•     By Sherri Oslick

    Gavel_2About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    The Medicines Company v. PLIVA-HRVATSKA d.o.o. et al.
    1:09-cv-00751; filed October 8, 2009 in the
    District Court of Delaware

    • Plaintiff:  The Medicines Company
    • Defendants:  PLIVA-HRVATSKA d.o.o.; PLIVA d.d.;
    Barr Laboratories Inc.; Barr Pharmaceuticals Inc.; Barr Pharmaceuticals, LLC;
    Teva Pharmaceuticals Industries Ltd.; Teva Pharmaceuticals USA Inc.

    Infringement of U.S. Patent No. 7,582,727 ("Pharmaceutical
    Formulations of Bivalirudin and Process of Making the Same," issued
    September 1, 2009) following a Paragraph IV certification as part of defendants'
    filing of an ANDA to manufacture a generic version of The Medicines Company's
    Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable
    angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint
    here.


    Glaxo Group Ltd. et al. v. Genentech, Inc. et al.
    0:09-cv-61608; filed October 8, 2009 in the
    Southern District of Florida

    • Plaintiffs:  Glaxo Group Ltd.; SmithKline
    Beecham Corp.
    • Defendants:  Genentech, Inc.; City of Hope

    Declaratory judgment of invalidity and
    non-infringement of U.S. Patent No. 6,331,415 ("Methods of
    Immunoglobulins, Vectors, and Transformed Host Cells for Use Therein,"
    issued December 18, 2001) based on GSK's manufacture and sale of its Arzerra
    product (ofatumumab, used to treat chronic lymphocytic leukemia).  View the complaint
    here.


    Pfizer Inc. et al. v. Sandoz Inc.
    1:09-cv-02392; filed October 7, 2009 in the
    District Court of Colorado

    • Plaintiffs:  Pfizer Inc.; Pfizer Pharmaceuticals,
    LLC; Pfizer Ireland Pharmaceuticals; Pfizer Ltd.; C.P. Pharmaceuticals
    International C.V.
    • Defendant:  Sandoz Inc.

    Pfizer Inc. et al. v. Sandoz Inc.
    1:09-cv-00742; filed October 6, 2009 in the
    District Court of Delaware

    • Plaintiffs:  Pfizer Inc.; Pfizer Pharmaceuticals
    LLC; Pfizer Ireland Pharmaceuticals; Pfizer Ltd.; CP Pharmaceuticals
    International CV
    • Defendant:  Sandoz Inc.

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent No. 6,455,574 ("Therapeutic Combination," issued September 24,
    2002) following a Paragraph IV certification as part of Sandoz's filing of an
    ANDA to manufacture a generic version of Pfizer's Caduet® (atorvastatin calcium — the active ingredient in Lipitor® — and amlodipine besylate — the active
    ingredient in Norvasc® — used to treat high cholesterol in combination with
    treating hypertension, angina, and/or coronary artery disease).  View the Colorado complaint
    here.


    Elan Pharma International Ltd. et al. v. Actavis Elizabeth
    LLC et al.

    1:09-cv-00744; filed October 6, 2009 in the
    District Court of Delaware

    • Plaintiffs:  Elan Pharma International Ltd.;
    Jazz Pharmaceuticals Inc.
    • Defendants:  Actavis Elizabeth LLC; Anchen
    Pharmaceuticals Inc.; Anchen Inc.

    Infringement of U.S. Patent No. 7,456,462 ("Multiparticulate
    Controlled Release Selective Serotonin Reuptake Inhibitor Formulations,"
    issued December 16, 2008) following a Paragraph IV certification as part of
    Actavis' filing of an ANDA to manufacture a generic version of Jazz's Luvox® CR
    (fluvoxamine maleate, used to treat social anxiety disorder and obsessive
    compulsive disorder).  View the
    complaint
    here.


    Teva Women's Health, Inc. v. Lupin, Ltd. et al.
    3:09-cv-05112; filed October 6, 2009 in the
    District Court of Delaware

    • Plaintiff:  Teva Women's Health, Inc.
    • Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals,
    Inc.

    Infringement of U.S. Patent No. RE39,861 ("Methods
    of Extended Use Oral Contraception," issued September 25, 2007) following
    a Paragraph IV certification as part of Lupin's filing of an ANDA to
    manufacture a generic version of Teva's Seasonale® (ethinyl estradiol and
    levonorgestrel, used as oral contraception).  View the complaint
    here.


    Boehringer Ingelheim Pharma GmbH
    & Co. KG et al. v. Kappos

    1:09-cv-01885; filed October 2, 2009 in the
    District Court of the District of Columbia

    • Plaintiffs:  Boehringer Ingelheim Pharma GmbH
    & CO. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim
    Pharmaceuticals, Inc.
    • Defendant:  David Kappos

    Review and correction of the patent term adjustment
    calculation made by the U.S. Patent and Trademark Office for U.S. Patent No.
    7,514,557 ("Process for Preparing Acyclic HCV Protease Inhibitors,"
    issued April 7, 2009).  View the
    complaint
    here.


