•     By
    James DeGiulio —

    Medicis
    Settles Solodyn Infringement Case with Ranbaxy


    Medicis Medicis
    Pharmaceutical Corp. has reached consent and licensing agreements with Ranbaxy
    Laboratories Inc., thus settling patent infringement claims against Ranbaxy
    over Medicis' oral acne drug Solodyn.  Medicis brought suit in May 2009 after
    receiving a Paragraph IV letter from Ranbaxy Inc. asserting that
    Medicis' U.S. Patent No. 5,908,838 covering Solodyn was invalid.  In its complaint, Medicis
    sought a permanent injunction, litigation costs, and an order barring
    Ranbaxy from receiving approval of its ANDA until after the expiration of the '838
    patent.  Medicis argued further
    that Ranbaxy Inc. aided, abetted, or induced the alleged infringement of its
    parent corporation Ranbaxy Laboratories Inc.


    Ranbaxy In
    the May 5th order, Ranbaxy acknowledged that Medicis' '838 patent is
    valid and enforceable and admitted that products described in its ANDA are
    covered by the patent.  Judge
    Farnan in the U.S. District Court for the District of Delaware entered the
    judgment enjoining Ranbaxy from continuing to market generic minocycline
    hydrochloride without a license.  Details of the settlement agreement were not available.

    The
    consent judgment and injunction can be found
    here.


    Orchid
    and Forest Labs Settle Namenda Infringement Dispute


    Orchid Chemical & Pharmaceuticals Orchid
    Chemicals & Pharmaceuticals Ltd. has reached a settlement with Forest Laboratories Inc.
    in the patent infringement suit over the Alzheimer's drug Namenda.  Forest brought suit against Orchid and
    a number of defendants in January of 2008, following the filing of several
    ANDAs seeking FDA approval to market generic Namenda.  The case was later transferred from Delaware to New Jersey, after the
    Delaware court ruled that it lacked personal jurisdiction over Orchid.


    Forest Laboratories Logo Judge
    Cooper of the U.S. District Court for the District of New Jersey approved a
    stipulation dismissing the case without prejudice and enjoining Orchid from
    marketing generic Namenda.  In the stipulation, Orchid admitted that the ANDA it
    filed for generic Namenda infringed Forest's U.S. Patent No. 5,061,703.  Additional terms of the settlement were not disclosed.

    The
    parties' stipulation and order can be found
    here.


    Sandoz
    and Takeda Settle Patent Dispute over Actos and Actoplus Met


    Sandoz Sandoz
    Inc. has reached a settlement with Takeda Pharmaceutical Co. Ltd. in the infringement suit
    over Sandoz' effort to sell generic versions of diabetes treatments Actos and
    Actoplus Met.  In Takeda's initial
    lawsuit against Sandoz, filed in May 2007, Takeda claimed that Sandoz's ANDA infringed
    seven of its patents describing pioglitazone for the treatment of diabetes,
    including U.S. Patent Nos.
    5,965,584, 6,166,043,
    6,172,090, 6,211,205, 6,217,243, 6,303,640, and 6,329,404.


    Takeda Takeda
    had two infringement suits pending against Sandoz.  On April 27, Judge Cote of
    the U.S. District Court for the Southern District of New York approved the
    parties' stipulations and voluntarily dismissed both suits without prejudice.  Each party agreed to bear its own fees and costs.  Though Takeda still has
    infringement cases pending against Teva Pharmaceutical Industries Ltd. and
    Aurobindo Pharma Ltd., it expects that the entry of generic versions of Actos
    and Actoplus Met will be August 17, 2012, and December 14, 2012, respectively.

    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.


  • Federal Circuit Seal On
    April 28, the Court of Appeals for the Federal Circuit granted the petition for
    rehearing en banc submitted by
    Plaintiffs-Appellants Abbott Diabetes Care, Inc. (formerly Therasense, Inc.)
    and Abbott Laboratories in Therasense, Inc. v. Becton, Dickinson & Co. (see "Federal Circuit Grants En Banc
    Review in Therasense v. Becton Dickinson
    ").  In response to requests they have
    received for access to the briefs, counsel for Plaintiffs-Appellants have asked
    Patent Docs to make the briefs
    accessible to the patent community.


    Brief of Plaintiff-Appellants Abbott Laboratories and Abbott Diabetes Care,
    Inc. (
    download), November 4, 2008

    Brief of Defendants-Appellees Becton, Dickinson and Company and Nova Biomedical
    Corporation (
    download), December 17, 2008

    Brief for Defendant-Appellee Bayer Healthcare LLC (
    download), December 17, 2008

    Reply Brief of Plaintiff-Appellants Abbott Laboratories and Abbott Diabetes
    Care, Inc. (
    download), February 9, 2009

    Petition for Rehearing En Banc of Plaintiffs-Appellants Abbott Diabetes Care,
    Inc. and Abbott Laboratories (
    download), February 24, 2010

    Brief of Amici Curiae Nine
    Intellectual Property Law Professors in Support of En Banc Review of
    Inequitable Conduct (
    download), March 8, 2010

    Brief of Amici Curiae The Honorable
    Bruce A. Lehman and The International Intellectual Property Institute in
    Support of Plaintiffs-Appellants' Petition for Rehearing En Banc (
    download), March 10, 2010

    Brief of Amici Curiae Ole K. Nilssen
    and Geo Foundation, Ltd. in Support of Plaintiffs-Appellants Abbott Diabetes
    Care, Inc. and Abbott Laboratories' Petition for Rehearing En Banc (
    download),
    March 10, 2010

    Brief of Washington Legal Foundation as Amicus
    Curiae
    in Support of Plaintiffs-Appellants' Petition for Rehearing En Banc
    (download), March 10, 2010

