• SkiingLaw Education Institute, Inc. (LEI) will be holding the 30th
    Annual National CLE Conference on January 2-5, 2013 in Snowmass, Colorado.  The Intellectual Property program of the
    conference will offer presentations on a number of topics, including:

    • Keynote Address: Adjudicating Intellectual Property Disputes in
    the Digital Age — Honorable Margaret McKeown, U.S. Court of Appeals for the
    Ninth Circuit
    • The America Invents Act — What You Need to Know Now
    • Were you Willful? — The Changing Landscape for Induced and
    Willful Infringement
    • Patent-Eligible Subject Matter — The
    State of the Union
    • Hot Topics in Patent Licensing
    • Objective Considerations of Non-Obviousness
    • Damages and Remedies in Patent Litigation
    • The Top Ten Patent Cases of 2012 Revealed (plus Predictions for
    2013)
    • What’s Keeping Corporate Counsel Awake at Night
    • A Dialogue Between Bench and Bar — panel to include the
    Honorable Kathleen M. O’Malley, U.S. Court of Appeals for the Federal Circuit,
    and the Honorable Ronald M. Whyte, U.S. District Court for the Northern
    District of California

    Law Education Institute (LEI)An agenda and list of speakers for the Intellectual Property
    program of the conference can be found here.

    The registration fee for the conference is $745.  Those interested in registering for the
    conference can do so by calling 888-860-2531, by faxing a registration form
    to 303-860-0624, or online here.  Information about lodging and skiing can be
    found here.

  • By Donald Zuhn

    USPTO SealLast week, the U.S. Patent
    and Trademark Office published a notice in the Federal Register (77 Fed. Reg.
    72830
    ) seeking
    public feedback on Request for Continued Examination (RCE) practice.  The notice indicates that the Office
    currently has a backlog of more than 90,000 applications that have not been
    examined since an RCE was filed, and states that this backlog diverts Office
    resources from the examination of new applications.  While the Office notes that several programs
    have been implemented to reduce the need to file an RCE, and thereby reduce the
    RCE backlog, the Office is now turning to its stakeholders "in an effort
    to better understand the full spectrum of factors that impact the decision to
    file an RCE."  The Office plans to
    use the information it gathers to design additional programs and initiatives
    aimed at reducing RCE filings and the RCE backlog.

    The
    Office describes some of its efforts to reduce the RCE backlog in the notice,
    pointing to the Quick Path Information Disclosure Statement (QPIDS) pilot
    program and the After Final Consideration Pilot (AFCP) as two examples (see
    "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot
    Program
    ";
    "USPTO to Assess After Final Consideration Pilot Program";
    and "USPTO News Briefs,"
    June 21, 2012).  The notice does not, however, discuss the Office's efforts to decrease RCE filings by raising the cost of
    filing a first RCE to $1,200 (from the current fee of $930), and further raise
    the cost of filing subsequent RCEs to $1,700 (see "More on USPTO's
    Proposed New Fees – Part II
    "),
    a proposal that the Patent Public Advisory Committee (PPAC) has called
    "illogical" (see "PPAC Issues Report on USPTO Patent Fees
    Proposal
    ").  On the topic of RCE filings, PPAC has
    previously explained that:

    [A]pplicants rely on RCEs to continue the
    prosecution and eventually (and justly) receive a patent on their
    invention.  RCEs are mostly filed by applicants genuinely attempting to
    move prosecution forward and get a patent and not generally, it is believed,
    simply to delay the prosecution (applicants have the ability to file further
    continuation applications to proceed with other claim sets or to keep a
    particular patent family in prosecution in any case).  RCEs are a source
    of frustration for both the Office and the applicants, with both parties
    contributing to the problem.  However, from both casual conversation and
    also in public statements, the USPTO seems to place the blame for the rapid
    growth in RCE applications solely and squarely on applicants.  The change
    several years ago to move RCEs to the special new case docket (rather than an
    examiner’s amended docket) causes (as one would expect) significant delays in
    acting on RCEs.  That the Office has proposed significant increases in the
    RCE fees adds salt to an existing wound:  applicants must pay more for
    what most perceive as a reduction in service.  Thus, the proposed increase
    in fees for RCEs was not well received by the public.

    Noting
    that "[t]he USPTO acknowledges that the cost of completing an RCE is less
    than that required for an original utility application," PPAC has also
    contended that "the increased costs to applicant being proposed to treat
    an RCE (and particularly a second and subsequent RCE) compared to the fees
    proposed for a utility or continuation application seems illogical." 
    Instead, PPAC has suggested that:

    [A] small increase in the fee for an RCE
    might be appropriate but it should align more closely to the associated
    required work, and certainly be less than the fees for new or continuation
    applications.  The higher fee for second and subsequent RCEs should be
    eliminated because these become easier and cheaper to examine and any number of
    continuations may be filed at the same cost per continuation.  Rather than
    punishing applicants for pursuing their inventions by filing an RCE, it is
    suggested that the USPTO continue to find ways to reduce applicants' need for
    the RCEs in the first place.

    The
    Office's request for comments on RCE practice also notes that a webpage
    devoted to its efforts to decrease the RCE backlog has been created on the
    USPTO website.  Data regarding RCE
    filings can be found at this webpage, including a chart showing the rise in the
    RCE backlog from just under 20,000 RCE filings awaiting an Office action in the
    fourth quarter of fiscal year (FY) 2009 to the current level of nearly 100,000.

    RCE Backlog
    The
    Office also provides data on RCE filings by technology, noting that the
    fraction of applications containing RCE filings is generally the same across
    technologies.

    RCE by Technology
    According to the notice,
    the public can provide feedback regarding RCE practice by submitting written
    comments by e-mail to rceoutreach@uspto.gov;
    by regular mail to the United States Patent and Trademark Office, Mail Stop
    Comments — Patents, Office of Commissioner for Patents, P.O. Box 1450, Alexandria,
    VA 22313–1450, marked to the attention of Raul Tamayo; or using the web-based
    collaboration tool IdeaScale®, which
    allows users to post comments, view and respond to others' comments, and indicate
    agreement or disagreement with particular comments.  Comments must be submitted by February 4, 2013.  The Office also plant to hold a series of
    roundtables on RCE practice.