    Apotex, Inc. et al. v. Sanofi Aventis et al.
    0:09-cv-61575; filed October 2, 2009 in the
    Southern District of Florida

    • Plaintiffs:  Apotex Corp.; Apotex, Inc.
    • Defendants:  Sanofi Aventis; Sanofi-Synthelabo,
    Inc.; Bristol-Myers Squibb Co.; Bristol-Myers Squibb Sanofi-Pharmaceuticals
    Holding Partnership

    Declaratory judgment of unenforceability of U.S.
    Patent No. 4,847,265 ("4,5-dihydro and
    4,5,6,7-tetrahydropyrazolo(1,5-A)-pyrimidines" issued July 11, 1989) based
    on defendants' failure to report all information to the FTC relating to a license
    agreement between the parties regarding Plavix ® (clopidogrel bisulfate, used
    for the reduction of atherothrombotic events).  View the complaint
    here.



  • CalendarOctober 14, 2009 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

    October 15-16, 2009 – Patent Litigation 2009 (Practising Law Institute) – Chicago, IL

    October 20-21, 2009 – 17th Forum on Biotech Patenting (C5) – London,
    United Kingdom

    October 22-23, 2009 – Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) – Philadelphia, PA

    October 26-28, 2009 – Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) – Washington, DC

    November 9-10, 2009 – Patent Litigation 2009 (Practising Law Institute) – Atlanta, GA

    November 9-11, 2009 – Developing
    IP Strategies for Crystalline Forms
    *** (
    International
    Quality & Productivity Center) –
    London,
    England

    November 10, 2009 – The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) – Baltimore, MD

    November 12-13, 2009 – Paragraph IV on Trial*** (American Conference
    Institute) – New York, NY

    November 13, 2009 – The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) – Las Vegas, NV

    November 16-17, 2009 – Patent Litigation 2009 (Practising Law Institute) – New York, NY

    November
    17-18, 2009 –
    Structuring,
    Negotiating, and Managing Pharma/Biotech Collaborative Agreements
    (
    American Conference
    Institute) – New York, NY

    December 7-8, 2009 – Foreign Patent Law &
    Regulation
    ***
    (American Conference
    Institute) – New York, NY

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

  •     By Donald Zuhn

    In August, we noted
    negative economic indicators for the biotech/pharma industry were finally giving
    way to more positive signs (see
    "Is Biotech/Pharma Beginning to Bounce Back?").  Among the positive signs was the return
    of the biotech/pharma initial public offering (IPO), with Cumberland
    Pharmaceuticals becoming the first U.S. drug company to go public in nearly two
    years, and Seattle Genetics and Inspire Pharmaceuticals announcing IPOs shortly
    thereafter.  A few additional
    biotech/pharma companies have now joined or are expected to soon join the fray.

    Omeros This week, Seattle-based
    Omeros Corp. announced
    that 6.82 million shares of its common stock would begin selling at $10.00 per
    share on the NASDAQ Global Market on Thursday under the ticker symbol
    OMER.  On Friday, Omeros' shares
    closed at $8.46.  The company
    announced that the proceeds of its IPO would be used to fund the completion of
    Phase III clinical trials and subsequent commercialization of its product
    candidate OMS103HP, for improving postoperative joint function and reducing
    postoperative pain during arthroscopic surgery.  Omeros also intends to use the IPO proceeds on two other
    product candidates it has in the clinic: 
    OMS302 for ophthalmology and OMS201 for urology.

    Talecris Biotherapeutics Talecris Biotherapeutics
    Holdings Corp., based in Research Triangle Park, NC, announced
    the closing of its own IPO on Wednesday. 
    According to a Bloomberg
    report
    ,
    Talecris raised $950 million in the second-largest IPO in the U.S. this year.  Talecris's shares, which were initially
    offered

    at $19 each, were trading at $21.18 on Friday.  Talecris makes protein therapies such as Prolastin and
    Gamunex, which are derived from human blood plasma and which are used in the
    treatment of immune deficiencies and disorders.

    Anthera Pharmaceuticals In September, the San Francisco Business Times reported
    that Anthera Pharmaceuticals of Hayward, CA had registered with the U.S. Securities
    and Exchange Commission for the purpose of selling up to $70 million in stock
    on the NASDAQ exchange under the symbol ANTH.  According to the Business
    Times
    , Anthera has an anti-inflammatory drug ready for Phase III clinical
    trials and two other drugs ready for Phase II trials.

  •     By
    Donald Zuhn

    Earlier
    today, the U.S. Patent and Trademark Office issued a press release
    announcing that Director David Kappos had "signed a new Final Rule
    rescinding highly controversial regulations, proposed by the previous
    administration, that patent applicants felt unduly restricted their capacity to
    protect intellectual property" (see
    "'New Rules' Officially Rescinded").  Not surprisingly, reaction to the Office's announcement
    has been positive and swift.

