that it is not restricting without unduly precisely claim more the claims and that it is possible for the scope of without the result verify the skilled person to undue burden. While there is no statutory bar on claims with with on claims bar is no statutory While there functional with only language, claims functional lack to considered outrightly limitations are of Controllers/Examiners by features technical be may This approach Office. Indian Patent Richard A. Williamson v. Citrix Online, LLC (Fed. Cir. 2015); Part III, Implementing Regulations to the Convention on the Grant of European Patents, The European Patent Convention; Ex parte Miyazaki, PTAB (2008); Claiming: A Way Forward, Landslide, Vol. 12, No. 3, January/February 2020, by the American Bar Association; O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1854); Examination, EPO; Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1, 12-13 (1946); General Electric Co v Wabash Appliance Corporation (304 US 364 (1938));

T 0068/85, EPO; for F-IV 4.10 Guidelines

43 (1), Chapter II, Rule

Functional Recalibrating 2 3 4 5 6 7 8 9 Manisha Singh Pradeep Kumar Kamal 1 4 Halliburton Oil Oil Halliburton However, claim claim However, 5 (1946) held that it is EPO specifically considers EPO specifically 8 However, EPO, in its Guidelines EPO, However, 7 6 case the U.S. patent statute was was statute patent case the U.S. General Electric Co v Wabash Appliance Wabash v Co Electric General The US Supreme Court in Court Supreme US The 3 In 1938, the US Supreme Court invalidated a Court invalidated In 1938, the US Supreme European Patent Convention (EPC) on the (EPC) on the Convention Patent European The present practice of USPTO to consider consider to USPTO of practice present The 2 reciting only function as the limitation to its its function as the limitation to only reciting specification the in describing without scope the performing for structure the corresponding invalid considered often are function recited being indefinite. CTC Legal Media there is divergent jurisprudence for acceptance acceptance jurisprudence for is divergent there patent different among claims such of of been plenty have While there jurisdictions. with dealing precedents judicial insightful and Europe, States claiming in United functional guidance on enablement and which provide pockets claims, functional of issues indefiniteness dynamism to which is inherent - remain area grey of other side stipulates that the claims should define side stipulates other is sought in which protection for the matter and does not features, technical of terms facilitating for specific provision any provide claiming. functional functional of inclusion permit Examination, for that a skilled a claim, provided in features providing in difficulty no have would person said function performing some means of The approach skill. inventive without exercising and lenient one as flexible more EPO is rather of USPTO. to compared Claims certain prerequisite. of upon satisfaction new technologies and associated functional functional associated and technologies new claiming. any like just limitation, functional evaluate and of outcome the is claim, the of limitation other 150 than more over developed jurisprudence v. Morse Court in O’Reilly US Supreme years. primary Morse’s of portion a invalidated (1854) produced being defined as an effect for patent distinct, from electromagnetism the use of by produce to necessary machinery or the process it. filament because it claimed a tungsten Corporation than its rather its performance of in terms adequately and did not characteristics physical the of characteristics define the structural grains. Halliburton Post § 112(f) enacting to amended in 1952 by The means-plus-function claiming. authorize be that needs to requirement suggested only claiming is that the in functional care taken function claimed the performing for structure specification. must be described in the patent’s Citrix Online case v. in Williamson Circuit Federal functional of amplitude wider for guided further considering non-means claims as claiming, by means-plus-function claims. one subset of functional claiming to be acceptable be to claiming functional of subset one Well Cementing Co. v. Walker Walker v. Cementing Co. Well functional “conveniently use to impermissible novelty”. point of language at the exact patent in patent LexOrbis_LSL4_v3.indd 61

