October 28, 2021

Volume XI, Number 301

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Federal Circuit Agrees to Reconsider Ruling in GSK v. Teva Drug Patent Case

A Federal Circuit panel on Tuesday vacated its earlier finding that Teva induced infringement of U.S. Patent No. RE40,000, GSK’s patent covering its drug, Coreg®, and set a new round of oral argument for February 23.  Back in October, the Court in a 2-1 decision found Teva liable for induced infringement, even though Teva’s original label did not include the indication covered by the ’000 Patent.  In its ruling, the Court took issue with Teva’s marketing materials stating that its generic product is an AB rated generic of Coreg tablets without specific reference to any indication.  Following the decision, generic drug manufacturers and other interest groups asked the Court to reconsider, arguing that the ruling would impede the availability of low-cost generic drugs to reach the market and would effectively nullify the purpose of the Section viii statement, which allows a generic company to “carve out” any reference to a patented indication from its product’s labeling.

Argument during February’s rehearing will be limited to whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011, or during the period when the ’000 Patent reissued to when the FDA ordered Teva to amend its label to conform with the approved Coreg® labeling.  Thus, the order implies that the evidence at issue will be limited to Teva’s promotional and marketing materials, i.e., evidence other than Teva’s label.

The case is GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020).

Copyright © 2021, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XI, Number 41
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About this Author

Evan T. Sumner Intellectual Property Attorney Sheppard Mullin San Diego, CA
Associate

Evan Sumner is an associate in the Intellectual Property Practice Group in the firm's San Diego (Del Mar) office.

Areas of Practice

Evan focuses his practice on patent litigation, trade secret misappropriation, and intellectual property licensing in the areas of pharmaceuticals, biologics, and medical devices.

Evan is experienced in Hatch-Waxman litigation, and leverages his technical background in pharmacology to effectively represent pharmaceutical companies in complex ANDA cases.

In addition to his litigation experience, Evan is also...

858.876.3521
Jesse Salen, Intellectual Property Legal Specialist, Sheppard Mullin
Associate

Jesse Salen is an associate in the Intellectual Property Practice Group in the firm's Del Mar office. 

Areas of Practice

Mr. Salen is an intellectual property attorney and focuses his practice on both intellectual property litigation and patent prosecution in the areas of healthcare information technology, medical software, medical devices, optics, nanotechnology, computer devices, and data storage.

Mr. Salen brings with him 16 years of non-legal business and technology experience in both the healthcare and data storage industries. He was Chief...

858.720.8964
Bradley Graveline, Patent Lawyer, Sheppard Mullin, commercial matters
Partner

Brad Graveline is a partner in the Intellectual Property and Litigation Practice Groups in the firm's Chicago office. 

Areas of Practice

Mr. Graveline has more than 20 years of experience litigating patent infringement cases, trademark disputes and other commercial matters. His patent infringement experience involves a variety of technologies, including pharmaceuticals, medical devices, nutrition supplements, biologics and wireless communications. He has particular expertise in Hatch-Waxman litigation and has represented pharmaceutical companies in over...

312-499-6316
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