A weekly summary of the precedential patent-related opinions
issued by the Court of Appeals for the Federal Circuit and the
opinions designated precedential or informative by the Patent Trial
and Appeal Board.
GlaxoSmithKline LLC, et al. v. Teva Pharmaceuticals
USA, Inc., Nos. 2018-1976, -2023 (Fed. Cir. (D. Del.)
Aug. 5, 2021). Per curiam opinion before Moore, Newman,
and Prost. Dissenting opinion by Prost.
This case involved a GSK patent for administering a combination
of a drug called "carvedilol" and an ACE inhibitor, a
diuretic, and digoxin. Teva applied for FDA approval of its generic
carvedilol, certifying that GSK's patent was invalid,
unenforceable, or not infringed. GSK then obtained a reissue patent
adding a requirement that the drug combination is administered
"to decrease a risk of mortality caused by congestive heart
failure." The FDA required Teva to amend its original
carvedilol label (i.e., the "partial" label / purported
"skinny" label) to