    The
    notice provides a series of questions on which the Office is particularly seeking comment:

        (1) If within your practice you file a
    higher or lower number of RCEs for certain clients or areas of technology as
    compared to others, what factor(s) can you identify for the difference in
    filings
    ?
        (2)
    What change(s), if any, in Office procedure(s) or regulation(s) would reduce
    your need to file RCEs
    ?
        (3)
    What effect(s), if any, does the Office’s interview practice have on your
    decision to file an RCE
    ?
        (4)
    If, on average, interviews with examiners lead you to file fewer RCEs, at
    what point during prosecution do interviews most regularly produce this effect
    ?
        (5)
    What actions could be taken by either the Office or applicants to reduce the
    need to file evidence (not including an IDS) after a final rejection
    ?
        (6)
    When considering how to respond to a final rejection, what factor(s) cause
    you to favor the filing of an RCE
    ?
        (7)
    When considering how to respond to a final rejection, what factor(s) cause
    you to favor the filing of an amendment after final (37 CFR 1.116)
    ?
        (8)
    Was your after final practice impacted by the Office’s change to the order
    of examination of RCEs in November 2009
    ? If so, how?
        (9)
    How does client preference drive your decision to file an RCE or other
    response after final
    ?
        (10)
    What strategy/strategies do you employ to avoid RCEs?
    (11)
    Do you have other reasons for filing an RCE that you would like to share?

  • By Donald Zuhn

    European ParliamentOn Tuesday, the European
    Patent Office reported
    that the European Parliament in Strasbourg had adopted two draft regulations on
    the creation of the unitary patent.  The
    EPO hailed the adoption of the draft regulations as "a historic
    achievement."  EPO President Benoît
    Battistelli declared that "[t]he European Union is to be congratulated on
    this decision, which clears the way for the completion of the European patent
    system with a unitary patent and a Unified Patent Court, which we have been waiting
    for in Europe for 40 years." 
    President Battistelli added that the unitary patent would cut patenting
    costs in Europe and "strongly benefit European enterprises, especially
    research centres and SMEs," as well as "strengthen[] Europe's
    competitiveness."

    The unitary patent, which will
    co-exist with national patents and the classical European patent, will provide
    protection for inventors in 25 EU member states through one single
    administrative step.  The unitary patent
    will differ from European patents with respect to the post-grant phase — i.e., unitary patents will be treated as
    a single patent that does not require validation (including translation) and that
    does not need to be administered nationally in each and every state.  The unitary patent is based on two
    regulations, one creating the instrument, and one on the applicable language
    regime for the new patent.  According to
    the EPO release, the positive vote in the Parliament became possible after EU
    member states endorsed the regulations in their Competiveness Council meeting
    on Monday.  The unitary patent now has to
    be formally adopted by the EU Council and the European Parliament, which the
    EPO said is expected soon.  It has been noted, however, that the unitary patent could still face a legal challenge from Italy and Spain, two EU member states that have challenged the unitary patent at the Court of Justice of the
    European Union (CJEU) (see "Progress for Single European Patent and Litigation System").

    The EPO will be responsible
    for delivering and administering unitary patents.  The Office said it expects to validate the
    first unitary patent in 2014.

    According to the EPO
    release, an agreement establishing the Unified Patent Court (UPC), a specialized
    court having exclusive jurisdiction over infringement and validity questions
    related to unitary patents, is expected to be signed on February 18, 2013 and
    will enter into force once thirteen EU member states have ratified the package,
    including France, Germany and the United Kingdom.

    For additional information regarding this topic please see:

    • "Unitary Patent & Unified Patent Court," December 12, 2012
    • "Progress for Single European Patent and Litigation System," November 12, 2012
    • "EU Patent Is Finally Born," July 2, 2012
    • "European Parliament Approves Enhanced Cooperation Procedure to Create Unified EP Patent System," March 1, 2011
    • "Several EU Members Push for Unified Patent System," December 30, 2010
    • "Europe Takes Step Closer to Single EU Patent and Patent Court," February 24, 2010

  • By Mark Richardson

    European Union (EU) FlagLast week the pan-European
    Intellectual Property Summit (IP Summit) was held in Brussels and the first
    morning of the summit saw a number of discussions regarding the unitary patent
    and unified patent court.  A common theme that seemed to crop up from anyone
    representing the official EU position was that the proposed unitary patent
    protection (UPP) package isn't perfect but it'll do!  Hmm.

    The opening keynote
    introduction was from Kerstin Jorna from the European Commission (Director,
    Intellectual Property – Internal Market & Services DG) who likened the UPP
    package to a cake that doesn't look like the picture in the recipe book when you
    remove it from the oven.  According to Ms Jorna, in such circumstances we should
    ask ourselves whether the cake is fit to be served to our family!  Apparently
    the UPP cake is fit to be eaten.  Please insert your own joke here about too
    many cooks in the kitchen . . . .

    One other point to come out
    of the keynote session was that the European Commission intends to do
    everything in its power to grant the first unitary patent in Spring 2014.  Selection of the unitary patent would be made at the validation stage which means
    that the first unitary patent is probably already in the system somewhere.

    The main session on the
    unitary patent and court threw up two main issues:  forum shopping in the
    unified patent court and the cost of maintenance fees for the unitary patent.

    The maintenance fee issue
    was raised by the representative from Proctor & Gamble Europe.  P&G
    currently have a validation programme of between four and six contracting
    states.  They generally welcome the unitary patent proposals as it provides the option
    of enforcing their IP over a wider geographic area.  However, they raised the
    concern that the maintenance fee levels are currently unknown and these could
    have a big impact on whether the system is seen as financially viable.  They
    made the point that once a unitary patent is chosen there is no going back if
    the maintenance fee burden becomes too high.  Currently of course they have the
    option of dropping some of the validated states if they desire to prune country
    coverage.

    A Dutch attorney later
    suggested that the proposed maintenance fee amounts being discussed would add
    approximately 50% to P&G's post-grant costs.  No basis was given for these
    figures.

