T H E W O R L D J O U R N A L O N J U R I S T I C P O L I T Y. BOLAR EXEMPTION VS. DATA EXCLUSIVITY: RIGHT TO HEALTH vs RIGHT OF PATENT HOLDER
|
|
- Lester Blair
- 6 years ago
- Views:
Transcription
1 BOLAR EXEMPTION VS. DATA EXCLUSIVITY: RIGHT TO HEALTH vs RIGHT OF PATENT HOLDER Rhea Roy Mammen M.S. Ramaiah College of Law, Bangalore Introduction Pharmaceutical Patent has seen an increasing conflict for the past decade especially when we have a constitutionally guaranteed right of Right to Health. The same has been covered under the international conventions. Right to health, necessarily includes the access to the medicines especially the essential drugs. This has been a major consideration in the international arena as well. This was evidenced by the 2001 World Trade Organisation(WTO) ministerial Conference. 1 When Experimentation and research are necessary to meet the developmental needs of the future, it is equally important to have a balance maintained in the right to health. India s accession to the WTO, and to comply with the provisions of Trade related aspects of Intellectual Property Rights (TRIPs), amendments were brought about in the Patent Law in India. With 2005, major amendments were inserted which disrupted the balance between Right to Health and Right of the patent Holder. One of the amendments brought about in the patent Act was with respect to Bolar Provisions. It was introduced as an exemption to the patent holders right. On the contrary, Data Exclusivity has been widely discussed as one of the protective step available for the patent holders. This was considered by the western state prior to TRIPs in and Though the discussion was widely available around the globe, India was reluctant to accept the concept. but currently we can see that, it has been re-introduced into the patent system of the country with respect to pharmaceuticals. Bolar Exemption Bolar Provision refers to the particular circumstances in which the proprietors of the patent is precluded from preventing the third person from carrying out an act which is otherwise not permitted under the patent laws. 4 It permits the third party, access to the information 1 WTO, declaration on the TRIPs agreement and Public Health, Ministerial conference, Fourth Session, WTO Doc. WT/MIN(01)/ Dec/2(2001). 2 It was talked applied in United States of America 3 It was introduced in European union 4 Heinonline, Shamnad Basheer and Prashant Reddy on The Experimental use exception through a developmental Lens, available at 50 IDEA pdf(last visited on 11 feb, 2017) 1 THE WORLD JOURNAL ON JURISTIC POLITY ALL RIGHTS RESERVED.
2 of the patented medicine during the patent period for the purpose of research, experiment use and education. 5 The exemption was to encourage the generic drugs in the market, so as to ensure that soon after the expiry of the period of 20 years, they will be able to provide the medicines at a cheaper rate into the market. Generic Drugs Generic Drugs is a drug which is identical or bioequivalent to the brand name (patented) drug in dosage form, safety, and strength, route of administration, quality and performance character 6. They are not patent protected as they use the information of the patented drug and develop the same through the mechanism of reverse engineering. They are sold and made available at cheaper rates due to the low manufacturing cost. Generic Drugs have been encouraged in the markets as these are made available to the needy parts of the society at a cheaper price. History 1. The Patent ACt, S.47(3) Amendment into the 1970 Act 2. in 1984, Roche v. Bolar case 4.TRIPS- Art.30 3.The Hatchwaxman Act - 5 Roche Product, Inc v. Bolar Enterprises, 733 F.2d International Journal of Pharmaceutical, chemical and Biological Sciences, Ajay Bera and Ashish Mukerjee on the importance of generic drugs in India, available at last visited on 11 feb, 2017 ) 2 THE WORLD JOURNAL ON JURISTIC POLITY ALL RIGHTS RESERVED.
3 1. The Patent Act, 1970: Patent Law of India was enacted with the objective of ensuring that the patent rights are not worked in a manner detrimental to the consumer interest. For the same reason, provisions were included in the Act where exceptions were given in using patented product. Under S.47, where the exceptions are provided, clause 3 pertains specifically to the purpose merely of experiment or research including the imparting instructions to pupils The exception was to ensure that the innovations are brought to stand still merely because certain products are patented. the provision applies to all the inventions and not restricted to the Pharmaceutical inventions Bolar Pharmaceutical Case: In the case of Roche Product, Inc., v. Bolar Enterprises 7, where Bolar enterprises produced generic version of the Petitioners patented drugs. When they were sued before the court of law, the argument that the defendant took was on research and experimental use. But the court provided that the intended use of the research was the commercial exploitation of the market. This was not permitted by the court. It was held that limited use of the patented drug for testing and investigation must be strictly related to FDA drug approval requirements during the last 6months of the term of the patent. The exemption brought forward in the case came to be known as the Bolar exemption. 3. The Hatch Waxman Act, 1984: The Drug Price Competition and Patent Term Restoration Act which is informally known as the Hatch- Waxman Act, 1984, was enacted following the decision of the Court in Bolar case. It encouraged the manufacture of the generic drugs by the pharmaceutical industries. 4. Trade Related aspects of Intellectual Property Rights (TRIPs): TRIPs do not provide for particular provision with respect to Bolar exemption, but Art.30 specifies general exemption. Art.30 reads as follows: Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exception does not unreasonably conflict with a normal exploitation of patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking into account of the legitimate interests of the parties The provision was intended to provide a balance between the patent holders right and the interest of the consumers. India being a member to the TRIPs agreement had made corresponding amendments the law. 5. The Patent Act, 1970 with 2002/2005 Amendment: 7 Supra n.3 3 THE WORLD JOURNAL ON JURISTIC POLITY ALL RIGHTS RESERVED.
