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  • Conference & CLE Calendar

    CalendarApril 25, 2017 – "Having Your AIA Cake and Eating It Too: Recent Decisions Addressing the Scope of AIA Estoppel" (Federal Circuit Bar Association) – 1:00 pm to 2:00 pm (ET)

    April 26, 2017 – Post-argument discussion on Sandoz Inc. v. Amgen Inc. (American University Washington College of Law Program on Information Justice & Intellectual Property) – beginning at 4:30 pm (Eastern), American University Washington College of Law, Washington, DC

    April 27, 2017 – "Navigating Section 112 Issues in IPR Proceedings: Using Section 112 as a Sword or a Shield — Addressing Section 112 Issues in IPR Petitions, Establishing Priority or Earlier Critical Date of Asserted Reference, and More" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 27, 2017 – 33rd Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

    April 27, 2017 – "The Hunt for Prior Art — From Filing to Challenge, Modern Patent Practice Is All About the Search" (CPA Global) – 2:00 pm (ET)

    April 27, 2017 – "After Form 18: Pleading Infringement" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    May 2, 2017 – "Protecting Trade Secrets, Confidential Information and NDAs in China — Maintaining Confidential Information, Preventing Infringement, and Enforcing Trade Secret Rights" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 4, 2017 – "Overcoming 101 Rejections for Computer and Electronics Related Patents — Leveraging USPTO Guidance and Recent Decisions to Meet 101 Patent Eligibility Requirements" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 5, 2017 - Ethics in the Practice of Intellectual Property Law (John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 8:15 am to 1:30 pm, Chicago, IL

    May 10-11, 2017 - Post-Grant PTO Proceedings Conference*** (American Conference Institute) – New York, NY

    May 11, 2017 – "Protecting IP Rights in Joint Development Agreements and Strategic Alliances — Structuring JDAs to Apportion Contributed, Joint and Derivative IP; Planning for Involuntary Early Endings; Avoiding Unintended Consequences" (Strafford) – 1:00 to 2:30 pm (EDT)

    ***Patent Docs is a media partner of this conference or CLE

  • ACI Post-Grant PTO Proceedings Conference

    BrochureAmerican Conference Institute (ACI) will be holding is 3rd Annual Post-Grant PTO Proceedings Conference on May 10-11, 2017 in New York, NY.  ACI faculty will help attendees:

    • Evaluate the pros and cons of making a motion to amend claims during an IPR proceeding, especially in view of the en banc In re Aqua Products Federal Circuit case;
    • Explore which decisions related to institution can be reviewed by the Federal Circuit in view of the pending en banc review of Wifi One v. Broadcom and related cases;
    • Review “injury-in-fact” standing to challenge a final Board decision in view of the Phigenix, Inc. v. ImmunoGen, Inc. Federal Circuit case;
    • Examine recent trends in CBM review proceedings;
    • Analyze the impact of recent PTAB decisions in different industries, including tech, financial services, and pharmaceutical/life sciences;
    • Develop best practices for satisfying and defending against the public accessibility standard for non-patent printed publications;
    • Identify pros and cons for filing a PGR petition versus an IPR petition; and
    • Dive into the scope of IPR estoppel.

    In particular, ACI's faculty will offer presentations on the following topics:

    • Keynote Address — The Honorable David Ruschke, CAPJ, Chief Judge, Patent Trial and Appeal Board, U.S. Patent and Trademark Office
    • Exploring Changes to the Patent System under the New Administration and their Probable Impact on PTO Proceedings
    • A Deep Dive Analysis into Amending Claims in IPRs post-Aqua Products
    • Keeping Up-to-Speed with Cuozzo, its “Properly Reviewable Shenanigans,” and Related Jurisprudence
    • Construing the Covered Business Method Classification
    • PTAB Roundtable – The Judges Speak
    • Analyzing Recent Trends and Decisions from the PTAB
    • Mastering the “Ins and Outs” of Selecting and Authenticating the Best Prior Art References
    • Parsing the PGR Process
    • Who’s the Boss? Interplay between Identification of Real Parties in Interest (“RPIs”), Privy, and Estoppel

    In addition, a post-conference workshop entitled "Parallel Proceedings: The Good, The Bad, and the Ugly " will be offered from 1:45 to 4:45 pm on May 11, 2017.

