•     By Sherri
    Oslick

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


    Biogen Idec, Inc. et al. v. Glaxosmithkline LLC et al.
    3:10-cv-00608; filed March 24, 2010 in the Southern
    District of California

    • Plaintiffs: 
    Biogen Idec, Inc.; Genentech, Inc.
    • Defendants:  Glaxosmithkline LLC; Glaxo Group Ltd.

    Infringement of U.S. Patent No. 7,682,612 ("Treatment
    of Hematologic Malignancies Associated with Circulating Tumor Cells Using
    Chimeric Anti-CD20 Antibody," issued March 23, 2010) based on GSK's
    manufacture and sale of its Arzerra product (ofatumumab, used to treat chronic
    lymphocytic leukemia).  View the
    complaint
    here.


    Gen-Probe Inc. v. Becton, Dickinson & Co.

    3:10-cv-00602; filed March 23, 2010 in the Southern
    District of California

    Infringement of U.S. Patent No. 7,560,255 ("Automated
    Process for Detecting the Presence of a Target Nucleic Acid in a Sample,"
    issued July 14, 2009), 7,524,652 (same title, issued April 28, 2009), 7,482,143
    (same title, issued January 27, 2009), and 7,118,892 (same title, issued
    October 10, 2006) based on BD's manufacture and sale of its BD MAX System
    nucleic acid testing system.  View
    the complaint
    here.


    Eli Lilly & Co. v. Hospira, Inc.
    1:10-cv-00346; filed March 23, 2010 in the Southern
    District of Indiana

    Infringement of U.S. Patent Nos. 4,808,614 ("Difluoro
    Aantivirals and Intermediate Therefore," issued February 18, 1989) and
    5,464,826 ("Method of Treating Tumors in Mammals with 2',2'-difluoronucleosides,"
    issued November 7, 1995) following a Paragraph IV certification as part of Hospira's
    filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to
    manufacture a generic version of Lilly's Gemzar® (gemcitabine hydrochloride for
    injection, used to treat non-small cell lung cancer, pancreatic cancer, breast
    cancer, and ovarian cancer).  View
    the complaint
    here.


    Sanofi-Aventis U.S. LLC et al. v. Wockhardt Ltd. et al.
    3:10-cv-01471; filed March 23, 2010 in the District
    Court of New Jersey

    • Plaintiffs: 
    Sanofi-Aventis U.S. LLC; Aventisub II INC.; Carderm Capital L.P.
    • Defendants: 
    Wockhardt Ltd.; Wockhardt USA LLC; Wockhardt USA Inc.

    Infringement of U.S. Patent Nos. 7,138,524 ("Processes
    for Preparing Anhydrous and Hydrate Forms of Antihistamine Piperidine
    Derivatives, Polymorphs and Pseudomorphs Thereof," issued November 21,
    2006), 7,135,571 ("Processes for Preparing Anhydrous and Hydrate Forms of
    Antihistaminic Piperidine Derivatives, Polymorphs and Pseudomorphs Thereof,"
    issued November 14, 2006), 6,399,632 ("Method of Providing an
    Antihistaminic Effect in a Hepatically Impaired Patient," issued June 4,
    2002), 6,187,791 (same title, issued February 13, 2001), and 6,037,353 (same
    title, issued March 14, 2000) following a Paragraph IV certification as part of
    Wockhardt's filing of an ANDA to manufacture a generic version of Aventis'
    Allegra-D® 12 Hour (fexofenadine hydrochloride/pseudoephedrine, used to treat
    allergies).  View the complaint
    here.


    Meda Pharmaceuticals Inc. v. Zydus Pharmaceuticals USA, Inc.
    3:10-cv-01475; filed March 22, 2010 in the District
    Court of New Jersey

    Infringement of U.S. Patent No. 5,164,194 ("Azelastine
    Containing Medicaments," issued November 17, 1992) following a Paragraph
    IV certification as part of Zydus' filing of an ANDA to manufacture a generic
    version of Meda's Astelin® (azelastine hydrochloride nasal spray solution, used
    to seasonal allergic rhinitis). 
    View the complaint
    here.


    Promote Innovation LLC v. Sanofi-Aventis US LLC
    2:10-cv-00099; filed March 22, 2010 in the Eastern
    District of Texas

    False marking based on Sanofi-Aventis' marking of its
    DDAVP products indicating that these products are covered by U.S. Patent No.
    5,047,398 ("DDAVP Antidiuretic and Method Therefor," issued September
    10, 1991), which was declared unenforceable.  View the complaint
    here.


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

    2:10-cv-01401; filed March 17, 2010 in the District
    Court of New Jersey

    • Plaintiffs:  Warner Chilcott Co., LLC; Warner
    Chilcott (US), LLC; Mayne Pharma International Pty. Ltd.
    • Defendant:  Heritage Pharmaceuticals Inc.

    Infringement of U.S. Patent No. 6,958,161 ("Modified
    Release Coated Drug Preparation," issued October 25, 2005) following a
    Paragraph IV certification as part of Heritage's filing of an ANDA to
    manufacture a generic version of Warner Chilcott's Doryx® (modified release
    doxycycline hyclate, used to treat a variety of bacterial infections).  View the complaint
    here.


