On the Challenges Facing Patent Pooling in Biotechnology (original) (raw)
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Patent pools and clearinghouses in the life sciences
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The biopharmaceutical industry is slowly absorbing the idea of collaborative patent licensing models. Recently, two patent pools for developing countries have been launched: the Pool for Open Innovation against Neglected Tropical Diseases initiated by GlaxoSmithKline (GSK), which is referred to as the BIO Ventures for Global Health (BVGH) pool, and the Medicines Patent Pool (MPP) initiated by UNITAID. Various organizations have recommended using pools or clearinghouses beyond the humanitarian dimension where many patents are owned by many different actors. As a first attempt, MPEG LA, which administers patent pools in various technology fields, is now setting up a clearinghouse for patents related to molecular diagnostics. These examples as well as the results from an empirical study provide useful insights for the design and administration of future pools and clearinghouses in the life sciences.
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During the last two decades, the genomics revolution has contributed enormously to the development of novel research approaches in the field of biological sciences. We have seen the development of new biotechnological tools capable of modifying organisms in order to perform specific tasks designing and assembling novel biological components. All these scientific and biotechnological innovations present also a substantial challenge for the law and especially for intellectual property rights. In particular – as a consequence of relevant patent case law in the United States and Europe affecting precision medicine – the debate on the possible future of biotech patents gained increasing momentum. Considering this multifaceted scenario, the purpose of this article is to analyse the impact of various judicial decisions with respect to patents subject-matter eligibility and the prosecution of biotech-related patent applications.
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The conventional wisdom is that the formation of patent pools is welfare enhancing when patents are complementary, since the pool avoids a double-marginalization problem associated with independent licensing. This conventional wisdom relies on the effects that pooling has on downstream prices. However, it does not account for the potentially significant role of the effect of pooling on downstream innovation. The focus of this paper is on downstream product development and commercialization on the basis of perfectly complementary patents. We consider development technologies that entail spillovers between rivals, and assume that final demand products are imperfect substitutes. When pool formation facilitates information sharing and either increases spillovers in development or decreases the degree of product differentiation, patent pools can adversely affect welfare by reducing the incentives towards product development and product market competition-even with perfectly complementary patents. The analysis modifies and even negates the conventional wisdom for some settings and suggests why patent pools are uncommon in science-based industries such as biotech and pharmaceuticals that are characterized by tacit knowledge and incomplete patents.
PICMET '07 - 2007 Portland International Conference on Management of Engineering & Technology, 2007
As research in biology transitions from the chemical, to the biological paradigm, and now to the information-based (systems biology) paradigm, researchers should be aware of how such a transition is likely to interact with the existing patent regime. Such interactions critically affect investments in research and decisions relating to when to patent and what to patent. Practicing researchers both in the biological sciences and other scientific disciplines are increasingly facing the need to develop research and exploitation strategies in domains that are dynamic and complex. The traditional research addressing patent thickets and patent pools offers insufficient guidance with respect to new biological knowledge structures and their accompanying challenges.