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  • Exelixis and BMS to Collaborate

        By Jason Derry —

    Exelixis
    Exelixis Inc. has announced a collaboration
    agreement with Bristol-Myers Squibb that the companies
    hope will result in the discovery and eventual commercialization of compounds
    to treat cancer.  Under the agreement,
    Exelixis will identify potential small molecule drugs candidates, and will
    carry the drugs through preclinical development.  BMS will have the right to choose up to three
    of the
    drug candidates for further development.  As reported in the press release, BMS will pay Exelixis $60 million at
    the start of the collaboration, and an additional $20 million for each drug
    candidate chosen for development.  Finalization of the agreement is subject to antitrust clearance.

    Bristol-Myers Squibb #2
    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  • Thailand Compulsory License Still in the News; Philippines Permits Parallel Importing of Norvasc Generic

        By Jason Derry —

    Merck
    As we reported on December 6, the Thailand government recently issued a compulsory license on Merck's AIDS drug, Efavirenz.  We also noted that Merck was not
    happy about the action because Thailand failed to contact Merck prior to
    making the decision.  Today, the Intellectual
    Property Owners Association (IPO) reported that U.S. pharmaceutical companies have joined Merck in criticizing
    Thailand's decision to issue the license without negotiating first with Merck.

    Pfizer
    In a related story about foreign countries
    permitting its citizens access to generic versions of patented drugs, Pfizer has filed charges
    against governmental agencies in
    the Philippines over the importation of a generic version of Pfizer's drug,
    Norvasc, into the Philippines.  The government in the Philippines, rather
    than issuing a compulsory license, followed a separate route for getting generic
    drugs to its citizens.  That route is
    known as "parallel importing."  The World Trade Organization (WTO) affords a right to exercise parallel importing.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  • Eli Lilly Increases Offer for Icos Corp.

        By Jason Derry —

    Lilly
    In a press release published this morning, Eli Lilly and Co. has announced
    that it has raised its bid for Icos Corp. to $2.3
    billion.  The proposed deal will be
    considered by Icos shareholders in a meeting scheduled for December 26.  According to its website, Icos is a
    biotechnology company dedicated to "discovering and developing
    breakthrough, proprietary products with high commercial potential for the
    treatment of serious medical diseases."  In 1998, Lilly and Icos formed a 50/50 joint venture to market Cialis®.

    Today's announcement lends credence to a recent article
    in BusinessWeek,
    which reports that big pharmaceutical companies are increasingly looking to
    acquire or enter licensing agreements with smaller biotechnology companies.

    Icos

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  • Court Report

        By Sherri Oslick —

    Gavel
    About Court Report: Each week we will report briefly
    on recently filed biotech and pharma patent cases.  A few interesting cases will be selected for
    periodic monitoring, providing our readers with an opportunity to follow the
    progress of these cases.


    Novartis Corp. et. a. v. Lupin Ltd. et al.
    1:06-cv-03338; filed December 14, 2006 in the District
    Court of Maryland

    Infringement of U.S. Patent No. 6,162,802
    ("Synergistic Combination Therapy Using Benazepril and Amlodipine for the
    Treatment of Cardiovascular Disorders and Compositions Therefor," issued
    December 19, 2000) following a paragraph IV certification as part of Lupin's
    filing of an ANDA to manufacture a generic version of Novartis' Lotrel®
    (amlodipine besylate/benazepril hydrochloride, used to treat
    hypertension).  View the complaint here.


    NexMed Holdings, Inc. v. Beta Technologies, Inc. et. al.
    2:06-cv-01014; filed December 8, 2006 in the District
    Court of Utah

    Infringement of U.S. Patent Nos. 5,133,352 ("Method
    for Treating Herpes Simplex," issued July 28, 1992) and 6,083,250
    ("Apparatus and Method for Inhibiting Lesion Formation by Selectively
    Treating the Prodromal Stage of the Lesion with a Pulsatile Electrical
    Stimulation," issued July 4, 2000) based on Beta Technologies' marketing
    and sale of "Cold Sore Inhibitor," an apparatus for performing a
    method of treating herpes simplex.  View
    the complaint here.

  • Patent Profile: Mirus Bio Corporation Announces Grant of U.S. Patent No. 7,148,205

        By Christopher P. Singer —

    Mirus_logo
    In a December 14, 2006 press release, Mirus Bio
    Corporation announced that U.S. Patent No. 7,148,205, titled "Intravascular
    Delivery of Non-Viral Nucleic Acid" has been granted by the U.S. Patent
    Office.  According to Mirus Bio, the
    patent covers a technology for the administration of molecules that can induce
    RNA interference (RNAi), called hydrodynamic intravascular injection.  This technique increases the permeability of
    blood vessels in a tissue by increasing the intravascular hydrostatic pressure
    through a rapid, large volume injection.  The effective and safe delivery of nucleic acid based therapeutics has
    been a major hurdle to the realization of that technology.

    The '205 patent claims priority through a series of
    divisional, continuation-in-part, and continuation applications back to
    December 13, 1995.  In brief, the patent
    claims relate to a process for delivering naked non-expressed double strand RNA
    to a mammal.  Representative independent
    Claim 1 recites:

    1.  A process for
    delivering a naked non-expressed double strand RNA to an extravascular cell of
    a mammal, comprising: a) injecting the naked non-expressed double strand RNA
    into a blood vessel lumen, in vivo; b) increasing the propensity for
    macromolecules to move through vessel walls and enter the extravascular space;
    and, c) delivering the naked non-expressed double strand RNA to the
    extravascular cell outside of the blood vessel.