    An agenda for the conference can be found here, and additional information regarding the workshop can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    ACI - American Conference InstituteThe registration fee is $2,295 (conference alone), $2,895 (conference and workshop).  Special rates are available for in-house counsel (see brochure).  Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD17.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's 3rd Annual Post-Grant PTO Proceedings conference.

  • Program on Ethics in the Practice of Intellectual Property Law

    JMLSThe John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be holding its 8th Annual Program on Ethics in the Practice of Intellectual Property Law from 8:15 am to 1:30 pm on May 5, 2017 in Chicago, IL.  The conference will consist of the following sessions:

    • What IP Lawyers Should Know About ARDC Proceedings and Client Complaints
    • Ethical Issues Faced by In-House IP Counsel
    • Conflicts of Interest in IP Practice
    • Ethical Issues for IP Lawyers Regarding Cybersecurity & Data Privacy and Protection
    • Ethical Issues in Patent Litigation
    • Ethical Issues in the Trademark Trial and Appeal Board

    Additional information about the program can be found here.  Those interested in registering for the conference online can do so here; the registration fee is $195 (general registration); JMLS Students, Faculty, Staff, and IP Advisory Board Members can register for free.

  • Webinar on Protecting IP Rights in Joint Development Agreements

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Protecting IP Rights in Joint Development Agreements and Strategic Alliances — Structuring JDAs to Apportion Contributed, Joint and Derivative IP; Planning for Involuntary Early Endings; Avoiding Unintended Consequences" on May 11, 2017 from 1:00 to 2:30 pm (EDT).  Adam Petravicius of Jenner & Block, Sharon Tasman Prysant of Health & Technology Law Firm, and Aaron K. Tantleff of Foley & Lardner will provide guidance to counsel on negotiating and structuring joint development agreements (JDAs) to allocate IP ownership, and discuss the key provisions of the JDA to protect IP rights and avoid unintended consequences.  The webinar will review the following issues:

    • What considerations should counsel keep in mind when negotiating the JDA?
    • What issues must be addressed by the JDA regarding IP ownership?
    • What obligations will the parties have in protecting the other party’s preexisting IP once the JDA is expired or terminated?

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • FCBA Webast on Scope of AIA Estoppel

    Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "Having Your AIA Cake and Eating It Too: Recent Decisions Addressing the Scope of AIA Estoppel" on April 25, 2017 from 1:00 pm to 2:00 pm (ET).  Jason Romrell of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will moderate a panel consisting of Benjamin Hickman, Associate Solicitor, U.S. Patent and Trademark Office; Andrew Trask, Patent Litigation Counsel, Google; and J. Steven Baughman of Paul, Weiss, Rifkind, Wharton & Garrison LLP.  The panel will explore recent decisions addressing the scope of AIA estoppel and what we can expect as more cases reach the Federal Circuit.

    Those interested in registering for the webcast, can do so here.

  • Webinar on Protecting Trade Secrets, Confidential Information and NDAs in China

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Protecting Trade Secrets, Confidential Information and NDAs in China — Maintaining Confidential Information, Preventing Infringement, and Enforcing Trade Secret Rights" on May 2, 2017 from 1:00 to 2:30 pm (EDT).  Helen Tang of Herbert Smith Freehills and Richard K. Wagner Steptoe & Johnson will provide guidance to counsel representing companies doing business in China on approaches for protecting and enforcing trade secret rights.  The webinar will review the following issues:

    • How does trade secret litigation work in China in comparison to the US? What have been the key recent developments in practice?
    • How does an NDA tailored for a China transaction differ from those typically used domestically in the U.S.?
    • What steps can counsel take to minimize the likelihood of infringement in China?
    • Given the challenges with prosecuting trade secret claims in China, are there any other options available?
    • How to make sense of the new Cyber Security Law and its implications for cross-border evidence collection in trade secret cases?

