Knowledge of a newly characterized antigen for patenting a genus of its cognate antibodies is not quite enough, according to Amgen Inc. v. Sanofi (Fed. Cir. 2017). The “newly characterized antigen” test is opined to be inappropriate in determining whether a patent application for an antibody satisfies the written description requirement. Although several pharmaceutical companies concurred with Amgen and voiced strong concerns about the “narrow and inflexible rule” created by the Federal Circuit, Amgen’s petition for certiorari to the Supreme Court to take up the issue of written description was denied in early January, 2019.
The United States Patent and Trademark Office (USPTO) issued a memorandum adopting Amgen as the law on written description as it applies to antibodies and pointed out that 35 U.S.C. § 112(a) requires adequate written description of the antibody itself.
Even in light of Amgen and the USPTO memorandum, successful prosecution of patent applications directed to antibodies and therapeutic methods of using antibodies can still be achieved. Applicants are reminded that:
The particular nuances of each invention need to be considered on a case-by-case basis against the evolving laws in each jurisdiction of interest when formulating and revisiting one’s strategy for antibody-related patent protection.
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