•     By
    Donald Zuhn

    Washington - Capitol #2 In
    a letter sent to Speaker of the House Nancy Pelosi (D-CA), House Majority
    Leader Steny Hoyer (D-MD), and House Minority Leader John Boehner (R-OH)
    earlier today, Representatives Mike Michaud (D-ME), Don Manzullo (R-IL), Dana
    Rohrabacher (R-CA), and Marcy Kaptur (D-OH) urged the House leaders to "remember
    the importance of patent protections" as the House begins the process of
    crafting legislation to promote job creation.  Noting the "persistently high"
    unemployment rate and "slow economic recovery," the bipartisan group
    of lawmakers sought "to underscore the importance of protecting U.S.
    intellectual property standards as a way to help U.S. businesses and create U.S.
    jobs."  According to the
    letter's signatories, a key aspect of economic growth would be "strong
    patent protections that ensure the patent application process is efficient and
    fair for big and small companies alike."

    House of Representatives Seal The
    four lawmakers expressed dissatisfaction with the House's last patent reform
    effort, a controversial bill (H.R. 1908) that was passed by the House in
    September 2007 (see "Patent
    'Reform' Bill Passes House of Representatives
    ").  Interestingly, that bill, which was
    passed by a 220-175 vote, received strong support from Democrats (who voted 160-58
    in favor of the bill) and little support from Republicans (who voted 117-60
    against the bill).  Calling the
    House's prior effort "misguided," the lawmakers noted that they had
    "strong objections" to the bill because it "would not have
    improved the quality of patents or reduced the cost of patent
    litigation."  Instead, the
    bill "would have increased uncertainty among patent holders; reduced
    patent value; reduced investment in research and development; and, therefore,
    further hindered the development of U.S. manufacturing."  The four lawmakers also noted that they
    had opposed the House (H.R. 1260) and Senate (S. 515) bills introduced last
    March (see "Senate and House Introduce New Patent Reform Legislation"),
    saying that the bills were "troubling for a number of reasons."  Despite the efforts of Senator Dianne
    Feinstein (D-CA) to rework the damages provision in S. 515 to codify the
    fifteen Georgia-Pacific factors (see "Senate 'Patent
    Reform' Bill (S. 515) Voted out of Judiciary Committee
    "),
    the letter's signatories contend that "there are still several hurdles to
    an acceptable bill."

    According
    to the lawmakers, the primary "hurdles" are an apportionment-centric
    system of patent damages that "ignores the fact that current patent
    protections adequately take into account apportionment concerns and would
    reduce the overall value of patents," and an expansion of administrative
    challenges to patents (via post-grant review and expanded inter partes reexamination) that "seem[s] wholly unnecessary,
    given [that the changes to the patent system] will not reduce patent litigation
    and that the U.S. Patent and Trademark Office (PTO) already has a reexamination
    process."  The four lawmakers
    also believe that the expansion of administrative challenges will "allow
    foreign competitors to easily and cheaply challenge U.S. patents."  Other possible hurdles include the move
    to a first-to-file system and changes to willful infringement.  The lawmakers contend that "Congress
    should hear from each affected group and consider their input carefully through
    open hearings."  It should be
    noted that both the Senate and House held hearings on patent reform last year,
    the Senate Judiciary Committee holding its hearing on March 10 (see "Senate Judiciary Committee
    Holds Hearing on Patent Reform
    ")
    and the House Judiciary Committee holding its hearing on April 30 (see "House Judiciary Committee
    Holds Hearing on Patent Reform
    ").

    The
    letter concludes by stating that:

    Reliable intellectual property
    protections are critical to incentivizing American companies to research,
    develop, and manufacture goods in the United States.  In addition, they are imperative for protecting our U.S.
    businesses in the face of our foreign competitors.  As such, strong patent protection policy must be a crucial
    part of our economic recovery, and we look forward to working with you to
    ensure that it is.

  •     By Kevin E. Noonan

    Fifteen hundred years ago everybody
    knew the Earth was the center of the universe.  Five hundred years ago,
    everybody knew the Earth was flat, and fifteen minutes ago, you knew that
    humans were alone on this planet.  Imagine what you'll know tomorrow.

    Men in Black (1997)

    Boston Globe And in 2010, everybody knows that gene patenting is
    a bad idea, at least if you define "everybody" as the editorial boards
    of major metropolitan newspapers (and, of course the ACLU).  Today, The Boston Globe took that brave stand in an editorial that proved they
    know much less than that.

    The conclusion is familiar, but the level of either
    ignorance or misinformation is impressive.  Here is a smattering:

    Under US patent law, no one can
    patent what occurs in nature.

    Ah, no.  Possibly correct if the sentence read ". . . what occurs in nature as it occurs in nature," but
    certainly not correct as written.  And a good thing, too, since the natural world is full of chemical
    compounds (such as taxol) that are useful as medicines.  An absolute ban on patenting chemicals
    that occur in nature (in an purified state) would preclude protection for any
    such medicine — a bad (and unnecessary) result, but one that would follow from
    the kind of absolute ban The Globe
    envisions.

    And it isn't even good law.  The closest Supreme Court case on
    point, the Wood Paper Patent Cases
    from the 19th Century, says (with regard to a claim for purified
    cellulose):

    Whether a slight difference in the degree of purity of an article produced by
    several processes justifies denominating the products different manufactures,
    so that different patents may be obtained for each, may well be doubted, and it is not necessary to decide.

