Second medical use or indication claims
|
|
- Sherilyn Harper
- 5 years ago
- Views:
Transcription
1 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 11, 2014 Questions I. Current law and practice 1) Does your country permit patents covering any aspect of new uses of known pharmaceutical compounds (hereafter referred to as second medical use claims)? If yes, please answer Questions 2) to 7) inclusive before proceeding to the questions in Parts I and II. If no, please proceed directly to the questions in Parts II and III. No. Egypt does not permit patents covering any aspect of new uses of known pharmaceutical compounds. According to Article 1 of the Egyptian Intellectual Property Law No. 82 of 2002 ( IP Law ), a patent shall be granted to any industrially applicable invention, which meets the requirements of novelty and inventive step, whether it is connected with new industrial products, new industrial processes, or a new application of known industrial processes. Second medical use lacks the inventive step requirement. In addition to the limitation imposed by this definition, the Egyptian Patent Office ( EPO ) considers second medical use as a discovery that is not patentable under Article 2 of the IP Law. 2) If the answer to Question 1) is yes, please answer the following sub questions. a) What is the basis for patent protection? b) What types of second medical use are patentable? See, for example, paragraphs 14) - 17) above/wgls. c) Are any types of second medical use impermissible subject matter? See, for example, paragraphs 14) - 17) above/wgls. d) What forms of second medical use claims are permissible? See, for example, paragraphs 26) - 33) above/wgls. e) What forms of second medical use claims are not permissible? See, for example, paragraphs 26) - 33) above/wgls. f) Has any guidance been provided by courts or the national patent office in relation to the meaning, scope and/or effect of 'treatment', 'treating' or 'use to treat' integers in second medical use claims? See, for example, paragraphs 34) - 39) above WGLs.
2 3) If your country permits second medical use claims: a) Who may be liable for infringement of such claims? For example: i) the party marketing the drug with label instructions which describe the patented use; ii) the physician prescribing the drug for such use; iii) the pharmacist dispensing a drug for such purpose; iv) the patient using the drug for such purpose? b) Are any parties exempt from infringement or liability for infringement of such claims. If so, what classes of party? c) Are such claims enforceable on the basis of direct or indirect infringement? Please provide details. 4) If a drug is approved for more than one indication, one or more of which (but not all) falls within the claims of a patent, is it an infringement if a party makes, supplies or uses a generic version of the drug for any use? 5) If the answer to Question 4) is yes, please answer the following sub questions in that context. a) Is each of the acts of making, supplying and using a form of infringement? If not, please specify which (or any other) acts which constitute infringement. b) Is it necessary for a finding of infringement that the party making, supplying or using the generic version of the drug does so in connection with the infringing use? c) If yes to b), is it necessary that the party knows that their actions are in connection with the infringing use? d) If yes to c), what standard of knowledge is required? See, for example, paragraphs 38) and 47) above. 6) How do the courts determine infringement of a second medical use claim? What are the legal tests and evidentiary requirements? 7) What relief is available for infringement of a second medical use claim: a) at a preliminary / interim / interlocutory level? b) by way of final relief? 8) In respect of Question 7)a), can a preliminary / interim / interlocutory injunction be granted solely upon the statements provided in the product packaging or based on the writing of a prescription? If not, what is the basis for relief? 9) In respect of Question 7)b), what level of proof is required to obtain a final injunction? II. Policy considerations and proposals for improvements to your current law 10) If your country permits second medical use claims, please answer the following sub questions. a) What are the policy reasons behind permitting such claims? 2
3 b) Are such claims as are currently permissible in your country considered to strike the right balance between the interests of relevant stakeholders? c) Is it considered that such claims better serve the interests of some stakeholders and/or are detrimental to other stakeholders? d) If there is any empirical or anecdotal data available, please address the following. i) What is the prevalence of second medical use claims in your country? ii) What is the profile of patentees for second medical use claims in your country? 