4 In 2002, the second Amendment After TRIPs was witnessed with the introduction of Art.107A, which specifically referred to the pharmaceutical Patents. The provision provided as follows: For the Purpose of this Act- (a) Any act of making, constructing,[using, selling or importing] 8 a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, [use, sale or import] 9 of any product The amendment of 2002, was exclusively for pharmaceutical patented products. But the amendment can be seen to have encroached upon the rights of the Patent holder, by the insertion of the terms selling and importation. The purpose of the provision was said to meet the demands of the society and make sure that the medicines are available at the cheaper rate soon at the expiration of the patent term. But the inclusion of the above said terms have defeated the very objective of the Patent law. This can be further clarified with two case laws, F.Hoffmann la Roche Ltd v. Cipla Ltd 10 and Bayer Corporations v. union of India & Ors 11. In the facts of the former case, the petitioners had sought for an injunction against the defendant company, which was engaged in the manufacture of the generic version of the petitioner s drugs. The injunction was not granted on the ground that if it be granted, it will violate the rights of many unknown persons. The court failed to consider the fact that the sale and importation of the generic Drugs was carried out during the subsistence of the patent period. Similarly, in the latter case, right to health was given higher weightage than the rights of the patent holders right. Right to health v. Right of the Patent Holder: India being a welfare state has the duty to ensure that the right to access to medicines are safeguard. At the same time, there exist the duty to respect and acknowledge the right of the person over the property he has created. It is the natural right of the person to enjoy the ownership of the property. Through the incentive Theory and Social Contract Theory, we can see that IP laws have made an attempt to bring a balance between the rights of the Patent Holder and the citizen. Art.48 enumerates the right of the patent Holder, where under he has been given the exclusive right to sell and import the drugs for 20 yrs. 8 Subs by Act of 2005, sec 58 (a)(i), for using or selling (w.r.e.f ) 9 id (2008) DLT LAP 443/2009, decided on February 9, 2010, available on visited on 30 th Jan 2017) 4 THE WORLD JOURNAL ON JURISTIC POLITY ALL RIGHTS RESERVED.
5 In the claim of welfare, there is clear encroachment into the exclusive rights guaranteed under the constitution. Furthermore, provisions like Compulsory licensing are prevalent to ensure that the drugs are made available to the public at affordable price as the situation demands. The Advantages and Disadvantages of Bolar Exemption in consideration to our society can be better under from the below table. Advantages 1. Increase in the production of generic drugs 2. There is increase in innovation around the patented information Disadvantages a. Loss of incentive to the patent holder b. Decrease in the flow of foreign direct investment due to poor patent protection c. Lack of innovation due to poor patent protection While considering the recent amendments made in the provision we can see that the balance has been disrupted which strikes at the soul of the Patent Act. In order to balance the interests considering the health care requirements yet to encourage the innovations, the following suggestions are put forward. Suggestions 1. Data Exclusivity: Data Exclusivity refers to the time period after approval of a new drug before the competitor can rely on the data submitted in the original approval process for its own filling to the regulatory authorities 12. In simple words, the regulatory authorities 13 are not permitted to disclose any information for a limited period of time. The whole limitation pertains to commercial utilisation of the pharmaceutical information and not to the genuine case. Moreover, it is essential to compensate the time lost by the patent holder in the regulatory procedure. This has been recognized under the TRIPs agreement, Art.39(3) and the US law. The Provision provides as: 12 Satwant Reddy, Gurdial Singh Sandhu, Report on Steps to be taken by government of India in the Content of Data provisions of Art.39.3 of TRIPs agreement, 13 In India, the Authority is the Controller of Drug and Cosmetics. the Drug and Cosmetics Act, THE WORLD JOURNAL ON JURISTIC POLITY ALL RIGHTS RESERVED.
6 Members, when requiring, as a condition of approving the marketing of pharmaceutical or agricultural chemical products which utilize the new chemical entities, the submission of undisclosed test or other data, the origination of which shall involve a considerable effort, shall protect such data against unfair commercial use. In addition, members shall protect such data against disclosure, except where necessary to protect public or interim steps are taken to ensure that the data are protected against unfair commercial use. This is to ensure that the patent holder s right is safeguarded against unfair commercial purpose and to protect his exclusive right. Presently, where Bolar Exemption has been introduced with such encroachment into the exclusive rights of the patent holder, such provision in law ensures that the adequate protection is provided to the patent holder. The Advantages of data Exclusivity are that: a. During the initial stages of patent process, safety and efficacy can be ensured. Without having the fear of the information being used by the competitors. b. The inventor will be able to enjoy the monopoly right for the speicified time period, without being interfered. c. This will reduce the commercial exploitation of the patented product in the initial stage. d. Will promote Foreign direct investment in to the market, due to safe market condition, thereby encouraging and promoting innovation. 2. The use of term selling and importation must be removed from the patent law, it is in clear violation with the exclusive rights guaranteed to the patent Holder. 3. Unlike in compulsory licensing and other exceptions, use of such information s by the generic drugs does not require the payment of royalty. Royalty provisions must be specified, taking into consideration the investment made into the R& D. 6 THE WORLD JOURNAL ON JURISTIC POLITY ALL RIGHTS RESERVED.
