• Calendar

    February
    4-5, 2013 – Naples Midwinter Patent Law Experts Conference (Akron University Law School) – Naples, FL

    February 5, 2013 – Single Claim Restriction Requirements: 
The Interplay Between 35 USC
    Section 112 and 35 USC Section 121
    (American Bar
    Association) – 12:00
    – 1:30 pm (Eastern)

    February 13, 2013 – Corporate Intellectual
    Property Law Conference
    (Law Bulletin
    Publishing Company) – Chicago, IL

    February 14, 2013 – Last Chance! The Top Ten Things
    In-House Counsel Need to Do to Prepare for The AIA’s March 2013 Deadline
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CST)

    February 20, 2013 – AIA Strategy Considerations for Patent Filings in
    2013: Should You File on March 15 or March 16 (or Both)?
    (Intellectual Property Owners Association) – Washington, DC

    February 20, 2013 – First to File: Final Rules and Guidance — Navigating
    Significant Changes to Derivation Practice, What Constitutes Prior Art and More
    (Strafford) – 1:00 – 2:30 pm (EST)

    February 20-22, 2013 – Intensive Patent Law Seminar (Chisum Patent Academy) – New York, NY

    February
    21, 2013 – When Trade Secrets Go Abroad:
    Strategies for Combating Trade Secret Misappropriation
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    February
    26-27, 2013 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

    February 27-28, 2013 – Life Sciences
    Collaborative Agreements and Acquisitions
    *** (American Conference
    Institute) – New
    York, NY

    March 5-6, 2013 – Medical Device
    Patents
    *** (American Conference
    Institute) – Chicago, IL

    March 7, 2013 – Implementing the New
    Priority Rules Under the AIA
    (Technology
    Transfer Tactics) – 1:00 – 2:00 pm
    (Eastern)

    March 10-13, 2013 – Genes & Diagnostics: A Myriad
    of Issues in Biotech IP
    (Cold
    Spring Harbor Laboratory) – Cold
    Spring Harbor Laboratory

    March 19-20, 2013 – FDA Boot Camp*** (American Conference
    Institute) – New York, NY

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

  • Cold Spring Harbor LaboratoryA special Cold
    Spring Harbor Laboratory conference on "Genes & Diagnostics: A Myriad
    of Issues in Biotech IP" will be held on March 10-13, 2013.  The conference will offer the following
    sessions:

    • Keynote address
    — "Reexamining the promise and perils of personalized medicine: Patents
    and beyond" — to be presented by Timothy Caulfield, Faculty of Law,
    University of Alberta
    • Patenting Genes
    & Diagnostics: The Judiciary's View
    • A Global
    Perspective on Patentable Subject Matter, Patentability, Validity, and
    Enforceability
    • Patenting &
    Biotechnology at Cold Spring Harbor Laboratory
    • Are Gene &
    Diagnostic Patents a Help or Hindrance to Industry?
    • The Impact of
    Prometheus on Personalized Medicine
    • Patenting Genes
    & Diagnostics: Policy and Ethics

    Optional
    pre-conference workshops on "IP 101" and "Biotechnology
    101" will be offered on March 10.

    The registration
    fee for the conference is $1,250 (no housing package) or $1,300 (no housing and
    one workshop).  Those interested in
    registering for the conference can do so here.

  • Technology
    Transfer Tactics will be offering a webinar entitled "Implementing the New
    Priority Rules Under the AIA" on March 7, 2013 from 1:00 – 2:00 pm
    (Eastern).  Charles R. Macedo of Amster,
    Rothstein and Ebenstein, LLP will discuss how to adjust filing strategies and
    procedures in view of the AIA's new prior art and priority rules.  The webinar will cover the following topics:


    Premises of old first to invent system, traditional first-to-file system, and
    new U.S. priority rule under AIA
        -
    Explanation of new rules
        -
    102(a) — What is prior art?
        -
    102(b) — Exceptions to prior art?
        -
    Transition

    Implications of new rules
        -
    Use of Provisionals
        -
    Use of Publications
        -
    Use of NDAs

    New PTO Procedures
        -
    Changes in PTO rules to address new requirements

    Recommended Procedures
        -
    Docketing Implications
        -
    Budgeting Implications
        -
    Revisions to NDAs
        -
    Revisions to Publication Policies

    The
    registration fee for the webinar is $197. 
    Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • By Kevin
    E. Noonan


    American Soybean Association (ASA)The "conventional
    wisdom" surrounding the Bowman v.
    Monsanto
    case now before the Supreme Court on certiorari is that it is "David v. Goliath," the
    salt-of-the-earth farmer versus the corporate monolith, and an example of the
    traditional commoditization of American values by purveyors of "Frankenfood"
    looking merely to maximize shareholder profit.  So it may come as a shock (to some) that a group of farmers and farmers'
    organizations have filed a brief in support of Monsanto.  These include the American Soybean
    Association, Illinois Soybean Association, Indiana Soybean Alliance, Iowa
    Soybean Association, Kansas Soybean Association, Kentucky Soybean Association,
    Michigan Soybean Association, Minnesota Soybean Growers Association,
    Mississippi Soybean Association, Missouri Soybean Association, Nebraska Soybean
    Association, North Dakota Soybean Growers Association, Ohio Soybean
    Association, Tennessee Soybean Association, Virginia Soybean Association,
    Wisconsin Soybean Association, National Corn Growers Association, National
    Association of Wheat Growers, American Sugarbeet Growers Association, and
    Growers For Biotechnology.  Maybe these
    farmers' groups know something other than what "everybody knows."

    The
    groups' bona fides are set forth in the Statement of Interest portion of the
    brief:

    American Soybean Association (ASA) is the
    national trade association representing U.S. soybean farmers on domestic and
    international issues of importance to the soybean industry.  ASA's advocacy and
    representational efforts are made possible through the voluntary membership of approximately 22,000 farmers in 31 states.  ASA represents the interests of 280,000
    American soybean farms
    .

    (emphasis added).

