•     By Kevin Noonan

    Much has been written in the comments to my response to Michael
    Crichton’s recent OpEd piece in The New York Times.  In order to open up the debate
    to those who haven’t read the comments, here is a thought experiment:

    You isolate a petrochemical with excellent lubrication
    qualities.  It is used in very expensive machinery so you can charge a lot of
    money for it.

    You isolate Vitamin B12 from beef muscle, and use it as a
    cure for anemia.  You charge a lot of money for it, because anemia kills people.

    You isolate a new drug, penicillin, from a mixture of
    naturally-produced chemicals made by a mold.  You use it to cure, among other
    things, syphillis, which otherwise kills people.  You charge a lot of money for
    it.

    You isolate erythropoietin from urine and use it for
    kidney dialysis patients, who otherwise die of anemia.  You charge a lot of
    money for it.

    You isolate a gene responsible for Gaucher’s disease, a
    lipid storage disease, and use the gene to make the missing protein.  It is
    efficiently gobbled up by macrophages in the affected childrens’ blood, which
    cures the disease that otherwise kills them at a young age.  You charge a lot of
    money for it.

    Now, if there is a logical position why the last of these
    is different from the rest, we would like to hear it.  And if the problem
    devolves into objections to inventors getting to charge a lot of money for cures
    for fatal diseases, or any other reason, then we would like to hear about that, too.

  •     By Jason Derry

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    The Biotech Feature of the Month at PipelineReview.com provides an overview and discussion relating to the current state of biogenerics in the industry and marketplace.  The Feature specifically discusses the major classes of biologics currently having branded products, including erythropoietin, somatotropin, interferon, granulocyte colony stimulating factor (G-CSF), insulin, and thrombolytics.  The Feature also discusses the biogenerics related to these classes, along with links to the European Medicines Evaluation Agency guidelines for biologic products, and links to competitive analysis studies relating to particular biogenerics.

  •     By Christopher P. Singer

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    In a February 14, 2006 press release, Idera Pharmaceuticals,
    Inc. announced that U.S. Patent No. 7,176,296,
    titled "Modulation of Oligonucleotide CpG-Mediated Immune Stimulation by Positional Modification of Nucleosides," has been granted by the U.S. Patent
    Office.  According to Idera, the patent
    covers a series of compounds that comprise modifications to the CpG
    dinucleotide motif.  These modifications
    include chemical groups that can modulate the immune response.  The "CpG" nomenclature stands for
    the dinucleotide 5′-deoxycytidine-deoxyguanidine or deoxyguanidine analog-3′,
    where "p" is an internucleotide linkage, such as a phosphodiester,
    phosphorothioate, or an alkylphosphonate, to name a few examples.  According to Idera, this patent encompasses
    components of its current candidate compounds that target Toll-Like Receptors
    (TLRs).

    The ‘296 patent claims priority as a divisional application
    (of U.S. Patent No. 7,115,579)
    back to April 30, 2001.  In brief, the
    patent claims relate to CpG compounds modified with a variety of
    immunomodulatory groups, which can either increase or decrease
    immunostimulatory effect relative to the unmodified compound.  Representative independent Claim 1 recites:

    1. A compound
      having increased or reduced immunostimulatory effect, the compound comprising a
      5′-CpG-3′ dinucleotide, wherein C is cytosine and G is guanosine or a
      substituted guanosine, and an immunomodulatory moiety, wherein the
      immunomodulatory moiety is selected from the group consisting of abasic
      nucleoside, 1,3-propanediol linker, nitropyrrole, nitroindole, deoxyuridine,
      inosine, isoguanosine, 2-aminopurine, nebularine, 7-deazaguanosine,
      4-thiodeoxyuridine, 4-thiothymidine, d-isoguanosine, d-iso-5-methylcytosine,
      P-base, and 3′-3′ linkage, wherein the compound is 12 to 35 nucleotides in
      length, wherein the compound does not have antisense activity, and wherein the
      increased or reduced immunomodulatory effect is relative to a similar compound
      lacking the immunomodulatory moiety.

    More information regarding this technology and Idera
    Pharmaceuticals, Inc. can be found here.

  • JMLS The Center for Intellectual Property Law at the John Marshall Law School in Chicago, Illinois will be holding its annual Intellectual Property Law Conference on February 23, 2007.  The morning session of the conference will focus on recent developments in patent, trademark, copyright, and trade secret law as well as electronic discovery under the new federal court rules.  The patent track of the afternoon session will consist of a panel discussion on the mediation of patent disputes, presentations on willful infringement and waiver of privilege and Federal Circuit obviousness law, and a bench/bar dialogue on jury instructions in patent cases.

    The registration fee for the conference ranges from $95 to $195.  Information about the conference and registration can be found here.

