As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written description and enablement defenses. Amgen has asked the full court to reconsider the panel’s decision, which vacated the district court’s judgement of invalidity for lack of written description and enablement. As discussed previously, Amgen asserted two primary grounds for rehearing. First, Amgen argued that the panel improperly abrogated the Federal Circuit’s “newly characterized antigen” rule, which holds that written description of an antibody genus claim can be satisfied by describing the target antigen rather than the structure of all antibodies in the genus. Second, Amgen argued that the panel erred in allowing defendants to rely on evidence dated after the patent’s priority date in support of their defenses.
On December 20, Bristol Myers Squibb, Bavarian Nordic, and Enzo Biochem submitted an amicus brief as “innovator biopharmaceutical companies that research targeted treatments for human diseases.” According to the brief, the amici “fear that the Panel’s decisions on 35 U.S.C. § 112 will result in major harm to further innovation in the burgeoning field of antibody therapeutics” and argue that “[e]n banc review is necessary to ensure adequate patent protection for innovators.”
Amici addressed the two grounds raised in Amgen’s petition. First, they argue that the panel “all but cast aside” the newly characterized antigen rule, as set forth in Noelle v. v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), and express concern that “undermining Noelle is incorrect as matter of both science and law.” In particular, they assert that the newly characterized antigen rule is “based on a sound understanding of antibody science,” and that only an en banc court could overturn Noelle. Second, amici argue that long-settled case law establishes that the adequacy of a patent’s disclosures for satisfying the written description and enablement requirements must be judged based on the state of the art as of the priority date, without considering “after-arising embodiments.” They state that “amici have long relied on this settled case law to protect their pharmaceutical inventions,” including during prosecution and enforcement of patents, and that any change to this law also needs full consideration of the en banc court.
Finally, the amici argue that the panel’s decision as a whole would have adverse practical consequences because it would “profoundly burden innovators” by forcing them to “channel their valuable time and investment away from patients and onto patents.” They assert that the panel decision would require that, to obtain genus protection with “meaningful scope” for antibodies to newly characterized antigens, innovators would have to provide an “exhaustive list of sequences that bind the antigen,” forcing them to “carry out unnecessary multiple actual reductions to practice ahead of filing” patent applications. This, in turn, they say, would increase research and development costs and “divert resources away from developing new therapies and toward using routine methods to generate multiple actual reductions to practice simply for patent purposes” while still failing to prevent “an ingenious challenger from later producing additional, unexemplified embodiments.”
Stay tuned to Big Molecule Watch for further coverage of this case.