Legal Requirements for Patentability and Typical Parts of a Patent Application
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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to provide a basis for discussion concerning a possible new novelty concept applicable to th e prior art effect of unpublished earlier applications under Article 8(2) of the draft Substantive Patent Law Treaty (SPLT).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 The divergences among national laws and practices in resp ect of the prior art effect of unpublished earlier applications seem to reflect different principles and objectives underlying the prevention of double patenting.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 -
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. -
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. -
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. -
Patents and the Public Domain: Improving Patent Quality Upon Reexamination
Patents and the Public Domain: Improving Patent Quality Upon Reexamination Prepared by Policy Intern Raeanne Young [email protected] May 2008 ELECTRONIC FRONTIER FOUNDATION eff.org Table of Contents EXECUTIVE SUMMARY ........................................................................................................................3 PATENTS AND THE PUBLIC DOMAIN .....................................................................................................4 The Problem With Patent Quality ..................................................................................................4 Policy Rationale: Encouraging Innovation .......................................................................................4 PATENT REEXAMINATION ...................................................................................................................6 Ex parte and Inter partes .............................................................................................................6 OVERALL REEXAMINATION TRENDS ......................................................................................................8 Ex Parte Reexamination Filing Data: July , 98 - December 3, 2007 ...............................................8 Inter Partes Reexamination Filing Data: November 29, 999 - December 3, 2007 .............................0 Comparison of Ex Parte and Inter Partes ......................................................................................0 PROMOTING FAIRNESS IN THE PATENT SYSTEM THROUGH REEXAMINATION .............................................2 -
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. -
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. -
Structure and Function of the Patent Specification August 2014
Structure and Function of the Patent Specification August 2014 Structure and Function of the Patent Specification The structure of a patent specification is described below, with some explanations of underlying patent law concepts that the specification is designed to address. At the end of this note is a section which guides applicants in checking a specification that we prepare on their behalf. General Purpose The purpose of the patent specification is to fulfil the patentee’s part in the contract that a patent constitutes. In return for a full disclosure of the invention, the patentee can have a time-limited monopoly for the invention. During that time, the patentee has the right to stop others working the invention without permission. The monopoly generally lasts for twenty years, although annual renewal fees are usually payable. After the patent expires, the invention enters the public domain and cannot be patented again. A patent is enforced if necessary against infringers by action brought before the court. A patent specification is a legal document. Third parties and the court must be able to understand it, so that the limits of the protection it affords can be determined precisely. Structure of the specification • A patent specification normally has the following parts in the order given: • A title to identify the invention. • A statement as to the field to which the invention relates. • An explanation of the background “state of the art” – what was already known prior to the invention. • A statement of an objective technical problem which the invention seeks to solve, or an objective the invention is aimed at achieving.