During the week of July 9, the Board issued four decisions in Technology Center 1600, three decisions denying institution of inter partes review and one Final Decision finding the challenged claims patentable. In addition to these four decisions the Board, in ABS Global, Inc. v. XY, LLC, No. IPR2017-02184, also granted Patent Owner’s request for an adverse judgement. The four decisions are as follows:
Pfizer, Inc. v. Genentech, Inc., No. IPR2018-00330 (Decision Entered July 9, 2018). In its petition, Pfizer challenged claims 1¬–3 of U.S. Patent No. 6,339,142 (“the ’142 patent”) on anticipation and obviousness grounds—the same three claims it challenged on anticipation and obviousness grounds in its petition filed on August 29, 2017, in IPR2017-02019. Genentech argued that the Board should exercise its discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d). The Board agreed and denied institution under both provisions. With respect to § 314(a), the Board agreed with Genentech that all seven factors provided in General Plastic Industrial Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) supported exercising its discretion to deny institution. Pfizer failed to address the General Plastic factors and the Board was “left to wonder why [Pfizer] . . . filed a second petition challenging the same claims over the same grounds covered in a first petition.” As such, the Board exercised its discretion to deny institution under § 314(a). Regarding § 325(d), Genentech asserted that the same grounds were raised by Pfizer in IPR2017-02019. The Board observed that Pfizer did not provide a reason why the Board should not exercise its discretion under § 325(d). Accordingly, the Board declined to institute under § 325(d).
Pfizer, Inc. v. Genentech, Inc., No. IPR2018-00331 (Decision Entered July 10, 2018). In its petition, Pfizer challenged claims 1 and 5–7 of U.S. Patent No. 9,249,218 (“the ’218 patent”) on anticipation and obviousness grounds—the same three claims it challenged on anticipation and obviousness grounds in its petition filed on August 29, 2017, in IPR2017-02020. Like in IPR2018-00330, discussed above, the Board exercised its discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d). Here, like in IPR2018-00330, Pfizer did not address the General Plastic factors. The Board found Genentech’s request to deny institution under § 314(a) “well-reasoned and persuasive.” Similarly, Pfizer failed to assert a reason why the Board should deny institution under § 325(d).
Pfizer, Inc. v. Biogen, Inc., No. IPR2018-00285 (Decision Entered July 9, 2018). In ground 1 of its petition, Pfizer challenged claim 1 of U.S. Patent No. 8,329,172 (“the ’172 patent”) as obvious based on the Hochster I, Maloney, and McNeil references. In ground 2, Pfizer challenged claim 1 of the ’172 patent as obvious over a combination of Hochster I, the Rituxan label, and McNeil. The claim at issue relates to a method of treatment for patients with low grade B-cell non-Hodgkin’s lymphoma (LG-NHL), comprising the steps of administering “chemotherapy consisting of CVP therapy to which the patient responds, followed by rituximab maintenance therapy, wherein the maintenance therapy comprises four weekly administrations of rituximab at a dose of 375 mg/m2 every 6 months” for two years. The Board instituted inter partes review, observing that “[t]he fact that a safe and effective maintenance dosing regimen had not been conclusively identified in the prior art does not demand a conclusion of nonobviousness[.]” The Board also held that Pfizer provided sufficient information to support a reasonable likelihood of success in showing that one of skill in the art would have been motivated to use with a reasonable expectation of success (i) selecting rituximab as an anti-CD20 agent in the maintenance therapy method of Hochster I, and (ii) using a “known, FDA-approved dosing regimen for rituximab (disclosed in Maloney or Rituxan Label), at the frequency and duration suggested for rituximab maintenance therapy as disclosed in McNeil.” The Board acknowledged Biogen’s arguments that there would be a certain degree of unpredictability establishing maintenance therapy, and that there existed differences between the scope and content of the prior art and the claims (e.g., McNeil involved elderly patients suffering from intermediate-grade NHL and the present claim is directed to a method of treatment for patients with LG-NHL). The Board concluded that even in light of Biogen’s arguments, Pfizer offered sufficient evidence to demonstrate a reasonable likelihood of success. The Board declined Biogen’s request to deny institution under 35 U.S.C. § 325(d) because Pfizer presented new arguments regarding Hochster I not previously considered by the Board. The Board also declined Biogen’s request to deny institution under 35 U.S.C. § 314(a) because in a previous decision challenging the ’172 patent, the Board, in a divided panel, concluded that the petitioner failed to establish that the Rituxan Label was publicly accessible and denied institution. In that decision, the Board did not conduct claim construction, “[t]herefore, the particular facts of this case do not present a situation in which Petitioner is ‘using our decisions as a roadmap’ regarding those issues.” Accordingly, the Board instituted inter partes review.
