During the week of October 29, 2018, the Board issued three decisions in Technology Center 1600: one Final Written Decision and two institution decisions. The decisions are summarized as follows:
Pfizer, Inc. v. Biogen, Inc., IPR2017-01168 (Final Written Decision, October 31, 2018). Petitioner Pfizer challenged the patentability of claims 1-5 of U.S. Patent No. 8,821,873 (the ’873 patent) as being obvious over Moreau, Link, McNeil, Maloney, and Coiffier. The Board found the challenged claims unpatentable.
The ’873 patent relates to methods for treating a patient who is older than 60 and has diffuse large cell lymphoma (DLCL). The claimed treatment includes administration of CHOP chemotherapy and a chimeric anti-CD20 antibody (e.g., rituximab), wherein the antibody is administered in combination with stem cell transplantation. The Board found the broadest reasonable construction of the claim phrase directed to administering rituximab “in combination with stem cell transplantation” means that rituximab may be administered at any time “during bone marrow or stem cell transplant for the purpose of improving the survival rate of transplant recipients.” Thus, the Board agreed with Pfizer that the claimed method encompasses an administration of rituximab at the induction of CHOP chemotherapy but before the actual collecting or transplanting of stem cells.
The Board found that Pfizer established by a preponderance of the evidence that a POSITA would have had a reasonable expectation of success carrying out the claimed treatment by modifying the method disclosed in Moreau. Moreau taught an effective and tolerable method of treating patients over the age of 60 with DLCL by administering CHOP at the induction stage of the stem cell transplant and again after stem cell collection. And a POSITA would have understood from the teachings of the other references that an alternative to CHOP in elderly patients may be CHOP plus rituximab. The CHOP-rituximab combination may provide an increased response and significant anti-lymphoma activity in DLCL patients without impairing their bone narrow reserves. Thus, a POSITA would have understood the CHOP-rituximab combination to be a well-tolerated and effective treatment, especially for elderly patients who are known to have larger risk of toxicity.
Accordingly, the cited references not only provided motivation for combining rituximab with Moreau’s method, but also supported a POSITA’s reasonable expectation of success in the CHOP-rituximab combination treatment. Accordingly, the Board found all challenged claims unpatentable as obvious.
Grünenthal GMBH v. Antecip Bioventures Ii LLC, PGR2018-00062 (Decision Instituting Post-Grant Review, October 30, 2018). Petitioner Grünenthal challenged claims of U.S. Patent No. 9,707,245 (the ’245 patent). Patent Owner Antecip did not file a preliminary response. The Board found that Petitioner demonstrated that it is more likely than not that 1) claims 1-4, 9, 10, 12, 14, 16-18, 23, 24, and 27-29 are anticipated by Varenna published in 2012 (Varenna 2012); and 2) claims 1-30 are obvious over Varenna 2012 alone or in combination with one or more other references. Thus, the Board instituted a post grant review. The Board was not persuaded that Petitioner was likely to prevail on asserted written description or enablement grounds.
The challenged claims relate to a method for treating pain associated with complex regional pain syndrome (CRPS) using a salt or acid form of neridronic acid, wherein bone fracture is a predisposing event for CRPS. The challenged claims were allowed after Patent Owner submitted data published in 2016 (Varenna 2016) that demonstrated patients “with fractures as the predisposing factor” exhibited a response to neridronic acid that “was superior” to the response in patients “with other pre-disposing factors.”
The Board agreed with Petitioner that the earlier-published Varenna 2012 showed that neridronate effectively mitigated pain in CRPS patients having bone “fracture” as a “[p]recipitating event” for CRPS. Furthermore, the Board agreed with Petitioner that Varenna 2012 disclosed that “the particular type of precipitating event did not influence outcomes in the study, indicating that patients with all types of precipitating events, including fractures, benefited from the neridronate treatment.”
For similar reasons, the Board also concluded that claim 1 would have been obvious over the disclosure of Varenna 2012 alone or in combination with Bruehl, Gatti, La Montague, and Muratore because the cited references would have led a POSITA to reasonably expect effectiveness of the claimed method. In particular, bone fracture was recognized as one of the most common triggering events for CRPS, neridronic acid was known to effectively treat CRPS pain generally, and Varenna 2012 suggested that neridronate would successfully relieve pain in patients presenting with fracture-induced CRPS.
The Board rejected, however, Petitioner’s challenges based on lack of written description support and enablement. The Board found that the specification of the ’245 patent described suitable dosing regimens, and the disclosure of Varenna 2012 would have informed an ordinary artisan how to administer neridronic acid with an expectation of mitigating pain associated with fracture-induced CRPS.
Celltrion, Inc. v. Genentech, Inc., IPR2018-01019 (Decision Instituting Inter Partes Review and Granting Motion for Joinder, October 30, 2018). Petitioner Celltrion challenged claims 1-14 of U.S. Patent No. 7,976,838 (“the ’838 patent”) and filed a motion for joinder to join this proceeding to IPR2017-01923 filed by Pfizer, Inc. (Pfizer IPR).
The Pfizer IPR was already instituted and pending before the Board. Patent Owner Genentech filed a preliminary response to Celltrion’s petition and an opposition to the motion for joinder. Because Celltrion’s petition was concededly a “copycat” of the instituted petition in the Pfizer IPR, the Board concluded that Celltrion demonstrated a reasonable likelihood that it would prevail on Celltrion’s petition.
The Board rejected Genentech’s arguments that the Board should exercise discretionary authority under 35 U.S.C. § 314(a) to deny institution based on a follow-on petition on the same patent. The Board also rejected Genentech’s arguments that the Board should deny review because Celltrion previously had filed two petitions challenging the ’838 patent (Celltrion voluntarily dismissed the first, and the second was denied). The Board concluded that instituting an inter partes review on Celltrion’s petition would not unduly prejudice Genentech, in substantial part because Celltrion sought to join with the already-granted Pfizer IPR. In addition, because Celltrion represented that it would play an “understudy” role when joined with the Pfizer petition, the Board concluded that joinder would not unduly burden or interfere with the Pfizer IPR. Finally, even if Pfizer and Genentech were to settle their dispute and seek to terminate the Pfizer IPR, the Board found that granting Celltrion’s petition would not result in undue prejudice against Genentech because: 1) the Board may enter a decision even after the petitioner settles and drops out of the proceeding; and 2) Celltrion cannot “strategically stage their prior art and arguments in multiple petitions, using our decisions [in Pfizer IPR] as a roadmap,” since once joined, this case will be on the same schedule as Pfizer IPR for all the filings and oral hearing.
Accordingly, the Board granted Celltrion’s petition to institute an inter partes review of claims 1-14 of the ’838 patent on all grounds. The Board also granted Celltrion’s motion for joinder and joined Celltrion as a petitioner in the Pfizer IPR. The Board ordered Celltrion to play an “understudy” role with respect to Pfizer in Pfizer IPR.