IPR Updates: Trastuzumab, Rituximab, Abatacept

Below are a few recent updates in IPR proceedings concerning biologic-related patents:

Today, the Board denied Samsung Bioepis’ petition for IPR of Genentech’s U.S. Patent No. 7,846,441 (IPR2017-00192), directed to cancer treatment methods using trastuzumab.  In its decision, the Board explained that it was exercising its discretion to deny the petition in view of the other pending IPR proceedings regarding this patent that rely on some of the same prior art as in Samsung Bioepis’ petition.  As noted by the Board and as previously reported on Big Molecule Watch, the Board already instituted IPRs in response to Pfizer’s petitions in IPR2017-00731 and IPR2017-02063 and Celltrion’s petition in IPR2017-01121, which are currently pending.  In addition, Genentech is asserting this patent in BPCIA litigations against Pfizer and against Celltrion and Teva regarding their respective proposed trastuzumab biosimilars.

On June 14, 2018, the Board instituted Pfizer’s petition in IPR2018-00186 seeking IPR of all claims of U.S. Patent No. 9,296,821.  The patent is directed to methods for treating low grade or follicular non-Hodgkin’s lymphoma using rituximab with another specific treatment (CVP).  The patent is already the subject of Celltrion’s IPR2017-01095 and has been asserted by Genentech in its BPCIA litigation against Celltrion and Teva concerning their proposed rituximab biosimilar.

Also on June 14, 2018, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged claims “purport to claim nucleic acid sequences that encode the C-terminal part of a human immunoglobulin heavy chain and a method for improving the expression of such an immunoglobulin by using the claimed sequences.” This patent is also subject to a recently ordered ex parte reexamination (Control No. 90/014,063) and is being asserted by Genentech in its BPCIA litigations against Pfizer regarding its proposed trastuzumab biosimilar and against Sandoz regarding its proposed rituximab biosimilar.

As we previously reported, this past December, a Federal Circuit panel heard oral argument in Momenta’s appeal from the Board’s final written decision upholding the validity of Bristol-Myers Squibb’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which is directed to stable liquid formulations of the molecule CTLA4Ig, the active ingredient in Orencia® (abatacept).  BMS argues that the appeal should be dismissed for lack of Article III standing because Momenta does not market a product within the purview of the patent claims and is years away from filing an FDA application to market any such product.  On June 4, while still awaiting a decision from the Federal Circuit, Momenta filed a notice of supplemental authorities concerning, among other things, the Federal Circuit’s May 2, 2018 precedential panel decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., No. 17-1487.  According to Momenta, Altaire supports Momenta’s Article III standing to appeal because the Court, there, found that Altaire faced imminent harm and had standing to appeal an adverse IPR decision under factually similar circumstances including where Altaire had plans to file, but was years away from filing, an application for FDA approval to market a drug.  On June 14, BMS filed a response, arguing that “Momenta’s proffered authorities do not support its Article III standing” because the “unique circumstances [of Altaire] are inapposite to Momenta” and “Momenta also mischaracterizes Altaire’s reasoning.”

Stay tuned to Big Molecule Watch for further developments in these IPR proceedings. Summaries of biologics-related IPRs can be found on our IPR Tracker page.