  • Calendar

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

    April
    7, 2010 –
    First
    Annual Board
    Conference
    (
    U.S.
    Patent and Trademark Office
    Board
    of Patent
    Appeals and Interferences) –
    Alexandria,
    VA

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

    April
    11-17, 2010 –
    Advanced
    Patent Courses
    (
    Patent
    Resources
    Group) –
    Bonita
    Springs, FL

    April
    14, 2010 –
    "Obviousness
    Standard for Patents
    Post-KSR: Strategies to Withstand USPTO
    Obviousness Rejections and
    Attacks on Patent Validity
    " (Strafford) – 1:00
    – 2:30 PM (EST)

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

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

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

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

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

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

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

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

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

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

  • George Washington University Law School The George Washington
    University Law School (with Howrey LLP and Cornerstone Research) will be holding
    its second annual Law Symposium on Intellectual Property on May 11, 2010 on The
    George Washington University Law School, at 2000 H Street NW, Washington, DC.  The Symposium will will offer
    presentations on the following topics:

    • Keynote Address
    — Hon. David Kappos, Under Secretary of Commerce for Intellectual Property and
    Director of the U.S. Patent and Trademark Office (USPTO);

    • Judges
    Panel:  Tips and Trends for
    Litigating in the Busiest Patent Districts in the Country — Hon. Joan Ericksen
    of the U.S. District Court of Minnesota; Hon. Jeremy Fogel of the U.S. Northern
    District Court of California; Hon. Marilyn Huff of the U.S. Southern District
    Court of California; Mary A. Woodford, Vice President of Cornerstone Research;
    and William Rooklidge (moderator) of Howrey LLP;

    • Written
    Description/Enablement Interplay: Biotech and Hi-Tech Perspectives — Todd Dickinson,
    Executive Director of the AIPLA; Sherry Knowles, Senior Vice President and
    Chief Intellectual Property Counsel of GlaxoSmithKline plc; Kevin Kramer,
    Intellectual Property Counsel of Yahoo! Inc.; Hans Sauer, Associate General Counsel
    for Intellectual Property of the Biotechnology Industry Organization (BIO);
    Willem Hoyng of Howrey LLP; and Terri Gillis (moderator) of Howrey LLP;

    • Luncheon Address
    — Hon. Chief Judge Paul R. Michel, U.S. Court of Appeals for the Federal
    Circuit;

    • Strategic Management
    of an Intellectual Property Portfolio in Hard Economic Times — John Cheek,
    Senior Corporate Counsel of Caterpillar Inc.; Amy Hamilton, Vice President and
    Deputy General Patent Counsel of Eli Lilly and Company; Jeff Ranck, Associate
    General Counsel of Microsoft Corp.; Kirk Dailey, Vice President of Intellectual
    Property Strategy of Mobile Devices Business, Motorola Inc.; Shailendra
    Bhumralkar, Vice President of Intellectual Property Portfolio Development of SAP;
    and Jonathan Retsky (moderator) of Howrey LLP; and

    Bilski v. Kappos:  Multiple Industry Views — John Duffy,
    Professor of Law at The George Washington University Law School; F. Scott
    Kieff, Professor of Law at The George Washington University Law School; Rusty
    Day of Howrey LLP; Matt Wolf of Howrey LLP; Mark Glueck, Chairman of The
    CapAnalysis Group, LLC; and Mark Whitaker (moderator) of Howrey LLP.

    Additional
    information about the Symposium, including a program, list of speakers, and
    directions can be found at the Symposium's website.
     A cocktail reception will take place
    following the Symposium.

    The registration
    fee for the Symposium is $25 (GW IP Law Student), $195 (government employees),
    $295 (GW Law School Alumni or IP Advisory Board), or $395 (regular
    registration).  Those interested in
    registering for the Symposium can do so here.

  • London Pharma IQ will be
    holding its 5th Annual Pharmaceutical & Biotech Patent Litigation
    Strategies conference on May 24-26, 2010 in London, England.  The conference will allow attendees to:

    • Protect a patent
    portfolio through implementation of the best practice policy and efficient
    management strategies;
    • Discover the
    intricate relationship between the EPO and the London Patents Court to
    understand the affect it has on EPO decisions and Patent Court judgments;
    • Defend a patent
    portfolio against attack on the grounds of obviousness through strategies of
    obviousness attacks and defense in the UK;
    • Understand
    preliminary injunctions to enable an efficient obtainment and explore important
    recent case decisions; and
    • Prepare for a
    patent litigation in court by considering the European Court perspectives.

    Brochure-1 In particular, the
    conference will offer presentations on the following topics:

    • Patent litigation
    from a practical corporate perspective: 
    The internal and external organization need;
    • Review of recent
    European cases and decisions to understand and implement best practice
    strategies for the future;
    • International
    patent litigation:  Do less, gain
    more;
    • An update on
    current trends in patent litigation;
    • A comparison of
    biosimilars legislation and Hatch-Waxman Act procedures in the U.S.A.;
    • Best practice
    strategies to manage patent protection;
    • Exploring the
    application of Supplementary Protection Certificates (SPCs) to extend patent
    life and in turn, maximize profit;
    • Pro-competitive
    aspects of patent settlements;
    • P.I.T. STOP
    1:  Panel discussion:  Exploring the implications of changes
    to antitrust laws on patent litigation;
    • From Pan-European
    litigation to the Patents County Court;
    • The view from the
    Intellectual Property Office of the UK;
    • Assessment of
    inventive step in the UK;
    • An overview of
    preliminary injunctions in Denmark;
    • The London
    Patents Court v. the EPO;
    • P.I.T. STOP:  The view of the Courts;
    • The view of the
    Courts:  Interactive panel
    discussion; and
    • The inequitable
    conduct defense in U.S. patent litigation:  A shield, a sword, a scourge and a trap for the unwary.

    The agenda for the
    Pharmaceutical & Biotech Patent Litigation Strategies conference can be
    found here (Day 1) and
    here (Day 2).  A complete brochure for this
    conference, including an agenda, list of speakers, and registration form can be
    downloaded here.

    Three
    pre-conference workshops will be offered on May 24, 2010:

    The first workshop, entitled "The Best
    Practice Strategies for Drafting and Litigating Your Patent," will be
    offered from 9:00 to 11:30 am, and will allow attendees to understand the
    evolving IP landscape in emerging markets in order to protect a patent
    portfolio effectively, cover key factors that must be considered when
    litigating in various countries, and provide examples of best practice
    strategies from recent cases.
    The
    second workshop, entitled "Protecting Your Product and Conducting Pre-suit
    Investigations in the U.S.," will be offered from 12:00 to 2:30 pm, and
    will provide a review of listing patents in the FDA Orange Book and using
    different regulatory exclusivity periods to protect products in the U.S.,
    methods for assessing the strength of a case in the face of generic challenge
    in the U.S., and considerations regarding whether and where to file a
    litigation in the U.S.
    The third
    workshop, entitled "Review of Recent Case Law, Settlements, Competition
    Law and Best Practice Strategies for Protecting a Patent Portfolio," will
    be offered from 3:00 to 5:30 pm, and will provide a review of recent case law,
    an overview of preliminary injunctions, how to protect against irreparable harm
    and damages, an outlook to the future and foresight for the changing IP
    landscape.

    Pharma IQ The registration
    fees for the conference and focus day are as follows:  £499 (one workshop), £1,998 (conference and one workshop),
    £2,497 (conference and two workshops), and £3,495 (conference and three
    workshops).  Those registering on
    or before April 16, 2010 will receive a discount of £100 (conference alone),
    £200 (conference and one workshop), £300 (conference and two workshops), or
    £400 (conference and three workshops) off the registration fee.  Those interested in registering for the
    conference can do so here.

    Patent Docs is a media partner of Pharma IQ's Pharmaceutical & Biotech Patent
    Litigation Strategies conference.

  •     By Kevin E. Noonan

    Applera The Federal Circuit waded into the question of
    patent ownership in a dispute between a patent attorney and Applera-Applied
    Biosystems over patents involving nucleic acid sequencing technology in Applera Corp. v. Illumina, Inc.  The case is unusual in at least three
    respects:  the inventor is a lawyer, not a scientist; the patents are
    substantially prophetic in a technology that is heavily dependent on
    experimental results; and the dispute was resolved not on the basis of a patent
    law issue but with the Federal Circuit interpreting the provisions of California
    employment law.  The result, while
    nonprecedential, does shed some light on how these issues are intimately
    dependent on the underlying facts of the inventor's employment as well as the
    provisions of state law (which, in view of its variability, prevents there
    being any definite rubrics from this decision for resolving these issues).

    The patents at issue were U.S. Patent Nos.
    5,750,341; 5,969,119; and 6,306,597 (all three patents are related).  All three name Stephen Macevicz, Ph.D. as inventor.  While employed as a patent
    attorney for Applera, Dr. Macevicz developed a method for nucleic acid
    sequencing based on "repeated rounds of ligation and cleavage of
    oligonucleotide probes."  Claim 1 of the '597 patent is illustrative of these methods:

    1.  A method for identifying a sequence of nucleotides in a
    polynucleotide, the method comprising the steps of:
        (a)  extending an
    initializing oligonucleotide along the polynucleotide by ligating an
    oligonucleotide probe thereto to form an extended duplex;
        (b)  identifying one or
    more nucleotides of the polynucleotide; and
        (c)  repeating steps (a)
    and (b) until the sequence of nucleotides is determined.

    It is undisputed that Dr. Macevicz did not inform
    Applera of these applications while they employed him.  It is also undisputed that these
    patents stemmed from related but distinct technology developed by Sydney Brenner, a Nobel Prize-winning
    biologist for whom Dr. Macevicz had prepared and prosecuted patents for the
    technology.  (Curiously, he
    performed this patent prosecution work for Dr. Brenner while being employed by
    Applera, who apparently had a policy of allowing their patent professionals to
    take on "outside work.")  Finally, it is undisputed that Applera was given the opportunity to
    license Dr. Brenner's patents but declined based on its determination that
    the technology was
    "'far
    too expensive' and 'complex and thus not a 'viable commercial product' for
    Applera."  Thereafter, Applera
    acquired Agencourt Personal Genomics, which had developed its own "ligation-and-cleavage"
    sequencing technology and formed the basis of Applera's "SOLiD™ System DNA
    sequencing technology."  Dr.
    Macevicz had moved on to Solexa by this time, which licensed both Dr. Brenner's
    patents as well as Dr. Macevicz's.  The instant lawsuit resulted from Applera filing a declaratory judgment
    action claiming ownership of Dr. Macevicz's patents, as well as
    non-infringement and invalidity.

    Solexa Solexa won
    jury verdicts in its favor on the ownership issues and that claim 1 of the '119
    patent was not invalid, but the jury also determined that this claim was not
    infringed by Applera.  The District Court denied the parties' motions for JMOL.

    The Federal
    Circuit, in an opinion by Judge Moore joined by Judges Lourie and Gajarsa,
    considered three contested issues:  patent ownership, non-obviousness of claim 1 of the '119 patent, and
    claim construction of claim 1 of the '597 patent (which the parties stipulated
    was not infringed under the District Court's interpretation).  On the ownership issue, the Federal
    Circuit construed the provisions of Dr. Macevicz's employment agreement with
    Applera, which provided that Dr. Macevicz was obligated to assign any
    inventions he developed while employed by Applera unless:

    (1)  the
    invention was developed entirely on his own time;
    (2)  "no equipment, supplies, facility, or trade secret of the
    Company was used in its development"; and
    (3)  "(i)
    it does not relate to the business or actual or demonstrably anticipated
    research or development of the Company, or (ii) it does not result from any
    work performed by [him] for the Company."

    The jury by
    special verdict found that Dr. Macevicz satisfied all three of these
    provisions.  According to the
    opinion, the first provision was not in dispute.  Dr. Macevicz's satisfaction of the second provision stemmed
    from the singular nature of his invention — it was purely prophetic and there
    was no experimental verification in the specification — as well as from Dr.
    Macevicz's sagacity in "detail[ing] his inventions in a laboratory
    notebook he purchased himself."  There was a secondary issue of whether Dr. Macevicz had utilized any of
    Applera's trade secrets, specifically the work of an Applera scientist (Dr.
    Fung), but there was substantial evidence that Dr. Fung's work was unrelated to
    conception of Dr. Macevicz's invention.