  • LSI - Law Seminars International - blue Law Seminars International's second annual conference on Complex IP and Technology Transactions will be held on March 21-22, 2007 in Chicago, Illinois.  The conference will focus on the business factors that must be considered and the legal issues that can arise in complex licensing transactions.  In particular, the conference will offer presentations on the following topics:

    • Initial Planning: Identifying the Work to be Done, and Setting Up an Organizational Structure for Accomplishing It
    • A Key Foundational Element: Keeping Up-to-Date on the Latest Developments in Substantive Law
    • Avoiding Antitrust Risks
    • Transactions with Public Entities
    • Selection, Design and Drafting of Complex Licensing Documents
    • The Blurring of Technology Transactions and IP Transactions, and the Need to Keep Up with Privacy and Data Security Laws
    • Special Issues Arising from the Geographic Scope of the Transaction
    • Establishing a Due Diligence Process that Fits the Deal
    • Special Issues Arising in Information Technology Transactions
    • Special Issues Arising in Transactions Involving Use of Trademarks and Copyrighted Materials on the Internet
    • Maximizing the Bottom Line and Receiving Full Value
    • Ethics for Transactional Lawyers

    The registration fee for the conference ranges from $497.50 to $995.  Those interested in registering for the conference can do so here.

  • The National Constitution Center is offering an audio conference entitled: "Intellectual Property Valuation: What's Your IP Worth?" on February 22, 2007 from 1:00-2:00 PM (EST).  Speaker John O'Malley of Volpe and Koenig, P.C. will discuss specific practices for conducting effective IP due diligence and performing routine IP audits.  In particular, the conference will cover the following topics:

    • Methods of valuation: Which type is right for you?
    • Converting IP into a profit center
    • Potential pitfalls: Preserving privilege and confidentiality
    • Key concepts and methods to ensure you've covered everything
    • Understanding the type of deal involved
    • Strategies and checklists: Patents, trademarks, trade secrets and copyrights
    • Tips for identifying and locating IP assets
    • When should IP audits be conducted?
    • Licenses and other agreements:  What to look for today
    • Budget, timing and responsibilities for the audit

    The registration fee for the audio conference is $199.  Those interested in registering for the audio conference can do so here.

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  •     By Mark Chael

    The National Collegiate Inventors & Innovators
    Alliance
    (NCIIA) co-produces the Invention to Venture (I2V)
    Workshop in association with various universities across the country throughout
    the year.  Upcoming I2V Workshops in
    February and March will be held at the University of Illinois at
    Urbana-Champaign, Valparaiso University, the University of Portland, Cornell
    University, and the University of Texas – El Paso.

    According to the NCIIA, I2V Workshops are an introduction
    to the process and practice of technology entrepreneurship.  The workshops are geared toward businesses
    seeking to identify new technology opportunities, business people seeking
    connections with university faculty and students, investors seeking high growth
    potential companies, members of university communities who are
    entrepreneurially ambitious, as well as faculty and students interested in
    technology entrepreneurship and how to commercialize research.  A full schedule of upcoming workshops with
    links to additional information is available here.

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  •     By Sherri Oslick

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    On February 12, 2007 the House of Representatives passed bill H.R. 34, designed to "encourage enhancement of expertise in patent cases
    among district judges."  The bill
    establishes a pilot program in certain district courts providing the judges of
    those districts with the opportunity to decline to hear patent cases.  Under the program, district court judges who
    request to hear patent cases must be so designated by the chief judge.  Patent cases will still be randomly assigned
    to one of the judges of the court, regardless of designation status, however a
    judge not designated to hear patent cases may decline to accept the case.  If a case is declined by a non-designated
    judge, it will be randomly assigned to one of the judges who has requested to
    hear patent cases.

    It remains to be decided which district courts will
    participate in the program, however the bill provides for no fewer than five
    courts to participate, and they are to be selected from among the fifteen district
    courts in which the largest number of patent and plant variety protection cases
    were filed prior calendar year.  The bill
    also provides for the allocation of funds for educational and professional
    development of the district judges designated to hear patent cases in matters
    relating to patents and plant variety protection, as well as funds to
    compensate law clerks with technical expertise.

    The bill now awaits senate approval.

  •     By Kevin Noonan

    Michael Crichton has always hated – or feared –
    technology.  In his novels The Andromeda
    Strain
    , The Terminal Man, and Jurassic Park, he has been a technology Cassandra, a
    modern-day Luddite warning that technology would get us if we weren’t very
    careful.  And while space viruses,
    inhuman cyborgs, and thunder lizards are entertaining as fiction, they shouldn’t
    inform national policy.

    That is what Dr. Crichton has been trying to do recently,
    neatly dovetailing these efforts with promoting his latest book, Next.  The bogeyman this time is DNA patenting,
    which he assails in an OpEd piece in The New York Times today.  Unfortunately, the misstatements and
    exaggerations in the piece make it closer to fiction than it has any right to
    be, appearing in the pages of the "paper of record."

