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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Federal Circuit Remands PTAB Decision to Assess Dependent Claim Patentability
In MaxLinear Inc. v. CF Crespe LLC the Federal Circuit ruled that the PTAB did not address arguments concerning patentability of certain dependent claims of the patent at issue separate from the corresponding independent claims, and vacated and remanded the PTAB’s final written decision.
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Motion to Amend Substituting Claims Granted in Full, Possibly Reflecting the Change Wrought By Aqua Products
The Board recently granted a motion to amend, to replace unpatentable claims with proposed substitute claims, a rare occurrence that may signal a change compelled by Aqua Products (summarized here). In Apple, Inc. v. Realtime Data, LLC, Case No. IPR2016-01737 (PTAB March 13, 2018), the Board determined that all challenged claims were unpatentable and then granted the patent owner’s contingent motion to amend with respect to all proposed substitute claims. Based on a USPTO study on motions to amend (see Graph III here), only four motions to amend substituting claims were granted in full before September 30, 2017, mere days before the Federal Circuit issued its en banc decision in Aqua Products.
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The Supreme Court Finds IPR Proceedings Constitutional
Inter partes review (IPR) is a procedure that allows a party to challenge the validity of an issued patent based on prior art patents or printed publications. IPRs first became available in 2013 following passage of the Leahy-Smith America Invents Act. Some have questioned whether this post-grant review of patent validity is constitutional. Today, the United States Supreme Court declared that neither Article III of the Constitution nor the Seventh Amendment right to trial by jury precluded such reviews by the Patent Trial and Appeal Board (PTAB).
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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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Should I Stay or Should I Go? – Co-Pending IPR and Litigation Can Lead to Discovery Obligations
Fighting a war on two fronts is rarely an enviable strategic position. While district court judges do not always grant stays of patent infringement cases until resolution of co-pending inter partes reviews (IPR’s), accused infringers considering whether to request a stay of litigation should note the PTAB’s February 28, 2018, Order in Becton, Dickinson and Company v. B. Braun Melsungen AG, IPR2017-01586, -01587, -01588, -01589, and -01590.
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Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication”
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.
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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.
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Precedential and Informative Board Decision on Serial IPR Petitions
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.
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CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition
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.
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