    Biotechnology Industry Organization (BIO) One
    of the first groups to issue a statement regarding the rescission of claims and
    continuations rules was the Biotechnology Industry Organization (BIO).  In a press release entitled "BIO
    Commends PTO Director for Withdrawal of Harmful Rules
    ,"
    BIO President and CEO Jim Greenwood stated that the group "applauds the
    action by Under Secretary Kappos today to formally withdraw the controversial
    and harmful proposed rules that would have limited the ability of biotechnology
    applicants to secure full coverage of their inventions."  Mr. Greenwood noted that the action was
    "a positive sign that the new Administration wants to work in a
    constructive manner with the patent applicant community to address the serious
    challenges facing the PTO," and said the group "stands ready to work
    with Under Secretary Kappos and others at the PTO to do so."

    AIPLA The
    American Intellectual Property Law Association (AIPLA) also issued a quick
    response to the news.  In its
    announcement,
    AIPLA Executive Director Todd Dickinson stated that the group "applauds
    the decision of Director Kappos to rescind this hugely unpopular rules
    package."  Mr. Dickinson added
    that the AIPLA viewed the action as "a significant step by Director Kappos
    towards rebuilding the relationship between the USPTO and the user
    community," and offered "to move forward and work with the Director
    in a constructive way to address the challenges facing the USPTO."

    Boundy, David David
    Boundy (at right), one of the architects of the campaign against the claims and continuations
    rules, asserted via e-mail that although the USPTO had announced the formal withdrawal
    of the rules in today's press release, "[t]he Continuations and Claims
    rules had been effectively killed eighteen months ago, along with the IDS rule,
    by the White House Office of Management and Budget."  Mr. Boundy noted that the claims and
    continuations and IDS rules packages had all come under review pursuant to the Paperwork
    Reduction Act (PRA) in September 2007, and that this review required a notice
    and comment period.  Between November
    2007 and January 2008, Mr. Boundy, Richard Belzer, and Dr. Ron Katznelson
    (names that should be quite familiar to Patent
    Docs
    readers) filed letters with the Office of Management and Budget (OMB)
    "showing that PTO had underestimated the paperwork burdens of the
    Continuations and Claims Rule by billions of dollars per year, and had failed
    to comply with procedural requirements of the [PRA]."  Mr. Boundy states that because the
    USPTO was unable to secure PRA clearance from the OMB for the claims and
    continuations rules, "even if the PTO had won the Tafas case, the PTO would have been forbidden by law from demanding
    this information from patent applicants."  While he acknowledges that "the information on OMB's
    web site is not crystal clear on dates," Mr. Boundy says that "it
    appears that the directive from the White House to PTO to withdraw the rules
    was issued no later than late January 2008, and that PTO had fully acquiesced
    by mid-April."  The OMB's
    final determination regarding PRA review of the claims and continuations, which
    was issued on July 1, 2009, can be found here.

  •     By Kevin E. Noonan

    USPTO Seal The infamous "claims and continuation" rules
    promulgated over the vocal protests of patent applicants and the patent bar by
    the Dudas administration of the U.S. Patent and Trademark Office have been
    officially rescinded by Director David Kappos.

    In a press release expected to be issued shortly, the Office
    will announce that the Director has signed a new Final Rule rescinding the rules,
    originally published in the Federal Register on August 21, 2007.  The rules were never implemented as the
    result of a preliminary injunction granted by the U.S. District Court for the
    Eastern District of Virginia on October 31, 2007 (the day before they were
    scheduled to come into effect), which injunction was made permanent by the District Court on April 1, 2008.  The government
    appealed this decision, which was overturned in substantial part by the Federal
    Circuit earlier this year (see "Tafas v. Doll (Fed. Cir. 2009)".  The CAFC had accepted review en
    banc
    , but briefing was postponed on motion of all parties (see "Federal Circuit Grants Stay in Tafas v. Kappos").

    In the press release, the Office proffers the
    following rationale for its decision:

    "The USPTO should incentivize innovation, develop rules that are
    responsive to its applicants' needs and help bring their products and services
    to market," Kappos said.  "These regulations have been highly unpopular
    from the outset and were not well received by the applicant community.  In
    taking the actions we are announcing today, we hope to engage the applicant
    community more effectively on improvements that will help make the USPTO more
    efficient, responsive, and transparent to the public."
     
    "We are grateful to GlaxoSmithKline for working with us to file this joint
    motion to both dismiss the rules and vacate the district court's decision.  This
    course of action represents the most efficient way to formally and permanently
    move on from these regulations and work with the IP community on new ways to
    take on the challenges these regulations were originally designed to address."

