I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same Humira patent, four of which are pending and awaiting institution decisions. Coherus’s aggressive use of PTAB proceedings to challenge Humira patents shows that biosimilar applicants may be able to eliminate at least some patent disputes without participating in the patent dance of the Biologics Price Competition and Innovation Act (BPCIA).
The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a certain dose or combination of ingredients, or methods using the products. The decisions were rendered in the context of a motion to dismiss filed by defendant HBS International Corp. in Natural Alternatives International, Inc. v. Allmax Nutrition, Inc., and underscore the growing threat of current patent eligibility jurisprudence to pharmaceutical and biotechnology patents.
In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the reference product sponsor. Still, the Court directed the Federal Circuit to revisit Amgen’s state law claims to determine whether such conduct is “unlawful” under California’s unfair competition laws and/or whether the Biologics Price Competition and Innovation Act (BPCIA) preempts any remedies available under state law. Here, we consider how the Federal Circuit may address these issues.
The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized medicine patents. The court affirmed the invalidity of claims related to a blood test for atherosclerotic cardiovascular disease, and agreed with the district court that diagnostic company True Health was not liable for contributory or induced infringement of claims directed to treating patients diagnosed by the blood test. Continue reading this entry
On June 12, 2017, the Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc. (No. 15-1039), deciding that 42 U.S.C. § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application, and that 42 U.S.C. §262(l)(8)(A) permits a biosimilar applicant to provide 180-days premarketing notice “either before or after receiving FDA approval.” Although the Court left open the possibility that California state law might provide another remedy for Sandoz’s decision not to share its biosimilar application with Amgen and engage in the biosimilar patent dance, it seems unlikely that the Federal Circuit will find both that Sandoz’s decision was “unlawful” and that any additional state law remedies are not preempted by the Biologics Price Competition and Innovation Act (BPCIA).