    Forum shopping was also
    raised as a concern by a number of people in the audience with one audience
    member suggesting that there might be a danger of some local divisions
    promoting a pro-patentee stance to get more cases coming their way.  If such
    local divisions were also associated with referring validity back to the
    Central Division, then this would make them potentially very attractive to
    patent rights holders looking to get a geographically significant injunction.

    It was at this point that a
    representative from (I believe) the EPO suggested in the space of two minutes
    that (i) forum shopping from the point of view of efficiency and costs was
    healthy; (ii) forum shopping (in the manner suggested by the concerned audience
    members) would not take place, and; (iii) even if forum shopping developed, the
    Appeal Court would overturn matters so that the system would be self
    correcting!

    This point of view was
    quite worrying.  Even if the Appeal Court did eventually overturn infringement
    decisions from the local division, it doesn't change the fact that until the
    patent is either shown to be invalid or the decision is overturned, a valid
    injunction is in place.  The other issue here is one of cost.  If the alleged
    infringer is forced to appeal the decision then this will add to their costs.

    A point was made later in
    the session that under the system being developed the Appeal Court would be
    able to intervene and suspend the effect of an injunction if they felt it was
    wrong or the local division was issuing "crazy" decisions.  However,
    whether the Appeal Court would want to get involved that often is unknown.

    A question was asked during
    the session on "Rules of Procedure for the Unified Patent Court" as
    to when we might expect to see the draft rules (apparently we are up to the
    12th draft).  The answer, eventually, came that there would be a public
    consultation at some point next year (February onwards).

    Mr. Richardson is a Director
    at Keltie in London, UK.

    This article was reprinted
    with permission from the IPCopy blog.

  • Cats and the Federal Circuit

    By Kevin E. Noonan

    Uptoyou_duFarWestwithBePacific2Unlike dog breeds
    that tend to be of ancient vintage (Labra-doodles and Yorkie-poos to the
    contrary), many cat breeds are of relatively recent parentage.  While there are many naturally occurring
    breeds (such as Maine Coons and Norwegian Forest Cats), a surprising number of
    cat breeds were developed in the last 50 years or so.  The most recent (and perhaps most extreme)
    are Savannahs, that are the result of breeding between a domestic short-haired
    cat and a serval, a wild, undomesticated African cat.  The Federal Circuit had the opportunity to
    opine on whether another (relatively) recent cat breed, the Pixie-Bob (at right), was
    patent-eligible subject matter or novel in an appeal from rejection on both
    these grounds before the Patent Office.  While the Court avoided the statutory subject matter question, it affirmed
    rejection for lack of novelty for the remarkably named applicant, Frank Robert
    Ditto.

    Mr. Ditto claimed a
    breed of cats produced by mating a bobcat, lynx or bobcat-lynx mix with a
    domestic cat.  The sole independent claim
    is directed to "[a] domestic cat breed produced by breeding a purebred cat
    produced by mating a Bobcat, Lynx, or Bobcat Lynx species with a domestic cat,"
    with dependent claims reciting various phenotypic characteristics of the cats
    (in most part relating to the cats' propensity to vocalize).  As explained in the specification, the breed
    has a unique combination of domesticated behaviors and "the spirit and
    disposition of the wild" cat as well as other specific traits (including "a
    variety of colors, have hind legs that are larger than their front legs, may
    have spotted fur or a stump tail, and have 'sturdy muscular bodies.'"

    The Board affirmed
    the Examiner's rejection of §§ 101 and 102 grounds.  The basis for the § 101 rejection was that the
    breed was a "product of nature" that resulted from breedings that
    occurred in the wild.  The Board affirmed
    this rejection insofar as the claims did not require any particular degree of
    interbreeding and that naturally occurring cats could satisfy the limitations
    recited in claim 1.  With regard to the
    § 102 rejections, the Examiner cited two prior art references:  a 1994 Seattle Times article by Green relating
    to a Pixie-Bob produced by mating of a wild bobcat and a domestic cat (in a
    family barn without human intervention); and a 1995 Bellingham Herald article by Porter describing the Pixie-Bob breed
    and its introduction to The International Cat Association (TICA) as an "official"
    cat breed.  These references also
    satisfied the limitations recited in claim 1 on similar grounds, i.e., that
    there was no limitation as to the degree of breeding required and that "there
    was no evidence . . . suggest[ing] any difference between the Pixie-Bob cat
    [described in the cited prior art] and the claimed cats."

    Federal Circuit SealThe Federal Circuit
    affirmed in a per curiam opinion
    before Judges Dyk, Prost, and Reyna.  Their
    opinion did not address the § 101 rejection, finding sufficient evidence that
    the claims were anticipated under § 102.  According to the panel, the term "purebred" was properly given
    its "broadest reasonable interpretation," particularly in view of the
    lack of any particular definition in Inventor Ditto's specification.  And the panel apparently relied on a
    dictionary definition of "breed" as meaning "a distinctive group
    of domestic animals differentiated from the wild type under the influence of
    man and usu[ally] incapable of maintaining its distinctive qualities in nature,"
    citing Webster's Third New International Dictionary of the English Language 274
    (1993).  Like the Board, the panel
    rejected Inventor Ditto's argument that the Green and Porter references did not
    describe a breeding that had achieved the desired level of domesticity
    (particularly with reference to the TICA "SBT" breeding
    standards).  Tellingly, Inventor Ditto's
    filing date (March 25, 1999) was after the date (May 1, 1998) when TICA accepted
    the Pixie-Bob as a recognized breed.  According to the panel, both the Green and Porter references disclosed
    characteristics and features of the Pixie-Bob cats that are distinctive and
    comprise the "desired effects" recited as a limitation in Inventor
    Ditto's claims.