    The other
    soybean groups are aligned and support the ASA's position, not only on this
    brief but also in support of biotechnology in agriculture.  The other food grower groups (National Corn
    Growers Association, National Association of Wheat Growers, American Sugarbeet
    Growers Association, and the Growers for Biotechnology) represent their
    respective food growers.

    Their
    brief uniquely reviews the history of soybean production in America and states uncomfortable facts and inconvenient truths about how soybeans are
    actually produced and the role of agricultural biotechnology in food production.

    The
    brief identifies weeds (not patents) as "the most significant economic
    challenge to global food production" and that "[i]mprovements in weed
    management are critical to increasing crop yields."  Amici pierce the canard that biotechnology as
    applied to agriculture is unnecessary or deleterious, noting that "[a]lthough
    soybeans and other crops have been cultivated for centuries, advances in plant
    genetics were historically stifled by a lack of incentives to invest in new
    technologies and breeding techniques."  In contrast (according to the
    brief), "enormous progress" has been made since passage of the Plant
    Variety Protection Act in 1970 and "[g]enetic innovation in Soybeans"
    increased "like Jack's magical beanstalk" (i.e., exponentially) after the Supreme Court's decision in Diamond
    v. Chakrabarty.  This "prolific record in developing new
    crop varieties" depends on patent protection, amici contend, because without it "seed
    and biotechnology companies would not have undertaken the expensive and
    time-consuming research necessary to improve existing plant technology."  These assertions are supported by facts,
    including that:

    Since 1980, total domestic soybean production
    has increased 96% and yields per acre have increased 55%.  Soybean production
    has also become more environmentally friendly.  On a per bushel basis, the land
    needed to produce a bushel of soybeans declined by 35%, soil erosion decreased
    66%, irrigation water applied declined by 42%, fuel consumption decreased 42%,
    and greenhouse gas emissions declined by 41%.

    For at
    least these reasons, these amici contend that "[u]pholding
    the [Federal Circuit's] decision below will ensure that technological
    innovation in crop breeding and genetic traits continues unhindered, thereby
    leading to the development of more productive, manageable, and
    environmentally-sustainable varieties" while "permitting unrestricted
    replication of soybean biotechnology will have a wide variety of harmful
    effects on Amici, other farmers, and society as a whole."

    MonsantoThe brief then provides some
    historical context.  First, though, some
    statistics:  soybeans are grown on more than 280,000 farms encompassing 77
    million acres in 31 states (it is the "second most-planted field crop"
    in the country), with sales of $37 billion (18% of agricultural sales).  In addition to benefits of soybean sales in
    the U.S., soybean production is a major export crop, amounting to $21.5 billion in 2012
    (18% of all agricultural exports).  The
    effects of Monsanto's soybeans on the soybean economy are illustrated in the
    brief by noting that soybean exports increased from 882 million to 1.3 billion
    bushels since 1996 (when Roundup Ready® seeds
    were first introduced).

    The brief follows these statistics
    from today with a brief history of soybean cultivation and attempted
    improvements before and after Monsanto developed its Roundup Ready®
    seeds.  Early efforts were undertaken by
    the U.S. government, starting (paradoxically) with the Patent Office, which
    distributed seeds to U.S. farmers.  These
    "free seed" programs eventually came under the auspices of the U.S.
    Department of Agriculture and lasted until 1934.  One consequence of this government largess,
    according to amici, was that "[e]arly seed breeders had little incentive to make
    costly investments in developing more productive plants because the free seed
    program crowded private breeders from the marketplace."  These disincentives were exacerbated by the
    lack of patent protection, say amici, due in part to the inability to prevent farmers from saving
    seed for replanting.  As a result, the
    brief cites "little progress" being made to increase crop yields.

    Fortuitously, the exit of the
    government from seed distribution was accompanied by the development of hybrid
    corn, which "substantial[ly] increase[d] yields" and coincidentally
    investment was not impeded because hybrid corn could not be replanted.  While commercial development of hybrid corn
    thus did not depend on patent protection the same is not true for "self-pollinating"
    crops such as wheat and soybeans (and these crops were not capable of protection using
    alternative forms of intellectual property protection like trade secret).  And although the PVPA afforded some level of
    protection for plant breeders, exceptions that permitted seed saving provided
    "soybean breeders [with] little incentive to invest resources in
    developing new varieties."

    The combination of the Court's Chakrabarty decision in 1980 and J.E.M.
    Ag Supply v. Pioneer Hi-Bred Intern., Inc.
    ,
    534 U.S. 124, 131-32 (2001), provided these much-needed incentives.  "Breeders responded vigorously to these
    new assurances of intellectual property protection," say amici, supporting this assertion with
    the following statistics.  Agricultural
    genetic research spending increased from $146 million in 1979 to $305 million
    in 1982, by 1994 had risen to $634 million, and by 2010 amounted to $2
    billion.  The focus of most of this
    research has been on "seed and genetic trait development" and
    intellectual property protection (both under the PVPA and the Patent Act) "provided
    incentives for private seed developers and genetic researchers to create
    innovative and highly productive crop varieties and genetic traits."  Publically funded research, conversely, "leveled
    off in the 1970s and began to decrease by the mid-1990s."

    Roundup Ready SoybeansFar from being imposed on
    unwilling farmers, the brief explains that "[a]lthough Roundup Ready® seed
    is more expensive than conventional seed, soybean farmers readily adopted
    glyphosate-resistant technology because it simplified weed management"
    (recall that amici asserted earlier in their brief that weed management poses the greatest obstacle to
    successfully increasing crop yields).  The
    statistics again bear out these statements: 
    two years after Monsanto introduced their seed, 38% of farmers had
    adopted it, and this percentage rose to 54% by 2000 and to 93% by 2012.  These statistics illustrate not that farmers
    did not want to plant Roundup Ready® seed but precisely the opposite:  Monsanto's
    seed provided clear advantages that justified their increased cost.

