As announced a few weeks back, the Patent Trial & Appeal Board (PTAB) will be taking on a limited number of law clerks. The posting on USA Jobs (here) explains that: “[t]he Judicial Law Clerk will be responsible for assisting Administrative Patent Judges in
In Cuozzo Speed Technologies, LLC v. Lee, the Supreme Court unanimously upheld the use of the broadest reasonable interpretation (BRI) of patent claims in AIA trial proceedings, and, upheld (6-2) the appeal bar for AIA trial institution decisions. While many simply assumed that the High Court would not have granted certiorari absent an interest in reversing the Federal Circuit, my take all along was that this was just a “kick of the tires” on a BRI issue the Court had not had occasion to address previously. As I, and the rest of the patent world, have beaten the BRI topic to death, let’s move onto the second issue as this one is more than a bit murky going forward.
Continue Reading Did Cuozzo Unravel Versata CBM Reviewability?
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
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
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
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.
Continue Reading PTAB Violates APA When Construing New Claim Terms in FWD
Given the increased willingness of courts to dismiss Alice cases on the pleadings, petitioners may be inclined to withhold 101 grounds from CBM petitions. This is despite the fact that patent claims that qualify for a CBM challenge are often times equally susceptible to a patent eligibility challenge. That is, claims deemed CBM-eligible must satisfy a two-part test that overlaps in material respects with the Alice framework. Still, the ability to reserve the 101 issue for the court while simultaneously pursuing a CBM seems an attractive, defense strategy.
Continue Reading Will a Failed CBM Unravel Your Alice Motion?
This Tuesday, June 7th, the USPTO’s Patent Trial & Appeal Board (PTAB) will host its June Boardside Chat webinar. The June program will address best practices for presenting patentability/unpatentability arguments before the Board. The free webinar will be hosted by from noon to 1PM (EST) by Administrative Patent Judges (APJs) Jay Moore, Christopher Crumbley, and Kal Deshpande. The webinar will include a Q&A portion for submitted questions.
Webinar access information is provided below.
Continue Reading PTAB to Host Webinar on Argument Strategy
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
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.
Continue Reading PTAB Trial Records Leveraged for Summary Judgement Wins