DOCSLIB.ORG

Update from the PMPRB

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Update from the PMPRB Update from the PMPRB Isabel Jaen Raasch General Counsel and Director, Legal Services Branch Patented Medicine Prices Review Board 1. Background and organizational structure of PMPRB 2. Recent legal developments 3. Update on cases pending before Board 4. Guidelines Modernization 5. Expression of Interest Process – Potential outside counsel to Board Staff 2 1. Background and organizational structure of PMPRB 3 Background Mandate and Purpose of the PMPRB PMPRB is an independent and autonomous quasi-judicial body and federal consumer protection agency tasked with ensuring that patentees do not abuse their patent rights by charging consumers excessive prices during the statutory monopoly period. Although part of the Health Portfolio, because of its quasi-judicial responsibilities, the PMPRB carries out its mandate at arm’s length from the Minister of Health and of Health Canada. The PMPRB has a two-part regulatory and reporting mandate: • Ensure the prices at which patented medicines are sold are not excessive (Patent Act, ss 80-88) • Report on pharmaceutical trends of medicines and R&D spending (Patent Act, ss 89-90, 100) 4 Organizational Structure Chairperson Members (3) Vice-chairperson Director General Counsel Executive Director Board Secretariat, Communications & Strategic Planning Director Director Director Policy & Economic Analysis Regulatory Affairs & Outreach Corporate Services The PMPRB is composed of approximately 70 Board Staff, who are public servants responsible for carrying out the organization’s day to day work, and up to 5 Board members. Members are Governor-in-Council appointees who serve as hearing panel members in the event of a dispute between Board Staff and a patentee over the price of a patented medicine. Currently, over 1250 patented medicines are under PMPRB jurisdiction. 5 Reporting functions . Reports on research and development (R&D) spending by patentees (Patent Act, s 89) . Annual Reports from the Board (Patent Act, s 100) on its activities Include information on pricing trends in the pharmaceutical industry and certain regulatory matters before the Board . Reports as a result of inquiries (Patent Act, s 90) – not limited to patented medicines E.g., National Prescription Drug Utilization Information System (NPDUIS) initiative established by the federal, provincial and territorial (F/P/T) Ministers of Health in 2001 • Partnership with Canadian Institute for Health Information • PMPRB conducts critical analyses of price, utilization and cost trends for patented and non- patented prescription drugs • Reports are independent from regulatory function and do not represent the views of Board Members 6 Regulatory functions . Patentees statutorily required to file with PMPRB information related to patented medicines (Patent Act, s 80-82). Board Staff may undertake review of the filings. Guidance as to how this review may be performed appears in the Compendium of Guidelines and Policies of the PMPRB. If Board Staff determines that there is a concern with the price of a patented drug product, the patentee is offered the opportunity to voluntarily lower its price and/or refund its excess revenues (debt due to Her Majesty) through a Voluntary Compliance Undertaking (VCU). If the matter cannot be resolved, it is forwarded to the Chairperson for determination of whether the matter should proceed to a hearing. 7 Hearings . If Chairperson of Board decides that it is in the public interest to hold a hearing re excessive pricing, then Chairperson will issue Notice of Hearing and appoint a panel of Board members to preside at hearing (Patent Act, s 83) . Chairperson may also decide to issue Notice of Hearing if there is an allegation that a patentee has failed to file pricing information related to a patented medicine (Patent Act, s 81) “Until a matter is brought before the Board at a public hearing, no Board member is involved in, or aware of, the results of the staff investigation other than the Chairperson in his/her management capacity as Chief Executive Officer of the Board.” Hoechst Marion Roussel Canada Inc v Canada (AG), 2004 FC 489 8 Hearings “The issue of actual excessive pricing is a matter to be resolved at the public hearing, when all interested parties