    The panel's
    decision finishes the patenting process for Inventor Ditto.  However, the "product of nature"
    rejection before the Office remains unscrutinized and intriguing (and,
    truthfully and in full compliance with the Supreme Court's analytical protocol,
    is based in part on the prior existence — i.e., on § 102 grounds — of the breeding
    in nature).  But the question can be
    presented more starkly with the Savannah cat mentioned above.  This cat is bred
    solely with human intervention (there is no evidence that the African serval
    ever mated in the wild with a domestic cat and certainly not with an American
    domestic cat).  In addition, males in the
    F1 generation are sterile; indeed, it is not until the F4 generation that
    fertile males are produced.  This
    required backcrossing into the domesticated cat stock in order to produce cats
    that breed "true," i.e., that have both parents of the Savannah breed.  All of these aspects evince the "hand of man" and represent
    something that is the "product of human ingenuity 'having a distinctive
    name, character [and] use,'" Chakrabarty
    at 310, citing Hartranft v. Wiegmann, 121 U. S.
    609
    , 121 U.
    S. 615
    (1887).  Thus it is clear
    under prevailing precedent that the Savannah cat should comprise
    patent-eligible subject matter.  Although
    this question is beyond the scope of the question presented to the Supreme
    Court in the Myriad case or in Mayo v. Prometheus, the question remains
    whether this Court would find these "routine" and "conventional"
    breeding methods to provide "enough" for the Savannah cat to be "more
    than" a product of nature and become a patent-eligible product of man.

    In re Ditto (Fed. Cir. 2012)
    Panel: Circuit Judges Dyk, Prost, and Reyna
    Opinion per curiam

    Image of Pixie-bobs (above) by Angie 1900, from the Wikipedia Commons under the Creative Commons Attribution 3.0 Unported license.

  • By Sherri Oslick

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

    Glycobiosciences,
    Inc. v. Anika Therapeutics, Inc.

    1:12-cv-01963;
    filed November 25, 2012 in the District Court of the District of Columbia

    Infringement
    of U.S. Patent Nos. 6,120,804 ("Topical Drug Preparations," issued
    September 19, 2000) and 6,723,345 (same title, issued April 20, 2004) based on
    Anika's manufacture, use, offer for sale, and sale of their Hyalofill® product
    (wound dressings composed of an ester of hyaluronic acid, used to treat
    wounds).  View the complaint here.


    Cellectis
    S.A. v. Precision Biosciences Inc. et al.

    1:12-cv-01662;
    filed December 5, 2012 in the District Court of Delaware

    • Plaintiff: 
    Cellectis S.A.
    • Defendants: 
    Precision Biosciences Inc.; Duke University

    Declaratory
    judgment of invalidity and non-infringement of U.S. Patent No. 8,304,222 ("Rationally-Designed
    Meganucleases with Altered Sequence Specificity and Heterodimer Formation,"
    issued November 6, 2012).  View the
    complaint here.


    Medicis
    Pharmaceutical Corp. v. Alkem Laboratories Ltd. et al.

    1:12-cv-01663;
    filed December 5, 2012 in the District Court of Delaware

    • Plaintiff: 
    Medicis Pharmaceutical Corp.
    • Defendants: 
    Alkem Laboratories Ltd.; Pharma Network LLC; Ascend Laboratories LLC

    Medicis
    Pharmaceutical Corp. v. Sidmak Laboratories (India) Pvt. Ltd.

    1:12-cv-01664;
    filed December 5, 2012 in the District Court of Delaware

    The
    complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,908,838 ("Method
    for the Treatment of Acne," issued June 1, 1999), 7,790,705 ("Minocycline
    Oral Dosage Forms for the Treatment of Acne," issued September 7, 2010),
    and 8,268,804 (same title, issued September 18, 2012) following a Paragraph IV
    certification as part of defendants' filing of an ANDA to manufacture a generic
    version of Medics' Solodyn® (minocycline hydrochloride extended release
    tablets, used to treat acne).  View the Alkem complaint here.


    Merial
    Limited et al. v. Ceva Animal Health LLC

    3:12-cv-00154;
    filed December 5, 2012 in the Middle District of Georgia

    • Plaintiffs: 
    Merial Ltd.; Merial SAS
    • Defendant: 
    Ceva Animal Health LLC

    Infringement
    of U.S. Patent No. 6,096,329 ("Insecticidal Combination to Control Mammal
    Fleas, in Particular Fleas on Cats and Dogs," issued August 1, 2000),
    licensed to Merial in the animal health field, based on Ceva's manufacture and impending
    sale of infringing flea and tick products. 
    View the complaint here.


    Jazz
    Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.

    2:12-cv-07459;
    filed December 5, 2012 in the District Court of New Jersey

    Infringement
    of U.S. Patent No. 8,324,275 (" Microbiologically Sound and Stable
    Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,"  issued December 4, 2012) following a
    Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture
    a generic version of Jazz's Xyrem® (sodium oxybate, used to treat
    narcolepsy).  View the complaint here.


    Supernus
    Pharmaceuticals, Inc. v. Kappos

    1:12-cv-01385;
    filed November 30, 2012 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. 8,193,211 ("Controlled Release
    Compositions of Gamma-Hydroxybutyrate," issued June 5, 2012).  View the complaint here.


    Bayer Pharma
    AG et al. v. Lupin Ltd. et al.

    1:12-cv-03526;
    filed November 29, 2012 in the District Court of Maryland

    • Plaintiffs: 
    Bayer Pharma AG; Bayer Intellectual Property GmbH; Bayer Healthcare
    Pharmaceuticals Inc.
    • Defendants: 
    Lupin Ltd.; Lupin Pharmaceuticals, Inc.

    Infringement
    of U.S. Patent No. 8,071,577 ("Multi-phase Contraceptive Preparation Based
    On a Natural Estrogen," issued December 6, 2011) following a Paragraph IV
    certification as part of Lupin's filing of an ANDA to manufacture a generic
    version of Bayer's Natazia® (estradiol valerate and estradiol
    valerate/dienogest, used as oral contraception).  View the complaint here.

