• Chicago #2 The Law Bulletin
    Publishing Company will be holding its Corporate Intellectual Property Law Conference
    on May 25, 2010 in Chicago, IL. 
    The conference will address the following topics:

    • General Session
    — A discussion of conflicts and ethical challenges facing management and
    outside counsel;
    • Patent Track
    Sessions —
    • Patent Law
    Update:  A discussion of recent
    case law led by Chief Judge James Holderman, U.S. District Court for the
    Northern District of Illinois;

    "Unfair" patent marking: 
    The law may be changing, but has management learned its valuable lesson?
    • Managing IP assets,
    patent enforcement & damages, and the Patent Reform Act of 2010.


    Law Bulletin Additional
    information regarding the conference can be found here.  The registration fee for the conference
    is $109.  Those registering before May
    10, 2010 will receive a $20 discount off the registration fee.  Those interested in registering for the
    conference can do so here.


  • Munich, Germany Intellectual Asset
    Management (IAM) magazine will be hosting its next IP Business Congress on June
    20-22, 2010 in Munich, Germany. 
    The IP Business Congress is designed to meet the needs of senior
    business executives responsible for the creation and management of IP value
    inside corporations, as well as those who advise them.  Among the plenary and breakout sessions
    being offered are:

    • The evolving IP
    business market;
    • IP and small and
    medium-sized enterprises (SMEs);
    • Patents in
    Europe;
    • Patents in the
    USA;
    • Chief IP Officer
    (CIPO) clinic;
    • Meet the decision
    makers;
    • Getting to grips
    with non-practicing entities (NPEs);
    • IP markets;
    • Working together;
    • The future of
    patent pools; and
    • The CIPO role in
    knowledge-based business.


    IAM The programme for
    the IP Business Congress can be found here.

    The registration
    fee for the IP Business Congress is EUR €1,500 ($
    2,006.42).  Those interested in registering for the
    conference can do so here.

  •     By Kevin E. Noonan


    Commerce Department Seal On April 13th, the Department of Commerce released a White Paper entitled "Patent
    Reform: Unleashing Innovation, Promoting Economic Growth & Producing High-Paying Jobs
    ."  All admirable goals, but unfortunately
    the paper is more hortatory than informatory.  Disappointingly, department economists, including Mark Doms,
    the chief department economist, and Stuart Graham, Chief Economist of the U.S. Patent
    and Trademark Office, offer precious little evidence or even data supporting
    their assertions that the proposals they recommend will lead to these goals.  (The first author of the report, Arti Rai, is the Administrator of the PTO's
    Office of External Affairs and thus responsible for advocating for these
    proposals, but realistically she can only work with what her economists provide
    her.)

    The Executive Summary sets forth some economic
    statistics related to the goals contained in the Paper's title.  According to this portion of the report,
    75% of post World War II economic growth in America is "linked" to
    technological innovation.  This
    statistic is extrapolated from the proportion of the average annual growth rate
    (3.4%) due to capital investment and increased efficiency (2.5%).  In addition, average compensation has increased from
    1999-2007 at a rate 2.5-fold in "innovation-intensive" sectors (not
    expressly defined) than in the economy as a whole.  Not surprisingly, the Paper also states that 76% of venture
    capital investors "consider" a company's patents when deciding to
    fund "[h]ighly innovative firms."  The consequences of delayed patent grant (purportedly due to
    the backlog of 750,000 applications) has "substantial costs," which
    the Paper estimates "could ultimately cost the U.S. economy billions of
    dollars annually in 'foregone innovation'."  The Executive Summary ends with the two proposed
    solutions:  giving the USPTO fee-setting authority, which the Paper states would "contribute
    significantly" to a 40% reduction in patent pendency; and establishing an "enhanced
    post-grant review" regime.  Claims for the latter are even more dramatic:  according to the Summary, "[t]he cost of such
    proceedings is expected to be 50-100 times less expensive than litigation and
    could yield $8 to $15 in consumer benefit for every $1 invested."

    The Summary provokes the expectation that the rest
    of the White Paper will disclose the economic and statistical underpinnings to
    these claims (after all, in economics of all the sciences it seems reasonable
    to expect to "see the work" underlying the conclusions).  Unfortunately, that data is not
    found in the Paper.  The Discussion
    following the Summary sets forth policy presumptions ("[s]timulating
    economic growth and creating high-paying jobs are key priorities for the Obama
    Administration"), a history of recent patent reform efforts, and the need
    for the latter to achieve the former:  "[p]atent reform legislation will
    accelerate [a virtuous cycle of innovation, growth and additional innovation]
    and speed the pace of growth and of job creation."

    The Paper then cites academic sources relating
    innovation/technological change and job growth, something akin to bringing
    coals to Newcastle for an intended technology-savvy audience.  (It is unlikely even any troglodytes in
    Congress have failed to hear the message linking technology to Progress.)  The 75% (2.5%/3.4%) statistic recited
    in the Summary is supported by a 2007 paper by Jorgenson et al. ("Industry Origins of the American
    Productivity Resurgence
    ," 19(3) Economic Systems Research 229) and a 2000
    National Bureau of Economic Research study (Boskin & Lau, "Generalized Solow-Neutral Technical Progress
    and Postwar Economic Growth
    ," Working Paper 8023).  Innovation also produces high-paying jobs, the Paper
    notes, citing Basu & Fernald (2009, "What
    Do We Know (and Not Know) about Potential Output
    ," 91(4) Federal Reserve Bank of St. Louis
    Review
    187), with 75% of the differences in industrial output between countries
    being attributed to "innovation-driven productivity differentials,"
    citing Hall & Jones, 1999, "Why Do
    Some Countries Produce So Much More Output Than Others?
    " 114(1) Quarterly
    Journal of Economics
    83.  Technology-related differences can be discerned between industries:  while the Paper reports that "the
    average rate of real compensation per employee" in the U.S. private sector
    increased by 20.2% from 1997-2007 (supported by data in accompanying Table I),
    in "the most innovative industries" (at least computers, electronics
    and chemicals) the increase was more than 50% (a greater than 2.5-fold
    difference).