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • Webinar on Overcoming 101 Rejections for Computer and Electronics Related Patents

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Overcoming 101 Rejections for Computer and Electronics Related Patents — Leveraging USPTO Guidance and Recent Decisions to Meet 101 Patent Eligibility Requirements" on May 4, 2017 from 1:00 to 2:30 pm (EDT).  Charles Bieneman of Bejin Bieneman and Isaac T. Slutsky of Brooks Kushman will provide guidance to patent counsel for overcoming § 101 rejections for computer and electronics-related patents, and review recent case law and USPTO guidance on § 101 patent eligibility and offer strategies to address § 101 rejections.  The webinar will review the following issues:

    • What are the key recent §101 decisions, not only at the Federal Circuit but in the District Courts and at the Patent Trial and Appeal Board?
    • How can specifications and claims be drafted to guard against §101 rejections?
    • What strategies and arguments can be used in patent prosecution to overcome §101 rejections?

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • Webinar on Patent Search Strategies

    CPA GlobalCPA Global will offer a one-hour webinar entitled "The Hunt for Prior Art — From Filing to Challenge, Modern Patent Practice Is All About the Search" on April 27, 2017 beginning at 2:00 pm (ET).  Gene Quinn of IPWatchdog, Inc. will discuss:

    • What level of search should be undertaken prior to filing a patent application?
    • What level of search is required before filing a post grant challenge?
    • Where to look, what to disclose (Rule 56) and how much to use in an IPR petition.

    Those interested in registering for the webinar can do so here.

  • IPO Webinar on Pleading Infringement

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "After Form 18: Pleading Infringement" on April 27, 2017 from 2:00 to 3:00 pm (ET).  David Donoghue of Holland & Knight LLP, Chris Freeman of Blackbird Technologies, and Mark Hannemann of Shearman & Sterling LLP will consider the spectrum of views district courts have embraced regarding the pleading standard for direct infringement since the abrogation of Form 18 in late 2015, and offer strategies for both plaintiffs and defendants.  The panel will also analyze the new challenges, such as defendants' need to reply to a detailed complaint with little time to prepare affirmative defenses, such as invalidity, and discuss how the Federal Circuit has addressed the new pleading standard in Lyda v. CBS, and whether more definitive guidance is likely to be forthcoming.

    The registration fee for the webinar is $135 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • PTAB Life Sciences Report — Part II

    By John Cravero —

    USPTO SealAbout the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents.

    Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc.

    PTAB Petition:  IPR2017-00853; filed February 8, 2017.

    Patent at Issue:  U.S. Patent No. 8,822,438 ("Methods and compositions for treating cancer," issued February 11, 2014) claims methods for treating cancer comprising administering a 17α-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid.

    Petitioners Actavis Laboratories FL, Inc., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC, Dr. Reddy's Laboratories, Inc., Dr. Reddy's Laboratories, Ltd., Sun Pharmaceuticals Industries, Ltd., Sun Pharmaceuticals Industries, Inc., Teva Pharmaceuticals USA, Inc., West-Ward Pharmaceutical Corp., and Hikma Pharmaceuticals, LLC are challenging the '438 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '438 patent is involved in the following litigations:  BTG Int'l Ltd. v. Amerigen Pharms., Inc., No. 16-cv-02449-KM-JBC (D.N.J.); BTG Int'l Ltd. v. Glenmark Pharms. Inc., USA, No. 16-cv-03743-KM-JBC (D.N.J.); and Janssen Biotech, Inc. v. Mylan Pharms. Inc., No. 15-cv-00130-IMK (N.D.W. Va.).  Also, the '438 patent is the subject of IPR2016-00286 (Petitioner Amerigen Pharms. Ltd.; filed 12/04/2016; instituted 05/31/2016; pending); IPR2016-01317 (Petitioner Argentum; filed 06/29/2016; instituted and joined to IPR2016-00286 09/19/2016; pending); IPR2016-01332 (Petitioner Mylan Pharmaceuticals Inc., filed 06/30/2016; instituted 01/10/2017; pending); and IPR2016-01582 (Petitioner Wockhardt Bio AG, filed 08/10/2016; instituted 01/19/2017; pending).


