• Calendar February 14, 2007 – "MedImmune v. Genentech: Impact of the Supreme
    Court's Jan. 9 Decision on Patent Licenses
    " Teleconference (Strafford CLE Teleconferences)

    February 16, 2007 – Patent Claim Construction Conference (Law Seminars International) – Chicago, IL

    February 20, 2007 – "Potential
    Licensing Responses to MedImmune: The Supreme Court's Latest Word on
    Declaratory Judgment Actions Challenging Patent Validity
    " (ABA CLE)

    February 27-28, 2007 – Patent Portfolio Management (American Conference Institute) – New York, NY

    March 25-29, 2007 – American Chemical Society National Meeting – Chicago, IL

    April 16-18, 2007 – Biotechnology: Patent Prosecution, Licensing, Litigation &
    Hatch-Waxman
    (Patent Resources Group) – Orlando, FL

    April 27, 2007 – Patent Claim Construction Workshop (Law Seminars International) – Atlanta, GA

    May 6-9, 2007 – BIO International Convention – Boston, MA

  •     By Donald Zuhn

    Bio_logo_picture_landscape
    The Biotechnology Industry Organization (BIO) will be holding its annual BIO International Convention on May 6-9, 2007 in Boston, MA.  Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,100 biotechnology companies, state and international affiliates, and related organizations, as well as providing business development services for many emerging biotech companies.  According to BIO, the BIO International Convention serves to educate the public and policymakers about biotechnology, while fostering partnering meetings and other business development activities to keep the biotech industry growing.  A schedule of events for the Convention can be obtained here.  As part of the Convention, more than 1,700 biotech companies, organizations, and institutions will participate in the BIO Exhibition.  A list of exhibitors can be found here.  Information regarding registration pricing can be obtained here.

  •     By Kevin Noonan

    On first blush, it might appear that Indonesia’s decision
    to stop supplying avian influenza virus samples to global public health organizations, such as the U.N’s World
    Health Organization (WHO), is short-sighted or greedy or both (see "Virus for Sale").   However, the "rest of the story,"
    at least in part, is supplied in today’s New York Times.

    New_york_times_2
    An Op-Ed piece by Ruth R. Faden and Patrick S. Duggan
    from the Johns Hopkins Berman Institute of Bioethics and Ruth Karron from the
    Center for Immunization Research at the Johns Hopkins Bloomberg School of
    Public Health describes more about the economic consequences of bird flu in
    Indonesia. The biggest economic impact has been the result of Indonesia’s only current response to a bird flu outbreak – killing the infected birds. The killing
    of birds is necessary because it is believed that persistence of the virus in bird
    populations, especially ones close to human populations, increases the chance
    that a strain capable of human-to-human transmission will arise, due to the
    high mutation rate of influenza viruses. Obviously, the benefits of these prophylactic measures are global
    insofar as they forestall a pandemic of this lethal flu strain (70% mortality
    for infected Indonesians).

    According to the Hopkins authors, Indonesian Health Ministry
    officials have imposed a ban on household poultry farming in Jakarta, the
    capital. Indonesians were given a
    deadline of February 1 to Birdflu1051110_2
    "consume, sell or kill" approximately 1.3
    million birds, and the ban was enforced by door-to-door inspections by officials
    empowered to kill any remaining birds.

    While the government promised to pay a ransom of about
    $1.50 for each flu-infected bird (which is approximately its fair market
    value), the government will pay nothing for any healthy birds (the overwhelming
    majority).  Thus, thousands of
    Indonesians lost an inventory of substantial value from this edict. Moreover, it is the small local farmers,
    rather than multinational companies with poultry farms in Indonesia, that
    suffer disproportionately, since they cannot replace the destroyed birds.

    Although the authors are part of a group attempting to
    influence governments, international organizations, and multinational
    corporations to provide compensation for the world’s disadvantageous populations
    when the costs of avoiding (or at least postponing) a bird flu pandemic fall on
    their shoulders, there is no compensatory plan now in place.

