On May 20, 2016, the PTAB granted Kyle Bass and Erich Spangenberg’s petition for IPR (IPR2016-00245) against a patent owned by Alpex Pharma SA (Alpex). The petition sought cancellation of claims 1-9 of U.S. Patent No. 8,440,170, asserting that the claims were obvious in view of numerous references. The claims of the ‘170 patent are generally directed to orally disintegrating tablets with a speckled appearance. According to the ‘170 patent, the speckled appearance can be achieved by using colored granules of a water-soluble sugar, and provides easy identification by doctors and patients. Bass and Spangenberg argue in the petition that the patent is invalid as obvious because speckles comprising colored granules of a water-soluble sugar were well-known in the art at the time of the invention.
Continue Reading The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition
Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs
The Federal Circuit recently affirmed the Board’s IPR decision that IBS failed to satisfy its burden of demonstrating obviousness of the challenged claims of Illumina’s U.S. Patent No. 7,566,537 (“the ‘537 patent), and determined that the Board did not abuse its discretion in refusing to consider IBS’s reply brief. Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., Case No. 2015-1693 (Fed. Cir. May 9, 2016). Illumina contended that its challenged claims, directed to a method of labeling nucleotides to determine their identity in a sequencing by synthesis (SBS) method, were nonobvious based on its use of a particular azidomethyl group as a 3′ OH blocking (or protecting) group.
Continue Reading Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs
PTAB Provides Procedural Guidance with Five Precedential Opinions
Update: The Supreme Court issued a decision on April 20, 2020 holding that the patent statute (35 U.S.C. § 314(d)) bars judicial review of a PTAB decision of whether an inter partes review petition is time-barred pursuant to 35 USC 315(b). As stated by the Court, the PTAB’s “application of §315(b)’s time limit, we hold, is closely related to its decision whether to institute inter partes review and is therefore rendered nonappealable by§314(d).”
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Original Post: The Patent Trial and Appeal Board recently designated five opinions as “precedential.” Each of these opinions addresses procedural aspects of AIA proceedings, including requests for additional discovery, the one-year time period for filing a petition, amending claims, and requirements for PTAB consideration of a petition. A summary of each opinion follows.
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Trial Verdict Means Time Has Run Out to Get a Stay
Federal district courts are inclined to stay patent litigations when requested by patent challengers on the basis that the patent-in-suit is undergoing an AIA review proceeding at the USPTO; and those not so inclined, specifically in the Eastern District of Texas, have been corrected by the Federal Circuit. But this favorable disposition toward stays occurs only up to a point. That point appears to be when the trial verdict has been rendered – even if that verdict is contrary to the PTAB’s determination.
Continue Reading Trial Verdict Means Time Has Run Out to Get a Stay
Motion(s) to Amend (Almost Always) Denied!
Responsive to public interest in whether it is too difficult for Patent Owners to amend claims during PTAB Trials, the Patent Office recently published a study providing aggregate data about motions to amend filed with the PTAB since its inception in 2013. The study, which was published by PTAB Chief Judge Nathan Kelly in the May 9, 2016 edition of the USPTO’s “Director’s Forum Blog,” confirms what the public, and certainly the patent bar, has suspected since the AIA created the PTAB to handle IPR, CBM, and PGR Trials: (1) that Patent Owners very rarely filed motions to amend, and (2) motions to amend, when filed, are rarely successful.
Continue Reading Motion(s) to Amend (Almost Always) Denied!
Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR
In IPR2015-01537, Momenta petitioned for IPR of claims 1-15 of U.S. Patent No. 8,476,239 owned by Bristol-Myers Squibb (BMS) on grounds of obviousness over three references: Cohen, Shire, and Carpenter. Petitioner also relied on expert testimony. The claims recite formulations containing CTLA4Ig, which is a stabilized form of a negative regulator (checkpoint inhibitor) of the immune system useful in treating autoimmune disease and rheumatoid arthritis, for example. The Patent Owner opposed institution by attacking the Petitioner’s position as failing to provide a reason to combine the cited references and as relying on impermissible hindsight in arriving at a formulation that satisfied all features recited in the claims (i.e., tonicity, pH, excipient concentration, excipient:therapeutic mass ratio, volume, and stability).
Continue Reading Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR
Patent Applicants Who Appeal Must Wait Their Turn with the PTAB
Biotechnology patent applicants dissatisfied with the examination of their patent applications can look to the PTAB for relief by filing an appeal – but they will need to be very, very patient. The procedures created by the America Invents Act (AIA) for challenging U.S. patents – inter partes review, post grant review, and covered business methods – have transformed strategies for contesting the validity of patents. In just a few years, the Patent Trial and Appeal Board (PTAB) has become one of the busiest forums for contesting patent validity, due in part because the PTAB must complete its review within 18 months of receiving a petition. Patent applicants dissatisfied with a patent examiner’s rejection of their patent application may appeal the rejections to the same PTAB that administers AIA trials. But, these applicants cannot expect the PTAB to decide their appeal with the same timeliness with which the PTAB completes AIA trials.
Continue Reading Patent Applicants Who Appeal Must Wait Their Turn with the PTAB
PTAB Grants Motion to Amend Claims
In IPR2015-00208, Shinn Fu petitioned for IPR of USPN 6,681,897 owned by Tire Hanger. All five claims of the patent were drawn to methods of supporting vehicle wheels removed from a vehicle while on a service lift, wherein the supports would allow technicians to remove and replace the wheels without risking back injury by bending. By all accounts, Shinn Fu mounted a strong attack against all claims in the ‘897 patent, and the PTAB instituted review. Foregoing a dogged defense of the granted claims, Tire Hanger maintained a clear head and responded to the petition by filing a contingent motion to amend the claims rather than a Patent Owner Response.
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Patent Ineligibility Under §101 Continues Slow Ooze Over More Territory
Biotech companies have increasingly found themselves the target of IPRs, and we have discussed this in some of our past posts. Meanwhile, in the District Courts, biotech companies are defending against a new wave of challenges to the patent-eligibility of their inventions under 35 U.S.C. § 101. While challenges under § 101 cannot be raised as grounds in an IPR, the PTAB has required proof of eligibility where patent owners have sought to amend their claims during IPRs. In at least two final written decisions in IPRs, the PTAB denied motions to amend claims because the PTAB concluded the amended claims recited subject matter ineligible for a patent under § 101 and in view of previous rulings in related district court proceedings that claims of similar scope were ineligible subject matter.
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Groundhog Day . . . Again: Observations on the Oral Argument in Cuozzo Speed Technologies, LLC v. Lee
The much anticipated argument in Cuozzo Speed Technologies, LLC v. Lee occurred Monday, April 25, 2016 before the United States Supreme Court. One can glean some insight from the Justices’ questions and remarks, but the ultimate outcome in this seminal decision remains uncertain. The following reflects the tenor of the remarks of seven of the Justices’ who spoke during oral argument. In keeping with his much reported practice at these arguments, Justice Thomas remained mute. The following discussion focuses exclusively on the arguments concerning whether or not the PTAB may employ the “broadest reasonable construction” standard in IPRs.
Continue Reading Groundhog Day . . . Again: Observations on the Oral Argument in Cuozzo Speed Technologies, LLC v. Lee