    Which says nothing about
    a purified chemical (and the patent rolls abound which such patents).  Providing a nice counterpoint is much
    more recent, binding Supreme Court precedent that "anything under the sun
    made by man" is patentable, for things that are "
    a
    product of
    human ingenuity 'having a distinctive name, character [and] use'" (Diamond v. Chakrabarty).  Isolated nucleic acid qualifies under this proper standard.

    Gene It is also sad (albeit not surprising) that the
    message that gene patents do not impede basic research hasn't penetrated — the
    editorial states that "
    researchers who
    discover what a specific gene does can retain the exclusive right to study it."  Again, no, and that isn't
    even a matter of opinion.  Had the
    esteemed editorial writers at The Globe
    bothered to do their own basic research (something much less difficult than
    scientific research), they would have realized that thousands of papers written
    by hundreds of researchers other than the
    scientists who patented the BRCA1 and BRCA2 genes have been published since the
    late 1990's (the time when the patents at issue were granted).  So the inventors named on those patents
    (and their assignees and licensees, including Myriad Genetics) don't seem to
    have exercised any exclusive rights with regard to such basic research.  The Globe thinks that "[s]uch research
    should be an open avenue of scientific inquiry," and apparently it is.

    Then the editorial
    strives for — and attains — complete unreality.  Addressing the argument that gene patenting is necessary for
    attracting investment and to insure a return on such investment, the writers
    assert:

    Yet even without gene patents, it's
    hard to imagine that companies would not invest in the basic research that
    leads them to tests and treatments that can be patented — and become
    highly profitable — for devastating diseases.

    It appears that no one
    told The Globe's editorial board that
    the ACLU has sued not only on claims to the genes, but to the genetic tests as well — the very tests The Globe agrees should be patentable.  And insofar as those "treatments" The Globe endorses include the drugs — in this case, biologic drugs —
    used in those treatments, gene patents are an important component of protecting
    those drugs and making investment capital available for their commercialization.

    Blissfully ignorant of
    these realities, The Globe concludes
    its editorial like this:

    Eliminating these patents would attract
    new researchers and sources of capital that could lead to treatments for many
    diseases, including Alzheimer's and cancer.  It would also encourage market
    competition for tests and treatments based on gene sequences, saving money as
    well as lives.

    On the contrary,
    without these patents there would be much less investment, and it is difficult
    to see how there could be more basic research than is already being done.  "Market competition" is fine,
    but the concept can't be cherry-picked — the very market that promotes
    competition can completely stifle progress by precluding the conditions
    necessary to attract investment.  That is the future The Globe
    envisions, because its editorial writers blindly accept the wisdom of what
    everybody knows.

  •     By
    Donald Zuhn

    BIO CEO Asks President to
    Focus on Unresolved Issues in Health Care Debate

    Greenwood, Jim Writing
    for True/Slant earlier this month,
    Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood provided
    his organization's take on recent efforts by President Obama to re-write the biosimilars provisions of the House and Senate
    health care bills ("Health Care Reform Negotiations: Focus on Unresolved
    Issues
    ").  A little more than two weeks ago, President
    Obama informed Congressional Democratic leaders, including Rep. Anna Eshoo
    (D-CA), of his continued opposition to a 12-year data exclusivity period in a
    meeting at the White House.  Noting
    that the "clock was ticking away" on health care reform, Mr.
    Greenwood (at right) wondered why the President and some members of Congress, like
    Rep. Henry
    Waxman (D-CA)
    , would focus
    on the long resolved data exclusivity provisions of the House and Senate bills
    rather than "on some of the 20+ areas where the House and Senate bills
    don't line up — employer mandates, a public option, taxes, to name a few."

    Contending
    that biosimilars provisions represent a "legislative solution . . . that
    would encourage life-saving biomedical research while expanding access to
    powerful biologics," Mr. Greenwood also asserted that the proposed
    legislation would "preserve[] existing U.S. jobs and maintain[] the
    biotechnology sector's ability to create high-wage, high-value jobs."  Despite the fact that the biosimilars
    provision "happens to be one of the few provisions that is almost
    identical in both the House and Senate versions of the health care reform
    bill," and that the provision received bipartisan support in both the Senate Health,
    Education, Labor and Pensions (HELP) Committee (by a 16-7 vote) and House
    Energy and Commerce Committee (by a 47-11 vote), the President has pressed for
    a shorter data exclusivity period.

    In
    his brief article, Mr. Greenwood notes that "[t]he biosimilars provision is the
    result of a careful compromise overwhelmingly approved months ago in each
    Chamber," and that "[i]n addition to receiving support in both
    Chambers and by both parties, the biosimilars provision is supported by
    universities, patient groups, venture capitalists and economic development
    groups."  The BIO CEO
    concludes by stating that "[i]t's time for Rep. Waxman and the White House
    to take on the tough issues that are weighing down the health care reform
    debate — not reopen one of the few issues that has long been resolved."


    38 Patients Groups and
    Research Universities Back 12-Year Data Exclusivity Period

    Earlier
    this month, the Gazette.Net reported
    that despite the election of Republican Scott Brown to the Massachusetts Senate
    seat once occupied by Ted Kennedy, a number of legislators have been pushing
    for the passage of the proposed biosimilars regulatory pathway that was
    approved in both the Senate and House health care reform bills ("BioWatch:
    Federal biosimilar regulation gathers support
    ").  In two separate letters, one to Senate
    Majority Leader Harry Reid (D-NV) from eight Senate Democrats and another to
    House Speaker Nancy Pelosi (D-CA) and Majority Leader Steny Hoyer (D-MD) from
    45 members of the House, legislators continue to support a biosimilars
    regulatory pathway providing a 12-year data exclusivity period.

