The Federal Circuit recently vacated or reversed-in-part two PTAB final written decisions on the basis that the PTAB did not adequately describe its reasons for concluding the claimed invention is obvious. In both instances, the court criticized the Board’s “broad, conclusory statements” regarding one of ordinary skill’s motivation to adjust prior art teachings. These decisions highlight an attractive grounds for appealing a PTAB’s final written decision.
Continue Reading Federal Circuit to PTAB – Explain yourself!!
The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition
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.
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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.
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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.
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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.
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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.
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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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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.
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On the Clock: Appellate Standard of Reviewing PTAB’s AIA Trial Decisions
Now that Cuozzo Speed Techs., LLC v. Lee has been submitted to the Supreme Court, the next issue that may well make its way to the Court is the propriety of the Federal Circuit’s standard of reviewing the PTAB’s AIA trial decisions. Currently, the Federal Circuit reviews these decisions for substantial evidence. At least four Federal Circuit Judges do not, however, think that the court’s application of that review standard is consistent with the AIA and have concluded that the standard makes too little sense in the context of an appeal from the PTAB’s IPR decision. But because the court is bound by Supreme Court precedent to apply that standard of review, the Federal Circuit issued an order denying a petition Merck & Cie recently filed asking the full Federal Circuit to rehear a late-2015 decision issued by a divided three-judge panel in Merck & Cie v. Gnosis S.p.A., 808 F.3d 829 (Fed. Cir. 2015) (discussed here and here), rehearing en banc denied (Apr. 26, 2016) (order linked here).
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