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Amgen Inc. v. Sanofi, Aventisub LLC

Post-Priority Date Reference May Be Used to Interrogate Sufficiency of Written Description’s Disclosure of Representative Species

Amgen Inc. v. Sanofi, Aventisub LLC2017 U.S. App. LEXIS 19416 (Fed. Cir. Oct. 5, 2017) (PROST, Taranto, Hughes) (D. Del.: Robinson) (3 of 5 stars)

Fed Cir part-affirms, part-reverses judgment that Amgen’s patents were not invalid, and entry of a permanent injunction against sale of Sanofi’s “Praluent” product. Amgen’s patents relate to antibodies that reduce bad cholesterol.

Written description/enablement: The district court erred by excluding certain evidence tendered by Sanofi, bearing on whether Amgen’s patent disclosed a representative number of the claimed species. Though post-patent evidence is typically not germane to evaluating written description, it may be used to evaluate the sufficiency of the species disclosure. Hogan, 559 F.2d 585 (C.C.P.A. 1977), is not contrary because in that case, the post-priority-date evidence was being used for a different purpose (i.e., to show a change in the state of the art relevant to evaluating enablement of the genus). The Fed Cir remands for a new trial on written description and enablement (“[f]or many of the same reasons”). The district court also erred by instructing the jury that disclosure of a “newly characterized antigen” could satisfy the written description requirement for a claim to an antibody. The opinion discusses how prior precedent on this issue (including Enzo Biochem, 323 F.3d 956 (Fed. Cir. 2002); Noelle, 355 F.3d 1343 (Fed. Cir. 2004); and Centocor, 636 F.3d 1341 (Fed. Cir. 2011)) did not endorse such a rule. The district court did not err, however, in denying Sanofi’s motion for JMOL of no written description and no enablement, as the record was incomplete without the post-patent evidence discussed above.

Obviousness: The district court correctly granted JMOL of nonobviousness. The opinion discusses how the court was correct to exclude Sanofi’s alleged prior art. The references were published PCT applications claiming priority to provisionals that predated the priority date of Amgen’s patents. The district court correctly determined that Sanofi had not shown that the provisional applications provided written description support for the claims of the PCT applications, and on that basis concluded that the PCT applications were not prior art. Dynamic Drinkware, 800 F.3d 1375 (Fed. Cir. 2015), was not contrary, as it described how, for a non-provisional application to claim priority to a provisional application for prior art purposes, the provisional’s specification must support the claims in the non-provisional application.

Permanent injunction: Because the written description/enablement judgment is vacated, the permanent injunction is also vacated. The opinion notes that the district court’s permanent injunction analysis failed to properly apply the public interest factor from eBay, 547 U.S. 388 (2006). The district court concluded that a permanent injunction would disserve the public interest by reducing consumer choice in drugs, but entered the injunction anyway. A district court may not enter a permanent injunction if a plaintiff fails to show that the public interest would not be disserved. Further, the district court erred in reasoning that reduction in consumer choice, without more, was sufficient to disserve the public interest. “Under such an approach, courts could never enjoin a drug[.]” Op. at 23.

KEYWORDS: WRITTEN DESCRIPTION; REPRESENTATIVE SPECIES; ENABLEMENT; OBVIOUSNESS (NO); PERMANENT INJUNCTION