Apotex Inc. v. Novartis AG, No. IPR2017-00854 (Final Written Decision Entered July 11, 2018). In the petition, Apotex Inc. and Apotex Corp., Argentum Pharmaceuticals LLC, Actavis Elizabeth LLC, Teva Pharmaceuticals USA, Inc., Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., and Sun Pharma Global FZE (collectively “Petitioner”) challenged claims 1¬–6 of U.S. Patent No. 9,187,405 (“the ’405 patent”) on two grounds of obviousness based on the references of (i) Kovarik and Thomson, and (ii) Chiba, Kappos 2005, and Budde, and on an anticipation ground based on the reference of Kappos 2010. The ’405 patent relates to “the use of an S1P receptor modulator in the treatment or prevention of neo-angiogenesis associated with a demyelinating disease, e.g. multiple sclerosis.” The three independent claims at issue relate to methods of “treating,” “reducing or preventing or alleviating relapses,” or “slowing progression” of “Relapsing-Remitting multiple sclerosis [RR-MS] in a subject” by orally administering 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1, 3-diol (fingolimod) in free form or as a pharmaceutically acceptable salt. The three dependent claims at issue “specify that the 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1, 3-diol is the hydrochloride salt form—i.e., fingolimod hydrochloride.”
With respect to ground 1, the Board credited Patent Owner’s argument that Kovarik was insufficient to link treating RR-MS to administering a 0.5 mg daily dose of fingolimod because Kovarik relates to loading dose rates and ratios which are expressly excluded from the challenged claims. Similarly, the Board agreed that Thomson failed to teach or suggest the claimed 0.5 mg daily dose would be effective at treating RR-MS because Thomson disclosed the drug effectively treats RR-MS at 1.25 and 5 mg daily doses. Accordingly, the Board found that Petitioner did not show by a preponderance of the evidence that claims 1–6 would have been obvious based on the combination of Kovarik and Thomson. Regarding ground 2, the Board rejected Petitioner’s argument that claims 1–6 would have been obvious because (i) Chiba teaches treating MS by orally administering fingolimod hydrochloride, (ii) Kappos 2005 confirms the drug’s utility in RR-MS patients, and (iii) Budde confirms the efficacy of a 0.5 mg daily dose. Patent Owner argued that prior art references Webb, Kahan 2003, and the Park references taught away from the claimed dosing regimen. In light of all the evidence, the Board concluded that Patent Owner established that the prior art taught away from Petitioner’s proposed combination. As such, Petitioner failed to demonstrate by a preponderance of the evidence that claims 1–6 would have been obvious.
Petitioner also argued that claims 1–6 were anticipated by Kappos 2010. Patent Owner did not dispute that Kappos 2010 discloses each element of the challenged claims, but instead argued that Petitioner’s anticipation argument was “a ruse to unlawfully smuggle a 112 written description argument into an IPR” and that Kappos 2010 is not prior art. The Board rejected Patent Owner’s first argument that Petitioner’s anticipation argument was an attempt to subvert 35 U.S.C. § 311(b) and “smuggle” in a written description argument. However, the Board rejected Petitioner’s argument that Kappos 2010 was prior art because—contrary to Petitioner’s assertion—the Board found the claims at issue had written description support in an earlier application. The Board concluded that Petitioner failed to demonstrate by a preponderance of the evidence that Kappos 2010 qualified as anticipatory prior art.
Accordingly, in its Final Written Decision, the Board determined Petitioner failed to demonstrate that claims 1–6 are unpatentable.