    The costs are daunting – about $2 million for the
    current program, which could expand to as much as $450 million should a similar
    program be needed throughout Indonesia. Indonesia has less than $50 million in its budget for all aspects of
    bird flu, so some form of assistance is necessary.

    Under the circumstances, Indonesia’s attempt to be
    compensated for providing avian flu samples to Western scientists,
    organizations, and in particular, vaccine-producing companies, may be
    justified. It is true that Indonesia,
    and many other Third World countries will be disproportionately affected by a
    flu pandemic, or even a localized epidemic. However it is also true that governments, global organizations and the
    world’s population needs to be more willing to provide the funding necessary to
    prevent the pandemic. Poor countries
    like Indonesia cannot do it, and we are all in danger if the rest of the world
    does not step up to do our share.

  •     By Christopher P. Singer

    Sanofi_aventis
    In a February 9, 2007 press release, Sanofi-Aventis announced that it has lost its patent infringement suit against
    generic drugmakers Amphastar Pharmaceuticals, Inc. and Teva Pharmaceutical
    Industries Ltd., filed in the U.S. District Court for the Central District of
    California.  The suit relates to Sanofi-Aventis’ blockbuster blood thinning drug, Lovenox®, which is covered
    by patent until February 2012.  According
    to its press release, Sanofi-Aventis is considering its legal options going
    forward.  The company also notes that
    while a number of manufacturers have requested FDA approval of purported
    generic versions of Lovenox®, the FDA has yet to approve any such request.

    Amphastar_logo
    Logo_teva

  •     By Kevin Noonan

    Indonesia is a country of over 200 million encompassing more than 17,000 islands in
    the Malay archipelago.  It also has the largest number
    (81) of humans infected with the H5N1 strain of influenza virus (commonly
    called "bird flu"), with 63 fatalities.  And until recently, it was a
    principle source of virus and samples from infected humans for
    international agencies such as the World Health Organization (WHO), which provided Indonesia with no financial consideration for the samples.

    But no more.  The Indonesian Health Ministry has decided
    that the country "cannot share samples for free."  A Ministry
    spokesperson, Ms. Lily Sulistyowati, said "There should be rules of the
    game for it.  Just imagine, they  [i.e., Westerners] could research,
    use and patent the Indonesia strain."

    Some of the Indonesian government’s concern relates to
    negotiations with Baxter Healthcare of Deerfield, IL for rights to the
    Indonesian strains.  Baxter asserts that it has not asked Indonesia to stop
    cooperating with the WHO, and the Baxter agreement is
    non-exclusive.  However, the contract is a commercial contract, and the company
    will pay the Indonesian Health Ministry for virus and related samples.

    This issue is related to so-called "biopiracy," the practice of Western companies and
    governments obtaining biological materials from Third World countries and
    developing drugs, seeds, and other valuable products, typically with no
    compensation to the country’s people or government.  It is also related to demands
    from aboriginal peoples for repatriation of relics and other valuable artifacts
    taken by Western explorers and adventurers over the past half-millennium.

    The issue is also related to ownership concepts relating
    to whether compensation is due to patients when scientists use patient
    materials to develop treatments and therapeutic agents (for example, the
    dispute over Canavan disease) and Richard Epstein’s position that individuals should have
    the right to sell their organs (and Lori Andrews’ related property-right
    analysis: Body Bazaar: The Market for Human Tissue in the Biotechnology Age).

    Fundamentaly, however, the
    underlying problem is the economic inequities between First World and
    Third World access to drugs, especially in cases such as AIDS where Third World
    populations are overwhelmingly affected by the disease.  These inequities
    are exacerbated with regard to influenza, since Western
    companies are able to produce enough vaccine in a
    "normal" year for less than a quarter of the world’s population, and
    Indonesia’s poverty prevents it from obtaining an affordable supply for its
    people.  But Indonesia’s decision is particularly troubling because the bird flu
    virus, like all influenza viruses, mutates so rapidly that contemporaneous
    samples are critical to developing effective vaccines.  The most important
    mutation, permitting human-to-human transmission, has not yet occurred in this
    strain, and having virus with the enabling mutation is essential for developing
    a vaccine effective in preventing a pandemic.

