Data protection timing disputes for biologics pharmaceutical products and TPP

An article in the New York Times (July 30, 2015) titled “Patent Protection for Drugs puts Pressure on US in Trade Talks” (http://www.nytimes.com/2015/07/31/business/international/pacific-trade-deal-drugs-patent-protection.html?_r=0) describes a conflict between Trans-Pacific Partnership (TPP)  countries regarding the duration that data collected during development of biologic medicines is protected. The US has set it at 12 years, while Australia has set it at 5 years. The timing of this data protection is intended to increase the costs for generic manufacturers to repeat these trials before launch. The conflict thus pitches intellectual property protection and costs, but does not involve a discussion of patent protection duration. Should the benefits of the $28 trillion in trade under TPP be incentive for the US to decrease protection time to 7 years from 12 ? Will the US pharmaceutical industry, which has the bulk of the medicines, 3372 out of the 5600 in development across TPP countries, suffer the most and if so, how should incentives for development be protected ? How should the demands from patients in TPP countries for cheaper drug costs be balanced against industry demands ? How will the rest of the global supply chain for biosimilars from non TPP countries offer an alternative to keep costs manageable ?

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About aviyer2010

Professor
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