During the week of December 17, 2018, the Patent Trial and Appeal Board (“the Board”) issued five decisions in TC 1600. Those decisions instituted inter partes review (“IPR”) of five petitions, four of which involved related patents. As detailed below, the Patent Owners did not substantively challenge the petitions at the Preliminary Response stage, but instead opposed institution on procedural grounds—namely, failure to name a real party in interest or duplicative issues under 35 U.S.C. § 325(d).
Merck Sharp & Dohme Corp. v. GlaxoSmithKline Biologicals SA, Nos. IPR2018-01229; IPR2018-01234; IPR2018-01236; and IPR2018-01237 (Decisions Granting Institution Entered December 18, 2018). Merck Sharp & Dohme Corp. (“Merck”) filed four IPR petitions, two to cancel GSK’s Patent No. 8,753,645 (“the ’645 patent”), and two to cancel GSK’s Patent No. 9,265,839 (“the ’839 patent”). Both patents covered a process called “reductive animation,” which involved oxidation of an antigen and subsequent reduction of the antigen and a carrier protein to form a conjugate. See, e.g., IPR2018-01229, Paper 13 at 3. The patents explained that using less periodate in the oxidation step of the method mitigated an undesirable size-reducing effect, and the patents claimed certain steps (i.e., specific ranges of periodate used) to avoid size reduction. Merck raised five grounds of unpatentability in one petition for each patent (IPR2018-01229, Paper 13 at 5 (’645 patent) and IPR2018-01234, Paper 13 at 6 (’839 patent)) and three grounds of unpatentability in the second petition for each patent (IPR2018-01236, Paper 13 at 5 (’645 patent) and IPR2018-01237, Paper 13 at 6 (’839 patent)).
GSK opposed institution mainly by arguing that Merck did not name all real parties in interest, including Pfenex, Inc., who had exclusively licensed its recombinant protein expression technology to Merck for production of a vaccine product. See, e.g., IPR2018-01229, Paper 13 at 6–10. The Board rejected GSK’s argument, reasoning that a preexisting relationship with the petitioner and potential to benefit from the petition did not make Pfenex a real party in interest. GSK’s expansive approach would “ensnare third parties … with no connection to the Petition.” Instead, the real party in interest inquiry must focus on whether the potential real party in interest is exercising or could exercise control over the IPR, whether the IPR was filed at the potential real party in interest’s behest, or whether the potential real party in interest desired review of the patent at issue. See, e.g., id. at 10–13. After analyzing Merck’s evidence and the relationship between Pfenex and Merck, the Board determined that Pfenex did not need to be named as a real party in interest. See, e.g., id. at 13.
Because GSK did not substantively oppose any of Merck’s grounds of invalidity (including by not filing an expert declaration with its Preliminary Response), the Board reviewed the evidence of record and determined that all grounds in Merck’s IPR petitions established a reasonable likelihood that Merck would prevail in showing one or more claims of the patents are invalid. IPR2018-01229, Paper 13 at 21–29; IPR2018-01236, Paper 13 at 22–30; IPR2018-01234, Paper 13 at 22–33; and IPR2018-01237, Paper 13 at 22–31.
Pfizer Inc. v. Hoffman-La Roche Inc., No. IPR2018-01219 (Decision Granting Institution Entered December 18, 2018). Pfizer Inc. (“Pfizer”) petitioned for IPR of Hoffman-La Roche Inc.’s (“Roche’s”) Patent No. 8,314,225 (“the ’225 patent”), which covers methods of improving gene expression of an immunoglobulin protein. IPR2018-01219, Paper 12 at 3. Roche did not substantively oppose Pfizer’s petition, but instead disclaimed all but one claim and argued that Pfizer’s petition on the remaining claim should be denied under 35 U.S.C. § 325(d). Id. at 2. Roche argued that a pending reexamination addressing similar grounds—including a shared reference—dictated that the IPR petition should be denied. Id. at 5–6. The Board nevertheless instituted IPR, reasoning that the reexamination arguments (including the one involving the reference overlapping with the IPR petition) were too dissimilar, and the reexamination process had not yet reached completion. Id. at 6–10.
After addressing § 325(d), the Board walked through Pfizer’s substantive evidence, which Roche’s preliminary response left unrebutted. Although the Board did not decide whether the non-disclaimed claim’s preamble was limiting, and preliminarily found that some arguments were not fully supported, it instituted IPR on all asserted grounds in light of SAS. Id. at 13–30; see also SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018).