    A potential silver lining in this age of genomic sequence
    analysis is that the genetic complement of the H5N1 influenza strain is known,
    and this information is not dependent on any Indonesian demand for payment.  Moreover, Indonesia has in the past sent samples to the WHO, and these
    strains survive and can be the basis for on-going work.  If a
    human-to-human  transmission strain arises, Indonesia may change
    its mind in the face of the growing pandemic.  But for now, Western companies
    need to address what may be an increasingly-common tactic of Third World
    countries having biological resources essential to developing new agricultural
    and pharmaceutical products: a demand to be compensated for both their
    biological materials and their cooperation.  Western governments and the international
    community will need to decide whether such arrangements will be left
    to private commercial entities, or will be the subject of international
    agreements between governments.  It is unfortunate but likely that such
    arrangements will not be in place in time to effectively address these
    issues as they apply to an influenza pandemic.

  • Chicago #5
    Law Seminars International's second annual conference on Patent Claim Construction will be held on February 16, 2007 in Chicago, Illinois.  The conference, entitled "New Developments in Patent Claim Construction," will focus on current case law updates, patent litigation strategies, effective advocacy tactics for presenting Markman Hearing cases, choosing and working with outside counsel, and handling claim construction on appeal.  The registration fee for the workshop ranges from $347.50 to $695.  Those interested in registering for the workshop, can do so here.

    Law Seminars International (LSI)
    Law Seminars International will also be offering a workshop on Patent Claim Construction on April 27, 2007 in Atlanta, Georgia.  According to LSI, the workshop will provide tools and information on proper claim construction, including a case law overview and update, recent developments from the Federal Circuit, litigation strategies, and effective appellate advocacy.  The registration fee for the workshop ranges from $347.50 to $695.  Those interested in registering for the workshop, can do so here.

  •     By Christopher P. Singer

    Wall Street Journal
    In a February 7, 2007 Wall Street Journal article entitled: "Small Firms Seek to Profit From Drug Giants' Castoffs" (subscription required), Jeanne Whalen discusses a drug development strategy that is more frequently being employed by small drug companies.  In particular, smaller companies employing this strategy enter into agreements with larger companies to license the rights to drug candidate programs that have been discontinued.  In the hope of finding a potential blockbuster, the smaller firm attempts to overcome the hurdles that caused the larger company to halt work on the drug.  These hurdles typically involve costs associated with manufacturing the drug and/or difficulty formulating the drug.

    Speedel
    This article presents several examples where this strategy has succeeded, as well as examples where it has failed.  In particular, Ms. Whalen focuses on the story of a renin-inhibitor drug candidate that was dropped by Novartis and picked up by Dr. Alice Huxley, a Novartis scientist originally involved with the discontinued Novartis project.  After Dr. Huxley learned that the project was to be shelved, she decided to leave Novartis, form her own company — Speedel Holding AG — and acquire the rights to the drug, now called aliskiren.  Speedel Holding eventually shepherded the hypertension drug to the clinic, overcoming the problems that had influenced Novartis to drop the program.  Under the terms of the original agreement, Novartis has repurchased the rights to the drug, and hopes that the drug's mechanism of action and efficacy will capture a sizeable chunk of the crowded hypertension drug market.  The financial reward for Dr. Huxley:  her Speedel stock holdings are estimated to be worth about $230 million.

  •     By Christopher P. Singer

    Cell Genesys
    In a February 5, 2007 press release Cell Genesys announced that it has secured a Committed Equity Financing
    Facility (CEFF) of up to $75 million with institutional investor Kingsbridge
    Capital Limited.  The financing will
    derive from the sale of newly issued common shares of stock from Cell Genesys
    to Kingsbridge over the next three years.  During the term of the agreement Kingsbridge cannot short Cell Genesys
    stock.  Some additional details regarding
    this CEFF are provided at the link above.

