Is 'evergreening' a cause for concern? A legal perspective

1969 ◽  
Vol 13 (4) ◽  
Author(s):  
Scott Parker ◽  
Kevin Mooney
Keyword(s):  
Patent Protection ◽  
Cost Effective ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
Patent System ◽  
Pharmaceutical Companies ◽  
Generic Competition ◽  
Legal Perspective ◽  
The Uk ◽  
Weak Patents

A number of fundamental principles (and misconceptions) of patent law and of the system for granting and enforcing patents lie at the heart of the so-called 'evergreening' debate on patent protection for pharmaceutical products. The purpose of this paper is to consider 'evergreening' from a legal perspective and to evaluate the extent to which the patent system operates to safeguard against the claimed abuses. In the authors' view the allegation that pharmaceutical companies have been able to delay substantially the entry of generic competition by 'evergreening' many of their patents simply does not reflect the reality and mischaracterises how the patent system operates in the context of technological innovation. A patent over an improvement does not restrict a generic company from launching a competitor of the originator product and, in the UK at least, the procedure and attitude of the court is conducive to the speedy and cost-effective challenge of 'weak' patents.

scholarly journals An Analysis of the Transformation of Mega-Pharma’s Business Model toward the Emerging Market

2020 ◽  
Vol 4 (4) ◽  
pp. 253-262
Author(s):  
Yaeko Mitsumori
Keyword(s):  
Patent Protection ◽  
Business Models ◽  
Emerging Market ◽  
Patent Application ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies ◽  
Indian Market ◽  
Application Data

The Trade-Related Aspects of Intellectual Property Rights（TRIPS) requires all member countries of the World Trade Organization (WTO) to introduce a TRIPS-compatible patent law into their countries. Due to the enforcement of TRIPS in 1995, India in 2005 revised its patent law and enacted the Patents (Amendment) Act, 2005. The 2005 ACT included product patent in pharmaceutical field. Due to the new patent law with product patent protection, large foreign capital pharmaceutical companies one after another re-entered the Indian market and started engaging in both R&D and production targeting the Indian market. However recent data shows the number of patent applications has been declining over the past several years and the number of patented drugs launched in India did not increase so rapidly. This study analyzes transitions of business models of foreign pharmaceutical companies in India based on the patent application data, and the trend of patented drugs in the market. A data analysis and a series of interviews with stakeholders were conducted. As a result of both a quantitative and a qualitative analysis, it was found that foreign pharmaceutical companies changed their strategies in the Indian pharmaceutical market. Since India was required to introduce product patents in the pharmaceutical area, there have been many arguments that once India introduces a product patent, the Indian pharmaceutical industry may decline due to the rapid introduction of foreign pharmaceutical products in the country; many academic papers were published in this context during that time. However, since 2005, when product patents were actually introduced in India, few academic papers were published. This study is unique as it discusses the effects of the introduction of product patents on the Indian pharmaceutical market.

Historical Developments

2016 ◽  
Author(s):  
Philip W. Grubb ◽  
Peter R. Thomsen ◽  
Tom Hoxie ◽  
Gordon Wright
Keyword(s):  
Patent Protection ◽  
Biological Diversity ◽  
Patent Law ◽  
Patent System ◽  
Convention On Biological Diversity ◽  
European Patent ◽  
Industrialized Countries ◽  
System P ◽  
Historical Developments ◽  
The Uk

This chapter describes historical developments in patent systems and patent law. It highlights key developments in the UK from 1800–2014, in the US from 1790–2014, in other industrialized countries (Germany, France, the Netherlands, Switzerland, and Japan), and in developing countries. The final section discusses international developments such as the Paris Convention, the European Patent Convention, the Unitary Patent system in Europe, the Patent Cooperation Treaty, the TRIPs Agreement, the Convention on Biological Diversity, the Patent Law Treaty, the London Agreement, and the Substantive Patent Law Treaty. These developments, which have generally acted to strengthen patent protection, did not simply happen of their own accord; political, diplomatic, and industry lobbying activities have played a larger role than any objective analysis of the economic and social benefits of the patent system.

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

14. Key elements of the patent system

2020 ◽  
pp. 230-245
Author(s):  
Ian J. Lloyd
Keyword(s):  
Patent Protection ◽  
World Trade Organisation ◽  
Patent System ◽  
The European Union ◽  
The United Kingdom ◽  
System P ◽  
To Come ◽  
The Uk ◽  
Near Future

This chapter considers the nature and manner of operation of the patent system. Patents date back to around the 14th century. For the United Kingdom they began as a means to encourage the importation of foreign skills and technology, fell into disrepute as they were used by monarchs to confer monopolies in respect of the sale of well-known objects such as playing cards and eventually from the late seventeenth century settled into their present role of granting temporary monopolies to those who make inventions. The chapter examines the criteria that will be applied in determining whether an invention is eligible for patent protection and the procedures that will required to be followed in order to obtain this. Unlike copyright which applies effectively on a global basis, the patent system has operated on a national basis. A UK patent will be valid and enforceable in the UK but nowhere else. There are international agreements, however, designed to simplify the task of obtaining protection in a range of countries and the operation of these will be considered as well as the treatment of intellectual property within the General Agreement on Trade in Services and the World Trade Organisation. Within the European Union, the possible introduction of a unitary patent has been the subject of discussion for many years and appears likely to come to fruition in the near future although the involvement of the UK post Brexit is uncertain.

