During the week of May 6, 2019, the Patent Trial and Appeal Board (“the Board”) issued four decisions in TC 1600. In those, the Board instituted two inter partes reviews (“IPR”) and one post grant review (“PGR”), but refused to institute one IPR.
Neptune Generics LLC v. Aventis Pharma S.A., Case IPR2019-00136 (Decision Denying Institution Entered May 6, 2019). In this case, the Board exercised its discretion under 35 U.S.C. § 325(d) to deny institution of an IPR. The petitioner, Neptune Generics LLC (“Neptune”), requested review of two claims of Patent No. 5,847,170 (“the ’170 patent”) covering a specific compound that is active against treatment-resistant tumors, and pharmaceutical compositions with that compound. IPR2019-00136, Paper 15 at 4–5, 9. Neptune raised two obviousness grounds, one based on three references and another based on those same references with an additional one. Id. at 9. Neptune argued the prior-art treatment paclitaxel would have been chosen as the lead compound (id. at 27) and the references rationalized modifications needed to reach the claimed compound (id. at 31).
The Board previously denied a 2016 IPR petition on the same two claims of the ’170 patent. Id. at 3, 20–23. Instead of Neptune’s lead compound, paclitaxel, the earlier petitioner had asserted an analogue of paclitaxel disclosed in a reference that Neptune included in its combinations. Id. at 21. In the earlier proceeding, the Board found there was no suggestion in the petitioner’s asserted references to modify the lead compound, and that the challenge was based on hindsight. Id. at 23.
At the time of Neptune’s petition, the ’170 patent was also subject to co-pending district court litigation in which a court had rejected an obviousness challenge. Id. at 23. The court chose paclitaxel (or docetaxel) as lead compound and heard testimony on Neptune’s three main references. Id. at 24. But according to the court, that obviousness case was based on hindsight, motivation for the needed modifications was not established, and secondary considerations supported the patentee. Id. at 25.
Based on these two proceedings, the Board denied Neptune’s petition under § 325(d). Id. at 37. The Board was unpersuaded that the different lead compound in the earlier IPR petition sufficiently distinguished that case from this one. Id. at 31. Paclitaxel (Neptune’s lead compound) was a precursor of the earlier petitioner’s lead compound, and Neptune pressed for modifications that resulted in the earlier lead compound before reaching the invention. Id. The references in both proceedings were substantially similar according to the Board, and Neptune relied on its references for the same teaching as the earlier petitioner. Id. Neptune tried to distinguish the references based on a reference in the earlier case’s teaching of a modification that led away from the claimed compound. Id. at 32–33. But the Board was unpersuaded the teaching-away issue distinguished the two challenges because Neptune had made the same argument as the earlier petitioner. Id. at 33. Moreover, while Neptune made motivation arguments not raised in the earlier petition, the Board concluded those arguments were inadequately developed. Id. at 34. Finally, the Board ruled that the stage and overlap of the related court litigation favored a discretionary denial. Id. at 37.
Grünenthal GmbH v. Antecip Bioventures II LLC, Case PGR2019-00003 (Decision Granting Institution Entered May 7, 2019). Grünenthal GmbH (“Petitioner”) sought PGR of all claims of Patent No. 9,867,839 (“the ’839 patent”). The patent owner, Antecip Bioventures II LLC, did not file a preliminary response, and the Board instituted PGR on all grounds. PGR2019-00003, Paper 7 at 2.
The claims of the ’839 patent covered methods of treating joint pain with neridronic acid (claims 1-14) or zoledronic acid (claims 15-30), two bisphosphonate compounds. Id. at 3–5. All claims required a minimum pain intensity as measure by one of two pain scales. Id. at 4–5. The neridronic acid claims additionally required joint pain for “at least 3 months”; the zoledronic acid claims additionally required oral administration of the treatment at a specific monthly dosage range. Id.
After finding the ’839 patent eligible for PGR and adopting Petitioner’s skill level and claim construction proposals, the Board rejected two grounds against the neridronic acid claims based on § 112, a written description and enablement ground. Id. at 9–17. While the specification contained no disclosure pertaining to the requirement of pain for “at least three months,” the Board explained, the originally filed claim itself provided adequate written support. Id. at 12–14. Even though the specification included no examples of treatment with neridronic acid and disclosed only broad ranges of possible doses, the Petitioner had not established “anything other than straightforward, routine, and empirical” experimentation and failed to “account adequately for the general knowledge of the ordinarily skilled artisan” as demonstrated by the prior art. Id. at 16.
The Board, however, was persuaded that the Petitioner was likely to demonstrate the claims of the ’839 patent were unpatentable with respect to four obviousness grounds. The Board found the first ground, which was directed to the neridronic acid claims and was based on a primary reference describing neridronic acid treatment of chronic regional pain syndrome (“CRPS”) with no explicit disclosure of “joint pain,” was likely to succeed. Id. 20–21. The Board also found two other grounds against the neridronic acid claims were reasonably likely to succeed because the combination of references disclosed neridronic acid treatment of joint pain and “at least 3 months” of pain requirement in connection with a different bisphosphonate. Id. at 23–25. Finally, for the zoledronic acid claims, the Board accepted the fourth obviousness ground, which was based on two references disclosing zoledronic acid treatment of CRPS (with no disclosure of oral formulations or treatment of joint pain), a reference describing oral formulations of zoledronic acid (with no disclosure of actual treatment), and the reference connecting CRPS to knee pain. Id. at 28–31. The Board accordingly instituted PGR on all grounds. Id. at 32–33.