    GlaxoSmithKline - GSK The Office plans on filing a joint motion with plaintiff GlaxoSmithKline,
    asking the Federal Circuit to "dismiss and vacate" the District Court
    decision, thereby mooting the question of the precedential effect of the lower court's
    decision on the scope of the Office's rulemaking authority (and, possibly by
    implication, the scope of other Executive agencies' rulemaking authority).  This question has been raised as a
    reason for the government to pursue the case, which risk now seems to have been
    avoided.

    It is fervently to be hoped that this is the
    beginning of renewed cooperation between the Office and its constituency in
    resolving the real problems plaguing the patent system.

    UPDATE:  The Patent Office's press release regarding the rescission of the claims and continuations rules has now been posted on the USPTO website.

  •     By Suresh Pillai

    Federal Court Approves Eloxatin® Settlement
    Agreement

    Sanofi-Aventis_small The U.S. District Court for the District of New
    Jersey has signed off on Sanofi-Aventis'
    settlement agreement with Sun Pharmaceutical Industries Ltd. despite the
    fact that Sanofi failed to exchange all relevant signature pages.  The agreement ends the litigation over
    a generic version of Eloxatin®,
    a colon cancer drug manufactured and marketed by Sanofi (see "Biotech/Pharma
    Docket
    ," July 14, 2009).  Sanofi originally filed suit against
    Sun, Sandoz,
    Actavis Inc.,
    and Par Pharmaceutical Inc.,
    among other generic manufacturers, in June 2007, accusing them of infringing Sanofi's patent covering Eloxatin®, U.S. Patent No. 5,338,874
    (see "Court Report," July 30, 2007).  During the course of litigation, Sanofi
    and Sun began negotiating for a settlement and reached a final agreement in May
    2009.  On June 16, Sanofi summarily
    verified to Sun that Sun had fully executed and signed Sun's portions of the
    agreement and that Sanofi had obtained almost all of the signatures required
    for the settlement.  Sanofi also
    stated that it would send out the final completed document to Sun on June 17.  However, on June 17, having concluded
    that the parties used a different method for the formulation of the drug's
    active ingredient, the District Court granted motions for summary judgment of
    non-infringement for Sandoz, Mayne Pharma, Teva Pharmaceutical Industries, Ltd., and Hospira,
    Inc
    .

    Sun Pharma Following the Court's ruling, Sanofi refused to
    turn over a signed copy of the settlement, stating that the Court's ruling had
    diminished the value of any such settlement agreement.  In its most recent ruling, however, the Court ruled that because the essential terms of the agreement were set forth in
    both the letter of intent and the term sheets, the agreement was enforceable
    regardless of whether all required signatures had been obtained.  The Court also concluded that both
    parties, prior to the Court's ruling on June 17, had considered the settlement
    complete, with no further revisions required.


    Lupin Acquisition Ends Oscient Infringement Suit

    Lupin In the wake of Lupin Ltd.'s
    acquisition of U.S. rights to Oscient Pharmaceuticals Corp.'s cholesterol drug
    Antara®, the U.S. District Court for the District of Maryland has accepted two
    stipulations dismissing with prejudice all claims and counterclaims in the
    lawsuit involving Oscient, Ethypharm SA, and Lupin.  Oscient and Ethypharm
    originally filed suit in January 2009 following Lupin's filing of an ANDA
    seeking approval to manufacture and market a generic version of Antara® (see
    "Court Report," January 18, 2009).  In the suit, Oscient (the
    exclusive licensee of the patent) and Ethypharm (the patentee) alleged
    that Lupin's ANDA filing infringed U.S.
    Patent No. 7,101,574,
    the patent covering pharmaceutical compositions of Antara®.  However, during the course of the litigation,
    Oscient filed for Chapter 11 bankruptcy protection.  Lupin subsequently
    purchased the rights to the patent pursuant to bankruptcy court
    procedures.  Lupin's purchase of
    the patent-in-suit rendered moot the initial case or controversy.


    Court Bifurcates Infringement and Antitrust
    Determinations in Amrix Dispute

    Mylan The U.S. District Court for the District
    of Delaware has denied Mylan Inc.,
    in its patent dispute with Cephalon Inc.,
    the opportunity to raise either antitrust counterclaims or a patent misuse
    defense until the completion of the infringement trial.  Cephalon originally filed suit in
    November 2008 following Barr Pharmaceuticals' and Mylan's
    submissions of ANDAs seeking approval to manufacture and market generic
    versions of Cephalon's drug Amrix®
    (see "Court Report," November 30, 2008).  In its complaint, Cephalon alleged that
    both Barr and Mylan had infringed U.S. Patent No. 7,387,793,
    Cephalon's patent covering Amrix®.

    Cephalon #1 In its answer, Mylan alleged that its generic did
    not infringe Cephalon's patent, that the patent was invalid, and that
    Cephalon had failed to make a good faith effort to investigate Mylan's drug
    formulation prior to filing the suit.  Mylan also alleged that Cephalon's filing was a preemptive measure aimed
    to monopolize the marketing and manufacture of Amrix®, thereby violating
    federal antitrust laws.