Global Access to Medicines Program Compiled by Stephanie Rosenberg. December 2, This chart compares provisions from the following texts:
Comparative chart of patent and data provisions in the TRIPS, Free Trade s between Trans-Pacific negotiating countries and the U.S., and the U.S. proposal to the Trans-Pacific This chart compares provisions
More informationFDA, PATENT TERM EXTENSIONS AND THE HATCH WAXMAN ACT. Dr.Sumesh Reddy- Dr. Reddys Lab Hyderabad-
FDA, PATENT TERM EXTENSIONS AND THE HATCH WAXMAN ACT Dr.Sumesh Reddy- Dr. Reddys Lab Hyderabad- FDA Regulatory approval-time and cost Focus of FDA approval process-safety and efficacy Difference between
More informationWIPO-ESCAP-IIUM Regional Workshop on Intellectual Property and Public Health and Environment Policy for Asia and Pacific
Intellectual Property and Public Health Cambodian Perspective WTO-ESCAP-IIUM REGIONAL WORKSHOP ON IP AND PUBLIC HEALTH AND ENVIRONMENT POLICY FOR ASIA AND PACIFIC REGION Kaula Lumpur, Malaysia 10-12 JULY
More informationEarly Resolution Mechanism for Patent Disputes Regarding Approved Drug Products - Canada
Early Resolution Mechanism for Patent Disputes Regarding Approved Drug Products - Canada Pharma Workshop 4 AIPPI Toronto September 16, 2014 Warren Sprigings Direct Dial: +1-416-777-2273 warren@sprigings.com
More informationThe Korean Drug Approval-Patent Linkage System: A Comparison with the US Hatch-Waxman Act
FEBRUARY 2015 The Korean Drug Approval-Patent Linkage System: A Comparison with the US Hatch-Waxman Act Authors: Ki Young Kim, Hyunsuk Jin, Samuel SungMok Lee Pursuant to the implementation of the Korea-US
More informationComparative Analysis of the U.S. Intellectual Property Proposal and Peruvian Law
!!! Dangers for Access to Medicines in the Trans-Pacific Partnership Agreement: Comparative Analysis of the U.S. Intellectual Property Proposal and Peruvian Law ! Issue US TPPA Proposal Andean Community
More informationExperimental Use Exemption of Patent Infringement A Brief Comparison of China and the United States
BIOTECH BUZZ International Subcommittee January 2015 Contributors: Li Feng, PhD, Jiancheng Jiang and Yuan Wang Experimental Use Exemption of Patent Infringement A Brief Comparison of China and the United
More informationUS-China Business Council Comments on the Draft Measures for the Compulsory Licensing of Patents
US-China Business Council Comments on the Draft Measures for the Compulsory Licensing of Patents The US-China Business Council (USCBC) and its member companies appreciate the opportunity to submit comments
More informationDEFINITIONS. May be written into the law, or based on court decisions.
DEFINITIONS Research (Experimental Use) Exemption A provision that certain actions which fall within the claims of a granted patent are not patent infringement if they are done for the purposes of research.
More informationYoung EPLAW Congress. Bolar provision: a European tour. Brussels, 27 April 2015 Guillaume Bensussan Kathy Osgerby Agathe Michel de Cazotte
Young EPLAW Congress Bolar provision: a European tour Brussels, 27 April 2015 Guillaume Bensussan Kathy Osgerby Agathe Michel de Cazotte Introduction Bolar provision: a European tour Part 1 UK A) Recent
More informationExamining Patent Enforcement and Litigation in India from A Development Perspective A study
Examining Patent Enforcement and Litigation in India from A Development Perspective A study Ayyappan Palanissamy + School of Business and Design, Swinburne University of Technology Sarawak, Kuching, Malaysia
More informationQuestionnaire on Exceptions and Limitations to Patent Rights. The answers to this questionnaire have been provided on behalf of:
Questionnaire on Exceptions and Limitations to Patent Rights The answers to this questionnaire have been provided on behalf of: Country: Australia... Office: IP Australia... Person to be contacted: Name:
More informationPatent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues
Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues John R. Thomas Visiting Scholar February 9, 2012 CRS Report for Congress Prepared for Members and Committees of Congress
More informationPatent Enforcement in India
Patent Enforcement in India Intellectual property assets are touted as the cornerstone of competitiveness in international trade and are the driving factors behind socio-economic development in India.
