Do Current Incentive Models for Biologicals and Pharmaceuticals (patent term extensions, data and market exclusivities), Pediatrics and Orphan Drugs Deliver on the Promise in Return for Which They are Granted, and Do We Need Other Incentives for Those and Other Drugs such as Antibiotics?
Panel
Panel 1: IP and the Future of Medicine
Moderator
George Randels, Professor of Religious Studies, University of the Pacific
Description
The life sciences sector is one of the most regulated in the world, and innovation requires in a fair amount of cases huge investments. That also means that for life science companies, an effective term of protection from competition is seen as indispensable for the continuation of their business model. To that effect, the life science industry cannot only avail itself of patent protection and patent term extensions, but it has also a rather extensive range of rewards and exclusivities at its disposal (paediatric extension, market exclusivity, data exclusivity, orphan drug designation and related market exclusivity if a marketing authorization is obtained, reduced fees for regulatory processes, variety of systems of tax benefits, etc, to name only the most common ones), more so than any other sector of technology. We see that the importance of some of these incentives, in particular data and market exclusivity, has grown rapidly, and they are today a crucial tool in any product lifecycle strategy.
The question is now whether some of these incentives, which are granted with a specific innovation goal in mind, are now in fact leading to the innovation in those areas where it was supposed to be promised, and/or whether the existence of those incentives becomes part of the mix of possibilities to optimize profits. Research has shown that at least for some of these incentives, there is no conclusive evidence that they have led to the expected results. It has at the same been established that some of these incentives have become a useful tool in profit optimization for blockbuster drugs, whilst the intended goal of the incentives has played a less than prominent role.
It seems appropriate to develop a more critical approach to the plethora of systems, and preserve and improve what works, and change what does not provide the expected effects.
Location
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
Do Current Incentive Models for Biologicals and Pharmaceuticals (patent term extensions, data and market exclusivities), Pediatrics and Orphan Drugs Deliver on the Promise in Return for Which They are Granted, and Do We Need Other Incentives for Those and Other Drugs such as Antibiotics?
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
The life sciences sector is one of the most regulated in the world, and innovation requires in a fair amount of cases huge investments. That also means that for life science companies, an effective term of protection from competition is seen as indispensable for the continuation of their business model. To that effect, the life science industry cannot only avail itself of patent protection and patent term extensions, but it has also a rather extensive range of rewards and exclusivities at its disposal (paediatric extension, market exclusivity, data exclusivity, orphan drug designation and related market exclusivity if a marketing authorization is obtained, reduced fees for regulatory processes, variety of systems of tax benefits, etc, to name only the most common ones), more so than any other sector of technology. We see that the importance of some of these incentives, in particular data and market exclusivity, has grown rapidly, and they are today a crucial tool in any product lifecycle strategy.
The question is now whether some of these incentives, which are granted with a specific innovation goal in mind, are now in fact leading to the innovation in those areas where it was supposed to be promised, and/or whether the existence of those incentives becomes part of the mix of possibilities to optimize profits. Research has shown that at least for some of these incentives, there is no conclusive evidence that they have led to the expected results. It has at the same been established that some of these incentives have become a useful tool in profit optimization for blockbuster drugs, whilst the intended goal of the incentives has played a less than prominent role.
It seems appropriate to develop a more critical approach to the plethora of systems, and preserve and improve what works, and change what does not provide the expected effects.
Speaker Bio
Dr. Sven J.R. Bostyn (LLB, Lic. Jur., LLM law, PhD law) is Associate Professor of Biomedical Innovation Law at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL http://cebil.dk), Faculty of Law, University of Copenhagen. He also lectures at the Institute for Information Law (IVIR) of the University of Amsterdam. He is also a regular guest professor at CEIPI in Strasbourg. He is specialized in all areas of IP law, with special emphasis on patent law relating to pharmaceuticals, biotechnology, medical devices, software, Artificial Intelligence and SPC’s. Sven is one of the most prominent authorities in Europe in the area of patent law. He is also specialised in regulatory exclusivities (data and market exclusivity, orphan drug designation etc.), and researches more generally also innovation incentivising mechanisms. He has written extensively on most areas of patent law, and apart from those subjects already mentioned, he has also published in the field of plant patent protection, plant variety rights, software related inventions, European and international harmonization of patent law and the Unitary Patent system. Sven has also been in private practice for the last 14 years where he advised and advises clients on most aspects of patent law, competition law, licensing and regulatory exclusivities. He also acted and acts as an expert witness in court cases.
He was member of a Scientific Advisory Committee at the Dutch Royal Academy of Sciences (Gene Patents Committee) and was from 2013-2016 the Chair of the Expert Committee at the European Commission on the development and implications of patent law in the field of biotechnology and genetic engineering, after having been a member of and Rapporteur at an earlier European Commission Expert Group (between 2003 and 2005). Besides the European Commission, he has also advised both the Belgian and Dutch governments on policy regarding patentability of biotechnological and pharmaceutical inventions. He was recently one of the lead researchers in a study commissioned by the Dutch ministries of Health and Economic Affairs and Climate regarding protection mechanisms for pharmaceuticals (SPC’s, data and market exclusivity, paediatric extensions, orphan drug designations and competition law issues relating to pharmaceuticals).
Sven is the single author of more than 60 scientific publications in the aforementioned areas, and is a regular speaker on international conferences, where he speaks on a wide variety of topics, including IP protection in life sciences, pharma patents, SPC’s, regulatory exclusivities in life science, IP issues relating to software and artificial intelligence, patent protection for plants and plant variety rights systems.