    In
    addition to the letters above, and a letter from six Governors also supporting
    the 12-year period (see "Governors
    Write President in Support of 12-Year Data Exclusivity Period
    "),
    Sen. Reid and Speaker Pelosi also recently received a similar letter from 38
    organizations, including groups representing surgeons plus advocacy groups such
    as Easter Seals, the Parkinson's Disease Foundation and the Muscular Dystrophy
    Association.  (Patent Docs has not had an opportunity to review the above letter, but would gladly post a copy if any of
    our readers can provide one.)


    NATF Says Patient Safety
    Should Be Top Priority When Crafting Biosimilar Regulatory Pathway

    NATF In
    an
    advertisement appearing in the Eastern edition of The Wall Street Journal on January 27, the North American
    Thrombosis Forum
    (NATF) states that "patient safety must be the top
    priority and must be ensured prior to making [biosimilar] drugs available to
    the U.S. public."  The ad
    notes that both the House and Senate health care bills would provide for the creation
    of a biosimilars regulatory pathway in the U.S., and contends that "[t]he
    potential of [biologic medicines] to reduce costs is why we believe follow-on
    biologics are a critical component for meaningful heathcare reform."  While acknowledging that "healthcare
    reform legislation is a massive undertaking with many competing
    interests," the ad warns that "when compared to a fight over billions
    of dollars, threats to patient safety from follow-on biologics may be easily
    overlooked."

    The
    ad proposes several changes to the biosimilars provisions of the House and
    Senate health care bills in order to better address patient safety.  First, the ad contends that "it is
    critical that this piece of healthcare reform requires well-designed and
    properly conducted clinical trials demonstrating safety and efficacy of
    biosimilars."  The ad also
    contends that the "potency and biological effects of the biosimilar and
    approved product must be equivalent," and therefore, the FDA must
    "set out clear criteria to demonstrate whether biosimilars can be
    substituted for approved products (interchangeability), and biosimialrs
    themselves must be excluded as reference products."  Finally, the ad states that
    "long-term safety must be established and rigorously monitored in patients
    treated with biosimilars."

    According
    to the ad, the NATF is a nonprofit advocacy group of scientists, clinicians,
    and patients focusing on the unmet needs and issues related to thrombosis and
    cardiovascular diseases. 
    Representing NATF on the ad are Dr. Craig Kessler, Professor of Medicine
    and Pathology at the Georgetown University Medical Center, and Dr. Craig
    Jackson, Associate Professor of Internal Medicine and the Washington University
    School of Medicine.

  • Calendar

    February 4, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Chicago

    February 4, 2010 – Bay Area Pharma and Life Sciences IP Summit (Fish
    & Richardson and Berkeley Center for Law & Technology) –
    San Mateo, CA

    February 9, 2010 – Patent
    Prosecution: Best Practices for Reducing Costs While Improving Patent
    Quality
    (
    Technology
    Transfer Tactics) –
    1:00 – 2:30 PM (EST)

    February
    17-18, 2010 –
    Biotech & Pharmaceutical Patenting (IIR) – Munich, Germany

    February 24-25, 2010 – 2nd Expert Forum on ITC Litigation &
    Enforcement
    (
    American Conference
    Institute) –
    New York, NY

    March 1-2, 2010 – 4th Annual Patent Law Institute (Practising
    Law Institute) –
    New York, NY

    March 2-4, 2010 – 6th Annual Biosimilars Conference (Visiongain) – Boston,
    MA

    March 17-18, 2010 – 18th Forum on Biotech Patenting (C5) – Munich,
    Germany

    March 18-19, 2010 – 4th Summit on Biosimilars and
    Follow-on Biologics
    *** (
    Center for
    Business Intelligence) –
    Washington, DC

    March 22-23, 2010 4th Annual Patent Law Institute (Practising
    Law Institute) –
    San Francisco,
    CA

    March 24-25, 2010 – FDA Boot Camp*** (American Conference
    Institute) –
    New York, NY

    March 30,
    2010 – "The Bilski Decision: Expert Strategies to Manage Its Impact on University IP"
    (Technology
    Transfer Tactics) –
    1:00 – 2:30 PM (EST)

    April 7-10, 2010 – 25th
    Annual Intellectual Property Law Conference
    (
    American Bar
    Association Section of Intellectual Property Law) –
    Arlington,
    VA

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

  •     By Christopher P. Singer

    USPTO Seal In a January 15, 2010 press release,
    the U.S. Patent and Trademark Office announced three new members to the Patent Public Advisory Committee
    (PPAC) and two new members to the Trademark Public Advisory Committee (TPAC), as named by
    Commerce Secretary Locke.  The Public Advisory Committees for the USPTO, which were
    created by statute in the AIPA,
    review the policies, goals, performance,
    budget, and user fees of the patent and trademark operations, and advise the
    Director on those matters. 
    The committees are comprised of
    U.S. citizens who are selected to represent the interests of the diverse
    users of the USPTO.  Each committee consists of
    nine voting members who are
    appointed by the Secretary of Commerce and who serve
    three-year terms.  The new members of the Patent Public Advisory Committee are:

    Borson, Benjamin Dr.
    Benjamin Borson
    is the founder of Borson Law Group, PC
    where he advises small, mid-sized, and large clients in developing
    business-based IP strategies in the life sciences and high technology
    industries.  He has been an IP professional for 15 years and is a frequent
    author and speaker on IP law.  Dr. Borson has been active in organizing
    discussions and meetings regarding science and law, including symposia
    highlighting USPTO Technology Center 1600 practices and procedures through the
    San Francisco area BioScience Forum which he founded and has previously served
    as its president.  He is the
    current chairman of the Legislation Committee of the IP Section of the
    California State Bar and is a former member of the Executive Committee of the
    Intellectual Property Section of the California State Bar.  According to
    his resume, Dr. Borson earned his Ph.D. in physiology at the University of
    California, San Francisco and his J.D. from the University of San Francisco
    School of Law.  Prior to exploring law, he worked at UCSF as a
    researcher and adjunct lecturer, and was later a visiting scientist with
    Genentech.  Dr. Borson has
    published over seventy scientific articles, including reviews, book chapters,
    and research articles and owns two patents.  He has also published over
    twenty publications in legal periodicals and has presented a number of lectures
    on legal matters to legal, academic, and industrial organizations.  During his legal practice, Dr. Borson
    worked in a wide array of technologies including biotechnology, chemistry,
    pharmaceutical, semi-conductor, electronic compression technology, medical,
    analytical instrumentation, and bioinformatics fields.

    11_Gurry_Miller_Michel Steven
    W. Miller
    is Vice President and General Counsel-Intellectual
    Property for Proctor & Gamble in Cincinnati, Ohio and has worked in various
    positions in within the I.P. section of its law department since he started in
    1984.  Mr. Miller received his degrees (B.S. and J.D.) from The Ohio State
    University.  He is affiliated with number organizations, including serving
    as a member of the Executive Committee for the Association of Corporate Patent
    Counsels, the Steering Committee for the Coalition for 21st Century Patent
    Reform and the Board of Directors for the National Inventors Hall of
    Fame.  He is a past president and serves as a Board of Directors member
    for the Intellectual Property Owners Association and the Intellectual Property
    Owners Association Education Foundation.

    Kepplinger, Esther Esther
    Kepplinger
    is the director of patent operations and serves as
    the liaison to the USPTO for Wilson Sonsini Goodrich & Rosati, PC according
    to her profile page.  Prior to joining the firm in 2005, she served as deputy commissioner for patent
    operations in the USPTO where she oversaw the nation's patent-examination
    process, with all the patent examiners in the United States reporting to her.  Ms.
    Kepplinger managed a budget of $700 million and approximately 4,500 people.  During her service as deputy commissioner, the number of filed patent
    applications increased to more than 350,000 and the Office granted about
    170,000 patents.  She helped to establish the policies and strategic direction
    of the patent examining corps, implement the PTO's goals for improving quality
    and efficiency of service.  She began working for the USPTO in 1973 and held a
    variety of positions within the Office, including patent examiner and
    supervisor in a biotechnology art unit and group director for the chemical and
    materials engineering group.  While at the USPTO, Ms. Kepplinger received a
    number of awards, including the Presidential Rank Award in 2002 and the
    Department of Commerce Gold Medal in 1998 and 2004.  She is active in the AIPLA where she serves as the vice
    chair of the Patent Agents Committee and is a member of the Special Committee
    on Legislation.  She holds a certificate in Advanced Public Management
    from Syracuse University's Maxwell School of Citizenship and Public Affairs and
    a B.S. in Biology from Indiana University of Pennsylvania.

    Matteo, Damon Damon
    Matteo
    is the Vice President and chief intellectual
    property officer of the Palo Alto Research Center (PARC).  Prior to joining PARC, he managed
    Hewlett-Packard's licensing organization.  Secretary Locke appointed Mr. Matteo to serve as chairman of PPAC for a
    three-year term.  He has spent over two decades deeply involved in intellectual
    capital management (ICM) and has extensive experience in the creation,
    strategic management, venture/funding, and commercialization of corporate
    intellectual property assets.  Mr.
    Matteo has received a variety of professional awards, including: being named
    one of the "Fifty Most Influential People in Intellectual Property";
    the National Technology Transfer Excellence Award; the R&D 100 Award; and
    Senior Distinguished Fellow with the Center for Advanced Technology.  Mr. Matteo
    also serves on the Board of Directors for the European Center for Intellectual
    Property Studies, and was selected principal industry expert in intellectual
    capital for both the U.S. Security & Exchange Commission (SEC) and the
    United Nations.

    The next PPAC meeting is currently scheduled for
    February 11, 2010, with the time and location yet to be determined.

  • Technology Transfer Tactics
    Technology
    Transfer Tactics will be offering an audioconference entitled "The Bilski Decision: Expert Strategies to
    Manage Its Impact on University IP
    " on March 30,
    2010 from 1:00 – 2:30 PM (EST).  Patent Docs author Dr. Kevin Noonan, a
    partner at McDonnell Boehnen Hulbert & Berghoff LLP; Dr. Jim Baker,
    Director of Technology and Economic Development at Michigan Technological
    University; and Wesley Blakeslee, Executive Director of Johns Hopkins
    Technology Transfer, will cover the Bilski
    decision's implications for every step of the commercialization and patenting
    process and deliver guidance for tech transfer, licensing, and legal
    professionals, including:


    What's affected?  The scope extends
    further than one might think, beyond software and IT;

    Understanding the machine-or-transformation test;

    Pre-disclosure:  Working with
    faculty to configure innovations with M&T test in mind;

    Disclosure and triage/assessment: 
    How should investment and patent criteria change post-Bilski?