are given the opportunity to lead evidence, cross-examine and make submissions. […] the issuance of the notice of hearing does not represent the Board’s conclusion on the issue, but rather constitutes an allegation that is sufficiently substantiated to justify a hearing on the merits.” Hoechst Marion Roussel Canada Inc v Canada (AG), 2005 FC 1552 “In conducting hearings with respect to the price of a patented medicine, the Board's staff is segregated from the Board. The Board's staff, through its own counsel, adduces evidence, tests evidence of other parties, and makes submissions on procedural, jurisdictional, legal, and substantive issues arising during the course of the proceeding.” ICN Pharmaceuticals Inc. v. Canada, [1997] 1 FC 32, citing Genentech Canada Inc (Re) (1992),44 CPR (3d) 317 (PMPRB) 9 Hearings Hearing Process: . Not a review of the investigation or of the application of the Guidelines. Hearing panel is not involved in investigations and cannot be bound by Guidelines. Procedure is similar to civil case: pleadings, fact and expert evidence, motions, written and oral submissions. There is no discovery and the hearing panel is not strictly bound by evidence rules. Hearing Panel hears matter in a full or abbreviated hearing. Hearing outcome: . Board may issue Order requiring patentee to reduce price and/or refund excessive revenues . Board may also issue Order requiring patentee to provide Board with pricing information . Board’s decisions are open to judicial review by the Federal Court 10 2. Recent legal developments – Federal Court . Canada (AG) v Sandoz Canada Inc, 2015 FCA 249, rev’g 2014 FC 501 & 2014 FC 502 . Alexion Pharmaceuticals Inc. v. Canada (AG), 2016 FC 716 11 Canada (AG) v Sandoz Canada Inc, 2015 FCA 249 [Sandoz FCA] . Confirms PMPRB jurisdiction over all patentees, including those who operate in the “generic” market . FCA decision relates to two matters: • Judicial review of Board decision finding that Sandoz was a “patentee” and obliging Sandoz to file pricing information related to patented medicines • Judicial review of Board decisions re ratiopharm (now Teva): – Obliging ratiopharm to file pricing information related to patented medicines for which ratiopharm had licences to sell in Canada (“Failure to file” decision) – Obliging ratiopharm to pay excess revenues with respect to ratio-salbutamol HFA (“Excessive pricing” decision) 12 Sandoz FCA Sandoz: • Patents at issue not owned by Sandoz Canada Inc. • Sandoz Canada Inc. is a wholly-owned subsidiary of Novartis Canada Inc., who is a wholly-owned subsidiary of Novartis AG • Novartis AG is patent owner of several patents – either directly or through subsidiaries • Novartis AG mandates and authorizes Sandoz Canada Inc. to sell medicines to which patents held directly or indirectly by Novartis AG pertain Issues: • Is Sandoz a “patentee” within the meaning of subsection 79(1) and, thus, within Board’s jurisdiction? • Are the PMPRB’s enabling provisions (ss 79-103 of the Patent Act) constitutional? 13 Sandoz FCA Sandoz – Board decision • The Board held that, consistent with its consumer protection mandate, Sandoz was a “patentee” within meaning of subsection 79(1) • Sandoz was entitled to sell medicines without being sued for infringement and thus was entitled to benefit of, and to exercise rights in relation to, the patents • Legislation is constitutional 14 Sandoz FCA Sandoz – FC decision (2014 FC 501) • Held that Board’s finding that Sandoz was a “patentee” was unreasonable based primarily on the following findings: – Board’s jurisdiction should be limited to patent holders – Federal government has no jurisdiction to regulate price of generic medicines – Board’s jurisdiction limited to “factory-gate” pricing • Legislation is constitutional, when “properly interpreted” 15 Sandoz FCA ratiopharm: • Excessive pricing decision: – ratiopharm sold an authorized generic version of GSK’s Ventolin HFA (ratio- salbutamol HFA) pursuant to licensing/supply agreements Issues: • Are the PMPRB’s enabling provisions (ss 79-103 of the Patent Act) constitutional? • Is ratiopharm a “patentee” within the meaning of subsection 79(1) and, thus, within Board’s jurisdiction? • Is the price at which ratiopharm sold ratio-salbutamol HFA in Canada excessive? 