This Blog previously highlighted the risks involved when a petitioner does not submit an expert declaration with their petition. This risk may be lessened where the “the invention and prior art references are directed to relatively straightforward and easily understandable technology.” [Paper No. 41 at 17 n.6 of IPR2014-00169] (ruling in favor of petitioner despite its failure to present expert declaration until its Reply brief). However, a petitioner should strongly consider submitting an expert declaration to support their arguments in technology areas that are considered complex.
Continue Reading It’s Complicated: PTAB Reinforces Notion That Petitioners Should Consider Expert Testimony in Complex Technology Areas
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
A Second Bite at the Apple? Kyle Bass’s CFAD is Awarded IPR Institution of Follow-on Petitions
Remember when the PTAB denied institution of two IPR petitions filed by Kyle Bass’s Coalition for Affordable Drugs V LLC’s (CFAD) against Acorda Therapeutics, Inc. (Acorda)? Well, if at first you don’t succeed, try citing different prior art!
Continue Reading A Second Bite at the Apple? Kyle Bass’s CFAD is Awarded IPR Institution of Follow-on Petitions
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
Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties
In a recent order by the magistrate judge in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (NJD, Jan. 22, 2016), defendants Amneal Pharmaceuticals and Par Pharmaceuticals were reprimanded and threatened with sanctions and monetary fines for trying to use confidential information from the litigation to move for additional discovery in a related IPR proceedings. The judge ruled this behavior violated a Discovery Confidentiality Order (DCO) in place in the litigation.
Continue Reading Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties
PTAB Reminds Petitioners That Conclusions in Expert Declarations Must be Supported by Explanations
On January 19, 2016, the PTAB denied Coalition for Affordable Drugs V LLC’s (CFAD) request for rehearing following the Board’s decision denying institution of IPR. In IPR2015-01086, CFAD filed a petition requesting an IPR of claims 1–13 in Biogen International GmbH’s (Biogen) U.S. Patent No. 8,759,393. The Board denied the petition and CFAD filed a request for rehearing on the (same) grounds of anticipation and obviousness. As discussed below, the denial of the rehearing highlights the importance of supporting all conclusions in an expert declaration with reasoned explanations.
Continue Reading PTAB Reminds Petitioners That Conclusions in Expert Declarations Must be Supported by Explanations
PTAB Warns Again That Prosecution Declarations Without Depositions May Be Given Little or No Weight
If you rely in an IPR on a declaration submitted during prosecution, the PTAB may give it little or no weight if your opponent cannot cross-examine the declarant.
In Praxair Distribution, Inc. v. INO Therapeutics LLC, the PTAB instituted inter partes review of U.S. Patent No. 8,846,112, directed to methods of providing nitric oxide gas for treating newborn children suffering from hypoxia.
In response, the Patent Owner relied not only on a supporting expert declaration, but also on three declarations submitted during prosecution of the ’112 patent.
Continue Reading PTAB Warns Again That Prosecution Declarations Without Depositions May Be Given Little or No Weight
Broader is Better for the Petitioner, but Inherency is Intrinsically Difficult
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
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