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

2002 ◽  
Vol 9 (1) ◽  
pp. 67-71
Author(s):  
M Cousté ◽  
F Jonquères
10.5912/jcb9 ◽  
1969 ◽  
Vol 9 (1) ◽  
Author(s):  
Marina Cousté ◽  
François Jonquères

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.


2018 ◽  
Author(s):  
Antonia Panayi ◽  
◽  
Slavka Baronikova ◽  
Jim Purvis ◽  
Eric Southam ◽  
...  

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar

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.


Author(s):  
Carlo A. Piria ◽  
Carlo A. Piria

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.


Vestnik NSUEM ◽  
2021 ◽  
pp. 168-174
Author(s):  
M. I. Berkovich ◽  
A. Yu. Volin

The article provides with different approaches to the assessment of pharmaceutical manufacturers’ innovation activity. The peculiarities of pharmaceutical industry product that can be characterized as innovative are taken into consideration. Special attention has been given to the pharmaceutical industry peculiarities originating from differentiation of original drug products and generics in the structure of pharmaceutical industry production. Based on these findings the classification of Russian pharmaceutical manufacturers in accordance with their innovation activity extent evaluated by their activity in clinical trials conducting was developed. The classification is based upon k-means clustering algorithm with 5 clusters specified.The small amount of manufacturers involved in clinical trials conducting and some optimistic insights about the original products share were concluded hereafter.


2019 ◽  
pp. 1165-1181
Author(s):  
Naina Singh ◽  
Rajinder Kaur ◽  
Rashmi Aggarwal

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.


2020 ◽  
Vol 58 (4) ◽  
pp. 533-558
Author(s):  
Joseph M. Gabriel ◽  
Bennett Holman

This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical legitimacy. This new framework fundamentally altered the set of epistemic virtues—a phrase we draw from the philosophical field of virtue epistemology—considered necessary to conduct reliable scientific inquiry regarding drugs. In doing so, it also made possible new forms of fraud in which newly emergent epistemic virtues were violated. To make this argument, we focus on the efforts of Francis E. Stewart and George S. Davis of Parke, Davis & Company. Therapeutic reformers within the pharmaceutical industry, such as Stewart and Davis, were an important part of the broader normative and epistemic transformation we describe in that they sought to promote laboratory science and systematized clinical trials toward the twin goals of improving pharmaceutical science and promoting their own commercial interests. Yet, as we suggest, Parke, Davis & Company also serves as an example of a company that violated the very norms that Stewart and Davis helped introduce. We thus seek to describe one possible origin point for the widespread fraudulent practices that now characterize the pharmaceutical industry. We also seek to describe an origin point for why we conceptualize such practices as fraudulent in the first place.


Sign in / Sign up

Export Citation Format

Share Document