    Patent strategy:
           
    Impact on non-U.S. rights;
           
    Using "do-not-publish" applications during pendency;
           
    Claim construction to match PTO guidance;
           
    Considering reissue applications for issued patents;
           
    Responding to rejections;

    Alternatives to patent protection: 
    trade secrets, know-how, and copyrights;

    Assessing and minimizing impact on existing licenses;

    Recalibrating enforcement actions; and

    A bright side?  Impact on patent
    trolls.

     The
    registration fee for the audioconference is $197.  Those interested in registering for the audioconference, can
    do so here or
    by calling 239-263-0605.

  • Springbrochure10-1 The American Bar
    Association (ABA) Section of Intellectual Property Law will be holding the 25th
    Annual Intellectual Property Law Conference on April 7-10, 2010 in Arlington,
    VA.  Among the topics that will be
    covered at the conference are:

    • Patent reform
    legislation — Where we are, how did we get here, and what does the future hold
    in store?
    • The year in
    patent law;
    • Hot topics in
    foreign patent procurement and enforcement;
    • Biosimilars 2010;
    • Best practices
    for selecting, retaining and working with experts in patent cases;
    • Litigating
    validity:  Obviousness and
    collateral challenges;
    • Insurance
    challenges:  What every
    intellectual property lawyer should know about legal malpractice insurance,
    litigation, sanctions, and ethical violations;
    • The use of
    opinion of counsel as evidence in patent litigation;
    • Navigating inter partes reexamination;
    • Patent and
    trademark prosecution ethics — Shifting sands or new directions?
    • Patent licensing
    for standards:  How the deal is
    done;
    • Anatomy of an
    infringement claim:  Analyzing and
    responding to a letter asserting trademark or patent infringement;
    • Patent practice
    perspectives:  Addressing client
    and subject matter conflicts;
    • Mock preliminary
    injunction hearing; and
    • Strategic forum
    selection in patent litigation.

    On the second day
    of the conference, the luncheon speaker will be David Kappos, Under Secretary
    of Commerce for Intellectual Property and Director of the U.S. Patent and
    Trademark Office, who will share his perspective on USPTO challenges and
    strategies for the future.  In
    addition, an evening reception will be held at the U.S. Court of Appeals for
    the Federal Circuit.

    The program
    schedule for the conference can be found here.  A complete brochure for the conference,
    including the program schedule, a list of speakers, and registration form can
    be downloaded here.

    ABA The registration
    fee is $245 (law students), $295 (corporate counsel and government, public
    interest, and academic rate), $645 (ABA-IPL section members and members of co-sponsoring
    section), $715 (ABA members), or $795 (non-ABA members).  Those registering before March 23, 2010
    will receive a $50 discount. 
    Detailed registration information can be found in the conference
    brochure or on the ABA website.

  •     By
    Donald Zuhn

    USPTO Seal In
    a press release issued today, the
    U.S. Patent and Trademark Office announced that it would be implementing an
    interim procedure by which patentees can request Patent Term Adjustment (PTA)
    recalculations while the Office revises its procedures to comply with the
    Federal Circuit's decision in Wyeth v.
    Kappos
    .  In Wyeth, which was decided on January 7th,
    the Federal Circuit affirmed an order by the District Court for the District of
    Columbia granting summary judgment in favor of Wyeth, in which the lower court
    found that the USPTO had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a
    result, had denied Wyeth a portion of the patent term to which it was entitled
    (see Patent Docs report).  Last week, the Office posted a notice
    on its website stating that the Office and Department of Justice would not be
    seeking further review of the Federal Circuit's decision in Wyeth (see "USPTO and DOJ Will Not
    Seek Review of Wyeth v. Kappos
    ").

    The
    press release states that the Office will be:

    [P]roviding
    patentees with the ability to request a recalculation of their patent term
    adjustment without a fee or petition as is normally required pending completion
    of necessary modifications to the USPTO's computer program for calculating
    patent term adjustments.  The
    agency expects to complete by March 2, 2010, the software modification
    necessary to comply with the U.S. Court of Appeals for the Federal Circuit's
    recent decision in Wyeth v. Kappos regarding the overlapping delay provision of
    35 USC 154(b)(2)(A).  In the
    meantime, the USPTO will be processing recalculation requests under an interim
    procedure that is available to a patentee whose patent issues prior to March 2,
    2010, and who requests it no later than 180 days after the issue date.  This procedure is available only for
    alleged errors in calculation that are specifically identified in Wyeth.  A copy of the notice submitted to the
    Federal Register for publication and the form for patentees to use in
    requesting a recalculation of patent term is on the USPTO Web site at http://www.uspto.gov/patents/announce/pta_wyeth.pdf.

    In
    the Federal Register notice mentioned in today's press release, the Office states
    that the interim procedure "provid[es] patentees with the ability to
    request a recalculation of their patent term adjustment without a fee as an
    alternative to the petition and fee required by 37 CFR 1.705(d)."  Section 1.705(d) states that:

    If there is a revision to the patent
    term adjustment indicated in the notice of allowance, the patent will indicate
    the revised patent term adjustment. 
    If the patent indicates or should have indicated a revised patent term
    adjustment, any request for reconsideration of the patent term adjustment
    indicated in the patent must be filed within two months of the date the patent
    issued and must comply with the requirements of paragraphs (b)(1) and (b)(2) of
    this section.  Any request for
    reconsideration under this section that raises issues that were raised, or
    could have been raised, in an application for patent term adjustment under
    paragraph (b) of this section shall be dismissed as untimely as to those
    issues.