24/02/2021 12:07 at the Functional Functional 1 CTC Legal Media may be inherently be inherently may At times, an invention (e.g., one one (e.g., invention an times, At claiming, in one of its forms, is is its forms, claiming, in one of as a define inventions to known for’, ‘mechanism for’, ‘component ‘component ‘mechanism for’, for’, for’, ‘system for’, ‘apparatus for’, point of novelty. point of ‘member for’, ‘compound for’, for’, ‘compound for’, ‘member claiming may be preferable and even and even be preferable claiming may by using expressions viz. ‘means viz. ‘means using expressions by ‘agonist for’, ‘antibodies for’, ‘probe ‘probe for’, ‘antibodies for’, ‘agonist for’ etc. Such means plus function Such means plus function etc. for’ functional or at least functional at least functional or functional software based) software unavoidable. functional functional ‘Functional claiming’ is one such way of drafting drafting of way such one is claiming’ ‘Functional Functional claiming has always remained a a remained claiming has always Functional jurisdictions. While many of the patent jurisdictionsthe patent of While many jurisdictions. an where be situations may that there recognize terms, be defined in functional may invention with almost every field of invention in conjugation invention field of with almost every claims with a much wider coverage with respect with respect coverage wider with a much claims The expression components. structural to define the claims to refers claiming” “functional limitations functional of in terms an invention of than component, rather the structural of of Use component itself. defining the structural any confined to claiming is not functional but is associated invention field of particular ‘means for’ performing a function, wherein wherein function, a performing for’ ‘means broader any to refers “means for” expression element the structural of generic representation structural of claims thus encompass a range the referred components that can perform these inventions, science related function. In life be compound, components may structural biomolecule, nucleic acid, polypeptide, active, lines, etc. cell protein, patent dynamic concern among the different with its related terminology. Depending on the terminology. with its related and the specific invention, technology ” Runs the risk of invalidation. “

THE LIFE SCIENCES LAWYER tructuring of claims which constitute a a which constitute claims tructuring of an scope of defining the text, legal is of application, a patent of invention

to offer guidance for its use in India where the practice is still unsettled.to offer guidance for its use EPC, and EPO for examples and guidelines of the use of functional claimingEPC, and EPO for examples Manisha Singh & Pradeep Kumar Kamal, of LexOrbis, look to the USPTO,Manisha Singh & Pradeep paramount importance in protecting inventions. inventions. importance in protecting paramount limit the unnecessarily narrowly Claims crafted in infringers overcoming and result protection, In variations. trivial showing infringement by scope a claiming, defining broad contrast, the by encompassed is what beyond is which invalidation. runs the risk of disclosure,

60 S in India life science inventions inventions science life Functional claiming inclaiming Functional FUNCTIONAL CLAIMING FUNCTIONAL LexOrbis_LSL4_v2.indd 60 FUNCTIONAL CLAIMING FUNCTIONAL CLAIMING

