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Need for Patent Reform May be Overblown

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Amid the cacophony of calls for patent reform legislation, mounting evidence demonstrates patent trolling may be on the wane. As we reported earlier this month, the number of new patent cases filed in federal court has dropped by an astonishing 40 percent as compared to this time last year. A new data analysis by Unified Patents data shows more signs that patent troll suits are in decline.

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Milwaukee Journal Sentinel Story on Use of Surrogate Measures

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Earlier this week, John Fauber of the Milwaukee Journal Sentinel wrote an article on measures used to determine whether new medicines for serious and life-threatening diseases should reach patients. Fauber seem(s) to suggest that the use of surrogate measures – such as tumor shrinkage – do not provide evidence of drug efficacy. The story fails to present a balanced view of the complex benefit-risk assessments that the FDA must carefully consider when reviewing applications for Read More >

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BIO Submits Joint Supplemental Comments on the USPTO March Guidance

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Last week BIO, alongside a number of member companies and private individuals, submitted supplemental comments to the U.S. Patent and Trademark Office concerning their March 2014 Guidance on patent subject matter eligibility. In July, BIO and international bio-industry associations had submitted comments to the USPTO expressing concern about the Guidance, and its impact on the patent eligibility of biotechnology inventions. Since July, USPTO staff has indicated a final revision to the Guidance would be released Read More >

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Richard Pops: A Greater Patient Voice in Drug Development

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In the October issue of MedNous, Alkermes’ CEO Richard Pops writes about the move toward increased engagement with patients in the development, review and delivery of new medicines, as well as the challenges and opportunities associated with access and reimbursement. Pops asserts that patients must organize to share data that can be used in regulatory decision-making. Furthermore, he writes that this input must be integrated through the process – from the early stages of development Read More >

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Patent Cases Down by 40% in 2014

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The number of new patent cases filed in federal court has dropped by an astonishing 40 percent as compared to this time last year. This trend has some questioning whether Congressional patent reform is even necessary. Some legal experts are attributing this drop to the fallout from the U.S. Supreme Court’s recent Alice vs. CLS Bank decision. In June, SCOTUS ruled in the case of Alice that certain subject matter which had been patentable (a computer-implemented Read More >

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