In October 2020, as reported in a previous Cooley alert, the US Court of Appeals for the Federal Circuit reinstated a jury’s verdict that Teva infringed GSK’s patented method of using its Coreg drug product, even though...more
The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations....more
Signed into law on December 27, 2020, the Biological Product Patent Transparency Act (42 U.S.C. § 262(k)(9)) requires biological reference product sponsors to provide to the US Food and Drug Administration within 30 days of...more
In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reinstated a jury's verdict that Teva infringed GSK's patented method of using its Coreg® drug product, even though Teva's product was initially...more
10/7/2020
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Teva Pharmaceuticals
On January 20, 2015, the Supreme Court issued a 7-2 decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854, 574 U.S.__ (2015), holding that the Federal Circuit must apply a "clear error" standard when...more