Confusing Patent Eligibility
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"Enlarged" Concept of Novelty: Initial Study
December 2, 2004 DRAFT “ENLARGED ” CONCEPT OF NOVELTY : INITIAL STUDY CON CERNING NOVELTY AND THE PRIOR ART EF FECT OF CERTAIN APPL ICATIONS UNDER DRAFT ARTICLE 8(2) OF THE SPLT prepared by the International Bureau I. SUMMARY 1. The present initial study is submitted upon request of the Standing Committee on the Law of Patents (SCP) at its tenth session, held in Geneva from May 10 to 14, 2004, in order to provide a basis for discussion concerning a possible new novelty concept applicable to th e prior art effect of unpublished earlier applications under Article 8(2) of the draft Substantive Patent Law Treaty (SPLT). The study aims at providing broad background information and at facilitating further substantive discussion in the SCP, and thus addresses not only national and regional laws and practices regarding the prior art effect of earlier applications, but also the policy objectives underlying these different practices. 2. The divergences among national laws and practices in resp ect of the prior art effect of unpublished earlier applications seem to reflect different principles and objectives underlying the prevention of double patenting. Examining a number of national and regional laws and practices, it appears that those differ ent practices correspond mainly to one or more of the following three models: (i) Strict novelty: if a claimed invention is explicitly or inherently disclosed in an earlier application, the earlier application defeats the patentability of the claimed in vention; (ii) Broader novelty: even if the claimed invention is not fully disclosed (explicitly or inherently) in the earlier application, the earlier application defeats the patentability of the claimed invention if the differences between the two are minor (for example, a replacement with a well -known equivalent element); (iii) Novelty and inventive step (non-obviousness): the earlier application defeats the patentability of the claimed invention if the latter lacks either novelty or inventive step (non-obviousness) compared to the earlier application. -
Public Health and Intellectual Property Management: the Challenges on Access to Medicines
Public Health and Intellectual Property management: the challenges on access to medicines Dr. Inthira Yamabhai 1 | Public health, innovation and intellectual property Overview Intellectual property (IP) and implications on access to medicine – Trade Related Aspect of Intellectual Property Rights (TRIPS) – TRIPS+ through trade agreements Sources of information 2 | Different forms of IP Trademark: name under which product is marketed Patent: compound, crystalline forms, process, method of use, etc Protection of undisclosed data: clinical test data Copyright: package insert Design protection: packaging 3 | Patents There is nothing such as a worldwide patent! WIPO Patent Cooperation Treaty allows for worldwide filing, but applicant receives a bundle of national patents; same principle under European Patent Convention WTO TRIPS sets certain minimum standards: – Term: 20 years from filing data – Mandatory for all fields of technology – Criteria: novelty, inventive step, industrial applicability – Flexibilities: e.g. parallel importation and compulsory licensing 4 | One drug = one patent??? "…a key element of life cycle management strategies is to extent patent protection for as long as possible by filing secondary patents to keep generics off the market" (Burdon and Sloper 2003) Sofosbuvir: Expiry without patent term extension(s) • Broad compound patent (Markush) Market 2024 • WO2005003147A2 Authorization US: 2013/14 • Compound patent on prodrug • WO2008121634A2 2028 www.who.int/phi/impl ementation/ip_trade/ip • Crystalline forms _patent_landscapes/e -
Union Calendar No. 481 104Th Congress, 2D Session – – – – – – – – – – – – House Report 104–879
1 Union Calendar No. 481 104th Congress, 2d Session ± ± ± ± ± ± ± ± ± ± ± ± House Report 104±879 REPORT ON THE ACTIVITIES OF THE COMMITTEE ON THE JUDICIARY OF THE HOUSE OF REPRESENTATIVES DURING THE ONE HUNDRED FOURTH CONGRESS PURSUANT TO CLAUSE 1(d) RULE XI OF THE RULES OF THE HOUSE OF REPRESENTATIVES JANUARY 2, 1997.ÐCommitted to the Committee of the Whole House on the State of the Union and ordered to be printed U.S. GOVERNMENT PRINTING OFFICE 36±501 WASHINGTON : 1997 COMMITTEE ON THE JUDICIARY HOUSE OF REPRESENTATIVES ONE HUNDRED FOURTH CONGRESS HENRY J. HYDE, Illinois, Chairman 1 CARLOS J. MOORHEAD, California JOHN CONYERS, JR., Michigan F. JAMES SENSENBRENNER, JR., PATRICIA SCHROEDER, Colorado Wisconsin BARNEY FRANK, Massachusetts BILL MCCOLLUM, Florida CHARLES E. SCHUMER, New York GEORGE W. GEKAS, Pennsylvania HOWARD L. BERMAN, California HOWARD COBLE, North Carolina RICH BOUCHER, Virginia LAMAR SMITH, Texas JOHN BRYANT, Texas STEVEN SCHIFF, New Mexico JACK REED, Rhode Island ELTON GALLEGLY, California JERROLD NADLER, New York CHARLES T. CANADY, Florida ROBERT C. SCOTT, Virginia BOB INGLIS, South Carolina MELVIN L. WATT, North Carolina BOB GOODLATTE, Virginia XAVIER BECERRA, California STEPHEN E. BUYER, Indiana JOSEÂ E. SERRANO, New York 2 MARTIN R. HOKE, Ohio ZOE LOFGREN, California SONNY BONO, California SHEILA JACKSON LEE, Texas FRED HEINEMAN, North Carolina MAXINE WATERS, California 3 ED BRYANT, Tennessee STEVE CHABOT, Ohio MICHAEL PATRICK FLANAGAN, Illinois BOB BARR, Georgia ALAN F. COFFEY, JR., General Counsel/Staff Director JULIAN EPSTEIN, Minority Staff Director 1 Henry J. Hyde, Illinois, elected to the Committee as Chairman pursuant to House Resolution 11, approved by the House January 5 (legislative day of January 4), 1995. -