Merck Sharp & Dohme Corp. v. GlaxoSmithKline Biologicals SA, Case IPR2019-00230, IPR2019-00241 (Decisions Granting Institution Entered May 9, 2019): The Board instituted two related inter partes reviews sought by petitioner Merck Sharp & Dohme Corp. (“Merck”) against patent owner GlaxoSmithKline Biologicals SA (“Glaxo”). Both petitions involved claims 1, 2, 4–14, and 16–21 of Patent No. 9,422,345 (“the ’345 patent”). IPR2019-00230, Paper No. 8 at 2; IPR2019-00241, Paper No. 8 at 2.
The ’345 patent related to the expression of bacterial toxins, in particular diphtheria toxins. ’345 Patent at 1:9–10. The ’345 patent also described processes for the expression and manufacture of bulk cultures of the toxins as well as polynucleotides and polypeptides that can be used or produced during the processes. Id. at 1:10–15.
Merck concurrently filed IPR2019-00230 and IPR2019-00241 and contended in both that the challenged claims were unpatentable under 35 U.S.C. §§ 102 and 103 but on different groundsIPR2019-00230, Paper No. 8 at 2, 5; IPR2019-00241, Paper No. 8 at 2, 5. The petitions also differed because, in IPR2019-00241, Merck argued that the ’345 patent could not claim priority to an earlier filed application due to lack of written description support, an argument not pursued in IPR2019-00230. IPR2019-00230, Paper No. 8 at 12–13; IPR2019-00241, Paper No. 8 at 12–13.
In IPR2019-00230, Merck asserted all the challenged claims were anticipated by or obvious over prior art references under 102(b). IPR2019-00230, Paper No. 8 at 5–6, 12–13. Specifically, Merck asserted that claims 1, 2, 18, 19, and 21 were anticipated by U.S. Patent Application Number 2003/0157093 (“Neville”). Id. at 14. In one example described in Neville, a polynucleotide construct related to diphtheria contained a 5′ signal sequence portion and a 3′ toxin portion that encoded an amino acid sequence that was 99.6% identical to SEQ ID NO: 32 in the ’345 patent. Id. at 14–15. The 5′ portion of the polynucleotide sequence also encoded a PelB leader (signal) sequence. Id. at 15. Accordingly, the Board determined that Merck established a reasonable likelihood that Neville anticipated claims 1, 2, 18, 19, and 21. Id. at 16.
With respect to claims 4–14, 16, 17, and 20, Merck asserted an obviousness argument based on Neville in view of an article from Huber et al. (“Huber”). Id. at 6. Merck argued that “Huber demonstrated that nine of the thirteen signal sequences recited in the ’345 patent claims, including FlgI (which is present in each of claims 4–14, 16–17 and 20), are capable of directing transport of a normally cytoplasmic polypeptide (thioredoxin) to the E. coli periplasm.” Id. at 17 (citation omitted). Merck further explained that the teachings of Neville and Huber “would have provided POSAs with a reasonable expectation that combining the teaching of Neville and Huber would successfully produce the polynucleotides of claims 4–14, 16–17 and 20.” Id. at 18 (citation omitted). The Board determined that Merck established a reasonable likelihood that claim 6 was obvious over Neville in view of Huber. Id.
Merck made several additional anticipation and obviousness arguments that the Board did not substantively review but did include in their institution decision. Id. at 19 (citing SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018)).
In IPR2019-00241, Merck argued that the ’345 patent could not claim priority back to an earlier filed application (GB App No. 0917647) because that foreign application contained no written description support for certain claim terms in the ’345 patent. IPR2019-00241, Paper No. 8 at 12–13. The Board determined the foreign application did provide written description support for one of the disputed claim terms, but not for another claim term. Id. at 15, 18. The Board found that “the earliest effective filing date of the challenged claims of the ’345 patent [wa]s October 7, 2010,” which was nearly one year after the October 8, 2009 filing date of the foreign priority application. Id. at 21.
Merck then asserted that claims 1, 2, 18–19, and 21 were anticipated by WO2011/123139 (“Retallack”) and U.S. Patent No. 9,580,719 (“Retallack-719”) under 35 U.S.C. § 102(e). Id. at 5. Retallack was filed on April 9, 2010, and Retallack-719 was filed on October 30, 2009. Id. According to Merck, Retallack disclosed nucleotide sequences encoding a protein fused to a signal that directed its transfer to the periplasm. Id. at 23. The polynucleotides contained a 3′ toxin portion encoding the protein and a 5′ signal sequence encoding a secretion leader. Id. Merck also argued that the amino acid sequence of the protein was 100% identical to SEQ ID NO: 32 of the ’345 patent. Id. The Board held that Merck established a reasonable likelihood of prevailing on its assertion that Retallack anticipated claims 1, 2, 18, 19, and 21 of the ’345 patent. Id. at 24.
Merck also asserted that Retallack in combination with Huber, as described above, rendered claims 4–14, 16, 17, and 20 obvious. Id. The Board concluded that Merck established a reasonable likelihood of prevailing with respect to this ground as well. Id. at 26.