11) If your country does not permit second medical use claims, please answer the following sub questions. a) What are the policy reasons behind not permitting such claims? Considering a second medical use claims as non patentable is due to the legal characterization of the claims. Second medical use claims do not involve any inventive step in order to make them different from original patented compounds. In addition, such claims lack novelty which makes Patents Office characterize them as discoveries rather than inventions. b) Would such claims serve the interests of relevant stakeholders? Refusal to grant patents to second medical use claims does not mean that such claims cannot be utilized commercially. The Egyptian General Administration of Pharmaceutical Affairs ( GAPA ) may approve registration of a medicine even if it is based on a second medical use; provided that, the producing company submits all relevant studies supporting such new indication. The above scheme allows other pharmaceutical companies to compete with the inventor/discoverer of the second medical use. Although the above scheme is intended to favor consumers by lowering the price of medicines, it does decrease the incentive of the inventor to enter the local market. This may be offset by the fact that the local market is big with the population nearing 90 million which incentivizes pharmaceutical companies to enter the local market even if the margin of profit is less than desired. c) Would such claims be considered to better serve the interests of some stakeholders and/or be detrimental to other stakeholders? These claims, if allowed, would better serve the interest of the inventor pharmaceutical company and to the consumer if the incentive rationale is followed but it might adversely affect competitors and consumers, with respect to pricing; although the Government can resort to mandatory pricing/licensing to mitigate this effect. 12) To what extent does your country's law in relation to second medical use claims affect the pharmaceutical industry (originator and generic) in your country? Egypt does not have a significant pharmaceutical industry which is based on local inventions, but it has a large market which is based on generic products and a market focusing on local production of foreign invented products. Thus, most medicines are 3
4 initially approved outside Egypt prior to their commercial use in Egypt. The more significant effect therefore relates to availability and pricing to consumers. III. Proposals for harmonisation 13) Is it desirable to permit second medical use claims? It is desirable to permit second medical use claims whether to the original inventor or the discoverers of the second medical use in order to open the market for a wider range of products as well as incentivize local pharmaceutical companies to allocate more resources and effort to research and development. Although pricing for the consumers is always a key issue, it can be addressed through pricing mechanisms. A shorter term of protection may be considered as a compromise between the interests of consumers, local producers and international pharmaceutical companies. 14) Is harmonisation of laws relating to second medical use claims desirable? Yes. Harmonization of laws relating to second medical use claims, and more generally to intellectual property rights in the pharmaceutical industry, is desirable as it provides more certainty and predictability for pharmaceutical companies; therefore facilitating their entry into newer markets. 15) Please provide a standard that you consider to be best in each of the following areas relating to second medical use claims. a) Types of second medical use constituting permissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. The following examples may constitute permissible grounds for patentability: Where a drug is developed for a certain purpose and after research was found to be useful for another medical purpose. Unsuccessful compounds used originally to treat specific conditions and subsequently used successfully to treat other diseases. b) Types of any second medical use constituting impermissible subject matter. See, for example, paragraphs 14) - 17) above/wgls. Dosage and method of administration should not be patentable as this is more difficult to demonstrate. In addition, in many cases there is no agreement within the scientific community regarding the dosage and methods of administrations. It may also be the case that dosage and method of administration require less research and development cost, especially if intended to treat the same disease. c) Form of permissible claims. See, for example, paragraphs 26) - 33) above/wgls. The EBA decision G2/08 seems to be a good standard for allowing second medical use claims: Substance X for use in the treatment of condition Y. We understand that this standard requires more than merely using the same substance without any additions/amendments to treat a different condition. It is therefore possible to pass a more lenient inventive step test. 4