Uncertainty and the Standard of Patentability Robert P
ARTICLE UNCERTAINTY AND THE STANDARD OF PATENTABILITY ROBERT P. MERGES" Table of Contents I. INTRODU CTION ................................................................................ 2 II. THE LEGAL STANDARD .................................................................. 4 A . Threshold Issues ............................................................................ 4 B. Doctrine .......................................................................................... 12 C. The Patent Standard and Races to Invent ................................. 15 D. Relationship Between Patent Standards and Patent Scop e ............................................................................................. .. 17 E. The Proposed Patent Standard ................................................... 19 II1. MODELING THE STANDARD: PATENTS AS INCENTIVES TO IN V EN T ........................................................................................ 20 A. A Formal Model of the Invention Process ............................... 20 B. Low Uncertainty Research and the Model ............................... 29 C. Incentives to Develop ................................................................. 32 D. Why Not Use Commercial Certainty as the Patentability Standard? ................................................. ................................... 33 E. Nonobviousness Doctrine and the Uncertainty-Based Model ............................................................................................. 34 F. Risk Aversion and High-Cost -
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. -
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. -
TRIPS and Pharmaceutical Patents
FACT SHEET September 2003 TRIPS and pharmaceutical patents CONTENTS Philosophy: TRIPS attempts to strike a balance 1 What is the basic patent right? 2 A patent is not a permit to put a product on the market 2 Under TRIPS, what are member governments’ obligations on pharmaceutical patents? 2 IN GENERAL (see also “exceptions”) 2 Exceptions 3 ELIGIBILITY FOR PATENTING 3 RESEARCH EXCEPTION AND “BOLAR” PROVISION 3 ANTI-COMPETITIVE PRACTICE, ETC 4 COMPULSORY LICENSING 4 WHAT ARE THE GROUNDS FOR USING COMPULSORY LICENSING? 5 PARALLEL IMPORTS, GREY IMPORTS AND ‘EXHAUSTION’ OF RIGHTS 5 THE DOHA DECLARATION ON TRIPS AND PUBLIC HEALTH 5 IMPORTING UNDER COMPULSORY LICENSING (‘PAR.6’) 6 What does ‘generic’ mean? 6 Developing countries’ transition periods 7 GENERAL 7 PHARMACEUTICALS AND AGRICULTURAL CHEMICALS 7 For more information 8 The TRIPS Agreement Philosophy: TRIPS attempts to strike a balance Article 7 Objectives The WTO’s Agreement on Trade-Related Aspects of The protection and enforcement of intellectual property Intellectual Property Rights (TRIPS) attempts to strike rights should contribute to the promotion of technological innovation and to the transfer and a balance between the long term social objective of dissemination of technology, to the mutual advantage providing incentives for future inventions and of producers and users of technological knowledge and creation, and the short term objective of allowing in a manner conducive to social and economic welfare, and to a balance of rights and obligations. people to use existing inventions and creations. The agreement covers a wide range of subjects, from Article 8 copyright and trademarks, to integrated circuit Principles designs and trade secrets. -
Bars to Patentability Bars to Patentability
A lthough you may not be a patent attorney, you may be asked to protect your client’s right to file a patent application on his or her inven- tion. If that occurs, it is imperative that you know how to advise him or her about filing before it’s too late. In the United States, there are eight statutory “bars to patentability.” Any one of these will forever bar an inventor from being able to file an application on an invention that may otherwise meet the criteria for patentability. If that occurs, the invention will fall into the pub- lic domain. Bars to How might these statutory bars arise? Bars to They certainly will come up during the pros- ecution of a patent application. But any one of PatentabilityPatentability these also may be raised in litigation by an accused A Guide for the infringer seeking to evade a judgment of infringe- A Guide for the ment. The defendant will try to demonstrate that GeneralGeneral the patent is invalid, despite the presumption of validity accorded by its issuance by the U.S. Patent PractitionerPractitioner & Trademark Office. Because these bars are the death knell for a client’s rights to an invention, it is important that all lawyers be familiar with them. The “Public Disclosure” Bar: 35 U.S.C. §102(b) A U.S. patent application may not be filed more than one year from the date of a publication in any country disclosing the invention or pub- lic use of the invention in this country. It does not matter whether the publication or public use is by the inventor or someone else; disclosures of the invention to any third party who is not under an obligation to keep it confidential fall within the scope of this statutory bar. -