process involving an inventive step and capable biomolecules, but there is no limitation to rescue on its face would even cover peptide that may of the scope of claims during prosecution in of industrial application” is wide enough to a person of ordinary skills to derive the entire not yet have been invented but could interact general and in particular during invalidation/ accommodate functional claiming. The set of molecules covered by the scope of such with said target for treating cancer. Nevertheless, infringement proceedings, as the Indian courts definition only necessitate that an invention “Structural claims.13 Such reach-through claim, like other said claim, along with additional limitation “All of which have preference to infer the scope of claims by should be a new product or a new process claims, may be a product claim, a process claim, defining the target of such peptide, is likely to be considering the limitation recited in the claims. involving an inventive step and capable of components or a product by process claim. For example, an considered as ‘quasi reach-through’ claims, either fail to The description should include sufficient examples industrial application. However, Section 10(4)(c) may be invention related to identification of peptide, depending upon simplification of techniques recognize to cover range of structural limitations that can of the Indian Patents Act, 1970 (as amended) which modulate the activity/function of an involved therein to reach the possible products. perform the claimed functional limitation. which require the claim(s) to define the scope of compound, important gene/protein, may be drafted as Owing to importance of such claims in life functional the invention for which protection is claimed, active, “molecules/agent capable of modulating the science and the existing vacuum in Indian legal claiming upon its interpretation may impede claims activity/function of particular gene/protein” or texts to steer functional claiming, Indian Patent defined only with functional limitations.10 The biomolecule, as “molecules/agent capable of identifying office may resort to guiding jurisprudence of US or provide interpretation of Section 10(4)(c) of the Act may particular gene/protein”. Such claims would and EP and come up with guidelines to consider be attributed to an Indian patent jurisprudence nucleic acid, literally cover all molecules that modulate the functional claiming in a right perspective. Meanwhile, leeway. having tendency to make literal interpretation of polypeptide, activity of the gene/protein as identified in inventions proposed to be protected in India claims. This is in contrast with practice of USPTO said invention and if no structural limitation is must avoid claims defined only by functional and EPO which consider structural features protein, considered for construing the scope of claim, it limitations, and must at least define structural recited in the description and place reliance on cell lines. would also cover future molecules that would feature responsible for ingenuity of subject the ability of a skilled person to infer such perform the same function, or that are possible invention in the claims itself. In other words, the ” structural features. Another, limiting reference in theory. The same approach may be translated claim language by itself should be sufficient to comes from the Guidelines for Examination of to process claims, wherein process elements convey a person of ordinary skill in the art about Patent Applications in the Field of Pharmaceuticals, are not defined by their structure but are defined the structural limitations or process steps Contact which consider that functional claiming should ” by its function i.e., ability to modulate the encompassed by said claim. The invention must LexOrbis be discouraged because such claims lead to expression of a protein or gene. A claim related be drafted with sufficient number of dependent 709/ 710, Tolstoy House, 15-17, Tolstoy confusion regarding the scope of the invention with production of important biomolecule may claims reciting structural features leading to Marg, New Delhi, Delhi 110001, India and that in most of the occasions such claims be drafted as reach-through claim with a functional limitation, for the fallback position. Tel: +91 11 2371 6565 encompass a scope which is inconsistent language “A cell culture capable of producing This would eventually help in addressing the www.lexorbis.com and much wider to the scope afforded by the biomolecule with amino acid sequence 1”. In issues related with the clarity and indefiniteness descriptions.11 Owing to specific absence of such claim if there happens to be no limitations permissible or qualifying requisites for functional (process or product) related with cell culture, claiming in legal sources, the claim encompasses production of biomolecule (IPO) practice on functional claiming is considerably with amino acid sequence 1 using any cell restrictive than that of the USPTO and the EPO. culture. There is still another type of functional Claims defined only with functional limitations claims, which are not absolutely ‘reach-through’ are often objected by Indian Patent Office for claims but are considered as ‘quasi reach-through’, lacking technical features, being unclear and as these claims seek to protect molecules, indefinite in their scope. IPO practice related which are not defined by structure but are with claim definitiveness require claims to be comparatively confined to be derived using defined by at least the inventive feature.12 This a particular protein or gene.14 A claim to a mono- may be due to a relatively lower degree of clonal antibody against particular protein reliance placed on person skilled in the art for without structurally defining the antibody, a the purpose of determining the scope of claims probe against nucleic acid or amino acid for evaluating definitiveness and enablement sequence, a cDNA sequence of a gene are 10 Section 2(1)(j); Section 10(4) requirement as compared to USPTO and the (c) Indian Patents Act; examples of quasi reach-through claiming, since EPO. 11 Paragraph 11:13, page 40, such antibodies, probes and cDNA sequences Inventions in life science often relate to complex Guidelines for Examination can be reasonably presumed to have been biomolecules, which at times may be difficult to of Patent Applications in obtained in routine manner by using well-known depict by words. This is the reason claims with the Field of techniques. simple reference to sequence in form of Pharmaceuticals (2014); The device of functional claim allows a patent 12 Paragraph 05.03.17 k), page sequence ID is universally accepted. Owing to drafter to cover a potentially broad class of 44, Manual of Patent Office the complex nature of inventions in life sciences Practice and Procedure, structures with a single claim limitation. For and considering the need to protect the invention Version 3.0 (2019); example, a claim with broad or generic structural with a scope sufficient to cover the trivial 13 F-III 9, Guidelines for and functional limitation “A peptide capable of structural changes, claims with functional limitations Examination, EPO; treating a cancer”, the generic structural limitation hold specific significance. Functional claims in 14 Reach-through Patent construed along with function limitation life sciences, like other claims may, relate to a Claims in Biotechnology: “capable of treating a cancer” would cover a An Analysis of the protein, polypeptide, antibody, or gene. Such diverse range of peptides that may interact with Examination Practices of functional claims in their extreme form may be the United States, diverse target for treating a cancer. Considering considered as ‘reach-through’ claims, if there exists European and Japanese that such claim also has additional limitation only a functional relationship among the different Patent Offices; defining the target of such peptide, such claim