    According to the press release, this is the second CEFF
    between the parties, with funds from the first CEFF helping to advance Cell
    Genesys' GVAX® prostate immunotherapy into Phase 3 clinical trials.  For more information about Cell Genesys'
    clinical pipeline and development see this link.

  •     By Christopher P. Singer

    Regeneron
    In a February 5, 2007 press release Regeneron
    Pharmaceuticals, Inc. announced that it has entered into a non-exclusive
    license agreement with AstraZeneca involving Regeneron's VelocImmune®
    antibody technology.  The license
    includes an upfront $20 million payment to Regeneron in addition to as many as
    five additional annual payments of $20 million, subject to AstraZeneca's
    termination option after making the first three payments.  Should a commercial product as a result of
    AstraZeneca's use of VelocImmune®, Regeneron will receive a mid-single digit
    royalty payment.

    AstraZeneca_small
    VelocImmune® is an aspect of Regeneron's technology
    that focuses on the development and discovery of fully human antibodies.  The technology allows for the rapid
    generation of fully human antibodies through the immune response of the
    VelocImmune® mouse, which has a response nearly identical to the response
    of a wild type mouse.  More specific
    information about VelocImmune® can be found at this link.  AstraZeneca
    will utilize the VelocImmune® technology at Cambridge Antibody Technology
    (UK) in an effort to build its presence in the biopharmaceutical market.

  • West LEGALworks
    West Legalworks® is offering a webcast entitled:
    "Rethinking Patent License Agreements in the Wake of MedImmune v.
    Genentech
    " on February 6, 2007 from 12:00-1:30 PM (EST).  Speakers Brian Kacedon and Kathleen Daley will
    discuss patent license provisions and strategies in view of the
    MedImmune decision.  According to
    Thomson-West, the speakers will also address the following issues:

    • Will
    MedImmune affect your existing license agreements, and if so, to what extent?
    • What do
    licensees and licensors need to know for future negotiations and agreements?
    • What license
    provisions are a must after MedImmune?
    • How should
    you draft your license agreements in the future?
    • How can
    licensees and licensors best protect their interests in light of this decision?
    • How will
    MedImmune affect the ability of generic drug manufacturers to seek declaratory
    judgments?
    • What
    questions has the Supreme Court left unanswered?

    The registration fee for this webcast is $125.  Those interested in registering for the
    webcast, can do so here.

    Strafford
    Strafford CLE Teleconferences is offering a telephone
    conference entitled: "MedImmune v. Genentech: Impact of the Supreme
    Court's Jan. 9 Decision on Patent Licenses" on February 14, 2007 from
    1:00-2:30 PM (EST).  Speakers Michael
    O'Shea, Charles Baker, and David Segal will discuss the impact of the MedImmune
    decision on patent owners, licensees, and license agreements. According to Strafford, the speakers will
    also address the following questions:

    • How has
    MedImmune shifted the balance of power between patent owners and licensees –
    and how can licensors protect their rights?
    • How will
    MedImmune impact license negotiations and enforcement?
    • What are the
    best practices for licensors to protect themselves from patent challenges by
    licensees?

    A program outline for the teleconference can be obtained
    here.  The registration for the teleconference is
    $297.  Those interested in registering
    can do so here.

    Aba_cle_1
    The ABA is offering a webcast entitled: "Potential
    Licensing Responses to MedImmune: The Supreme Court's Latest Word on
    Declaratory Judgment Actions Challenging Patent Validity" on February 20,
    2007 from 1:00-2:30 PM (EST).  Speakers
    Monique Morneault, William Murray, and Lawrence Pope will discuss licensing
    approaches following the MedImmune decision.  The registration for this webcast ranges from $75 to $150.  Those interested in registering, can do so
    here.

    Kevin Noonan's report on the MedImmune decision can be found here.