    Becton, Dickinson and Company and Nova Biomedical Corp.'s Response to Abbott's
    Petition for Rehearing En Banc
    (
    download), March 18, 2010

    Bayer's Response to Abbott's Petition for Rehearing En Banc (
    download), March 19, 2010

    Reply of Plaintiffs-Appellants Abbott Diabetes Care, Inc. and Abbott Laboratories
    in Support of Petition for Rehearing En
    Banc
    (
    download), March 25, 2010

  •     By Andrew Williams


    Scantibodies Laboratory Last week, in Scantibodies
    Laboratory, Inc. v. Immutopics, Inc.
    , the Federal Circuit affirmed a claim
    construction decision and corresponding summary judgment of non-infringement
    rendered by the U.S. District Court for the Central District of California.  The patent at issue was U.S. Patent No.
    6,689,566 ("the '566 patent"), "Methods, Kits, and Antibodies for Detecting
    Parathyroid Hormone."  Claim 5, the
    only claim addressed on appeal, reads (with the claim terms at issue
    underlined):

    5. 
    A method for measuring an amount of whole parathyroid hormone in a
    sample comprising:

        a)  adding to a sample a labeled antibody or
    antibody fragment specific for an initial peptide sequence of whole
    parathyroid hormone wherein said initial peptide sequence consists of VAL-SER-GLU-ILE-GLN-LEU-MET
    (SEQ ID NO:3), and wherein at least four amino acids in said initial peptide
    sequence are part of a reactive portion to said labeled antibody;

        b)  allowing said labeled antibody to bind to whole
    parathyroid hormone present, thereby forming a complex; and

        c)  measuring the amount of said labeled complex to
    measure the amount of whole parathyroid hormone in said sample while
    not
    detecting an interfering non-(1-84) parathyroid hormone fragment.

    The District Court construed these terms to mean:

    • "specific for" = having a measurable affinity for
    and detectable binding to an epitope having at least four amine acids of the
    seven in SEQ ID No. 3 (VAL-SER-GLU-ILE-GLN-LEU-MET)

    • "not detecting an
    interfering non-(1-84) parathyroid hormone fragment" = having no detectable
    binding to an interfering non-(1-84) parathyroid hormone fragment

    Because Scantibodies conceded that the accused
    Immutopics antibody did not meet the later limitation, the District Court
    granted summary judgment of non-infringement.


    Parathyroid hormone The application that issued as the '566 patent was
    filed January 14, 1999.  The
    application described antibodies, methods of use, and kits for detecting whole
    or non-fragmented parathyroid hormone ("w-PTH") in a biological
    sample.  Measuring serum levels of
    PTH in patients is important for a large number of diseases, including familial
    hypocalciuric, osteoporosis, and Paget's bone disease.  However, measuring biologically active
    levels of PTH in humans has been challenging.  One problem is that PTH circulates at extremely low
    levels.  In addition, these
    circulating levels of protein are heterogeneous due to the large number of PTH
    fragments, which leads to interference when attempting to measure the
    biologically active form ("the (1-84) PTH fragment").  In order to overcome this fragment
    interference, two-site immunoradiometric assays had previously been developed,
    which allow for the measurement of intact PTH ("I-PTH").  A measurement of I-PTH, however,
    includes w-PTH and a large PTH fragment cleaved at amino acids 5 to 8.  In fact, patients with hyperparathyroid
    or renal failure have significant concentrations of these large, non-whole PTH
    fragments, which can give inaccurate measurements of the biologically active
    form.  To overcome this problem,
    the Scantibodies scientists discovered methods for detecting w-PTH in a
    biological sample while not detecting this non-(1-84) large PTH fragment
    component of I-PTH.  They also
    developed antibodies for use with such methods.  The Scantibodies method used an antibody "specific for"
    at least four amino acids of seven amino acids disclosed from the N-terminal
    end of the protein.  Use of such an
    antibody was important, because it would not react with the interfering
    non-(1-84) parathyroid hormone fragment.

    The originally filed claims in the application that
    lead to the '566 patent did not contain the limitation "not detecting an
    interfering non-(1-84) parathyroid hormone," even though the necessity of
    not detecting this fragment was described in the specification.  During prosecution, however, the
    examiner cited to several pieces of art in both novelty (§ 102) and obviousness
    (§ 103) rejections.  The most
    significant art described the methodology of the measurement of I-PTH.  In order to obtain allowable claims,
    therefore, the applicant amended the claims to include the "not detecting"
    limitation, because apparently all of the prior art methods couldn't
    differentiate w-PTH from this interfering non-(1-84) parathyroid hormone.


    Immutopics Scantibodies filed the present lawsuit on October
    26, 2004.  Subsequently, both
    parties filed reexamination requests, which eventually resulted in a
    reexamination certificate that altered the antibody and kit claims, but apparently
    did not change the method of use claims.  This may be the reason that the parties focused on claim 5 during the
    appeal.  The District Court
    determined that it needed to construe the claims before it could issue a
    non-infringement summary judgment order.  And, after two claim construction orders, the Court did just that.  Scantibodies appealed.