    Now is not the time for this trend
    to be inhibited by reducing patent protection for agricultural biotechnology, amici argue.  While these improvements have been
    impressive, genetic engineering of crop plants is "a relatively new
    phenomenon" and there are other desirable traits (including "saturated
    fat and trans fat levels, increased Omega-3 levels, improved yields, and
    genetic resistance to insects and pervasive diseases") now being developed (by
    companies like Bayer, Pioneer, Dow, and Syngenta in addition to Monsanto).  The brief also notes that soybeans are "hardly
    the only crop benefitting from biotechnology research," mentioning several
    crop plants where genetic variants with traits including "resistance to
    drought, stress, and a wider spectrum of herbicides, with a higher nutritional
    content, and which more efficiently utilize nitrogen fertilizer" are in
    development.  Accordingly:

    There can be no doubt that if intellectual
    property protections remain in place, biotechnology will continue to play a
    substantial role in crop improvement.  These advances are largely premised upon
    the continuation of private research conducted by seed breeders.  Absent utility
    patent protection, little incentive will exist for biotechnology companies to
    conduct research.

    As in other briefs, the
    application of biotechnology to food crops also promotes "environmental
    sustainability," the brief asserts.  Lest there be any doubt, these amici remind the Court that "[s]ustainability
    is not merely a buzzword that receives lip service from the agricultural
    community" but is a necessity to enable demand for food to be met
    currently while "ensuring that food producers [will be able to] meet
    future food demands."  Between
    increased global population and decreased availability of arable land, "[f]eeding
    a growing world with dwindling resources requires the adoption of a
    comprehensive approach to ensure this daunting challenge can be met."  Conventional methods of food production not
    only cannot meet these needs but also involve other practices (such as "multiple
    passes of primary and secondary tillage" and "the use of a variety of
    herbicides to control weeds") that have their own environmentally
    deleterious effects.  The introduction of Monsanto's Roundup Ready®
    seed actually reduced excessive tillage practices and thus reduced soil
    erosion, water pollution caused by pesticide runoff and even greenhouse grass
    production (because reduced tillage entails reduced use of diesel fuel for
    tractors).  Finally, the active
    ingredient in Roundup®, glyphosate, is "'practically
    non-toxic by ingestion' and noncarcinogenic, making it safer for applicators
    seed," in contrast to alternative herbicides that "EPA
    estimates are 3.4 to 16.8 times more toxic to humans."

    This portion of this amicus brief concludes by discussing the
    "unorthodox practice" of replanting commodity seed.  While the reasons are multiple, the brief
    mentions protections against the spread of weeds from the commodity seed and
    regulations preventing grain elevators from certifying that their soybeans can
    be sold as seed (like the Indiana Seed Law and other "Federal and state
    laws and regulations").  As a
    result, imparting the Court's imprimatur to Farmer Bowman's actions and
    resulting "widespread adoption" of this scheme would "place elevators in the untenable position of serving as de facto state
    inquisitors regarding the intended uses of grain purchased by their customers."

    The brief then sets forth its
    argument for affirmance, these arguments being consistent with other amici and Monsanto in arguing that
    Farmer Bowman's replanting amounted to unauthorized reconstruction of a
    patented article and that Monsanto's patent rights were not exhausted with
    regard to the replanted seed.

    The brief ends with the following:

    In 1836, the State Department instituted the
    free seed distribution program to obtain the best seed technology for America's
    farmers in order to produce food for the nation.  The free seed program was
    terminated because seed technology was not keeping pace with society's demands.  During 2012, the State Department re-affirmed its support of agricultural
    biotechnology as a way to produce the food needed by a growing world
    population.  In order to meet this challenge, "more food will need to be
    produced in the next 50 years than has been produced during the last 10,000
    years combined."  Agricultural biotechnology is a "proven means of
    building global food stores."  Little incentive exists for innovation
    unless seed research and development is afforded intellectual property
    protection.  Soybean, corn, wheat and sugar beet farmers can help achieve these
    goals, but will require access to continued improvements in seed technology.

    Amici
    provide a unique perspective based on the experience of real farmers and their
    organizations concerned with the future of American agriculture.  With luck, the Supreme Court will be
    listening.

    For additional information regarding this topic, please see:

    • "BayhDol25 Files Amicus Brief in Bowman v. Monsanto," January 30, 2013
    • "
    Government Sticks to Its Guns in Bowman v. Monsanto Amicus Brief," January 28, 2013
    • "IPO Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," January 24, 2013

  • "Happy families are
    all alike; every unhappy family is unhappy in its own way."  Leo Tolstoy, Anna Karenina

    By Kevin E. Noonan

    A
    great many amicus briefs have been filed in support of affirmance of the
    Federal Circuit's decision in Bowman v. Monsanto and many of them are
    reminiscent of Tolstoy's happy families.  Accordingly, in reviewing these briefs, these posts will endeavor to
    identify unique aspects or arguments raised by amici, to avoid dulling
    the impact of the relevant arguments relating to patent exhaustion, the
    repair/reconstruction doctrine, and other robust grounds for affirmance.

    BayhDole25BayhDole25, Inc. is, according to the brief's Statement of Interest, a private,
    non-profit, non-governmental organization dedicated to "increase[ing]
    awareness of the importance of Bayh-Dole for enabling an environment for
    commercialization and assimilation of new technologies for the creation of
    economic and social benefit."  The BayhDole25 brief is directed to two aspects of the case:  the contractual limitations of
    the Technology Agreement and their violation by Farmer Bowman, with its
    implications; and the importance of patenting for agricultural innovation.

    Regarding the first argument, BayhDole25 argues that the Court should give "great weight" to the contractual
    aspects of case, including not only the Technology Agreement but also the role
    of grain elevators and commodity seed in the agricultural economy.  The brief explains why the Technology
    Agreement did not expressly bar Farmer Bowman's activities — based on what
    commodity grain elevators historically do, including:

    • Direct use as feed for livestock,
    • Milling or other processing for industrial or food products, and
    • Shipment
    to markets, including possible export to world markets.

    "With this
    backdrop, it becomes clear that barring commercial sale of the soybean crop to
    grain elevators would be impracticable and would impose unreasonable added
    transaction fees and logistical burdens onto farmers."  Thus, the brief argues that the economic
    arrangements protected by contract were insufficient to prevent Farmer Bowman's
    activities and that patent protection was necessary.

