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  • Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until [the] Court resolves the appeal."  The Order also sets a date of no later than seven days from today for Sandoz to propose an amount of the bond (for damages accruing daily) the Court should order, with Amgen being given seven days thereafter for responding.

    AmgenThe Court’s Order thus maintains the status quo ante between the parties, who are involved in a declaratory judgment action brought by Amgen in the Northern District of California before Judge Seeborg.  Last month, the District Court denied Amgen’s motion for an injunction (see "Gotta Dance? Apparently Not — A Biosimilar Update"), based in part on the court’s opinion that Sandoz correctly interpreted the "patent dance" provisions of Biologics Price Competition and Innovation Act of 2009 (BPCIA) to permit Sandoz to refuse to disclose to Amgen its biosimilar application and "such other information that describes the process or processes used to manufacture the biological product that is the subject of such application" as apparently mandated by the Act ("Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant—(A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application") (see "The Tyranny of the Judiciary").  Thus, the first biosimilar product approved by the FDA (see "FDA Approves Sandoz Filgrastim Biosimilar") will remain off the market in the U.S. at least until the Federal Circuit decides whether Sandoz’s creative construction of the statutory language comports with Congressional intent in enacting this portion of the omnibus health care reform legislation.

    Oral argument is scheduled for June 3rd.

  • Primer on Global and IP5 Patent Prosecution Highway Pilot Programs

    By Donald Zuhn —

    PPH LogoFollowing the implementation of its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) in 2006, the U.S. Patent and Trademark Office proceeded to establish PPH programs with nearly thirty other patent offices over the next seven years.  The PPH enables applicants who receive a positive ruling on patent claims from one participating office to request accelerated prosecution of corresponding claims in another participating office.  Last year, the USPTO announced the implementation of two new pilot PPH programs — the Global PPH and IP5 PPH –- which the Office indicated would simplify access to participating PPH offices.  In moving to the Global/IP5 programs, the USPTO noted that the administration of multiple PPH programs with so many other offices, each having its own particular requirements, had become increasingly cumbersome.

    For twenty of the patent offices that once participated in individual PPH programs with the USPTO, the two pilot programs replaced existing forms and procedures that were unique to each PPH country pairing, with one form and common rules for participating countries.  Because the USPTO elected to participate in both programs, the Office noted that a PPH request could be filed with the USPTO based on the work product of any office participating in either pilot program.  In addition, because the requirements for participation in both programs are equivalent, USPTO applicants need not specify which pilot program is being utilized (in fact, the Office provided a single form — PTO/SB/20GLBL — for use in requesting participation in either program).

    The Global PPH and IP5 PPH pilot programs are substantially identical, differing only with regard to the participating offices in each program.  The twenty-one offices participating in the Global/IP5 programs are IP Australia (IP AU), the Austrian Patent Office (APO), the Canadian Intellectual Property Office (CIPO), China's State Intellectual Property Office (SIPO), the Danish Patent and Trademark Office (DKPTO), the European Patent Office (EPO), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Intellectual Property Office (HIPO), the Icelandic Patent Office (IPO), the Israel Patent Office (ILPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the Nordic Patent Institute (NPI), the Norwegian Industrial Property Office (NIPO), the Portugal National Institute of Industrial Property (INPI-PT), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Intellectual Property Office of Singapore (IPOS), the Spanish Patent and Trademark Office (SPTO), Swedish Patent and Registration Office (PRV), the United Kingdom Intellectual Property Office (UK IPO), and the United States Patent and Trademark Office (USPTO).  The IP5 offices are the EPO, JPO, KIPO, SIPO, and USPTO.

    Globalip5flagsIn order to participate in the Global/IP5 PPH programs, USPTO applicants must meet the following requirements:

    (1) The U.S. application for which participation in either program is requested must have the same priority date or filing date as that of a corresponding national or regional application filed with another participating office, or a corresponding PCT application for which a participating office was the International Searching Authority (ISA) or the International Preliminary Examining Authority (IPEA).

    (2) The corresponding application has at least one claim indicated by the office of earlier examination (OEE) to be allowable/patentable.

    (3) All claims in the U.S. application for which participation in either program is requested must sufficiently correspond to the allowable/patentable claims in the corresponding OEE application.

    (4) Substantive examination of the U.S. application for which participation in either program is requested has not begun.

    A more comprehensive discussion of the requirements for participation in the Global/IP5 programs can be found here.

