Inter Partes Review

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A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018). The PTAB determined that the Petitioners failed to establish that the challenged claims of the patent were obvious over prior art, in part, because of the Petitioners’ failure to establish the prior art status of the product label for RITUXIN®, which contains rituximab.
Continue Reading Rituxan Patent Spared by Failure to Establish Product Label as “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

Serial IPR petitions directed to previously-challenged patents account for many of the petitions filed with the PTAB; however, 35 U.S.C. § 325(d) provides the Board with discretion to reject petitions where the same, or substantially the same, prior art or arguments have already been presented to the USPTO.  The Board recently designated as precedential part of its decision in General Plastic Industrial Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, Paper 19 (6 September 2017), addressing factors to be considered in determining whether to institute review for a serial, or “follow-on” petition.  Petitioner General Plastic filed a first set of petitions seeking IPR of U.S. Patent No. 9,046,820 B1 (“the ’820 patent”) and U.S. Patent No. 8,909,094 B2 (“the ’094 patent”).  Institution of a trial was denied for each petition based upon the merits.
Continue Reading Precedential and Informative Board Decision on Serial IPR Petitions

Research Corporation Technologies, Inc. (RCT) sued Mylan Pharmaceuticals, Inc. (Mylan), Breckenridge Pharmaceutical, Inc. (Breckinridge), and Alembic Pharmaceuticals Ltd. (Alembic), in federal district court, accusing them of infringing United States Reissued Patent No. RE38,551. The patent claims pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. Within one year of being served with the infringement complaint, Breckenridge alone petitioned the PTAB to institute inter partes review of the patent, but the PTAB denied the petition on its merits.
Continue Reading CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition

Student and Math Book

In Shinn Fu Co. of America, Inc. v. The Tire Hanger Corp., Dkt. No. 2016-2250 (Fed. Cir. July 3, 2017), Shinn Fu appealed the Board’s holding in IPR2015-00208 (discussed here), a rare case in which the PTAB granted a motion to amend, and determined that substitute claims 6-10 of USPN 6,681,897 were patentable.  The claims are drawn to methods of changing the wheels of vehicles on lifts without the operator having to bend while supporting the wheel.
Continue Reading PTAB Gets A Math Lesson

In Arthrex, Inc. v. Smith & Nephew, Inc., No. 2017-1239 (Fed. Cir. Jan. 24, 2018), the Federal Circuit affirmed the PTAB’s entry of adverse judgment against Patent Owner Arthrex, before instituting inter partes review. Specifically, the PTAB entered judgment after Arthrex had disclaimed all challenged claims, but before the PTAB decided whether to institute a trial. As a result of the PTAB’s adverse judgment, the Patent Owner is estopped, under 37 C.F.R. § 42.73(d)(3)(1), from obtaining another claim in a continuation application, for example, that is “not patentably distinct” from a canceled claim. Estoppel would not have applied if the PTAB would have instead decided not to institute the IPR.
Continue Reading Patent Owner Estoppel May Apply When Patent Owner Cancels Claims Before IPR Institution

PTABWatch Takeaway: Sovereign immunity is not available to dismiss an IPR challenge where the Patent Owner has filed an infringement action against the Petitioner. Ericsson v. Regents of the University of Minnesota, IPR2017-01186, -01197, -01200, -01213, -01214, and -01219 (Dec. 19, 2017).

The Eleventh Amendment was rarely mentioned in the same breath as patent law until last year, which began with the Board’s decision in Covidien LP v. University of Florida Research Foundation Inc., IPR2016-01274, -01275, -01276 (Jan. 25, 2017), discussed here. In Covidien, the Board dismissed petitions for IPR challenging the claims of a patent owned by the University of Florida Research Foundation, determining that the university is an arm of the state and entitled to invoke sovereign immunity to bar IPR institution. Sovereign immunity does not shield against any and all challenges, however. In Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., Case No. IPR2017-00572 (July 13, 2017), discussed here, the Board acknowledged that sovereign immunity may be asserted by a state university in an IPR, but held that an IPR may continue against a non-sovereign co-owner of the challenged patent.
Continue Reading PTAB Defines Further Limitation to Sovereign Immunity Defense

Update: The Supreme Court issued a decision on April 20, 2020  holding that the patent statute (35 U.S.C. § 314(d)) bars judicial review of a PTAB decision of whether an inter partes review petition is time-barred pursuant to 35 USC 315(b). As stated by the Court, the PTAB’s “application of §315(b)’s time limit, we hold, is closely related to its decision whether to institute inter partes review and is therefore rendered nonappealable by§314(d).”

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Original Post: In Wi-Fi One, LLC v. Broadcom Corporation, an en banc panel of the Federal Circuit decided on January 8, 2018, that the PTAB’s application of the 35 U.S.C § 315(b) time bar to institution of inter partes review (IPR) proceedings is reviewable on appeal. The decision overrules Achates Reference Publishing, Inc. v. Apple Inc., 803 F.3d 652 (Fed. Cir. 2015), which held to the contrary.
Continue Reading PTAB’s Time Bar Determinations Are Reviewable by the Federal Circuit

Update: On June 10, 2019, the Supreme Court issued a decision, 6-3, reversing the Federal Circuit’s judgment and remanding the case for further proceedings. The Court held that “a federal agency is not a ‘person’ who may petition for post-issuance review under the AIA.” On August 9, 2019, the Federal Circuit issued an order vacating the PTAB’s decision and remanding with instructions that the PTAB dismiss the CBM proceeding for lack of jurisdiction.

PTABWatch Takeaway: When “sued for infringement” within the meaning of 28 U.S.C. § 1498(a), the United States has standing to petition the Patent Office to institute Covered Business Method (CBM) review.  Return Mail v. U.S. Postal Service, Appeal 2016-1502 (Fed. Cir. Aug. 28, 2017)

Background

Patentee, Return Mail, Inc., filed suit in the U.S. Court of Federal Claims Court alleging that the United States, through the actions of the United States Postal Service, used without license the subject matter claimed in U.S. Pat. No. 6,826,548.
Continue Reading The United States Can Have Standing in AIA Proceedings

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

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Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.