United States: Will 2023 Be The Year Of § 112 At The Supreme Court?

The Supreme Court recently agreed to review the enablement standard for genus claims,¹ the first time the Court has considered 35 U.S.C. § 112 since evaluating the standard for indefiniteness in 2014.² This is especially notable considering the Court granted cert. contrary to the recommendation of the Solicitor General and also denied two additional opportunities to review section 112 this term.³,⁴ Of further interest, Juno, petitioner in one of the denied cert. petitions, is seeking rehearing, arguing that its case warrants consideration in view of the question presented in Amgen v. Sanofi.

Amgen v. Sanofi

Amgen first brought suit against Sanofi in 2014, alleging Sanofi's hyperlipidemia product Praluent® (alirocumab) infringed two Amgen patents that each claim a genus of antibodies by their function of binding a particular antigen.⁵ Sanofi stipulated to infringement but alleged invalidity. After two jury trials finding no invalidity,⁶ two Federal Circuit appeals finding invalidity,⁷ two denials of petitions for rehearing en banc,⁸ a 2019 denial of petition for cert.,⁹ and a recommendation by the Solicitor General to deny cert.,¹⁰ the Supreme Court granted cert. to address the question:

The Solicitor General recommended cert. be denied.¹¹ Principally, the government explained that where a patentee purports to invent an entire genus, it must enable the entire genus. The government further argued the case is not a good vehicle to review the enablement standard because the degree of experimentation is just one Wands factor, the Federal Circuit enablement test that Amgen did not dispute during trial, and that Amgen does not provide an alternative test. On the other side, multiple amici wrote in support of Amgen's petition.¹²

Juno Therapeutics, Inc. v. Kite Pharma

Juno Therapeutics (now part of Bristol Myers Squibb) first brought suit against Kite Pharma (now part of Gilead Sciences) in 2017, alleging Kite's CAR-T cell therapy Yescarta® (axicabtagene ciloleucel) infringes a Juno patent. A jury found no patent invalidity, Kite infringed, and awarded Juno $752 Million in damages.¹³ The District Court then increased damages to $1.2 Billion for willful infringement and denied Kite's motion for JMOL for patent invalidity.¹⁴ Kite appealed, arguing the Juno patent lacked written description because the asserted claims broadly claimed a genus of recombinant antibodies, but the specification disclosed only two species without guidance as to how a POSA could determine which recombinant antibodies would bind the functional target.¹⁵ The Federal Circuit agreed, vacating the $1.2 Billion judgment.¹⁶

The Supreme Court denied Juno's petition for writ of certiorari just three days after it granted Amgen's petition for certiorari.¹⁷ The issue Juno raised was:

Is the adequacy of the "written description of the invention" to be measured by the statutory standard of "in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same," or is it to be evaluated under the Federal Circuit's test, which demands that the "written description of the invention" demonstrate the inventor's "possession" of "the full scope of the claimed invention," including all "known and unknown" variations of each component?

Juno Petition for Rehearing

Following the denial of cert. for Juno v. Kite¹⁸ and the grant of cert. for Amgen v. Sanofi,¹⁹ Juno petitioned the Supreme Court for rehearing, arguing that reconsideration of Juno v. Kite is warranted in view of Amgen v. Sanofi.²⁰ Juno points out that the "two cases involve the very same sentence of the very same statute, 35 U.S.C. § 112(a). Both ask whether the 'make and use' language from the statute provides the proper statutory test and both ask whether the Federal Circuit's addition of a 'full scope' requirement is [] appropriate."²¹ Juno further asserts "[the issues presented are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of {Juno]."²² Although the Federal Circuit decided Amgen under a theory of non-enablement and Juno under a theory of inadequate written description, Juno alleges "[t]hese purportedly distinct standards derive from the exact same statutory sentence of § 112(a) whose meaning is now under review in Amgen, and, as the substantial overlap in the arguments and authority demonstrates, are plainly related to each other."²³

