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Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman
Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman
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A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …
Branded Drug Companies Are Successfully Asserting The Doctrine Of Equivalents In Hatch-Waxman Litigation, Christopher M. Holman
Branded Drug Companies Are Successfully Asserting The Doctrine Of Equivalents In Hatch-Waxman Litigation, Christopher M. Holman
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This article reports the results of a study analyzing every Federal Circuit decision the author could find dating back to 2005 that applies the doctrine equivalents (DOE) in the context of pharmaceutical patent litigation, and in particular infringement lawsuits brought against Abbreviated New Drug Application (ANDA) applicants by branded drug companies under the Hatch-Waxman Act. The results of this study show that pharmaceutical innovators were prevailing against would-be generic competitors under the DOE both prior to, and subsequent to, a 2007 article by Professors Lemley and Allison describing the demise of the doctrine equivalents, but that patentees’ success rate has …
Government Involvement In Pharmaceutical Development Can Come Back To Haunt A Drug Company, Christopher M. Holman
Government Involvement In Pharmaceutical Development Can Come Back To Haunt A Drug Company, Christopher M. Holman
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The U.S. government has long played a significant role in pharmaceutical innovation, often through the funding of research, or collaboration in clinical trials. Unfortunately, government involvement can come at a cost for innovative drug companies, leading to allegations that taxpayers are being required to “pay twice” for the resulting drugs, particularly when the drug is considered essential and is offered at a price that is seen as “unreasonably” high. This Article discusses two aspects of ongoing efforts to leverage government involvement in pharmaceutical development and commercialization as a means for regulating of drug prices. The first is the assertion that …
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, …