Tag Archives: data exclusivity

Data Exclusivity Protects Innovators and Assures Investors

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Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time. This protection helps companies secure much-needed venture capital funding, which is the lifeblood of the industry. A failure to include substantial data exclusivity would undermine incentives to invest in biomedical innovation and thus would slow progress in the development of breakthrough therapies to improve the health and lives of patients Read More >

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Strong IP Protection is Critical Component of Trade Agreement

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The next round of discussion on the Trans-Pacific Partnership (TPP) began yesterday in nearby Leesburg, VA.  The TPP currently includes eleven countries (Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, U.S. and Vietnam) and other countries in the region, such as Japan and Korea, may join in the future. The TPP will set an important precedent for global trade rules.  It is described by the U.S. Trade Representative as “an ambitious, 21st-century … Read More >

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Bi-partisan Senate Letter asking for 12 years of Data Protection in TPP

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Senators Hatch and Kerry, along with 35 other Senators, sent a letter to Ambassador Kirk asking for 12 years of regulatory data protection consistent with U.S. law in the Trans Pacific Partnership Agreement. We are united in urging you to propose a strong minimum term of regulatory data protection for biologics consistent with U.S. law. As you are aware, U.S. law provides for a 12-year term of regulatory data protection for biologics and we believe that should serve Read More >

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Data Protection, Trans Pacific Partnership, and the US-Jordan FTA (Post 2 of 2)

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This post is a continuation of a previous post: Data Protection, the Trans Pacific Partnership, and the US-Jordan FTA (Post 1 of 2). 4.  Oxfam criticizes pharmaceutical innovators for not making all of their innovative drugs available in Jordan. Ryan responds: a.  Innovator companies introduced few new drugs before IP reform because local companies were using their know-how and clinical data to get marketing approval and brochures describing the drug’s therapeutic function and side effects Read More >

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Huffington Post: Data Exclusivity: Getting the Balance Right

Huffington Post: Data Exclusivity: Getting the Balance Right      A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be limited somehow (not 50 years) to ensure generics can entire the market and lower costs.    Finally, the author states that lowering the data exclusivity Read More >

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