  • By Kevin E. Noonan

    Supreme Court Building #1The
    Supreme Court granted certiorari Friday in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with
    certiorari petitions before the Court relating to reverse payment settlement
    agreements in ANDA litigation under the Hatch Waxman Act.  (The petition in
    the other case, In re K-Dur Antitrust
    Litigation
    , was
    undecided.)  The Court's certiorari grant
    marks the culmination of almost a decade of effort by the Federal Trade
    Commission to get the case before the Court; what clinched the effort this time
    was the decision in the K-Dur case by the Third Circuit in favor of the FTC's
    position, finding such settlements to be presumptively anticompetitive and
    subject to a "rule of reason" antitrust analysis.  This result was contrary to decisions in the
    11th Circuit (Valley Drug Co. v. Geneva Pharmaceuticals, Inc.,
    344 F.3d 1294 (11th Cir. 2003) and Schering-Plough Corp. v. Federal Trade Commission,
    402 F.3d 1056 (11th Cir. 2005)); 2nd Circuit (In re Tamoxifen Citrate Antitrust Litigation,
    466 F.3d 187 (2d Cir. 2006) and Arkansas Carpenters Health & Welfare Fund v. Bayer AG,
    604 F.3d 98, 105 (2d Cir. 2010)); and the Federal Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation,
    544 F.3d 1323 (Fed. Cir. 2008)) that such agreements are legal provided that
    they stay within the legitimate bounds of the patent grant (applying the "scope
    of the patent" test).  (It should be noted that the lone appellate
    exception (before K-Dur), In re Cardizem CD Antitrust Litigation,
    332 F.3d 896 (6th Cir. 2003), involved different facts leading to the
    conclusion that there was anticompetitive behavior.)

    The Question Presented in the FTC's
    successful cert. petition is as follows:

    Whether
    reverse-payment agreements are per se lawful unless the underlying patent
    litigation was a sham or the patent was obtained by fraud (as the court below
    held), or instead are presumptively anticompetitive and unlawful (as the Third
    Circuit has held)

    The FTC petitioned the Court to
    preferentially grant certiorari in the Watson case, asserting that the Watson case provides a "superior
    vehicle" for Supreme Court review, supported by four arguments.  First, the brief argued, the K-Dur case is a private cause of action (no
    matter how encouraged and supported by the FTC) and the Watson case is
    an FTC enforcement action, brought by the government agency "charged by
    Congress with challenging unfair methods of competition, see 15 U.S.C. 45, and
    responsible for reviewing agreements settling litigation under the Hatch-Waxman
    Amendments."  "The Court would benefit from the experienced
    presentation that the FTC, represented by the Solicitor General, would offer as
    a party" rather than an amicus, the brief argues.  Unmentioned
    are the procedural advantages of being a petitioner rather than an amicus
    in framing and presenting the arguments to the Court; the private plaintiffs
    were useful in the matter below but now that policy is to be decided, the
    government wants to control how the case is presented to the Court.

    The FTC's second argument was that this
    case has a "simpler" procedural history, arising from a motion to
    dismiss under Fed. R. Civ. Pro. 12(b)(6) rather than from a grant of a summary
    judgment motion.  Of course, unmentioned in the brief is the consequence
    that this case is devoid of the extensive record that exists in the K-Dur
    case, both before the Commission as well as in the District Court and the Third
    Circuit, and also the proceedings in parallel litigation in the 11th Circuit
    where the Court came to the contrary conclusion.

    The third argument set forth by the FTC was
    that the K-Dur case is about post hoc damages (the agreements
    expired long ago), whereas the Watson case is about injunctive relief on
    agreements that will keep the generic parties off the market until 2015.  "That
    makes this case the more attractive vehicle because whatever uncertainties may
    arise in fixing the damages caused by a reverse-payment agreement — a question
    no court of appeals has confronted or passed upon — the FTC unquestionably
    will be entitled to the remedy of an injunction if it proves that the
    reverse-payment agreements here are unfair methods of competition," is the
    way the brief summarized the FTC's position.

    The FTC's fourth and final argument was
    that the K-Dur case does not involve a Paragraph IV allegation of
    invalidity.  However, the grounds for deciding
    whether the agreement is anticompetitive and thus illegal should not depend on
    whether the product does not infringe or the patent is invalid; those
    considerations are only relevant to the type of arguments FTC petitioner wants
    to make, which at root are that the litigation is based on a "bad" patent
    and thus the patent should not be entitled to the presumption of validity.

    These reasons may have had something to do
    with the Court's decision to grant cert. in the Watson case rather than the
    K-Dur case; the circuit split provoked support for the Court to grant cert. in
    order to resolve it from branded and generic pharmaceutical companies, industry
    and patient groups and other amici,
    all unanimously advocating the certiorari grant.  But perhaps the best reason for the Court's
    choice is that the FTC did not prevail below, and taking the Watson case gives
    the Court the opportunity to reverse.  This reasoning suggests that the Court may engage in another round of "everybody
    knows" jurisprudence, wherein the "conventional wisdom"
    indicates that reverse payment settlement agreements should be anticompetitive
    (even in the face of affirmative evidence that they are not).  Once again the Court will hear the different
    perspectives of producers of technology and its consumers, and once again the
    simple will be at odds with the complex (and reality).  And once again we will get to see what
    position provides the best arguments, and which one prevails (which are not
    necessarily the same thing).

  • Calendar

    December 11, 2012 – Preissuance Prior Art Submissions at the USPTO — Best Practices
    for Third-Party Challenges to Patent Applications and Monitoring
    Competition
    (Strafford) – 1:00 – 2:30 pm (EST)

    December 12, 2012 – Saving the Best for Last: Top 10 Things In-House Counsel Need to Do to
    Prepare for the AIA's March 2013 Deadline
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    January 23-24, 2013 – The Comprehensive Guide to Patent Reform*** (American Conference
    Institute) – New York, NY

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

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

  • By Kevin E. Noonan

    Smith, LamarLurking
    in H.R. 6621, a bill entitled "To correct and improve certain provisions of the Leahy-Smith
    America Invents Act and title 35, United States Code
    " and introduced on November 30th by Rep. Lamar Smith (R-TX)
    is a provision that would substantively affect (and effectively eliminate)
    patent rights for the ~200 pending U.S. patent applications having a filing
    date prior to June 7, 1995 (when legislation enabling the provisions to the
    Uruguay Rounds of the General Agreement on Tariffs and Trade (GATT) were
    enacted that changed the term of U.S. patents from 17 years from grant to 20
    years from earliest priority/filing date).  That provision reads as follows:

    (m) Effective Date of Uruguay Round
    Agreements Act –

        (1) CERTAIN PATENT APPLICATIONS
    Notwithstanding section 534(b)(1) of the Uruguay Round Agreements Act (35
    U.S.C. 154 note), section 154(a) of title 35, United States Code, as amended by
    section 532 of the Uruguay Round Agreements Act (Public Law 103-465; 108 Stat.
    4809), shall apply, and section 154(c)(1) of title 35, United States Code,
    shall not apply, to any application that is –

    (A) filed before the date that is
    6 months after the date of the enactment of the Uruguay Round Agreements Act;
    and

    (B) pending on a date that is 1
    year or more after the date of the enactment of this Act.