More informationAnswer of the Canadian National Group
AIPPI INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY SPECIAL COMMITTEE Q94 QUESTIONNAIRE NO. 4 on the IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON TRIPS AND PUBLIC HEALTH
More informationTRIPS Article 28 Rights Conferred. 1. A patent shall confer on its owner the following exclusive rights:
TRIPS Article 28 Rights Conferred 1. A patent shall confer on its owner the following exclusive rights: (a) where the subject matter of a patent is a product, to prevent third parties not having the owner
More informationArticle 30. Exceptions to Rights Conferred
1 ARTICLE 30... 1 1.1 Text of Article 30... 1 1.2 General... 1 1.3 "limited exceptions"... 2 1.4 "do not unreasonably conflict with a normal exploitation of the patent"... 3 1.5 "do not unreasonably prejudice
More informationPatent Act, B.E (1979) As Amended until Patent Act (No.3), B.E (1999) Translation
Patent Act, B.E. 2522 (1979) As Amended until Patent Act (No.3), B.E. 2542 (1999) Translation BHUMIBOL ADULYADEJ, REX. Given on the 11th day of March, B.E. 2522; Being the 34th year of the present Reign
More informationRegional Comprehensive Economic Partnership. Intellectual Property Chapter and the Impact on Access to Medicines
MSF RCEP IP Chapter Technical Analysis NOVEMBER 2016 Regional Comprehensive Economic Partnership Intellectual Property Chapter and the Impact on Access to Medicines This briefing note details Médecins
More informationip LAB Delhi High Court frees Indian drug regulator from the shackles of patent linkage Nishith Desai Associates Legal & Tax Counseling Worldwide
ip LAB Delhi High Court frees Indian drug regulator from the shackles of patent linkage IP Pharma Team Aditi Nadkarni & Gowree Gokhale October 26, 2009 This ip Lab is a copyright of Nishith Desai Associates.
More informationSecond medical use or indication claims. [Please insert name last name in CAPITAL letters please]
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: New Zealand Second medical use or indication claims Michael BROWN, Partner Helen BELLCHAMBERS, Associate A J Park [Please
More informationSlide 13 What rights does a patent confer?
Slide 13 What rights does a patent confer? The term of the European patent shall be 20 years from the date of filing of the application (Article 63(1) EPC. However, nothing in Article 63(1) EPC shall limit
More informationAre the Patented Medicines (Notice of Compliance) Regulations Working?
Are the Patented Medicines (Notice of Compliance) Regulations Working? Edward Hore Hazzard & Hore 141 Adelaide Street West, Suite 1002 Toronto, ON M5H 3L5 (416) 868-1340 edhore@hazzardandhore.com March
More informationPeople s Republic of China State Intellectual Property Office of China
[English translation by WIPO] Questionnaire on Exceptions and Limitations to Patent Rights The answers to this questionnaire have been provided on behalf of: Country: Office: People s Republic of China
More informationPATENT, TRADEMARK & COPYRIGHT!
A BNA s PATENT, TRADEMARK & COPYRIGHT! JOURNAL Reproduced with permission from BNA s Patent, Trademark & Copyright Journal, 81 PTCJ 36, 11/05/2010. Copyright 2010 by The Bureau of National Affairs, Inc.
More informationQuestionnaire on Exceptions and Limitations to Patent Rights
Questionnaire on Exceptions and Limitations to Patent Rights The answers to this questionnaire have been provided on behalf of: Country: Office: India The Patent Office Person to be contacted: Name: Dr
More informationPHARMACEUTICAL LAW GROUP PC
in L PHARMACEUTICAL LAW GROUP PC AT THE INTERSECTION OF FDA REGULATION AND INTELLECTUAL PROPERTY 900 SEVENTH STREET, NW - SUITE 650 - WASHINGTON, DC 20001-3886 T 202 589 1780 F 202 318 2198 WWW.PHARMALAWGRP.COM
More informationThe Third Amendment to the Patent Law of China. On December 27, 2008, the Standing Committee of the National People's
The Third Amendment to the Patent Law of China On December 27, 2008, the Standing Committee of the National People's Congress adopted the third amendment to the Patent Law of the People's Republic of China,
More informationTime allowed : 3 hours Maximum marks : 100. Total number of questions : 6 Total number of printed pages : 8
OPEN BOOK EXAMINATION Roll No... : 1 : 344 Time allowed : 3 hours Maximum marks : 100 Total number of questions : 6 Total number of printed pages : 8 NOTE : Answer ALL Questions. 1. Read the following
More informationLitigation Webinar Series. Hatch-Waxman 101. Chad Shear Principal, San Diego
Litigation Webinar Series Hatch-Waxman 101 Chad Shear Principal, San Diego 1 Overview Hatch-Waxman Series Housekeeping CLE Contact: Jane Lundberg lundberg@fr.com Questions January 25, 2018 INSIGHTS Litigation
More informationExceptions and Limitation of Patent Rights and its Enforcement in India
Journal of Intellectual Property Rights Vol 20, September 2015, pp 297-304 Exceptions and Limitation of Patent Rights and its Enforcement in India Biplab Kumar Lenin 1 and Harsha Rohatgi 2 1 IIT Kharagpur,
More informationJOINT DOH-DTI-IPO-BFAD ADMINISTRATIVE ORDER NO
JOINT DOH-DTI-IPO-BFAD ADMINISTRATIVE ORDER NO. 2008-01 THE IMPLEMENTING RULES AND REGULATIONS OF REPUBLIC ACT 9502 OTHERWISE KNOWN AS THE UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008
More informationIntellectual Property Department Hong Kong, China. Contents
Intellectual Property Department Hong Kong, China Contents Section 1: General... 1 Section 2: Private and/or non-commercial use... 3 Section 3: Experimental use and/or scientific research... 3 Section
More informationDetailed Table of Contents
Detailed Table of Contents Foreword... vii Preface... ix vii Summary Table of Contents... xi ix I. Introduction 1. Introduction to Pharmaceutical Patents... 3 3 I. The Drug Patent Debate... 4 II. Overview
More information4. COMPARISON OF THE INDIAN PATENT LAW WITH THE PATENT LAWS IN U.S., EUROPE AND CHINA
4. COMPARISON OF THE INDIAN PATENT LAW WITH THE PATENT LAWS IN U.S., EUROPE AND CHINA Provisions of the Indian patent law were compared with the relevant provisions of the patent laws in U.S., Europe and
More informationSupreme Court Invites Solicitor General s View on Safe Harbor of the Hatch-Waxman Act
Supreme Court Invites Solicitor General s View on Safe Harbor of the Hatch-Waxman Act Prepared By: The Intellectual Property Group On June 25, 2012, the United States Supreme Court invited the Solicitor
More informationANNEX XVII REFERRED TO IN ARTICLE 5 PROTECTION OF INTELLECTUAL PROPERTY
ANNEX XVII REFERRED TO IN ARTICLE 5 PROTECTION OF INTELLECTUAL PROPERTY ANNEX XVII REFERRED TO IN ARTICLE 5 PROTECTION OF INTELLECTUAL PROPERTY SECTION I GENERAL PROVISIONS Article 1 Definition of Intellectual
More informationWe have carefully considered the Petition.! For the reasons described below, the Petition is granted.
