Patenting of Biosimilars and Its Impact on Global Pharmaceutical Markets
Panel
Panel 12: Biologics, Biosimilars, and Data
Moderator
David Collum, Associate Clinical Professor and Chair, Entrepreneurial Program, University of the Pacific, Thomas J. Long School of Pharmacy and Health Sciences
Description
A biosimilar is purely a biological medical product. It is an identical copy of an original product manufactured by different companies. Biosimilars can be manufactured while the original products’ patent expires. Research and development in all the fields of technology, including pharmaceutical areas are taking place at an impressive pace today. Patent law intends to strike a balance between the promotion of technological innovation and the dissemination of its fruits. Accessibility and availability of drugs are the main objectives of public health policy in almost all countries. Reasonable prices and innovation are two fundamental goals of health policies. On one hand, governments have the task of attracting Foreign Direct Investment in the pharmaceutical sector and on the other hand, they have to control drug prices, quality and availability. It is a well-recognised fact that many modern medicines, largely discovered and developed by the pharmaceutical industry are in general unaffordable to the majority of patients in economically backward, developing countries. Since they constitute the around 75 per cent of the world’s population, it is a matter of great concern for the future of healthcare itself, if for the majority of the world’s population, access to medicines, which are patent protected, is denied. The questions have raised that whether the patenting of biosimilars is an alternative for all other inventions regarding pharmaceutical drugs. It is pertinent to note here that emerging markets including Mexico, Brazil and India developed their own biosimilar approval pathways. In this paper, the patenting of biosimilars in the world including India and to explore the impact on global pharmaceutical markets has been discussed in detail.
Location
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
Patenting of Biosimilars and Its Impact on Global Pharmaceutical Markets
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
A biosimilar is purely a biological medical product. It is an identical copy of an original product manufactured by different companies. Biosimilars can be manufactured while the original products’ patent expires. Research and development in all the fields of technology, including pharmaceutical areas are taking place at an impressive pace today. Patent law intends to strike a balance between the promotion of technological innovation and the dissemination of its fruits. Accessibility and availability of drugs are the main objectives of public health policy in almost all countries. Reasonable prices and innovation are two fundamental goals of health policies. On one hand, governments have the task of attracting Foreign Direct Investment in the pharmaceutical sector and on the other hand, they have to control drug prices, quality and availability. It is a well-recognised fact that many modern medicines, largely discovered and developed by the pharmaceutical industry are in general unaffordable to the majority of patients in economically backward, developing countries. Since they constitute the around 75 per cent of the world’s population, it is a matter of great concern for the future of healthcare itself, if for the majority of the world’s population, access to medicines, which are patent protected, is denied. The questions have raised that whether the patenting of biosimilars is an alternative for all other inventions regarding pharmaceutical drugs. It is pertinent to note here that emerging markets including Mexico, Brazil and India developed their own biosimilar approval pathways. In this paper, the patenting of biosimilars in the world including India and to explore the impact on global pharmaceutical markets has been discussed in detail.
Speaker Bio
Dr.P.R.L.Rajavenkatesan hails from State of Tamil Nadu, India. He did Bachelor of Law (B.L) from Government Law College,Thiruchirappalli during 2003-2006 and LL.M (Intellectual Property Rights) from School of Legal Studies, Cochin University of Science and Technology from 2006-2008. He was awarded Ph.D. in the topic entitled “A Study on Public Use of Private Rights: With Special Reference to Intellectual Property Rights in India” in 2012 from Department of Legal Studies, University of Madras, Chennai. He was a teaching cum research fellow then Senior Research Fellow (Ministry of Human Resource Development, India) in Intellectual Property Rights Chair in Department of Legal Studies, University of Madras. He has cleared both National Eligibility Test and State Eligibility Test. He started his career as a Guest Faculty for Post Graduate Department of Intellectual Property Rights in the Tamil Nadu Dr.Ambedkar Law University, Chennai and thereafter Assistant Professor (III) at School of Law, SASTRA University, Thanjavur, then joined as Assistant Professor (Senior) in VIT School of Law VIT Chennai Campus in the year 2015 and co-ordinating Centre for Research on Intellectual Property Laws and also Research co-ordinator of VIT School of Law. His areas of expertise are Intellectual Property Rights, Environmental Law, Criminal Law and Media Law. He is guiding One Ph.D Candidate in VIT School of Law and external member of Doctoral Committee for Ph.D Candidates in other Institutions. He authored 8 Books (4+4 Edited) and published around 46 Research papers and delivered a good number of Lectures on Intellectual Property Rights, Criminal Law, Environmental Law etc.,. In addition to this, he received 3 research awards from VIT University for exemplary commitment, dedication and motivation towards research publications in the year of 2015, 2016 and 2017. He has presented papers in more than 77 International/National Conferences and Seminars and Participated/Presented Paper in 12 Workshops. Moreover, He attended 7 Orientation/Faculty Development Programme and 2 refreshers course. He has organized 5 National Conferences/Seminars, 2 Workshops and 1 International Conference as Coordinator/Convenor and Chief Editors/Associate Editors of 3 International Journals such as European Journal of Biotechnology and Biosciences, International Journal of Law and International Journal of Law and Social Sciences. He acted as a Judge in 9 Internationa/National Moot Court Competitions.