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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 …
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 …