Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. With respect to granted cases, a reply brief was filed in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case addressing the enablement requirement. With respect to petitions, a new petition was filed with the Court in a veterans case and another in a pro se case; the government waived its right to respond in a pro se case; a brief in opposition was filed in a patent case; and a reply brief was filed in a trade case. Here are the details.
Amgen filed its reply brief on the merits in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case raising questions related to the enablement requirement. In its responsive brief, Sanofi argued that “the statutory text [35 U.S.C. § 112], this Court’s cases, and a whole line of Federal Circuit precedents guard against what Amgen has done here: claim a lot and disclose a little, such that skilled artisans . . . must engage in undue experimentation.” According to Sanofi, moreover, “[t]here is no special rule for functional or genus claims, but the more that is claimed, the more that must be enabled.” It argued that Amgen “attack[s] a straw man, adding its own language to a passage in the decision below to claim that the Federal Circuit adopted a novel enablement standard.” This assertion, Sanofi contended, “egregiously mischaracterizes the decision, which neither endorses nor relies on any such cumulative-effort standard—and in fact, expressly rejects it.” It maintained that, “[d]espite Amgen’s sky-is-falling lamentations, innovation has not been harmed by the decision below.” Finally, Sanofi argued, the “flaws in Amgen’s specification are fundamental and would fail any viable test for enablement.”
Now, in reply, Amgen argues that the Federal Circuit’s opinion “plainly turns on the effort required to identify and make all or nearly all the antibodies within Amgen’s patent claims.” It maintains that, while Sanofi “downplays the “‘cumulative-effort standard as a ‘straw man,’” it was Sanofi that “pressed that standard below.” Amgen contends that the Section 112(a) enablement requirement is “a practical test, focused on the ability of skilled artisans to do something concrete—to make the invention and to use it.” It argues that, in contrast to Sanofi’s “specific undisclosed embodiment” test, Section 112(a) “imposes no requirement that every ‘specific embodiment’ one can hypothesize be ‘predictably produced.’” In response to the government’s contention that Amgen’s patents are not enabled because they cover more antibodies than the “exemplars” in the specification, Amgen argues “the government ignores the rule that it is ‘not necessary to describe in the specification all possible forms in which the claimed principle may be reduced to practice.’” Finally, Amgen maintains, “[n]o one defends the Federal Circuit’s reach-the-full scope test for enablement of genus claims as consistent with the patent ‘bargain.’”
One new petition was filed in Thornton v. McDonough, a veterans case.
Another new petition was filed in McCormick v. McDonough, a pro se case.
Waiver of Right to Respond
Brief in Opposition
HEC Pharm Co. filed its brief in opposition in Novartis Pharmaceuticals Corporation v. HEC Pharm Co., a patent case raising questions related to appellate procedure and patent law’s written description requirement. The petitioner presented the following questions for review:
- “Whether 28 U.S.C. § 46 and principles of sound judicial administration preclude a court of appeals from adding a new judge to form a new panel and redecide a case after an original three-judge panel has already decided the case and entered its judgment.”
- “Whether 35 U.S.C. § 112 should be interpreted consistent with its plain text as requiring that a patent specification contain a ‘written description of the invention’ in a form that need only be understandable to ‘any person skilled in the art,’ or whether the court of appeals properly read in a heightened requirement that allows it to deem the specification inadequate on de novo review and displaces the perspective of a person skilled in the art.”
In its brief in opposition to the petition, HEC argues that “the Federal Circuit procedure at issue here violates no statute, rule, precedent, or uniformly accepted notion of fairness.” According to HEC, moreover, “Nocartis’s assertion of a circuit split is frivolous.” It argues “Novartis falsely describes a ‘uniform’ practice of other circuits and, regardless, permissible variations in procedure do not constitute a circuit split.” Finally, HEC contends, the Federal Circuit added no new requirement to Section 112 enablement, and was “clear that it was not ‘creat[ing] a heightened standard.’”
USP Holdings filed its reply brief in USP Holdings, Inc. v. United States, a trade case. In its brief in opposition to the petition, the government argued that the Secretary’s relevant report “is not subject to [Administrative Procedure Act] review because the report is not final agency action.” According to the government, moreover, “even if the report could be reviewed for compliance with the Constitution and federal statutes, it could not be reviewed for arbitrariness.” Anyway, the government maintained that “decisions about national security are ‘confided by our Constitution to the political branches.’” And, it contended, “the Secretarial finding that petitioners challenge was not arbitrary and capricious.” The government also argued that, “[b]ecause the Secretary’s report is not final agency action and is not subject to arbitrary-and-capricious review in the first place, this case presents no occasion for reaching any subsidiary questions of statutory interpretation.”
Now, in response, USP contends the Federal Circuit “properly rejected” the government’s argument that the Commerce decision did not constitute final agency action. USP argues, however, that the Commerce decision at issue “granted new authority to the President to adjust imports, and therefore the decision was not ‘purely advisory’ and had ‘direct and appreciable legal consequences.’” According to USP, therefore, the Federal Circuit “committed error by deciding that the Secretary’s decision is not subject to arbitrary or capricious standard of review.” Moreover, “the question of the proper standard of review under the APA is properly presented in this case.” In sum, USP argues, “[b]ecause the Secretary’s decision is not ‘purely advisory,’ it is and must be subject to judicial review, and the standard of review under the APA must be adhered to.”