Federal Circuit Trumped By Supreme Court On Stay Of Mandate In Gilenya

October 3, 2022

Just two days after the Federal Circuit denied a stay of its mandate in Novartis v. HEC Pharm Co., Ltd., the Supreme Court granted a stay of the mandate pending a further order of the Court and requiring HEC to file a response to the Novartis stay request.

Novartis’ petition raises issues with the Federal Circuit which go beyond the issues in this case. One issue is the Federal Circuit’s failure to follow it own precedent regarding written description. The Federal Circuit and its predecessor have a string decisions where written description is determined by what the application teaches one skilled in the art. An haec verba description is not required merely that one skilled in the art would understand from the written description that the inventor had possession of the invention. Instead, the Federal Circuit adopted a standard it was clarity to the court which mattered and refused to consider what was implicit in the disclosure at odds with Marconi Wireless Tel. Co. of Am. v. United States, 320 U.S. 1, 34 (1943) where the Court held that in prosecution before the patent office one could amend claims to make what was implicit explicit.  The Federal Circuit ignored the language of 35 USC §112 which requires both written description and enablement is determined by reference to “any person skilled in the art.”

Novartis also pointed out that “although the Federal Circuit is to achieve“desirable uniformity” in cases involving patent law, Markman, 517 U.S. at 390, the decision in this case only increases the substantial uncertainty that already existed regarding written description. As commentators have explained, “[p]roper application of the written description doctrine is challenging” because “the Federal Circuit’s development of the law surrounding the written-description requirement has been turbulent” and “the contours of the legal test for written description are ever-evolving.” Aaron B. Rabinowitz, Ending the Invalidity Shell Game: Stabilizing the Application of the Written Description Requirement in Patent Litigation, 12 Minn. J.L. Sci. & Tech. 127, 148 (2011). Because “predictability and stability are of prime importance” in matters affecting “property rights,” Landgraf v. USI Film Prods., 511 U.S. 244, 271 (1994),[1]” coupled with Marconi the Court will grant certiorari.

On the same day the Court granted the stay of the mandate it considered the writ of certiorari in Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 21-1566 (filed June 13, 2022), where issue of the need to “show possession of the invention” is at issue as here. The difference is this case is one where the unrebutted evidence shows “possession” of the invention. It is possible that the Court could combine Juno and this case to resolve the mess the Federal Circuit has created.

[1] Novartis petition at page 24.