62 THE LIFE SCIENCES LAWYER CTC Legal Media CTC Legal Media THE LIFE SCIENCES LAWYER 63

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Mehta & Mehta Associates United Trademark & Patent Romulo Mabanta Buenaventura Sojuzpatent Mehta & Mehta Associates (Gurgaon, INDIA) is Services Sayoc & de Los Angeles Sojuzpatent is the oldest leading IP law firm on the a full-service boutique IP Law Firm, providing Filing, territory of the former USSR, with seven offices in L.S. DAVAR & CO. International Intellectual Property Attorneys Founded in 1902, the firm is now 114 years old. A Prosecution and Litigation services in respect of Russia, and associates in all the neighboring We are India’s oldest Intellectual Property and Litigation specialising in Trademarks, Patents, Designs, full-service IP firm, it has pioneered in Intellectual Patents (in different fields of science and engineering), countries. We employ more than 150 people, Firm. Since 1932, we have been as a trusted IP partner Copyrights, Domain Name Registration, Litigation & Property law practice, and some of its key cases Trade Marks, Designs and Copyright. The Firm assists including 50+ patent attorneys and litigation lawyers, of Global Large and Mid-size companies and foreign IP Enforcement services. decided by the Philippine Supreme Court have been law firms. We have been widely acknowledged by Govt. both national and international clientele, from different to achieve seamless prosecution and successful Address: 85 The Mall Road, Lahore 54000, Pakistan featured in Philippine Reports, formerly the repository of India. In the last 90 years, we have retained number geographical locations and backgrounds for all IP litigation. We offer everything you may need for Tel: +92 42 36285588, +92 42 36285590, of the decisions of the Philippine Supreme Court, and one position in India in not only filing the Patents, related contentious and non-contentious matters. protecting your IP in the whole region. +92 42 36285581, +92 42 36285584 now in the Supreme Court Reports Annotated Designs, Trademarks, Copyright, and Geographical Address: Mehta & Mehta Associates, Mehta House, Address: Myasnitskaya St., 13, Bldg. 5, Moscow, Fax: +92 42 36285585, +92 42 36285586, (SCRA). Indications but also in getting the grants. B-474, Sushant Lok-1, Sector-27, 101000, Russia +92 42 36285587 Address: 21st Floor, Philamlife Tower, 8767 Paseo Gurgaon-122002, NCR, India Tel: +7 495 221 88 80/81 Tel: 033- 2357 1015 | 1020 Website: www.utmps.com & www.unitedip.com de Roxas, Makati City 1226 Philippines Tel: +91-124-410 8474, 410 8475 Fax: +7 495 221 88 85/86 Fax: 033 – 2357 1018 Email: [email protected] Tel/Fax: (632) 5559555; (632) 8134558; Fax: +91-124-410 8476 Website: www.sojuzpatent.com Contact: Yawar Irfan Khan, Hasan Irfan Khan (632) 8103110 Website: www.lsdavar.org.in Website: www.mehtaip.com Email: [email protected] Website: [email protected] Email: [email protected] Email: [email protected] Contact: Svetlana Felitsina, Managing Partner Email: [email protected] Contact: Dr Joshita Davar Khemani Contacts: Dr. Ramesh Kr. Mehta, Founder Tatiana Petrova, Head of Trademark Contact: Rogelio Nicandro; Joaquin V. Sayoc Mrs. Dahlia Chaudhuri Ankush Mehta, Principal Attorney Department