DEPARTMENT OF HEALTH &. HUMAN SERVICES... -------------_._- Food and Drug Administration Rockville MD 20857 JUN 17 2010. Pankaj Dave, Ph.D. Vice President, Regulatory Affairs Navinta LLC 1499 Lower Ferry
More informationChina Intellectual Properly News
LEGAL LANGUAGE SERVICES A n affiliateofalsinternationalt e l e p h o n e (212)766-4111 18 John Street T o l l Free (800) 788-0450 Suite 300 T e l e f a x (212) 349-0964 New York, NY 10038 w v, r w l e
More informationDenmark and Italy Trade-related intellectual property rights, access to medicines and human rights
Summary Denmark and Italy Trade-related intellectual property rights, access to medicines and human rights October 2004 1. Denmark and Italy, as members of the European Union (EU), have committed themselves
More informationWIPO Sub-Regional Workshop on Patent Policy and its Legislative Implementation
WIPO Sub-Regional Workshop on Patent Policy and its Legislative Implementation Topic 12: Patent-related provisions in the framework of preferential trade agreements Marco M. ALEMAN Deputy Director, Patent
More information[English translation by WIPO] Questionnaire on Exceptions and Limitations to Patent Rights
Questionnaire on Exceptions and Limitations to Patent Rights The answers to this questionnaire have been provided on behalf of: Country: Chile... Office: National Institute of Industrial Property (INAPI)...
More informationLEGAL DEVELOPMENTS. The important legal updates from the previous quarter are summarized below: Trade Marks Rules, 2017 Notified
z This Newsletter brings to you the IP updates during the first quarter of this year. The first quarter saw remarkable changes in trademark practice and procedure in India. With substantial changes in
More informationAntitrust and Intellectual Property
and Intellectual Property July 22, 2016 Rob Kidwell, Member Antitrust Prohibitions vs IP Protections The Challenge Harmonizing U.S. antitrust laws that sanction the illegal use of monopoly/market power
More informationGoing full circle: Bolar in Europe and the UPC
Going full circle: Bolar in Europe and the UPC ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC : VOL 14 ISSUE 2 BSLR 1 Article 10(6) of the Directive provides that the following
More informationRecent developments in US law: Remedies and damages for improper patent listings in the FDA s Orange Book
Daniel G. Brown is a partner in the New York law firm Frommer Lawrence & Haug, LLP, and practises extensively in the Hatch Waxman area. He has been practising in New York since 1993 in the patent and intellectual
More informationHow patents work An introduction for law students
How patents work An introduction for law students 1 Learning goals The learning goals of this lecture are to understand: the different types of intellectual property rights available the role of the patent
More information6 th India IP IPR Summit 23 Feb 2009
Obviousness Under India Patent Laws 6 th India IP IPR Summit 23 Feb 2009 Naren Thappeta US Patent Attorney India Patent Agent Bangalore, India www.iphorizons.com 23/Feb/2009 2009 Naren Thappeta 1 Broad
More informationANNEX XV REFERRED TO IN ARTICLE 7 PROTECTION OF INTELLECTUAL PROPERTY
ANNEX XV REFERRED TO IN ARTICLE 7 PROTECTION OF INTELLECTUAL PROPERTY ANNEX XV REFERRED TO IN ARTICLE 7 PROTECTION OF INTELLECTUAL PROPERTY SECTION I GENERAL PROVISIONS Article 1 Definition of Intellectual
More informationFederal Circuit Provides Guidance on Methodologies for Calculating FRAND Royalty Rates, Vacating the Jury Award in Ericsson v.
In this Issue: WRITTEN BY COURTNEY J. ARMOUR AND KOREN W. WONG-ERVIN EDITED BY KOREN W. WONG-ERVIN The views expressed in this e-bulletin are the views of the authors alone. DECEMBER 1-6, 2014 Federal
More informationThe Patented Medicines (Notice of Compliance) Regulations: What patents are eligible to be listed on the register?