16 Sandoz FCA ratiopharm: • Failure-to-file decision: – Ratiopharm did not own patents but was licenced to sell patented medicine • Some licence agreements stipulated that patent owner was retaining IP rights • Some licences were exclusive, some non-exclusive • Some licences did not expressly grant a licence under the patent that pertained to the medicine • Some licences were sub-licences granted by other generic companies Issue: Is ratiopharm a “patentee” within the meaning of subsection 79(1) and, thus, within Board’s jurisdiction? 17 Sandoz FCA ratiopharm – Board decisions: • Excessive pricing decision: – Board held that the case law affirmed that its mandate and purpose are constitutional – Board held that ratiopharm was a “person entitled to exercise any rights” in relation to the patent, and thus was a “patentee” within the meaning of subsection 79(1) – Board found that excessive revenues should be calculated on basis of Board’s Guidelines and later ordered ratiopharm to pay back excessive revenues • Failure-to-file decision: – Board
Load more

Recommended publications
  • Confusing Patent Eligibility
    CONFUSING PATENT ELIGIBILITY DAVID 0. TAYLOR* INTRODUCTION ................................................. 158 I. CODIFYING PATENT ELIGIBILITY ....................... 164 A. The FirstPatent Statute ........................... 164 B. The Patent Statute Between 1793 and 1952................... 166 C. The Modern Patent Statute ................ ..... 170 D. Lessons About Eligibility Law ................... 174 II. UNRAVELING PATENT ELIGIBILITY. ........ ............. 178 A. Mayo Collaborative Servs. v. Prometheus Labs............ 178 B. Alice Corp. v. CLS Bank Int'l .......... .......... 184 III. UNDERLYING CONFUSION ........................... 186 A. The Requirements of Patentability.................................. 186 B. Claim Breadth............................ 188 1. The Supreme Court's Underlying Concerns............ 189 2. Existing Statutory Requirements Address the Concerns with Claim Breadth .............. 191 3. The Supreme Court Wrongly Rejected Use of Existing Statutory Requirements to Address Claim Breadth ..................................... 197 4. Even if § 101 Was Needed to Exclude Patenting of Natural Laws and Phenomena, A Simple Statutory Interpretation Would Do So .................... 212 C. Claim Abstractness ........................... 221 1. Problems with the Supreme Court's Test................221 2. Existing Statutory Requirements Address Abstractness, Yet the Supreme Court Has Not Even Addressed Them.............................. 223 IV. LACK OF ADMINISTRABILITY ....................... ....... 227 A. Whether a
    [Show full text]
  • Patent Law: a Handbook for Congress
    Patent Law: A Handbook for Congress September 16, 2020 Congressional Research Service https://crsreports.congress.gov R46525 SUMMARY R46525 Patent Law: A Handbook for Congress September 16, 2020 A patent gives its owner the exclusive right to make, use, import, sell, or offer for sale the invention covered by the patent. The patent system has long been viewed as important to Kevin T. Richards encouraging American innovation by providing an incentive for inventors to create. Without a Legislative Attorney patent system, the reasoning goes, there would be little incentive for invention because anyone could freely copy the inventor’s innovation. Congressional action in recent years has underscored the importance of the patent system, including a major revision to the patent laws in 2011 in the form of the Leahy-Smith America Invents Act. Congress has also demonstrated an interest in patents and pharmaceutical pricing; the types of inventions that may be patented (also referred to as “patentable subject matter”); and the potential impact of patents on a vaccine for COVID-19. As patent law continues to be an area of congressional interest, this report provides background and descriptions of several key patent law doctrines. The report first describes the various parts of a patent, including the specification (which describes the invention) and the claims (which set out the legal boundaries of the patent owner’s exclusive rights). Next, the report provides detail on the basic doctrines governing patentability, enforcement, and patent validity. For patentability, the report details the various requirements that must be met before a patent is allowed to issue.