    Turning to Farmer Bowman's actions, the
    brief argues that this was an "intentional strategy" employed "each
    year" as a way to permit Farmer Bowman to replant saved seed — something
    that is an "atypical and unconventional" use of grain elevators that "should
    be viewed as extraordinary and unexpected."  BayhDole25 asserts that
    Farmer Bowman "laundered" his saved seed through the grain elevator, "delivering
    his soybean crop on one end of the grain elevator and for all intents and
    purposes re-purchasing the same or similar soybeans on the other end for
    planting."  Characterizing this use
    of the grain elevator as raising a "strawman," the brief states that
    it is "disingenuous" for Farmer Bowman to argue that this activity "complied
    with his contractual obligations under the Technology Agreement as written."

    MonsantoAnd with regard to the "self-replicating"
    technology aspect of the Question Presented, the brief notes the multiplicity
    of other uses for soybeans — including "crop
    breeding, R&D, generation of herbicide registration data, and seed
    production" (not to mention animal feed, human food, and other uses such as
    in biofuels) put the lie to these allegations.  In view of this evidence, the brief "excuses" (albeit tongue
    in check) Farmer Bowman's rhetorical excess regarding this characterization of
    soybeans as "self-replicating," quoting Abraham Maslow that "if the only tool you have is a hammer, to treat everything as if it were a
    nail."  The Psychology of Science: A Reconnaissance 1966.

    BayhDole25's second argument,
    regarding the importance of effective patent protection for agriculture, reminds
    the Court that while this case may be one of "David vs. Goliath,"
    should the Court reverse the Federal Circuit, this precedent in favor of Farmer
    Bowman "would apply to any and all innovators, fundamentally altering the
    existing business model for agricultural biotechnology — substantially curtailing
    return on investment with profound adverse consequences for global development."  And the brief provides perspective:

    In this broader context, for every
    commercial farmer like Petitioner in the U.S. claiming harm from payment for
    continued access to advanced seed technologies — where the eight fields at issue
    in this case alone total 399 acres — there may be tens of thousands of
    subsistence farmers in developing countries operating on a few hectares or
    less, and relying on continued transfer of technology from innovative private
    agricultural companies to meet agricultural challenges in the 21st century.  In
    the grander scheme of global agriculture, Petitioner is a Goliath.

    The benefits of biotechnology for agriculture
    set forth in the brief include "increased agricultural productivity,
    greater efficiencies in water usage and reduced need for chemical fertilizers
    and/or crop protection products."  Also noted is that, before the biotechnology era in agriculture, most innovation
    in agricultural methods was funded by governments and universities that created
    a "global commons" of intellectual property.  Private funding, requiring "investment
    of intensive resources over a long time-period, development of large genetic
    databases and validation through field-testing" has "led to a
    fundamental realignment, "with the private sector now investing
    significantly more than the public sector in biotechnology R&D."  (The brief argues that this is a positive
    outcome, in view of the advances in agriculture over the resulting time
    period.)  The brief notes that the agricultural biotechnology environment
    in Europe is "adverse," with consequently leadership by the U.S., which "has
    become the engine for innovation and transfer of technology to partners in the
    developing world."

    The brief ends with further relating
    the efforts of those, like Farmer Bowman, who attempt to avoid paying patent
    licensing fees and royalties:

    Compensation paid by Petitioner and
    other American farmers to license advanced agricultural technologies like
    Roundup Ready® soybeans, accordingly, are an important part of the social contract
    supporting continued technology transfer needed for productivity gains and
    poverty reduction efforts in developing countries around the world.  Petitioner's
    and other similarly situated parties refusal to compensate Respondents for
    continued use of the Roundup Ready® technology would upset the carefully
    constructed balance of benefits fueling technology transfer globally,
    potentially reversing hard-won gains of subsistence farmers in the developing world
    and elsewhere.

    In a word, perspective.

    For additional information regarding this topic, please see:

    • "Government Sticks to Its Guns in Bowman v. Monsanto Amicus Brief," January 28, 2013
    • "IPO Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," January 24, 2013

  • By Michael Greenfield

    AllerganThose of you who dabble with chemical structures
    while prosecuting or litigating pharmaceutical patents may find Allergan v. Barr Laboratories, Inc.,
    interesting.  In this ANDA litigation
    brought by Allergan against Barr, Teva, and Sandoz ("Barr"), the
    Federal Circuit opined on issues of claim construction and obviousness with
    respect to Allergan's Lumigan®, an ophthalmic solution used to treat high
    eye pressure in people with open-angle glaucoma or ocular hypertension.  The
    active ingredient in Lumigan® is bimatoprost (cyclopentane N-ethyl
    heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5-dihydroxy,
    [1α,2β,3α,5α]):

    FIG1
    (The ethyl amide moiety in the red square is where
    all the action was focused in the case.)  Allergan asserted claim 10 of U.S. Patent No. 5,688,819 ("the '819 patent"), which recited a method of treating
    ocular hypertension or glaucoma with a compound selected from a Marksuh group
    of five compounds listed by their chemical name.  Bimatoprost was one of them.

    Claim Constructions

    Barr had argued that bimatoprost did not fall within the scope of
    claim 5, from which claim 10 ultimately depended.  Claim 5 recited a method of
    treating ocular hypertension or glaucoma using a compound of formula

    FIG2
    where Z can be =O and X can be –N(R4)2,
    "wherein R4 is selected from the group consisting of hydrogen,
    a lower alkyl radical having from one to six carbon atoms . . . ."  The issue was
    framed as whether claim 5 encompassed compounds in which the two R4
    moieties of "-N(R4)2" must be identical or
    could differ (as required by bimatoprost, where one R4 moiety must
    be hydrogen and the other C2-alkyl).  Both the District Court and the
    Federal Circuit held that claim 5 encompassed compounds in which the R4
    moieties were non-identical.

