Two recent PTAB final written decisions highlight the benefits that the “broadest reasonable interpretation” standard for claim construction provides to Petitioners, as well as the difficulty Petitioners face in proving inherent anticipation. The PTAB instituted two IPRs on the same patent: one on an anticipation ground, and another on an obviousness ground. The Petitioner failed to prove anticipation, but prevailed on obviousness of all claims of the patent.
Continue Reading Broader is Better for the Petitioner, but Inherency is Intrinsically Difficult
Don’t Try To Observe Your Own Witness
While it is obviously frustrating when an opponent files a paper citing snippets of your own expert’s testimony out of context, a party’s attempt here to right the wrong after the fact was rebuffed by the PTAB and illustrates why mastering the PTAB’s guidelines and prior decisions, and thinking ahead with the same firmly in mind, is paramount. Seagate Technology (US) Holdings, Inc. v. Enova Technology Corp., IPR2014-01178, Paper 45 (Oct. 28, 2015).
Continue Reading Don’t Try To Observe Your Own Witness
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 Although Celltrion initially had permission to rely on testimony of BI’s expert, that permission was withdrawn after BI unilaterally requested adverse judgment in its IPRs.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
Mind The Gap: The PTAB Will Not Bridge It For You
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 Considers Qualifications To Testify Concerning The Understanding of One of Ordinary Skill
En route to holding the claims of the challenged patent invalid, the PTAB addressed two issues regarding the qualifications of a declarant providin
g testimony concerning how one of ordinary skill would understand the applied prior art. U.S. Endoscopy Group, Inc. v. CDX Diagnostics, Inc., IPR2014-00639, Paper 27 (Sept. 14, 2015). The first issue was whether the declarant needed to be qualified as an “expert” on the relevant subject matter under Fed.R.Evid. 701, 702, at least in instances where the testimony was not sought to be excluded.
Continue Reading PTAB Considers Qualifications To Testify Concerning The Understanding of One of Ordinary Skill
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
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