    In its ruling, the District Court determined that because
    the evidence presented in support of the counterclaims was irrelevant in the
    determination of the issues of infringement and validity, judgment on the
    counterclaims would be stayed until the completion of the infringement trial
    in order to prevent jury distraction.


    Supreme Court Refuses to Hear Mylan's Appeal over
    Takeda's Attorneys' Fees

    Takeda The U.S. Supreme Court has refused to
    grant certiorari to review a Federal Circuit decision affirming a lower court
    decision that the case of Mylan Laboratories Inc. v. Takeda
    Pharmaceutical Inc.

    was exceptional and warranted the award of attorneys' fees.  Takeda filed suit against Mylan and
    Alphapharm,
    a Mylan subsidiary, alleging that Mylan had infringed Takeda's patent
    covering the diabetes treatment Actos® by filing ANDAs with Paragraph IV
    certifications.  In March 2006, the
    U.S. District Court for the Southern District of New York issued its ruling
    that Mylan and Alphapharm, had infringed Takeda's patent.  During the trial, Mylan had originally
    alleged that patent was invalid on grounds of obviousness.  Following discovery, however, Mylan
    alleged that Takeda had committed inequitable conduct before the USPTO.  The shifting arguments led the lower
    court to conclude that Mylan had acted in bad faith, and the lower court summarily
    awarded Takeda $16.8 million in attorneys' fees, the largest amount ever granted
    under Section 285 in Hatch-Waxman patent litigation.

    The Federal Circuit concluded that both Alphapharm
    and Mylan had committed misconduct by claiming in their Paragraph IV
    certifications that the patents were invalid.  The Federal Circuit affirmed the lower court's finding that
    Mylan's ANDA certification letter was submitted in bad faith (see Patent Docs report).


    Settlement Announced in Flomax® Dispute

    Impax Laboratories Impax Laboratories Inc. has announced a
    settlement in its ongoing patent dispute with Astellas Pharma Inc.
    and Boehringer Ingelheim Pharmaceuticals Inc.
    over generic versions of Astellas' and Boehringer Ingelheim's blockbuster drug
    Flomax®, which
    is used to treat symptoms associated with enlarged prostates.  Astellas and Boehringer Ingelheim filed
    their infringement suit in July 2008 after Impax filed an ANDA seeking to
    manufacture and market a generic version of Flomax® (see "Court Report,"
    July 27, 2008).  The ANDA included a Paragraph IV certification that Impax' generic did not
    infringe any valid or enforceable claim of U.S. Patent No. 4,703,063,
    the patent covering Flomax
    ®.

    Astellas As part of the terms of the settlement, Impax will
    be allowed to market and manufacture a generic version of the drug as of March
    2, 2010, prior to the expiration of pediatric exclusivity.  The U.S. District Court for the
    Northern District of California has signed off on a consent order closing the
    case in the wake of the settlement agreement.  Under the terms of the consent order, Impax has admitted
    that the '063 patent is enforceable and valid.  Impax has also agreed not to dispute these Boehringer Ingelheim admissions in any
    other related litigation proceedings.  In addition, Impax admitted that the manufacture, use, sale or
    distribution of its generic Flomax® product prior to the patent's expiration
    date would infringe the patent.

  •     By Kevin E. Noonan

    Locke, Gary Commerce Secretary Gary Locke (at right) has written a letter
    to the Senate Judiciary Committee giving qualified support to
    S. 515, the patent
    "reform" bill voted out of committee months ago but languishing in
    the wake of more pressing health care reform legislation.  Unfortunately, upon close reading, the
    Secretary's letter seems to say much more that it does.

    The letter begins with the usual platitudes about
    the patent system:

    The
    American spirit
    of innovation is essential to creating jobs
    and hastening that recovery.  Innovation and creativity are the wellspring
    of economic growth and progress.  As the framers of the Constitution recognized, a robust system of intellectual property protection ensures that innovation
    will flourish.  To this end, landmark patent reform is urgently needed.  We
    believe
    S. 515 incorporates the essential
    elements
    of patent reform; and, therefore, the
    Department
    of Commerce supports the bill with
    additional recommendations below.

    In the 21st Century, innovations in science
    and technology are crucial drivers
    of our
    economy.  Now, more than ever, strong, transparent, and predictable incentives
    to invest
    in research and development are vital.  At the same time, legislative and administrative actions involving the
    establishment and enforcement
    of intellectual property rights must
    encourage healthy competition and facilitate continuing innovation.  A 21st
    Century U.S. patent system must balance incentives for innovation and
    competitive markets through strong intellectual property protections and by
    only rewarding truly innovative ideas with those protections
    .

    We must
    recognize the international dimensions
    of innovation
    by encouraging reforms that promote innovation in the United States and success
    in the global marketplace
    A more harmonized international
    patent system will benefit U.S. applicants by simplifying the patent process,
    reducing legal costs, and enabling American innovators to obtain patents more
    quickly, both domestically and abroad.  Developing an effective international
    system will help ensure that American intellectual property rights are
    protected around the world.