    New technologies are "disproportionally"
    generated from venture capital-backed startup companies, and VCs rely on
    patents when making investment decisions (assertions supported by Kortum &
    Lerner, 1998, "Does Venture Capital Spur
    Innovation?
    " National Bureau of Economic Research, Working Paper 6846; Mann &
    Sager, 2007, "Patents, Venture Capital and
    Software Startups
    ," 36 Research Policy 193;  and Graham et al., 2010, "High
    Technology Entrepreneurs and the Patent System: Results of the 2008 Berkeley Patent Survey
    ,"
    forthcoming).  (As has been noted by others, it is a
    pity Dr. Graham's work is not yet available; it should be posted on the PTO
    website.)  The Paper also
    cites certain "anecdotal" evidence supporting these "large-scale
    empirical findings," ranging from medical device incubators to companies
    acquired by big pharma companies.  The Paper picks out the pharmaceutical industry as one dependent in
    particular on "high-quality" patents, this being one of the reasons
    why patents in the pharmaceutical industry do not support Bessen and Meurer's
    conclusions that patents are inimical to innovation (2008, Patent Failure: How Judges, Bureaucrats and Lawyers Put Innovators At Risk).  This produces a "patent premium" for biotechnology,
    pharmaceutical, and medical device companies, according to the Paper (appropriately citing Arora et al., 2008, "R&D
    and the Patent Premium
    ," 26(5) International Journal of Industrial Organization 1153) for this
    proposition.  It should be heartening
    for members of that sector to hear the Office understands the importance of
    patents for these industries.

    The Paper then identifies the problems it intends
    to address:  untimeliness in the
    patent procurement process and inconsistent quality of granted patents.  "Delay, uncertainty and poor
    quality" are the principal characteristics of the current U.S. patent
    system, according to the Paper, which "makes private investments in
    innovation less likely," undermining economic growth and job
    creation.  The consequences of this
    situation are not illustrated by academic studies but by anecdotal evidence,
    using stories of companies that had not been able to obtain high-quality
    patents in a timely fashion.  The one large study cited, by London Economics (2010, "Economic Study on Patent Backlogs and a
    System of Mutual Recognition
    "), was used as the basis for the
    assertion that problems with patenting could account for "foregone
    innovation" costing "billions of dollars annually" (albeit this
    study was not confined to the U.S. but included the Japanese and European
    Patent Offices, which are usually not thought of as suffering from the problems
    of the U.S. Patent and Trademark Office addressed in the Paper).

    For poor
    patent quality (defined as "patents that are obvious, overly broad or
    unclear in the inventive territory they cover"), Bessen and Meurer were
    again cited, for the proposition that even low-quality patents can be "profitably
    asserted against genuine innovators in litigation."  (It would be a benefit to this debate
    if examples were provided showing this morality play of "false"
    versus "true" innovators; 
    while this may happen, it seems to be an overreaction to overhaul the
    U.S. patent system without evidence that such behavior is widespread.)  Such "bad patents" are
    also asserted to constitute a "tax" on innovation, purportedly
    because they are more likely to be licensed than challenged, both because of
    the inherent costs of patent infringement litigation as well as the economic
    behaviorialist position that a challenger is unwilling to bear the cost and
    risk for an outcome in which all potential infringers will share (i.e.,
    invalidating a bad patent).  While
    these scenarios are plausible on their face, without evidence they are just
    that — mere scenarios.

    Having discussed the problems the Paper provides
    the solutions.  The fee-setting
    provisions of the Senate Manager's Amendment would provide as follows:

    The Director shall have authority to
    set or adjust by rule any fee established or charged by the Office under
    sections 41 and 376 of title 35, United States Code, or under section of the
    Trademark Act of 1946 (15 U.S.C. 1113), or any other fee established or charged
    by the Office under any other provision of law, notwithstanding the fee amounts
    established or charged thereunder, for the filing or processing of any
    submission to, and for all other services performed by or materials furnished
    by, the Office, provided that patent and trademark fee amounts are in the
    aggregate set to recover the estimated cost to the Office for processing, activities,
    services and materials relating to patents and trademarks, respectively,
    including proportionate shares of the administrative costs of the Office.

    The benefits of enactment of these provisions,
    according to the White Paper, would be a decrease in the 750,000 application
    backlog and a reduction in the average 34-month pendency for applications (the
    time between original filing date and "a final disposition").  (Unexplained in these statistics is how
    the 750,000 figure for the backlog was calculated, and whether a "final
    disposition" is limited to allowance, abandonment, or appeal, or if
    intermediate stages, such as a Request for Continued Examination, are
    counted.)  The Paper does correctly
    point out that the pendency period is even longer than average for arts such as
    information and communications technology, and that these delays can have
    significant impacts in arts that are characterized by "rapid technological
    turnover and short product life-cycles."  Here, the Paper asserts, untimeliness in procuring patents
    can lead to "worthless and obsolete" patents.  While undoubtedly true, in such fields
    it is reasonable to ask whether patent protection, procured at significant
    investments of time and money, is an appropriate avenue for protecting
    intellectual property that is ephemeral at best; such questions are not
    addressed in the Paper.

