Inter Partes Review

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RPI Determination Under 315(b) Focuses on Litigation Control

In determining whether a party is a real party-in-interest subject to the one-year statutory bar of 35 U.S.C. § 315(b), the focus of the Patent Trial & Appeal Board (PTAB) to date has been honing in on the exercise of control over the earlier filed patent infringement lawsuit. The PTAB recently considered whether control of the allegedly infringing activity is enough to transform a party not named in the original complaint to an RPI for 315(b) purposes in Department of Justice v. IRIS Corporation Berhad, Case IPR2016-00497, slip op. at 7-9 (PTAB Jul. 25, 2016) (Paper 7).
Continue Reading Intervenor Activities & PTAB RPI Determinations

Anti-Competitive IPR Settlements for Orange Book Patents?

The Patent Trial & Appeal Board (PTAB) has the power to terminate an Inter Partes Review (IPR), Post Grant Review (PGR), or Transitional Proceeding for Covered Business Method Patents (CBM) upon request of the parties. As provided in 35 U.S.C. 317 (b), such settlement agreements must be in writing, and submitted to the agency before the proceeding can be terminated.  These submissions may be, at party request, maintained as business confidential— not surprisingly, almost all are submitted under seal.  The statute explains that the the confidential nature of these settlements will be generally maintained, but “shall be made available only to Federal Government agencies on written request, or to any person on a showing of good cause.”

The rationale behind making these agreements available to government agencies in particular is to safeguard the public from ant-competitive practices. Some commentators have begun to question whether or not “reverse payment” settlements are being made to terminate PTAB trial proceedings involving Orange Book patents.

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Continue Reading Reverse Payment PTAB Settlements in Bio/Pharma?

CAFC Clarifies Burden of Production in AIA Trial Proceedings

In patent examination, once a prima facie case of obviousness is presented in a rejection by the agency, the burden of production switches to the Applicant. In AIA trials, such as Inter Partes Review (IPR) there are no “rejections,” instead, there are “grounds” of unpatentability. These grounds are first presented in a petition, and if satisfying the reasonable likelihood of prevailing standard, instituted for trial by the Patent Trial & Appeal Board (PTAB).  However, institution of a trial ground by the agency is not the same as establishing a prima facie case. 

As the Federal Circuit held yesterday in In re Magnum Oil Tools Int’l, Ltd. the burden of production does not shift to the patentee upon trial institution.
Continue Reading PTAB Institution is Not Akin to Rejection in Patent Examination

Much Maligned PRPS to Phase Out Shortly

In the rush to develop an e-filing system in the months ahead of September 16, 2012, the USPTO deployed a serviceable e-filing system for AIA trial proceedings known as the Patent Review Processing System (PRPS).  While understandable given the time constraints to pull it together, PRPS was a bare bones system that left much to be desired.  Since then, PRPS has done its job, but, the agency has been developing a new, and improved system.  Halleluljah!

That new system is called Patent Trial and Appeal Board End to End (PTAB E2E).  PTAB E2E uses a web browser…
Continue Reading PTAB To Debut New E-Filing System July 9th

HUMIRA® Subject to Additional IPRs

Guest Post by Tia Fenton & Jeff McIntyre

As discussed previously, biosimilar applicants can gain significant strategic advantage by availing themselves of Patent Trial & Appeal Board (PTAB) patent challenge mechanisms. Last week, the Board agreed to consider two additional patentability disputes over AbbVie’s HUMIRA® drug (IPR2016-00188 and IPR2016-00189).
 
In the new ‘188 and ‘189 IPRs, Coherus challenged the patentability of AbbVie’s U.S. Patent Nos. 9,017,680 (“the ‘680 patent) and 9,073,987 (“the ‘987 patent”), respectively.  The ‘680 and ‘987 patents are two of a series of patents covering various aspects of AbbVie’s HUMIRA® drug.  HUMIRA®, one of the top selling drugs in the world, is used to treat numerous autoimmune diseases including rheumatoid arthritis. Coherus announced its plans to file an application to market a biosimilar version of HUMIRA® in the second half of 2016 and filing IPRs against HUMIRA® patents is part of Coherus’s strategy for entering the market.
Continue Reading BioSimilar Battle Expands at PTAB

Instituted Grounds Can be Supported with New Evidence Not Present in Petition/Institution Decision

Within the past week, the Court of Appeals for the Federal Circuit (CAFC) has issued two significant opinions on AIA trial practice—both of which explain the critical import of the Administrative Procedure Act (APA). As discussed earlier this week, 5 U.S.C. § 554(b)(3) prevents the Patent Trial & Appeal Board (PTAB) from introducing new claim interpretation theories without notice, or opportunity to respond in SAS Institute Inc., v. ComplemenSoft LLC. On the heels of that decision comes perhaps an even more significant decision in Genzyme Therapeutic Products LP v. BioMarin Pharmaceutical Inc.