    Federal Circuit Seal The Federal Circuit recognized that the District Court's construction of "not detecting" to mean "no detectable
    binding" created a difficult, although not insurmountable, hurdle for
    finding infringement.  Apparently,
    Scantibodies argued that such a definition would exclude all antibodies,
    because it was impossible not to have some cross-reactivity.  However, the specification of the '566
    patent apparently touted the fact that no cross-reactivity could be
    achieved.  Moreover, the Federal
    Circuit pointed out that this construction was based on another limitation that
    Scantibodies did not challenge ("does not specifically bind to an interfering non-(1-84) parathyroid hormone fragment").  The Court did not give much weight to the
    testimony of one of the patentees, nor did the Court find it relevant that
    Scantibodies' product literature defined "no cross-reactivity" as "no
    significant cross-reactivity."  Scantibodies argued that no PTH assay can absolutely detect PTH without
    detectable cross-reactivity.  However, the Court pointed out a 2001 reference from Gao et al., which
    included the inventors as authors, disclosing that an N-terminal PTH antibody that
    bound to the first few amino acids, and did not have detect the (7-84) PTH
    fragment at concentrations of 10,000 pg/ml.  The Federal Circuit used this as proof that it was possible
    to meet the limitations of the claim as construed by the District Court.

    Finally, the Federal
    Circuit noted that the error should be assigned to the patent drafters, because
    if they had wanted "not detecting" to mean something else, they could
    have either used different claim language, or provided a different definition
    in the specification.  This
    analysis ignores the reality that this claim limitation was required to
    overcome prior art cited during prosecution.  Moreover, it ignores the fact that the specification
    highlighted the criticality of not detecting an interfering non-(1-84)
    parathyroid hormone fragment.  In
    fact, it is possible that if the claims had issued without the "not
    detecting" limitation, Scantibodies could have had a written description
    problem.  Therefore, the Federal
    Circuit is correct in pointing out that claim drafters need to be careful in
    choosing the language of claim limitations, but claim drafters also
    need to mindful of the invention that is actually disclosed in the
    specification.

    Scantibodies Laboratory, Inc. v. Immutopics, Inc. (Fed. Cir. 2010)
    Nonprecedential disposition
    Panel: Chief Judge Michel and Circuit Judges Plager and Moore
    Opinion by Chief Judge Michel

    Image of parathyroid hormone (above) by Emw, from the Wikipedia
    Commons
    under the Creative Commons
    license
    .

  •     By Kevin E. Noonan


    BIO International Convention Steve Burrill, President and CEO of Burrill &
    Co. took the stage at BIO 2010 in Chicago last week, and once again provided in
    90 minutes his impressions and opinions on the state of the biotechnology
    industry.  Although decidedly more
    upbeat than last year, Mr. Burrill's talk, entitled "Adapting for Success,"
    included a large measure of caution to go along with his trademark futuristic
    optimism.  That optimism was best
    encapsulated by his overarching message, that those in the industry were
    fortunate to be alive at this time, when all current world problems — climate
    change, sustainability, energy security, food production and security,
    healthcare and healthcare "reform" — could be tackled if not solved
    by biotechnology.  (The only world
    problem not amenable to the biotechnology approach, according to Mr. Burrill,
    was terrorism, and even there some would argue that detecting biohazards through
    biotechnological means was another example of the power of the technology.)


    Burrilll, Steven Mr. Burrill's talk began, almost unavoidably, with
    the economy.  He contrasted
    the situation a year ago, with the Dow around 8500, the capital markets "essentially
    closed," the threat of an influenza pandemic, and the prospects for a new
    administration in Washington (including healthcare reform and leadership
    vacuums at FDA and CMS) with today.  The most remarkable fact about the past year, according to Mr. Burrill (at left),
    was that U.S. biotechnology companies raised (through capital markets and
    partnering with traditional pharmaceutical companies and others) a record
    forty-eight billion dollars, and saw an increase in market capitalization of
    31%.  These successes were
    not limited to traditional therapeutic drug development:  industrial biotechnology (such as
    industrial enzyme sales) constitute a $2.9 million global market, and "biogreentech
    is hot."  Not everything
    was rosy in the industry last year, however; biotech sales and revenue lost
    almost $8 billion, and investment in research and development was down by more
    than $18 billion.  The number of
    biotech companies fell almost 14% (from 357 in 2008 to 310 in 2009).

    With regard to the capital markets, Mr. Burrill
    said that venture capitalists and other funding sources had little interest in "microcap"
    companies — those having less than $1 billion in market capitalization.  However, biotech companies were in much
    better shape in some ways than traditional "top-tier" pharmaceutical
    firms, which had lost 48% ($530 billion) in market capitalization over the past
    ten years.  In addition, total
    financial returns for several major pharmaceutical companies — including Eli
    Lilly, Pfizer, Merck, and Schering-Plough — were negative over that period, and
    a comparison of market capitalization between biotech companies and pharmaceutical
    companies showed (surprisingly) that several of the biotech companies (such as
    Amgen) had higher market caps than pharma firms.  While the number of initial public offerings (IPOs) had
    plummeted during the financial crisis, they are beginning to come back, with
    seven companies having IPOs in 2010 (including AVEO Pharmaceuticals, CorMedix, and Alimera Sciences).  The amounts
    raised, however, were predictably much less than what similar IPOs had
    commanded prior to 2008, and the share price for more than half of these
    companies had dropped from 1-22% from the offering price.  In addition, another six biotech
    companies are set for IPOs in 2010.  He also detailed the patterns of acquisitions and partnering between
    biotechnology and pharma, as a way to "acquire technology" for
    traditional pharmaceutical companies facing the "patent cliff" of
    lost exclusivity on blockbuster drugs and generic competition.

    Turning to healthcare, he contended that we had not
    had healthcare reform but rather insurance reform, and noted that it was "Economics
    101" that increasing the number Americans with healthcare insurance by 32
    million without providing more doctors, hospitals, or drugs would result in
    increased costs (from $2.3 trillion in 2010 to $4 trillion in 2015).  Other negatives include the
    effects on major businesses, many of whom have already take large charges
    against earnings to offset expected revenue losses due to health care
    costs.  Positive developments
    include passage of a follow-on biologics bill with a 12-year data exclusivity
    term, and the Therapeutic Discovery Tax Credit, which will funnel more than $1
    billion in grants and tax credits to biotechnology companies (although he
    predicts it will take several years for the money to be disbursed).  He also mentioned the increased
    emphasis on drug safety and comparative effectiveness as tending to retard new
    drug approvals, and the recent gene-patenting ruling in the Myriad case.