    The question
    to be decided by the panel was whether the jury's determination that the third
    criterion was satisfied was supported by substantial evidence.  The parties disagreed on whether Dr.
    Macevicz needed to satisfy only one (Solexa) or both (Applera) provisions of
    this criterion, i.e., whether Dr.
    Macevicz's invention did not "relate to the business or actual or
    demonstrably anticipated research or development of the Company," or did
    not "result from any work performed by [him] for the Company."  This question came down to a matter of
    contract interpretation, which the Federal Circuit said was a state law question, subject
    to the Court's de novo review.  In analyzing this issue, the Court
    cited a California Court of Appeals case, Cubic
    Corp. v. Marty
    , and how that court construed the provisions of a "similar
    provision" (§ 2870) of the California Labor Code, which reads as follows:

    Any
    provision in an employment agreement which provides that an employee shall assign
    or offer to assign any of his or her rights in an invention to his or her
    employer shall not apply to an invention for which no equipment, supplies,
    facility, or trade secret information of the employer was used and which was
    developed entirely on the employee's own time, and
        (a)  which does not relate
            (1)  to the business of the employer or
            (2)  to the employer's actual or demonstrably anticipated research
    or development, or
        (b)  which does not result from any work performed by the employee
    for the employer.
        Any provision, which purports to apply to such an invention, is to
    that extent against the public policy of this state and is to that extent void
    and unenforceable.  Cal. Lab. Code §
    2870 (West 1979).

    In the Cubic
    case, the California court held that unless both conditions (a) and (b) were
    met, the contract was enforceable under California law.  Here, the Federal Circuit distinguished
    Cubic, deciding that the better view (and one that the panel was not convinced
    the California Supreme Court would dispute) was to construe the language of the
    employment agreement according to the plain meaning of its terms.  Thus, the CAFC held that the
    provisions of the third criterion were in the alternative, i.e., disjunctive
    not conjunctive, and that if Dr. Macevicz satisfied either provision, then there
    was substantial evidence to support the jury's determination that he was not
    obligated to assign his rights to Applera.  The panel found that there was substantial evidence that Dr.
    Macevicz's inventions did not result from any work he performed for
    Applera.  This conclusion was
    supported by the existence of another patent on nucleic acid sequencing Dr.
    Macevicz obtained before he began working for Applera, refuting Applera's
    contention that his work for them was the basis for conception of the
    inventions disclosed and claimed in the patents-in-suit.

    The
    non-obviousness question regarded claim 1 of the '119 patent:

    1.  An oligonucleotide probe of the
    formula:

    HO—(3')(B)j(5')—OP(=O)(O—)NH—(B)k-Bt*

    wherein:
    B is a nucleotide or an analog thereof;
    j is in the range of from 1 to 12;
    k is in the range of from 1 to 12, such that the sum of j and k is
    less than or equal to 12;
    Bt* is a
    labeled, nonextendable chain terminating moiety.

    It was not disputed that the prior art disclosed
    every aspect of the oligonucleotide recited in this claim except that the
    chain-terminating moiety, Bt, comprised a label.  Also undisputed was that labeled oligonucleotides were known
    in the prior art.  The
    question of whether the skilled worker would have been motivated to combine
    these references (or, in the language of KSR
    v. Teleflex
    , whether there would have been a reasoned basis to do so) was
    presented to the jury as a factual question, with each parties' contentions
    supported by expert testimony.  According to the Federal Circuit, "[t]he jury apparently found the
    testimony of Solexa's expert more credible.  We will not disturb its verdict."

    Finally, regarding construction of claim 1 of the '597
    patent (set forth above), the issue before the Court was the meaning of the
    following terms:

    • "extending an initializing oligonucleotide along the
    polynucleotide by ligating an oligonucleotide probe thereto to form an extended
    duplex" in step (a);
    • "identifying" in step (b)
    and
    • "repeating steps (a) and (b)
    until the sequence of nucleotides is determined" in step (c).

    Illumina Solexa argued that the
    first term must be interpreted to mean that "
    each oligonucleotide probe must be
    ligated to an initializing nucleotide during repetition of the cycle"
    rather than that "the oligonucleotide probe can be ligated to an extended
    duplex (an initializing probe that has already been extended by an
    oligonucleotide probe)."  The District Court disagreed,
    interpreting the claim to require that "step (a) includes an
    extension process, whereby, with each repetition, an additional probe is added
    to what is already there, so that the chain gets longer and longer."  In construing the claim in agreement
    with the District Court, the Federal Circuit referenced the specification, "which
    repeatedly describes regenerating an extendable end on the extended duplex to
    allow for successive cycles of ligation."

    Regarding the meaning of the term "identifying" in step
    (b) of the claimed method, the District Court construed the term to mean that "at
    least one nucleotide [is] identified during step (b), that is, its identity as
    an A, G, C or T must be determined."  The Court also construed step (c) as requiring such
    identification to occur during each cycle of repeating steps (a), (b) and
    (c).  Solexa argued that the use of
    the word "comprising" meant that the method could be practiced in
    such a way that the identifying step was "skipped" in some iterations
    of the method, and then multiple nucleotides identified by the end of the
    process.

    The Federal Circuit disagreed with Solexa's
    interpretation, citing
    Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed. Cir. 2007)
    that "'[c]omprising' is not a weasel work with which to abrogate claim
    limitations."  Again
    consulting the specification, the panel held that the invention was described
    as comprising repeated cycles of the steps (a), (b) and (c), and that "in
    order to repeat steps (a) and (b)" (as required in step (c)), "one
    must actually perform step (b)."  Moreover, the Court cited the prosecution history of the '597 patent to
    reject Solexa's construction of step (c), affirming the District Court's
    construction giving the words of claim step (c ) their ordinary and customary
    meaning.

    Applera Corp. v. Illumina, Inc. (Fed. Cir. 2010)
    Nonprecedential diposition
    Panel: Circuit Judges Lourie, Gajarsa, and Moore
    Opinion by Circuit Judge Moore

  •     By
    Donald Zuhn

    PUBPAT Last
    week, in a letter
    addressed to Senate Judiciary Chairman Patrick Leahy (D-VT) and Ranking Member
    Jeff Sessions (R-AL), Public Patent Foundation (PUBPAT) Executive Director
    Daniel Ravicher expressed "deep concern" over the Committee's addition
    of a provision
    to the Senate patent reform bill (S. 515) that would eliminate qui
    tam
    false patent marking suits.  Earlier this month, the Senate
    Judiciary Committee released a Manager's Amendment for S. 515 that would only
    allow "[a] person who has suffered a competitive injury as a result of a [patent
    marking] violation [to] file a civil action in a district court of the United
    States for recovery of damages adequate to compensate for the injury" (see "Qui Tam Actions in Senate Sights").

