Tag Archives: Biotechnology

Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody.  The methods of the claimed invention involve subcutaneously administering … Continue Reading

CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Joinder
Research Corporation Technologies, Inc. (RCT) sued Mylan Pharmaceuticals, Inc. (Mylan), Breckenridge Pharmaceutical, Inc. (Breckinridge), and Alembic Pharmaceuticals Ltd. (Alembic), in federal district court, accusing them of infringing United States Reissued Patent No. RE38,551. The patent claims pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. Within one year of being … Continue Reading

Kyle Bass Gets Fresenius’ Diprivan Claims Canceled in IPR

By Eric M. Brusca, Ph.D. on Posted in Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Joinder
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

By Eric M. Brusca, Ph.D. on Posted in Inter Partes Review, Sections 102/103
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.

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Trial Procedures
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!!

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, IPR, Sections 102/103
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

By Eric M. Brusca, Ph.D. on Posted in Inter Partes Review, Sections 102/103
On 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 … Continue Reading

IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Sharon M. Sintich, Ph.D. on Posted in Biotechnology, Institution / Denial, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Institution / Denial, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Real Party-in-Interest, Sections 102/103
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

thumbnail image of DNA strandBy David A. Gass on Posted in Appeals, Biotechnology, Inter Partes Review, Post Grant Review, Section 101
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Biotechnology, Discovery, Inter Partes Review
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Discovery, Inter Partes Review
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

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Estoppel
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

thumbnail image of DNA strandBy John R. Labbé on Posted in Biotechnology, Inter Partes Review, Legislation
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
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