    [Show full text]
  • Horizon Book of Authorities
    PATENTED MEDICINE PRICES REVIEW BOARD IN THE MATTER OF THE PATENT ACT R.S.C. 1985, C. P-4, AS AMENDED AND IN THE MATTER OF HORIZON PHARMA PLC (THE “RESPONDENT”) AND THE MEDICINE CYSTEAMINE BITARTRATE SOLD BY THE RESPONDENT UNDER THE TRADE NAME PROCYSBI® BOOK OF AUTHORITIES OF THE RESPONDENT (MOTION TO BIFURCATE, STRIKE EVIDENCE AND FOR THE INSPECTION AND PRODUCTION OF DOCUMENTS) Torys LLP 79 Wellington St. W., Suite 3000 Toronto ON M5K 1N2 Fax: 416.865.7380 Sheila R. Block Tel: 416.865.7319 [email protected] Andrew M. Shaughnessy Tel: 416.865.8171 [email protected] Rachael Saab Tel: 416.865.7676 [email protected] Stacey Reisman Tel: 416.865.7537 [email protected] Counsel to Respondent, Horizon Pharma PLC INDEX 1. Board Decision – Alexion Pharmaceuticals Inc. and the Medicine “Soliris” (September 20, 2017) 2. Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2019 FC 734 3. Celgene Corp. v. Canada (Attorney General), 2011 SCC 1 4. Board Decision – Alexion Pharmaceuticals Inc. and the Medicine “Soliris” (March 29, 2016) 5. Mayne Pharma (Canada) Inc. v. Aventis Pharma Inc., 2005 FCA 50 6. P.S. Partsource Inc. v. Canadian Tire Corp., 2001 FCA 8 7. Harrop (Litigation Guardian of) v. Harrop, 2010 ONCA 390 8. Merck & Co v. Canada (Minister of Health), 2003 FC 1511 9. Vancouver Airport Authority v. Commissioner of Competition, 2018 FCA 24 10. Merck & Co, Inc. v. Canada (Minister of Health), 2003 FC 1242 11. H-D Michigan Inc. v. Berrada, 2007 FC 995 12. Roger T. Hughes, Arthur Renaud & Trent Horne, Canadian Federal Courts Practice 2019 (Toronto: LexisNexis Canada Inc., 2019) 13.
    [Show full text]
  • Compulsory Patent Licensing: Is It a Viable Solution in the United States Carol M
    Michigan Telecommunications and Technology Law Review Volume 13 | Issue 2 2007 Compulsory Patent Licensing: Is It a Viable Solution in the United States Carol M. Nielsen Michael R. Samardzija University of Texas M.D. Anderson Cancer Center Follow this and additional works at: http://repository.law.umich.edu/mttlr Part of the Administrative Law Commons, and the Intellectual Property Law Commons Recommended Citation Carol M. Nielsen & Michael R. Samardzija, Compulsory Patent Licensing: Is It a Viable Solution in the United States, 13 Mich. Telecomm. & Tech. L. Rev. 509 (2007). Available at: http://repository.law.umich.edu/mttlr/vol13/iss2/9 This Symposium Article is brought to you for free and open access by the Journals at University of Michigan Law School Scholarship Repository. It has been accepted for inclusion in Michigan Telecommunications and Technology Law Review by an authorized editor of University of Michigan Law School Scholarship Repository. For more information, please contact [email protected]. COMPULSORY PATENT LICENSING: IS IT A VIABLE SOLUTION IN THE UNITED STATES? Carol M. Nielsen* Michael R. Samardzija** Cite as: Carol M. Nielsen and Michael R. Samardzija, Compulsory Patent Licensing: Is It a Viable Solution in the United States?, 13 MICH. TELECOMM. TECH. L. REV. 509 (2007), available at http://www.mttlr.org/volthirteen/nielsen&samardzija.pdf As technology continues to advance at a rapid pace, so do the number of patents that cover every aspect of making, using, and selling these innovations. In 1996, to compound the rapid change of technology, the U.S. Supreme Court affirmed that business methods are also patentable.