    To participate in the Global/IP5 pilot programs, a USPTO applicant must submit the following via the EFS-Web:

    (1) A request for participation in either program and a request that the U.S. application be advanced out of tum for examination by order of the Director.

    (2) A claims correspondence table in English, indicating how and certifying that all the claims in the U.S. application correspond to allowable/patentable claims in the OEE application.

    (3) A copy of the office action issued just prior to decision to grant in the OEE national/regional application, along with an English translation thereof (if necessary), or the latest work product in the international phase of the OEE PCT application.

    (4) An information disclosure statement (IDS) listing the documents cited in the office action or PCT work product submitted for item 3 along with copies of all documents except U.S. patents and U.S. patent application publications.

    Separate PPH programs with the USPTO remain in place for nine other offices that are not participating in the Global/IP5 programs:  the Colombian Superintendence of Industry and Commerce (SIC), the Industrial Property Office of the Czech Republic (IPOCZ), the German Patent and Trade Mark Office (DPMA), the Mexican Institute of Industrial Property (IMPI), the Nicaraguan Registry of Intellectual Property (NRIP), the Intellectual Property Office of the Philippines (IPOPHL), the Patent Office of the Republic of Poland (UPRP), the Romanian State Office for Inventions and Trademarks (OSIM), and the Taiwan Intellectual Property Office (TIPO).

    Additional information regarding the Global/IP5 PPH and separate PPH programs, including links to the appropriate request forms, can be found here.

  • Important Drug Discoveries in Medicine

    Aris Grigoriou of Study Medicine Europe Ltd. has created an infographic that describes several important drug discoveries.

    Important-Drug-Discoveries-In-Medicine-Infographic

  • Court Report

            By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Horizon Pharma Ireland Ltd. et al. v. Lupin Ltd. et al.
    1:15-cv-03051; filed April 30, 2015 in the District Court of New Jersey

    • Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Limited; Horizon Pharma USA, Inc.
    • Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,252,838 ("Diclofenac Topical Formulation," issued August 28, 2012), 8,546,450 ("Treatment of Pain with Topical Diclofenac," issued October 1, 2013), 8,563,613 ("Diclofenac Topical Formulation," issued October 22, 2013), 8,618,164 ("Treatment of Pain with Topical Diclofenac," issued December 31, 2013), and 8,871,809 ("Diclofenac Topical Formulation," issued October 28, 2014) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Horizon's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the complaint here.

    Apotex Inc v. Daiichi Sankyo, Inc. et al.
    1:15-cv-03695; filed April 27, 2015 in the Northern District of Illinois

    • Plaintiff:  Apotex Inc
    • Defendants:  Daiichi Sankyo, Inc.; Daiichi Sankyo Co., Ltd.

    Declaratory judgment of non-infringement of U.S. Patent No. 6,878,703 ("Pharmaceutical Composition," issued April 12, 2005) in conjunction with Aptoex's filing of an ANDA to manufacture a generic version of Daiichi's Benicar® HCT (olmesartan medoxomil/ hydrochlorothiazide, used to treat hypertension).  View the complaint here.

    Eli Lilly and Co. et al. v. Lupin Ltd. et al.
    1:15-cv-00673; filed April 27, 2015 in the Southern District of Indiana

    • Plaintiffs:  Eli Lilly and Co.; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
    • Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

    Infringement of certain of U.S. Patent Nos. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) and 8,569,325 ("Method of Treatment with Coadministration of Aspirin and Prasugrel," issued October 29, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention).  View the complaint here.

    Noven Pharmaceuticals, Inc. et al. v. Mylan Technologies, Inc. et al.
    1:15-cv-00069; filed April 24, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Noven Pharmaceuticals, Inc.; Hisamitsu Pharmaceutical Co., Inc.
    • Defendants:  Mylan Technologies, Inc.; Mylan Pharmaceuticals, Inc.; Mylan Inc.

    Noven Pharmaceuticals Inc. et al. v. Mylan Technologies Inc. et al.
    1:15-cv-00328; filed April 23, 2015 in the District Court of Delaware

    • Plaintiffs:  Noven Pharmaceuticals Inc.; Hisamitsu Pharmaceutical Co. Inc.
    • Defendants:  Mylan Technologies Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,841,716 ("Patch," issued January 11, 2005) and 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis).  View the Delaware complaint here.