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Y. J. Trivedi & Co. Patent 42 IPSOL Vakhnina and Partners Fenix Legal Deep & Far Attorneys-at-law The firm is elated to have completed 50 years in the practice Patent 42 is a law firm acting in Industrial Property. IPSOL is a key service line focused on the planning, One of the leading IP firms in Russia. Advising our Fenix Legal, a cost-efficient, fast and professional Deep & Far attorneys-at-law deal with all phases of of IPR Law (full service) with offices in Mumbai, Delhi and Our job is to help and assist companies and registration and management of trademark, patent clients on all aspects of IP in Russia, , Patent and Law firm, specialized in intellectual laws with a focus on IPRs, and represent some Jaipur. The firm has a strong base of well-credentialed legal entrepreneurs in protecting and defending their and other IP rights portfolios, offering solutions that ex-USSR countries and Baltic States. Using our own property in Europe, Sweden and Scandinavia. Our international giants, e.g. InterDigital, MPS, Schott and technical professionals offering quality services in all investments in innovation and creation. enable to maximize the protection of your IP assets in trademark search engine. Services: Patents, consultants are well known, experienced lawyers, Glas, Toyo Ink, Motorola, Cypress. The patent areas of IPR. Whether working on a precedent-setting case If innovation is first of all a state of mind, it is also Macau and worldwide. trademarks, designs, utility models, copyright, European patent, trademark and design attorneys, attorneys and patent engineers in Deep & Far or preparing opinions, the firm endeavours to be innovative a necessity and a source of development and growth Address: Avenida da Praia Grande, 759, 5° andar, litigation and enforcement. Members of Russian PA business consultants, authorized mediators and normally are generally graduated from the top five in its approach and adopt pragmatic strategies to meet its for your company. Investments carried out to develop Macau Association, INTA, AIPPI, LESI, ECTA, PTMG, GIPC. branding experts. We offer all services in the IP field universities in this country. More information client’s interest. Through interdisciplinary collaboration and new products or new activities deserve to be Tel: (853) 2837 2623 Address: Bld. 6, Preobrazhenskaya Pl., Moscow, including trademarks, patents, designs, dispute regarding this firm could be found from the website specialized experience in its clients' industries, the firm protected.seeking to protect valuable original Fax: (853) 2837 2613 107061, Russia resolution, mediation, copyright, domain names, IP above-identified. provides effective solutions that aligns with clients’ short- creations. Website: www.ipsol.com.mo Tel: +7-495-231-4840 Due Diligence and business agreements. Address: 13 Fl., 27 Sec. 3, Chung San N. Rd., term and long-term business objectives. Address: 34, rue Dicks Email: [email protected] Fax: +7-495-231-4841 Tel: +46 8 463 50 16 Taipei 104, Taiwan Address: 2nd Floor, City Square Building, L-4081 Esch-sur-Alzette Contact: Emalita Rocha Website: www.vakhnina.com Fax: +46 8 463 10 10 Tel/Fax: 886-2-25856688/886-2-25989900 Opp. Kashiram Hall, Polytechnic, Luxembourg Email: [email protected] Website: www.fenixlegal.eu Website: www.deepnfar.com.tw Ahmedabad – 380 015, Gujarat, India Tel: +352 691 999 350 Contact: Dr. Tatyana VAKHNINA Email: [email protected] Email: [email protected] Tel: +91 79 26303777, 26305040 Fax: +352 24 61 10 10 Dr. Alexey VAKHNIN Contacts: Ms Maria Zamkova Contact: C.F. Tsai, Yu-Li Tsai Website: www.yjtrivedi.com Email: [email protected] Mr Petter Rindforth Email: [email protected] Contact: Mr. Jatin Trivedi

MEXICO NIGERIA PAKISTAN TAIWAN R.O.C. TAIWAN, ROC TURKEY

Goodrich Riquelme Asociados Aluko & Oyebode Bharucha & Co. Giant Group International Patent, LEWIS & DAVIS Destek Patent Our staff of attorneys, engineers and computer We are a full-service law firm focusing on patent Established in 1948, Bharucha & Co. is one of the Trademark & Law Office LEWIS & DAVIS offers all services in the IPRs field, We are a multinational legal practice that has specialists help adapt foreign patent specifications and prosecution rated for Patent Contentious by Managing leading Intellectual Property law firms in Pakistan Giant Group is specialized in domestic and international including prosecutions, management and litigation of provided full range Intellectual Property services claims to Mexican law, secure patent inventions and Intellectual Property. The Firm was named Law Firm of providing full range of IP services including all patent application, litigation and licensing, as well as Trademarks, Patent, Designs and Copyright, and including trademarks, patents, designs, plant variety trademark registrations and maintain them by handling the Year 2015 and Intellectual Property & Technology aspects of patents, trademarks, designs, copyright, trademark and copyright registration. Regardless of payment of Annuity and Renewal fee. Our firm assists protection and more since 1983. With more than the necessary renewals. Our computer system, which Team of the Year 2017 by Law Digest Africa Awards. domain names, licensing, franchising and litigation. whether you are seeking legal protection for a piece of both domestic and international clients in Taiwan, 200 qualified in-house staff, including 50 patent and is linked to the Mexican Patent and Trademark The Firm was also named the Law Firm of the Year The firm is ranked among the leading law firms in intellectual property, or being accused of infringing China, Hong Kong, Macau and Japan. Our experienced trademark attorneys, we are able to assist domestic Department, permits us to provide our clients with a 2016 and Intellectual Property Team of the Year 2017 Asia by most of the prestigious legal referral guides. someone else's intellectual property, you can deal with this attorneys, lawyers, and specialists provide professional and international clients worldwide. complex area of law successfully through Giant Group. timely notice of their intellectual property matters. We by ESQ Nigerian Legal Awards. We will continue to Address: F-7/1, Block 8, K.D.A Scheme 5, services of highest quality while maintaining costs at Address: Eclipse Business D Blok No:5, ISTANBUL also prepare and register license agreements. advise clients on patent strategy in Nigeria, Ghana, Kehkashan Clifton, Karachi, Pakistan. Tel: +886-2-8768-3696 efficient level with rational charge. Tel: +90 212 329 00 00 OAPI and ARIPO. Fax: +886-2-8768-1698 Address: Paseo de la Reforma 265, M2, Col. Y Del. Tel: +92-21-3537 9544 Tel: +886-2-2517-5955 Website: www.destekpatent.com Website: www.giant-group.com.tw/en Cuauhtemoc, 06500 Mexico, D.F. Address: 1 Murtala Muhammed Drive, Ikoyi, Fax: +92-21-3537 9557-58 Fax: +886-2-2517-8517 Email: [email protected] Email: [email protected] Tel: (5255) 5533 0040 Lagos, Nigeria Website: www.bharuchaco.com Website: www.lewisdavis.com.tw Contact: Claudia Kaya Fax: (5255) 5207 3150 Tel: +234 1 462 8360 / +234 806 680 3387 Email: [email protected] Contacts: Marilou Hsieh, General Manager, ([email protected]) Tel: +886-911-961-128 Email: [email protected] Website: www.goodrichriquelme.com Website: www.aluko-oyebode.com Contact: Mohammad Fazil Bharucha, Abdul Aziz Murat Bürkev Email: [email protected] [email protected] Email: [email protected] Email: [email protected] ([email protected]) Amanda Kuo, Manager Contact: Lewis C. Y. HO Contact: Enrique Diaz [email protected] Simay Akba Tel: +886-2-87683696 #362 David M. C. HO Email: ediaz@ goodrichriquelme.com Contact: Uche Nwokocha, Partner Email: [email protected] ([email protected])