    Koios Pharmaceuticals LLC v Medac Geselleschaft Fuer Klinische Spezial Praparate MBH

    PTAB Petition:  IPR2016-01370; filed July 20, 2016.

    PTAB Trial Instituted; entered February 8, 2017.

    Patent at Issue:  U.S. Patent No. 8,664,231 ("Concentrated methotrexate solutions," issued March 4, 2014) claims a method for the treatment of inflammatory autoimmune diseases comprising subcutaneously administering a methotrexate in a  pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml.

    Petitioner Koios Pharmaceuticals LLC is challenging the '231 patent on six grounds as anticipated under 35 U.S.C. § 102(b) (grounds 1 and 4) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 5, and 6).  View the petition here.  Administrative Patent Judges Jacqueline Wright Bonilla (author), Toni R. Scheiner, and Erica A. Franklin issued a decision instituting inter partes review of claims 1, 2, 4–6, 11–13, 17, and 22 under 35 U.S.C. § 102(b) as being anticipated by Grint; claims 7–10, 14–16, and 19–21 under 35 U.S.C. § 103(a) as being obvious over Grint, Arthur, Moitra, and Insulin Admin.; claim 18 under 35 U.S.C. § 103(a) as being obvious over Grint and Alsufyani; claims 1–6, 11–13, 17, 18, and 22 under 35 U.S.C. § 102(b) as being anticipated over Wyeth; and claims 1–6, 11–13, 17, 18, and 22 under 35 U.S.C. § 103(a) as being obvious over Wyeth, Brooks, Arthur, and Moitra.

    Related Matters:  According to the petition, the '231 patent is the subject of IPR2014-01091 (Petitioners Antares Pharm, Inc., Leo Pharma A/S, and Leo Pharma Inc.; filed 07/01/2014; instituted 01/06/2015; terminated 04/30/2015 through settlement) and IPR2016-00649 (Petitioner Frontier Therapeutics, LLC; filed 02/22/2016; terminated 12/08/2016 through settlement).


    Amneal Pharmaceuticals LLC v Hospira, Inc.

    PTAB Petition:  IPR2016-01578; filed August 10, 2016.

    PTAB Trial Instituted; entered February 9, 2017.

    Patent at Issue:  U.S. Patent No. 8,338,470 ("Dexmedetomidine premix formulation," issued December 25, 2012) claims a ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL disposed within a sealed glass container.

    Petitioner Amneal Pharmaceuticals LLC is challenging the '470 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Michael J. Fitzpatrick, Sheridan K. Snedden (author), and Zhenyu Yang issued a decision instituting inter partes review of claims 1-7 under 35 U.S.C. § 103(a) as being obvious over 2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and Lavoisier.

    Related Matters:  According to the petition, the '470 patent is the subject of the following litigation:  Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697 (D.Del.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,242,158 (IPR2016-01577; filed 08/10/2016; instituted 02/09/2017); 8,455,527 (IPR2016-01579; filed 08/10/2016; instituted 02/09/2017; pending); and 8,648,106 (IPR2016-01580; filed 08/11/2016; institution denied 02/03/2017).


    Amneal Pharmaceuticals LLC v Hospira, Inc.

