Tag Archives: congress

BIO on CNBC: IPR System Weakens Medical Innovation

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Last night Ron Cohen, M.D., CEO of Acorda Therapeutics and BIO’s board chair, appeared on CNBC’s Fast Money where he discussed our industries concerns’ with the U.S. Patent and Trademark Office’s patent challenge system known as Inter Partes Review (IPR). Dr. Cohen concisely explained this complicated and rapidly evolving issue and made clear why Congress must quickly address abuses to the IPR system within current Patent reform legislation. Regrettably, this system that was designed by Read More >

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Here are the Facts about the IPR Kill Rate

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FiercePhrma recently ran an article repeating a dubious analysis of the crisis caused by the rapidly increasing number of biopharma related inter partes reviews (IPR) currently within the United States Patent and Trademark Office (PTO). It is troubling that in a single breath Ronny Gal both dismissed the biopharmaceutical industry’s concerns with the PTO’s IPR process and acknowledged that limited data prevents any firm conclusions about the potential impact of IPR on biotech innovation. If Read More >

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Reflecting on July 2015: “The Ag Biotech Debate Was Front and Center”

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Agri-Pulse recently published an op-ed titled “The Biotechnology Riddle” by Marshall Matz which outlined how ag biotech was “front and center” in both executive and congressional affairs this past July. He guides readers through the actions taken by legislative officials to promote the benefits of biotechnology and scientific literacy. First on July 2nd the White House Office of Science and Technology Policy and the Office of U.S. Trade Representative issued an Executive Memorandum to “Modernize Read More >

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Seventy Nine House Members Express Concern with H.R. 9

Vote No on HR 9

House leaders made the decision earlier this month to remove patent reform legislation from the schedule for the remaining days before the August recess. While a vote is expected to occur sometime in September, House Majority Leader Kevin McCarthy made the decision to review and address many of the concerns that have been voiced by an array of industries that require the value of dependable and enforceable patents. In the words of Representative McCarthy, “I Read More >

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Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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