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This blog has previously explained on July 23, 2015, December 10, 2015, and December 16, 2015 why it is important for parties to AIA trials to carefully consider the patent prosecution history.  Under 35 U.S.C. § 325(d), the Board has discretion to deny an AIA trial if “the same or substantially the same prior art or arguments previously were presented to the Office.”  The Board recently exercised that discretion in denying an inter partes review petition and, in doing so, provided yet another warning to petitioners: do not waste the Board’s time presenting in a petition prior art and arguments that were already considered during prosecution, and be sure to address deficiencies in prior art combinations the patentee overcame during prosecution.  Drug Prices for Consumers,  LLC v. Forest Labs. Holdings Ltd., Case IPR2016-00379, Paper 14 (PTAB July 1, 2016).
Continue Reading Been There, Done That: Petitioners Should Find Art and Arguments Not Previously Considered During Prosecution

The Board initially denied institution of Mylan Pharmaceuticals’ petition for inter partes review of U.S. Patent No. RE44,186, owned by AstraZeneca.  After a rare grant of Mylan’s request for rehearing, the Board reconsidered the record and decided to institute the IPR.  The decision to institute focused on the content of Mylan’s expert testimony; and although not mentioned in the decision, the replacement of one APJ in the PTAB panel for the decision on rehearing might have played a role in the grant of the request for rehearing and the decision to institute the IPR on rehearing even though both decisions were unanimous.
Continue Reading Rare Grant of Rehearing of Denial of Petition for Inter Partes Review

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

Gavel and PillOn May 20, 2016, the PTAB granted Kyle Bass and Erich Spangenberg’s petition for IPR (IPR2016-00245) against a patent owned by Alpex Pharma SA (Alpex).  The petition sought cancellation of claims 1-9 of U.S. Patent No. 8,440,170, asserting that the claims were obvious in view of numerous references.  The claims of the ‘170 patent are generally directed to orally disintegrating tablets with a speckled appearance.  According to the ‘170 patent, the speckled appearance can be achieved by using colored granules of a water-soluble sugar, and provides easy identification by doctors and patients.  Bass and Spangenberg argue in the petition that the patent is invalid as obvious because speckles comprising colored granules of a water-soluble sugar were well-known in the art at the time of the invention.
Continue Reading The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition

Line of business people in profileBiotechnology 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

This Blog previously highlighted the risks involved when a petitioner does not submit an expert declaration with their petition.  This risk may be lessened where the “the invention and prior art references are directed to relatively straightforward and easily understandable technology.” [Paper No. 41 at 17 n.6 of IPR2014-00169] (ruling in favor of petitioner despite its failure to present expert declaration until its Reply brief).  However, a petitioner should strongly consider submitting an expert declaration to support their arguments in technology areas that are considered complex. 
Continue Reading It’s Complicated: PTAB Reinforces Notion That Petitioners Should Consider Expert Testimony in Complex Technology Areas

AppleRemember when the PTAB denied institution of two IPR petitions filed by Kyle Bass’s Coalition for Affordable Drugs V LLC’s (CFAD) against Acorda Therapeutics, Inc. (Acorda)?  Well, if at first you don’t succeed, try citing different prior art! 
Continue Reading A Second Bite at the Apple? Kyle Bass’s CFAD is Awarded IPR Institution of Follow-on Petitions

Bumble beeIn a recent order by the magistrate judge in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (NJD, Jan. 22, 2016), defendants Amneal Pharmaceuticals and Par Pharmaceuticals were reprimanded and threatened with sanctions and monetary fines for trying to use confidential information from the litigation to move for additional discovery in a related IPR proceedings.  The judge ruled this behavior violated a Discovery Confidentiality Order (DCO) in place in the litigation.  
Continue Reading Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties

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On January 19, 2016, the PTAB denied Coalition for Affordable Drugs V LLC’s (CFAD) request for rehearing following the Board’s decision denying institution of IPR.  In IPR2015-01086, CFAD filed a petition requesting an IPR of claims 1–13 in Biogen International GmbH’s (Biogen) U.S. Patent No. 8,759,393.  The Board denied the petition and CFAD filed a request for rehearing on the (same) grounds of anticipation and obviousness.  As discussed below, the denial of the rehearing highlights the importance of supporting all conclusions in an expert declaration with reasoned explanations.
Continue Reading PTAB Reminds Petitioners That Conclusions in Expert Declarations Must be Supported by Explanations

Pen poised to sign a declaration. Classic silver and gold ballpoint, shallow depth of field.

If you rely in an IPR on a declaration submitted during prosecution, the PTAB may give it little or no weight if your opponent cannot cross-examine the declarant.

In Praxair Distribution, Inc. v. INO Therapeutics LLC, the PTAB instituted inter partes review of U.S. Patent No. 8,846,112, directed to methods of providing nitric oxide gas for treating newborn children suffering from hypoxia.

In response, the Patent Owner relied not only on a supporting expert declaration, but also on three declarations submitted during prosecution of the ’112 patent.
Continue Reading PTAB Warns Again That Prosecution Declarations Without Depositions May Be Given Little or No Weight

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.