  • Conference & CLE Calendar

    CalendarMay 5, 2015 – "Conducting a Freedom to Operate Investigation" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    May 12, 2015 – "Patent Prosecution: Leveraging Declarations to Strengthen Patents Against Post-Grant Proceedings" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 12, 2015 – 31st Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

    May 12-14, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – Chicago, IL

    May 19, 2015 – "Best Practices for Cost-Effective Filing of PCT and EPO Patent Applications" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    May 19-21, 2015 – EU Pharmaceutical Law Forum (Informa Life Sciences) – Brussels, Belgium

    May 20, 2015 – "Never Been a Better Time (For IP) Than Right Now?" (Intellectual Property Owners Association (IPO) European Practice Committee) – London, UK

    May 28, 2015 – "Hedge Fund IPR Challenges to Pharma Patents: Strategies to Strengthen Patents to Withstand Attack" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 1-2, 2015 – Biosimilars (American Conference Institute) – New York, NY

    June 4, 2015 – "Navigating Section 112(a) Enablement and Written Description — Withstanding 112(a) Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 9-10, 2015 – Due Diligence Summit for Life Sciences (ExL Events) – Boston, MA

    June 15-17, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

    July 8-10, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

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

  • AIPLA Webinar on Freedom to Operate Investigations

    AIPLA #1The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "Conducting a Freedom to Operate Investigation" on May 5, 2015 from 12:30 – 2:00 pm (Eastern).  Les Bookoff of Bookoff McAndrews, ​Susie Jones of Jones Robb, PLLC, and Bill Shaw of Biogen Idec will explore the role of freedom to operate investigations to startups and large corporations alike, and take the audience through a "mock FTO investigation" that shows the roles of in-house counsel and outside counsel in the FTO process.  The panel will also provide practice tips, including crafting an FTO strategy to different budgets, preparing a search letter, and drafting opinions.

    The registration fee for the program is $145 (AIPLA member rate) or $175 (non-member rate).  Those interested in registering for the program, can do so here.

  • PLI Fundamentals of Patent Prosecution Seminar

    PLI #1Practising Law Institute (PLI) will be holding its Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing seminar on May 12-14, 2015 in Chicago, IL, on June 15-17, 2015 in New York, NY, and on July 8-10, 2015 in San Francisco, CA.  The three-day program, which is directed to patent prosecuting and litigating attorneys and patent agents with or without a Patent Office registration number or little patent experience, will focus on teaching the basics of claim drafting, patent application preparation and prosecution, as well as a review of recent developments in the law.  A litigator's perspective is also presented to show how drafting and prosecution can influence the development, and often the outcome, of subsequent patent litigation.  The seminar will feature lectures in the morning followed by small clinic sessions in the afternoon, with day 1 focusing on invention disclosures and patent preparation, day 2 on prosecution and issuance, and day 3 on litigation and opinion drafting.  Lectures will explain:

    • How to decide which elements of the invention should be included in the patent application and which aspects should be featured in the claims;
    • How to prosecute an application to obtain allowance of an enforceable patent;
    • How to interview an Examiner;
    • How to use reissues, reexamination supplemental examinations, Inter Partes review and other post-issuance proceedings;
    • How to anticipate patent litigation issues during the patent prosecution process; and
    • How to approach patent opinion drafting.

    PLI faculty will offer presentations on the following topics:

    • Taking Invention Disclosures;
    • Overview of Claim Drafting and Preparation of Patent Application;
    • Claim Drafting;
    • Review of Model Claims;
    • Patent Prosecution;
    • Conducting the Examiner Interview;
    • Review of Model Amendment; and
    • Litigation Issues.

    A program schedule and list of speakers for each of the locations can be found here.  Patent Docs authors Kevin Noonan (Chicago co-chair) and Donald Zuhn will be presenting on day 1 at the Chicago seminar.

    The registration fee for the conference is $1,895.  Those interested in registering for the conference can do so at the PLI website.

