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Full-Text Articles in Law
Congress Should Decline Ill-Advised Legislative Proposals Aimed At Evergreening Of Pharmaceutical Patent Protection, Christopher M. Holman
Congress Should Decline Ill-Advised Legislative Proposals Aimed At Evergreening Of Pharmaceutical Patent Protection, Christopher M. Holman
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There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, …
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 …
Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman
Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman
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The patent eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, principles of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon a pronounced expansion in its definition of patent eligible subject matter, particularly with respect to software and business method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics from the public and private sectors arguing that the threshold for patent eligibility needs to be raised in order to ensure that patents fulfill their constitutional objective of encouraging innovation …