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…