    Barr PharmaceuticalsBarr argued that the plain meaning of "-N(R4)2"
    required identical R4 moieties, relying on extrinsic evidence such
    as, for example, expert testimony that "[t]he (X)y nomenclature"
    was "commonly used" to represent identical substituents.  The Federal
    Circuit was unpersuaded, relying heavily on Phillips
    v. AWH Corp
    .
    for the proposition that claim terms are to be given the
    meaning as one of ordinary skill in the art would understand them in the
    context of how they are used in the patent at issue and concluding, "[t]he
    inventor's lexicography governs when the specification reveals a special
    definition given to a claim term by the patentee that differs from the meaning
    it would otherwise possess."

    In arriving at the conclusion that "-N(R4)2"
    encompassed compounds in which the R4 moieties were non-identical,
    the Court pointed to the fact that of the five compounds recited in claim 10
    (which, you'll remember, depended from claim 5), three (including bimatoprost)
    possessed an "-N(R4)2" moiety having
    non-identical R4 moieties.  The Court also noted that same
    relationship between claim 18 (which recited the same three compounds) and
    claim 11 (which recited a method of treating other diseases using compounds
    defined in the same manner as claim 5.  (It's of some interest to note that the
    specification used the exact same language at issue in the claims.)  And,
    finally, the Court noted that the specification disclosed the same three
    compounds as useful in the pharmaceutical compositions and methods of the
    invention.  The Court held that in this context the patent clearly manifested that
    "-N(R4)2" encompassed compounds with non-identical
    R4 moieties.

    Practice tip:  Save yourself a lot of heartache and
    your client a lot of money, and in these situations define R4 more
    clearly, such as, "each R4 is independently selected from . . . ."

    Obviousness

    The Federal Circuit next considered the Barr's
    assertion that claim 10 (the method of treating glaucoma using one of bimatoprost or
    four other compounds) was obvious, first (a) dismissing the credibility of the defendants'
    expert, who was described as being "eviscerated" (ouch!) on cross
    examination and whose testimony was "flawed on a fundamental level"
    and (b) determining that the nature of the involved technology did not lend
    itself to lay interpretation, but required expert testimony.  This appears to
    have left Barr in the position of having to rely on the plaintiff's experts, an
    uncomfortable position, one imagines, at best.  As explained below, and not
    surprisingly, the defendants were unable to extract the support they needed to
    carry their burden of proving the claim obvious.

    Barr asserted that bimatroprost was obvious over the
    isopropyl ester analog of compound 2 of Stjernschantz (WO 90/02253 [sic, WO
    90/02553
    ]),

    FIG3
    which was disclosed as useful for treating the very
    same conditions as bimatoprost.  The defendants argued that the plaintiff's
    expert testimony supported three facts necessary to establish obviousness:

    (1)    Stjernschantz taught that bimatoprost-free
    acid lowered intraocular pressure;
    (2)    Stjernschantz's
    compound 2 hydrolyzed into bimatoprost-free acid when placed in the eye; and
    (3)    a
    skilled artisan would have known that substituting an amide for the ester at
    the C-1 position would result in a prodrug that hydrolyzed into
    bimatoprost-free acid in the eye.

    In not so many words, the Federal Circuit held, "close,
    but no cigar," finding that although Allergan's expert testimony supported
    the first two points, the testimony in fact contradicted the third point.  Allergan's expert testified that an amide (such as found in bimatoprost) converts
    into a carboxylic acid at such a low rate ("500-year half life" of an
    amide in water) that one of ordinary skill in the art would not have considered
    it as a prodrug.  With Barr left empty-handed expert-wise, Allergan's expert
    opinion prevailed, and the Federal Circuit upheld the District Court's finding that
    claim 10 was not invalid as obvious.

    Allergan,
    Inc. v. Barr Laboratories, Inc.
    (Fed. Cir. 2013)

    Panel: Chief Judge Rader and Circuit Judges Bryson
    and Wallach
    Opinion by Circuit Judge Wallach

  • By Kevin E. Noonan

    Department of Justice (DOJ) SealOver the past decade, the Supreme Court's
    increased interest in patent law cases was paralleled by briefs from the
    Solicitor General advising the Court to grant certiorari.  The apparent
    influence of the government has waned in recent years, beginning with the Court's
    grant of certiorari in Laboratory Corp. v.
    Metabolite Labs., Inc.
    ("LabCorp")
    against the SG's advice, and accelerating during the Obama Administration where
    the Court has expressly rejected the government's position (Stanford v. Roche; Mayo v. Prometheus).  Most recently,
    the Court also ignored the SG's opinion not to grant certiorari in Bowman v
    Monsanto
    (see "Solicitor General Recommends the Supreme Court Deny Cert in Bowman v. Monsanto").  Regardless, the government
    has filed an amicus brief, at the
    Court's invitation, that reiterates many of the arguments the government urged
    in its CVSG brief.

    The amicus
    brief is endorsed by both the Department of Justice and the U.S. Patent and
    Trademark Office (in marked contrast to the government's ill-considered amicus briefs to the Federal Circuit in AMP v. Myriad).  Indeed, in its Statement of Interest, the
    brief asserts that the government's interest is the PTO's interest, due to its
    role of "issuing patents and advising the President on
    issues of patent policy."  The brief characterizes the Question
    Presented as:

    Whether
    the authorized sale of one generation of a patented plant seed exhausts a
    patentee's right to control subsequent generations of that seed.

    Which modifies Farmer Bowman's Question,
    which begged the question it purportedly asked (see "Supreme Court Grants Certiorari in Monsanto v. Bowman").  The government's brief makes four arguments:

    • Monsanto's patent right to "make"
    recombinant, Roundup-Ready® soybeans was not exhausted in sales of
    commodity seed
    • Statutory (the Plant Variety Protection
    Act) and judicial (J.E.M.
    Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc.
    ,
    534 U.S. 124 (2001)) authority supports the argument that
    Monsanto's rights were not exhausted
    • Farmer Bowman's additional arguments "are
    not persuasive" and can be summarily addressed (and rejected)
    • While the
    Federal Circuit's "conditioned sales" doctrine is inconsistent with the
    Court's decision in Quanta Computer, Inc.
    v. LG Elecs., Inc.
    ,
    553 U.S. 617, 625-28 (2008), the appellate court did
    not base its decision here on the discredited doctrine.

