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

March 13, 2018, marked the fifth anniversary of the transition from the previous “first to invent” system to the AIA’s “first to file” regime.  The PTAB seemingly marked the occasion by instituting the first ever derivation proceeding one week later in Anderson Corporation v. GED Integrated Solutions, Inc., Case DER2017-00007, Paper 32 (March 21, 2018).

The concept of “derivation” was not created by the AIA.  Pre-AIA 35 U.S.C. § 102(f) dictated that a person shall not be entitled to a patent if he did not himself invent the claimed subject matter. 
Continue Reading First Derivation Proceeding Instituted by PTAB

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

Caution Sign on Laptop

In re Janssen Biotech, Inc., Appeal 2017-1257 (Fed. Cir. Jan. 23, 2018), is a cautionary tale concerning patents protecting a blockbuster drug providing patients an important therapy and bringing its owners billions of dollars in annual revenue. It began twenty-five years ago with a then-unremarkable decision to file a patent application. The filed application was of a type that others then also filed—and some may still be filing today. The Patent Office issued that application, without proper examination it turns out, as a patent. Under the circumstances of this case, this type of patent, the courts and Patent Office have since determined, is invalid for obviousness-type double patenting.
Continue Reading ODP Dooms CIP

Can the disclosure in a prior art reference be too extensive for the art not to anticipate? According to a recent decision, the Federal Circuit apparently thinks so.

In Microsoft Corp. v. Biscotti Inc., Case Nos. 2016-2080, -2082, -2083 (Fed. Cir. Dec. 28, 2017), a split Federal Circuit panel affirmed a Board’s decision—also a split decision with one judge dissenting—that the contested claims were not invalid for anticipation, determining that the factual findings of the Board’s majority were supported by substantial evidence. But, in dissent, Judge Newman criticizes the panel majority for misperceiving the law of anticipation and finding that a person of skill in the art would not “at once envisage” the claimed arrangement of limitations due to the breadth of disclosure in the prior art.
Continue Reading A Split Federal Circuit Panel “at Once Envisaged” Different Conclusions of Anticipation

The Board recently denied a post grant review petition because the challenge was deemed redundant of the Patent Office’s earlier examination of similar claims in a related application. Live Nation Entertainment, Inc. v. Complete Entertainment Resources  B.V., Case No. PGR2017-00038 (PTAB January 16, 2018). The decision offers a cautionary tale for patent practitioners.  The Board learned of the earlier examination from the patent owner, not the petitioner who was obliged to advise the Board of “related matters.”
Continue Reading Avoid Creating Bad Blood with the Board