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 Cir. Aug. 16, 2016) affirmed in a non-precedential decision the PTAB’s final written decision in IPR2014-00115 that the challenged claims were not unpatentably obvious over three references.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
Federal Circuit Reaffirms that Phillips applies when Patent has expired
It is well accepted that the broadest reasonable interpretation (BRI) standard, which the PTO employs during patent examination, and not the Phillips standard applied in district court proceedings, is generally the proper standard to be used when interpreting claims in Post-Grant proceedings such as IPRs and reexamination proceedings. However, in In Re CSB-System International, Inc., Appeal No. 2015-1832, the Federal Circuit reminded the PTAB that the BRI standard is not to be applied in all Post-Grant proceedings. Instead, the Federal Circuit reaffirmed its precedent that “when an expired patent is subject to reexamination, the traditional Phillips construction standard attaches.” (p. 8). The court further held that the Phillips standard also applies when the patent expires during reexamination.
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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.
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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.
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“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.”
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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.
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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.
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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