    Section
    1.705(b), which is referenced above, states in part that:

    Any request for reconsideration of the
    patent term adjustment indicated in the notice of allowance, except as provided
    in paragraph (d) of this section, and any request for reinstatement of all or
    part of the term reduced pursuant to § 1.704(b) must be by way of an application
    for patent term adjustment.  An
    application for patent term adjustment under this section must be filed no
    later than the payment of the issue fee but may not be filed earlier than the
    date of mailing of the notice of allowance.

    As
    we reported in September, the Office has been advising applicants for several
    months that "[r]ather than file an application for patent term adjustment
    under 37 CFR 1.705(b) contesting the 37 CFR 1.702(b) [i.e., B-delay] calculation at
    the time of the mailing of the notice of allowance, . . . [applicants] may wait
    until the time of the issuance of the patent and file a request for
    reconsideration of the patent term adjustment pursuant to 37 CFR 1.705(d)"
    (see "USPTO Says Some Requests
    for PTA Reconsideration Are Premature
    ").  In response to requests for
    reconsideration under § 1.705(b), the Office has explained that it "does
    not calculate the amount of time earned pursuant to 37 CFR 1.702(b) until the
    time of the issuance of the patent," and therefore, has assured applicants
    that it "will consider any request for reconsideration of the patent term adjustment
    due to an error in the calculation of 37 CFR 1.702(b) to be timely if the
    request for reconsideration is filed within two months of the issuance of the
    patent."

    The
    Office warns applicants in the Federal Register notice that it "will deny
    as untimely any request for recalculation of patent term adjustment indicated
    on a patent that is not filed within
    180 days of the day the patent was granted."  (Thus, the interim procedure for requesting PTA recalculation
    applies only to patents that issued after August 1, 2009 — i.e., on or after Tuesday, August 4,
    2009 — and before March 2, 2010.) 
    In contrast with the deadlines set forth in § 1.705(b) and (d), which
    are not specified in Title 35, the 180-day deadline discussed in the notice relates
    to 35 U.S.C. § 154(b)(4), which states in part that:

    An applicant dissatisfied with a
    determination made by the Director under paragraph (3) shall have remedy by a
    civil action against the Director filed in the United States District Court for
    the District of Columbia within 180 days after the grant of the patent.

    To
    facilitate the process of requesting a PTA recalculation under the interim
    procedure, the Office has created a new form (PTO/SB/131) for use in making
    such requests.  The form, which will
    be made available on the Office's forms page,
    can be obtained immediately in the Federal Register notice posted on the
    Office's website.

    In
    addition, for patents in which a request for reconsideration under 37 C.F.R. §
    1.705(d) was filed, the notice indicates that:

    Patentees who received a decision on a
    request for reconsideration of the patent term adjustment indicated in the
    patent under 37 CFR 1.705(d) under the USPTO's pre-Wyeth interpretation
    of 35 U.S.C. 154(b)(2)(A) may file a request for reconsideration of that
    decision if such a request for reconsideration is filed within two months of
    the date of the decision on a request for reconsideration (37 CFR
    1.181(f)).  If the patentee's sole
    basis for requesting reconsideration of the decision is the USPTO's pre-Wyeth
    interpretation of 35 U.S.C. 154(b)(2)(A), the request for reconsideration need
    only state that reconsideration is being requested in view of the Federal
    Circuit's decision in Wyeth (the Request for Recalculation of Patent
    Term Adjustment in View of Wyeth form (PTO/SB/131) may also be used for this
    purpose).

    Interestingly,
    the Office explains in the notice that:

    [T]he patent term adjustment provisions
    of 35 U.S.C. 154(b) are complex, there are numerous types of communications
    that are exchanged between applicants and the USPTO during the patent
    application process, the PALM system was not originally designed for the
    purpose of calculating patent term adjustment as provided in 35 U.S.C. 154(b),
    and one or more of the time frames specified in [] 35 U.S.C. 154(b)(1)(A) and
    (B) are not met presently in a high percentage of the patents.  In addition, revisions to the patent
    term adjustment computer program necessary to calculate overlapping delays
    consistent with the Federal Circuit's interpretation of 35 U.S.C. 154(b)(2)(A)
    in Wyeth significantly increases the complexity of the patent term adjustment
    computer program.

    The
    Office also notes that "[t]he USPTO is modifying and will continue to
    modify the patent term adjustment computer program as it becomes aware of
    situations in the patent term adjustment computer program where it is not
    correctly calculating the applicable patent term adjustment."

    Because
    the Office may only refund fees paid by mistake or in excess of that required (pursuant
    to 35 U.S.C. § 42(d)), the Office advises applicants that "the procedure
    set forth in this notice is not a
    basis for requesting a refund of the fee specified in 37 CFR 1.18(e) for any
    request for reconsideration under 37 CFR 1.705, including any previously filed request
    that was solely based on the USPTO's pre-Wyeth interpretation of 35
    U.S.C. 154(b)(2)(A)."

    Finally,
    the Office advises in the notice that it will be revising the PTA calculation
    screen that is viewable through PAIR so that it complies with Wyeth.  The revised screen, which the Office expects to be ready by
    July, will show:

    (1)
    the number of days of A-delay;

    (2)
    the number of days of B-delay;

    (3)
    the number of days of C-delay;

    (4)
    the number of days of A-delay that overlap with a day of B-delay plus the
    number of days of A-delay that overlap with a day of C-delay;

    (5)
    the number of days of non-overlapping USPTO delay;

    (6)
    the number of days of applicant delay; and

    (7)
    the total PTA.

