The Federal Circuit recently affirmed the PTAB’s decision that tribal immunity cannot be asserted in an IPR (Saint Regis Mohawk Tribe v. Mylan Pharma Inc., Case No. 2018-1638 (Fed. Cir. July 20, 2018). On appeal, Allergan, Inc. (“Allergan”) argued that the Board improperly denied its motion to withdraw from IPR proceedings, and the Saint Regis Mohawk Tribe (“the Tribe”) argued that the Board improperly denied its motion to terminate the IPR based on sovereign immunity. See Mylan Pharma Inc. v. Saint Regis Mohawk Tribe, Case IPR2016-01127, Paper 130 (February 23, 2018) (discussed here).
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PTAB Issues First Biotech/Pharma PGR Final Written Decision Based On Written Description Challenge
The Patent Trial and Appeal Board has received 37 petitions for post grant review of patents issuing from examination conducted by the Patent Office’s Group Art Unit 1600. The Board has issued four final written decisions thus far. We discussed the first final written decision here, where all claims were upheld in the face of a challenge based on obviousness grounds only. Three of the four final written decisions issued so far on biotech/pharma subject matter dealt only with art-based challenges. Grünenthal GmbH v. Antecip Bioventures II LLC, Case PGR2017-00008 (June 22, 2018) marks the first PGR final written decision addressing written description of a patent arising from Art Unit 1600; all claims were held to be unpatentable under Section 112.
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Proposed Hatch-Waxman Amendment Would Effectively Eliminate IPR Challenges by Generics
On June 13, 2018, Senator Orrin Hatch (R-UT) introduced to the Senate Judiciary Committee an amendment to restore the careful balance sought in the Hatch-Waxman Act, which provided incentives for both pharmaceutical innovation and drug affordability. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would modify the IPR process for pharmaceuticals—under Hatch-Waxman and the BPCIA—and would amend sections of the Federal Food, Drug and Cosmetic Act that provide abbreviated pathways for generic drug and biosimilar product approval.
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Federal Circuit Admonishes PTAB for Taking Short-cuts
In Application in Internet Time v. RPX Corp., Nos. 2017-1698, -1699, -1701 (Fed. Cir. July 9, 2018), the Federal Circuit decided that the Patent Trial and Appeal Board “applied an unduly restrictive test for determining whether a person or entity is a ‘real party in interest’ within the meaning of [35 USC] § 315(b) and failed to consider the entirety of the evidentiary record in assessing whether § 315(b) barred” IPRs petitioned by RPX more than one year after one of its clients, Salesforce.com, Inc. (Salesforce), was served with a complaint for infringing the challenged patents. Based on these decisions, the court vacated the Board’s final written decisions that canceled the challenged claims. The court’s decision is important if only because it offers guidance in determining how a non-party may be a real party in interest or in privity with a petitioner.
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PTAB May Cite New References Not Cited in the IPR Petition
In affirming a PTAB IPR decision canceling claims for obviousness, the Federal Circuit concluded that the PTAB’s reliance on references not included in the original petition did not violate due process or the patent owner’s procedural rights under the Administrative Procedure Act (APA). Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372 (Fed. Cir. 2018).
Citing Genzyme Therapeutic Products Ltd. v. Biomarin Pharmaceutical. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016) (discussed here), the court stated that new evidence was to be expected during an IPR and was permissible under the APA provided the opposing party receives notice and an opportunity to reply.
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Federal Circuit Requests Briefing from Patent Office Regarding § 315(b) Time-Bar Determinations
On June 7, 2018, the Federal Circuit in Wi-Fi One, LLC v. Broadcom Corp. requested that intervenor, Patent Office director Andrei Iancu, and appellee Broadcom, file a response to Wi-Fi One’s second petition for rehearing. Wi-Fi One, Case No. 2015-1944, Docket No. 212 (June 7, 2018). At issue was whether the court should grant Wi-Fi One’s second petition for panel or en banc rehearing regarding 35 U.S.C. § 315 (b) time-bar challenges. See Wi-Fi One, LLC v. Broadcom Corp., Case No. 2015-1944, Doc. No. 210 (May 21, 2018).
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IPR and Estoppel after SAS Institute
The Supreme Court held on April 24, 2018 that if the Patent Office institutes and inter partes review (IPR) proceeding, it must issue a final written decision with respect to the patentability of every patent claim challenged by the petitioner. SAS Institute, Inc. v. Iancu, (discussed in greater detail here). Within days, the Patent Office issued Guidance on the impact of SAS on AIA Trial Proceedings explaining the procedures it intends to implement in view of the Court’s decision. The resulting changes are likely to be extensive, both in IPR practice and in the scope of estoppel that litigations in parallel proceedings will need to consider.
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Tribal Sovereign Immunity Alone Cannot Protect Patents from IPR
In late March, the Federal Circuit issued an order staying the PTAB proceedings concerning numerous related IPRs of patents issued to Allergan, Inc. (“Allergan”), but assigned to the Saint Regis Mohawk Tribe (“the Tribe”). These IPRs were headed toward a final hearing on the merits previously scheduled for April 3rd. In those IPRs, the PTAB denied the Tribe’s motions to terminate the proceedings based upon the Tribe’s sovereign immunity. Mylan Pharma Inc. v. Saint Regis Mohawk Tribe, Case IPR2016-01127, Paper 130 (February 23, 2018). This post explains the PTAB’s decision that the court will now review on appeal.
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Supreme Court Decides that IPR Final Decisions Must Address All Challenged Claims
On April 24, 2018, the Supreme Court issued its decision in SAS Institute, Inc. v. Iancu, holding that if the Patent Office institutes an inter partes review (IPR) proceeding, it must issue a final written decision with respect to the patentability of every patent claim challenged by the petitioner. The Court reversed the Federal Circuit’s judgment, which upheld the Patent Trial and Appeal Board’s (PTAB) common practice of instituting review on some, but not all challenged claims, and then issuing a final written decision addressing only the claims for which review was instituted.
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Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication
On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody. The methods of the claimed invention involve subcutaneously administering to a patient an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week starting one week after the initial dose. The patent is one of several patents AbbVie owns that relate to its blockbuster autoimmune drug Humira.
Continue Reading Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication