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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

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A PTAB decision denying a patent owner’s motion for discovery concerning privity illustrates what may be a carefully-structured business transaction that permitted a petitioner to avoid the effect of the one-year time-bar for filing a petition under 35 U.S.C. § 315(b). 
Continue Reading Petitioner Avoids One-Year Time Bar by Acquiring ANDAs after Filing IPR Petition

While the Federal Circuit has accepted, en banc, the question of what a patent owner must demonstrate to the Board to obtain leave to amend its claims in an IPR as discussed in our earlier blog post (In re Aqua Products, No. 2015-1177 petition for rehearing en banc granted, 2016 WL 4375651 (Fed. Cir. Aug. 12, 2016)), the court provided some guidance this week on what is not a sufficient basis for denying a motion to amend.
Continue Reading A Limit on the Board’s Power – Denial of Motion to Amend Claims was Unreasonable

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The PTAB’s August 22, 2016, decision in IPR2013-00440 on remand from the Federal Circuit, Dell, Inc. v. Acceleron, LLC,¹ sheds light on how the PTAB may treat seemingly new or different arguments raised post-petition.  After Dell, and as discussed below, practitioners may expect the PTAB to exercise a greater degree of scrutiny when considering arguments that differ from those raised in the original petition, or that are otherwise not responsive to a patent owner’s positions raised in a response.  See 37 C.F.R. § 42.23(b).  For petitioners, the decision should serve as a reminder that petitioners should satisfy their burden of proof based on arguments made in the petition, including originating alternative theories of invalidity where identified.  For patent owners, the decision suggests that the PTAB may be more receptive to entertaining motions or arguments from patent owners seeking to respond to allegedly new or different arguments raised post-petition.
Continue Reading PTAB’s Decision on Remand in Dell v. Acceleron Shows Strict treatment of Post-Petition Arguments

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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

3d render - Telephone directoryIn Arendi S.A.R.L. v. Apple, Inc., Appeal No. 2015-2073 (Fed. Cir. 2016), the Federal Circuit reversed the PTAB’s final written decision canceling claims for obviousness, on the basis that the PTAB improperly relied on “common sense” to determine that the claims were obvious.

The challenged patent is directed to a computer-implemented method for providing beneficial coordination between a first computer program displaying a document and a second computer program for searching an external information source. The Board determined that the claims were obvious over a single reference (Pandit), although Pandit did not expressly disclose a step of “performing a search” of an information source, as recited in the claims. 
Continue Reading Federal Circuit Identifies Limits to the Application of “Common Sense” in an Obviousness Analysis

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

Equal Arm _ Balance ScaleThe Federal Circuit’s precedential decision in In re: Warsaw Orthopedic, Inc., No. 2015-1050, 2015-1058 (Fed. Cir. Aug. 9, 2016), highlights recurring themes in appeals of PTAB IPR decisions.  On one hand, the Federal Circuit is reluctant to overturn a PTAB decision canceling claims for obviousness based on Patent Owner’s assertions that the PTAB failed to properly weigh certain facts found in reaching its decision.  On the other hand, the Federal Circuit will not hesitate to vacate and remand PTAB decisions where the PTAB does not adequately describe its reasons for concluding a claimed invention is obvious. 
Continue Reading Federal Circuit Refuses to Reweigh Factual Findings, But PTAB’s Conclusory Statements Are Insufficient

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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.
Continue Reading Federal Circuit Reaffirms that Phillips applies when Patent has expired

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.