In Genzyme, the Court dispelled a widely held belief held by many practitioners and PTAB judges alike.  Namely, that an AIA trial petition must function as a storehouse for all possible evidence and arguments.  In a plainly worded opinion the Federal Circuit found that “[t]he purpose of the trial in an inter partes review proceeding is to give the parties an opportunity to build a record by introducing evidence—not simply to weigh evidence of which the Board is already aware.” (emphasis added) (here)

Simply stated, this decision is an AIA trial practice game changer.
Continue Reading CAFC Makes Clear New Evidence During AIA Trials is Expected

Pre-Suit Opinion of Counsel/PTAB Challenge Critical to Avoiding Enhanced Damages

Section 284 of the Patent Act provides that, upon a finding of patent infringement, courts “may increase the damages up to three times the amount found or assessed.” Up until this past Monday, the Federal Circuit’s en banc decision in In re Seagate Technology, LLC controlled  this determination, requiring patentees to show that an accused infringer’s actions were both objectively and subjectively reckless—both by clear and convincing evidence.

Needless to say, patentees rarely met these exacting burdens of proof.  

In most cases, accused infringers would raise ex post infringement defenses that raised “a substantial question as to the validity or non-infringement of the patent” to negate a finding of objective recklessness. In other words, even if the infringer was unaware of the colorable defense when infringement began, Seagate’s-objective prong could provide a get-out-of-jail free card if a colorable defense was later developed during trial. The ability to wait for a lawsuit was an especially cost effective tool for in-house counsel that hoped to avoid costly, proactive strategies such as procuring an opinion of counsel, or openly challenging the patent on at the PTAB.  That is, pre-suit, smoking gun evidence of infringement was readily negated by a proficient trial defense. 

The game has now changed—significantly—with the Supreme Court’s decision this week in Halo Elecs. v. Pulse Elecs (here)…
Continue Reading How The PTAB Can Maintain Your Willfulness Halo

APA Precludes New Theories Absent Requisite Notice § 554(b)(3)

The Patent Trial & Appeal Board (PTAB) will often change its construction of a disputed claim term over the course of an AIA patent trial proceeding. What was less clear, however, was whether or not the Board had the authority to advance an entirely new claim construction of its own—of  a term not in dispute—for the first time, at final decision. This practice, occurring with increasing frequency as of late, was addressed last Friday by the Federal Circuit.

This decision will have significant impact on both PTAB trial and appeal practice going forward.

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Continue Reading PTAB Violates APA When Construing New Claim Terms in FWD

Unpredictable Arts = Unpredictable Success at PTAB

In a previous post I noted the growing interest from Bio/Pharma in the patent challenge mechanisms of the Patent Trial & Appeal Board (PTAB).  While the Board offers strategic value, speed and a cost effective, technical review, these benefits are not without risk. Recent statistics out of the PTAB demonstrate that patent challenges in the unpredictable arts are far more likely to fail as compared to those in the predictable arts.  

Going forward, the PTAB institution rate for bio/pharma will drop even further.
Continue Reading Bio/Pharma Patents To Prove a Tougher Sell at PTAB

Impact of Concluded PTAB Proceedings on Litigation

Patent challenge proceedings of the USPTO’s Patent Trial & Appeal Board (PTAB) are designed to provide a low cost, expedited option to district court litigation. Of course, if a patent challenger is unsuccessful at the PTAB, the district court is left to make the ultimate resolution on validity.  Now several years into the PTAB’s existence, closed AIA trial records are being leveraged by the courts to resolve disputed issues of fact.  

Especially as to matters of claim scope, the PTAB’s expansion of the intrinsic record is providing courts with a short cut in assessing otherwise thorny factual determinations. Accused infringers are beginning to favorably leverage this record in related litigation—such as in a motion for summary judgment.   

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Continue Reading PTAB Trial Records Leveraged for Summary Judgement Wins