    Reducing pendency takes money, of course, and some
    of the uses for the cash the Office anticipates it will collect if granted
    fee-setting authority (and in the context of the economics set forth in the
    Paper, this is really fee-increasing authority)
    include "expenditure on IT infrastructure upgrades and additional hiring of
    examiners."  Fee-increasing
    authority is needed, according to the Paper, because "the fee schedule in
    the current patent statute fails to provide the USPTO with the flexibility it
    needs to assure that its future revenues are commensurate with the costs it
    will incur to modernize its operations."  Further, "[t]he current fee structure is inflexible and
    poorly aligned with actual costs, making it exceedingly difficult to fund
    long-needed modernizations" according to the Paper.  Some of the ways the fee structure is
    thus "poorly aligned," the Paper asserts, is that applicants do not
    pay fees sufficient to support the actual cost of the services the Office
    provides them.  The estimate set
    forth in the Paper is that applicants pay fees equivalent to about one-third
    the actual cost of examination, making "back-end" fees (such as issue
    fees, publication fees, and patent maintenance fees) necessary to make up the
    shortfall.  And these fees are
    sufficiently indeterminate that they do not provide the needed reliable source
    of necessary funds.


    Rai, Arti The biggest strategic deficiency in this proposal
    is that no matter what Congress does with regard to fee-setting authority, what
    needs to be achieved is a commitment, backed by legislation, that that same
    Congress will not expropriate the additional fees for its own, non-patent
    related purposes  (Indeed, after
    several years of eschewing this type of fee-diversion, this Congress mandated
    that any fees in excess of $100 million would go into the general coffers for
    other expenses.)  Arti Rai (at left), lead
    author of the White Paper, explained to a gathering of the Biotechnology
    Industry Organization (BIO) Intellectual Property Counsels Committee in New
    Orleans this week that demanding this type of assurance was unwise because it annoyed
    Congressional appropriators.  Regardless of the soundness of this realpolitick,
    however, without such a pledge
    there is an automatic disconnect between the proposed solution and any evidence that it will achieve the
    goal of appropriate funding for the Office.  Additionally, permitting the Office to have fee-setting
    authority creates the possibility that the fees will be used not just to
    modernize the IT infrastructure or hire more examiners, but to modify applicant
    behavior (as has been proposed in the past, unsuccessfully at least in part because
    Congress would not adopt the proposed behavior-modifying fee structure in the
    face of the resulting political firestorm of criticism).  Having endured five years of the
    Dudas regime, it is not irrational for members of the patent community to have
    these fears; even with the general
    acceptance of the benevolence of the Kappos administration, there is no assurance
    that the next Director will have the public interest at least as much in mind
    as meeting bureaucratic goals.

    The other proposal for patent reform is post-grant
    review, needed according to the Paper to ensure only "high-quality"
    patents are granted (or at least maintained).  The issue is framed in David v. Goliath terms, with patent
    challenges being cast as particularly difficult for "small firms with
    limited resources."  While
    certainly true, the Paper ignores the equally-likely converse situation:  a resource-rich company using
    post-grant review to harass a small firm with high-quality patents but limited
    resources.  While the Paper's
    scenario poses a problem, the converse situation is even more fraught with
    innovation-stifling potential, inter alia
    because small firms with limited resources are highly dependent on patents for
    investment (a reality discussed at the beginning of the Paper with regard to
    VC-investment in technology-based companies), and anything that creates
    uncertainty about such a small firm's patents will inhibit investment (making
    acquisition by resource-rich companies of their undervalued patent assets more
    likely).  Regardless of these
    unexplored possibilities, the Paper discusses threatened enforcement of "poor-quality"
    patents by "large firms" that could "forc[e] small competitors
    [of such large firms] with breakthrough technologies out of business,"
    citing Benjamin & Rai, 2008, "Fixing
    Innovation Policy: A Structural Perspective
    ," 77 Geo. Wash. L. Rev. 1.  The purported benefits of post-grant
    review are supported by academic studies, including Graham & Harhoff, 2009, "Separating Patent Wheat from Chaff: Would
    the U.S. Benefit from Adopting a patent Post-Grant Review?
    " (curiously, an
    unpublished paper "on file
    with the authors," which would benefit from being made publicly available
    on the Patent Office website).

    Disclosure of the bases for the assumptions is not set
    forth in the Paper, however:  in
    the post-grant review section, the authors make most of the economic benefit
    assertions, including that "the cost of post-grant review is expected to
    be 50-100 time lower than the cost of patent litigation," that "between
    one-third and one-half of [post-grant review] challenges can be expected to
    result in an invalidity decision (which is frankly a dubious assertion unless
    the post-grant review is expected to encompass the full range of invalidity
    defenses available at trial), and cost-benefit analyses (which almost cry out
    for data supporting them) estimating a return of from $8 to $15 for every $1 invested in the post-grant review
    system.  Instead of a quantitative
    review of the assumptions behind these statements, the Paper merely asserts
    that "almost every academic economist who has ever examined whether an
    enhanced system of post-grant review should be adopted has favored such
    adoption," and notes that the Federal Trade Commission, the National
    Research Council, and the National Academy of Sciences also support this
    reform.  While comforting, this is
    hardly a substitute for the kind of hard-headed, explicit economic analysis
    that might be persuasive for such a proposal.  The Paper does note that there is at least one academic
    study that differs with the seemingly universal approval of another post-grant
    review system (Shane, 2009, "Problems to
    be Expected from Expanded Administrative Challenges to U.S. Patents
    ," prepared for the Manufacturing Alliance for Patent Policy), but disputes its assumptions
    (which are expressly set forth for examination).  Benefits from decreasing the delay in invalidating patents
    (which the Paper asserts can take 8-11 years in litigation) are supported by
    another unpublished paper by Dr. Graham (2010, "Slow courts and the cost of uncertainty: How patent post-grant reviews
    may offer a partial solution") (being another paper that would benefit the
    public by being posted in the PTO website).

    The Paper is valuable in setting forth goals the
    current PTO administration believes to be important and how they propose to
    achieve those goals.  It is less
    valuable in providing the public with the evidence it needs to assess whether
    these proposals are related to achieving the goals or whether the reasoning
    behind choosing these goals is sound.  The patent community cannot and should not be expected to blindly accept
    these proposals or their relationship to the purported goals, and it is justified
    in expecting and demanding that the Office provide sufficient evidence in favor
    of these proposals.  This White
    Paper does not fulfill those needs and expectations.

  •     By
    Donald Zuhn

    MPEG LA In
    a press release
    issued earlier this month, MPEG LA, LLC
    announced that it was launching an initiative to enhance the availability of
    gene patents for diagnostic testing. 
    MPEG LA, which describes itself as the world's leading packager of
    patent pools for standards and other technology platforms, would accomplish
    this objective by creating a new gene patent pool.  Currently, MPEG LA has formed patent pools for MPEG-2, ATSC,
    AVC/H.264, VC-1, MPEG-4 Visual, MPEG-2 Systems, 1394, and MPEG-4 Systems, so the
    company would be venturing outside of consumer electronics-related pools for
    the first time in creating the gene patent pool.

    MPEG
    LA notes that it neither owns nor uses the patents in its pools, but rather
    seeks to create markets for patents that maximize profits for the patent
    holders and make utilization of patents affordable for manufacturers,
    consumers, and other users.  According
    to the company's press release, the new gene patent initiative will address
    "the market's need for nonexclusive access to patents for diagnostic
    genetics tests leading to personalized medical solutions that save lives and
    reduce healthcare costs." 
    While MPEG LA President and CEO Larry Horn described diagnostic genetics
    testing as "hold[ing] great promise as a driver of precision therapy,"
    he noted that patent thickets and restrictive licensing arrangements threaten the
    delivery of such tests.  Pointing
    to the recent decision in Association for
    Molecular Pathology vs. U.S. Patent and Trademark Office
    , Mr. Horn
    contended that a solution that "balances social cost and open access with
    innovation incentive" was needed.

    MPEG
    believes that by aggregating patent rights for existing and emerging tests that
    may lead to personalized treatment for diseases and disorders such as hereditary
    hearing loss in infants, breast cancer, ovarian cancer, cardiovascular disease,
    and Lynch syndrome, and licensing these patents nonexclusively for diagnostic
    use, it can assist laboratories, testing companies and researchers in obtaining
    the rights they need to design comprehensive diagnostic genetics tests, and as
    a result, make such tests widely available through multiple channels at
    affordable prices.

  •     By Donald Zuhn –-

    NVCA On
    Friday, the National Venture Capital Association (NVCA), a trade association
    representing the U.S. venture capital industry, released the results of its
    latest MoneyTree Report on venture funding.  The study, conducted with PriceWaterhouseCoopers based on
    data from Thomson Reuters, indicates that venture capitalists invested $4.7 billion
    in 681 deals in the first quarter of 2010, a 9% decrease in dollars and 18%
    increase in deals as compared to the fourth quarter of 2009.  After adjusting its fourth quarter
    numbers, the NVCA determined that $5.2 billion had been invested in 832 deals,
    as opposed to its initial determination that $5.1 billion had been invested in
    794 deals.  While the NVCA report
    indicated that both the dollars and deals were down from the fourth quarter of
    2009, the NVCA noted that the numbers for the first quarter of 2010 were higher
    than for the same quarter in 2009, when $3.4 billion was invested in 635 deals.

    Total Venture Capital Investment (Quarterly) Q1 2010.
    PricewaterhouseCoopers (PWC) It
    was a case of good news, bad news for the Life Sciences sector (biotechnology
    and medical devices) in the first quarter.  On the bad news side, Life Sciences investing dropped to $1.3
    billion in 160 deals for the first quarter, which constituted a 26% drop in
    dollars and a 21% decrease in deals as compared with the fourth quarter of
    2009.  On the good news side, Tracy
    Lefteroff of PricewaterhouseCoopers noted that "Life Sciences continues to
    be the number one sector for VC investing, with biotechnology being the
    absolute single-industry leader in dollars invested over the past four quarters."  In particular, the
    biotech
    sector drew $825 million in 99 deals in the first quarter.  However, these numbers still
    represented a 24% decrease in dollars (down from $1.1 billion in the
    fourth
    quarter) and a 14% drop in deals (down from 115 deals in the fourth
    quarter).

    Investment Activities - Top Industries Q1 2010
    Thomson Reuters NVCA
    President Mark Heesen said that
    "[d]espite a great deal of economic uncertainty in the first quarter,
    the
    venture capital industry moved forward with a more active start than it
    did in
    2009, which bodes well for the remainder of the year."  He
    expected venture funding to increase
    moderately throughout the remainder of 2010, in part because of the
    passage of
    health care reform legislation.

    Additional
    information regarding the latest report can be found here.

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

    • "VentureDeal Report Shows 65% Increase in Fourth Quarter Biotech Venture Funding," March 16, 2010
    • "NVCA Report Shows Slight Drop in 4Q Venture Funding and Sharp Decline for 2009," January 24, 2010

    "Biotech/Pharma
    Companies Look to Market for Capital
    ," December 29,
    2009

    "NVCA
    Study Shows Increase in Third Quarter Venture Funding
    ," October
    23, 2009


    "Biotech/Pharma
    Financing Improving, R&D Spending Up
    ," August 31,
    2009


    "Investors
    Saw Biotech Rebound Coming
    ," August 17, 2009


    "Is
    Biotech/Pharma Beginning to Bounce Back?
    " August 12, 2009


    "First
    Quarter Venture Capital Funding at 12-Year Low
    ," April 23,
    2009


    "NVCA
    Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech
    Rebound in 2009
    ," February 16, 2009

  •     By Sherri
    Oslick

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


    Biovail Laboratories International SRL v. Paddock Laboratories,
    Inc.