    In
    its letter to Senate leadership, PUBPAT contends that the new provision "would
    eliminate an important method of protecting the public from false and deceitful
    statements," and therefore, should be removed from the legislation.  The letter asserts that "[f]alsely
    marking an unpatented item as patented harms the public by misleading consumers,
    deterring competition, and depriving legitimate patentees of the marketplace
    distinction they deserve," and states that "[b]y offering citizens a
    share of recovery in suits they bring on behalf of the government against false
    markers, the statute provides an incentive for citizens to expend time and
    resources to keep manufacturers honest," while saving the government from
    having to bear the expense of prosecuting such actions.

    Since
    the December 28, 2009 decision in Forest
    Group, Inc. v. Bon Tool Co.
    , the number of qui tam lawsuits that have been filed has topped one hundred, including
    at least fifteen suits against biotech or pharma companies:

    Simonian v. Allergan, Inc.,
    March 9, 2010

    Simonian v. Abbott Laboratories
    ,
    March 9, 2010

    Simonian v. Amgen Inc.
    ,
    March 9, 2010

    Simonian v. Baxter Healthcare Corp.
    ,
    March 9, 2010

    Simonian v. Astellas Pharma US, Inc.
    ,
    March 9, 2010

    Hollander v. Ortho-McNeil-Janssen
    Pharmaceuticals, Inc.
    , March 1, 2010
    Simonian v. Merck & Co., Inc.
    ,
    February 25, 2010

    Simonian v. Novartis Pharmaceuticals Corp.
    ,
    February 25, 2010

    Simonian v. Novartis Consumer Health, Inc.
    ,
    February 24, 2010

    Simonian v. Novartis Consumer Health, Inc.
    ,
    February 24, 2010

    Public Patent Foundation, Inc. v. Novartis
    Consumer Health, Inc.
    , February 24, 2010
    O'Neill v. Roche Diagnostics Corp.
    ,
    February 23, 2010

    Simonian v. Pfizer, Inc.
    ,
    February 23, 2010

    Simonian v. Merial L.L.C.
    ,
    February 23, 2010

    Hollander v. Ranbaxy Laboratories Inc.
    ,
    February 23, 2010

    (see "Court Report," March 14,
    2010
    ; March 7, 2010;
    March 1, 2010).  Referring to the large number of recent
    suits, the PUBPAT letter states that:

    Arguments forecasting the rise of a
    "cottage industry" of false marking suits [citing "Pfizer,
    P&G Sued as Part of New 'Cottage Industry
    ,' Bloomberg.com]
    are completely overblown.  While
    there indeed has been a surge in such suits recently, this will undoubtedly
    lead to a virtual extinction of the practice [of false patent marking].  Once manufacturers get the message that
    attempting to deceive the public with false patent markings will be punished,
    they will stop doing so and the need to bring such suits will disappear.  To be sure, false marking plaintiffs
    will work themselves out of a job very quickly.  If, however, you change the statute to disarm citizens from
    policing the market for false patent markings, then the harmful practice will
    continue unabated, to the severe detriment of the public.

    The
    letter offers two checks to "potential windfalls" to citizen
    plaintiffs:  first, that the
    statute only applies to those who falsely mark "for the purpose of
    deceiving the public," and second, that district court judges have "wide
    discretion" to set appropriate fines for false patent marking
    violations.  PUBPAT also notes that
    half of each fine goes to the Federal government.

    Washington - Capitol #6 PUBPAT
    also sent a separate letter
    to House leadership in which Mr. Ravicher "applaud[ed a recent House] statement
    that 'a number of changes are essential' to the patent reform bill proposed by
    the Senate Judiciary Committee before the House will consider it."  In the letter, addressed to House
    Judiciary Chairman John Conyers, Jr. (D-MI), and Ranking Member Lamar Smith (R-TX),
    PUBPAT asked that the House "protect the existing qui tam provision." 
    The letter to House leadership was otherwise similar to the letter to
    Senate leadership.

    In
    a press release issued last Friday, PUBPAT called the Senate false patent
    marking proposal "surprising," adding that it would "substantially
    eviscerate the current law against false patent marking that has been in place
    for over one hundred and fifty years."  The release noted that the new provision would completely
    eliminate false patent marking suits in some markets because in those markets "there are no competitors, and thus no one would be able to pursue a
    company for deceitfully marking its products as patented."

  •     By Suresh Pillai

    Settlement Announced in Carbatrol® Suit

    Shire Pharmaceuticals The U.S. District Court for the District of New
    Jersey has approved a settlement of the infringement suit between plaintiff
    Shire LLC and defendant Nostrum Pharmaceuticals Inc. concerning
    the alleged infringement of U.S. Patent Nos. 5,326,570 and 5,912,013.  According to Shire's complaint, filed
    in 2008 (see "Court Report," July 6, 2008),
    Nostrum's proposed generic version of Shire's epilepsy drug, Carbatrol®, would
    infringe both of the patents-in-suit.  The patents cover extended-release, immediate-release, and
    enteric-release versions of Carbatrol®.  Shire was made aware of Nostrum's intent to market its generic version of the drug upon
    Nostrum's filing of an Abbreviated New Drug Application (ANDA) with the FDA.

    Under the terms of the settlement agreement, Shire
    has will grant Nostrum a license to both of the patents-in-suit in
    exchange for Nostrum's acknowledgment that both patents are valid and
    enforceable.  Other terms of the
    settlement agreement were not disclosed.

    Read the District Court's Judgment and Order of Permanent Injunction here.


    Genentech Files Counterclaims in Arzerra®
    Infringement Suit

    GlaxoSmithKline - GSK In the latest development in GlaxoSmithKline's declaratory judgment suit concerning U.S. Patent No. 6,331,415,
    the patent holder, Genentech, recently filed its answer and counterclaims.  In its complaint, GSK contended that its cancer drug Arzerra®
    does not infringe the
    '415 patent,
    and that the '415 patent is invalid and unenforceable (see "Court Report,"
    February 21, 2010).  In response, Genentech has alleged that GSK's marketing of Arzerra® infringes the '415 patent.