    [Show full text]
  • Chapter 2 Novelty and Inventive Step (Patent Act Article 29(1) and (2))
    Note: When any ambiguity of interpretation is found in this provisional translation, the Japanese text shall prevail. Part III Chapter 2 Section 1 Novelty Chapter 2 Novelty and Inventive Step (Patent Act Article 29(1) and (2)) Section 1 Novelty 1. Overview Patent Act Article 29(1) provides as the unpatentable cases (i) inventions that were publicly known, (ii) inventions that were publicly worked (iii) inventions that were described in a distributed publication or made available to the public through electric telecommunication lines in Japan or a foreign country prior to the filing of the patent application. The same paragraph provides that a patent shall not be granted for these publicly known (Note) inventions (inventions lacking novelty, hereinafter referred to as "prior art” in this chapter.). The patent system is provided to grant an exclusive right to the patentee in exchange for disclosure of the invention. Therefore, the invention which deserves the patent should be novel. This paragraph is provided to achieve such a purpose. This Section describes the determination of novelty for an invention of the patent applications to be examined (hereinafter referred to as "the present application" in this Section.) (Notes) The term "publicly known" generally falls under Article 29(1)(i), or under the 29(1)(i) to (iii), hereinafter the latter is applied. 2. Determination of Novelty Inventions subject to determination of novelty are claimed inventions. The examiner determines whether the claimed invention has novelty by comparing the claimed inventions and the prior art cited for determining novelty and an inventive step (the cited prior art) to identify the differences between them.
    [Show full text]
  • Compulsory Licensing of Patented Inventions
    Compulsory Licensing of Patented Inventions -name redacted- Visiting Scholar January 14, 2014 Congressional Research Service 7-.... www.crs.gov R43266 Compulsory Licensing of Patented Inventions Summary The term “compulsory license” refers to the grant of permission for an enterprise seeking to use another’s intellectual property without the consent of its proprietor. The grant of a compulsory patent license typically requires the sanction of a governmental entity and provides for compensation to the patent owner. Compulsory licenses in the patent system most often relate to pharmaceuticals and other inventions pertaining to public health, but they potentially apply to any patented invention. U.S. law allows for the issuance of compulsory licenses in a number of circumstances, and also allows for circumstances that are arguably akin to a compulsory license. The Atomic Energy Act, Clean Air Act, and Plant Variety Protection Act provide for compulsory licensing, although these provisions have been used infrequently at best. The Bayh-Dole Act offers the federal government “march-in rights,” although these have not been invoked in the three decades since that legislation has been enacted. 28 U.S.C. Section 1498 provides the U.S. government with broad ability to use inventions patented by others. Compulsory licenses have also been awarded as a remedy for antitrust violations. Finally, a court may decline to award an injunction in favor of a prevailing patent owner during infringement litigation, an outcome that some observers believe is akin to the grant of a compulsory license. A number of international agreements to which the United States and its trading partners are signatories, including the Paris Convention for the Protection of Industrial Property, World Trade Organization agreements, and certain free trade agreements, address compulsory licensing.
    [Show full text]
  • Biopatents – a Threat to the Use and Conservation of Agrobiodiversity?
    Advisory Board on Biodiversity and Genetic Resources at the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) Biopatents – A Threat to the Use and Conservation of Agrobiodiversity? Position Paper of the Advisory Board on Biodiversity and Genetic Resources at the Federal Ministry of Food, Agriculture and Consumer Protection (Translation of German original paper) May 2010 Lead author Dr. Peter H. Feindt, Cardiff University Members of the Advisory Board on Biodiversity and Genetic Resources at the BMELV (05/2010) Prof. Dr. Bärbel Gerowitt, University of Rostock (Chair) Dr. Peter H. Feindt, Cardiff University, Great Britain (Vice Chair) Dr. Frank Begemann, Federal Office for Agriculture and Food, Bonn Prof. Dr. Leo Dempfle, Technical University Muinch (TUM) Dr. Jan Engels, Bioversity International, Italy Dr. Lothar Frese, Julius Kuehn-Institute, Quedlinburg Prof. Dr. Hans-Rolf Gregorius, University of Goettingen Prof. Dr. Dr. h.c. Alois Heißenhuber, Technical University Muinch (TUM) Prof. Dr. Hans-Jörg Jacobsen, University of Hannover Dr. Alwin Janßen, Northwest German Forest Research Institute, Hann. Münden Dr. Ingrid Kissling-Näf, Federal Office for Professional Education and Technology, Switzerland Prof. Dr. Konrad Ott, University of Greifswald Prof. Dr. Lucia Reisch, Copenhagen Business School, Denmark Prof. em. Dr. Werner Steffens, Deutscher Fischerei-Verband e. V., (German Fisheries Association), Bonn Dr. Steffen Weigend, Friedrich-Loeffler-Institute, Federal Research Institute for Animal Health, Mariensee Citation of this paper Peter H. Feindt, Advisory Board on Biodiversity and Genetic Resources at the BMELV, 2010: Biopatents – A Threat to the Use and Conservation of Agrobiodiversity? Position Paper of the Advisory Board on Biodiversity and Genetic Resources at the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), 36 pp.
