To date, only 43 petitions for Post-Grant Review have been filed with the PTAB.  Nine PGR petitions (21% of total petitions) have been filed to challenge patents arising from Art Unit 1600, which examines applications directed to biotechnology and organic chemistry subject matter.  The PTAB recently instituted the third ever PGR for a biotech-related patent in B.R.A.H.M.S. Gmbh v. Becton, Dickinson & Co., PGR2016-00018.

The petitioner requested PGR of claims 1-12 of U.S. Patent No. 9,091,698, directed to a method for the advanced detection of sepsis in a systemic inflammatory response syndrome (SIRS)-positive subject involving measuring procalcitonin levels and one or more clinical markers over multiple time points, wherein an increase in the amount of procalcitonin from a previous amount over a 24-hour interval detects sepsis. 
Continue Reading PTAB Institutes Third Biotech/Pharma Post-Grant Review

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In considering a novel issue of Post-Grant Review (PGR) eligibility, the Patent Trial and Appeal Board followed the straightforward language of the America Invents Act (“AIA”), and longstanding precedent, holding that post-filing amendments to a pre-AIA patent application do not change its effective filing date and, thus, do not make it eligible for PGR.  David O.B.A. Adebimpe v. Doang-Trang T. Vu & The Johns Hopkins Univ., Case PGR2016-00020, Paper No. 14 (P.T.A.B. July 25, 2016).
Continue Reading Post-Filing Claim Amendments Don’t Change the Effective Filing Date for Post Grant Review

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The Patent and Trial Appeal Board invoked the doctrine of prosecution history disclaimer to construe the claims at issue narrowly for the inter partes review of U.S. Patent No. 5,884,033; and thus, concluding that the claims had not been shown to be unpatentable in light of prior art. The Board rejected the Petitioner’s additional arguments that the claims as construed were not adequately described in the specification. The Board noted that it was not proper for it to consider whether the claims as construed were valid under 35 U.S.C. §112, first paragraph.
Continue Reading No Written Description, No Problem when Prosecution History Disclaimer is Applied

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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

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The PTAB has continued the trend of pushing the -“antibody exception” to written description into an ever-smaller corner. Claims to methods of using antibodies that bind Siglec-15 to impair osteoclast differentiation and inhibit bone resorption were deprived of priority because the parent application failed to disclose the “antigenic regions useful for generating antibodies having the desired functional properties.” Consequently, the claims were anticipated by the cited reference under 35 U.S.C. §102(a), and Patentee’s other evidence of prior conception, diligence and reduction to practice was insufficient to antedate the reference. Daiichi Sankyo Co., Ltd. v. Alethia Biotherapeutics, Inc., IPR2015-00291 (Paper No. 75, June 14, 2016) (final written decision).
Continue Reading Squeezing the ‘Antibody Exception’ to Written Description into a Corner

In a recent appeal from a PTAB final written decision, the Federal Circuit determined that a patentee was not denied notice or an opportunity to respond to references cited in the final written decision as representing the state of the art,  but that were not the basis for a grounds for institution.  (Genzyme Therapeutic Prods. Ltd. v BioMarin Pharm. Inc., Appeal Nos. 2015-1720, -1721 (Fed. Circ., June 14, 2016)).  The court concluded that there is no requirement, either in the PTAB’s regulations, in the Administrative Procedure Act (APA), or as a matter of due process, for the institution decision to anticipate and set forth every legal or factual issue that might arise during the trial, and that the PTAB acted properly in citing the additional references. 
Continue Reading Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution

The transitional program for covered business method (CBM) patents is a review proceeding administered by the Patent Trial and Appeal Board to reconsider the patentability of one or more claims in a CBM patent. Uphill BattlePetitioners seeking CBM review have enjoyed good success in knocking out claims for reciting subject matter ineligible for a patent. They have not, however, enjoyed similar success when challenging claims under 35 USC § 112 (concerning clarity, enablement, or written description).
Continue Reading Petitioners Are Not Faring Well on 112-challenges in CBM Review

The PTAB’s final written decision in Butamax Advanced Biofuels LLC v. Gevo, Inc. Case IPR2013-00539, Paper 33 (P.T.A.B. 2015), illustrates the importance of providing more than attorney argument to show that claims have written description support in a provisional application. 
Continue Reading Establishing Written Description Support May Require Supporting Evidence, More Than Attorney Argument