  • Webinar on Navigating Section 112(a)

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Navigating Section 112(a) Enablement and Written Description — Withstanding 112(a) Rejections and Attacks on Patent Validity and Patentability" on June 4, 2015 from 1:00 to 2:30 pm (EDT).  Rekha Bansal, Sr. Director of IP, Principia Biopharma; and Thomas L. Irving, Dr. Jill K. MacAlpine, Deborah M. Herzfeld, and Cory C. Bell of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on leveraging Federal Circuit and PTAB decisions and offer strategies to overcome § 112 challenges or, in the context of AIA's post grant proceedings how to utilize the extant § 112 precedent to break chains of date benefit or mount substantive § 112 attacks in PGR.  The webinar will review the following questions:

    • What judicial lessons can patent counsel draw when drafting claims and making during ex parte prosecution arguments at the USPTO of written description support and enablement for those claims?
    • What steps can counsel for patentees take to meet the written description requirement and withstand invalidity/unpatentability challenges based on written description and enablement, whether at the PTAB, in expert prosecution or in district court litigation?
    • What steps can counsel for alleged infringers and/or clients concerned about freedom to operate take to utilize § 112 to make challenges to date benefit/priority in IPRS and to do the same, as well as make substantive § 112 challenges in PRGs?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by May 8, 2015 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • ACI Biosimilars Conference

    New York #1American Conference Institute (ACI) will be holding a conference on Biosimilars on June 1-2, 2015 in New York, NY.  ACI faculty will help attendees:

    • FDA's approval of Sandoz's Zarxio biosimilar: Analysis of FDA standards for labeling, biosimilarity, interchangeability, and clinical studies;
    • Reviewing the biosimilars litigation cases to date including Sandoz v. Amgen and Celltrion v. Janssen and detailing strategies for declaratory judgment actions, preliminary injunctions, and using new USPTO inter partes review procedures;
    • US Federal Trade Commission and state law updates: Understanding the controversy surrounding competition, substitution, and naming in the biosimilars arena; and
    • Cost-benefit analysis: determining the potential value of biosimilars revenue based on relevant pricing, IP, regulatory, and commercial factor.

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

    • FDA Keynote Address: Insights into FDA's Current Position and Initiatives Regarding Biosimilars
    • The Road Ahead: Minimizing the Uncertainty Surrounding FDA Standards for Interchangeability and Biosimilarity
    • Protecting Both Innovation and Competition: Finding Compromise Within Federal and State Biosimilars Substitution Laws
    • Biosimilars Around the World: Leveraging Regulatory, IP, Pricing, and Safety Lessons Learned So Far
    • Judges’ Spotlight: Lessons from the Hatch-Waxman Experience for Biosimilars Litigation
    • Declining to Dance? Lessons Learned from Early BPCIA Cases on Whether the Pathway is Mandatory
    • What’s at Stake: Commercial Opportunity, Risk, and Pricing Considerations for the Emerging U.S. Biosimilars Landscape
    • Incorporating Inter Partes Review and New USPTO Procedures Into Branded and Biosimilar Litigation Strategies
    • Following the Rules of the BPCIA: A Cheat Sheet for Managing the Complicated Timing and Logistics of the Statutory IP Exchange Process
    • The Next Battle Ground: Strategies for Obtaining or Challenging Preliminary Injunctions
    • Obtaining Adequate Patent Protection While Operating in an "Anti-Patent" Climate: Factoring Key Cases into Your Biosimilars Patent Strategy
    • Open Floor Session Benchmarking Session: Putting It All Together: Is the Biosimilars Abbreviated Pathway Worth It?

    In addition, a post-conference workshop, entitled "Workshop: Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space," will be offered from 9:00 am to 12:00 pm on June 3, 2015.  The post-conference workshop will be presented in part by Patent Docs author Dr. Kevin Noonan.

    The agenda for the Biosimilars conference can be found here and an agenda for the post-conference 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 for the conference is $2,195 (conference alone) or $2,695 (conference and post-conference workshop).  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 the Biosimilars conference.

  • Webinar on Hedge Fund IPR Challenges to Pharma Patents

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Hedge Fund IPR Challenges to Pharma Patents: Strategies to Strengthen Patents to Withstand Attack" on May 28, 2015 from 1:00 to 2:30 pm (EDT).  Rekha Bansal, Sr. Director of IP, Principia Biopharma; and Thomas L. Irving, Dr. Amanda K. Murphy, and Dr. Barbara R. Rudolph of Finnegan Henderson Farabow Garrett & Dunner will provide patent counsel with guidance on the recent inter partes review (IPR) challenges by hedge funds to pharmaceutical patents, examining the patents that are being attacked and the grounds for attack, and discuss the lessons learned from these challenges and will offer strategies for strengthening patents to withstand attack.  The webinar will review the following questions:

    • What types of pharma patents are being challenged in representative patents challenged by hedge funds in IPR?
    • What grounds are being asserted?
    • What can the pharma patent owner do to strengthen their patents to enhance the chance of survival in IPR, irrespective of the identity of the petitioner?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by May 8, 2015 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.