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. -
Demythologizing PHOSITA
Osgoode Hall Law Journal Article 3 Volume 47, Number 4 (Winter 2009) Demythologizing PHOSITA - Applying the Non- Obviousness Requirement under Canadian Patent Law to Keep Knowledge in the Public Domain and Foster Innovation Matthew eH rder Follow this and additional works at: http://digitalcommons.osgoode.yorku.ca/ohlj Part of the Intellectual Property Law Commons Article Citation Information Herder, Matthew. "Demythologizing PHOSITA - Applying the Non-Obviousness Requirement under Canadian Patent Law to Keep Knowledge in the Public Domain and Foster Innovation." Osgoode Hall Law Journal 47.4 (2009) : 695-750. http://digitalcommons.osgoode.yorku.ca/ohlj/vol47/iss4/3 This Article is brought to you for free and open access by the Journals at Osgoode Digital Commons. It has been accepted for inclusion in Osgoode Hall Law Journal by an authorized editor of Osgoode Digital Commons. Demythologizing PHOSITA - Applying the Non-Obviousness Requirement under Canadian Patent Law to Keep Knowledge in the Public Domain and Foster Innovation Abstract The uS preme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical "selection patent" case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although the Court was cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped its attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the "person having ordinary skill in the art" (PHOSITA) for the purpose of the obviousness inquiry. The ra ticle argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation--one which assumes that actors consult patents to learn about scientific developments, devalues the importance of the public domain, and ignores the industry--specific nature of innovation. -
Supreme Court Round-Up (July 2019)
July 2, 2019 Vol. 11, No. 4 Overview The Supreme Court Round-Up previews upcoming cases, summarizes opinions, and tracks the actions of the Office of the Solicitor General. Each entry contains a description of the case, as well as a substantive analysis of the Court’s actions. October Term 2018 Argued Cases 1. Rucho v. Common Cause, No. 18-422 (M.D.N.C., 318 F. Supp. 3d 777, consolidated with Lamone v. Benisek, No. 18-726 (D. Md., 348 F. Supp. 3d 493); jurisdiction postponed Jan. 4, 2019; argued Mar. 26, 2019). The Questions Presented are: (1) Whether plaintiffs have standing to press their partisan gerrymandering claims. (2) Whether plaintiffs’ partisan gerrymandering claims are justiciable. (3) Whether North Carolina’s 2016 congressional map is, in fact, an unconstitutional partisan gerrymander. Decided June 27, 2019 (588 U.S. __). M.D.N.C. and D. Md./Vacated and remanded. Chief Justice Roberts for a 5-4 Court (Kagan, J., dissenting, joined by Ginsburg, Breyer, and Sotomayor, J.J.). The Court held that partisan gerrymandering claims present a nonjusticiable political question because no “judicially discoverable and manageable standards” exist for resolving them. Baker v. Carr, 369 U.S. 186, 217 (1962). The Framers were aware of electoral districting problems, including partisan gerrymandering, when they chose to assign the task of districting to state legislatures. Specifically, the Elections Clause of the U.S. Constitution empowers States to decide the “Times, Places and Manner of holding Elections” for members of Congress, and grants Congress the authority to “make or alter” any such rules. -
Supreme Court October Term 2017: a Preview of Select Cases
Supreme Court October Term 2017: A Preview of Select Cases Andrew Nolan, Coordinator Acting Section Research Manager Valerie C. Brannon Legislative Attorney Michael John Garcia Acting Section Research Manager Ben Harrington Legislative Attorney Jay B. Sykes Legislative Attorney L. Paige Whitaker Legislative Attorney September 19, 2017 Congressional Research Service 7-5700 www.crs.gov R44956 Supreme Court October Term 2017: A Preview of Select Cases Summary On October 2, 2017, the Supreme Court is to begin its new term. While the Court issued a number of notable decisions during its last full term, Court watchers have largely agreed that, at least compared to recent terms, the Court’s October 2016 term was diminished both with regard to volume and content. With the Court already accepting over 30 cases for its next term, many of which raise deep and difficult questions in various areas of law, the October 2017 Supreme Court term could be considerably different. The next Court term has the potential to be one of the most consequential in years. A full discussion of every case that the Court will hear during the October 2017 term is beyond the scope of this report (indeed, the Court has to grant certiorari to the majority of cases that will likely make up its docket for the upcoming year). But Table 1 provides brief summaries of the cases the Court has already agreed to hear during the October 2017 term, and many of the cases on the Court’s docket are discussed in existing or forthcoming CRS products. The majority of this report highlights four notable cases of the new term that could impact the work of Congress: (1) Carpenter v.