Category Archives: Public Policy

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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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PTAB Ruling Proves Medical Innovation Under Attack

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There’s more evidence today that the IPR system needs to be fixed. PTAB ruled on Friday that under current rules, hedge fund managers are free to manipulate the system by shorting drug company stocks and then challenging their patents. Here’s what the panel said: “Profit is at the heart of nearly every patent and nearly every inter partes review. As such, an economic motive for challenging a patent claim does not itself raise abuse of Read More >

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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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102 Organizations Urge Congress to Maintain a Strong Patent System and Protect Innovation

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A diverse group of more than 100 national and state-based advocacy organizations have united to urge Congress to preserve important patent protections that incentivize biopharmaceutical research necessary to innovate and develop new cures and treatments for serious diseases. In a letter sent to the Hill this week, these patient advocates asked Congress to amend the Innovation Act (H.R. 9) to preserve the highly-detailed and sophisticated systems designed by Hatch-Waxman and BPCIA and avoid weakening the Read More >

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