The Patented Medicines (Notice of Compliance) Regulations: What patents are eligible to be listed on the register? Edward Hore Hazzard & Hore 141 Adelaide Street West, Suite 1002 Toronto, ON M5H 3L5 (416)
More informationQuestionnaire on Exceptions and Limitations to Patent Rights. The answers to this questionnaire have been provided on behalf of:
The answers to this questionnaire have been provided on behalf of: Country: Austria... Office: Austrian Patent Office (APO)... Person to be contacted: Name:... Title:... E-mail:... Telephone:... Facsimile:...
More informationPATENT ACT, B.E (1979) 1. BHUMIBOL ADULYADEJ, REX; Given on the 11 th Day of March B.E. 2522; Being the 34 th Year of the Present Reign
Unofficial Translation PATENT ACT, B.E. 2522 (1979) 1 BHUMIBOL ADULYADEJ, REX; Given on the 11 th Day of March B.E. 2522; Being the 34 th Year of the Present Reign His Majesty King Bhumibol Adulyadej is
More informationAUSTRALIA Patents Act 1990 Compilation date: 24 February 2017 Includes amendments up to: Act No. 61, 2016 Registered: 27 February 2017
AUSTRALIA Patents Act 1990 Compilation date: 24 February 2017 Includes amendments up to: Act No. 61, 2016 Registered: 27 February 2017 TABLE OF CONTENTS Chapter 1. Introductory 1 Short title 2 Commencement
More informationTHE SAFE HARBOR PROVISION OF HATCH-WAXMAN IS THERE A HOLE IN THE SAFETY NET?
THE SAFE HARBOR PROVISION OF HATCH-WAXMAN IS THERE A HOLE IN THE SAFETY NET? The Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the Hatch-Waxman Act) was enacted for the
More informationTHE JOHN MARSHALL REVIEW OF INTELLECTUAL PROPERTY LAW
THE JOHN MARSHALL REVIEW OF INTELLECTUAL PROPERTY LAW HATCH-WAXMAN S SAFE-HARBOR PROVISION FOR PHARMACEUTICAL DEVELOPMENT: A FREE RIDE FOR PATENT INFRINGERS? KATE Y. JUNG ABSTRACT The Safe-Harbor provision
More informationTrade-related intellectual property rights, trade in services and the fulfilment of children s rights - Botswana September 2004
Trade-related intellectual property rights, trade in services and the fulfilment of children s rights - Botswana September 2004 Introduction 1. Botswana has emerged as a model of access to medicines and
More informationIntellectual Property Laws Amendment Bill 2013 No., 2013
00-0-0-0 The Parliament of the Commonwealth of Australia HOUSE OF REPRESENTATIVES Presented and read a first time Intellectual Property Laws Amendment Bill 0 No., 0 (Industry, Innovation, Climate Change,
More informationSecond medical use or indication claims
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: Egyptian National Group Second medical use or indication claims Eman MOHEY, Gamal ABOU ALI Ahmed ABOU ALI Date: May
More informationSecond medical use or indication claims. Mr. Antonio Ray ORTIGUERA Angara Abello Concepcion Regala & Cruz Law Offices Philippines
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: PHILIPPINES Second medical use or indication claims Mr. Alex Ferdinand FIDER Mr. Antonio Ray ORTIGUERA Angara Abello
More informationLaw on the protection of inventions No. 50/2008 of the Republic of Moldova can be found at:
The answers to this questionnaire have been provided on behalf of: Country: Republic of Moldova... Office: The State Agency on Intellectual Property... Person to be contacted: Name: Cicinova Olga... Title:
More informationCHAPTER TEN INTELLECTUAL PROPERTY
CHAPTER TEN INTELLECTUAL PROPERTY 1. The objectives of this Chapter are to: Article 10.1 Objectives facilitate the production and commercialisation of innovative and creative products and the provision
More informationANNEX VII REFERRED TO IN ARTICLE 25 PROTECTION OF INTELLECTUAL PROPERTY
ANNEX VII REFERRED TO IN ARTICLE 25 PROTECTION OF INTELLECTUAL PROPERTY ANNEX VII REFERRED TO IN ARTICLE 25 PROTECTION OF INTELLECTUAL PROPERTY SECTION I GENERAL PROVISIONS Article 1 Definition of Intellectual
More informationTHE ISSUE OF BALANCING RIGHTS IN THE PATENT PROTECTION
THE ISSUE OF BALANCING RIGHTS IN THE PATENT PROTECTION FINAL REPORT JPO FUND RESEARCH FELLOWSHIP PROGRAM 01 October, 2002 29 March, 2003 Prepared by: TA QUANG MINH VIETNAM TOKYO February, 2003 TABLE OF
More informationLaw on Inventive Activity*
Law on Inventive Activity* (of October 19, 1972, as amended by the Law of April 16, 1993) TABLE OF CONTENTS** Article Part I: General Provisions... 1 9 Part II: Inventions and Patents 1. Patents... 10
More informationCOMPULSORY LICENSING OF IPR: INTERFACE WITH COMPETITION AUTHORITY
COMPULSORY LICENSING OF IPR: INTERFACE WITH COMPETITION AUTHORITY By Aparajita 407 INTRODUCTION The Competition act 2002 governs the conduct of compulsory license and acts on its abuse. Like the competition
