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
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Patent Law ◽  
French Patent

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.

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.

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.

On Innovative Activity in Pharmaceutical Industry

Vestnik NSUEM ◽  
2021 ◽  
pp. 168-174
Author(s):  
M. I. Berkovich ◽  
A. Yu. Volin
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clustering Algorithm ◽  
Innovative Activity ◽  
Innovation Activity ◽  
Drug Products ◽  
Pharmaceutical Manufacturers

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.

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.

Clinical trials and the origins of pharmaceutical fraud: Parke, Davis & Company, virtue epistemology, and the history of the fundamental antagonism

2020 ◽  
Vol 58 (4) ◽  
pp. 533-558
Author(s):  
Joseph M. Gabriel ◽  
Bennett Holman
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Virtue Epistemology ◽  
Medical Science ◽  
Ethical Framework ◽  
Late Nineteenth Century ◽  
Laboratory Science ◽  
Epistemic Virtues ◽  
History Of ◽  
Origin Point

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.

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