        (2) EFFECTIVE DATE – This subsection shall
    take effect on the date that is 1 year after the date of the enactment of this
    Act and shall apply to any original plant or utility patent application that is
    pending on or after that effective date.

    Hiding in this verbiage is the requirement that the
    20-year term (35 U.S.C. § 154(a)) shall be applied to
    pre-GATT filed patents provided that they are pending "1 year or more after
    enactment of" the bill.  This means,
    in effect, that unless the U.S. Patent and Trademark Office has granted these
    patents within this time the term of any patent that grants on such a pending
    application would be 20 years from earliest filing date (which would eliminate
    term for any pending application having an effective filing date of ~1994, i.e.,
    the vast majority of the pending pre-GATT cases).

    Washington - Capitol #4The motivation for this provision in the bill is
    unclear.  These cases are somewhat of an embarrassment to the Office, of course,
    insofar as their existence can be used to insinuate that the Office has been
    tardy in examining them.  But this is
    mostly not the case:  the majority of these applications have been involved in
    protracted interferences, appeals, or had examination suspended for Office
    consideration of third party interferences that would influence the
    patentability of pending claims.  What is decidedly the case is that the delay
    in prosecuting these applications has not been the result of applicant delay,
    strategic or otherwise.  This is because
    the implementing legislation and PTO rules were drawn to prevent such
    shenanigans.  For example, filing a continuation
    or Request for Continued Examination in these applications strips such
    applications of their pre-GATT status (and would result in the same
    loss-of-rights that the present bill would cause).  Transitional procedures adopted by the Office
    permitted an applicant to petition for withdrawal of the finality of a
    rejection but this opportunity could only be used twice; thereafter, the only
    recourse for pre-GATT applications was filing an appeal.  Thus, the Office carefully crafted its rules
    to minimize long pendencies for pre-GATT cases, a policy that undoubtedly is
    responsible for limiting the number of existing cases to 200.

    In view of the lack of culpability of patent
    applicants for the situation (and keeping in mind how skewed expectations have
    become since the change to the 20-year term), it applies particular prejudice
    on applicants to have their patent rights be completely dependent on the PTO completing prosecution and granting a patent
    within one year of enactment of the bill.  Besides the obvious logistical difficulties this scheme would occasion,
    it also raises the likelihood that citizens' property rights would evaporate by
    agency inaction, an outcome that fails Civics 101.

    There are alternatives if Rep. Smith or the Office
    are serious about bringing prosecution of these cases to conclusion.  For example, the Office could establish a
    program, analogous to the "Fast Track" program for patent
    prosecution, that would be dedicated to these applications and having them
    granted, abandoned, or appealed within some reasonable timeframe.  There are undoubtedly other ideas that could
    be explored.  What should not be enacted
    is a bill passed on the "fast track" in a lame duck Congress and
    touted as being merely technical in nature.  Although the bill is rumored to be slated to be passed without comment
    or amendment in the House, concerned citizens or their interest groups should
    contact their Senator to put a hold on this legislation until it can be
    considered more deliberately in the next Congress.

    Hat tip to
    Hal Wegner for recognizing this provision of the bill.

  • By Kevin E. Noonan

    Department of Justice (DOJ) SealThere are more issues in patent law
    that the Supreme Court may consider than those raised by Association for Molecular Pathology v. Myriad Genetics, and as if to
    illustrate that point, the Solicitor General filed his brief at the end of
    November in Retractable Techs.,
    Inc. v. Becton, Dickinson & Co.
      The Questions Presented by Petitioner
    Retractable Technologies are these:

    1.  Whether a court, in construing a disputed
    term in a patent claim, may draw inferences from the patentee's use of the same
    term elsewhere in the patent's specification.

    2.  Whether, in reviewing a district court's
    interpretation of a patent claim, the court of appeals should give deference to
    the district court's resolution of subsidiary factual questions.

    In the Solicitor General's view, "neither
    of the questions set forth in the petition for a writ of certiorari warrants
    review in this case."

    To recap the proceedings below,
    Retractable Technologies sued Becton Dickinson for infringing claims of U.S.
    Patent Nos. 5,632,733; 6,090,077; and 7,351,224.  These patent
    claims were directed to syringes configured to retract the needle into the body
    of the syringe after use, to reduce the likelihood of needle-stick
    injury.  The claim term at issue was "body," specifically
    whether the term should be construed to be limited to single-piece versus
    multiple piece embodiments.  The District Court construed "body"
    as "a hollow outer structure that houses the syringe's components,"
    and concluded that the term "body" was not limited to a one-piece
    structure.

    The Federal Circuit reversed, in a
    decision by Judge Lourie joined by Judge Plager
    and (in part) by Chief Judge Rader.  The panel reversed the District Court
    with regard to meaning of "body," finding that the term should be
    limited to a one-piece structure.  The panel found that the claim language
    was not determinative, and disclosure in the specification supported its
    one-piece body construction.  The specification described the claimed
    invention as comprising a one-piece body, all the figures illustrated syringes
    comprising a one-piece body, and the specification disparaged prior art
    syringes made of multiple piece bodies.  Moreover, there was no disclosure
    of a multiple piece syringe body in specification.  In reversing the
    District Court's construction, the majority said:

    There is a fine
    line between construing the claims in light of the specification and improperly
    importing a limitation from the specification into the claims.  In
    reviewing the intrinsic record to construe the claims, we strive to capture the
    scope of the actual invention, rather than strictly limit the scope of claims
    to disclosed embodiments or allow the claim language to become divorced from
    what the specification conveys is the invention.