5 d) Form of impermissible claims. See, for example, paragraphs 26) - 33) above/wgls. We are of the opinion that the new dosage regime should be a form of impermissible claims. e) Who may be liable for infringement? Producers of the same compounds for different treatment may be liable for infringement. f) Any parties/institutions that should be exempted from infringement or liability for infringement. It may be difficult and impracticable to hold doctors prescribing a medicine for a second medical use liable. It may also not be desirable to require the competent authority GAPA in Egypt s case to be held liable for authorizing second medical use as this may result in a restrictive approach by GAPA which may result in refusing to allow medicines that may otherwise not be violating second medical use claims. g) Where a drug is approved for more than one indication, one or more of which (but not all) falls within the claims of a patent, the acts that should constitute patent infringement, and in particular, the standard of knowledge of the alleged infringer. Patent infringement should be invoked only where the producer of the drug markets it expressly for the second medical use (i.e. one or more the indications which falls within the claims of a patent) but not with respect to unprotected claims. Actual knowledge, in this approach, would be presumed without need for evidence by the infringed party if the claims are patented (i.e. a knew or should have known standard should be applied). h) Relief available upon a finding of infringement: i) at a preliminary / interim / interlocutory level; and ii) by way of permanent relief. A preliminary / interim / interlocutory level would be more desirable so as to avoid the prevention of the drug s use for unprotected claims. i) In each case for h)i) and h)ii), the level of proof for the granting of such relief. The standard of proof is that the infringer knew or should have known. Summary Q238 Egypt does not permit second medical use claims, on the grounds that they do not meet the requirements of novelty and inventive step. Refusal to grant patents to second medical use claims does not mean that such claims cannot be utilized commercially. 5
6 It is desirable to permit second medical use claims in order to open the market for a wider range of products as well as incentivize local pharmaceutical companies to allocate more resources and effort to research and development. A good standard for allowing second medical use claims is: substance X for use in the treatment of condition Y, as it requires more than merely using the same substance and may therefore pass a more lenient inventive step test. Doctors and relevant health authorities should not be held liable for second medical use infringement. Patent infringement should be invoked against producers who knew or should have known of the infringement. 6
Second medical use or indication claims
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: Bulgarian National Group Second medical use or indication claims Valentina NESHEVA Valentina NESHEVA Date: 16 May 2014
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 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 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 informationSecond medical use or indication claims
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: Canada Second medical use or indication claims Matthew ZISCHKA Santosh CHARI Carol HITCHMANN Roseanne CALDWELL Charles
More informationNo. According to the PTO s internal examination guidelines, second medical use claims are not patentable.
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: Argentina Second medical use or indication claims Gastón RICHELET, Ricardo D. RICHELET Gastón RICHELET Date: May 19,
More informationSecond medical use or indication claims
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: AUSTRIA Second medical use or indication claims Marc KESCHMANN Marc KESCHMANN Date: May 12, 2014 Questions I. Current
More informationPatentable Subject Matter and Medical Use Claims in the Pharmaceutical Sector
Patentable Subject Matter and Medical Use Claims in the Pharmaceutical Sector 2012 LIDC Congress, Prague, 12 October 2012 Dr. Simon Holzer, Attorney-at-Law, Partner 3 October 2012 2 Introduction! Conflicting
More informationWorking Guidelines Q238. Second medical use and other second indication claims
Working Guidelines by Thierry CALAME, Reporter General Sarah MATHESON and John OSHA, Deputy Reporters General Anne Marie VERSCHUR, Sara ULFSDOTTER and Kazuhiko YOSHIDA Assistants to the Reporter General
More informationConstruction of second medical use claims. The Hon. Mr Justice Richard Arnold
Construction of second medical use claims The Hon. Mr Justice Richard Arnold The problem Claim 1 of European Patent (UK) No. 0 934 061 reads: Use of [pregabalin] or a pharmaceutically acceptable salt thereof
More informationSecond Medical Use Patents in Europe: Are the UK and Germany Swapping Approaches?
WHITE PAPER January 2019 Second Medical Use Patents in Europe: Are the UK and Germany Swapping Approaches? The UK Supreme Court s ruling in Warner Lambert v Actavis resulted from deliberations over the
More informationNotwithstanding Article 29, any invention that is liable to injure public order, morality or public health shall not be patented (Article 32).
Japan Patent Office (JPO) Contents Section 1: General... 1 Section 2: Private and/or non-commercial use... 2 Section 3: Experimental use and/or scientific research... 3 Section 4: Preparation of medicines...
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 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 informationSWEDEN PATENTS ACT No.837 of 1967 in the version in force from July 1, 2014
SWEDEN PATENTS ACT No.837 of 1967 in the version in force from July 1, 2014 TABLE OF CONTENTS Chapter 1. General Provisions Article 1 Article 1a Article 1b Article 1c Article 1d Article 2 Article 3 Article
More informationSuzannah K. Sundby. canady + lortz LLP. David Read. Differences between US and EU Patent Laws that Could Cost You and Your Startup.