    Genentech The patent-in-suit concerns methods of
    using recombinant techniques for designing antibodies that act in a manner
    similar to those produced naturally.  GSK had originally filed for an accelerated approval for Arzerra®, and
    upon the FDA's approval of the drug in October, GSK immediately began marketing
    it.  In addition to the answer and
    counterclaims, Genentech also filed a motion seeking to transfer the case from
    the District Court for the Northern District of California to the District
    Court for the Central District of California.  Read Genentech's Answer
    here.


    Covidien
    Prevails in Infringement Suit Versus
    Applied Medical

    Covidien The U.S. District Court for the
    Eastern District of
    Texas has found Applied Medical Resources Corp.
    liable for infringement of U.S. Patent No. 5,895,377,
    which is held by Covidien
    PLC
    .  The '377 patent, which is directed to a valve
    system for cannula
    assembly in a surgical device, was issued to U.S. Surgical,
    a Covideien subsidiary and co-plaintiff in the suit.  In
    addition to the finding of infringement, the District Court also found
    that another
    patent-in-suit, U.S. Patent No. 5,895,377
    (also issued to U.S. Surgical) was invalid on grounds of obviousness. 
    The original suit was filed by Tyco
    Healthcare Group

    in 2006.  Subsequently, Covidien
    was formed as a spin-off from Tyco.  U.S. Surgical was
    added as a party following Applied Medical's assertion
    that U.S. Surgical was the true owner of all the patents-in-suit.

    Applied Medical The District Court
    concluded that Applied Medical had
    infringed a single claim of the '377 patent and ordered Applied Medical
    to pay $4.8 million in damages.

  •     By Donald Zuhn

    Clipboard Earlier
    this year, we
    released our annual list of top biotech/pharma stories (see "Top Stories of 2009: #4 to #1").  At
    the top of our list, we placed the biotech/pharma industry's attempts to
    recover from the Great Recession.  Back in February of 2009, we noted
    that
    almost a third of the Biotechnology Industry Organization's membership
    had less
    than six months of cash on hand, 45% had less than one year of cash
    remaining,
    and only 10% of the 370 publicly-traded biotechnology companies reported
    a
    positive income.  Last April, the National Venture Capital Association
    (NVCA) and PricewaterhouseCoopers announced that venture capitalists had
    invested $3.0 billion in 549 deals in the first quarter of 2009, a 47%
    decrease
    in terms of dollars invested and a 37% decrease in terms of the number
    of deals
    as compared with the fourth quarter of 2008 — levels of venture funding
    that
    had not been seen since 1997.

    As 2009
    wore on, some of
    the negative indicators appeared to be giving way to more positive
    signs. 
    Last August, Nashville-based Cumberland Pharmaceuticals snapped a
    two-year
    industry dry spell when it conducted an initial public offering (IPO)
    that
    raised $85 million, and in October, Talecris Biotherapeutics and Omeros
    Corp.
    conducted their own IPOs, raising $950 million and $68.2 million,
    respectively.  Other biotech/pharma companies have filed for IPOs since
    then (although a few recent biotech/pharma IPOs have produced somewhat
    disappointing results).  With respect to venture funding, VentureDeal's
    latest quarterly VC funding report indicated that biotech funding
    increased a
    "whopping" 65% during the fourth quarter of 2009 (see "VentureDeal Report Shows 65% Increase in Fourth Quarter Biotech Venture Funding"), and while the NVCA's report for
    the
    same period was less promising, the NVCA noted that the life sciences
    sector
    received the highest level of funding when compared with the other
    sixteen
    sectors the organization tracks.

    However,
    while IPOs and
    venture funding levels speak to the impact of the recession on the
    biotech/pharma industry as a whole, these indicators provide little
    information
    regarding the impact of the recession on biotech/pharma patent practice
    in
    particular.  In order to get a better handle on the impact of the
    recession on biotech/pharma patent practice, we have begun to analyze
    data
    available at the U.S. Patent and Trademark Office website and other
    sources.  While this analysis progresses, we thought it might be a good
    idea to solicit comments from Patent Docs
    readers who have responded in the past to our call for an identification
    of
    "bad" patents (see "A Simple Question about Patent Quality")
    and
    ways to address the problems facing the USPTO after Tafas/GSK (see
    "Post-GSK: Where Do We Go from Here?").

    So, our
    question to readers
    is this:  How has the recession impacted your patent practice?  In
    particular, has it changed the way you prosecute applications or
    litigate
    cases, and if so, how?  We would appreciate any and all comments you may
    have on the topic.  You may feel free to provide such comments in
    response
    to this post, e-mail them to the Patent
    Docs
    Gmail address (PatentDocs@gmail.com), or e-mail them
    directly to
    me (zuhn@mbhb.com).
     If
    you would prefer that we withhold your name from any future posts on
    this subject, just let us know.  Over the next few weeks, we will
    collect
    your comments, perhaps post a few short surveys, and then report back
    with the
    results.  We thank you in advance for the help.

  •     By Kevin E. Noonan

    Federal Circuit Seal It's settled, then — unless the Supreme Court
    decides to weigh in, there is a
    separate written description requirement in 35 U.S.C. § 112, first paragraph.  The precedent developed since Regents of the University of California v.
    Eli Lilly & Co.
    is good law.  This is the judgment of the Federal Circuit in an opinion by the en banc Court, written (appropriately)
    by Judge Lourie, and joined by every member of the Court except (predictably)
    Judge Linn and soon-to-be Chief Judge Rader.

