The Rules and Standards of Patentable Subject-Matter
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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to provide a basis for discussion concerning a possible new novelty concept applicable to th e prior art effect of unpublished earlier applications under Article 8(2) of the draft Substantive Patent Law Treaty (SPLT).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 The divergences among national laws and practices in resp ect of the prior art effect of unpublished earlier applications seem to reflect different principles and objectives underlying the prevention of double patenting.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. -
Patent Law As Public Law
The Catholic University of America, Columbus School of Law CUA Law Scholarship Repository Scholarly Articles and Other Contributions Faculty Scholarship 2012 Patent Law as Public Law Megan M. La Belle The Catholic University of America, Columbus School of Law Follow this and additional works at: https://scholarship.law.edu/scholar Part of the Intellectual Property Law Commons, and the Litigation Commons Recommended Citation Megan M. La Belle, Patent Law as Public Law, 20 GEO. MASON. L. REV. 41 (2012). This Article is brought to you for free and open access by the Faculty Scholarship at CUA Law Scholarship Repository. It has been accepted for inclusion in Scholarly Articles and Other Contributions by an authorized administrator of CUA Law Scholarship Repository. For more information, please contact [email protected]. 2012] PATENT LAW AS PUBLIC LAW Megan M La Belle* INTRODUCTION Public law, or public impact, litigation takes many forms. The para- digm of public law litigation includes structural challenges to public institu- tions like segregated schools and overcrowded prisons,' yet it also encom- passes employment discrimination, securities fraud, antitrust, and environ- mental cases.2 In his seminal article on the subject, Professor Abram Chayes explains that public law adjudication usually concerns complaints about governmental conduct, and is characterized by complex party struc- tures and requests for ongoing remedial measures that have widespread effects on individuals not before the court.' Public law adjudication is fur- ther typified by active judges who decide substantive matters and are re- sponsible for the overall management of the suit.4 Patent litigation historically has been regarded as private law litiga- tion, meaning "disputes between private parties about private rights."5 It has been compared to property, contract, and tort litigation, all of which fall within the realm of private law adjudication.6 Were patent litigation to con- Assistant Professor, The Catholic University of America, Columbus School of Law. -
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 -
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 -
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. -
An Overview of Changes to the Patent Law of the United States After the Patent Law Treaty, 26 J
UIC Law Review Volume 26 Issue 3 Article 3 Spring 1993 An Overview of Changes to the Patent Law of the United States after the Patent Law Treaty, 26 J. Marshall L. Rev. 497 (1993) Richard C. Wilder Follow this and additional works at: https://repository.law.uic.edu/lawreview Part of the Comparative and Foreign Law Commons, Intellectual Property Law Commons, International Law Commons, International Trade Law Commons, and the Transnational Law Commons Recommended Citation Richard C. Wilder, An Overview of Changes to the Patent Law of the United States after the Patent Law Treaty, 26 J. Marshall L. Rev. 497 (1993) https://repository.law.uic.edu/lawreview/vol26/iss3/3 This Article is brought to you for free and open access by UIC Law Open Access Repository. It has been accepted for inclusion in UIC Law Review by an authorized administrator of UIC Law Open Access Repository. For more information, please contact [email protected]. AN OVERVIEW OF CHANGES TO THE PATENT LAW OF THE UNITED STATES AFTER THE PATENT LAW TREATY RICHARD C. WILDER* INTRODUCTION A. The Negotiations on the PatentLaw Treaty In 1984, negotiations began under the auspices of the World In- tellectual Property Organization ("WIPO")' to harmonize "grace period" provisions.2 These negotiations soon developed beyond their original scope and eventually led to the Diplomatic Confer- ence for the Conclusion of a Treaty Supplementing the Paris Con- vention as Far as Patents are Concerned ("Diplomatic Conference"). The first part of the Diplomatic Conference was held June 3 to 21, 1991. While a second part of the Diplomatic Con- ference was scheduled for July 12 to 30, 1993, 3 this has been post- 4 poned at the request of the United States of America. -
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. -
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. -
Life Sciences & Biotechnology Legal Bulletin
ISSUE 29 | FEBRUARY 16, 2012 LIFE SCIENCES & BIOTECHNOLOGY LEGAL BULLETIN SCIENCE • TECHNOLOGY ENGINEERING • ENERGY PHARMACEUTICAL CONTENTS IP NEWS IP News USPTO Proposes New Rules of Trial and Appellate Practice Under AIA ...........1 USPTO Proposes New Rules of Trial and Appellate Practice Under AIA Investor News The U.S. Patent and Trademark Office (USPTO) has issued proposed rules of Massachusetts Biotech Adds $6.3 Million practice to implement sections of the America Invents Act (AIA) that provide Targeted to Stem Cell Reagents .........2 for trials before the Patent Trial and Appeal Board and address judicial review of Biopharmaceutical Secures $2.2 Million to Develop Pancreatic Cancer Vaccine ...2 board decisions. Comments are requested by April 9, 2012. Business Climate According to USPTO’s notice, “the proposed rules would provide a consolidated Life Sciences Startups Generate More Capital in 2011, Biotech Job Ads Down set of rules relating to Board trial practice for inter partes review, post-grant Slightly in Q4 ...........................2 review, derivation proceedings, and the transitional program for covered Companion Diagnostics in Personalized business method patents by adding a new part 42 including a new subpart A Medicine Facing Explosive Growth ......3 to title 37 of the Code of Federal Regulations. The proposed rules would also Indian Official Calls for Passage of Biotech Regulatory Legislation and provide a consolidated set of rules to implement the provisions of the Leahy- Increased VC Funding. 3 Smith America Invents Act related to seeking judicial review of Board decisions Legislative and Regulatory Developments by adding a new part 90 to title 37 of the Code of Federal Regulations.” Separate FDA Issues Draft Biosimilars Guidance, rulemakings address proposed rules specific to inter partes review, post-grant Gaps Leave Practitioners Wondering ....4 review, the transitional program for covered business method patents, and Pay-for-Delay Deals and Biologics’ Exclusivity Period Part of President’s derivation proceedings.