Differences between US and EU Patent Laws that Could Cost You and Your Startup Suzannah K. Sundby United States canady + lortz LLP Europe David Read UC Center for Accelerated Innovation October 26, 2015
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 informationALABAMA BOARD OF MEDICAL EXAMINERS ADMINISTRATIVE CODE CHAPTER 540 X 12 QUALIFIED ALABAMA CONTROLLED SUBSTANCES REGISTRATION CERTIFICATE (QACSC)
Medical Examiners Chapter 540 X 12 ALABAMA BOARD OF MEDICAL EXAMINERS ADMINISTRATIVE CODE CHAPTER 540 X 12 QUALIFIED ALABAMA CONTROLLED SUBSTANCES REGISTRATION CERTIFICATE (QACSC) TABLE OF CONTENTS 540
More informationEgypt Égypte Ägypten. Report Q194. in the name of the Egyptian Group by Samir HAMZA, Ahmed Abou ALI, Tamer EL HENNAWY and Heba EL TOUKHY
Egypt Égypte Ägypten Report Q194 in the name of the Egyptian Group by Samir HAMZA, Ahmed Abou ALI, Tamer EL HENNAWY and Heba EL TOUKHY The Impact of Co Ownership of Intellectual Property Rights on their
More informationInjunctions in cases of infringement of IPRs. The Groups are invited to answer the following questions under their national laws:
Question Q219 National Group: Italy Title: Injunctions in cases of infringement of IPRs Contributors: Reporter within Working Committee: Lamberto Liuzzo Date: 5-4-2011 Questions I. Analysis of current
More informationFrequently Asked Questions. Trade/service marks: What is a trade/service mark?
Frequently Asked Questions Trade/service marks: What is a trade/service mark? Is a distinctive sign that serves to distinguish the goods and/or services of one enterprise from those of other enterprises.
More informationGERMAN UTILITY MODEL THE UNDERRATED INTELLECTUAL PROPERTY RIGHT DATE: WEDNESDAY 12 NOVEMBER 2014 LOCATION: GLASGOW, UK
GERMAN UTILITY MODEL THE UNDERRATED INTELLECTUAL PROPERTY RIGHT DATE: WEDNESDAY 12 NOVEMBER 2014 LOCATION: GLASGOW, UK INTRODUCTION In Germany the utility model is an unexamined, technical IP right having
More informationJordanian Patent Office
Jordanian Patent Office Industrial Property Protection Directorate Ministry of Industry and Trade UNDP/WHO - Examination of pharmaceutical patents from a public health perspective Cairo, 14-15 April 2009
More information[English translation by WIPO] Questionnaire on Exceptions and Limitations to Patent Rights
[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: Morocco... Moroccan Industrial
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 informationThe methods and procedures described must be directly applicable to production.
National Patent Administration Argentina Contents Section 1: General... 1 Section 2: Private and/or non-commercial use... 3 Section 3: Experimental use and/or scientific research... 3 Section 4: Preparation
More informationQuestionnaire May 2003 Q Scope of Patent Protection. Response of the UK Group
Questionnaire May 2003 Q 178 - Scope of Patent Protection Response of the UK Group 1.1 Which are, in your view, the fields of technology in particular affected by recent discussions concerning the scope
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 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 informationEricsson Position on Questionnaire on the Future Patent System in Europe
Ericsson Position on Questionnaire on the Future Patent System in Europe Executive Summary Ericsson welcomes the efforts of the European Commission to survey the patent systems in Europe in order to see
More informationNew IP Code changes regarding patents, new post-grant opposition and enforcement provisions
INTELLECTUAL PROPERTY - TURKEY New IP Code changes regarding patents, new post-grant opposition and enforcement provisions AUTHORS Mehmet Nazim Aydin Deriş January 08 2018 Contributed by Deris Avukatlik
More informationSwitzerland. Esther Baumgartner Christoph Berchtold Simon Holzer Kilian Schärli Meyerlustenberger Lachenal. 1. Small molecules
Esther Baumgartner Christoph Berchtold Simon Holzer Kilian Schärli Meyerlustenberger Lachenal 1. Small molecules 1.1 Product and process claims Classic drug development works with small, chemically manufactured
More informationI. Current law and practice
Question Q241 National Group: Title: Contributors: Reporter within Working Committee: Egyptian National Group IP licensing and insolvency Mohamed-Hossam LOUTFI Mohamed-Hossam LOUTFI Date: May 11, 2014
More informationCA/PL 7/99 Orig.: German Munich, SUBJECT: Revision of the EPC: Articles 52(4) and 54(5) President of the European Patent Office