    More information regarding this technology and Mirus Bio
    Corporation can be found here.

  • Upcoming Biotechnology Conference in San Francisco

    San Francisco #3
    A two-day conference entitled Biotechnology 2007 will be held in San Francisco
    on January 29-30, 2007.  The conference
    is presented by Law Seminars International, and will cover a wide variety of topics
    related to legal and business aspects of the biotechnology industry.  According to LSI's website, by attending the
    conference "you will learn":

    • New developments at the FDA;
    • New California
    legislative initiatives;
    • The state of stem cell research and generics;
    • Commercialization of university technology;
    • Recent federal and Supreme Court
    cases;
    • Tips and strategies for successful Biotech litigation;
    • Strategies for
    early and late stage financing;
    • The venture capital climate;
    • Corporate
    partnering and M&A transactions;
    • IP strategies;
    • A checklist for licensing
    joint ventures and collaborative arrangements; and
    • Outsourcing issues in
    Biotechnology.

    Law Seminars International
    We note that one of our colleagues and author of the
    Orange Book Blog, Dr. Aaron Barkoff, will be presenting a talk entitled:
    "Is a Thriving Generic Biotechnology Industry Just Around the Corner?

  • Upcoming Conference on Patent Portfolio Management

    New York #3
    The American Conference Institute has organized a conference dedicated to patent portfolio
    managing and strategies.  The event will
    be held on February 27-28, 2007
    in New York, NY.  The two-day conference will cover topics such
    as:

    • Making the Critical Determination of When R&D
    Becomes IP;

    • Protecting Market Share Through Competitive
    Intelligence;

    • Investigating Labeling Tactics and Patent Carve-Outs;

    • Brand Name v. Generic;

    • The Future of "Follow-On" Biologics: Trickle
    or Onslaught; Contemplating Change After Omnitrope;

    • Bracing for the Impact of Patent Reform on Patent
    Portfolio Management in the Life Sciences Industries;

    • Examining Special Portfolio Considerations that Arise
    with IP Ownership in Collaboration;

    ACI - American Conference Institute
    • Controlling Spiraling Costs as Pipelines Get Filled and
    Portfolios Go Global; and

    • Advanced Strategic Business Considerations for
    Maneuvering in the Global Patent Market.

    Visit ACI's website for more information.

  • Court Report Update

      By Sherri Oslick —

    Gavel
    Earlier this week we reported on Savient Pharmaceuticals,
    Inc. v. Sandoz, Inc. and Upsher-Smith Laboratories, Inc.    , 2:06-cv-05782, filed December 4, 2006 in the District Court of
    New Jersey.  Judge Sheridan had granted,
    then vacated, the temporary restraining order sought by Savient to prevent
    Sandoz from taking any actions to market, launch, sell or distribute generic
    Oxandrin® (oxandrolone).  Judge
    Sheridan denied Savient's request for a preliminary injunction, granting
    permission to the parties to file an interlocutory appeal on the issue.

    Savient filed its appeal on December 8th, and on December
    12th the CAFC granted a TRO, temporarily
    enjoining Sandoz from launching generic oxandrolone product, pending receipt of
    Sandoz's response and court's consideration of the parties' papers.  Sandoz's response is due by the end of the
    day on Friday, December 15th.

    The patents in suit are U.S. Patent Nos. 5,872,147;
    6,090,799; 6,670,351; 6,576,659; and 6,828,313, all directed to uses of
    oxandrolone.

  • Google Launches Patent Search Service

        By Christopher P. Singer —

    Google_patent_search_1
    Internet heavyweight Google has recently launched Google Patent Search, a beta
    version of a patent searching feature.  Currently, the search program covers issued
    U.S. Patents from the 1790s through the middle of 2006.  As the company discusses on the FAQ page
    relating to this service, it hopes to expand the program's search coverage to
    include published applications, international patents, and recently issued U.S.
    Patents in the coming months.

    Google Patent Search allows for a either a full text or
    advanced search strategy.  The full text
    search     is presented in the familiar Google search format, as are the search
    results.  The search results link to
    information-laden pages that include sections containing a patent summary,
    claims, drawings, citations, and a feature that allows for searching within the
    particular patent result.  The patent
    summary section includes an image of the patent that has your original search
    term(s) highlighted.  The advanced
    strategy allows for searches by patent number, inventor name, title, assignee,
    filing date, issue date, and U.S. and/or International classification.

  • Innovation Asset Group Reports Increased Use of Its IP Management Software

        By Jason Derry —

    Iag_banner_logo1
    Innovation Asset Group provides web-based applications for managing intellectual assets.  According to
    a December 13th press release,
    the company's major product, Decipher®, has seen a "notable
    adoption" of use from life sciences companies.  Decipher® is designed to help companies
    manage several aspects of their intellectual property.  According to its website, IAG indicates that
    Decipher® can be used to:

    • Capture, store and retrieve IP assets instantly in a
      secure yet accessible central repository.
    • Schedule and monitor critical IP-sensitive dates, such
      as maintenance renewals and responses to office actions.
    • Get 24/7 alerts and notify stakeholders about key
      action items, such as filing dates, expirations and office actions.
    • Define and systematize the relationships between IP
      assets and their inventors, licenses, products, managers and more.
    • Identify existing and potential licensing and royalty
      arrangements.

    For more information, visit IAG's website.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.