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    The problems begin with the title, "Patenting
    Life."  Patenting life isn’t what he
    is concerned with – it is patenting DNA.  DNA is not life, any more than patenting Vitamin B12, proteins, or
    hormones isolated from animal (or human) material.  Writers like Dr. Crichton (particularly
    academics, who should know better) have created a "new vitalism;" in
    this philosophy DNA is "different" and patenting DNA should be
    prohibited.  One problem with their
    position is its intellectual dishonesty: as Dr. Crichton does here, they accuse
    gene patentees of having ownership rights to "your" DNA (the DNA in
    the cells of a person’s body).  This is
    nonsense, since anyone familiar with this space or any other truthful
    description of DNA patenting knows that patented DNA must be
    "isolated" or "isolated and purified."  In short,
    no one has ownership rights over "your" DNA (or mine, or Dr. Crichton’s).

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    Dr. Crichton chooses an easy target as "bad
    guys" in his fiction: the
    oft-maligned patent examiners that he holds responsible for gene
    patenting.  If there are culprits, of
    course, it would be the U.S. Supreme Court who in the Diamond v. Chakrabarty
    decision opened the doors for patenting genes and a host of other things that
    have been important components of the biotech industry.  Dr. Crichton would have you believe that the
    "good guys" are those commercial interests in the rest of the world
    who provide genetic testing using patented DNA more cheaply than in the
    U.S.  What Dr. Crichton doesn’t say is
    that these "free-riders" on American innovation only exist due to
    their governments’ tardiness in protecting biotechnology inventions.  Dr. Crichton characterizes as a
    "disaster" the decision to permit gene patents in the U.S.  The real disaster has been in the rest of the
    world, particularly Europe, where they are paying the price today of their
    political decisions that frustrated patent protection for biotechnology.  As recently reported in The Washington Post, European pharmaceutical companies have suffered both economically and
    in their drug product pipeline: where a generation ago the Europeans
    predominated, now it is American inventions and American companies that lead
    the world.  Much of this advantage stems
    directly from patent protection available for the biotechnology industry.

    There are a host of other pertinent facts omitted from
    the piece.  Examples include: that the
    patent right is limited (to 20 years from the initial filing date), so that the
    invention becomes freely available to the public for eternity once the patent
    expires (the robust generic drug industry depends on this fact).  That DNA is both a patented chemical compound
    (that can be infringed) and genetic information, which information is freely
    available upon publication.  That no one
    "owns" a disease nor has inhibited research on a disease.  That DNA patenting has not encumbered
    research; indeed, despite fears (voiced, famously, by Rebecca Eisenberg) that patenting
    DNA would lead to a "tragedy of the anticommons," research shows that
    gene patents have not impeded DNA research in academia.  See "The ‘Anti-Commons’ Aren’t So Tragic, After All."

    What patents do is protect inventors from commercial
    infringement of their inventions, and permit small companies to obtain the
    financial backing necessary to develop the very genetic tests and therapeutic
    drugs Dr. Crichton complains about.  The
    pages of the Times recently provided stark evidence of the economic advantages of
    patents in the U.S., in a profile of Xoma Corporation.  The Times writer decried the amount of
    investment ($700 million) in a company that in 25 years had not developed a
    successful commercial product.  Paradoxically, this demonstrates the genius and strength of the patent system, since it is only
    with this type of investment that companies like Xoma (and a host of more
    successful biotechnology companies) have been able to survive.  What the piece shows is how difficult and
    expensive it is to develop a biotechnology product; no sane investor would
    place his bets on such companies without patent protection, and without
    investment the industry could not survive.

    Dr. Crichton’s attack is political, as is the bill introduced
    on Friday by Representatives Becerra of California and Weldon of
    Florida, which would ban gene patenting (more on that in a later post).  This is a mistake, and there is ample
    evidence from our recent history that it is a mistake.  At least one reason why the U.S. did not
    become the country Dr. Crichton described in another of his books, Rising
    Sun
    – an aging, rust-bucket, economic
    wreck that could not compete with the facile new democracies of Europe and
    Asia – is that America was quick to
    protect its innovators and innovative industries like telecommunications,
    computers and biotechnology.  Thirty
    years ago, everyone had a Sony Walkman, today it’s an iPod.  And thirty years ago Europeans were producing
    most new drugs; today, it is America.  Whether the political motivations are "Green" or religious or
    merely careerism (by either novelists or academics), the mistake would be to
    ignore the lessons of history.  We
    shouldn’t be killing the golden goose of American innovation.

        Dr. Noonan has written a number of Patent Docs articles on the issue of gene patenting, including:

  •     By Jason Derry

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    Reportlinker has announced the availability of a new report that covers strategies and information relating to creating successful licensing deals in the biotechnology industry.  The report, "Biopartnering Strategies: Maximizing returns from biotechnology deal-making," covers topics such as in-licensing and out-licensing biotechnologies, as well as biopartnering trends and strategies.  In addition, the report provides a number of relevant case studies.

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