Category Archives: Public Policy

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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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Ebola Highlights Importance of Vaccine Development in Protecting Global Health

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The current Ebola crisis shows how government regulators and research institutions, global health organizations, and biopharmaceutical research companies can work collaboratively and efficiently to speed the development of novel vaccines and therapeutics in response to an urgent global health problem. Yet just as importantly, it underscores the need to move innovation forward before a crisis breaks out in order to prevent illness and suffering, and save the lives of countless people around the world. Vaccines Read More >

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Center for Medicine in the Public Interest Challenges Accuracy of 60 Minutes Cancer Story

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This week, the Center for Medicine in the Public Interest issued a press release criticizing CBS’ “60 Minutes” segment on cancer treatment prices as not just distorted but ‘dead wrong.’ “Featuring physicians that argue that treatment prices are too high does not change the fact that the cost of cancer drugs are about 12 percent of what health insurers spend on cancer or that new cancer drugs actually save health insurers money. Yet insurers are Read More >

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