On December 20, 2017, Bristol Myers Squibb Company, Bavarian Nordic, and Enzo Biochem, Inc. filed an amicus brief in support of Amgen’s petition for rehearing en banc. We reported previously that on November 6, 2017, Amgen filed a petition for rehearing en banc of a Federal Circuit panel’s decision vacating a permanent injunction against Sanofi and Regeneron’s Praluent® and remanding the appeal to the district court for a new trial on the defendants’ written description and enablement defenses.

As “innovator biopharmaceutical companies that research targeted treatments for human diseases,” amici expressed concern that the panel’s decision alters existing law under 35 U.S.C. §112 such that it “undermines a reasonable scope of patent coverage” and will cause them to lose their previously-held patent protection.[1] Amici requested that the Court vacate the previous panel’s decision and reconsider the issues.

As previously reported, in its petition Amgen asserted two grounds for rehearing. The amicus brief discussed both of these grounds.

Amici argued that the Federal Circuit panel’s undermining of the “newly characterized antigen rule” set out in Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004) is incorrect because the decision is sound and may only be overturned en banc. Although the panel did not outright overrule Noelle, amici argued that its criticisms and dismissal of the decision leads to the conclusion that it did overturn the decision. Amici also argued that the panel erred by viewing the “newly-characterized antigen rule” as an “antibody exception” to the written description requirement.[2] Instead, the rule is based on antibody science where an antibody genus may be described by the antigen’s structure without the need to describe the multiple representative antibody sequences. Amici asserted that to hold “that a person of ordinary skill in the art does not have possession of the genus of antibodies that bind a well-characterized antigen until she has provided detailed sequence information of multiple representative CDS sequences is an unwarranted extrapolation from organic chemistry.”[3]

Amici then asserted that forty years of precedent demonstrates that an analysis using after-arising embodiments to determine validity based on written description is impermissible. They argued that the rule in In re Hogan, 559 F.2d 595 (C.C.P.A. 1977) makes it clear that an inventor cannot be expected to enable embodiments that were unknown as of the priority date. They further argued that they have relied on this precedent and have operated under this presumption when prosecuting and enforcing their patents.

In addition to addressing the two grounds raised in Amgen’s petition, the brief also emphasized that the panel’s decision will have profound impacts on companies in the molecular medicine field. When researchers seek to obtain genus protection for antibodies, they will now face the burden of having to include a list of the sequences that bind to the antigen. This burden in turn will lead to “never-ending pre-filing actual reductions to practice,” a requirement that small businesses and non-profit organizations cannot afford.[4] Amici argue that even larger companies who can afford the costs will be forced to expend time and resources to create actual reductions to practice when those resources could otherwise go towards other development efforts.