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In Juno V. Kite The Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation In Car T-Cell Therapy, Christopher M. Holman
In Juno V. Kite The Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation In Car T-Cell Therapy, Christopher M. Holman
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Chimeric antigen receptor T-cells (also known as CAR T-cells) are T-cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy. In recent years CAR-T cell therapy has emerged as an important new modality of cancer treatment, particularly for blood-borne cancers like leukemia. As would be expected, important advances in the development of CAR T-cell therapy have been the subject of extensive patenting and licensing activity. Juno v. Kite, a recent decision of the Court of Appeals of the Federal Circuit striking down a foundational CAR T-cell therapy patent, has raised serious questions as to …
The Federal Circuit Continues To Grapple With The Question Of Patent Eligibility For Diagnostic Methods, Christopher M. Holman
The Federal Circuit Continues To Grapple With The Question Of Patent Eligibility For Diagnostic Methods, Christopher M. Holman
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This article considers the current state of affairs at the Federal Circuit with regard to the patent eligibility of diagnostic methods. Diagnostics v. Mayo Collaborative Servs. I then look at all of the decision decisions I could find in which the court strikes down diagnostic method claims as patent ineligible under Mayo v. Prometheus, of which there are quite a few. Finally, I turn to the handful of cases, all decided in 2018 or later, in which the Federal Circuit has upheld the patent eligibility of diagnostic claims, the most significant of which I believe to be Vanda Pharmaceuticals v. …
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 …
In Minerva V. Hologic, The U.S. Supreme Court Reins In The Equitable Doctrine Of Assignor Estoppel, Christopher M. Holman
In Minerva V. Hologic, The U.S. Supreme Court Reins In The Equitable Doctrine Of Assignor Estoppel, Christopher M. Holman
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Assignor estoppel is an equitable remedy that prohibits an assignor of a patent, or one in privity with an assignor, from attacking the validity of that patent when he is sued for infringement by the assignee. On June 29, 2021, the U.S. Supreme Court issued its decision in Minerva v. Hologic, holding that while AE remains a viable doctrine, the Federal Circuit has on many occasions, including the instant case, applied the doctrine in an overly expansive manner, particularly in cases where the patent claims at issue differ substantially from any patent claims that were in existence at the time …