Clinical trials in the pharmaceutical industry: The scope of the research exemption under French patent law – clarification is still awaited

10.5912/jcb9 ◽  
1969 ◽  
Vol 9 (1) ◽  
Author(s):  
Marina Cousté ◽  
François Jonquères
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Marketing Authorisation ◽  
Patent Law ◽  
Drug Substance ◽  
Court Decision ◽  
Judicial Interpretation ◽  
French Patent ◽  
Patented Drug ◽  
Patent Rights

This paper discusses a recent French Court decision and its impact on the judicial interpretation of the extent to which pharmaceutical clinical trials may or may not fall within the scope of the exemption provided under French law for infringement of patent rights when conducting unauthorised clinical trials aimed at securing marketing authorisation of a patented drug substance.

Influence of Patent Law on Price of Medicines

2019 ◽  
pp. 1165-1181
Author(s):  
Naina Singh ◽  
Rajinder Kaur ◽  
Rashmi Aggarwal
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Law ◽  
Poor Countries ◽  
Regulatory Policies ◽  
International Policies ◽  
Patent Rights ◽  
The World ◽  
Randomised Controlled ◽  
Developed Nations ◽  
Aids Study

There is a great deal of disparity between the availability and affordability of medicines in least developed, developing and developed nations. Patents are one of the major reasons of this difference. The pharmaceutical industry spends over US$10 billion to fund some 90% of 40,000-80,000 randomised controlled trails being conducted across the world at any given time. A United Nations AIDS study reported that the number of people in poor countries who have access to anti-retroviral medicines remains extremely low; only 30,000 received medication in 2002, out of an estimated 5 million in need. The proposed chapter aims to study effect of patent law on pricing of medicines. The legal and regulatory policies such as TRIPs jointly introduced by various nations to regulate the pricing of patented products will be elaborated in this chapter. Apart from national and international policies, the behaviour of pharmaceutical companies also affect price of patented products. The chapter will also cover various techniques pharmaceutical industry adopt to control price of patented products such as proliferation of me-too drugs, product reformulation, prolonging patent rights, biasing research and large promotional expenditures.

Influence of Patent Law on Price of Medicines

2017 ◽  
pp. 20-40
Author(s):  
Naina Singh ◽  
Rajinder Kaur ◽  
Rashmi Aggarwal
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Law ◽  
Poor Countries ◽  
Regulatory Policies ◽  
International Policies ◽  
Patent Rights ◽  
The World ◽  
Randomised Controlled ◽  
Developed Nations ◽  
Aids Study

There is a great deal of disparity between the availability and affordability of medicines in least developed, developing and developed nations. Patents are one of the major reasons of this difference. The pharmaceutical industry spends over US$10 billion to fund some 90% of 40,000-80,000 randomised controlled trails being conducted across the world at any given time. A United Nations AIDS study reported that the number of people in poor countries who have access to anti-retroviral medicines remains extremely low; only 30,000 received medication in 2002, out of an estimated 5 million in need. The proposed chapter aims to study effect of patent law on pricing of medicines. The legal and regulatory policies such as TRIPs jointly introduced by various nations to regulate the pricing of patented products will be elaborated in this chapter. Apart from national and international policies, the behaviour of pharmaceutical companies also affect price of patented products. The chapter will also cover various techniques pharmaceutical industry adopt to control price of patented products such as proliferation of me-too drugs, product reformulation, prolonging patent rights, biasing research and large promotional expenditures.

Disclosing the results of clinical trials: how is the pharmaceutical industry doing?

2018 ◽  
Author(s):  
Antonia Panayi ◽  
◽  
Slavka Baronikova ◽  
Jim Purvis ◽  
Eric Southam ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry

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.

scholarly journals State Use Provisions for Patent Law, and Expropriations: Some Comparative Law Guidelines for South Africa during the Covid-19 Crisis and Beyond

2020 ◽  
Vol 23 ◽  
pp. 1-35
Author(s):  
Mikhalien Du Bois
Keyword(s):  
South Africa ◽  
State Government ◽  
Patent Law ◽  
The State ◽  
Patent Owner ◽  
Canadian Law ◽  
Patent Rights ◽  
The Republic ◽  
The Government ◽  
Suitable Framework