    PTAB Petition:  IPR2016-01579; filed August 10, 2016.

    PTAB Trial Instituted; entered February 9, 2017.

    Patent at Issue:  U.S. Patent No. 8,455,527 ("Methods of treatment using a dexmedetomidine premix formulation," issued June 4, 2013) claims a method of providing sedation to a patient in need thereof, the method comprising administering to the patient an effective amount of a composition, wherein the composition comprises dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL, wherein the composition is a ready to use liquid pharmaceutical composition for parenteral administration to the patient disposed within a sealed glass container.

    Petitioner Amneal Pharmaceuticals LLC is challenging the '527 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  In a per curiam decision, Administrative Patent Judges Michael J. Fitzpatrick, Sheridan K. Snedden, and Zhenyu Yang issued a decision instituting inter partes review of claims 1-11 and 13 under 35 U.S.C. § 103(a) as being obvious over 2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and Lavoisier.

    Related Matters:  According to the petition, the '470 patent is the subject of the following litigation:  Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697 (D.Del.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,242,158 (IPR2016-01577; filed 08/10/2016; instituted 02/09/2017); 8,338,470 (IPR2016-01578; filed 08/10/2016; instituted 02/09/2017; pending); and 8,648,106 (IPR2016-01580; filed 08/11/2016; institution denied 02/03/2017).


    Mylan Pharmaceuticals, Inc. v. Boehringer Ingelheim International GmbH

    PTAB Petition:  IPR2016-01565; filed August 10, 2016.

    PTAB Trial Instituted; entered February 9, 2017.

    Patent at Issue:  U.S. Patent No. 8,853,156 ("Treatment for diabetes in patients inappropriate for metformin therapy," issued October 7, 2014) claims a method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally administering to the patient a DPP-IV inhibitor wherein the contraindication is selected from the group consisting of renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.

    Petitioners Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., Mylan Inc., and Mylan N.V. are challenging the '156 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.  Administrative Patent Judges Toni R. Scheiner (author), Brian P. Murphy, and Zhenyu Yang issued a decision instituting inter partes review of claims 1, 2, 4, 5, and 23 under 35 U.S.C. § 102 as being anticipated by Mikhail; and claims 1, 2, 4, 5, and 23 under 35 U.S.C. § 103 as being obvious over Mikhail.

    Related Matters:  According to the petition, the '156 patent is the subject the following litigation:  Boehringer Ingelheim Pharmaceuticals Inc., et al. v. HEC Pharm Group, et al., No. 3:15-cv-05982-PGS-TJB (D.N.J.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 9,173,859 (IPR2016-01566; filed 08/10/2016; institution denied 02/03/2017); 8,846,695 (IPR2016-01564; filed 08/10/2016; instituted 01/31/2017; pending); and 8,673,927 (IPR2016-01563; filed 08/10/2016; instituted 02/03/2017; pending).


    Amneal Pharmaceuticals LLC v Hospira, Inc.

    PTAB Petition:  IPR2016-01577; filed August 10, 2016.

    PTAB Trial Instituted; entered February 9, 2017.

    Patent at Issue:  U.S. Patent No. 8,242,158 ("Dexmedetomidine premix formulation," issued August 14, 2012) claims a ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 4 μg/mL disposed within a sealed glass container.

    Petitioner Amneal Pharmaceuticals LLC is challenging the '158 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Michael J. Fitzpatrick, Sheridan K. Snedden, and Zhenyu Yang (Author) issued a decision instituting inter partes review of claims 1-4 under 35 U.S.C. § 103(a) as being obvious over Precedex Label, in view of the knowledge of one of skill in the art at the time of filing, as evidenced by De Giorgi, Eichhorn, Palmgrén, and Lavoisier.

