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…

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…

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…

In Immunex Corp. et al. v. Sandoz Inc. et al., the Federal Circuit found that there was no obviousness-type double patenting because there was no “common ownership” of patents under an agreement where Roche retained key rights to the patents-in-suit. Immunex Corp., v. Sandoz Inc., ___ F.3d ___, No. 2020-1037 (Fed. Cir. July 1, 2020)….

In the United States, a judge may increase the damages for patent infringement up to threefold[1] resulting in awards of millions, or even billons, of dollars.  In 2016, the Supreme Court, in Halo Electronics v. Pulse Electronics,[2] rejected the then prevailing objective standard for determining enhanced damages and replaced it with a subjective one requiring,…

For manufacturers of biologics and biosimilars facing potential patent litigation in the U.S., the Biologics Price Competition and Innovation Act (BPCIA) imposes a complex statutory scheme that restricts the timing and control of disputes in federal district court. Biosimilar applicants who find themselves on the receiving end of a potential patent infringement complaint in district…