Sections 102/103

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In two final written decisions (IPR2015-01093 and IPR2015-00990), the PTAB found that challenged claims in Shire’s U.S. Patent No. 7,056,886 (the ’886 patent) were invalid as obvious.  The decisions highlight potential issues related to patents directed to pharmaceutical formulations that petitioners and patent owners alike may want to consider if confronted with an IPR related to such subject matter.

The Coalition for Affordable Drugs filed two petitions for IPR, one challenging claims 1−45 of U.S. Patent No. 7,056,886 (IPR2015-01093) and one challenging claims 46−52 and 61−75 of the ’886 patent (IPR2015-00990). 
Continue Reading PTAB Cancels Gattax® Patent Claims in Coalition for Affordable Drugs IPRs

Woman whispering to her friend

The Federal Circuit reversed, in part, a PTAB final written decision after determining that several emails, wrongly excluded as hearsay, showed the inventor’s conception prior to allegedly anticipating art.  In REG Synthetic Fuels, LLC v. Neste Oil Oyj,  No. 2015-1773 (Fed. Cir. Nov. 18, 2016), the Federal Circuit reversed the PTAB’s finding that a prior art reference anticipated the challenged claims directed to a certain paraffin composition.  The Federal Circuit determined that emails the PTAB wrongly excluded from evidence sufficiently established that the Patent Owner conceived the invention before the filing date of the prior art reference.
Continue Reading Federal Circuit Reverses PTAB’s Anticipation Decision: Proof of Prior Conception Improperly Excluded as Hearsay

Members OnlyOn July 27, 2018, the Federal Circuit issued an opinion vacating the GoPro, Inc. decision discussed in the post below.

On June 11, 2018, the Federal Circuit issued a decision vacating and remanding the Medtronic decision discussed in the post below.

An updated discussion of the Medtronic decision is available here:
PTAB Failed to Properly Apply Test for Printed Publication

Two recent PTAB decisions highlight important developments in qualifying a publication as a reference, available as prior art.  In one case, the PTAB concluded that a printed catalog did not qualify as a printed publication prior art because it was distributed only at a private tradeshow to persons not necessarily skilled in the art.  In the other case, the PTAB concluded that a video and associated slide presentation did not qualify as printed publications because these materials were distributed only to experts at a private, invitation-only conference.  These decisions interpret precedents from the Federal Circuit and offer simple examples of what type of publications may not qualify as prior art.
Continue Reading Prior Art Made Available at Members Only Gatherings May Not Satisfy “Publically Accessible” Requirement

Failure Concept

On October 17, 2016, the PTAB denied institution of three IPRs [IPR2016-00912, IPR2016-00915, and IPR2016-00916] petitioned by Swiss Pharma AG against three patents owned by Biogen IDEC directed to its anti-α4 integrin antibody product, TYSABRI (natalizumab), marketed to treat multiple sclerosis and Crohn’s disease. The PTAB weighed the Petitioner’s assertions of routine experimentation against the Patent Owner’s arguments of unpredictability in deciding the outcome.Continue Reading PTAB Denies Institution of 3 IPRS Against Biogen’s TYSABRI® (natalizumab)

Woman Upset Hitting Forehead with her HandIn IPR 2015-01127, PAR Pharmaceuticals, challenged claims 1-11 of USPN 8,404,215 owned by Horizon Therapeutics, LLC on grounds of obviousness over various combinations of six references.  Lupin Ltd. and Lupin Pharmaceuticals, Inc. filed another challenge to the claims of the ‘215 patent on the same grounds using the same arguments and evidence as used by PAR.  The Board joined the two proceedings and construed the claims-at-issue in accordance with the plain meaning of the recited terms, crediting the unrebutted testimony of Petitioners’ expert in holding the claims unpatentably obvious under 35 U.S.C. § 103(a) over various combinations of the cited art.
Continue Reading Ignore Occam’s Razor at your Peril

A modified one way street sign indicating Second Chance

This blog previously referenced Athena Automation Ltd. v. Husky Injection Molding Systems Ltd., IPR2013-00290 as an example of the Board granting a request for rehearing, but ultimately confirming its original decision.  On appeal, the Federal Circuit vacated the Board’s decision on the particular issues raised by the Petitioner in the request for rehearing, suggesting that if at first you don’t succeed, try again at the Federal Circuit.  Husky Injection Molding Systems Ltd. v. Athena Automation Ltd., 2015-1726, 2015-1727 (Fed. Cir. Sep. 23, 2016). (As we will discuss separately, on the Patent Owner’s cross-appeal, the Federal Circuit determined that it lacked authority to review the PTAB’s refusal to extend the equitable doctrine of assignor estoppel to PTAB proceedings.)
Continue Reading PTAB Failed to Properly Apply Incorporation by Reference Standard for Anticipation

Traditional wooden Pinocchio toy. Italy.

In a recent non-precedential decision, the Federal Circuit suggested a very expansive interpretation for the oft-used phrase “adapted to.” Relying upon the prosecution history, the Federal Circuit determined that the Board correctly construed claims relating to interactive video programming, and on that basis affirmed the Board’s decision that the claims were anticipated by a prior art reference. Intertainer, Inc. v. Hulu, LLC, No. 2015-2065 (Fed. Cir. Sept. 26, 2016) (non-precedential).Continue Reading Federal Circuit Suggest Expansive Interpretation of “Adapted to” in Affirming CBM Cancellation

A set of three gummy letters in the shape of X isolated on white

In a series of unfortunate events for Teva Pharmaceuticals, three patents covering methods for administering the blockbuster multiple sclerosis (MS) drug Copaxone® (glatiramer acetate) (owned by Yeda Research and Development Co.) were struck down by the PTAB in recent IPR decisions (IPR2015-00830, IPR2015-00643, and IPR2015-00644).  These patents are directed to methods for administering Copaxone in a 40 mg dosage form, 3 times per week to treat relapsing-remitting MS:  U.S. Patent Nos. 8,232,250, 8,399,413 and 8,969,302.
Continue Reading 3 Is a Magic Number for Mylan: 3 Teva Copaxone Patents Struck Down in IPRs

Teenage driver adjusting the rear view mirror

On August 23, 2016, the PTAB denied Mylan Laboratories Limited’s (Mylan) petition for IPR (IPR2016-00627) against a patent owned by Aventis Pharma S.A. (Aventis). In doing so, the PTAB offered guidance regarding what is required to successfully make out a claim of obviousness regarding a new chemical compound. In particular, the PTAB’s decision offers insight into the threshold a petitioner will need to meet in order to establish that a person of ordinary skill in the art would have recognized a prior art reference as “promising to modify.”
Continue Reading IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments

The PTAB recently issued a final written decision in an inter partes review (IPR), refusing to cancel claims in Verinata Health, Inc.’s U.S. Patent No. 8,318,430.  Ariosa Diagnostics v. Verinata Health, Inc., Cases IPR2013-00276 and -00277 (P.T.A.B. Aug. 15, 2016). The claims are directed to methods for determining the presence or absence of fetal aneuploidy in a fetus.  This is the second such decision from the PTAB.  The first decision was the subject of an appeal to the Federal Circuit. Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015). In that appeal, which we previously discussed, the court vacated the PTAB’s prior conclusion of nonobviousness because the court could not discern from the appeal record that the PTAB properly considered the prior art. In its recent decision, the PTAB has considered that prior art, but nevertheless reaches the same conclusion of nonobviousness.
Continue Reading PTAB Accords Little Weight to Evidence without Analysis or Explanation

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

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Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.