    (citations omitted)

    Judge Plager filed a concurring opinion
    expanding on this theme, saying that "the claims cannot go beyond the
    actual invention that entitles the inventor to a patent" and that "the
    [patentee's] obligation [was] to make full disclosure of what is actually
    invented, and to claim that and nothing more."  Chief Judge Rader,
    dissenting-in-part, argued the primacy of the claim language, and that it is
    impermissible to read limitations from the specification into the claims.

    These disagreements regarding both the
    proper claim construction here and the proper method for performing claim
    construction generally also arose in the Federal Circuit's decision not to
    grant en banc review.  Two dissents were filed in the Court's
    decision not to hear the claim construction decision en banc:  one
    by Judge Moore, joined by Chief Judge Rader, and another by Judge O'Malley.  Judge Moore's dissent characterized claim construction as "the single most
    important event in the course of a patent litigation."  However, the
    Federal Circuit's rules for making claim construction determinations remain "ill-defined
    and inconsistently applied," even by the Court in her view.  While
    citing commentators to support this conclusion, this dissent focused on the
    question at issue in Retractable Technologies and, according to Judge
    Moore, arose generally from a deficiency in the Court's application of the
    law:  where to draw the "fine line" between "construing the
    claims in light of the specification and improperly importing a limitation from
    the specification into the claims."  Her dissent contended that
    this
    was the case to consider the issues of "the role of the
    specification in construing the claims and whether deference should be given to
    the district court in the claim construction process."

    Judge Moore relied principally on Phillips
    v. AWH C
    orp.
    , 415 F.3d 1303, 1312 (Fed.
    Cir. 2005) (en banc), and the "bedrock principle" that "the
    claims of a patent define the invention to which the patentee is entitled the right
    to exclude."  She discounted the concerns voiced by the Retractable
    Technologies
    majority, including that "the metes and bounds of what
    the inventor claims extend beyond what he has invented or disclosed in the
    specification."  In that case, the question would be one of validity
    rather than claim construction, she stated, and it is not the role of the court
    to "tailor the claim language to the invention disclosed."  Citing Phillips, the dissent relies on the mantra that the "plain
    meaning" of the clams controls (and the dissent voiced surprise that this
    question was not resolved in Phillips).  Judge Moore stated her
    (stringent) standard for the relationship between the claims and the
    specification:  "the specification cannot be used to narrow a claim
    term — to deviate from the plain and ordinary meaning — unless the inventor
    acted as his own lexicographer or intentionally disclaimed or disavowed claim
    scope," citing Phillips and Teleflex, Inc. v.
    Ficosa N. Am. Corp.
    , 299
    F.3d 1313, 1327 (Fed. Cir. 2002).  Any deviation from this procedure
    should be applied narrowly, in her opinion, and specifically, her dissent
    opined that the choice of an overbroad term may affect validity but should not
    be considered for claim construction.  Following a detailed recitation of
    the facts and legal principles enunciated in Phillips, the dissent
    contrasted the majority decision in Phillips with the panel decision
    here:  in the absence of "disclaimer or special lexicography,"
    the plain meaning standard must be applied.  And the evidence, according
    to this dissent, failed to support a claim limited to single-body embodiments.

    Judge Moore identified the problem with
    the panel decision with particularity:

    The error in Retractable
    is the majority's attempt to rewrite the claims to better conform to what
    it discerns is the "invention" of the patent instead of construing
    the language of the claim.  Indeed, the majority candidly explained that
    its construction, limiting "body" to a one-piece body, "is
    required to tether the claims to what the specifications indicate the inventor actually
    invented."

    While agreeing that the specification and
    claims must comply with the requirements of 35 U.S.C. § 112, her dissent stated
    simply that the Court "does not rewrite claims"; this is not a case,
    Judge Moore contended, where "the majority is choosing between two equally
    plausible plain meanings and adopting the one that comports with the disclosure
    in the specification."  Rather, this case was illustrative that there
    is "a fundamental split within the court as to the meaning of Phillips and
    Markman as well as the proper approach to claim interpretation." 
    That was enough to convince Judge Moore and Chief Judge Rader that claim
    construction required reconsideration by the court en banc.  Judge
    Moore also wrote that this case had a procedural posture that would permit the
    court to set forth the extent to which the "mongrel practice" of
    claim construction would permit or require deference to a district court's
    factual determinations under Markman v.Westview Instruments, Inc., 517
    U.S. 370, 378 (1996).

    Judge O'Malley dissented separately, a
    posture reflecting her singular experience as a district court judge tasked
    with performing factual determinations in support of claim construction
    decisions.  She was forthright:  "[i]t is time to revisit and
    reverse our decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448
    (Fed. Cir. 1998) (en banc)," if only because "the court's decision
    necessarily would change if even minimal deference were afforded to the trial
    judge's claim construction."  Her dissent noted that the Court's
    decision to give no deference to district court factual determinations was not
    required by the Supreme Court in Markman, and indeed the High Court "did
    not affirm this court's earlier conclusion that resort to a jury was
    unnecessary because claim construction is a pure question of law." 
    She believes the appellate court's decision to be "ill considered"
    when it was enunciated thirteen years ago and that it has not proven "beneficial"
    to patent jurisprudence "in the long run."

    Reflecting her own experience, Judge O'Malley
    opined that:

    [D]istrict
    judges have been trained to — and do — engage in detailed and thoughtful
    analysis of the claim construction issues presented to them.  They conduct
    live hearings with argument and testimony, sometimes covering several days, and
    certainly always extending beyond the mere minutes that courts of appeals have
    to devote to live exchanges with counsel.  Simply, "the trial court
    has tools to acquire and evaluate evidence that this court lacks." 
    Cybor,
    138 F.3d at 1477 (Rader, J., dissenting).