    0:10-cv-01571; filed April 15, 2010 in the District
    Court of Minnesota

    Infringement of U.S. Patent Nos. 7,569,610 ("Modified
    Release Formulations of a Bupropion Salt," issued August 4, 2009),
    7,572,935 (same title, issued August 11, 2009), 7,649,019 (same title, issued
    January 19, 2010), 7,563,823 (same title, issued June 21, 2009), 7,553,992
    (same title, issued June 30, 2009), and 7,671,094 ("Bupropion Hydrobromide
    and Therapeutic Applications," issued March 2, 2010) following a Paragraph
    IV certification as part of Paddock's filing of an ANDA to manufacture a
    generic version of Biovail's Aplenzin ER (bupropion, used to treat
    depression).  View the complaint
    here.


    Abbott Laboratories et al. v. Teva Pharmaceutical Industries
    Ltd. et al.

    1:10-cv-00302; filed April 14, 2010 in the District
    Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
    • Defendants:  Teva Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA
    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 Teva'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.


    Bayer Schering Pharma AG et al. v. Teva Pharamceuticals USA,
    Inc. et al.

    1:10-cv-00299; filed April 13, 2010 in the District
    Court of Delaware

    • Plaintiffs:  Bayer Schering Pharma AG; Bayer HealthCare Pharmaceuticals
    Inc.; Schering Corp.
    • Defendants:  Teva Pharamceuticals USA, Inc.; Teva Pharmaceutical
    Industries Ltd.

    Infringement of U.S. Patent No. 7,696,206 ("2-phenyl
    Substituted Imidazotriazinones as Phosphodiesterase Inhibitors," issued
    April 13, 2010) as part of Teva's filing of an ANDA to manufacture a generic
    version of plaintiffs' Levitra® (vardenafil hydrochloride, used to treat
    erectile dysfunction).  View the
    complaint
    here.


    Baker v. Bayer Aktiengescellschaft Corp. et al.
    2:10-cv-02271; filed April 13, 2010 in the Western
    District of Tennessee

    • Plaintiff:  Charles R. Baker
    • Defendants:  Bayer Aktiengescellschaft Corp. d/b/a Bayer AG; Bayer
    Corp.; Bayer Healthcare, LLC; Bayer Healthcare Pharmaceuticals, Inc.

    False
    marking based on Bayer's marking of certain of its Baytril®, Cipro®, Ciprodex®,
    Fludara®, Legend®, and Proleukin® products indicating that these products are
    covered by one or more of U.S. Patent Nos. 4,670,444 ("7-amino-1-cyclopropyl-4-oxo-1,
    4-dihydro-quinoline-and naphthyridine-3-carboxylic acids and antibacterial
    agents containing these compounds," issued June 2, 1987), 4,844,902 ("Topically
    applicable formulations of gyrase inhibitors in combination with
    corticosteroids," issued July 4, 1989), 4,357,324 ("Prodrug
    derivatives of 9beta-D-arabinofuranosyl-2-fluoroadenine," issued November 2, 1982), 4,808,576 ("Remote
    administration of hyaluronic acid to mammals," issued February 28, 1989), 4,530,787 ("Controlled
    oxidation of microbially produced cysteine-containing proteins," issued July 23, 1985), 4,569,790 ("Process
    for recovering microbially produced interleukin-2 and purified recombinant
    interleukin-2 compositions," issued February 11, 1986), 4,604,377 ("Pharmaceutical compositions
    of microbially produced interleukin-2," issued August 5, 1986), 4,748,234 ("Process for recovering
    refractile bodies containing heterologous proteins from microbial hosts,"
    issued May 31, 1988), 4,572,798
    ("Method for promoting disulfide bond formation in recombinant proteins,"
    issued February 25, 1986),
    4,853,332 ("Structural genes, plasmids and transformed cells for producing
    cysteine depleted muteins of biologically active proteins," issued August 1, 1989), and 4,959,314 ("Cysteine-depleted
    muteins of biologically active proteins," issued September 25, 1990), all of which are expired.  View the complaint
    here.


    Baker
    v. Novartis Pharmaceuticals Corp. et al.

    2:10-cv-02272; filed April 13, 2010 in the Western
    District of Tennessee

    • Plaintiff:  Charles R. Baker

    Defendants:  Novartis
    Pharmaceuticals Corp.; Novartis Animal Health US, Inc.; Novartis
    Opthalmics, Inc.

    False
    marking based on Novartis' marking of certain of its Denegard®, Milbemite®, and
    Ocupress® products indicating that these products are covered by one or more of
    U.S. Patent Nos. 4,278,674 ("Substituted 14-desoxy-mutilin compositions,"
    issued July 14, 1981), 4,547,520
    ("5-Oxime derivatives of milbemycins and veterinary and agricultural use
    thereof," issued October 15, 1985),
    3,910,924 ("3,4-Dihydrocarbostyril derivatives and a process for preparing
    the same," issued October 7, 1975),
    and 4,309,432 ("Compositions for treating glaucoma containing a
    carbostyril," issued January 5,
    1982
    ), all of which are expired.  View the complaint
    here.


    Baker
    v. Bausch & Lomb, Inc.

    2:10-cv-02273; filed April 13, 2010 in the Western
    District of Tennessee

    False
    marking based on Bausch & Lomb's marking of certain of its Xibrom® products
    with U.S. Patent No. 4,910,225 ("Locally administrable therapeutic
    composition for inflammatory disease," issued March 20, 1990) which is
    expired.  View the complaint
    here.