    The en banc
    opinion addressed all of Ariad's arguments, and found in favor of Lilly.  Ariad helped the Court in arriving at
    this decision, in how it framed its responses to the questions presented by acknowledging
    that the statute contained a requirement for a written description.  Ariad's position, according to the opinion, was that the measure of whether the written description was
    satisfied was enablement, and here the Court parted ways with Ariad's argument.  The Court characterized this situation
    as the parties agreeing that the specification must contain a written
    description of the invention, but disagreeing on the standard for fulfilling it
    (as well as whether the requirement applies to originally-filed claims).  The Court discussed Ariad's
    grammatical construction of 35 U.S.C. § 112, first paragraph, and particularly
    the argument regarding the significance of the comma after the phrase "and
    the manner and process of making and using it," and decided that Lilly's
    interpretation is the correct one.  Specifically, the Court held that § 112, first paragraph, contains two separate description
    requirements:  a written
    description of the invention and a written description of how to make and use
    it.  The Court dismissed the
    grammatical argument thusly:

    [W]e see nothing in the statute's
    language or grammar that unambiguously dictates that the adequacy of the "written
    description of the invention" must be determined solely by whether that
    description identifies the invention so as to enable one of skill in the art to
    make and use it.

    Ariad The argument rests on the parallelism of the
    language (an analysis that forms one of the bases for Judge Rader's dissent,
    joined by Judge Linn).  The Court
    also dismissed Judge Linn's position, that enablement is sufficient to satisfy
    the requirement of § 112, first paragraph, but on the backs of several of the
    amici's arguments (Judge Linn makes his "enablement is enough"
    argument in a separate dissent, joined by Judge Rader).  According to the en banc opinion, this
    reading of the statute renders either "and the manner and process of
    making and using it" or "[a written description] of the invention"
    as surplusage, "violating the rule of statutory construction that Congress
    does not use unnecessary words," citing U.S. v. Menasche, 348 U.S. 528, 538-39 (1955).  The Court completed this portion of its
    analysis by citing previous versions of the Patent Act, as well as first
    principles:  "[e]very patent
    must describe an invention.  It is
    part of the quid pro quo of a patent; one describes an invention, and, if the
    law's other requirements are met, one obtains a patent."

    The en banc Court then reviewed the several instances of Supreme Court precedent raised by
    the parties, including Evans v. Eaton,
    O'Reilly v. Morse, Schriber-Schroth Co. v. Cleveland Trust Co.,
    and Festo Corp. v. Shoketsu Kinzoku Kogyo
    Kabushiki Co
    ., agreeing with Lilly that this precedent recognizes a written
    description requirement that is separate from the enablement requirement of § 112,
    first paragraph.  And the Court
    rejected the argument that interpreting § 112, first paragraph, as containing a
    separate written description requirement conflicts with § 112, second
    paragraph, saying that the claims "define the subject matter that, after
    examination, has been found to meet the statutory requirements for patent";
    their purpose is not to describe the invention, but "to provide notice of
    the boundaries of the right to exclude and to define [the] limits" of the
    invention.

    Lilly The Court also held that stare decisis principles required its decision.  Having expounded on the existence of a
    separate written description requirement for over forty years, the Court held
    that they must "tread lightly"
    in upsetting the "settled expectations" of the patenting
    community.  "If the law of
    written description is to be changed, contrary to sound policy and the uniform
    holdings of this court, the settled expectations of the inventing and investing
    communities, and PTO practice, such a decision would require good reason and
    would rest with Congress."  The Court also opined that, while its use of the term "possession"
    regarding the written description requirement has "never been very
    enlightening," at the same time the Court had consistently applied the law
    in this area.  And any
    inconsistencies in the application of the law in this area arose, according to
    the Court, because satisfaction of the written description requirement is a
    question of fact, and the different facts in each case (and arguments based on
    those facts) produced (not unexpectedly) varied conclusions.  Thus, the Court did not intend to attempt
    to set forth any "bright line rules," for example, with regard to the
    number of species required to adequately describe a genus (thus dashing any
    hopes that this particular area of uncertainty would be settled by this
    opinion).  However, there were "a
    few broad principles" that the Court said "hold across all cases":

    We have made clear that the written
    description requirement does not demand either examples or an actual reduction
    to practice; a constructive reduction to practice that in a definite way
    identifies the claimed invention can satisfy the written description
    requirement.  Falko-Gunter Falkner v.
    Inglis
    , 448 F.3d 1357, 1366-67 (Fed. Cir. 2006).  Conversely, we have
    repeatedly stated that actual "possession" or reduction to practice
    outside of the specification is not enough.  Rather, as stated above, it is the
    specification itself that must demonstrate possession.  And while the description
    requirement does not demand any particular form of disclosure, Carnegie Mellon Univ. v. Hoffmann-La Roche
    Inc., 541 F.3d 1115, 1122 (Fed. Cir.
    2008), or that the specification recite the claimed invention in haec verba, a description that merely
    renders the invention obvious does not satisfy the requirement, Lockwood v. Am. Airlines, 107 F.3d 1565,
    1571-72 (Fed. Cir. 1997).

    The
    majority opined that while there may be many instances where there is "little
    difference" between describing an invention and enabling it, that will not
    always be the case, particularly in the chemical and biotechnological
    arts.  A separate written
    description requirement "plays a vital role in curtailing claims that
    that
    do not require undue experimentation to make and use, and thus satisfy
    enablement, but that have not been invented, and thus cannot be described."  And "particularly for the
    biological arts," having a separate written description requirement "ensures
    that when a patent claims a genus by its function or result, the specification
    recites sufficient materials to accomplish that function."

    Turning
    to the distinction, if any, between amended claims and original claims, the Court held that the analytical differences espoused by the parties with regard
    to the case law concerning amended claims — Ariad contending that the distinction was
    based on enablement and Lilly on written description — were semantic differences
    that did not change the outcome.  Regarding original claims, the Court agreed with Lilly that, although
    rare, even original claims could encompass subject matter not sufficiently
    described to satisfy the disclosure requirements of § 112, first
    paragraph.  There is "no
    principled basis" for distinguishing the requirements of original claims
    versus amended claims, or for restricting the written description requirement
    to policing priority (including nothing in the statutory language to support
    such a limitation).  The "truism"
    that the claims are part of the original specification, as advocated by Ariad,
    does not mean that the invention has been sufficiently described merely by
    reciting it in an original claim:

    For example, a generic claim may define the boundaries of a
    vast genus of chemical compounds, and yet the question may still remain whether
    the specification, including original claim language, demonstrates that the
    applicant has invented species sufficient to support a claim to a genus.  The
    problem is especially acute with genus claims that use functional language to
    define the boundaries of a claimed genus.  In such a case, the functional claim
    may simply claim a desired result, and may do so without describing species
    that achieve that result.  But the specification must demonstrate that the
    applicant has made a generic invention that achieves the claimed result and do so
    by showing that the applicant has invented species sufficient to support a
    claim to the functionally-defined genus.

