Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more
The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more
Addressing for the first time how patent term adjustments (PTAs) interact with obviousness-type double patenting (ODP), the US Court of Appeals for the Federal Circuit concluded that when members of a patent family have...more
Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more
In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic...more