Analyzing the Broadening Scope of Patentability in the Advancing Field of Biotechnology

2012 ◽  
Vol 18 (4) ◽  
Author(s):  
Jessica Downing
Keyword(s):  
Stem Cells ◽  
Embryonic Stem Cells ◽  
Growth And Development ◽  
Patent Protection ◽  
Embryonic Stem ◽  
Biotechnology Industry ◽  
Patent Law ◽  
Patent System ◽  
Legislative History ◽  
Public Debates

The current U.S. patent system is considered to provide the broadest patent protection of all patent systems in existence, especially with respect to the biotechnology industry. Advances in science and technology have been key contributors to the growth and development of legislation controlling patent law. With these advancements have come vivid public debates on the morality of research with embryonic stem cells and the fusion of human and animal DNA to find cures for disease. Despite the rapid developments, the legislation controlling such research has been slow to progress. This paper will explore the legislative history surrounding biotechnology patents, focusing on the specific need for strong, adequate protection to promote the survival of the biotechnology industry.

scholarly journals New Changes, New Possibilities: China’s Latest Patent Law Amendments

2021 ◽  
Author(s):  
Ronald Yu ◽  
Kenneth Yip
Keyword(s):  
Public Services ◽  
New Technology ◽  
Patent Law ◽  
Patent System ◽  
Pharmaceutical Companies

Abstract New amendments to China’s Patent Law feature open licensing which should encourage the use of patents, and promote the more rapid broadcast and dissemination of new technology. They should also offer the possibility of greater transactional visibility, transparency and traceability which has important ramifications for IP valuation and reporting in IPOs, annual and other reports. Other provisions underscore China’s efforts to improve its patent system by introducing new protections for patent holders, mechanisms to reduce abuse, provisions to strengthen patent-related public services and promote the use of patents. There are also a number of changes that should interest pharmaceutical companies, patent litigants, patent holders and app developers.

4. Introduction to European Patent Law

2019 ◽  
pp. 99-119
Author(s):  
Justine Pila ◽  
Paul L.C. Torremans
Keyword(s):  
Patent Protection ◽  
Patent Law ◽  
Patent System ◽  
European Patent ◽  
European Law ◽  
European Patent Convention ◽  
Unified Patent Court ◽  
Unitary Patent

This chapter introduces the European law of patents and related rights with a discussion of the nature of patents as limited-term monopoly rights granted in respect of new, inventive, and industrially applicable inventions and the routes to obtaining patent protection in Europe. It then considers the existing European patent system established by the European Patent Convention 1973/2000, including its basis in state-based conceptions of IP territoriality, and the challenges presented to that system by globalization and developing technology. And finally, it discusses the long-standing pursuit of a unitary patent and unified patent court for Europe, including the reasons for each, and the features of the proposed Unitary Patent Package of 2012/2013.

scholarly journals Correction: Patents, pills and politics: the Australia-United States Free Trade Agreement and the Pharmaceutical Benefits Scheme

2004 ◽  
Vol 28 (3) ◽  
pp. 381
Author(s):  
Ken Harvey
Keyword(s):  
United States ◽  
Developing Countries ◽  
Free Trade ◽  
Free Trade Agreement ◽  
Patent Protection ◽  
Trade Agreement ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
History Of ◽  
Pharmaceutical Benefits Scheme

Re: ?Patents, pills and politics: the Australia? United States Free Trade Agreement and the Pharmaceutical Benefits Scheme?, by Ken Harvey, (Aust Health Rev 2004, vol. 28, no. 2, pp. 218-226). Under the heading ?A brief history of patent law relevant to pharmaceuticals?, in the second paragraph, the second sentence was: ?Before TRIPS, many developing countries provided no patent protection on pharmaceutical products, or they recognised patents on products but not process?. The corrected version should be ?. . .process but not products?.

24. Rights related to patents

2018 ◽  
Author(s):  
L. Bently ◽  
B. Sherman ◽  
D. Gangjee ◽  
P. Johnson
Keyword(s):  
Patent Protection ◽  
Patent Law ◽  
Regulatory Approval ◽  
Patent Infringement ◽  
Plant Variety ◽  
System P ◽  
The Uk

This chapter is concerned with two areas of law that are related to, but not traditionally part of, patent law: the system of plant variety that gives protection to the breeders of new plant varieties, and supplementary protection certificates that extend the length of patent protection in the UK and are meant to compensate owners for time lost while awaiting regulatory approval to market their patented products. The procedure to be followed when applying for plant variety rights is also discussed, along with issues of ownership, duration, and patent infringement. The chapter concludes by considering exceptions and compulsory licences relating to the plant variety system.

10. Patent regimes and the application process

2019 ◽  
pp. 364-400
Author(s):  
Abbe Brown ◽  
Smita Kheria ◽  
Jane Cornwell ◽  
Marta Iljadica
Keyword(s):  
Patent Protection ◽  
International Agreements ◽  
Patent Law ◽  
European Patent ◽  
Application Process ◽  
Future Evolution ◽  
The Uk ◽  
Changes Over Time ◽  
Examination Process ◽  
Over Time

This chapter assesses the rationales and justifications commonly seen for and against patents, which inform all aspects of patent law. Against this backdrop, the chapter explains the architecture and procedures of contemporary patent systems as they operate in the UK, within the European patent system, and through international agreements, instruments, and procedures. The chapter considers the patent registration process in the UK. Unlike copyright—and like registered trade marks and registered designs—patent protection is a registered right, granted by an intellectual property office following an application and examination process. The chapter also reviews changes over time and areas of particular debate and possible future evolution.

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