Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved biologic drug constitutes an “artificial act of infringement” for which the biologic’s patent owner may file suit.[1]  In the recent AbbVie Inc. v. Alvotech hf.[2] decision, the district court…

The Hatch-Waxman Act allows the FDA to permit a generic version of a branded product, which is partially patent protected, to come to market if the generic manufacturer “carves out” the patent-protected indication from its label. The scope of protection from a finding of induced infringement afforded to generic manufacturers by this “skinny label” provision…

28 U.S.C § 1498 (a) (Governmental Use) The United States (U.S.) does not have any provisions for a compulsory license. The closest provision that it does have to the licensing of medicines and vaccines is what is called March-in rights. March-in rights allow the U.S. government to grant licenses to patented inventions provided the development…

In Omni MedSci, Inc. v. Apple Inc., ___ F.4th ___, Nos. 2020-1715, -1716 (Fed. Cir. Aug. 2, 2021), the U.S. Court of Appeals for the Federal Circuit held that the University of Michigan’s technology transfer bylaws did not constitute an automatic assignment of a professor’s patent rights. This decision has important implications for the drafting…

Patent asserted against Apple and Samsung merely claimed the abstract idea of taking two pictures and using those pictures to enhance each other in some way. A district court’s dismissal of infringement actions accusing Apple and Samsung of infringing a patent for digital cameras with multiple lenses was upheld by a divided Federal Circuit panel,…

Plaintiff’s arguments before the district court were often objectively unreasonable or frivolous; the frivolous nature of his appeal also warranted sanctions against plaintiff and his counsel of appellate fees and double costs. An individual who asserted that he was the co-inventor of a patent directed to a method of “reverse online dating” must pay the…

Biologic drugs, many of which are antibodies, represent an increasing share of the pharmaceutical market. In recent years, numerous broad functional patent claims directed at therapeutic antibodies have come under attack for failing to satisfy the written description and enablement requirements. The proper scope of these requirements has divided the biopharmaceutical industry. In its latest…

St. Jude Medical failed to show that challenged claims of patent owned by Snyders had been anticipated by other patents, nor did it prove that a particular combination demonstrated obviousness. Claims of a patent directed to an artificial heart valve manufactured by Snyders Heart Valve LLC and a system for inserting the valve were not…

PTAB did not err in its claim construction or obviousness findings in two IPRs filed by Westinghouse that challenged two Siemens patents. Substantial evidence supported two Patent Trial and Appeal Board decisions following inter partes review of two related patents directed toward methods and systems for automatically activating a train warning device, including a horn,…