Tag Archives: Biotechnology

Kyle Bass Gets Fresenius’ Diprivan Claims Canceled in IPR

On June 7, 2017, the PTAB issued a final written decision in IPR 2016-00254 canceling claims in a Fresenius Kabi USA, LLC (Fresenius) patent covering Diprivan®. The PTAB instituted the IPR in response to a petition filed by hedge fund manager Kyle Bass and his colleague Erich Spangenberg. Diprivan® is the commercial name for propofol, … Continue Reading

One-Year Time Bar Does Not Apply to a Request for Joinder of IPR Proceedings

Teva Pharmaceuticals USA, Inc. (“Teva”) filed a Petition, seeking an IPR of claims 1–20 of Allergan’s U.S. Patent No. 8,642,556. [IPR2017-00579, Paper No. 9]  Along with the Petition, Teva filed a Motion for Joinder to join Mylan Pharmaceuticals Inc. v. Allergan, Inc., IPR2016-01129.  This blog has previously reported on the topic of joinder in IPR … Continue Reading

Coalition for Affordable Drugs Fails to Knock Out Biogen’s Tecfidera® Patent

On March 21, 2017, the PTAB refused to cancel claims of a Biogen MA Inc. (Biogen) patent covering multiple sclerosis drug Tecfidera® during IPR2015-01993, which was instituted in response to a petition filed by the Coalition for Affordable Drugs V LLC (CFAD), a group started by hedge fund manager Kyle Bass. Biogen’s U.S. Pat. No. … Continue Reading

Your Supplemental Evidence is Timely, but is it Relevant to a Claim at Issue? PTAB Will Decide.

Once a trial has been instituted at the PTAB, a party seeking consideration of supplemental evidence may file a motion in accordance with the following requirements: (1) the request for the authorization to file a motion to submit supplemental information must be made within one month of the date the trial was instituted; and (2) … Continue Reading

Federal Circuit to PTAB (Again) – Explain Yourself!!

The Federal Circuit has once again vacated and remanded a PTAB final written decision on the basis that the PTAB did not adequately explain its reasons for finding a claimed invention obvious.  In In re Nuvasive, Appeal No. 15-1670 (Fed. Cir. Dec. 7, 2016), the Federal Circuit reviewed the PTAB’s final written decision in IPR2013-00506 … Continue Reading

Prior Art Made Available at Members Only Gatherings May Not Satisfy “Publically Accessible” Requirement

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 … Continue Reading

IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments

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 … Continue Reading

Been There, Done That: Petitioners Should Find Art and Arguments Not Previously Considered During Prosecution

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 … Continue Reading

Rare Grant of Rehearing of Denial of Petition for Inter Partes Review

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 … Continue Reading

Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution

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. … Continue Reading

The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition

On 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 … Continue Reading

Patent Applicants Who Appeal Must Wait Their Turn with the PTAB

Biotechnology 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 … Continue Reading

It’s Complicated: PTAB Reinforces Notion That Petitioners Should Consider Expert Testimony in Complex Technology Areas

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 … Continue Reading

Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties

In 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 … Continue Reading

PTAB Reminds Petitioners That Conclusions in Expert Declarations Must be Supported by Explanations

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 … Continue Reading

PTAB Warns Again That Prosecution Declarations Without Depositions May Be Given Little or No Weight

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 … Continue Reading

Broader is Better for the Petitioner, but Inherency is Intrinsically Difficult

Two recent PTAB final written decisions highlight the benefits that the “broadest reasonable interpretation” standard for claim construction provides to Petitioners, as well as the difficulty Petitioners face in proving inherent anticipation.  The PTAB instituted two IPRs on the same patent: one on an anticipation ground, and another on an obviousness ground.  The Petitioner failed … Continue Reading

PTAB Dismisses Biosimilar Company’s IPR Petition Without Prejudice, When Petitioner Loses its Expert

The PTAB recently granted Celltrion’s motion to dismiss its IPRs without prejudice, after Celltrion suddenly lost its ability to rely on a key expert declaration.  Celltrion had filed IPR petitions against two patents covering use of Rituxan®, and had sought joinder with pending IPRs filed by Boehringer Ingelheim (BI) against the same patents.  Although Celltrion … Continue Reading

Pharma industry continues efforts to exempt patents from IPR

The pharmaceutical industry continues its efforts to exempt pharmaceutical and biotechnology patents from inter partes review (IPR). Neither the House’s Innovation Act nor the Senate’s PATENT Act currently contain any provisions that would exempt particular patents from these proceedings. But as we reported in June, some members of the Senate judiciary committee appear sympathetic to … Continue Reading

Mind The Gap: The PTAB Will Not Bridge It For You

Petitioners should beware gaps in their evidence and reasoning.  Two DepoMed patents recently survived their second IPR challenge because the petitioner failed to meet its burden of proof.  The PTAB rejected petitioner’s obviousness arguments as “overly vague and nonspecific,” concluding that petitioner failed to “explain persuasively why or how a person of ordinary skill in … Continue Reading

PTAB Denies Institution of Another Investment Fund IPR Petition, Refusing to Ignore Claim Limitation Under BRI Standard

Score another win for pharma against investment funds-turned-IPR petitioners. On September 21, 2015, the PTAB denied institution of Ferrum Ferro Capital, LLC’s (“FFC”) petition for IPR of an Allergan patent claim related to its Combigan® eye-drop product for treating glaucoma. This dispute has attracted publicity for having bled into the courts, where Allergan has sued … Continue Reading

PTAB Applies the Estoppel Provision of the AIA to Deny an IPR Petition

The PTAB recently denied institution of an inter partes review (IPR) on the basis of the estoppel provision of the AIA (35 USC § 315(e)). Apotex Inc. v. Wyeth LLC, IPR2015-00873, Paper 8 (PTAB Sept. 16, 2015). The decision is not appealable, and is significant because it offers guidance on how the PTAB will construe this … Continue Reading
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