CA/PL 7/99 Orig.: German Munich, 2.3.1999 SUBJECT: Revision of the EPC: Articles 52(4) and 54(5) DRAWN UP BY: ADDRESSEES: President of the European Patent Office Committee on Patent Law (for opinion) SUMMARY
More informationThe EPO approach to Computer Implemented Inventions (CII) Yannis Skulikaris Director Operations, Information and Communications Technology
The EPO approach to Computer Implemented Inventions (CII) Yannis Skulikaris Director Operations, Information and Communications Technology March 2018 Background and context The EPO s approach to CII: fulfills
More informationEUROPEAN GENERIC MEDICINES ASSOCIATION
EUROPEAN GENERIC MEDICINES ASSOCIATION POSITION PAPER POSITION PAPER ON THE REVIEW OF DIRECTIVE 2004/48/EC ON THE ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS JUNE 2011 EGA EUROPEAN GENERIC MEDICINES ASSOCIATION
More informationPatent Law of the Republic of Kazakhstan. Chapter 1. General provisions. Article 1. Basic notions and definitions used in the present Law
Patent Law of the Republic of Kazakhstan Chapter 1. General provisions Article 1. Basic notions and definitions used in the present Law The following notions and definitions are used for the purposes of
More informationDiscovery in a patent infringement suit in Japan particularly about secrecy order (protective order)
Discovery in a patent infringement suit in Japan particularly about secrecy order (protective order) AIPLA AIPPI Japan/JFBA Joint Meeting April 23, 2009 Hideo Ozaki City-Yuwa Partners http://www.city-yuwa.com/ip-group/en
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 informationCHAPTER 2 AUTHORS AND PATENT OWNERS Article 5. Author of the Invention, Utility Model, and Industrial Design Article 6.
BELARUS Law of the Republic of Belarus On Patents for Inventions, Utility Models, and Industrial Designs December 16, 2002 No 160-Z Amended as of December 22, 2011 TABLE OF CONTENTS CHAPTER 1. LEGAL PROTECTION
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 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 informationPregabalin: Where stand plausibility, Swiss-form claims, late amendment and more?
University College London IBIL Innovation Seminar 2018 Pregabalin: Where stand plausibility, Swiss-form claims, late amendment and more? Dr. Matthias Zigann Presiding Judge Regional Court Munich I Swiss
More informationEUROPEAN COMMISSION COMMUNITY PATENT CONSULTATION COMPTIA S RESPONSES BRUSSELS, 18 APRIL
EUROPEAN COMMISSION COMMUNITY PATENT CONSULTATION COMPTIA S RESPONSES BRUSSELS, 18 APRIL 2006 http://www.comptia.org 2006 The Computing Technology Industry Association, Inc. The Patent System in Europe
More informationThe National Center of Intellectual Property Belarus. Contents
The National Center of Intellectual Property Belarus Contents Section 1: General... 1 Section 2: Private and/or non-commercial use... 3 Section 3: Experimental use and/or scientific research... 4 Section
More informationSelection Inventions the Inventive Step Requirement, other Patentability Criteria and Scope of Protection
Question Q209 National Group: Title: Contributors: AIPPI Indonesia Selection Inventions the Inventive Step Requirement, other Patentability Criteria and Scope of Protection Arifia J. Fajra (discussed by
More informationINTELLECTUAL PROPERTY LAW ARTICLE
INTELLECTUAL PROPERTY LAW ARTICLE How the New Multi-Party Patent Infringement Rulings Written by Brian T. Moriarty, Esq., Deirdre E. Sanders, Esq., and Lawrence P. Cogswell, Esq. The very recent and continuing
More information[English translation by WIPO] Questionnaire on Exceptions and Limitations to Patent Rights
[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: EL SALVADOR... National Registration
More informationAmended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EUROPEAN COMMISSION Brussels, 11.10.2011 COM(2011) 633 final 2008/0256 (COD) Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Amending Directive 2001/83/EC, as regards information
More informationRevision Draft of the Patent Law of the People s Republic of China (For Deliberation)
Revision Draft of the Patent Law of the People s Republic of China (For Deliberation) (Words in bold font are revised portion) Chapter 1: General Provisions Article 1 This law is enacted for the purpose
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 informationClinical Trial Research Agreement