66 THE PATENT LAWYER CTC Legal Media CTC Legal Media THE PATENT LAWYER 67 TPL DOS 4pp RHP Start_TPL52:Layout 1 23/2/21 12:31 Page 68

To enter your firm in the Directory of Services section please email [email protected] Directory of Services

UGANDA UKRAINE UNITED STATES

SIPI Law Associates Pakharenko & Partners Young & Thompson SIPI Law Associates is a boutique commercial law Pakharenko & Partners provides full IP service coverage Young & Thompson, established in 1903, is a full practice in Uganda, with a bias to Intellectual Property in Ukraine, CIS countries and Baltic states and has service intellectual property law firm focusing on U.S. Law. Our IP advisory services cover all transactional offices in Kyiv and London. We pride ourselves on an patent and trademark prosecution of the highest quality aspects of Patents, Trademarks, Copyright, Industrial exclusive expertise and experience in the fields of IP while maintaining costs at a moderate level. Young & designs, Trade Secrets and licensing aspects. The firm law, anti-counterfeiting and anti-piracy, pharmaceutical Thompson has been recognized as an industry leader philosophy is based on providing first class legal services law, competition law, advertising and media law, for innovation in new technologies and procedures, based on the integrity of our staff, giving our clients corporate law, litigation and dispute resolution. being among the first law firms adopting a paperless sound legal and timely advice, as well as holding our Address: P.O.Box 78, 03150 Kyiv, Ukraine workplace, and co-developed an automated solution for clients’ information in the utmost confidentiality. Visiting: Business Centre 'Olimpiysky', creating and executing all workflows. Address: PO BOX 4180, KAMPALA, UGANDA 72 Chervonoarmiyska Str., Kyiv 03150, Address: 209 Madison Street, Suite 500, Visiting: Jocasa House, Third Floor, Unit 5 Plot Ukraine Alexandria, VA 22314 14 Nakasero Road. Tel/Fax: +380(44) 593 96 93 Tel: 703-521-2297 Tel/fax: +256 393 272921/ +256 414 +380(44) 451 40 48 Fax: 703-685-0573 235391 / +256 752 403 763 Website: www.pakharenko.com Website: www.young-thompson.com Website: www.sipilawuganda.com Email: [email protected] Email: [email protected] Email: [email protected] Contact: Antonina Pakharenko-Anderson Contact: Andrew Patch Contact: Paul Asiimwe; Dinnah Kyasimiire Alexander Pakharenko