    The brief's first argument urges that
    affirming the Federal Circuit is consistent with, not contradictory to, the
    Court's patent exhaustion doctrines.  Citing a multitude of cases from the 19th and 20th
    Centuries, as well as Quanta, the brief repeatedly emphasizes that the Court
    should consider that exhaustion is limited to sale of a particular article ("that article") and does not extend
    to making an additional article.  Specifically,
    the brief cites United States v.
    Univis Lens Co.
    , 316 U. S. 241 (1942) (the
    intellectual forebear of the Court's Quanta
    decision) in support of its position:

    As
    the Court explained in Univis, "the purpose of the patent law is fulfilled with
    respect to any particular article
    when the patentee has received his reward for the use of his invention by the
    sale of the article," and "once that purpose is realized the patent law affords
    no basis for restraining the use and enjoyment of the thing sold."

    316 U.S. at 251 (emphases added).

    MonsantoCiting the Court's "repair/reconstruction"
    dichotomy, the brief asserts that the relevant precedent requires that "[a]
    patentee 'cannot prevent those to whom he sells from . . . reconditioning
    articles worn by use,' but it can prevent them from 'in fact mak[ing] a new
    article,'" citing Aro Mfg. Co. v. Convertible
    Top Replacement Co.,
    365 U.S. 336,343 (1961), and other authorities including Wilbur-Ellis
    Co. v. Kuther
    , 377 U.S. 422, 424 (1964); Cotton-Tie Co. v. Simmons, 106 U.S. 89, 93-94 (1882); Wilson v. Simpson, 50 U.S. (9 How.) 109,
    123-125 (1850); Jazz Photo Corp. v.
    International Trade Comm'n
    , 264 F.3d 1094, 1102 (Fed. Cir. 2001), cert.
    denied, 536 U.S. 950 (2002); and United
    States v. Aluminum Co. of Am
    ., 148 F.2d 416, 425 (2d Cir. 1945)).  Based on these authorities, the brief states
    that "the authorized sale of first-generation soybean seed exhausts
    the patentee's rights to control the use and disposition of that seed" and none other.

    This conclusion is reinforced,
    according to the brief, by decisions by the Court and Congress evincing
    intentions contrary to Farmer Bowman's position.  Congressional intent in this regard is
    illustrated by the Plant Variety Protection Act (PVPA), Pub. L. No. 91-577, 84
    Stat. 1542 (7 U.S.C. § 2321 et seq.),
    and specifically those provisions of the Act that permit (limited) seed-saving
    and replanting of saved seed.  As the
    Court recognized in J.E.M. AG Supply,
    the PVPA differs from the Patent Act in providing that:

    [I]t shall not infringe any right [under the PVPA] for a person to save
    seed produced by the person from seed obtained, or descended from seed
    obtained, by authority of the owner of the variety for seeding purposes and use
    such saved seed in the production of a crop for use on the farm of the person,
    or for sale as provided in this section.

    7 U.S.C. §§ 2543 and 2544.

    The Court in J.E.M.
    AG Supply
    recognized that plants are entitled to utility patent protection
    and that the "seed-saving" provisions of the PVPA were not included
    in the Patent Act, thus creating infringement liability under 35 US.C. § 271 for patented seed that did not arise for seed
    protected under the PVPA.  534 U.S. at 143.  But even these rights under the PVPA are not unlimited, being restricted
    to "sales only 'for other than reproductive purposes,' i.e., for purposes
    other than replanting," citing 7 U.S.C. § 2543; and Asgrow Seed Co. v. Winterboer, 513 U.S. 179, 184 n.2 (1995).  This precedent supports the government's view
    that Farmer Bowman's infringing activities were not absolved by patent
    exhaustion.

    The brief also notes Congressional intent by the
    absence of legislation, contrasting the instant case with software copyright,
    where Congress has created an
    exemption for copying.  Specifically, the
    brief references the "essential step defense" which provides that "it
    is not an infringement for the owner of a copy of a computer program to make or
    authorize the making of another copy or adaption of that computer program"
    as specified.  17 U.S.C. § 117(a)).  Congress clearly understands that there are
    circumstances where it should act to prevent overreaching of exclusive rights
    under the Copyright and Patent Clause, and notes that the Court has recognized
    the primacy of the role of Congress in making these policy decisions, citing Microsoft Corp. v. AT&T Corp., 550
    U.S. 437, 458-459 (2007), and Diamond v.
    Chakrabarty
    , 447 U.S. 303, 305, 318 (1980).

    The government includes in this section of the
    brief the potential for a contrary decision by the Court for consequences "not
    limited to genetically modified crops," including "enforcement of
    patents for man-made cell lines, DNA molecules, some nanotechnologies, and
    other technologies that involve self-replicating features."  These consequences would be visited on the numerous
    companies [that] have marketed patented recombinant plasmids and transformed
    cell lines capable of replication with limited human intervention"
    rendered patentable under the Court's Chakrabarty decision.  "These patents would lose much of their
    value if purchasers of patented bacteria or other self-replicating products
    could reproduce and sell those items free from the restraints of patent law,"
    according to the government.  Finally,
    the brief rejects Farmer Bowman's argument that contractual remedies are
    sufficient, because "[c]ontractual remedies are ineffective against
    downstream purchasers not in privity with the patent holder. . . [a]nd patent
    law provides remedies unavailable under contract law, including injunctive
    relief and enhanced damages," citing 35 U.S.C. §§ 283-285.

