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.
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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.
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PTAB Requests Further Briefing on Petition for Sanctions Against Hedge Fund Coalition
The PTAB recently revisited Patent Owners’ requests to file motions for sanctions against the Petitioner, Coalition for Affordable Drugs (“CFAD”). The CFAD was started in conjunction with hedge fund manager Kyle Bass, who has been accused of filing IPRs in order to manipulate company stock price for his hedge fund’s monetary gain. Recently, in Coalition for Affordable Drugs v Celgene Corp. (IPR2015-01169), the PTAB authorized Celgene to file a Petition for Abuse of Process against CFAD.
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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.
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USPTO Proposes Single APJ Pilot Program for IPR Institution
Citing an interest in improving efficiency, the USPTO published a request for comments on a proposed pilot program that would change the way Inter Partes Review petitions are decided. 
Currently, a panel of three administrative patent judges (APJs) consider IPR petitions and determine whether to institute and conduct a trial. The trial is then conducted before the same panel of APJs, which issues a final written decision on the merits.
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AIA Rule Changes About Patent Owner Responses and Misconduct
On August 20, the USPTO published for comment in the Federal Register proposed changes to the rules governing PTAB trials. In general, the proposed amendments address the claim construction standard applied by the Board, evidence that may be included in the patent owner’s response, and a Rule 11-like misconduct standard for practitioners before the PTAB.
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PTAB Provides Roadmap for Petitioning for IPR of Design Patents
Less than one percent of petitions for inter partes review (“IPR”) involve design patents. This is not surprising, as over 9,000,000 United States utility patents have issued compared to only about 735,000 design patents. Several recent developments in design patent law, however, may narrow the gap as applicants look for less expensive ways to enhance their portfolios. 
For example, U.S. design patents filed on or after May 13, 2015 enjoy a 15-year term with no maintenance fees. And U.S. design patent applicants may now file their design applications under the Hague Agreement, which publish six months after filing.
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Does Frequent Denial Of Motions To Exclude Evidence In IPRs Encourage Evidence Dumping?
Exclusion of evidence before the Patent Trial and Appeal Board in an Inter Partes Review is governed by the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, (Aug. 14, 2012), which states that a motion to exclude “must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.” Id at 48767. 
This provides little guidance to the party trying to exclude evidence in an IPR, and the frequent denial of Motions to Exclude in IPRs seems to encourage parties to include any and all possible evidence, even some that might not be admissible, and simply rely on the Board to consider the proper weight to give it.
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PTAB Clarifies Meaning of Prior Art “Of Record” and “Known” In Context of a Motion to Amend – What Now?
In MasterImage 3D, Inc. v. RealD Inc., the Patent Trial and Appeal Board (PTAB) reaffirmed that the patent owner bears the burden of establishing the patentability of any amended claims proposed in an AIA trial over two categories of prior art: (a) the “prior art of record” and (b) “prior art known to the patent owner.” IPR2015-00040, Paper 42 (PTAB July 15, 2015). Nothing new there. What is new is the PTAB’s “clarification” of what constitutes such prior art:
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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.
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