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Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery Inside an Enigma”
July 22, 2015 | Alert | By Thomas Wintner
On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No. 2015-1499.
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Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101
June 24, 2015 | Alert | By Terri Shieh-Newton
On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting paternally-inherited cell-free DNA (“cffDNA”) in maternal plasma or serum were not directed to patent eligible subject matter, and, therefore, were invalid.
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Supreme Court Upholds Brulotte Rule Prohibiting Post-Expiration Patent Royalties
June 23, 2015 | Alert | By Bruce Sokler, Sandra Badin, Rich Gervase
On June 22, 2015, the Supreme Court issued its decision in Kimble v. Marvel Entertainment, LLC, upholding the rule, first announced in Brulotte v. Thys Co., 379 U. S. 29 (1964), that an agreement allowing a patent owner to collect royalty payments after a patent’s expiration is unlawful per se.
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Second Circuit Holds a Hard Switch Between Drugs Is an Unlawful Product Hop Under Section 2
June 4, 2015 | Alert | By Bruce Sokler
On May 22, 2015, in a much-watched case, the Second Circuit upheld a preliminary injunction against Actavis PLC and its wholly owned subsidiary, Forest Laboratories, LLC (collectively “Actavis” or “Forest”), finding that Actavis’s “hard switch” strategy to launch an extended-release version of its blockbuster Alzheimer’s therapy and delist the immediate-release version would likely violate Section 2 of the Sherman Act.
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