Petitioners should beware gaps in their evidence and reasoning. Two DepoMed patents recently survived their second IPR challenge because the petitioner failed to meet its burden of proof. The PTAB rejected petitioner’s obviousness arguments as “overly vague and nonspecific,” concluding that petitioner failed to “explain persuasively why or how a person of ordinary skill in the art would modify the drug formulation” of the prior art to develop the claimed formulation, and failed to show a reasonable expectation of success.
Continue Reading Mind The Gap: The PTAB Will Not Bridge It For You
PTAB Denies Institution of Another Investment Fund IPR Petition, Refusing to Ignore Claim Limitation Under BRI Standard
Score another win for pharma against investment funds-turned-IPR petitioners. On September 21, 2015, the PTAB denied institution of Ferrum Ferro Capital, LLC’s (“FFC”) petition for IPR of an Allergan patent claim related to its Combigan® eye-drop product for treating glaucoma. This dispute has attracted publicity for having bled into the courts, where Allergan has sued FFC for extortion, unfair competition, and malicious prosecution. The PTAB’s non-appealable denial of FFC’s petition is obviously a significant victory for Allergan, and follows the PTAB’s recent denials of two IPR petitions filed by the Coalition For Affordable Drugs.
Continue Reading PTAB Denies Institution of Another Investment Fund IPR Petition, Refusing to Ignore Claim Limitation Under BRI Standard
PTAB Applies the Estoppel Provision of the AIA to Deny an IPR Petition
The PTAB recently denied institution of an inter partes review (IPR) on the basis of the estoppel provision of the AIA (35 USC § 315(e)). Apotex Inc. v. Wyeth LLC, IPR2015-00873, Paper 8 (PTAB Sept. 16, 2015). The decision is not appealable, and is significant because it offers guidance on how the PTAB will construe this provision and offers examples of when the PTAB will and will not apply the provision to deny grounds for an IPR.
Continue Reading PTAB Applies the Estoppel Provision of the AIA to Deny an IPR Petition
PTAB Denies Institution of Two IPR Petitions Filed by Hedge Fund
As the patent community anxiously awaits the PTAB’s decision concerning whether the Coalition For Affordable Drugs (CFAD) should be sanctioned for filing an IPR petition against a Celgene patent¹, the PTAB recently denied institution of two IPR petitions² the CFAD filed concerning two Acorda patents that cover Ampyra, a billion-dollar drug for treating multiple sclerosis. The CFAD is a wholly owned subsidiary of a hedge fund managed by Kyle Bass and, since February 2015, Bass and the CFAD have filed twenty nine IPR petitions against more than twenty patents different patents belonging to at least fifteen different companies.
Continue Reading PTAB Denies Institution of Two IPR Petitions Filed by Hedge Fund
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
PTAB Denies Institution in Cepheid v. Roche: PCR Primers Found Not Inherently Anticipated
On June 11, 2015, the PTAB denied institution of Cepheid’s petition seeking inter partes review of Patent No. 5,643,723 directed to methods of detecting tuberculosis in humans (IPR2015-00255). To defeat institution, the patent owner successfully used its preliminary response to persuade the Board to (a) narrowly construe claim terms (despite the broadest-reasonable-construction standard), and (b) reject inherent anticipation and obviousness arguments offered by the petitioner’s expert witness.
Continue Reading PTAB Denies Institution in Cepheid v. Roche: PCR Primers Found Not Inherently Anticipated
Pharma Patent Owner Attacks Bass IPR Petitions by Requesting Discovery of Real Parties-In-Interest
A picture can be worth a thousand words. This one illustrates the complex web of actual and potential real parties-in-interest (RPIs) that a pharmaceutical patent owner is attempting to pierce for two IPR petitions recently filed by Coalition For Affordable Drugs II—one of several similarly-named creations of hedge-fund manager Kyle Bass and his Hayman Credes Master Fund. It’s also an example of attacking IPR petitions by seeking discovery of RPIs.
Continue Reading Pharma Patent Owner Attacks Bass IPR Petitions by Requesting Discovery of Real Parties-In-Interest
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
Establishing Written Description Support May Require Supporting Evidence, More Than Attorney Argument
The PTAB’s final written decision in Butamax Advanced Biofuels LLC v. Gevo, Inc. Case IPR2013-00539, Paper 33 (P.T.A.B. 2015), illustrates the importance of providing more than attorney argument to show that claims have written description support in a provisional application.
Continue Reading Establishing Written Description Support May Require Supporting Evidence, More Than Attorney Argument