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Gilead Sciences Sued For Failing To Bring A Follow-On Version Of Truvada To Market Sooner., Christopher M. Holman
Gilead Sciences Sued For Failing To Bring A Follow-On Version Of Truvada To Market Sooner., Christopher M. Holman
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In 2012, the United States Food and Drug Administration (FDA) approved Truvada as the first drug for use in the prevention of HIV infection in healthy people who are at high risk of acquiring HIV through sexual activity. Developed and marketed by Gilead Sciences, Inc., Truvada is a fixed-dose combination of two antiretroviral compounds, tenofovir disoproxil fumarate (TDF) and emtricitabine. The World Health Organization (WHO) has identified both TDF and the combination of TDF and emtricitabine found in Truvada as “essential medicines.” In 2015, Gilead began marketing products containing tenofovir alafenamide fumarate (TAF) as a safer and more effective alternative …
Congress Considering Legislation Aimed At Increasing Competition In Pharmaceuticals, Christopher M. Holman
Congress Considering Legislation Aimed At Increasing Competition In Pharmaceuticals, Christopher M. Holman
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The U.S. Congress is currently considering a large number of bills that would attempt to bring down drug prices by a variety or means, including some aimed at reform of certain patent-related aspects of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This Article begins with a brief overview some key provisions of Hatch-Waxman and the BPCIA that have been targeted by these legislative initiatives. It then turns to a discussion of some specific bills currently being considered by Congress that would seek to promote greater competition in the market for pharmaceuticals by amendments …
Helsinn V. Teva: Lingering Ambiguity After The U.S. Supreme Court Holds The Aia Did Not Alter The On-Sale Bar To Patentability, Christopher M. Holman
Helsinn V. Teva: Lingering Ambiguity After The U.S. Supreme Court Holds The Aia Did Not Alter The On-Sale Bar To Patentability, Christopher M. Holman
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The American Innovation Act of 2011 (AIA) retained §102 of the pre-AIA Patent Act’s “in public use” and “on-sale” bars to patentability, but introduced an additional “or otherwise available to the public” category of prior art. Federal Circuit precedent pre-dating the AIA has held that, as a general matter, a sale or offer for sale can create an on-sale bar to patentability even if the sale or offer for sale is “secret” and does not render the invention available to the public. Some believed that the AIA’s introduction of the phrase “or otherwise available to the public” altered the meaning …