    The brief summarily dismisses Farmer
    Bowman's other arguments.  This includes
    Bowman's "fundamental misunderstanding" of Quanta, which the government argues is an attempt to graft Quanta's principles of patent exhaustion
    to method claims onto composition of matter claims (the Court's analysis in
    Quanta "is not easily applied to patents on "manufacture[s]"
    or "composition[s] of matter").  The brief further argues that "[n]othing in [the] Quanta [decision] casts doubt on the
    proposition that ". . . the general rule [of
    patent exhaustion] has always been subject to an important qualification:  even
    the lawful owner of a patented article may not, without authorization, use it
    to make a new copy of the patented article."  Second, the brief argues that planting is not
    the "only reasonable and intended use" of the commodity soybeans at
    issue here and thus this case can be distinguished from the Court's concerns in
    Quanta.

    Turning to Farmer Bowman's argument that replanting
    seed and recreating soybeans is not reconstruction of the patentees article,
    the brief states that while this statement is true it is "irrelevant"
    because "[u]nauthorized reconstruction is an act of infringement because
    it implicates a patent holder's exclusive right to "make" the
    patented invention," citing Wilbur-Ellis,
    377 U.S. at 424.  Contrary to Farmer
    Bowman's argument, the Court's "reconstruction" cases are relevant to
    the issue before the Court because those cases "exemplif[y] a critical
    qualification to the exhaustion doctrine — that, absent an express or implied
    license, the authorized sale of an article embodying a patented invention does
    not give the purchaser the right to make a new patented article."  The brief similarly dismisses Farmer Bowman's
    reliance on Deepsouth Packing Co. v.
    Laitram Corp
    ., 406 U.S. 518 (1972), because that case (standing for an  "unremarkable proposition") absolves
    from infringement someone who makes fewer than all the claimed elements of a
    claimed invention, whereas here Farmer Bowman's "activities culminated,
    and were intended to culminate, in the creation of the final patented product
    in the United States."

    (In an illuminating footnote, the brief addresses amici arguments regarding "unintentional"
    infringement by "organic" farmers and others, stating "[t]he
    speculative possibility that respondent could sue a truly inadvertent infringer
    for patent infringement provides no sound basis for a wholesale expansion of
    the patent-exhaustion doctrine to include the deliberate unauthorized 'mak[ing]'
    of self-replicating technologies.")

    Finally in this section of the brief the government
    responds to Farmer Bowman's various arguments relating to the distinction
    between "use" and "make" in § 271(a).  The
    brief cites provisions of the Copyright Act relating to the exclusive right of
    copyright holders to "reproduce" copyrighted works, 17 U.S.C. § 106(1), and rejects Farmer Bowman's argument that
    affirming the Federal Circuit would vitiate statutory provisions relating to "indirect"
    infringement.  The brief states that "petitioner
    appears to equate the dictionary definition of "make" with a but-for
    causation standard for direct infringement, under which any person who performs
    an act that ultimately leads to the creation of a patented invention 'makes'
    that invention.  Petitioner fails to recognize that cases of direct infringement — unlike
    indirect infringement — do not require the intervening act of another person."

    The brief in its last section turns to the Federal
    Circuit's "conditional sale" doctrine, agreeing with Farmer Bowman
    that the Supreme Court's Quanta decision discredited the line of cases,
    starting with Mallinckrodt, Inc. v.
    Medipart, Inc.
    ,
    976 F.2d 976 F.2d 700, 706-08 (1992), that followed this
    reasoning.  The government's brief does
    note, however, that the Quanta decision did not "explicitly overrule"
    these cases, just that the Court's decision "repeatedly describe[d] the
    patent-exhaustion doctrine in terms that leave little room for enforcement
    through patent law of post-sale restrictions on use or resale."  Regardless, because the Federal Circuit did
    not base its decision on the conditioned sale doctrine, the vitality vel non of that doctrine was neither
    dispositive nor at issue here.

    For additional information regarding this topic, please see:

    • "IPO Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," January 24, 2013

  • By Sherri Oslick

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

    Hoffmann-La
    Roche Inc. et al. v. Aurobindo Pharma Ltd. et al.

    1:13-cv-00124;
    filed January 22, 2013 in the District Court of Delaware

    • Plaintiffs: 
    Hoffmann-La Roche Inc.; Genentech Inc.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

    Infringement
    of U.S. Patent Nos. 7,718,634 ("Method of Treatment Using Bisphosphonic
    Acid," issued May 18, 2010), 7,410,957 (same title, issued August 12,
    2008), and 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic
    Acid or Salt Thereof," issued September 25, 2001) following a Paragraph IV
    certification as part of Aurobindo's filing of an ANDA to manufacture a generic
    version of Roche's Boniva® (150 mg once-monthly tablets) (ibandronate sodium,
    used to treat post-menopausal osteoporosis). 
    View the complaint here.


    Cadence
    Pharmaceuticals, Inc. et al. v. Fresenius Kabi USA, LLC

    1:13-cv-00453;
    filed January 18, 2013 in the Northern District of Illinois

    • Plaintiffs: 
    Cadence Pharmaceuticals, Inc.; SCR Pharmatop
    • Defendant: 
    Fresenius Kabi USA, LLC

    Infringement
    of U.S. Patent Nos. 6,028,222 ("Stable Liquid Paracetamol Compositions,
    and Method for Preparing the Same," issued February 22, 2000) and
    6,992,218 ("Method for Obtaining Aqueous Formulations of
    Oxidation-Sensitive Active Principles," issued January 31, 2006), both
    licensed to Cadence, following a Paragraph IV certification as part of
    Fresenius' filing of an ANDA to manufacture a generic version of Cadence's
    Ofirmev® (acetaminophen injection, used for the management of mild to moderate
    pain, the management of moderate to severe pain with adjunctive opioid
    analgesics, and the reduction of fevers). 
    View the complaint here.


    Jazz
    Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC

    2:13-cv-00391;
    filed January 18, 2013 in the District Court of New Jersey

    Infringement
    of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable
    Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,"
    issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004),
    7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued
    December 14, 2010), 7,895,059 ("Sensitive Drug Distribution System and
    Method" issued February 22, 2011), 8,263,650 ("Microbiologically
    Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of
    Narcolepsy,"  issued September 11,
    2012), 8,324,275 (same title,  issued
    December 4, 2012) following a Paragraph IV certification as part of Amneal's
    filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium
    oxybate, used to treat narcolepsy).  View
    the complaint here.