    Mr. Burrill set these changes in the context of the
    changes in healthcare, and Americans' perception of  "health," over the past 50 years, reminding his
    audience of improvements in treating illnesses that had resulted in greatly
    increased life expectancy.  Concomitantly there had been steady increase in the cost of healthcare,
    both in real dollars and percent of GNP, not only in the U.S. but in all
    industrially-developed countries.  He also returned to a recurrent theme, that the healthcare industry in
    the U.S. was fundamentally dysfunctional, focused on "late-stage detection"
    of disease and intervention rather than early detection and prophylaxis.  Much of the ill-health in the country —
    and its costs — are related to behavioral problems including obesity, alcohol
    abuse, smoking, and non-adherence to drug regimens, all of which were relatively
    intractable to intervention.  He
    cited statistics that 0.5% of patients "consumed" 25% of the healthcare budget, and that
    75% of healthcare costs are for patients suffering from chronic disease.  Solutions provided — potentially
    or otherwise — by biotechnology include personalized medicine, especially
    genomic diagnostics to predict susceptibility to genetic diseases.  (Of interest to the gene
    patenting debate, Mr. Burrill cited costs for other genetic tests, some of
    which are "even more" expensive than Myriad's BRCA1/2 test cost of
    $3,000.)  He did note the
    shrinking cost of "whole genome" sequencing approaching $1,000 — and the implications, and difficulties, of integrating this genetic
    information into appropriate diagnostics.  Some of the implications involved Mr. Burrill's typical "into the
    future" speculations, such as diagnostics built into cell phones (where
    you'll spit on a spot on a cell phone and have the genetic or other diagnostic
    information transmitted to your physician, for example).  Mr. Burrill also returned to his
    earlier (2008) prediction that healthcare delivery would change, this year
    focusing on digital delivery of medical information via the web and social
    networking.

    Mr. Burrill then turned to the "emerging"
    markets outside the U.S., not only in their conventional role as possible areas
    for commercial expansion but as competitors for innovation.  He noted that countries like China,
    India, and Brazil showed a much greater rate of increase in patent filings and
    R&D activity than in the U.S., and how their some of these markets outpaced the U.S. over
    the past year (albeit with their overall market capitalization remaining small
    compared to the U.S.).  But China
    has "dominated" the IPO markets over the past two years (raising
    almost $20 billion in 2008 and more than $50 billion in 2009), and showed
    robust (>10%) economic growth in 2010.  He also noted that clinical trials, while still predominantly conducted
    in the U.S., were increasing globally and particularly in China and Brazil.

    Finally, his talk turned to "biogreentech"
    and applications of biotechnology for food and fuel production.  Calling these "long term issues,"
    he said the value of biotech in these areas was to increase yields with lower
    water requirements (drought resistance) and increased pest and disease
    resistance that would involve "gene stacking" technologies for
    developing complex trait combinations.  He predicted that 37% of biofuel production would be from "3rd
    generation algae" and 33% from "1st generation ethanol"
    by 2020, with annual revenues in biofuels to top $100 billion by 2018.

    The complete
    Burrill Report can be purchased from Burrill & Co.; sales at BIO 2010
    include access to the company website for Mr. Burrill's presentation slides.

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

    • "Partnerships
    Between Startup Firms and Big Pharma Fueled 85% Increase in Biotech Funding in
    2009
    ," January 13, 2010

    • "Docs at
    BIO: Steve Burrill's State of the Biotechnology Industry Report 2009
    ," May
    19, 2009


    "Bio-irony: Biotech Turns a Profit in 2008," February 26, 2009

    • "Docs at BIO: Steve Burrill's State
    of the Biotechnology Industry Report 2008
    ," June 19, 2008

  •     By
    Donald Zuhn

    Secretary
    of Commerce Writes in Support of S. 515


    Locke, Gary On
    April 20, Secretary of Commerce Gary Locke (at right) wrote to Senate Judiciary Committee
    Chairman Patrick Leahy (D-VT) and Ranking Member Sen. Jeff Sessions (R-AL), indicating
    that the Obama Administration strongly supported their efforts to reform U.S. patent
    law and was "committed to working with members of both houses of Congress
    to bring these efforts to fruition as you seek to bring a bill to the Senate
    floor."  The
    Secretary's letter
    states that:

    We believe the agreement reflected in the draft Manager's Amendment to S. 515,
    the "Patent Reform Act of 2010," improves the reported bill and
    incorporates critical elements of patent reform.  In particular, we are pleased that the Manager's Amendment
    provides necessary authority for the USPTO to adjust patent and trademark fees
    as needed to reflect the costs of providing services to patent applicants.  It also establishes post-grant review
    procedures for reviewing questions of patent validity that will serve as a
    faster, lower-cost alternative to litigation.

    In addition to these proposals to
    streamline and strengthen the patent process, the Manager's Amendment contains
    provisions to promote international harmonization of patent laws and limit
    opportunities for abuse in patent litigation.  Among other important changes, these provisions maintain the
    compromise on the determination of reasonable royalty damages for patent
    infringement, and they transition our patent law to a first-inventor-to-file
    system.  In general, these
    provisions fairly balance the interests of innovation and competition across
    all industries and technologies without favoring one industry or any particular
    area of technology over another.

    The
    Secretary noted that the Administration was "eager" to see patent
    reform legislation enacted in the current Congressional session.