    Baker
    v. Glaxosmithkline Healthcare, LP et al.

    2:10-cv-02274; filed April 13, 2010 in the Western
    District of Tennessee

    • Plaintiff:  Charles R. Baker

    Defendants:  Glaxosmithkline
    Healthcare, LP; Glaxosmithkline, LLC

    False marking based on GSK's marking of certain of
    its Alli® products with U.S. Patent No. 4,598,089 ("Leucine derivatives,"
    issued July 1, 1986) and its
    NicodermCQ ® products with U.S. Patent No. 5,004,610 ("Subsaturated
    nicotine transdermal therapeutic system," issued April 2, 1991), which are expired.  View the complaint
    here.


    Warner Chilcott Co., LLC et al. v. Mylan Pharmaceuticals
    Inc.

    1:10-cv-00059; filed April 9, 2010 in the Northern
    District of West Virginia

    • Plaintiffs:  Warner Chilcott Co.; Hoffmann-La Roche Inc.
    • Defendant:  Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent No. 7,192,938 ("Method
    of Treatment Using Bisphosphonic Acid," issued March 20, 2007), licensed
    to Warner Chilcott, following a Paragraph IV certification as part of Mylan's
    filing of an ANDA to manufacture a generic version of Warner Chilcott's
    Once-a-Month Actonel® (risedronate sodium, used to treat and prevent
    postmenopausal osteoporosis).  View
    the complaint
    here.


    Astrazeneca Pharmaceuticals LP et al. v. Anchen
    Pharmaceuticals, Inc. et al.

    3:10-cv-01835; filed April 8, 2010 in the District
    Court of New Jersey

    • Plaintiffs:  Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.
    • Defendants:  Anchen Pharmaceuticals, Inc.; Anchen, Inc.

    Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical
    Compositions Using Thiazepine," issued September 7, 1999) following a
    Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture
    a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to
    treat schizophrenia and bipolar disorder).  View the complaint
    here.



  •     By Kevin E. Noonan

    At least since William Shockley's crackpot racial
    theories had their brief moment in the public discourse, it has been evident
    that merely achieving a Nobel Prize is not a guarantee of Solomonic wisdom,
    particularly outside the recipient's field of expertise.  Or perhaps it is just a reflection of
    the human reality that the fickle finger of genius touches even the most
    brilliant of us serendipitously and cannot be counted as a birthright of any
    constancy — strokes of genius perhaps being more like strokes of lightening than
    we would care to admit.

    This is particularly true of fields like economics,
    where the complexities of the subject matter (and the difficulties is fashioning
    meaningful "controls") frequently render conclusions that differ from
    reality — if it were different, we could just transport the Fed to the
    University of Chicago's economics department and be done with it.  But all too often, economic predictions
    and even analyses fall short, not due to anything other than the impossibility
    of accuracy in describing these aspects of the world around us.

    Stiglitz These characteristics of economic analysis come to
    mind in considering Professor Joseph Stiglitz's (at right) op-ed piece in Friday's Wall Street Journal, purportedly making "The
    Case Against Gene Patents
    ."  (The
    Professor is joined by another Nobelist, John Sulston (below), chair of the Institute
    for Science, Ethics and Innovation at the University of Manchester; his Nobel
    was for medicine, awarded in 2002.)  Professor Stiglitz, who is at Columbia University, won the Nobel Prize
    in 2001 for his work on information assymetry.  He was Chair of the President's Council of Economic Advisors
    under President Clinton, and in
    addition to the Nobel, has won the John Bates Clark Medal (1979) and is "one
    of the most frequently-cited economists in the world" according to the
    University of Connecticut's Department of Economics.

    Sulston And yet, Professor Stiglitz falls into the same
    errors that far lesser pundits and polemicists have been prey to in the gene
    patenting debate.  Of course, the Professor was part of the
    ACLU "team" that won a summary judgment verdict from a District Court
    judge last month, so he is hardly unbiased on the issue.  But he does make some idiosyncratic
    errors that illustrate how far afield from reality the anti-gene patenting
    folks are willing to go.

    First, he states that "Myriad [has] had total control over the BRCA1 and BRCA2 genes since the
    1990s.  No other companies have been able to do research on the genes without
    Myriad's permission."  Partially true, with regard to companies — it should come as no surprise
    that patents prevent competing commercial
    activity.  But this is hardly total
    control, since extensive basic research has been done on these genes since
    Myriad (and their licensor, the University of Utah) were granted the
    patents.  And there are extensive
    commercial uses for the genetic information that could have been pursued by
    companies without infringing.  What
    other companies have not been able to do is practice the patented invention.

    He then states that genes "contain
    the most fundamental information about humanity — information that should be
    available to everyone."  As
    they are — the information is not patented.  It has been a consistent theme of the ACLU and their friends
    that Myriad has somehow hijacked an individual's genes, when the fact is that
    gene patents do nothing of the sort.

    Wall Street Journal Speaking as an economist, Professor
    Stiglitz then purports to introduce "a deeper understanding of the
    economics and science of innovation" that, he says, "leads to exactly
    the opposite conclusion" asserted by gene patent proponents, viz. that "private companies will
    not engage in genetic research unless they have the economic incentives created
    by the patent system."  Unfortunately,
    he then misconstrues the fundamental societal benefit conferred by the patent
    system — not incentives to innovate, and not even incentives to commercialize,
    but the requirements for disclosure that are fundamental to the patent
    grant.  Again misunderstanding the
    difference between the patented article — an isolated nucleic acid encoding a
    specific protein — and the information content comprising the sequence,
    Professor Stiglitz asserts that patents "not only prevent the use of
    knowledge in ways that would most benefit society, they may even impede
    scientific progress."  His
    basis for this statement?  "Every
    scientific advance is built on those that came before it.  There is still a
    great deal to learn about our genes, particularly how they contribute to disease.  Gene patents inhibit access to
    the most basic information."