    And of course, the goal is fairness:

    The cornerstone of our comments is therefore to provide
    balance, flexibility and efficiency in the U.S. patent system.  The Administration seeks reforms that
    fairly balance the interests of innovation and competition across all industries
    and technologies without favoring one industry or any particular area of
    technology over another.

    USPTO Seal - background Number one on the list of priorities is the Patent Office, and
    (understandably, perhaps, in view of the current fiscal situation), the number
    one priority is fees.  The Office
    needs to be able to set fees, according to the Secretary, to address the
    backlog of pending applications and its "recent financial challenges"
    (many of which, ironically, are caused by its ineffective attempts to address a
    "patent quality" problem that may not have existed).  The letter also calls for the Office to
    be given substantive rulemaking authority, which Congress has not seen fit to
    grant to the Office.  Unfortunately, the letter tries to support its call for substantive
    rulemaking authority with a specious argument about the Tafas v. Kappos case, which the letter states has raised doubt
    regarding this authority.  There
    was no such doubt on the part of the Federal Circuit:  the Tafas decision affirmed that the PTO had procedural rulemaking authority,
    but not substantive authority, and that all four of the ill-advised "new
    rules" at issue were procedural (although one of them was contrary to 35 U.S.C.
    § 120).  Indeed, the debacle
    surrounding the "new rules" should be enough to affirm the wisdom of
    preventing the Office from enacting substantive rules; no matter what one
    thinks of the nascent Kappos regime, eventually it will be replaced, perhaps
    (God help us all) by a reincarnation of the Dudas/Toupin regime.

    The letter supports a post-grant review procedure that is "phased-in,"
    without providing any substance on how and what would be "phased."  The Secretary uses this aspect of the
    current reform bill to advocate again for fee-setting flexibility for the
    Office, but is silent on the substance of the kind of post-grant review or its
    implementation that the Administration supports.

    The Secretary also supports "transitioning" the U.S.
    patent system to a "first to file" system, in the name of
    harmonization and with the purported benefits of "simplify[ing] the patent
    system, reduc[ing] legal costs, [and] improv[ing] fairness [to whom, one
    wonders]."  The "complex,
    time-consuming and resource intensive" costs of global patent procurement
    is the supposed target of this "reform," which the letter asserts
    would benefit American innovators with "greater predictability,
    reliability and competitiveness."  Again, however, this section of the letter ends with vague references to
    making "various adjustments" to the provisions of S. 515, also for the
    sake of "fairness" to "all stakeholder" interests, without
    any hint of what those "adjustments" might be.

    The Secretary is direct in opposing provisions of the bill
    regarding patent search and examination, motivated (creatively) by the fear
    that such provisions might impede current and future work-sharing efforts
    between the USPTO and foreign patent offices.  In addition, the letter raises concerns about the "sovereign
    function" provisions with regard to including the public and U.S.-based "vendors
    of patent-related services" (presumably, search firms) from participating in
    the patent examination process.

    Feinstein, Dianne Turning to litigation, the Secretary's letter "generally
    supports" the Grand Compromise worked out between Senators Leahy,
    Feinstein (at right), and Specter (when he sat on the other side of the aisle as the
    Ranking Republican Member) giving a "gatekeeper" role to the Federal
    judiciary on patent damages.  The
    Administration wants to avoid damages provisions that give "lottery-atmosphere
    awards" to prevailing patentees while ensuring "fair compensation"
    (which suggests that compensation becomes more unfair the more egregious the
    scope of the infringement).  But the support is provisional:  the letter notes that "the median jury award for patent damages
    increased significantly from 1991 to 2005," suggesting that the
    gatekeepers of the judiciary were asleep at the switch (or at least dozing)
    during that time.  Thus,
    recognizing that "substantial work" has been done in reaching the
    compromise, the Administration seems content to take a "wait and see"
    approach to this aspect of "reform."  The Secretary also expresses a desire to "work
    with Congress" on provisions involving willful infringement to "ensure
    a fair enhanced damages standard" without setting out any specifics,
    instead talking vaguely about the "quite substantial threat of enhanced
    damages" (ignoring, apparently, the reality that the threat of enhanced
    damages is the point of the willful infringement section of the statute).

    Finally, the letter ends with a hodge-podge of provisions relating
    to telework for examiners, virtual marking, the inventor's oath or declaration,
    prior art submissions by the public during ex
    parte
    examination, best mode, venue, interlocutory appeals, and the patent
    expertise for judges pilot program, all of which the Administration supports
    with reservations about "a number of technical concerns" with
    the language of these provisions; the substance of these concerns is not disclosed.