    ABA
    IP Section Sends Letter of Support for S. 515 to Senate Leadership


    ABA In
    late March, the Section of Intellectual Property Law of the American Bar
    Association (ABA) also sent a
    letter to Chairman Leahy and Sen. Sessions, expressing "support for Senate consideration and approval of the
    bipartisan Amendment in the Nature of a Substitute for S. 515, which you and
    other senators announced on March 4, 2010" (see "Senate Leadership Unveils Details of Patent Reform
    Agreement
    ").  The IP Section noted that it had expressed support in April 2009 for the Senate
    bill then reported out of Committee, and was now "reaffirm[ing] that
    support for S. 515 as embodied in the Amendment in the Nature of a Substitute."  Among the "numerous improvements in U.S. patent laws" contained in
    the Senate bill, the IP Section lists "enhanced patent quality through
    procedures for third-party pre-issuance submission of prior art, improved
    efficiencies by utilizing an ABA-supported first-inventor-to-file system,
    improved patent quality by providing a fair and cost-effective post-grant
    review procedure, and clarification of the gate-keeping responsibilities of
    district courts in determining damages."  The letter states that the
    legislation no doubt contains provisions that members of the Committee "would
    prefer to have been addressed in a different manner."  However, in
    supporting enactment of the bill, the IP Section argues that "the perfect
    should not be the enemy of the good, and this is a good bill, perhaps the best
    possible."


    New
    Coalition Opposes Patent Reform Act


    Nevadans for Fair Patent Reform Last
    month, the Nevadans for Fair Patent Reform
    kicked off a campaign in opposition to the Patent Reform Act.  According
    to the group's website, the legislation will "so negatively impact
    innovation and entrepreneurial activity in Nevada."  Noting that "[f]or
    more than 100 years, the federal law in the United States has protected the
    small inventor," including "[t]he great men and women who worked in
    their garages, kitchens and workshops to develop the next 'big idea,'" the
    new coalition argues that "Senate Bill 515 and House Resolution 1260 would
    erode more than a century of law and traditions protecting the rights of
    inventors."  Representatives from a number of Nevada-based companies, the
    Reno law firm of Holland & Hart, and a student at the University of Nevada
    (there are currently thirteen signatories)
    bemoans the "elimination of the one-year grace period . . . under the
    supposed 'Reform' even if you are the first inventor and even if you file
    within the traditional one-year grace period as the law currently stands and
    has stood for long over 100 years in the U.S."  Contending that the
    proposed patent reform legislation will adversely impact job growth in Nevada,
    the group's website states that:

    The huge companies pushing Patent Reform claim they will devote savings earned
    from their version of patent reform to creating more jobs.  Their so-called
    savings will be gained at the expense of the small businesses and early stage
    innovation inventors and start up firms who oppose this reform.  Nevada's early
    recovery must be based in substantial part on such firms.  Those firms will need
    capital to grow.  Patent Reform as now proposed will deter such investment and
    resulting innovation, entrepreneurship, and competition with those pushing for
    this "Reform."

    The
    coalition urges Nevadans to write Sen. Harry Reid (D-NV) and Sen. John Ensign (R-NV)
    to oppose the Patent Reform Act of 2009.


    Innovation
    Alliance Believes House Patent Reform Bill Would Negatively Impact U.S. Economy


    Innovation Alliance Last
    week, the Innovation Alliance
    , a coalition of small and medium-sized technology
    companies, issued a press release
    stating that "the pending House patent reform legislation, H.R. 1260,
    would negatively impact the U.S. economy, U.S. innovation, and U.S. job growth,
    particularly with respect to its provisions on damages and post-grant review."  The coalition's press release came in
    response to the oversight hearing on the U.S. Patent and Trademark Office that
    the House Judiciary Committee held last Wednesday.  The group is concerned primarily with the post-grant review
    provisions in H.R. 1260 that it contends "would be detrimental to job
    growth and innovation in America."  In addition, the coalition asserts that "[t]he current version of
    the bill would devalue the contribution of inventors by devaluing valid
    patents, make the patent process subject to greater abuse, and make it more
    expensive, slower, and less predictable, especially for innovative smaller
    companies and universities." 
    The group concludes that in view of the slow economic recovery and
    financial pressures on the USPTO, "this is exactly the wrong time to add a
    major new post-grant review component to the USPTO's mandate."


    Two
    Representatives Oppose House Patent Reform Bill


    House of Representatives Seal Last
    Wednesday, on the same day that the House Judiciary Committee was scheduled to hold
    an oversight hearing on the U.S. Patent and Trademark Office, Rep. Don Manzullo
    (R-IL) and Rep. Mike Michaud (D-ME) released a joint statement
    expressing "significant concerns" with the House patent reform bill (H.R.
    1260).  In particular, the two
    members of the House expressed concern that the oversight hearing would "fail
    to address the fact that the current House version of the Patent Reform Act of
    2009 (H.R. 1260) hinders American innovation and undermines U.S. job creation
    by increasing patent lag times, decreasing patent quality, and making patents
    more difficult and expensive to obtain."  The pair encouraged the Committee "to promptly schedule
    hearings to address the valid concerns expressed by stakeholders in various
    sectors — including universities, manufacturing, labor, small inventors,
    information technology, biotechnology, nanotechnology, and agriculture — with
    the current version of H.R. 1260."

  •     By James DeGiulio —

    Celgene
    and Novartis Reach Settlement with Barr Laboratories in Ritalin ANDA Suit


    Celgene Celgene
    Corp. and Novartis AG have reached a settlement with Barr Laboratories Inc.
    over Barr's attempt to market a generic version of the ADHD drug Ritalin.  Celgene and
    Novartis brought suit claiming infringement of Celgene's U.S. Patent Nos. 5,837,284 and 6,635,284 after
    Barr filed an ANDA in May 2007.  Barr claimed that Celgene's patents were
    unenforceable due to the plaintiffs' inequitable conduct during prosecution.