    [Show full text]
  • Committee on Development and Intellectual Property
    E CDIP/13/10 ORIGINAL: ENGLISH DATE: MARCH 27, 2014 Committee on Development and Intellectual Property Thirteenth Session Geneva, May 19 to 23, 2014 PATENT-RELATED FLEXIBILITIES IN THE MULTILATERAL LEGAL FRAMEWORK AND THEIR LEGISLATIVE IMPLEMENTATION AT THE NATIONAL AND REGIONAL LEVELS - PART III prepared by the Secretariat 1. In the context of the discussions on Development Agenda Recommendation 14, Member States, at the eleventh session of the Committee on Development and Intellectual Property (CDIP) held from May 13 to 17, 2013, in Geneva, requested the International Bureau of the World Intellectual Property Organization (WIPO) to prepare a document that covers two new patent-related flexibilities. 2. The present document addresses the requested two additional patent-related flexibilities. 3. The CDIP is invited to take note of the contents of this document and its Annexes. CDIP/13/10 page 2 Table of Contents I. EXECUTIVE SUMMARY……………………………………………………………...…….….. 3 II. THE SCOPE OF THE EXCLUSION FROM PATENTABILITY OF PLANTS..…….…….…4 A. Introduction……..……………………………………………………………………….….4 B. The international legal framework………………………………………………………. 6 C. National and Regional implementation………………………………………………… 7 a) Excluding plants from patent protection……………………………………........ 8 b) Excluding plant varieties from patent protection………………………………... 8 c) Excluding both plant and plant varieties from patent protection……...……….. 9 d) Allowing the patentability of plants and/or plant varieties……………………… 9 e) Excluding essentially biological processes for the production of plants…….. 10 III. FLEXIBILITIES IN RESPECT OF THE PATENTABILITY, OR EXCLUSION FROM PATENTABILITY, OF SOFTWARE-RELATED INVENTIONS………………………….…….…. 12 A. Introduction………………………………………………………………………….….…12 B. The International legal framework………………………………………………………13 C. National implementations……………………………………………………………….. 14 a) Explicit exclusion …………………………………………………………………. 14 b) Explicit inclusion…………………………………………………………………... 16 c) No specific provision……………………………………………………………… 16 D.
    [Show full text]
  • Point of Novelty
    Copyright 2011 by Mark A. Lemley Printed in U.S.A. Northwestern University Law Review Vol. 105, No. 3 Essay POINT OF NOVELTY Mark A. Lemley* INTRODUCTION ........................................................................................................... 1253 I. THE POINT-OF-NOVELTY DOCTRINE ................................................................... 1255 A. Origins: The Rise of Peripheral Claiming ................................................ 1255 B. Combination Inventions and Obviousness ................................................ 1257 C. The Rule Expands ...................................................................................... 1258 II. CRACKS IN THE FAÇADE ..................................................................................... 1260 A. Ignoring the Commandment ...................................................................... 1261 B. Blindly Following the Commandment ....................................................... 1266 C. The Problem Is Systemic ........................................................................... 1274 III. CAN WE LIVE WITH POINT OF NOVELTY? ........................................................... 1275 A. Combination Inventions ............................................................................ 1275 B. Burdens of Proof ....................................................................................... 1276 C. Patentable Subject Matter ......................................................................... 1277 CONCLUSION .............................................................................................................