    Related Matters:  According to the petition, the '158 patent is the subject of the following litigation:  Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697 (D.Del.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,455,527 (IPR2016-01579; filed 08/10/2016; instituted 02/09/2017; pending); 8,338,470 (IPR2016-01578; filed 08/10/2016; instituted 02/09/2017; pending); and 8,648,106 (IPR2016-01580; filed 08/11/2016; institution denied 02/03/2017).


    Amneal Pharmaceuticals LLC v Purdue Pharma L.P., P.F. Laboratories, Inc., and Purdue Pharmaceuticals L.P.

    PTAB Petition:  IPR2016-01412; filed July 16, 2016.

    PTAB Trial Instituted; entered February 14, 2017.

    Patent at Issue:  U.S. Patent No. 9,034,376 ("Pharmaceutical formulation containing gelling agent," issued May 19, 2015) claims a controlled release oral solid dosage form comprising oxycodone and a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose.

    Petitioner Amneal Pharmaceuticals LLC is challenging the '376 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Michael P. Tierney, Lora M. Green, and Christopher G. Paulraj (Author) issued a decision instituting inter partes review of claims 1-13 and 16-19 under 35 U.S.C. § 103(a) as being obvious over Palermo, Joshi, and the Handbook; and claims 1-13 and 16-19 under 35 U.S.C. § 103(a) as being obvious over Oshlack, Joshi, the Handbook, and Doyon.

    Related Matters:  According to the petition, the '376 patent is the subject of the following litigations:  Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 1:15-cv-00831 (D.Del.); and Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 1:15-cv-1152 (D.Del.).  U.S. Patent No. 8,337,888, which claims priority to the same earlier-filed application as the '376 Patent, was the subject of a district court proceeding in the Southern District of New York in Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, No. 13-3372 (S.D.N.Y.).  The Federal Circuit upheld the invalidity of the claims of the '888 Patent on April 8, 2016.  Petitioner filed a separate petition for inter partes review challenging the same claims of the '376 Patent on other grounds (IPR2016-01413; filed 07/15/2016; instituted 01/18/2017; pending).  Also, Petitioner previously filed petitions seeking cancellation of claim 1 of U.S. Patent No. 9,060,976, which is another member of the same patent family (IPR2016-01027; filed 05/11/2016; instituted 11/09/2016; pending) and (IPR2016-01028; filed 05/11/2016; instituted 11/09/2016; pending).


    Par Pharmaceuticals, Inc. v Novartis AG

    PTAB Petition:  IPR2016-01479; filed July 22, 2016.

    PTAB Trial Instituted; entered February 15, 2017.

    Patent at Issue:  U.S. Patent No. 9,006,224 ("Neuroendocrine tumor treatment," issued April 14, 2015) claims a method for treating pancreatic neuroendocrine tumors, comprising administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.

    Petitioner Par Pharmaceuticals, Inc. is challenging the '224 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Lora M. Green, Christopher L. Crumbley (Author), and Robert A. Pollock issued a decision instituting inter partes review of claims 1–3 under 35 U.S.C. § 103(a) as being obvious over Oberg 2004, Boulay 2004, and O'Donnell; claim 2 under 35 U.S.C. § 103(a) as being obvious over Oberg 2004, Boulay 2004, O'Donnell, and Tabernero; claims 1–3 under 35 U.S.C. § 103(a) as being obvious over Boulay 2004, O'Donnell, and Duran; and claim 2 under 35 U.S.C. § 103(a) as being obvious over Boulay 2004, O'Donnell, Duran, and Tabernero.

    Related Matters:  According to the petition, the '224 patent is the subject of the following litigations:  Novartis Pharm. Corp. et al. v. Roxane Labs., Inc., No. 15-474-RGA (D.Del.); and Novartis Pharm. Corp. et al. v. Par Pharm., Inc., No. 15-475-RGA (D. Del.).  Claims 1 and 2 of the '224 patent were challenged in IPR2016-01461 (Roxanne Laboratories, Inc.; filed 07/22/2016; institution denied 02/13/2017).