    Once again, actually that is simply not
    the case.  Not only is there no
    evidence to support the statement that gene patents have impeded genetic
    research, there is copious evidence to the contrary — the almost 8,000 basic
    scientific references that have been published since the Myriad patents at
    issue in the ACLU lawsuit were granted.  So the "patents impede scientific progress" argument does not
    seem to have benefited from the Professor's deeper understanding of either
    economics or science.

    The next issue the Professor raises is
    the potential "patent thicket" that might arise in an era of
    personalized medicine when an individual's genetic information may be commonly
    obtained, at least for genetic loci identified as being involved in the
    etiology of common diseases.  Here
    he has a point, but it is a prospective one — that era is not yet upon us, for
    one, and the types of claims invalidated by the District Court are not the ones
    that will impact personalized medicine.  The invalidated claims were, in large part, directed to the isolated
    genes themselves.  These claims
    were targets because they had sufficient potential political impact — they
    supported the "don't patent my genes" campaign mounted by the ACLU to
    provide the background drumbeat of support from media and "grassroots"
    outlets, they could be easily fashioned into a "message" with great
    emotional impact, and they were the types of claims that are the bedrock of the
    biotechnology industry.

    However, it is unlikely that any of
    these claims are infringed in performing the types of genetic testing either as
    performed by Myriad for the BRCA1 and BRCA2 genes, or that would be implicated
    in personalized medicine.  That is
    because these claims have the following structure (illustrated for BRCA1 but in
    common with most other claims to isolated genes):

    1.  An isolated
    DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid
    sequence set forth in SEQ ID NO:2. [U.S. Patent No. 5,747,282]

    In order to be infringed, this claim
    requires that the full-length BRCA1 gene be isolated, and that it encode the
    polypeptide identified by SEQ ID NO: 2.  For personalized medicine, on the other hand, the identification of
    disease-related polymorphisms in BRCA1 (or any other gene) will not require
    isolation of the full-length gene.  Instead, the polymorphic site will be identified, and only that fragment
    of the gene will need to be interrogated.  However this is done, it will not infringe a gene claim like claim 1 of
    the '282 patent unless the entire, full-length gene is isolated.  For economic if not scientific reasons,
    this will simply not be done because it doesn't need to be.

    The Professor argues that in the brave new
    world of personalized medicine, "free sharing of information about genes will be vital to understanding the role of
    these variations in human disease and other
    traits" (emphasis added).  That, of course, is the world we have
    today, since the unpatentability of genetic information (and the patentability
    of isolated genes) has resulted in a free-flow of information from universities
    and governmental and non-governmental research institutes.  In short, there is no incentive to
    suppress this information, since the aspects that are patentable — isolated
    genes — can be protected.  Indeed,
    in view of the disclosure requirements of U.S. patent law — specifically 35
    U.S.C. § 112 — such full and complete disclosure is required (said disclosure
    requirements not being an aspect, for example, of scientific research
    papers).  So as things now
    stand (before the ACLU took up the anti-gene patenting torch), "the basic
    data" of our genes is "freely available to everyone to interpret and
    develop."  What is not
    permitted — during the temporary existence of a patent — is commercial activity
    in competition with the patent holder or her licensee.

    Of course, cost comes into the
    equation, and the fact that some women are not able to afford the Myriad
    test.  But those costs are not
    completely the consequence of the tests being patented, and any unavailability
    of the tests is more the result of the lunacy of permitting insurance companies
    instead of doctors to decide who does (and who does not) get needed care.  The Professor asserts that "[p]atents
    are also not necessary for ensuring that genetic tests come to market"
    based on the representations of  "[o]ther
    labs" that they are prepared to provide the test for "a few hundred
    dollars" rather than what Myriad charges.  This is not surprising — these "other
    labs" didn't have to incur the start-up costs and attract the investors at
    a time when the success of Myriad's test was not assured.  It is always easier to copy than to
    innovate and commercialize, and the ex
    post facto
    reasoning that these "other labs" can now provide
    these tests more cheaply ignores the frank reality that the patent system
    provides for that — these labs, and every other lab, will be able to enter the
    marketplace unfettered by Myriad's patent rights when the patents expire,
    sometime in 2014.

    Professor Stiglitz saves some of the
    best (or worst) flights of fancy until the end of the piece.  The consequence of less private
    investment in commercializing the fruits of genetic research by banning patents
    would result in "a slight slowdown in private research expenditures,"
    he says, which "can and should be made up for by an increase in public
    expenditures."  Governmental
    control over the means for production was tried, famously and unsuccessfully,
    in the 20th Century, and a non-existent limitation on genetic
    information hardly justifies trying that experiment again, particularly in a
    field like healthcare that is so important to everyone.  The uproar over this administration's
    healthcare initiative — which hardly substituted private with public control
    over the healthcare system — should convince dispassionate observers that the "public option"
    is not a viable one.

    He also states that genes "are an
    example of 'basic knowledge'" like mathematical theorems, again neglecting
    the tangible/intangible, patent-eligible/ineligible distinction between genetic
    information and isolated genes.  He
    compares patenting genes to patenting Alan Turing's "mathematical
    insights," which if patented might have "greatly delayed" the
    development of the modern computer according to the Professor.  In this he neglects the unfortunate
    facts that Turing's insights were made in the 1950's, while the personal
    computer was developed in the 1970's – 80's.  Moreover, even if patented, Turing's patents would have
    expired 15-20 years before Steve Jobs and Bill Gates created the personal
    computer revolution; an equally likely case might be made that patent protection would have provided the
    incentive to commercialize the personal computer more rapidly by companies like
    IBM and Xerox.