    Leahy, Patrick In short, the letter is a disappointment for anyone intending to
    understand the extent of the Administration's support of S. 515.  It is even more disappointing to anyone
    looking for an understanding of the Administration's vision for the patent
    system, or any concrete ideas that Secretary Locke, Director Kappos, or anyone
    else in the Administration may have regarding improving the patent system.  It is certainly the case that neither
    the Secretary nor (even more so) the Director have had much time in their
    respective positions to fully address the concerns and issues surrounding
    patent reform.  But besides
    jump-starting Senator Leahy's (at left) efforts to get S. 515 passed in this Congress
    (something fully understood by the Senator, who issued a press release
    attesting to his renewed commitment to the bill), there is little that needed
    to be said in Secretary Locke's letter.  Indeed, it is just as likely that the letter will galvanize the opposition
    to the bill, which fails to address the concerns (however ephemeral) of the
    major proponents of "reform" — the IT community.  In addition, the bill has dedicated
    opponents in Senators Kyl and Hatch, with Senator Hatch angrily storming out of
    the committee room during the vote that sent the bill to the Senate floor.  The Obama Administration may have good
    ideas or bad ones on the patent system, but this letter does little to inform
    those interested in the debate about ideas of either kind.

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

    "Not Everyone Thinks "Patent Reform" is a Great Idea,"
    April 7, 2009

    • "Senate 'Patent Reform' Bill (S. 515) Voted out of Judiciary Committee,"April 2, 2009


    "Some (But Not All) Amendments Introduced in 'Patent Reform' Bill,"
    April 1, 2009


    "'Progress' on Senate 'Patent Reform' Bill," March 31, 2009

    • "Senate Judiciary Committee Discusses
    S. 515 at Executive Business Meeting; Adopts "Technical" Amendment
    GRA09350
    ," March 26, 2009


    "Senate Judiciary Committee Places Patent Reform Bill on Agenda,"
    March 15, 2009


    "Senate Judiciary Committee Holds Hearing on Patent Reform," March
    10, 2009


    "Senator Specter Seeks Resolution of Issues before Vote on Patent Reform
    Bill
    ," March 5, 2009


    "Senate and House Introduce New Patent Reform Legislation," March 3,
    2009

  •     By Donald Zuhn –-

    USPTO Seal On Thursday, the U.S. Patent and Trademark Office announced that it was expanding
    the First Action Interview pilot program to encompass additional technology
    areas effective October 1, 2009. 
    The pilot program, which began on April 28, 2008, allows applicants of
    certain applications to interview their cases prior to the issuance of a first
    Office action on the merits.

    Under the initial pilot program, an examiner assigned to a participating
    application conducts a prior art search and provides the applicant with a
    pre-interview communication containing a condensed preview of objections or
    rejections against the claims of the participating application.  Within 30 days from the issuance of the
    pre-interview communication, the applicant then either schedules a first action
    interview or chooses not to have the interview.  If the applicant chooses the latter option, the examiner
    issues a First Action Interview Office action giving the applicant the longer
    of one month or 30 days to reply. 
    If agreement cannot be reached during the first action interview, the
    First Action Interview Office action is issued (with the reply period specified
    above).  Under the extended pilot
    program, the Office has made a few improvements to the process, including
    allowing applicants to extend the above reply period by 30 days.  Other changes can be found here.  Additional information regarding the expanded
    pilot program can also be found here.

    USPTO Building Facade Under the initial pilot, the program was limited to two technology areas:
     Class 709 (electrical computers
    and digital processing systems: multi-computer data transferring) and Class 707
    (data processing: database and file management or data structures).  Because the initial program "has
    shown that the patent process benefits when interaction between the applicant
    and the examiner are enhanced at the beginning of examination because
    patentability issues can be resolved early when the applicant and the examiner
    discuss them one-on-one," the program is being expanded to encompass the
    following art units:


    161X — applications filed on or before November 1, 2006

    1795 — appilications filed on or before October 1, 2006

    215X and 216X — applications filed on or before February 1, 2008

    244X and 245X — applications filed on or before July 1, 2008

    2617 — applications filed on or before June 1, 2007

    2811-2815, 2818, 2822-23, 2826, and 2891-2895 — applications filed on or before
    May 1, 2008

    3671 — applications filed on or before December 1, 2007

    3672 — applications filed on or before January 1, 2008

    3673 — applications filed on or before November 1, 2007

    3676 — applications filed on or before February 1, 2008

    3677 — applications filed on or before July 1, 2007

    3679 — applications filed on or before November 1, 2007

    3735 — applications filed on or before May 1, 2006

    3736 — applications filed on or before April 1, 2007

    3737 — applications filed on or before December 1, 2006

    3768 — applications filed on or before August 1, 2006

    3739 — applications filed on or before December 1, 2006

    3762 and 3766 — applications filed on or before September 1, 2007

    3769 — applications filed on or before September 1, 2006

    In its announcement regarding the expansion of the program, the USPTO
    indicated that the allowance rate for applications involved in the pilot
    program was six times higher than the allowance rate for applications in the
    same technology area that were not involved in the pilot program.  Explaining the success of the pilot
    program, USPTO Director David Kappos said that "[w]hen people talk to one
    another and listen to one another they can quickly understand points of
    agreement as well as differences, and resolve those differences in
    real-time," and added that "interviews present a clear path to
    resolve issues and move prosecution forward quickly."