More informationThe Hatch-Waxman Act and Market Exclusivity for Generic Manufacturers: An Entitlement or an Incentive
Chicago-Kent Law Review Volume 81 Issue 2 Symposium: Secrecy in Litigation Article 13 April 2006 The Hatch-Waxman Act and Market Exclusivity for Generic Manufacturers: An Entitlement or an Incentive Ashlee
More informationCompilation date: 24 February Includes amendments up to: Act No. 61, Registered: 27 February 2017
Patents Act 1990 No. 83, 1990 Compilation No. 41 Compilation date: 24 February 2017 Includes amendments up to: Act No. 61, 2016 Registered: 27 February 2017 This compilation includes commenced amendments
More informationIntellectual Property Laws Amendment Act 2015
Intellectual Property Laws Amendment Act 2015 No. 8, 2015 An Act to amend legislation relating to intellectual property, and for related purposes Note: An electronic version of this Act is available in
More informationInformal Brief. The Treatment Of Intellectual Property In The Ministerial Declaration: Mandated Negotiations And Reviews
Informal Brief The Treatment Of Intellectual Property In The Ministerial Declaration: Mandated Negotiations And Reviews By David Vivas Eugui Senior Attorney, Center for International Environmental Law
More informationPharmaceutical Patent Settlement Cases: Mixed Signals for Settling Patent Litigation
By Margaret J. Simpson Tel: 312 923-2857 Fax: 312 840-7257 E-mail: msimpson@jenner.com The following article originally appeared in the Spring 2004 issue of the Illinois State Bar Association s Antitrust
More informationA RE-LOOK INTO COMPULSORY LICENSING: AFTER NATCO
A RE-LOOK INTO COMPULSORY LICENSING: AFTER NATCO V. BAYER I. Introduction DeepikaSekar &Aishwarya H Patent is a legal right granted to an inventor as a reward for disclosing his invention. It is the right
More informationChina Patent Agent (H.K.) Ltd. Intellectual Property Attorneys
WHAT S NEW? Commissioner of SIPO Visits CPA Introduction of the Third Revision of Chinese Patent Law Commissioner of SIPO Visits CPA Mr. Tian Lipu, commissioner of the State Intellectual Property Office
More informationAlexandra Robertson. 2011). 2 See Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348 (Fed. Cir. 2012).
The Future of Patent Protection for Post-FDA- Approved Generics: A Look at the Federal Circuit s Incongruous Interpretations of the Safe Harbor Provision in 35 U.S.C. 271(e)(1) Alexandra Robertson I. INTRODUCTION...
More informationAnti-counterfeiting laws and access to essential medicines in East and Southern Africa
Regional Network for Equity in Health in East and Southern Africa (EQUINET) Anti-counterfeiting laws and access to essential medicines in East and Southern Africa EQUINET Policy Brief number 22 Co-published
More informationSouth-South Exchanges related to Patents in Developing Countries and LDCs: A Civil Society Reading
South-South Exchanges related to Patents in Developing Countries and LDCs: A Civil Society Reading Heba Wanis BSc, MPH Researcher Egyptian Initiative for Personal Rights Second WIPO Inter-Regional Meeting
More informationGovernment Contract. Andrews Litigation Reporter. Intellectual Property Rights In Government Contracting. Expert Analysis
Government Contract Andrews Litigation Reporter VOLUME 23 h ISSUE 6 h July 27, 2009 Expert Analysis Commentary Intellectual Property Rights In Government Contracting By William C. Bergmann, Esq., and Bukola
More informationFollow this and additional works at:
Seton Hall University erepository @ Seton Hall Law School Student Scholarship Seton Hall Law 5-1-2014 The Future of Patent Protection for Post-FDA- Approved Generics: A Look at the Federal Circuit s Incongruous
More informationMODULE. Conclusion. ESTIMATED TIME: 3 hours
MODULE 11 Conclusion ESTIMATED TIME: 3 hours 1 Overview I. MODULE 1 INTRODUCTION TO THE WTO SUMMARY... 3 II. MODULE 2 INTRODUCTION TO THE TRIPS AGREEMENT SUMMARY... 5 III. MODULE 3 COPYRIGHT AND RELATED
More informationIff/]) FEB Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC
DEPARTMENT OF HEALTH &. HUMAN SERVICES FEB 2 2 2011 Food and Drug Administration Rockville MD 20857 Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC 20001-3886
More informationIssue Brief for Congress Received through the CRS Web
Order Code IB10105 Issue Brief for Congress Received through the CRS Web The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents Updated November 25, 2002 Wendy H. Schacht and
More informationPatent Rights Retention by the Contractor (Short Form)
52.227 11 Patent Rights Retention by the Contractor (Short Form) As prescribed in 27.303(a), insert the following clause: Patent Rights Retention by the Contractor (Short Form) (Jun 1997) (a) Definitions.