    For
    additional information regarding this and other related topics, please see:

    "USPTO and DOJ Will Not
    Seek Review of Wyeth v. Kappos
    ," January 21, 2010

    • "USPTO Posts Notice Regarding Wyeth Decision," January 11, 2010
    • "The Federal Circuit's Wyeth v. Kappos Decision," January 10, 2010
    • "Wyeth v.Kappos (Fed. Cir. 2010)," January 7, 2010

    "Patent Term Adjustment: 37 C.F.R. § 1.704(b)'s Three-Month Provision,"
    November 17, 2009

    "USPTO Says Some Requests for PTA Reconsideration Are Premature,"
    September 7, 2009

    "Fish & Richardson Catches Error in Patent Office's PTA Calculation,"
    July 30, 2009

    "More § 154(b)(4)(A) Actions Filed against Director," February 8,
    2009

    "Three More Patentees File § 154(b)(4)(A) Actions against Director Dudas,"
    January 12, 2009

    "More Patentees Follow Wyeth's Lead in Seeking Additional PTA,"
    December 3, 2008

    "USPTO to Appeal Wyeth v. Dudas," December 2, 2008

    "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA,"
    November 12, 2008

    "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008

  •     By Suresh Pillai

    Mylan and Matrix Fail in Bid to Dismiss
    Sustiva® Case

    Bristol-Myers Squibb #2 The U.S. District Court for the District of
    Delaware has ruled that Bristol-Myers Squibb may proceed with its patent infringement suit against defendants Mylan
    Pharmaceuticals
    and Matrix Laboratories over Bristol-Myers' patent covering the HIV treatment Sustiva®, U.S. Patent No.
    6,673,372.  Bristol-Myers originally filed suit in
    August 2009 after the defendants both filed Abbreviated New Drug Applications
    (ANDAs) with the FDA in which they sought permission to manufacture and market generic
    versions of Sustiva® (see "Court Report," September 7, 2009).  Following the ANDA filings, the defendants informed Bristol-Myers of the
    filings by letter and included a Paragraph IV certification.

    Mylan In the most recent action, the defendants argued
    that because the '372 patent was not listed in the FDA's Orange Book, the
    defendants had not included a Paragraph IV certification in their ANDA
    filings.  Therefore, the defendants
    argued, the case should be dismissed because the District Court lacked the requisite
    subject matter jurisdiction over the case.  Bristol-Myers, however, countered with the argument that
    because listing the '372 patent in the Orange Book was not a prerequisite for
    it to assert infringement, the ANDA filings themselves provided a cause of
    action within the necessary subject matter jurisdiction of the District Court.  The District Court agreed
    with Bristol-Myers and refused to dismiss the case.


    Court Dismisses Protein Sciences from
    Circovirus Vaccine Suit

    Protein Sciences The U.S. District Court for the District of
    Connecticut has dismissed patentee Protein Sciences as
    a party in the licensing dispute between Boehringer Ingelheim
    and Merial
    over U.S. Patent No. 6,224,882, which is directed to a vaccine for porcine circovirus.  The original dispute centered on a pair of licensing
    agreements entered into by Protein Sciences and Boehringer, which permitted
    Boehringer to use the '882 patent.  These agreements were entered into prior to Protein Sciences assignation
    of the patent to Merial in 2008.  Though the subsequent assignation contained no reference to the earlier
    licensing agreement, Protein Sciences has maintained the existence of an oral
    agreement with Merial that permitted Protein Sciences to fulfill its
    obligations to Boehringer.

    Merial Merial
    originally filed suit in December 2008, alleging that Boehringer's CircoFLEX® products infringed their
    rights in the '882 patent.  Boehringer
    answered by filing a declaratory judgment suit against both Merial and Protein
    Sciences to establish Boehringer's rights under its licensing agreement with
    Protein Sciences (see "Court Report," February 8, 2009).  Although
    Boehringer argued that the assignment was void due to a lack of Boehringer's
    consent to the transfer, the District Court found that Boehringer's consent was
    not required.  The Court, however,
    also found that Merial, as a successor-in-interest to the '882 patent, was
    bound by the terms of the earlier Protein Sciences-Boehringer agreement.  In addition, the District Court ruled that as
    the earlier licensing agreement included a forum selection clause, the case
    must remain in Connecticut.  The Court also agreed to grant Merial's motion to dismiss Boehringer's declaratory
    judgment claim of invalidity of the '882 patent; however, Boehringer can refile
    on this matter.


    Second Settlement Announced in Stinski Patent
    Dispute

    University of Iowa The University of Iowa has announced a $9.5
    million settlement with Abbott Laboratories
    in its patent infringement suit over Abbott's alleged infringement of U.S. Patent
    Nos. 5,168,062 and 5,385,839.  The patents, which are collectively
    known as "the Stinski patents" after inventor Mark Stinski, cover a
    cytomegalovirus promoter used in the design and manufacture of a number of
    marketed vaccines and therapeutics.  The settlement brings to an end the dispute, originally filed in June
    2009 in the U.S. District Court for the District of Iowa (see "Court Report," June 28, 2009).

    Abbott A The settlement marks the second multimillion dollar
    settlement related to allegations of infringement over the Stinski
    patents.  In August 2009, the
    University of Iowa announced a separate $19 million settlement with Amgen
    (see "Biotech/Pharma Docket,"
    August 18, 2009).