    Barr Pharmaceuticals Judge
    Freda L. Wolfson of the U.S. District Court for the District of New Jersey
    dismissed the claims and counterclaims without prejudice after staying the suit
    in March to give federal officials a chance to review the settlement.  Each side
    agreed to pay its own costs and attorneys' fees, though further details of the
    settlement remained confidential.


    Three
    Claims of Schering's Zetia Patent Found Invalid


    Schering-Plough (SP) The
    U.S. District Court for the District of New Jersey found three of Schering's
    patent claims for Zetia invalid based on improper reissue in the patent
    infringement suit between plaintiff Schering and defendant Glenmark.  Following Glenmark's ANDA filing in
    2007, Schering launched suit against Glenmark claiming infringement of its reissued
    U.S. Patent No. RE37,721 covering ezetimibe, the active ingredient in the anti-cholesterol treatment Zetia.


    Glenmark Pharmaceuticals Schering's
    patent covering ezetimibe was reissued in 2002 after the original 1996 patent
    application inadvertently failed to include "bullet" claims for ezetimibe.  Glenmark argued that Schering's
    declaration to the USPTO provided an insufficient basis for reissuance, so the
    patent should not have been reissued and the three claims that were added to
    the patent on reissue were invalid.  Judge Linares found that the "bullet" claims were omitted by inadvertent
    error, the reissue was improperly granted, and thus the three new claims were
    invalid.  However, Judge Linares
    found that the remaining claims were sufficient to cover ezetimibe, and denied
    Glenmark's separate motion to invalidate the remaining claims due to double
    patenting of Schering's U.S. Patent No. 5,631,365.

    Judge
    Linares' opinion granting summary judgment for invalidity based on improper
    reissue can be found
    here.  Judge
    Linares' opinion denying Glenmark's motion for summary judgment for invalidity
    due to double patenting can be found 
    here.


    Jury
    Upholds Validity of Pfizer's Protonix Patent


    Pfizer A
    jury in the U.S. District Court for the District of New Jersey found that
    Pfizer's U.S. Patent No. 4,758,579 covering the heartburn drug Protonix is valid, disagreeing with allegations by Teva
    and other generic firms that the patent was invalid based on obviousness and
    double-patenting.  However, other legal issues still need to be decided by the
    judge, including certain double-patenting defenses.


    Teva Wyeth,
    the licensee of the '579 patent and now part of Pfizer, and Altana Pharma AG,
    now part of Nycomed, brought a patent infringement suit against Teva in May
    2004 following Teva's ANDA filing.  In September 2007, Judge Linares found that
    Teva had raised sufficient issues over the patent's validity, and denied a
    motion for preliminary injunction to stop Teva from launching generic
    versions of Protonix.  Teva has
    been commercially shipping its generic pantoprazole sodium since December 2007.

    The
    jury verdict form can be found
    here.

    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.

  •     By Nate Chongsiriwatana


    Hana Biosciences Hana
    Biosciences, Inc. recently announced that it received a Notice of
    Allowance from the U.S. Patent and Trademark Office for U.S. Application No. 11/886,803, entitled "Vitamin
    K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" (U.S. Patent Application Publication No. 2009/0209652 A1).  Skin rash is a painful and common side effect of all approved epidermal growth
    factor receptor (EGFR) inhibitors (such as Tarceva®, Iressa®, Erbitux®,
    Vectibix®, and Tykerb®) that can limit treatment or make dose reduction
    necessary.  As its title suggests, the '803 application discloses treatment of
    EGFR-associated skin rash with vitamin K3 (also known as menadione), a
    provitamin precursor of vitamin K2.  Once issued, the patent will extend
    protection for this technology into 2026.  Corresponding foreign
    applications are pending in Australia, Canada, Europe, Hong Kong, Japan, and
    Korea, and Hana reports that additional applications relating to the use of
    menadione have been filed.

    The sole independent claim allowed in the '803 application reads:

    1.  A method for treating a skin rash secondary to an anti-epidermal growth
    factor receptor (EGFR) therapy in a subject receiving said therapy, the method
    comprising applying vitamin K3 to the skin in an amount effective to treat the
    skin rash.


    Menadione A Phase I clinical study conducted by Hana demonstrated that a menadione
    topical lotion was generally well-tolerated, and that menadione was delivered
    into the skin without appreciable systemic absorption.  Recently, Hana completed
    enrollment for a proof-of-concept study of vitamin K3 lotion in cancer patients
    receiving EGFR inhibitor therapy; the company expects to present data from this
    study and initiate a Phase II trial by the end of 2010.

  •     By Sherri
    Oslick

    Gavel_2About
    Court
    Report:  Each week we will report briefly on recently filed
    biotech and pharma cases.


    Eli Lilly & Company v. Watson Pharmaceuticals, Inc. et al.
    2:10-cv-00647; filed May 5, 2010 in the District
    Court of Nevada

    • Plaintiff:  Eli Lilly & Company
    • Defendants:  Watson Pharmaceuticals, Inc.; Watson
    Laboratories, Inc.; Watson Pharma, Inc.

    Eli Lilly and Company v. Watson Pharmaceuticals, Inc. et al.
    1:10-cv-00549; filed May 3, 2010 in the Southern
    District of Indiana

    • Plaintiff:  Eli Lilly and Company
    • Defendants:  Watson Pharmaceuticals, Inc.; Watson
    Laboratories, Inc.; Watson Pharma, Inc.