Clinical Trial Research Agreement Investigator-Initiated, Company Supported Studies The body of the Agreement is not to be amended. Revisions are to be detailed in Schedule 3 with appropriate cross-referencing
More informationSCIENCE & TECHNOLOGY DEVELOPMENT FUND (STDF)
SCIENCE & TECHNOLOGY DEVELOPMENT FUND (STDF) www.stdf.org.eg This document is intended to provide information on the Intellectual Property system applied by the (STDF) as approved by its Governing Board
More informationpct2ep.com Guide to claim amendment after EPO regional phase entry
pct2ep.com Guide to claim amendment after EPO regional phase entry Claim amendments in the EPO Guide to the issues to consider After a PCT application enters the EPO regional phase, and before any search
More informationT 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
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
More informationINTELLECTUAL PROPERTY LAWYERS ASSOCIATION
INTELLECTUAL PROPERTY LAWYERS ASSOCIATION Response to the Questionnaire on the Patent System in Europe Introduction: Who IPLA Are The Intellectual Property Lawyers Association (previously known as the
More informationFINLAND Patents Act No. 550 of December 15, 1967 as last amended by Act No. 101/2013 of January 31, 2013 Enter into force on 1 September 2013
FINLAND Patents Act No. 550 of December 15, 1967 as last amended by Act No. 101/2013 of January 31, 2013 Enter into force on 1 September 2013 TABLE OF CONTENTS CHAPTER 1 General Provisions Section 1 Section
More informationGENEVA STANDING COMMITTEE ON THE LAW OF PATENTS. Thirteenth Session Geneva, March 23 to 27, 2009
E WIPO SCP/13/3. ORIGINAL: English DATE: February 4, 2009 WORLD INTELLECTUAL PROPERT Y O RGANI ZATION GENEVA STANDING COMMITTEE ON THE LAW OF PATENTS Thirteenth Session Geneva, March 23 to 27, 2009 EXCLUSIONS
More informationCOMPULSORY LICENCE in Germany. Markus Rieck LL.M.
COMPULSORY LICENCE in Germany Markus Rieck LL.M. 1 1877 - GERMAN PATENT ACT Bundesarchiv, Bild 183-R68588 / P. Loescher & Petsch / CC-BY-SA 3.0 2 Public interest Dependent patent Plant breeders privilege*
More informationGlobal 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 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 informationEGYPTIAN PATENT OFFICE
PCT Applicant s Guide National Phase National Chapter EG Page 1 EGYPTIAN PATENT OFFICE AS DESIGNATED (OR ELECTED) OFFICE CONTENTS THE ENTRY INTO THE NATIONAL PHASE SUMMARY THE PROCEDURE IN THE NATIONAL
More informationAugust 6, AIPLA Comments on Partial Amendment of Guidelines for the Use of Intellectual Property Under the Antimonopoly Act (Draft)
Person in Charge of the Partial Amendment of the IP Guidelines (Draft) Consultation and Guidance Office, Trade Practices Division Economic Affairs Bureau, Secretariat, Japan Fair Trade Commission Section
More informationEffective Mechanisms for Challenging the Validity of Patents
Effective Mechanisms for Challenging the Validity of Patents Walter Holzer 1 S.G.D.G. Patents are granted with a presumption of validity. 2 A patent examiner simply cannot be aware of all facts and circumstances
More informationNews Letter Autumn 2015
News Letter Autumn 2015 Seoul, Korea Recent Amendment to Patent Act 1. Available to claim presumption of novelty even after patent filing (Article 30(3) of Patent Act) Under old laws, a claim for presumption
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 informationHigh-Tech Patent Issues
August 6, 2012 High-Tech Patent Issues On June 4, 2013, the White House Task Force on High-Tech Patent Issues released its Legislative Priorities & Executive Actions, designed to protect innovators in
More informationREPUBLIC OF SINGAPORE GOVERNMENT GAZETTE ACTS SUPPLEMENT. Published by Authority NO. 28] FRIDAY, DECEMBER 21 [2012 REPUBLIC OF SINGAPORE
REPUBLIC OF SINGAPORE GOVERNMENT GAZETTE ACTS SUPPLEMENT Published by Authority NO. 28] FRIDAY, DECEMBER 21 [2012 First published in the Government Gazette, Electronic Edition, on 20th December 2012 at
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 informationCase 2:14-cv HRH Document 37 Filed 12/08/14 Page 1 of 8
Case :-cv-00-hrh Document Filed /0/ Page of 0 0 ERICKSON KERNELL DERUSSEAU & KLEYPAS, LLC 00 State Line Road, Suite 00 Leawood, Kansas 0 Telephone: () -00 Facsimile: () - Email: jjk@kcpatentlaw.com kdd@kcpatentlaw.com
More informationCan I Challenge My Competitor s Patent?