VIETNAM VIETNAM VIETNAM

Annam IP & Law ELITE LAW FIRM Pham & Associates ANNAM IP & LAW is one of the most professional ELITE LAW FIRM is born to provide professional and Established in 1991, staffed by 110 professionals Intellectual Property & Law Firms in Vietnam, qualified legal services in the field of Intellectual including 14 lawyers and 34 IP attorneys, member of APAA, INTA and VIPA. We provide our Property and Business Law in Vietnam as well as many Pham & Associates is one of the largest legal clients with a full range of IP services to protect their countries around the world such as Laos, Cambodia, practices in Vietnam specialized in IP. The firm is inventions, trademarks, industrial designs and related Myanmar and Thailand. Delivering success, effectiveness one of the biggest filers of patents, trademarks and matters not only in Vietnam, but also in Laos, and safety to our clients is the ultimate goal of ELITE industrial designs each year and has been renowned Cambodia, Myanmar and other jurisdictions. We also LAW FIRM. for appeals, oppositions, court actions and handling provide our clients with legal advices on Finance and Address: 255 Hoang Van Thai Street, IP infringements. The firm also advises clients in Corporate and Business Law. Thanh Xuan District, Hanoi, Vietnam. all aspects of copyright law. Tel: (84 24) 3718 6216 Tel: (84-24) 37373051 Tel: +84 24 3824 4852 Fax: (84 24) 3718 6217 Fax: (84-24) 37373056 Fax: +84 24 3824 4853 Website: https://annamlaw.com/ Mob: (84) 904110976 Website: www.pham.com.vn Email: [email protected] Website: www.lawfirmelite.com Email: [email protected] [email protected] Email: [email protected] Contact: Pham Vu Khanh Toan, Managing Partner Contact: Le Quoc Chen (Managing Partner) Contact: Mr. Nguyen Tran Tuyen General Director Dzang Hieu Hanh (Head of Trademark Tran Dzung Tien, Senior IP Consultant Department) Subscribe now! The GLOBALGLOBAL REACH,REA LOCAL KNOW CH, LOCAL KN www.patentlawyermagazine.comOWLEDLEDGEGE A subscription to The Patent Lawyer magazine will ensure that Approaches to January / February 2021 you and your colleagues have detailed information on all the patenting alloys most important developments within the international patent before the Russian and the Eurasian law industry. patent offices The Patent Lawyer magazine is dedicated only to the patent industry and is written by patent experts for patent L IDD E E M A S Law firm T professionals worldwide. RANKINGS A N Anatoly Nistuk and Mikhail Samsonov, of Gorodissky & Partners,D A F R I C A examine the patenting of alloys through history and give an A subscription includes a hard copy and an electronic copy evaluation of both the RUPTO and the EAPO approach to patenting. which can be read easily on your smartphone or tablet. Pharmaceutical patent Ben Hoopes, HP litigation Women Page 15 Page 20 in IP Leadership Page 35 Tel: +44 (0)20 7112 8862 Fax to: +44 (0)20 7084 0365

FEATURING LAWYER E-mail: [email protected] THE LIFE SCIENCESPG 45

68 THE PATENT LAWYER CTC Legal Media different issues. one simple solution.

For more than 50 years, GLP has been offering a complete range of services for a structured protection of intellectual property, by providing strategic consultancy, filing patent applications, registering trademarks, designs and models in more than 160 countries all over the world, including Italy.

The GLP Group – through its six offices located in Milan, Udine, Bologna, Perugia, Zürich and San Marino – stands as a strategic, precise and reliable partner, supporting its Clients in the complex and articulated path that leads to innovation and its protection.

Our Clients range from artisans to some of the Top Companies on the Forbes 500 list, for whom we provide initial consultancy and support in lawsuits – both as plaintiff and defendant – throughout the world.

The quality of our services and our ability to achieve our Clients’ high objectives make us leaders in this field at worldwide level.

The commitment of the Group has led to GLP being a top-level European player.

Your European IP Partner

Via L. Manara 13 Viale Europa Unita 171 Via di Corticella 181/4 Other offices: 20122 MILANO 33100 UDINE 40128 BOLOGNA PERUGIA ZÜRICH Tel +39 02 54120878 Tel +39 0432 506388 Tel +39 051 328365 SAN MARINO Fax +39 02 54121214 Fax +39 0432 507735 Fax +39 051 4173102 E-mail [email protected] E-mail [email protected] E-mail [email protected] www.glp.eu