    Endo
    Pharmaceuticals Inc. et al. v. IMPAX Laboratories, Inc.

    1:13-cv-00435;
    filed January 18, 2013 in the Southern District of New York

    • Plaintiffs: 
    Endo Pharmaceuticals Inc.; Grunenthal GmbH
    • Defendant: 
    IMPAX Laboratories, Inc.

    Endo
    Pharmaceuticals Inc. et al. v. Actavis Inc. et al.

    1:13-cv-00436;
    filed January 18, 2013 in the Southern District of New York

    • Plaintiffs: 
    Endo Pharmaceuticals Inc.; Grunenthal GmbH
    • Defendant: 
    Actavis Inc.; Actavis South Atlantic LLC; Watson Pharmaceuticals, Inc.

    The
    complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,114,383 ("Abuse-Proofed
    Dosage Form," issued February 14, 2012), 8,192,722 (same title, issued
    June 5, 2012), 8,309,060 (same title, issued November 13, 2012), 7,851,482 ("Method
    for Making Analgesics," issued December 14, 2010), 8,309,122 ("Oxymorphone
    Controlled Release Formulations," issued November 13, 2012), and 8,329,216
    (same title, issued December 11, 2012) following a Paragraph IV certification
    as part of Impax's filing of an ANDA to manufacture a generic version of Endo's
    Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in
    patients requiring continuous, around-the-clock opioid treatment for an
    extended period of time).  View the Impax complaint here.


    Horizon
    Pharma Inc. et al. v. Par Pharmaceutical Companies, Inc. et al.

    1:13-cv-00102;
    filed January 17, 2013 in the District Court of Delaware

    • Plaintiffs: 
    Horizon Pharma Inc.; Horizon Pharma USA Inc.
    • Defendants: 
    Par Pharmaceutical Companies, Inc.; Par Pharmaceutical Inc.

    Infringement
    of U.S. Patent Nos. 8,309,127 ("Stable Compositions of Famotidine and
    Ibuprofen," issued November 13, 2012) and 8,318,202 (same title, issued
    November 27, 2012) following a Paragraph IV certification as part of Par's
    filing of an ANDA to manufacture a generic version of Horizon's Duexis ®
    (famotidine and ibuprofen, used for the relief of signs and symptoms of
    rheumatoid arthritis and osteoarthritis and to decrease the risk of developing
    upper gastrointestinal ulcers).  View the
    complaint here.


    Emotional
    Brain B.V. v. Kappos

    1:13-cv-00076;
    filed January 17, 2013 in the Eastern District of Virginia

    Review and
    correction of the patent term adjustment calculation made by the U.S. Patent
    and Trademark Office for U.S. Patent No. 8,227,453 ("Pharmaceutical
    Formulations and Uses Thereof in the Treatment of Female Sexual Dysfunction,"
    issued July 24, 2012).  View the
    complaint here.

  • Calendar

    January 27, 2013 – Canadian
    IP Law Update — Practical Tips and Information for U.S. Attorneys
    (Smart & Biggar) – Minneapolis, MN

    January 29, 2013 – Combined Customer Partnership Meeting
    of TC3700 and TC1600
    (U.S. Patent and Trademark Office) – Alexandria, VA

    January
    29-30, 2013 – Biotech & Pharma Patent Litigation*** (C5) – Amsterdam, Netherlands

    February
    4-5, 2013 – Naples Midwinter Patent Law Experts Conference (Akron University Law School) – Naples, FL

    February 5, 2013 – Single Claim Restriction Requirements: 
The Interplay Between 35 USC
    Section 112 and 35 USC Section 121
    (American Bar
    Association) – 12:00
    – 1:30 pm (Eastern)

    February 13, 2013 – Corporate Intellectual
    Property Law Conference
    (Law Bulletin
    Publishing Company) – Chicago, IL

    February 14, 2013 – Last Chance! The Top Ten Things
    In-House Counsel Need to Do to Prepare for The AIA’s March 2013 Deadline
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CST)

    February 20, 2013 – AIA Strategy Considerations for Patent Filings in
    2013: Should You File on March 15 or March 16 (or Both)?
    (Intellectual Property Owners Association) – Washington, DC

    February 20, 2013 – First to File: Final Rules and Guidance — Navigating
    Significant Changes to Derivation Practice, What Constitutes Prior Art and More
    (Strafford) – 1:00 – 2:30 pm (EST)

    February 20-22, 2013 – Intensive Patent Law Seminar (Chisum Patent Academy) – New York, NY

    February
    21, 2013 – When Trade Secrets Go Abroad:
    Strategies for Combating Trade Secret Misappropriation
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    February
    26-27, 2013 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

    February 27-28, 2013 – Life Sciences
    Collaborative Agreements and Acquisitions
    *** (American Conference
    Institute) – New
    York, NY

    March 5-6, 2013 – Medical Device
    Patents
    *** (American Conference
    Institute) – Chicago, IL

    March 19-20, 2013 – FDA Boot Camp*** (American Conference
    Institute) – New York, NY

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

  • Strafford #1Strafford will be offering a webinar/teleconference
    entitled "First to File: Final Rules and Guidance — Navigating
    Significant Changes to Derivation Practice, What Constitutes Prior Art and More"
    on February 20, 2013 from 1:00 – 2:30 pm (EST). 
    Stephen G. Kunin of Oblon, Spivak, McClelland, Maier & Neustadt LLP
    and Brad D. Pedersen of Patterson Thuente Christensen Pedersen, P.A. will
    provide guidance for counsel to IP owners and inventors on the first-to-file
    system under the new America Invents Law, and in particular explain what
    constitutes prior art and outline considerations for the new derivation
    practice.  The webinar will review the
    following questions:


    How do the USPTO final rules differ from the proposed rules?

    What constitutes prior art under the new first-to-file system?

    How will the new first-to-file system under Section 102 work under the AIA?

    The
    registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the
    webinar, can do so here.