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent Nos. 6,458,811 ("Benzothiophenes Formulations Containing Same and
    Methods," issued October 1, 2002), 6,797,719 (same title, issued September
    28, 2004), and 6,894,064 (same title, issued May 17, 2005) following a
    Paragraph IV certification as part of Watson's filing of an ANDA to manufacture
    a generic version of Lilly's Evista® (raloxifene, used for the prevention and
    treatment of osteoporosis in postmenopausal women and for the reduction in risk
    of invasive breast cancer in postmenopausal women with osteoporosis and in
    postmenopausal women at high risk of invasive breast cancer).  View the Indiana complaint
    here.


    Pieczenik v. Astellaspharma, Inc. et al.
    3:10-cv-02253; filed May 5, 2010 in the District
    Court of New Jersey

    • Plaintiff:  George Pieczenik
    • Defendants:  Astellaspharma, Inc.; Canon, U.S.A.
    Inc.; Taiho Pharma U.S.A., Inc.; Dainippon Sumitomo Pharma America, Inc.;
    Dainippon Sumitomo Pharma America Holdings, Inc.; Kyowa Hakko Kirin America,
    Inc.; Kyowa Hakko Kirin Pharma, Inc.; Medarex, Inc.; Shionogi Pharma Sales,
    Inc.; Mitsubishi Tanabe Pharma America, Inc.; Mitsubishi Tanabe Pharma
    Development America, Inc.; Chugai Pharma USA, LLC Corp.; Daiichi Sankyo,
    Inc.; Shionogi USA Holdings, Inc.; Shionogi USA, Inc.; Shionogi Pharma, Inc.;
    John Does 1 Through 61

    Pieczenik v. Bayer Corp. et al.
    3:10-cv-02230; filed May 4, 2010 in the District
    Court of New Jersey

    • Plaintiff:  Dr. George Pieczenik
    • Defendants:  Bayer Corp.; Bayer Healthcare
    LLC; Bayer Healthcare Pharmaceuticals, Inc.; Bayer Cropscience (New Jersey)
    Inc.; Bayer Pharma Chemicals Inc.; Bayer Materialscience LLC; Bayer
    Pharmaceuticals Corp.; Boehringer Ingelheimroxane, Inc.; Boehringer
    Ingelheim Vetmedica, Inc.; Novartis Corp.; Novartis Pharmaceutical
    Corp.; Novartis Vaccines And Diagnostics, Inc.; Syngenta Crop Protection,
    Inc.; Syngenta Seeds, Inc.; Siemens Medical Solutions USA, Inc.; Siemens
    Diagnostics Finance Co. LLC; Siemens Healthcare Diagnostics Inc.; Siemens
    Corp.; Roche Laboratories Inc.; Roche Molecular Systems, Inc.; Roche
    Diagnostics Corp.; Hoffman-La Roche Inc.; Qiagen Inc.; Bracco
    Diagnostics Inc.; John Does 1 Through 61

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent No. 5,866,363 ("Method and Means for Sorting and Identifying
    Biological Information," issued February 2, 1999) based on defendants'
    research, commercial and licensing activities, and patent filings in the area of
    peptide and antibody combinatorial libraries.  View the Bayer complaint
    here.


    Purdue Pharma L.P. et al v. Ranbaxy Inc. et al.
    1:10-cv-03734; filed May 5, 2010 in the Southern
    District of New York

    • Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories,
    Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
    • Defendants:  Ranbaxy Inc.; Ranbaxy Pharmaceuticals
    Inc.; Ranbaxy Laboratories Ltd.; Actavis Elizabeth LLC; Mylan Pharmaceuticals
    Inc.; Mylan Inc.

    Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone
    Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March
    9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title,
    issued March 23, 2010) following a Paragraph IV certification as part of
    defendants' filing of an ANDA to manufacture a generic version of Purdue Pharma's
    OxyContin® (controlled release oxycodone hydrochloride, used to treat
    pain).  View the complaint
    here.


    Abbott Laboratories et al v. Watson Pharmaceuticals Inc. et al.
    1:10-cv-00373; filed May 4, 2010 in the District
    Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott
    Respiratory LLC
    • Defendants:  Watson Pharmaceuticals Inc.; Watson
    Laboratories Inc. – Florida; Watson Pharma Inc.

    Infringement of U.S. Patent Nos. 6,129,930 ("Methods
    and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia
    at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release
    Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary
    Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for
    Reducing Flushing in Individuals Being Treated with Nicotinic Acid for
    Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate
    Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique
    Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic
    Component Free Sustained Release Nicotinic Acid Compositions for Treating
    Hyperlipidemia and Related Methods Therefor," issued March 14, 2006),
    6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating
    Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic
    Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor,"
    issued June 27, 2000), and 6,469,035 ("Methods of Pretreating
    Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of
    Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by
    Nicotinic Acid," issued October 22, 2002) following a Paragraph IV
    certification as part of Watson's filing of an ANDA to manufacture a generic
    version of Abbott's Simcor® (niacin extended release / simvastatin tablets,
    used to treat hypercholesterolemia).  View the complaint
    here.


    Baker v. Pfizer, Inc. et al.
    2:10-cv-02331; filed May 4, 2010 in the Western
    District of Tennessee

    • Plaintiff:  Charles R. Baker
    • Defendants:  Pfizer, Inc.; Wyeth Inc.; Wyeth
    Consumer Healthcare, LTD.; Fort Dodge Animal Health, Inc.