Check out Derek Fahey's new firm's website! CLICK HERE Can I Challenge My Competitor s Patent? Yes, you can challenge a patent or patent publication. Before challenging a patent or patent publication,
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 informationNorway. Norway. By Rune Nordengen, Bull & Co Advokatfirma AS
Norway By Rune Nordengen, Bull & Co Advokatfirma AS 1. What are the most effective ways for a European patent holder whose rights cover your jurisdiction to enforce its rights in your jurisdiction? Cases
More information5 Multiple Protection of Inventions
5 Multiple Protection of Inventions From the perspective of helping front runners efforts to obtain multiple protection rights and achieving international harmonization of systems, research studies were
More information2016 Study Question (Patents)
2016 Study Question (Patents) Submission date: 25th May 2016 Sarah MATHESON, Reporter General John OSHA and Anne Marie VERSCHUUR, Deputy Reporters General Yusuke INUI, Ari LAAKKONEN and Ralph NACK, Assistants
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 informationIsrael. Contributing firm Pearl Cohen Zedek Latzer
Contributing firm Authors Nachman Cohen Zedek, Dor Cohen Zedek and Yossi Markovich Selection, clearance and registration Israel became party to the Madrid Protocol on September 1 2010. As of September
More informationSAFE IMPORTATION OF MEDICAL PRODUCTS AND OTHER RX THERAPIES ACT OF 2004 (SAFE IMPORT ACT) SECTION-BY-SECTION SEC. 1. SHORT TITLE.
SAFE IMPORTATION OF MEDICAL PRODUCTS AND OTHER RX THERAPIES ACT OF 2004 (SAFE IMPORT ACT) SEC. 1. SHORT TITLE. SECTION-BY-SECTION Provides that the short title of the bill is the ASafe Importation of Medical
More informationEnglish Language Translation Entry into New Zealand PCT National Phase
2009 Business Updates Request for postponement of acceptance under section 20(1) of the Patents Act 1953 Applicants may at any time prior to acceptance request that a patent application not be accepted
More informationCHAPTER 53 PHARMACY AND POISONS ORDINANCE ARRANGEMENT OF SECTIONS PART I PRELIMINARY PART II PHARMACY
2 CAP. 53 Pharmacy and Poisons LAWS OF CHAPTER 53 PHARMACY AND POISONS ORDINANCE ARRANGEMENT OF SECTIONS PART I PRELIMINARY SECTION 1. Short title 2. Interpretation PART II PHARMACY 3. Qualification and
More informationIP Law and the Biosciences Conference
IP Law and the Biosciences Conference Biologics in the International Arena April 26, 2018 Panelists Moderator: Justin Watts Partner, WilmerHale Jürgen Dressel Rebecca Eisenberg Professor of Law, University
More informationCanada Intellectual property enforcement
Sponsored by Statistical data supplied by Canada Intellectual property enforcement This article first appeared in IP Value 2004, Building and enforcing intellectual property value, An international guide
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: Bhutan Intellectual Property Division, Ministry of Economic Affairs, Thimphu Person to be contacted: Name: Mr. Sonam
More informationAmendments in Europe and the United States
13 Euro IP ch2-6.qxd 15/04/2009 11:16 Page 90 90 IP FIT FOR PURPOSE Amendments in Europe and the United States Attitudes differ if you try to broaden your claim after applications, reports Annalise Holme.
