Amgen Inc. et al. v. Sanofi, Regeneron et al. (Feb. 25, 2019 Update)

Docket No. 2017-1480
PROST, TARANTO, HUGHES
October 5, 2017

Update (Feb. 25, 2019): DC jury verdict (Case No. 1:14-cv-01317-RGA) found ‘165 claims 7 and 15 (“binds to at least D238” or “V380”, respectively) enabled but lacking written description; ‘165 claims 19 and 29 (“binds to at least two of the following residues…”) enabled and described; and ‘741 claim 7 (“wherein the epitope is a functional epitope”) enabled and described.

Brief summary: DC’s exclusion of post-priority-date evidence relating to whether a representative number of species were described in the patents’ specifications reversed and remanded; grant of permanent injunction against Sanofi therefore vacated.

Summary: Sanofi appealed DC final judgment that Amgen’s US 8,829,165 and 8,859,741 relating “to antibodies that help reduce…LDL-C, or ‘bad cholesterol’” (inhibitors of PCSK9, a protein that destroys liver cell receptors that extract LDL-C from blood; Amgen’s evolocumab (RepathaTM)) are not invalid and granting a permanent injunction (PI) enjoining sales of Praluent® alirocumab. Sanofi argued the DC improperly excluded post-fiilng date evidence regarding written description and enablement, improperly instructed the jury on WD, improperly denied its motion for JMOLs, and improperly issued the PI. Representative ‘165 claim 1 claims a mAb that “binds to at least one” of several PCSK9 amino acids and “blocks binding of PCSK9 to LDL[-]R.” The FC panel first considered the DC’s exclusion of post-filing date evidence regarding WD, explaining that while WD “is judged based on the state of the art as of the priority date” but that “evidence of species that fall within the claimed genus but are not disclosed by the patent…is likely to postdate the priority date” and “might well anticipate the claimed genus” (In re Koller, CCPA 1980 (“post-priority-date evidence may be relevant only if it illuminates the state of the art at the filing date”); In re Hogan, CCPA 1977 (dismissing post-priority-date evidence to show non-enablement due to a change in the state of the art); Ariad, FC 2010; AbbVie, FC 2014 (“The Centocor antibody…was a basis for the unrepresentativeness ruling without regard to whether it postdated the patent’s priority date.”)) And it found that Sanofi’s evidence was proferred “to argue that the claimed genus fails to disclose a representative number of species” and should not have been precluded, therefore reversing and remanding the DC decision for a new trial on WD. The FC panel similarly reversed and remanded the DC decision on enablement, finding Sanofi “purportedly sought to introduce post-priority-date evidence showing that [Amgen] engaged in lengthy and potentially undue experimentation to enable the full scope of the claims” (White Consol. Ind., FC 1983). Regarding the jury instructions, Sanofi argued the DC improperly instructed the jury, based on Enzo (FC 2002 (functionally-defined nucleic acid probes)) and the PTO’s WD Guidelines (2000), that disclosing an antigen can satisfy the [WD] requirement to a claim for an antibody. The FC panel acknowledged that “according to Enzo, as long an applicant has disclosed a ‘fully characterized antigen’, either by its structure [etc.]…the applicant can then claim an antibody by binding affinity to that described antigen”, but also explained that in view of Centocor (FC 2011 (disclosure of TNF-alpha protein found not to support WD of antibodies against the same)) “the underlying science [must] establish[] that a finding of ‘make and use’ (routine or conventional production) actually does equate to the required description of” antibodies (“[B]oth in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies…the ‘newly characterized antigen’ test flouts the basic legal principles of the [WD] requirement.”) It therefore found the DC’s jury instructions to be improper. The FC panel agreed with the DC’s refusal to grant JMOL to Sanofi on obviousness because Sanofi did not show the provisional applications of the § 102(e)(1) prior art PCTs provided WD support for the mAbs claimed therein (Dynamic Drinkware, FC 2015; New Railhead, FC 2002). The PI injunction against Sanofi, which was previously “stayed pending resolution of this appeal”, was vacated due to the above reasons, but the FC panel also noted that the DC improperly analyzed the PI by concluding that issuing a PI “would disserve the public interest…in clear violation of eBay” (US 2006) and because “eliminating a choice of drugs is not, by itself, sufficient to disserve the public interest” (WBIC, FC 2016).

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