    She went on to say that "[w]hile no
    one would urge deference to cryptic, unthinking rulings born of little or no
    real inquiry, where, as here, the trial court has thoroughly vetted all
    relevant aspects of the claim constructions at issue, 'careful consideration of
    the institutional advantages of the district court would counsel deference.'" 
    Reciting the history of the case, she noted that these claims had been
    construed by two separate district court judges and that the asserted "wrongdoing"
    reversed by the panel decision "did not promote the consistency and
    uniformity in patent law that Cybor was intended to foster; the decision
    here accomplished the opposite."

    In Judge O'Malley's view, the panel did
    not misapply the claim construction canons in Phillips; rather, she
    merely disagreed with their application.  But this fact, and the
    experience of the panel members that they "could not agree on the proper
    claim construction in this case, despite careful consideration of their
    respective obligations under Phillips," strongly suggested to Judge
    O'Malley that the "complicated and fact-intensive nature of claim
    construction" mandates "the need to rethink our approach to it." 
    For her, the "review of extensive documentary evidence" and possibly
    expert testimony suggest factual, not legal questions are being posed to the
    Court.  And:

    Where, as here,
    there is fair debate about the scope of the invention after application of Phillips's
    principles, we should defer to reasoned district court choices. 
    Reasonable minds can — and do — differ over the correct interpretation of the
    term "body" as used in the patent in suit.  These are not the
    circumstances under which we should be reversing carefully reasoned claim
    constructions and putting aside years of litigation in the process.

    Against this backdrop, the Solicitor
    General's brief concluded that, first, "Petitioners identify no unsettled question of claim construction
    methodology warranting this court's review," and second, "[t}his case
    is not an appropriate vehicle for determining what standard of appellate review
    should apply to a district court's subsidiary factual findings in claim
    construction."  The brief based its first argument, that there is no
    unsettled question, on the majority's reliance on Phillips
    v. AWH C
    orp., 415 F.3d 1303, 1312 (Fed.
    Cir. 2005) (en banc), cert. denied, 546 U.U. 1170 (2006).  There is no
    dispute between the Federal Circuit judges and thus nothing for the Court of
    review, according to the brief, because there is "broad agreement" in
    the Federal Circuit that both plain meaning and specification should be
    considered.  The brief characterizes a
    patent as an "integrated legal document," and thus, although the
    claims are what defines the scope of the right to exclude, claims must be
    interpreted according to the specification, citing United States v. Adams,
    383 U.S. 39 (1966); Schriber-Schroth Co. c. Cleveland Trust Co.,
    311 U.S. 211 (1940); Brooks v. Fiske, 56 U.S. 212 (1854).  "At bottom, then, the task
    of claim construction is to ascertain the meaning of the actual claim language
    approved by the U.S. Patent and Trademark Office, as "explained by and
    read in connection with the specification" in the Solicitor's view, citing
    Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 432
    (1902).  Again citing Phillips, the Solicitor General asserts
    that "[t]he Federal Circuit has faithfully implemented those principles in
    considering questions of claim construction."  Curiously, the brief accentuates the near
    unanimity achieved by the Federal Circuit in Phillips, ignoring the different views enunciated by the Federal
    Circuit in this case (and ignoring the changed composition of the lower court
    in the intervening time since Phillips).  Instead of different doctrinal camps, the Solicitor
    General sees the differing results as merely reflecting the "case-by-case"
    nature of claim construction.  Turning to
    the case at bar, although acknowledging that the question is "close,"
    the brief maintains that the Federal Circuit came to the right decision in this
    case.

    Even if the Court
    believes that Federal Circuit jurisprudence in this area is in need of
    reconciliation by the Court, the Solicitor General asserts that "[t}his
    case is not an appropriate vehicle for determining what standard of appellate
    review should apply to a district court's subsidiary factual findings in claim
    construction."  The reason is
    simple:  there is no factual determination by the district court at issue
    here.  Indeed, "[i]n an appropriate
    case, this court's intervention might be warranted to determine the proper
    standard of appellate review of district court factual determinations that bear
    on the interpretation of disputed patent claims" according to the
    Solicitor General's brief.  But this is
    not that case.  Here, the District Court
    relied "solely" on the parties' legal arguments, thus not raising the
    issue the petitioners ask the Court to resolve.  Moreover, the Federal Circuit's decision in Cybor Corp. v. FAS
    Techs., Inc.
    , 138
    F.3d 1448 (Fed. Cir. 1998),
    that factual determinations by a district court were due no deference on
    review, is "amply support[ed]" by the Court's Markman decision in the Solicitor's view.  The brief engages in the fiction that Cybor does not preclude deference to a district court's factual
    findings, but maintains its position that, regardless of the Federal Circuit's
    treatment in other cases there is no basis warranting review on this question
    in this case.

    The Solicitor
    General maintains that "the question whether deferential review is
    appropriate in those circumstances is of substantial and ongoing importance in
    patent law" but "[t]hat issue is not properly presented in this case,
    however, because the district court did not make any factual findings or
    resolve any evidentiary disputes in interpreting the patent claims at issue
    here."

    Taking into account the five "active"
    judges who voted to grant rehearing in Amgen Inc. v. Hoechst
    Marion Rousell, Inc.
    , 469
    F.3d 1039 (Fed. Cir. 2006), and contrary to the Solicitor General's views on
    the matter, the evidence suggests that the active members of the Federal
    Circuit are almost evenly split on the question of whether to grand en banc
    review, and by implication revisit the Court's decision in Cybor.  And an honest assessment of the Federal
    Circuit's jurisprudence supports the Petitioner's view that the Federal Circuit
    is split, at least loosely, into those judges who believe that claims must be
    strictly construed according to the specification in order to limit their scope
    to "what the inventor has invented," and those judges who believe
    that the plain meaning of the claim language is the primary determinant of the
    scope and meaning of the claims.  The
    Solicitor General discounts this evidence in encouraging the Supreme Court not
    to grant cert.  In view of the cases
    where the Supreme Court has already granted certiorari this term, and the continuing pattern
    of the Court to ignore the recommendations of the Solicitor General's Office,
    and the apparently unsettled posture of the question of claim construction in
    the Federal Circuit, there is a fair likelihood that the Supreme Court will decide that
    its supervision is required in yet another area of patent law.