Category Archives: Public Policy

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What They’re Saying about the Medicare Part B Demo

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Back in March, CMS’s Center for Medicare and Medicaid Innovation (CMMI) proposed a sweeping demonstration project that would dramatically lower the rate at which many providers are reimbursed for medicines administered under Medicare Part B. Medicare Part B  covers drugs administered in a provider setting, and patients served under the program include those fighting diseases such as cancer, multiple sclerosis, macular degeneration, rheumatoid arthritis and primary immunodeficiency diseases – those most in need of the Read More >

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NORD President: Congress must act now to help 15 million sick children

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Writing in The Hill, National Organization for Rare Disorders (NORD) President and CEO Peter Saltonstall called upon Congress to act swiftly to maintain an important program encouraging research into treatments for rare pediatric diseases. The Rare Pediatric Priority Review Voucher (PRV) Program is set to expire at the end of the month, unless Congress reauthorizes it. Saltonstall writes: Developing therapies for people with rare diseases is incredibly difficult. Rare diseases are scientifically and medically complex, Read More >

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PTAB, IPRs and Uncertainty in the Patent System

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The topic of inter partes reviews (IPRs) has dominated conversation in patent circles for the last several years (see our archive for some of our past articles on the subject). As uncertainty grows in the biopharma community about IPR procedures and the future of innovation, BIO will make IPRs a major topic of discussion at our upcoming IP and Diagnostics Symposium (BIO IPDX) as well as BIO’s IP Counsels Committee Meeting in November. An administrative Read More >

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BIO’s Statement Regarding SCOTUS Patent Review Decision

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BIO issued the following statement following yesterday’s Supreme Court decision in the case of Cuozzo Speed Technologies, LLC v. Lee. “Regrettably, today the Supreme Court missed an opportunity in the case of Cuozzo Speed Technologies, LLC v. Lee to reign in the United States Patent and Trademark Office’s Patent Trial and Appeal Board‘s invalidation of many patents under looser standards than would apply in federal court. “While we are disappointed in the Court’s ruling, it Read More >

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Will the PTAB Be A Roadblock for Biotech? Stories from Sessions at BIO 2016

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We’re at the beginning of day 3 here at BIO 2016, and that means we’ve already had a full day of high quality programming for our Intellectual Property track! Let’s take a look at one of yesterday’s most popular sessions. Will the PTAB be a Road Block for Biotech? Lessons Learned from the First Three Years of Inter-Partes Review and Future Prospects Moderated by William Kubetin, Managing Editor at Bloomberg BNA Panelists: Kevin Noonan, Partner at McDonnell, Boehnen, Read More >

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