    For additional information regarding this topic,
    please see:
    • "PTO Announces New Program to Reduce
    Pendency and Improve Patent Quality
    ," April 15, 2008

  •     By Sherri Oslick

    Gavel_2About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Genzyme Corp. v. Endo Pharmaceuticals Inc.
    1:09-cv-02589; filed October 1, 2009 in the
    District Court of Maryland

    Infringement of U.S. Patent No. 5,667,775 ("Phosphate-Binding
    Polymers for Oral Administration," issued on September 16, 1997) following a
    Paragraph IV certification as part of Endo's filing of an ANDA to manufacture a
    generic version of Genzyme's Renagel® (sevelamer hydrochloride, used for the
    control of serum phosphorus in patients with chronic kidney disease on
    dialysis).  View the complaint
    here.


    Monsanto Co. et al. v. Hargrove et al.
    4:09-cv-01628; filed September 30, 2009 in the
    Eastern District of Missouri

    • Plaintiffs: 
    Monsanto Co.; Monsanto Technology LLC
    • Defendants: 
    Brent M. Hargrove; H & H Farms

    Monsanto Co. et al. v. Lytle
    4:09-cv-01626; filed September 30, 2009 in the
    Eastern District of Missouri

    • Plaintiffs: 
    Monsanto Company; Monsanto Technology, LLC
    • Defendant: 
    Larry H. Lytle

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral
    Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant
    5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on
    defendant's use of cotton seed produced from earlier planted Roundup Ready®
    cotton seed.  View the Hargrove complaint
    here.


    Cephalon Inc. v. Watson Pharmaceuticals Inc. et al.

    1:09-cv-00724; filed September 25, 2009 in the
    District Court of Delaware

    • Plaintiff: Cephalon Inc.
    • Defendants: Watson Pharmaceuticals Inc.; Watson
    Laboratories Inc.; Watson Pharma Inc.

    Infringement of U.S. Patent No. 6,264,981 ("Oral
    Transmucosal Drug Dosage Using Solid Solution," issued July 24, 2001) following a
    Paragraph IV certification as part of Waton's filing of an ANDA to manufacture
    a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used
    to treat breakthrough pain in adult patients with cancer).  View the complaint
    here.


    Eurand Inc. et al. v. Anchen Pharmaceuticals Inc. et al.
    8:09-cv-01098; filed September 24, 2009 in the
    Central District of California

    • Plaintiffs: 
    Eurand Inc.; Anesta AG
    • Defendants: 
    Anchen Pharmaceuticals Inc.; Anchen Inc.

    Infringement of U.S. Patent Nos. 7,387,793 ("Modified
    Release Dosage Forms of Skeletal Muscle Relaxants," issued July 17, 2008) and
    7,544,372 (same title, issued June 9, 2009), licensed to Cephalon, following a
    Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture
    a generic version of Cephalon's Amrix® (cyclobenzaprine hydrochloride, used for
    relief of muscle spasm associated with acute, painful musculoskeletal
    conditions).  View the complaint
    here.  [NB: Eurand filed a similar
    complaint in Delaware on September 23, 2009, as noted here.]


  • CalendarOctober 5-6, 2009 – Patent Litigation 2009 (Practising Law Institute) – McLean, VA

    October 7-8, 2009 – Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) – New York, NY

    October 14, 2009 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

    October 15-16, 2009 – Patent Litigation 2009 (Practising Law Institute) – Chicago, IL

    October 20-21, 2009 – 17th Forum on Biotech Patenting (C5) – London,
    United Kingdom

    October 22-23, 2009 – Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) – Philadelphia, PA

    October 26-28, 2009 – Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) – Washington, DC

    November 9-10, 2009 – Patent Litigation 2009 (Practising Law Institute) – Atlanta, GA

    November 9-11, 2009 – Developing
    IP Strategies for Crystalline Forms
    *** (
    International
    Quality & Productivity Center) –
    London,
    England

    November 10, 2009 – The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) – Baltimore, MD

    November 12-13, 2009 – Paragraph IV on Trial*** (American Conference
    Institute) – New York, NY

    November 13, 2009 – The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) – Las Vegas, NV

    November 16-17, 2009 – Patent Litigation 2009 (Practising Law Institute) – New York, NY

    November
    17-18, 2009 –
    Structuring,
    Negotiating, and Managing Pharma/Biotech Collaborative Agreements
    (
    American Conference
    Institute) – New York, NY

    December 7-8, 2009 – Foreign Patent Law &
    Regulation
    ***
    (American Conference
    Institute) – New York, NY

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