In IPR2015-01537, Momenta petitioned for IPR of claims 1-15 of U.S. Patent No. 8,476,239 owned by Bristol-Myers Squibb (BMS) on grounds of obviousness over three references: Cohen, Shire, and Carpenter. Petitioner also relied on expert testimony. The claims recite formulations containing CTLA4Ig, which is a stabilized form of a negative regulator (checkpoint inhibitor) of the immune system useful in treating autoimmune disease and rheumatoid arthritis, for example. The Patent Owner opposed institution by attacking the Petitioner’s position as failing to provide a reason to combine the cited references and as relying on impermissible hindsight in arriving at a formulation that satisfied all features recited in the claims (i.e., tonicity, pH, excipient concentration, excipient:therapeutic mass ratio, volume, and stability).
Continue Reading Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR
On the Clock: Appellate Standard of Reviewing PTAB’s AIA Trial Decisions
Now that Cuozzo Speed Techs., LLC v. Lee has been submitted to the Supreme Court, the next issue that may well make its way to the Court is the propriety of the Federal Circuit’s standard of reviewing the PTAB’s AIA trial decisions. Currently, the Federal Circuit reviews these decisions for substantial evidence. At least four Federal Circuit Judges do not, however, think that the court’s application of that review standard is consistent with the AIA and have concluded that the standard makes too little sense in the context of an appeal from the PTAB’s IPR decision. But because the court is bound by Supreme Court precedent to apply that standard of review, the Federal Circuit issued an order denying a petition Merck & Cie recently filed asking the full Federal Circuit to rehear a late-2015 decision issued by a divided three-judge panel in Merck & Cie v. Gnosis S.p.A., 808 F.3d 829 (Fed. Cir. 2015) (discussed here and here), rehearing en banc denied (Apr. 26, 2016) (order linked here).
Continue Reading On the Clock: Appellate Standard of Reviewing PTAB’s AIA Trial Decisions
Failure to Establish Published U.S. Application is Prior Art Dooms IPR under Dynamic Drinkware
The PTAB’s final written decision in Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, should serve as a reminder to Petitioners challenging claims under 35 U.S.C. § 102(e) – take care to establish that your reference is prior art.
Continue Reading Failure to Establish Published U.S. Application is Prior Art Dooms IPR under Dynamic Drinkware
PTAB Revises Claim Construction in Final Written Decision, But Still Finds Claims Invalid
On January 11, 2016, the PTAB issued a final written decision in ABS Global, Inc. et al. v. XY, LLC, IPR2014-01161, holding claims 1 and 3 of U.S Patent No. 7,195,920 invalid for obviousness. The IPR is part of a long-running dispute between the parties involving multiple issues and multiple patents, as reported previously.
Continue Reading PTAB Revises Claim Construction in Final Written Decision, But Still Finds Claims Invalid
PTAB Dismisses Biosimilar Company’s IPR Petition Without Prejudice, When Petitioner Loses its Expert
The PTAB recently granted Celltrion’s motion to dismiss its IPRs without prejudice, after Celltrion suddenly lost its ability to rely on a key expert declaration. Celltrion had filed IPR petitions against two patents covering use of Rituxan®, and had sought joinder with pending IPRs filed by Boehringer Ingelheim (BI) against the same patents. Although Celltrion initially had permission to rely on testimony of BI’s expert, that permission was withdrawn after BI unilaterally requested adverse judgment in its IPRs. Left out in the cold, Celltrion requested dismissal without prejudice, to permit it to re-file its petitions with a new expert. The PTAB granted the request.
Continue Reading PTAB Dismisses Biosimilar Company’s IPR Petition Without Prejudice, When Petitioner Loses its Expert
Pharma industry continues efforts to exempt patents from IPR
The pharmaceutical industry continues its efforts to exempt pharmaceutical and biotechnology patents from inter partes review
(IPR). Neither the House’s Innovation Act nor the Senate’s PATENT Act currently contain any provisions that would exempt particular patents from these proceedings. But as we reported in June, some members of the Senate judiciary committee appear sympathetic to addressing the pharmaceutical industry’s concerns with an exemption for pharmaceutical and biotechnology patents.
Continue Reading Pharma industry continues efforts to exempt patents from IPR
Put Away The Blunderbuss – Attention to Detail and Thoroughness Are Needed in Preparing an IPR Petition
Boehringer Ingelheim filed three petitions attacking patents generally drawn to methods of treating RA patients with rituximab. The decisions on two of those petitions, i.e., IPR2015-00415 and IPR2015-00417, have been addressed elsewhere. In IPR2015-00418, the PTAB declined to institute an IPR on the petition’s challenges to the lone claim of U.S. Patent No. 8,329,172, drawn to a method of treating low-grade non-Hodgkins lymphoma (LG-NHL) with CVP tri-chemical chemotherapy and rituximab maintenance therapy.
Continue Reading Put Away The Blunderbuss – Attention to Detail and Thoroughness Are Needed in Preparing an IPR Petition
Gamble At Your Own Risk – The Danger Of Petition Overkill
Boehringer Ingelheim filed the petition at issue in IPR2015-00417 concurrently with the petitions at issue in IPR2015-00415 and IPR2015-00418 to challenge patents protecting methodologies for treating rheumatoid arthritis (RA) with rituximab, an FDA-approved antibody for treating certain cancers. The IPR2015-00417 petition specifically challenged the fourteen claims of U.S. Patent No. 7,976,838, which are drawn to methods of administering rituximab to RA patients not responding to TNF-α inhibitors, a subset of RA patients. The PTAB instituted an IPR of two of the 19 obviousness grounds contained in the petition. Given the number, and nature, of grounds to be reviewed, and the outcome, it is apparent that the more grounds found in a petition, the greater the chance that the best arguments will be lost in the shuffle.
Continue Reading Gamble At Your Own Risk – The Danger Of Petition Overkill
Grinning Patentees Get A Mulligan
Filed concurrently with the petitions at issue in IPR2015-00417 and IPR2015-00418, Boehringer Ingelheim filed the petition at issue in IPR2015-00415 seeking review of U.S. Patent No. 7,820,161 owned by Genentech and Biogen Idec. The Board’s institution decision steadily whittled down Boehringer’s varied attacks on the patent. Ultimately, IPR was granted on 2 of the 36 obviousness grounds in the petition (additional grounds were summarily denied for failure to identify the ground with particularity), with the two surviving grounds implicating half of the 12 claims of the ‘161 patent.
Continue Reading Grinning Patentees Get A Mulligan
Hatch-Waxman and BPCIA Patents May Be Exempted from Post-Grant Proceedings Under Pending Senate Legislation
On Thursday, June 4, the Senate Judiciary Committee approved the Protecting American Talent and Entrepreneurship (PATENT) Act. We previously reported the significant provisions of the bill.
Several members of the Judiciary Committee expressed support for a further proposal that would exempt from PTO post-grant proceedings patents that are subject to the Hatch-Waxman or Biologics Price Competition and Innovation Act (BPCIA) processes. In his prepared statement, Senator Grassley, Chairman of the Judiciary Committee said:
Continue Reading Hatch-Waxman and BPCIA Patents May Be Exempted from Post-Grant Proceedings Under Pending Senate Legislation