    [Show full text]
  • Copying in Patent Law Christopher A. Cotropia & Mark A. Lemley Patent Law Is Virtually Alone in Intellectual Property
    Copying in Patent Law Cotropia and Lemley DRAFT Copying in Patent Law1 Christopher A. Cotropia2 & Mark A. Lemley3 Patent law is virtually alone in intellectual property (IP) law in punishing independent development. To infringe a copyright or trade secret, defendants must copy the protected IP from the plaintiff, directly or indirectly.4 But patent infringement requires only that the defendant’s product falls within the scope of the patent claims. Not only doesn’t the defendant need to intend to infringe, but the defendant may be entirely unaware of the patent or the patentee and still face liability. Nonetheless, copying does play a role in some subsidiary patent doctrines. For example, the question of whether patent damages should be set in order to deter infringement depends critically on whether infringers are in fact aware they are infringing, or at least that they are using the plaintiff’s technology. Copying – or at least intent to infringe – is also an element of claims for indirect infringement. The definition of “willful infringement” also turns on the question of culpability, at least in the popular understanding of that term. More significantly, the rhetoric of patent law (and of IP law 1 © 2008 Christopher A. Cotropia & Mark A. Lemley. 2 Associate Professor, Intellectual Property Institute, University of Richmond School of Law. 3 William H. Neukom Professor, Stanford Law School; of counsel, Keker & Van Nest LLP. We thank the Stanford IP Litigation Clearinghouse for providing us with the complaint sample and Sarah Craven and Vinita Kailasanath for outstanding research assistance. 4 The Copyright Act defines the rights as ones involving a “copy” of a protected work, 17 U.S.C.
    [Show full text]
  • Recent Trends in Patent Infringement Lawsuits
    Inside the Minds™ Inside the Minds™ Top Attorneys Discuss New Recent Trends in Patent Developments in Patent Litigation Infringement Lawsuits Recent Trends in Patent Infringement Lawsuits is an authoritative, insider’s perspective on Leading Lawyers on Understanding Recent Cases the latest developments taking place in patent infringement litigation. Featuring partners and chairs from leading law firms across the nation, these experts guide the reader through today’s and Constructing Effective Defense Strategies legal environment, offering insights on the new standards for obviousness and prior art as well as the new rules governing areas such as false marking and business method patents. These top lawyers demonstrate the importance of keeping up with legal trends, knowing the economic 2011 Edition and legislative climate, and being aware of potential issues in a case or claim. Additionally, the authors discuss recent cases and laws relevant to patent infringement, such as Pequignot v. Solo Cup, Stauffer v. Brooks Brothers, and the Patent Reform Act of 2010. The different niches represented and the breadth of perspectives presented enable readers to get inside some of the great legal minds of today, as these experienced lawyers offer up their thoughts around the keys to success within this complex area of law. ABOUT THE AUTHORS: Richard J. Stark is a partner in Cravath, Swaine & Moore’s Litigation Department where he specializes in complex intellectual property and antitrust litigation in a variety of industries. Representative matters include patent infringement and validity matters for clients in the computer, semiconductor, software, Internet, pharmaceutical, mechanical and chemical industries. Andrei Harasymiak is a senior attorney in Cravath, Swaine & Moore’s Litigation Department, where he specializes in intellectual property matters.
    [Show full text]
  • The Effects of Licences Under Patents
    The effects of licences under patents Essentials The effect of licences under patents Grounds for Proceedings for Decisions and ADR invalidity invalidity judgments Jursidiction and procedure Fundamentals of Plaintiff/ Construction of patent Defences and OUT OF COURT IN COURT infringement claimant specifications remedies UPC Agreement Biological inventions Burden of proof Liability National approaches Introduction A granted patent confers upon the patentee the exclusive right to use Commission Regulation (EU) No. 316/2014 and exploit the patent during its term, which means that the patentee of 21 March 2014 on the application of Article 101(3) of the Treaty on the can prevent others from using the patented technology. If another Functioning of the European Union person or legal entity wishes to use the technology protected by a patent, to categories of technology transfer agreements. that person has to either acquire the patent by virtue of a purchase agreement, or obtain a licence to use the patent by virtue of a licence According to the EU Commission, licence agreements “will usually improve economic agreement. efficiency and be pro-competitive as they can reduce duplication of research and development, strengthen the incentive for There are various reasons why a patentee may either sell its patent or the initial research and development, spur grant a licence and, therefore, there are various types of agreement incremental innovation, facilitate diffusion and generate product market competition.” in which a patentee can grant another person the right to use its (Recital (4) of Commission Regulation patent. A common reason for granting a licence is that this provides an No.
    [Show full text]