This article views section 4 of the Patents Act 57 of 1978 against section 25 of the Constitution of the Republic of South Africa, 1996 and Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights of 1994 (hereafter TRIPS). The purpose is to find a suitable framework for the state/government use/utilisation of patented products or processes for public purposes. A comparison is done with the Crown use provisions in United Kingdom, Australian and Canadian law to find a suitable approach to questions relating to remuneration for state use, the prior negotiations requirement set by Article 31 of TRIPS, and the public purposes and exclusive patent rights that would be included under state use. The COVID-19 international pandemic has caused a state of national disaster in South Africa, which is exactly the kind of situation of extreme urgency envisioned by the exception in Article 31 of TRIPS, which permits the state use of patents without requiring prior negotiations with the patent owner. In the battle against COVID-19 and its concomitant fallout, the South African government (and authorised private parties) would be permitted to utilise patent rights without explicit authorisation from the patent owner and without prior negotiations, but subject to the payment of reasonable remuneration by the government and other terms and conditions as agreed upon or as determined by a court. This may include making (manufacturing), using, exercising, and importing patented products (for example, personal protective equipment, pharmaceuticals, ventilators and diagnostic tests) deemed necessary in the fight against COVID-19. Foreign jurisdictions considered in this article indicate that section 4 of the Patents Act 57 of 1978 may certainly benefit from an update to provide detailed guidance on the state use of patented products or processes for public purposes. In the interest of a timeous offensive against the COVID-19 virus, the patent provisions need a speedy update to allow state use compliant with TRIPS and the Constitution of the Republic of South Africa, 1996.

scholarly journals Pelindungan Hak Paten atas Pengetahuan Obat Tradisional Melalui Pasal 26 UU No. 13 Tahun 2016 tentang Paten (Protection of Patent Rights on Traditional Medicine Knowledge Through Article 26 of Law No. 13 of 2016 Concerning Patents)

2019 ◽  
Vol 10 (1) ◽  
pp. 49-65
Author(s):  
Trias Palupi Kurnianingrum
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Traditional Medicine ◽  
Traditional Knowledge ◽  
Intellectual Property Rights ◽  
Trips Agreement ◽  
Patent Law ◽  
Benefit Sharing ◽  
Traditional Medicines ◽  
Patent Rights

Patent as a branch of Intellectual Property Rights (IPR) serves to protect inventions on the field of technology, one of them being medicine. The rise on the number of cases on the theft of genetic resources and traditional knowledge on the field of medicine for commercialization purposes shows that the protection of patent rights on traditional medicine knowledge is still not optimal. This article is the result of a normative juridical research which is supported by an empirical data, examines the protection of patent rights on traditional medicine knowledge and the implementation of Article 26 of Law No. 13 of 2016 on Patents (Patent Law year 2016). In the research results, it was mentioned that even though the TRIPs Agreement did not accommodate the traditional knowledge, the presence of Patent Law year 2016 complemented the Indonesian government's efforts to save the knowledge of traditional medicines from biopiracy and misappropriation. It is necessary to regulate the disclosure obligation in TRIPs agreement and further mechanism regarding benefit sharing and granting access to traditional medicines knowledge. AbstrakPaten merupakan salah satu cabang Hak Kekayaan Intelektual yang berfungsi untuk melindungi invensi di bidang teknologi, salah satunya obat-obatan. Maraknya kasus pencurian sumber daya genetik dan pengetahuan tradisional di bidang obat-obatan untuk tujuan komersialisasi menunjukkan bahwa pelindungan hak paten atas pengetahuan obat tradisional masih belum maksimal. Artikel ini merupakan hasil penelitian yuridis normatif yang didukung dengan data empiris, membahas mengenai pelindungan hak paten atas pengetahuan obat tradisional dan implementasi Pasal 26 Undang-Undang Nomor 13 Tahun 2016 tentang Paten (UU Paten 2016). Di dalam hasil penelitian, disebutkan meskipun Perjanjian Trade-Related Aspects of Intellectual Property Rights (TRIPs) belum mengakomodasi pengetahuan tradisional namun hadirnya UU Paten 2016 melengkapi usaha pemerintah Indonesia dalam menyelamatkan pengetahuan obat tradisional dari biopiracy dan misappropriation. Perlu pengaturan kewajiban disclosure di dalam Perjanjian TRIPs dan mekanisme lebih lanjut mengenai benefit sharing dan pemberian akses atas pengetahuan obat tradisional.

Pharmaceutical Law and Patent Law

2021 ◽  
Vol 3 (2) ◽  
Author(s):  
Carlo A. Piria ◽  
Carlo A. Piria
Keyword(s):  
Clinical Trials ◽  
Medicinal Product ◽  
Legal System ◽  
Active Substance ◽  
Patent Law ◽  
Efficacy And Safety ◽  
Patent Claim ◽  
Laws And Regulations

The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.

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