RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar products.
PTAB Exercises its § 325(d) Discretion to Deny IPR of Piglet Vaccine Patent
The August 2018 Update to the PTAB Trial Practice Guide added guidance regarding the Patent Trial and Appeal Board’s (“the Board”) discretion under 35 U.S.C. § 325(d) to deny institution of an AIA trial when the same or substantially the same prior art or arguments were previously presented to the United States Patent and Trademark
Pfizer Loses Out On Its Follow-On Petition Challenges to Genentech’s anti-HER2 Patents Because It Did Not Follow General Plastics Guidance
Recently, Pfizer was denied institution of two follow-on inter partes review (IPR) petitions, IPR Nos. 2018-00330 and 2018-00331 (“the 2018 petitions”), filed on December 18, 2017, asserting invalidity of Genentech patents, U.S. 6,339,142 (“the ’142 patent”) and U.S. 9,249,218 (“the ’218 patent”). The Patent Trial and Appeal Board (“the Board”) denied instituting the IPRs using
AbbVie Files Suit Against Sandoz Alleging Infringement of Two Humira®-Related Patents
On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz International GMBH (collectively “Sandoz”) in the district of New Jersey alleging infringement of two patents related to Humira®: U.S. Patent 9,187,559 (“the ʼ559 patent”) and U.S. Patent No. 9,750,808 (“the ʼ808 patent”).
According to the complaint
PTAB Institutes a Second IPR on Rituxan®-related ’821 Patent
The PTAB recently instituted a second IPR of US Patent 9,296,821 (“the ’821 patent”), which covers certain uses of Rituxan® (rituximab), a monoclonal antibody marketed by Genentech and Biogen Pharmaceuticals. The ‘821 patent claims methods of treating low grade or follicular non-Hodgkin’s lymphoma (NHL) by administering rituximab during a chemotherapeutic regimen of cyclophosphamide, vincristine, and
First IPR Against Biogen’s ’172 Patent Instituted After Multiple Attempts
U.S. Patent No. 8,329,172 (“the ’172 patent”), a Biogen-owned patent covering a treatment regime for low-grade B-cell non-Hodgkin’s lymphoma, has been a relatively frequent subject of our posts. We first wrote about it in March of 2017, reporting on the filing of Celltrion’s IPR petition against the patent, then again that May, reporting
New Proposed Legislation: The Hatch-Waxman Integrity Act of 2018
On June 14, 2018, Senator Orrin Hatch of Utah, the co-author of the Hatch-Waxman Act, filed an amendment to the Hatch-Waxman Act in an effort to further incentivize generic drug development. The language of the amendment, known as the Hatch-Waxman Integrity Act of 2018, states that its purpose is “to prevent the inter partes review
PTAB Denies Another IPR Petition Relating to Adalimumab
The Patent Trial and Appeal Board (“PTAB”) recently denied Sandoz’s petition for inter partes review (“IPR”) of claims 1-30 of AbbVie’s patent, U.S. Patent No. 9,187,559 (“the ’559 patent”). The ’559 patent is directed towards a multiple-variable dose regimen for treating idiopathic inflammatory bowel disease. The patent discloses administering a high dose of a TNFα
Celltrion Seeks Joinder with Pfizer IPR Challenging Rituximab-Related Patent
Earlier this month, Celltrion, Inc. (“Celltrion”) filed a copycat IPR petition directed against U.S. Patent No. 7,976,838 (“the ʼ838 patent”) that is essentially identical to a petition filed by Pfizer, Inc. (“Pfizer”). The PTAB recently instituted review of the ʼ838 patent based on Pfizer’s petition in IPR2017-01923. Celltrion’s copycat petition was accompanied by a motion
PTAB Denies Sandoz’s IPR Petition for Humira®-Related Patent
Earlier this month, the Patent Trial and Appeal Board (“PTAB” or “the Board”) denied institution of Sandoz’s petition for inter partes review of Abbvie’s patent, U.S. Patent No. 9,512,216 (“the ’216 patent”), directed to methods for treating moderate to severe chronic plaque psoriasis with a human anti-tumor necrosis factor α (TNFα) antibody.[1] The petition,