    His conclusion shows how badly
    Professor Stiglitz has assessed the reality of biotechnology innovation:

    It's true that knowledge cannot be produced without cost,
    but there is a proven alternative:  government- and
    foundation-supported research in universities and research laboratories.

    For over a generation, this is
    precisely what has happened:  universities and research institutes have performed the basic scientific
    research, and the potential to protect the practical applications of that
    research through patenting have provided the incentives (and the economic
    benefits to those universities and research institutes) for companies to commercialize
    them.  This partnership has
    propelled the U.S. to the forefront of biomedicine, providing biologic drugs
    and diagnostic methods for important and previously-intractable diseases.  The industry has in some ways been a
    victim of these successes:  the
    uninformed and willfully misinformed see these beneficial consequences and
    misunderstand or misrepresent the critical importance of patenting in its
    historical development.  Professor
    Stiglitz characterizes the District Court's decision as a "critical
    achievement"; in ways only an economist can be, he is completely wrong,
    and the evidence of the past 30 years provides ample evidence of that fact.

  •     By
    Donald Zuhn

    Colbert Report On
    last Thursday's "Colbert Report," host Stephen Colbert turned his
    attention to the Association of Molecular
    Pathology v. U.S. Patent and Trademark Office
    case that was decided on
    March 29.  Pointing to the result
    in the BRCA1/2 gene patent case, Mr. Colbert said he had found "a reason
    to be disappointed in the Federal benchwarmers," and noted that the
    decision would be "a huge blow to the biotech industry."  The Comedy Central comedian said that
    he was "furious at the ACLU," and instead was "with Kevin Noonan
    here . . . the man who defended Myriad's right to patent the genes."  By defending Myriad, Mr. Colbert was
    referring not to the District Court litigation, but rather Dr. Noonan's appearance
    on "60 Minutes" earlier this month (see "'60 Minutes' and 'Newshour' Take Different Approaches to
    Covering Gene Patenting Story
    ").  Mr. Colbert then played the portion of
    Dr. Noonan's interview in which he argues that patents are necessary in order
    to promote investment.  Now, Patent Docs is well aware that the
    "Colbert Report" is
    a satire of news shows that can be found on a certain conservative cable
    network, and that there is a possibility that Mr. Colbert may actually side
    with the plaintiffs and the ACLU.  However,
    when one strips away the jokes, the segment still makes a good case for gene
    patenting (or at least a better case than "60 Minutes") — other than the part about 401 Man Seed knock-offs, of course.

    The
    "Colbert Report" segment on gene patenting can be viewed below:

    The Colbert Report Mon – Thurs 11:30pm / 10:30c
    Formula 01 Liquid Genetic Material
    www.colbertnation.com
    http://media.mtvnservices.com/mgid:cms:item:comedycentral.com:271371
    Colbert Report Full Episodes Political Humor Fox News
  • Calendar

    April
    19-21, 2010 –
    Intellectual
    Property Counsels
    Committee (IPCC) Spring Conference & Meeting
    (
    Biotechnology
    Industry
    Organization) –
    New
    Orleans,
    LA

    April
    22, 2010 –
    "Bio-Similars:
    The New Litigation Landscape
    " (
    Intellectual
    Property Owners Association) –
    2:00
    – 3:00 PM (EST)

    April
    23-24, 2010 –
    12th
    Comprehensive PCT Seminar
    (
    Franklin Pierce Law Center &
    World Intellectual Property
    Organization) –
    Concord,
    NH

    April 27-28, 2010 – 4th
    Annual Paragraph IV Disputes
    *** (
    American Conference
    Institute) –
    New York, NY

    April
    27-28, 2010 –
    Corporate
    IP Counsel Summit
    (
    World
    Research
    Group) –
    New
    York, NY

    April
    29,
    2010 –
    26th
    Annual Joint Patent Practice Seminar
    (
    Connecticut,
    New
    Jersey, New York, and Philadelphia Intellectual Property Law
    Associations) – New York, NY

    May
    3-6, 2010 – 2010
    BIO International Convention
    (Biotechnology
    Industry Organization) – Chicago, IL

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

    Munich, Germany

    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

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

  • USPTO Building Facade Patent
    Resources Group (PRG) will be offering a one-day conference on "The Future
    of U.S. Patent Law:  An In-Depth
    Discussion on the Congress, the Courts, and the USPTO" on June 11, 2010
    from 9:00 AM to 4:30 PM at Buchanan Ingersoll and Rooney PC in Alexandria,
    VA.  According to the PRG website,
    the in-depth panel discussion will bring together some of the best minds in
    patent law to inform, discuss, and debate the future of U.S. patent law, with
    the event comprising brief lectures, lively panel discussions, and audience
    participation.  Among the topics to
    be discussed are U.S. patent reform, ideas and approaches to improve pendency
    and efficiency at the USPTO, and the latest developments in, and tensions
    between, the U.S. Supreme Court and the U.S. Court of Appeals for the Federal
    Circuit.

    PRG The
    discussion will be moderated by Professor Michael Meurer of Boston University
    and co-author of "Patent Failure: 
    How Judges, Bureaucrats, and Lawyers Put Innovators at Risk," and
    include the following panelists: 
    Professor Michele Boldrin of the Department of Economics at Washington
    University in St. Louis, and co-author of "Against Intellectual Monopoly";
    Tom Irving of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Patrick C.
    Keane of Buchanan Ingersoll & Rooney PC; and Samuel C. Miller, III of
    Buchanan Ingersoll & Rooney PC.

    The
    registration fee for the event is $395. 
    Those interested in registering for the event, can do so here.