[Ip-health] Infojustice Roundup – February 15, 2016
mpalmedo at wcl.american.edu
Mon Feb 15 10:58:31 PST 2016
TPP Implementation, and Obama’s 2017 Budget Proposal to Reduce the Period of Biologics Exclusivity in the U.S.
[Mike Palmedo] As readers of this blog are well aware, one of the most controversial issues in the Trans Pacific Partnership was the length of data exclusivity for biologic drugs. The U.S. sought a twelve year period (which would be consistent with current U.S. law) during which competitors would be unable to enter the market to compete with innovator firms unless they duplicated safety and efficacy data to obtain regulatory approval. Other countries sought lesser terms, arguing that long periods of data exclusivity raised the price of biologic medicines by blocking generic competition.... Once again, the [Obama Administration's annual] Budget calls for seven years of exclusivity. Click here for more.<http://infojustice.org/archives/35735>
Lessons for the SADC from the Indian Case of Novartis AG v Union of India
[Lonias Ndlovu] Abstract: …It has been argued by health activists and academics that excessive patenting results in too many patents for minor innovations in medical technology and this in turn leads to higher prices of medicines, thus frustrating SADC citizens' right to access affordable essential medicines. This paper highlights how the legislative inclusion of World Trade Organisation (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities around the requirements for patentability can be effectively used to curb incremental patenting and limit the proliferation of evergreen patents. This is achieved through a critical analysis the 2013 Supreme Court of India case of Novartis AG v Union of India before extracting useful lessons for the SADC. The highlighted lessons will in all likelihood inform the current intellectual law reform projects in most SADC members, including South Africa. Click here for the full paper on SSRN.<http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2729190>
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