    Additional Disclaimer:  MBHB represents Bristol-Myers Squibb in
    the case discussed above.  To the
    extent that the above summary contains any
    opinions, the opinions are not those of Bristol-Myers Squibb or MBHB.

  •     By
    James DeGiulio —

    Torrance, Andrew Earlier
    this month, we reported on a study published last year in the
    The Columbia Science and Technology Law
    Review,
    which suggested a commons systems can generate
    significantly greater amounts of innovation, productivity, and social utility
    than currently predominating patent systems that combine both patent and open
    source protection for inventions
    ("Patents and the Regress of Useful Arts").  The authors of
    this study, Dr. Andrew W. Torrance (at right), Associate Professor at the University of Kansas
    School of Law and a Research Associate at the Biodiversity Institute at the
    University of Kansas, and Dr. Bill Tomlinson (below left), Assistant Professor in the
    Informatics Department of the Bren School of Information and Computer Sciences
    at the University of California-Irvine, have now tested their PatentSim
    software with individuals having patent "expertise," leading to some
    differing results.  Their newest
    study, published in the
    Southern
    Illinois University Law Journal
    , ("Patent Expertise and the Regress of Useful Arts") shows that
    there is no statistically significant difference in levels of innovation
    generated by expert users across the pure patent, patent/open source, and
    commons systems.

    Tomlinson, Bill The
    study utilized a computer program, PatentSim, to simulate the behavior of
    inventors and competitors under conditions approximating patent and non-patent
    systems.  A more detailed description of the PatentSim software can be found in
    our previous report.

    In
    this iteration of the study, the PatentSim subjects were second and third-year
    law students at the University of Kansas School of Law who had formally studied
    patent law and open innovation (including open source).  These subjects
    represented "expert" users of patent and open innovation systems.  This is in contrast to the original published study, which tested first-year
    law students Kansas School of Law with no knowledge of patent protection, open innovation, or any
    other intellectual property concepts.  Though the productivity and social utility levels (as defined by the
    authors) were consistent with the first study with uneducated subjects, the
    rates of innovation were noticeably different with expert users.

    Innovation
    was defined as the mean number of unique inventions.  Graph 1 (below) illustrates the relative amounts of innovation generated in the
    Pure Patent, Patent/Open Source, and Pure Commons systems.  The data reveals
    that there is no significant difference in innovation (p=0.441) between the
    Pure Patent and Patent/Open Source systems, no significant difference in
    innovation (p=0.197) between the Pure Patent and Pure Commons systems, and no
    significant difference in innovation (p=0.802) between the Patent/Open Source
    and Pure Commons systems.

    SIUInnovationGraph1
    Productivity
    was defined as the mean number of total inventions created.  Graph 2 (below)
    illustrates the relative amounts of productivity generated in the Pure Patent,
    Patent/Open Source, and Pure Commons systems.  The data reveals that there is a
    significant difference in innovation (p=0.017) between the Pure Patent and
    Patent/Open Source systems, a highly significant difference in productivity
    (p=0.0006) between the Pure Patent and Pure Commons systems, and a highly
    significant difference in productivity (p=0.0032) between the Patent/Open
    Source and Pure Commons systems.

    SIUproductivityGraph2
    Social
    Utility was defined as the mean amount of money with which each subject ended
    each trial.  Graph 3 (below) illustrates the relative amounts of social utility generated in
    the Pure Patent, Patent/Open Source, and Pure Commons systems.  The data reveals
    that there is a significant difference in social utility (p=0.020) between the
    Pure Patent and Patent/Open Source systems, a highly significant difference in
    innovation (p=0.0000051) between the Pure Patent and Pure Commons systems, and
    a significant difference in innovation (p=0.0021) between the Patent/Open
    Source and Pure Commons systems.

    SIUsocialutilityGraph3
    In
    contrast to the authors' original highly-publicized study, where the rates of innovation
    for the commons system were considerably higher than the patent and patent/open
    source systems, the current study with educated subjects revealed no
    statistical difference in innovation rates.  This suggests, perhaps obviously,
    that some knowledge of intellectual property is required to effectively capture
    the innovation incentives that patent protection provides.  If the results of
    the simulation are to be believed, the current patent system encourages
    innovation just as much as other non-patent systems, provided subjects are
    aware of patents and how they function.

    Interestingly,
    and not without some irony, the authors of the study have chosen patent
    protection for their PatentSim game rather than open sourcing.  As of the date
    of this post, their patent application (U.S. Application No. 12/189,770; U.S. Patent Application Publication No. 2009/0043552) is still pending and has yet
    to be examined.  The single
    independent claim reads as follows:

    1.  A system for simulating or operating
    an intellectual property environment, said system comprising:

        an
    administrator module;

        a
    rules module; and

        a
    user interface;
        wherein
    said administrator module sets rules for said rules module either before and/or
    during the operation of the environment;
        wherein
    a user interfaces with said system through said user interface;
        wherein
    said user puts together an invention object, using two or more invention elements
    from an invention repository or some other source;
        wherein
    said user has an option to manufacture said invention object in said intellectual
    property environment; and
        wherein
    said user has an option to apply for a patent or other protection for said invention
    object in said intellectual property environment.

    James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law
    student at the Northwestern University School of Law.  Dr. DeGiulio
    was a member of MBHB's 2009 class of summer associates, and he can be contacted at degiulio@mbhb.com.