During the week of March 18, 2019, the Patent Trial and Appeal Board (“the Board”) issued the following decision in TC 1600 instituting a post-grant review:

Hybrigenics SA v. Forma Therapeutics, Inc., No. PGR2018-00098 (Decision Granting Institution of Post-Grant Review Entered March 20, 2019). The Board instituted a post-grant review (“PGR”) sought by Hybrigenics SA (“Hybrigenics”) against U.S. Patent No. 9,840,491 (“the ’491 patent”) owned by Forma Therapeutics, Inc. (“Forma”). Hybrigenics raised three grounds for challenge: lack of written description, lack of enablement, and obviousness. PGR2018-00098, Paper 10 at 9. Forma, in turn, challenged Hybrigenics’s identification of real parties in interest. Despite finding issues with the enablement and obviousness grounds, the Board found the written description challenge was sufficiently established and instituted PGR on all grounds.

The claims at issue cover inhibitors of “ubiquitin-specific protease 7,” or USP7, which have potential to treat cancers and other disorders. The claims specifically cover compounds of a certain chemical formula and pharmaceutically acceptable salts, hydrates, solvates, prodrugs, stereoisomers, and tautomers of those compounds. Id. at 3.

The Board first considered Forma’s challenge to the identification of real parties in interest; according to Forma, a third party collaborating with Hybrigenics and two U.S. subsidiaries of Hybrigenics should have been listed. Id. at 11. The Board disagreed because Forma presented no evidence that (1) the third party controlled, directed, financed, or participated in the PGR petition; or (2) the two U.S. subsidiaries were involved in the petition, that Hybrigenics served as their proxy, or that they were intermediaries through which a real party in interest exercised control. Id. at 14–18.

Turning to the written-description grounds, Forma asked the Board to deny review under § 325(d) because a patent examiner supposedly considered Hybrigenics’s arguments during prosecution. Id. at 19. Forma had narrowed the claims to overcome a § 112 rejection and assured the examiner the added limitations had written support. Id. at 20. In the PGR petition, Hybrigenics claimed this same language was unsupported. Rejecting the § 325(d) argument, the Board found no evidence that the examiner had considered Forma’s assurances, or that the rejection overlapped with Hybrigenics’s petition arguments. Id. at 20–21. On the merits, the Board concluded it was more likely than not that the added claim language lacked support. Id. at 25. Forma had limited the possible substituents of the claimed compound from “heteroaryl” and “heterocycloalkyl,” generally, to 5- or 6-membered heteroaryl and 3- to 7-membered heterocycloalkyl, but had defined “heteroaryl” and “heterocycloalkyl” broadly in the specification with numerous examples and no guidance towards the narrower constituents it later claimed. Id. at 22–24. The Board thus instituted PGR. Id. at 26. It then briefly dismissed Hybrigenics’s second written description argument—that the broad genus of claim compounds lacked written support because the specification only gave 13 exemplary compounds—concluding that Hybrigenics failed to address the commonality of any structural features of the genus, the state of the art, the predictability of the technology, or the representativeness of the 13 examples. Id. at 27–28.

The Board next found that Hybrigenics failed to establish likely unpatentability for lack of enablement. Hybrigenics had argued that skilled artisans would be unable to synthesize the millions of claimed compounds without undue experimentation, given only four synthesis examples were disclosed in the patent and artisans would not know which of the claimed compounds were effective USP7 inhibitors. Id. at 30. But, according to the Board, Hybrigenics and its expert failed to explain why the general synthesis methods and four disclosed examples were insufficient to enable synthesis of the claimed genus, the degree of experimentation that would be needed, or why the two disclosed assays were insufficient to assess USP7 inhibition. Id. at 31–32.

Finally, the Board considered the obviousness grounds. It noted that Hybrigenics failed to establish likely unpatentability on this basis, but nevertheless instituted PGR on all grounds per PTO guidance. Hybrigenics had asserted obviousness over a prior art patent that disclosed fourteen compounds. According to Hybrigenics, skilled artisans would have modified those compounds in obvious ways, and those modified compounds rendered the claimed compounds obvious. But according to the Board, Hybrigenics used impermissible hindsight because it started with the claimed compounds and argued their substituents were obvious in light of the prior art, instead of explaining why skilled artisans would have modified the prior art compounds to arrive to the claimed compounds. Id. at 41–42. Hybrigenics had also argued that examples in the prior art patent rendered certain claimed compounds obvious, but the Board noted Hybrigenics’s expert failed to cite any prior art references that suggested the required modifications. Id. at 46-47.

During the week of March 4, 2019, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600.  One decision denied institution of a petition, and one decision was a final decision finding all claims unpatentable.

Luitpold Pharm., Inc. v. Apicore US LLC, IPR2018-01640 (Decision Denying Institution Entered March 6, 2019): In Luitpold, Continue Reading PTAB Tech Center 1600 Round-Up: Week of March 4-8, 2019

During the week of March 11–15, 2019, the Patent Trial and Appeal Board (“Board”) issued 1 IPR non-institution decision, 1 IPR institution decision, and 4 IPR final written decisions (on the same patent) in TC 1600.

Alvogen Pine Brook LLC v. Celgene Corp., IPR2018-01714

The Board denied institution of Alvogen Pine Brook LLC’s (“Alvogen”) petition Continue Reading PTAB Tech Center 1600 Round-Up: Week of March 11-15, 2019

On February 20, 2019, the PTAB held that the statutory grace period for PTO papers and fees due on a weekend or federal holiday applies to the one-year deadline for filing IPR petitions under 35 U.S.C. § 315(b). Under longstanding PTO practice, the Office has accepted filings after a formal deadline if that deadline fell on a weekend or federal holiday and the filing is completed on the next Continue Reading PTAB Applies Statutory Grace Period for Weekends and Holidays to IPR Petitions

During the week of February 11, the Patent Trial and Appeal Board (“the Board”) issued several decisions in TC 1600, including two final written decisions in inter partes reviews (“IPR”).  Summaries of the final written decisions follow. Continue Reading PTAB Tech Center 1600 Round-Up: Week of February 11-15, 2019

During the week of January 14–19, 2019, the Patent Trial and Appeal Board (“the Board”) issued 5 IPR institution decisions, 1 IPR final written decision, 1 PGR institution decision, and 1 PGR final written decision in TC 1600.  Continue Reading PTAB Tech Center 1600 Round-Up: Week of January 14-19, 2019

We previously published a post on the Federal Circuit’s decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., and Helsinn’s subsequent petition for certiorari.

On January 22, 2019, the Supreme Court affirmed the Federal Circuit in a unanimous decision, holding that a commercial sale to a party who is required to keep the invention confidential can still constitute prior art Continue Reading Helsinn Update: The Supreme Court Preserves the Substance of the Pre-AIA On-Sale Bar

During the week of January 7, the Patent Trial and Appeal Board (“the Board”) issued four decisions in TC 1600, one denying institution of inter partes review (“IPR”) and three final written decisions.  Summaries of the decisions follow: Continue Reading PTAB Tech Center 1600 Round-Up: Week of January 7-11, 2019