    False marking based on defendants' marking of
    certain of their Axid AR® and Synanthic® products indicating that these
    products are covered by one or more of U.S. Patent Nos. 4,375,547 ("N-Methyl-N'-2-([(2-dimethylaminomethyl)-4-thiazolyl]methylthio)ethyl
    2-nitro-1,1-ethenediamine," issued March 1, 1983), 3,929,821 ("5
    (6)-Benzene ring substituted benzimidazole-2-carbamate derivatives,"
    issued December 30, 1975), and 4,080,461 ("5(6)-Benzene ring substituted
    benzimidazole-2-carbamate derivatives having anthelmintic activity,"
    issued March 21, 1978), all of which are expired.  View the complaint
    here.


    Schering Corp. et al. v. Kappos
    1:10-cv-00673; filed April 30, 2010 in the District
    Court of the District of Columbia

    • Plaintiffs:  Schering Corp.; Merck &
    Co., Inc.
    • Defendant:  David Kappos

    Review and correction of the patent term adjustment
    calculation made by the U.S. Patent and Trademark Office for U.S. Patent No.
    7,612,058 ("Methods for Inhibiting Sterol Absorption," issued
    November 3, 2009).  View the
    complaint
    here.


    Takeda Pharmaceutical Co. Ltd. et al. v. Sandoz, Inc.
    1:10-cv-03571; filed April 29, 2010 in the Southern
    District of New York

    • Plaintiffs:  Takeda Pharmaceutical Co.
    Ltd.; Takeda Pharmaceuticals North America, Inc.; Takeda Global Research and
    Development Center, Inc.
    • Defendant:  Sandoz, Inc.

    Infringement of U.S. Patent Nos. 6,329,404 ("Pharmaceutical
    Composition," issued December 11, 2001) 6,211,205 (same title, issued
    April 3, 2001), 6,303,640 (same title, issued October 16, 2001), and 7,538,125
    (same title, issued May 26, 2009) following a Paragraph IV certification as
    part of Sandoz's filing of an ANDA to manufacture a generic version of Takeda's
    Duetact® (pioglitazone hydrochloride and glimepiride, used to improve glycemic
    control in patients with Type 2 diabetes).  View the complaint
    here.





  •     By
    Sarah Fendrick


    USPTO Seal In
    a press release published
    on April 16, 2010, the U.S. Patent and Trademark Office (USPTO) and
    the Korean Intellectual Property Office (KIPO) announced the expansion of their existing
    bilateral Patent Prosecution Highway (PPH) agreement.  Under the PPH agreement, an applicant that receives
    allowable claims from one patent office can request that a corresponding
    application pending before another patent office receive accelerated
    examination.  The goal of the PPH program is to promote efficient and high-quality patent examination by
    coordinating search results between patent offices.

    "Expanding the scope of
    our PPH cooperation with the KIPO will significantly benefit
    applicants in both countries," said USPTO Director David Kappos.  "The
    KIPO is elected to serve as a PCT International Authority by US PCT applicants
    in about 30 percent of cases.  Expanding the scope of our bilateral
    PPH agreement to include PCT 'international phase' work will
    significantly increase the benefits of the PPH and the PCT to both patent offices
    and their users."


    KIPO #2 Under
    the previous PPH agreement between the USPTO and KIPO, only search and
    examination results under the Paris Convention were eligible.  However, under the
    expanded agreement, international search reports with written opinions and Patent Cooperation Treaty
    international preliminary examination reports can be considered under the
    accelerated examination.

    The
    new program has not yet begun, so the starting date and further details will be
    forthcoming.

  • Calendar

    May
    11, 2010 –
    Law
    Symposium on Intellectual Property
    (
    George
    Washington
    University Law School, Howrey LLP & Cornerstone Research) –
    Washington, DC

    May
    18, 2010 –
    "The
    Role
    of Patent Agents in Intellectual Property in the Changing Economy
    " (
    Intellectual
    Property Law Association of Chicago) –
    Chicago, IL

    May
    20, 2010 –
    "The
    Federal Circuit: A
    National Court of Appeals: Approaching 30 Years
    "
    (U.S.
    Court of
    Appeals for the Federal Circuit) –
    Washington,
    DC

    May
    24-25,
    2010 –
    Hatch-Waxman
    Boot Camp
    *** (
    American
    Conference
    Institute) –
    San
    Diego, CA

    May
    24-26, 2010 –
    Pharmaceutical
    & Biotech Patent Litigation
    Strategies
    *** (Pharma IQ) –
    London,
    England

    May
    25, 2010 –
    Corporate
    Intellectual Property Law Conference
    (
    Law
    Bulletin) – Chicago, IL

    May
    26-27, 2010 –
    7th
    International Forum on Freedom to Operate
    (C5) –

    Munich, Germany

    June
    10, 2010 –
    "Patents
    and the Written Description
    Requirement: Meeting Section 112 Disclosure Obligations After Ariad
    v. Lilly
    " (
    Strafford) – 1:00
    – 2:30 PM (EST)

    June
    11, 2010 –
    "The
    Future
    of U.S. Patent Law: An In-Depth
    Discussion on the Congress, the Courts, and the USPTO
    " (
    Patent
    Resources
    Group) –
    Alexandria,
    VA

    June
    16-18,
    2010 –
    Fundamentals
    of Patent Prosecution
    2010: A Boot Camp for Claim Drafting & Amendment Writing
    (
    Practising
    Law
    Institute) – New York, NY

    June
    21-22,
    2010 –
    Follow-on
    Biologics
    (
    American
    Conference
    Institute) –
    New
    York, NY

    June
    20-22,
    2010 –
    IP
    Business Congress
    (
    Intellectual
    Asset
    Management (IAM) magazine) –
    Munich,
    Germany

    July
    7-9, 2010 –
    Fundamentals
    of Patent Prosecution
    2010: A Boot Camp for Claim Drafting & Amendment Writing
    (Practising
    Law
    Institute) – San Francisco, CA

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