More informationQuestion Q204P. Liability for contributory infringement of IPRs certain aspects of patent infringement
Summary Report Question Q204P Liability for contributory infringement of IPRs certain aspects of patent infringement Introduction At its Congress in 2008 in Boston, AIPPI passed Resolution Q204 Liability
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 informationREPUBLIC OF SOUTH AFRICA
Government Gazette REPUBLIC OF SOUTH AFRICA Vol. 451 Cape Town 17 January 2003 No. 24279 THE PRESIDENCY No. 115 17 January 2003 It is hereby notified that the President has assented to the following Act,
More informationREPUBLIC OF VANUATU BILL FOR THE PATENTS ACT NO. OF 1999
REPUBLIC OF VANUATU BILL FOR THE PATENTS ACT NO. OF 1999 Arrangement of Sections PART 1 PRELIMINARY PROVISIONS 1. Interpretation PART 2 PATENTABILITY 2. Patentable invention 3. Inventions not patentable
More informationMartín BENSADON, Alicia ALVAREZ, Damaso PARDO, Ignacio SÁNCHEZ ECHAÜE.
Question Q233 National Group: Argentina Title: Grace period for patents Contributors: Martín BENSADON, Alicia ALVAREZ, Damaso PARDO, Ignacio SÁNCHEZ ECHAÜE. Reporter within Working Committee: Martín BENSADON
More informationTHE PATENTS ACT 1970
THE PATENTS ACT 1970 (39 of 1970) An Act to amend and consolidate the law relating to patents. (19 th September, 1970) Be it enacted by Parliament in the twenty first year of the Republic of India as follows;-
More informationEuropean Patent Litigation: An overview
European Patent Litigation: An overview Tuesday 28 September 2010 Hogan Lovells in partnership with the Association of Corporate Counsel Europe Your speaker panel Co-Chairs: Marten Bezemer Associate General
More informationPharmaceutical Patent Settlements A Presumption in Reverse
AUGUST 2009, RELEASE ONE Pharmaceutical Patent Settlements A Presumption in Reverse Kristina Nordlander & Patrick Harrison Sidley Austin LLP Pharmaceutical Patent Settlements A Presumption in Reverse Kristina
More informationNote: When any ambiguity of interpretation is found in this provisional translation, the Japanese text shall prevail.
Note: When any ambiguity of interpretation is found in this provisional translation, the Japanese text shall prevail. (Applied to any applications to register a patent term extension filed on or after
More informationIntellectual Property and crystalline forms. How to get a European Patent on crystalline forms?
Intellectual Property and crystalline forms How to get a European Patent on crystalline forms? Ambrogio Usuelli Chief-Examiner European Patent Office, Munich, Germany Bologna, 19th January 2012 Sponsor:
More information(Translated by the Patent Office of the People's Republic of China. In case of discrepancy, the original version in Chinese shall prevail.
Patent Law of the People's Republic of China (Adopted at the 4th Session of the Standing Committee of the Sixth National People's Congress on March 12, 1984, Amended by the Decision Regarding the Revision
More information: Liability for contributory infringement of IPRs certain aspects of patent infringement
Question Q204P National Group : AIPPI Indonesia Title : Liability for contributory infringement of IPRs certain aspects of patent infringement Contributors : Migni Myriasandra Representative within Working
More informationHUNGARY Patent Act Act XXXIII of 1995 as consolidated on March 01, 2015
HUNGARY Patent Act Act XXXIII of 1995 as consolidated on March 01, 2015 TABLE OF CONTENTS PART I INVENTIONS AND PATENTS Chapter I SUBJECT MATTER OF PATENT PROTECTION Article 1 Patentable inventions Article
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: Germany Office: Federal Ministry of Justice and for Consumer Protection / German Patent and Trademark Office Person to be contacted:
More informationThe Supreme Court, Civil Liberties, and Civil Rights
MIT OpenCourseWare http://ocw.mit.edu 17.245 The Supreme Court, Civil Liberties, and Civil Rights Fall 2006 For information about citing these materials or our Terms of Use, visit: http://ocw.mit.edu/terms.
More informationAUSTRIA Utility Model Law
AUSTRIA Utility Model Law BGBl. No. 211/1994 as amended by BGBl. Nos. 175/1998, 143/2001, I 2004/149, I 2005/42, I 2005/130, I 2005/151, I 2007/81 and I 2009/126 TABLE OF CONTENTS I. GENERAL PROVISIONS
More information