Event Session
Strategic Considerations for Generics and Brands in Light of GSK v. Teva
October 26, 2022 @ 3:00 PM EST
3:00 PM ET
October 26, 2022
Strategic Considerations for Generics and Brands in Light of GSK v. Teva
Under the Hatch-Waxman Act, so-called “Section VIII carveout” also known as a skinny label, are intended to give generic drug companies protection from patent infringement liability as long as the uses the ANDA applicant lists are not covered by the innovator’s patents. GSK v. Teva arguably altered the skinny label landscape and unquestionably illustrates that the stakes could not be higher, even as the Supreme Court weighs whether to grant cert. GSK v. Teva, its status and development, and its implications should be understood by both generic and innovator companies. The panel will discuss the case, its impact, subsequent cases, and industry considerations.
Under the Hatch-Waxman Act, so-called “Section VIII carveout” also known as a skinny label, are intended to give generic drug companies protection from patent infringement liability as long as the uses the ANDA applicant lists are not covered by the innovator’s patents. GSK v. Teva arguably altered the skinny label landscape and unquestionably illustrates that the stakes could not be higher, even…
Session Speakers
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