More informationIN-HOUSE RESEARCH TOOLS AND THE FREE TESTING SAFE HARBOR FROM PATENT INFRINGEMENT FOR FDA-RELATED ACTIVITIES. Scott McNurlen
IN-HOUSE RESEARCH TOOLS AND THE FREE TESTING SAFE HARBOR FROM PATENT INFRINGEMENT FOR FDA-RELATED ACTIVITIES by Scott McNurlen Submitted in partial fulfillment of the requirements of the King Scholar Program
More informationThe ITC's Potential Role In Hatch-Waxman Litigation
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com The ITC's Potential Role In Hatch-Waxman
More informationA Comparative Analysis of the Impact of Experimental Use Exemptions in Patent Law on Incentives to Innovate
Northwestern Journal of Technology and Intellectual Property Volume 4 Issue 1 Fall Article 3 Fall 2005 A Comparative Analysis of the Impact of Experimental Use Exemptions in Patent Law on Incentives to
More informationCaraco V. Novo Nordisk: Antitrust Implications
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Caraco V. Novo Nordisk: Antitrust Implications Law360,
More informationMerck Sharp & Dohme & Anr. v Glenmark Pharmaceuticals Ltd
BIOTECH BUZZ International Subcommittee December 2015 Contributor: Archana Shanker Changing trends in Indian patent enforcement In the history of the Patent Litigation in India, at least since 1970, only
More informationCUSTOMER CONTRACT REQUIREMENTS A-160 HUMMINGBIRD CUSTOMER CONTRACT N
Page 1 of 5 CUSTOMER CONTRACT REQUIREMENTS A-160 HUMMINGBIRD CUSTOMER CONTRACT N00421-03-9-0001 (a) Patent Rights Note: The provisions of Patent Rights have been modified from the Prime Agreement to suitably
More informationPENDING LEGISLATION REGULATING PATENT INFRINGEMENT SETTLEMENTS
PENDING LEGISLATION REGULATING PATENT INFRINGEMENT SETTLEMENTS By Edward W. Correia* A number of bills have been introduced in the United States Congress this year that are intended to eliminate perceived
More informationThe India Patent System: A Decade in Review
Cybaris Volume 8 Issue 1 Article 2 2017 The India Patent System: A Decade in Review Vindhya S. Mani Divyanshu Srivastava Mukundan Chakrapani Jay Erstling Follow this and additional works at: http://open.mitchellhamline.edu/cybaris
More informationA I P P I ASSOCIATION INTERNATIONALE POUR LA PROTECTION DE LA PROPRIETE INTELLECTUELLE
A I P P I ASSOCIATION INTERNATIONALE POUR LA PROTECTION DE LA PROPRIETE INTELLECTUELLE INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY INTERNATIONALE VEREINIGUNG FÜR DEN SCHUTZ DES
More informationCERTAIN ASPECTS OF NATIONAL/REGIONAL PATENT LAWS *
CERTAIN ASPECTS OF NATIONAL/REGIONAL PATENT LAWS * (7) Albania Algeria Andorra 1. Acts concerning biological material put on the market by, or with consent of, patent owner. 2. Private acts for non-commercial
More informationIN THE HIGH COURT OF DELHI AT NEW DELHI. CS (OS) No of Versus CORAM: JUSTICE S. MURALIDHAR O R D E R
IN THE HIGH COURT OF DELHI AT NEW DELHI CS (OS) No. 2206 of 2012 KONINKLIJKE PHILIPS ELECTRONICS N.V.... Plaintiff Through: Mr. Sudhir Chandra, Senior Advocate with Mr. Pravin Anand, Ms. Vaishali Mittal,
More informationDraft 2 Hanoi, 2006 DECREE
THE GOVERNMENT No. /2006/ND - CP THE SOCIALIST REPUBLIC OF VIETNAM Independence Freedom Happiness ------------------------------ Draft 2 Hanoi, 2006 DECREE Making detailed provisions and providing guidelines
More informationSecond medical use or indication claims. Winnie Tham, Edmund Kok, Nicholas Ong
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: AIPPI SINGAPORE Second medical use or indication claims Winnie Tham, Edmund Kok, Nicholas Ong THAM, Winnie Date: 17
More informationArticle 2: A patent of invention shall not be granted in respect of the following:
Part One: Patents Chapter One: General Provisions Chapter Two: Procedure of Application for a Patent Chapter Three: Transfer of Ownership, Pledge, and Attachment of Patent Chapter Four: Compulsory Licensing
More informationQuestionnaire on Exceptions and Limitations to Patent Rights. The answers to this questionnaire have been provided on behalf of:
The answers to this questionnaire have been provided on behalf of: Country: Office: Republic of Poland Patent Office of the Republic of Poland Person to be contacted: Name: Piotr Czaplicki Title: Director,
More informationAgreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (1994)*
WORLD TRADE ORGANIZATION (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (1994)* TABLE OF CONTENTS** Article Part I: Part II: Section 1: Section 2: Section 3:
More informationHealth Care Law Monthly
Health Care Law Monthly February 2013 Volume 2013 * Issue No. 2 Contents: Copyright ß 2013 Matthew Bender & Company, Inc., a member of the Lexis- Nexis group of companies. All rights reserved. HEALTH CARE
More informationEXTENDING THE LIFE OF A PATENT IN THE UNITED STATES
EXTENDING THE LIFE OF A PATENT IN THE UNITED STATES by Frank J. West and B. Allison Hoppert The patent laws of the United States allow for the grant of patent term extensions for delays related to the
More information