Novartis International has won FDA approval for a biosimilar of an existing drug. The drug, a copy of Amgen’s Neupogen, is designed to boost white blood cell counts in certain patients. An abbreviated FDA approval pathway for biologic medical products that share most of their properties with an existing, approved biologic product was created by […]
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Entries by PatentAttorney.com
In Helferich Patent Licensing v. NYTimes and JCPenney, the Federal Circuit restricted the scope of the patent exhaustion doctrine by holding that the doctrine only protects “authorized acquirers” of a device against patent infringement claims instead of putting the device itself outside the scope of patent protection. In Helferich, the Helferich company owned patents on […]
In Pacing Tech v. Garmin, the Federal Circuit construed the claim preamble of an independent claim of a patent to be limiting for the dependent claims as well. The preamble of the claim, which referred to “a repetitive motion pacing system,” was found to be limiting because it “served as an antecedent basis” for limitations […]
In Teva Pharmaceuticals v. Sandoz, the U.S. Supreme Court adopted standards for claim construction that are more deferential to the claim constructions formulated by trial courts. Previously, the constructions of patent claims made by lower courts would be reviewed de novo in their entirety by the Federal Circuit and other appellate courts, which created a […]
In Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc. 14-1114 – 2015-01-13, the Federal Circuit upheld a district court decision finding willful infringement. To find willful infringement, “a patentee must show by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.” In […]