Tag Archives: TPP

Biotech Policy Outlook at #BIF15: 21st Century Cures, IPR, TPP, and PDUFA VI

BIO Investor Forum

To even the most casual observer, 2015 has been a big year in the biotech industry, particularly in Congress and in other venues wherein public policies that affect the sector take shape. Given the importance of the policy environment in determining how successful companies in our industry can be at delivering new cures and treatments to patients – and a return to the investors who finance their activities – we decided that a close look Read More >

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WSJ: U.S. Concessions on TPP Means Fewer Cures

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Today’s Wall Street Journal editorial, Pacific Trade Brinksmanship, does an outstanding job highlighting the important role that patent protection plays in promoting innovation and fostering medical breakthroughs. The article highlights why adequate protections for biologics must be a centerpiece of a successful Trans-Pacific Partnership (TPP). One of the issues being negotiated is the right amount of patent protection for innovative medicines. As the editorial notes, the U.S. currently wants “biologic protections to last a dozen Read More >

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New Report Suggests RDP Does Not Increase Healthcare Expenditures

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A new paper by the Geneva Network suggests that increasing the period of regulatory data protection (RDP) for biologic medicines would not increase expenditures for medicines. As countries navigate the final negotiations in the Trans-Pacific Partnership, the U.S. and Japan have advocated for increased regulatory data protection for biologic medicines by other TPP countries. In the U.S. biologics enjoy 12 years of data exclusivity; the only TPP countries, aside from the U.S, offering more than Read More >

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Patently Biotech’s Top Articles of 2014

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It’s been a whirlwind year for IP. From international trade negotiations, to revised PTO guidelines and dropping patent case stats, intellectual property is on the brain and in the news. Here are Patently Biotech’s top blog posts of 2014: TPP and IP: The Economic Benefits of a Pacific Trade Agreement Should the USPTO allow the patenting of living organisms? Gene Patent Questions Remain: USPTO Issues Examiner Guidelines Stopped at the Threshold: A New Study Reports 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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