Bottom Line

Amgen v. Sanofi has already had a profound impact on the application of section 112, even before Supreme Court review. After the first Amgen Federal Circuit appeal, the Court held "disclosing an antigen [alone] does not satisfy the written description requirement for a claim to an antibody."²⁴ This prompted the USPTO to end the decade old "antibody exception" to written description.²⁵ Now the Supreme Court is poised to decide the future of the enablement standard of section 112, and if it grants Juno's petition for rehearing, the written description standard as well. Of course, the Court could still reverse course and decide neither case, as occurred in Lab. Corp. v. Metabolite Labs., Inc., where it granted cert. to address § 101 against the recommendation of Solicitor General but eventually dismissed certiorari "as improvidently granted."²⁶

Footnotes

1. See Amgen Inc. v. Sanofi, No. 21-757, 2022 WL 16703751 (Nov. 4, 2022).

2. See Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) (clarifying the standard for indefiniteness).

3. See Brief for the United States as Amicus Curiae, Amgen Inc. v. Sanofi, 2022 WL 16703751 (Nov. 4, 2022) (recommending denial of Amgen's petition for cert., explaining, inter alia, "this case would be a poor vehicle for considering such a challenge").

4. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 21-1566, 2022 WL 16726060 (Nov. 7, 2022) (denying cert. for review of the standard for written description); see also Biogen Int'l GmbH v. Mylan Pharm. Inc., No. 21-1567, 2022 WL 4652058 (Oct. 3, 2022) (denying cert. for review of the standard for written description).

5. Amgen separately owns patents claiming the sequence of its competing Repatha® (evolocumab) product which were not part of this dispute.

6. See Amgen Inc. v. Sanofi, No. 14-1317-SLR, ECF No. 304 (D. Del. Mar. 16, 2016); Amgen Inc. v. Sanofi, No. 14-1317-SLR, ECF No. 818 (D. Del. Feb. 26, 2019).

7. See Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) (reversing and remanding denial of post-trial motion for judgment as a matter of law for patent invalidity and alternative motion for new trial); Amgen Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021) (affirming post-trial judgment as a matter of law order for patent non-enablement).

8. See Amgen Inc. v. Sanofi, No. 17-1480, ECF No. 178 (Fed. Cir. Feb. 23, 2018); Amgen Inc. v. Sanofi, 850 Fed. Appx. 794 (Fed. Cir. 2021).

9. See Amgen Inc. v. Sanofi, 139 S. Ct. 787 (2019) (denying cert. for review of the standard for written description).

10. Supra note 3.

11. Id.

12. See, e.g., Brief for Association of University Technology Managers, Inc., et al. as Amicus Curiae, Amgen Inc. v. Sanofi, 2022 WL 16703751 (Nov. 4, 2022); Brief for GlaxoSmithKline plc as Amicus Curiae, Amgen Inc. v. Sanofi, 2022 WL 16703751 (Nov. 4, 2022); Brief for Intellectual Property Professors as Amicus Curiae, Amgen Inc. v. Sanofi, 2022 WL 16703751 (Nov. 4, 2022).

13. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 17-7639, ECF No. 593 (C.D. Cal. Dec. 13, 2019).

14. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 17-7639, ECF No. 727 (C.D. Cal. Dec. 13, 2019).

15. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Cir. 2021).

16. Id.

17. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 21-1566, 2022 WL 16726060 (Nov. 7, 2022); Amgen Inc. v. Sanofi, No. 21-757, 2022 WL 16703751 (Nov. 4, 2022).

18. Supra note 4.

19. Supra note 1.

20. Pet. for Reh'g, Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 21-1566 (Nov. 23, 2022), ECF No. 19.

21. Id. at 2.

22. Id.

23. Id. at 6.

24. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378 (Fed. Cir. 2017) ("the 'newly characterized antigen' test flouts basic legal principles of the written description requirement. Section 112 requires a 'written description of the invention.'").

25. See March 26, 2008, USPTO Written Description Training Materials, Example 13 ("Considering the facts . . . one of skill in the art would have recognized that the disclosure of the adequately described antigen X put the applicant in possession of antibodies which bind to antigen X."); Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials (Feb. 22, 2018) ("In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.").

26. See 548 U.S. 124, 125–26 (2006).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.