In what has been a rare outcome to date, the Federal Circuit in Apotex v. Wyeth, dkt. no. 2015-1871 (Fed. Cir. Aug. 16, 2016) affirmed in a non-precedential decision the PTAB’s final written decision in IPR2014-00115 that the challenged claims were not unpatentably obvious over three references. At trial, the PTAB found that Apotex did not sustain its burden of showing by a preponderance of the evidence that there was a reason to substitute the claim-recited antibiotic for a prior art antibiotic and that there was a reason to combine the three references. In its appeal, Apotex unsuccessfully argued that the structural similarity of the antibiotics provided a reason to substitute, and argued that the PTAB failed to consider reasons to combine other than solving the problem addressed by the Patent Owner.
Continue Reading Federal Circuit Affirms PTAB Upholding Patent Claims
Priority Claims Unchallenged In Prosecution Can Be Weak Links
IPR2015-00291 decided a petition filed by Daiichi Sankyo Co. Ltd. against USPN 8,168,181 owned by Alethia Biotherapeutics, Inc. The ‘181 patent issued from a continuation-in-part of the U.S. national phase of a PCT application and contains claims drawn to methods of impairing osteoclast differentiation, useful in treating various bone diseases. The Board denied the Patent Owner’s priority claim and found an attempt to antedate intervening art inadequate, leading to a holding that the ‘181 claims were unpatentable under 35 U.S.C. § 102(a). The decision illustrates the potential of intervening art not considered during prosecution and also illustrates the shifting legal view of the patentability of antibody-based technologies.
Continue Reading Priority Claims Unchallenged In Prosecution Can Be Weak Links
The Three-Front Assault: PeroxyChem Uses IPR, PGR and District Court to Challenge Opponent
In what could become a common patent challenge strategy, PeroxyChem, a chemical company that sells products useful in water and soil remediation, has employed a three-front assault—combining the relatively young post-grant review procedure, with an IPR and litigation–to take on one of its competitors, Innovative Environmental Technologies (IET). Litigation together with an IPR has become a rather common means to challenge a competitor’s patent. However, post grant review is gaining in popularity among litigants, adding to the available strategies of overcoming potential barriers to market entry for companies. For example, while 12 Petitions for PGR were filed in all of 2015, 15 have been filed so far in the first half of 2016.
Continue Reading The Three-Front Assault: PeroxyChem Uses IPR, PGR and District Court to Challenge Opponent
“It’s a Bird, It’s a Plane, NO it’s a Granted Motion to Amend.”
We previously reported the May 9, 2016, Patent Office’s study that the PTAB rarely grants motions to amend. There, we explained that patent owners rarely file motions to amend and, even when such motions are filed, the PTAB rarely grants such motions. Last week, in Google Inc. and Apple Inc., v. ContentGuard Holdings, Inc., Case CBM2015-00040, Paper 8 (PTAB June 21, 2016), the PTAB granted a Patent Owner’s motion to amend. This case is thus a rare example of the PTAB’s willingness to grant a motion to amend when the Patent Owner provides detailed arguments evidencing why a proposed, substitute claim is patentable over the “prior art known to the patent owner.”
Continue Reading “It’s a Bird, It’s a Plane, NO it’s a Granted Motion to Amend.”
Status Report on IPR Statistics for the Biotech/Pharma Technology Center
On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided a status report on Inter Partes Review/Post Grant Review in the Biotechnology and Chemical Technology Center 1600 during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference. The statistics discussed during this BCP Conference are current as of May 31, 2016.
Continue Reading Status Report on IPR Statistics for the Biotech/Pharma Technology Center
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.
Continue Reading PTAB Grants Motion to Amend Claims