    "[G]eneric claim language appearing in ipsis verbis in the original
    specification does not satisfy the written description requirement if it fails
    to support the scope of the genus claimed."  The Court also rejected Ariad's argument that the written
    description requirement was disproportionately applied to biotechnology
    inventions:  generic language
    in an application as filed does not automatically satisfy the written
    description requirement in instances such as Fiers v. Revel, Eli Lilly
    and Enzo v. Genprobe.

    The majority also rejected Ariad's argument that the Court applied the written description requirement disproportionately to basic research
    and inventions by academics and universities.  This result is not
    inconsistent with sound
    policy that "basic" research may not lead to patentable inventions,
    characterizing the difference between "academic theories, no matter how
    groundbreaking," which are not patentable with inventions having a
    practical use, citing Brenner v. Manson
    that "[a] patent is not a hunting license.  It is not a reward for the search, but compensation for a
    successful conclusion."  While
    this situation may decrease incentives for university research, the Court is
    mindful of disincentives on "downstream research"; the goal, according to the Court, is to
    strike the right balance, which the majority believes it does:  "
    giving
    the incentive to actual invention and not 'attempt[s] to preempt the future
    before it has arrived,'" citing Fiers.

    Turning to the subject matter of the appeal, the
    Federal Circuit reversed the District Court's denial of JMOL, on the basis that
    no reasonable jury could have found for Ariad based on the facts adduced at
    trial.  Specifically, the CAFC
    held that Ariad's evidence was either directed to the wrong priority date (the
    jury having found that the patent-in-suit was entitled to a priority date in
    1989 while the majority of the evidence did not extend earlier than 1991) or
    was insufficient to support the "vast scope of these generic claims,"
    especially in view of the "gaping holes in its disclosure" and the "primitive
    and uncertain" state of the art (considerations that, admittedly, resonate
    with the Wands factors used to assess
    compliance with the enablement requirement).  The Court specifically disapproved Ariad's strategy of
    avoiding reciting any NF-kB inhibitor molecules in the claims in an effort to
    avoid the court's holding in University
    of Rochester v. G.D. Searle
    (that claims were invalid for failure to
    satisfy the written description requirement based on the failure to support a
    claim term for an inhibitor of COX-2).

    Judges Newman and Gajarsa filed separate concurring
    opinions, Judge Newman addressing the need to protect early-stage technologies
    such as those developed by universities, and Judge Gajarsa opining that the
    majority's statutory construction was "reasonable" but not the only
    (or even a preferable or necessary) way to construe the statutory disclosure requirements
    (calling the text of 35 U.S.C. § 112, first paragraph, "a model of
    legislative ambiguity").  Judge Linn dissented based on his opinion that enablement is a
    sufficient measure of the proper extent of disclosure, and Judge Rader
    dissented (vigorously) based on his entirely contrary interpretation of the
    statute.

    Regardless of these disparate voices, the Court
    majority affirmed the existence of a separate written description
    requirement.  This opinion puts to
    bed one of the many recurring examples of uncertainty that have crept into its
    jurisprudence in recent years (at least until sufficient members of the Court
    have accepted senior status and new judges bring their views to bear on the
    question).

    Ariad
    Pharmaceuticals, Inc. v. Eli Lilly & Co.

    (Fed. Cir. 2010) (en banc)

    Before: Chief Judge Michel and Circuit Judges Newman, Mayer, Lourie, Rader, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore
    Opinion by Circuit Judge Lourie, joined by Chief Judge Michel and Circuit Judges Newman, Mayer, Bryson, Gajarsa, Dyk, Prost, and Moore; additional views by Circuit Judge Newman; concurring opinion by Circuit Judge Gajarsa; dissenting-in-part and concurring-in-part opinion by Circuit Judge Rader, joined by Circuit Judge Linn; dissenting-in-part and concurring-in-part opinion by Circuit Judge Linn, joined by Circuit Judge Rader

  •     By
    Donald Zuhn

    Washington - Capitol #3 On
    Sunday night, the House of Representatives voted by a narrow 219-212 margin to
    agree to the version of the Patient Protection and Affordable Care Act (H.R.
    3590)
    that the Senate passed on December 24, 2009 (see "Follow-on Biologics News Briefs – No. 11").  Less than an hour later, the House
    added 135 pages of amendments
    to the Senate bill by a 220-211 vote. 
    Those amendments will now go to the Senate for approval.

    As
    we reported in December, the Senate bill contains a section providing for an
    approval pathway for biosimilar biological products.  This portion of the bill would preclude a biosimilar
    application from being approved "until the date that is 12 years after the
    date on which the reference product was first licensed," as well as offer
    an additional 6 months of exclusivity for the use of reference products
    "in the pediatric population." 
    We also noted in January that an effort by Sen. Herb Kohl (D-WI) to add a
    pay-for-delay provision to the Senate health care bill had failed (see "Consumer
    Groups Ask Congress to Add Pay-for-Delay Provision to Health Care Bill
    ").  The provision, which was based on a
    bill (S. 369) Sen. Kohl introduced in February 2009, would have prohibited payments
    from brand name to generic drug manufacturers with the purpose to prevent or
    delay the entry of competition from generic drugs.

    The
    additional House amendments that were passed yesterday leave the biosimilars
    portion of the Senate bill untouched, but do not add the pay-for-delay ban that
    President Obama was seeking as recently as last month.  The President had included a ban of pay-for-delay
    settlements among 34 key improvements in his health care
    proposal released prior to the Bipartisan Meeting on Health Reform (see "President's Health Care Plan
    Includes Pay-for-Delay Ban and Biosimilar Regulatory Pathway
    ").