In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron Pharmaceuticals v. Merus N.V., where the requisite intent to deceive was inferred as a sanction for Regeneron’s “widespread litigation misconduct.” Chief Judge Prost and Judge Wallach agreed such a sanction was permissible, while Judge Newman urged otherwise.
In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court explained that a novel product with unexpected advantageous properties is not obvious just because the process by which it was made might have been.
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.