• Chicago #3American Conference
    Institute (ACI) will be holding its 3rd Advanced Summit on Medical Device
    Patents on March 5-6, 2013 in Chicago, IL. 
    The conference will allow attendees to:

    • Integrate the
    monumental changes under the AIA including first-to-file and patent validity
    assessment at the PTO into their medical device patents practice;
    • Prepare for the
    fallout of Akamai on medical device
    method patents including increased vulnerability to allegations of joint infringement
    and inducement of infringement;
    • Protect medical
    device diagnostic patents post-Mayo v.
    Prometheus
    and draft claims to withstand § 101 patentability challenges;
    • Maximize medical
    device patent life cycles globally through a consistently executed international
    medical device patent prosecution and litigation strategy for established and
    emerging markets; and
    • Analyze the
    drivers of the billion dollar medical device patent infringement verdict and
    position their device portfolios for litigation and NPE attacks.

    BrochureIn particular,
    ACI's faculty will offer presentations on the following topics:

    • Evaluating the state of
    the medical device industry: Key developments to factor into portfolio
    management in a game-changing year;
    • PTO keynote: Update on the
    implementation of the American Invents Act: Lessons learned in the first six
    months of the post-patent reform world — presented by Janet Gongola, Patent
    Reform Coordinator for the U.S. Patent and Trademark Office;
    • Proving or disproving joint infringement:
    Bracing for the fallout from Akamai
    in device method prosecution and litigation;
    • Revolutionizing medical device patent
    prosecution and litigation strategies post-patent reform: Preparing for the
    monumental switch to validity assessment in the PTO;
    • Demystifying the current standards for
    device obviousness: Defeating rejections at the PTO and combating challenges in
    the courts;
    • Practical strategies for dealing with
    the written description / enablement dichotomy: Satisfying ever-evolving § 112
    standards for validity;
    • Vigilantly protecting device IP
    globally: Developing a plan for international medical device patent life cycle
    management;
    • View from the Bench: The judicial
    perspective on medical device patent litigation — panel includes The Honorable
    James F. Holderman, Chief Judge, U.S. District Court for the Northern District
    of Illinois; The Honorable James L. Robart, District Judge, U.S. District Court
    for the Western District of Washington; and The Honorable Sue L. Robinson,
    District Judge, U.S. District Court for the District of Delaware;
    • Protecting method and diagnostic claims:
    Tailoring medical device patents to comply with increasingly strict § 101
    patentability standards;
    • Calculating and proving medical device
    damages: Analyzing drivers of the billion dollar infringement verdict;
    • Establishing
    freedom-to-operate: Mitigating patent infringement risks when commercializing
    medical devices;
    • Preparing your device portfolio for
    litigation: Limiting liability and managing and reducing costs; and
    • Is inequitable conduct dead?  Updating medical device prosecution and
    litigation strategies post-Therasense.

    In addition, a
    pre-conference interactive working group session entitled "Integrating
    Changes at the PTO into Medical Device Patent Practice: Supervisory Patent
    Examiners Weigh In" will be offered from 9:00 am to 12:00 pm on March 4,
    2013, and a pre-conference master class entitled "Maximizing Device Patent
    Scope and Life: Navigating Through the Medical Device Patent Minefield"
    will be offered from 1:00 pm to 4:00 pm on March 4, 2013.

    The agenda for the
    Medical Device Patents conference can be found here, and the agenda for
    the pre-conference interactive working group session and master class can be
    found here.  A complete brochure for this conference,
    including an agenda, detailed descriptions of conference sessions, list of
    speakers, and registration form can be obtained here.

    ACI - American Conference InstituteThe registration
    fee for the conference is $2,295 (conference alone), $2,895 (conference and one
    pre-conference session), or $3,295 (conference and both pre-conference
    sessions).  Those registering by January
    8, 2013 will receive a $300 discount, and those registering by February 1, 2013
    will receive a $200 discount.  Patent Docs readers who reference the
    discount code "PD 200" will receive $200 off the current price tier
    when registering.  Those interested in
    registering for the conference can do so here, by e-mailing
    CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing
    a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's Medical Device Patents conference.

  • IPO #2The
    Intellectual Property Owners Association (IPO) will offer a one-hour webinar
    entitled "European Unitary Patent: An Update" on January 10, 2013
    beginning at 1:00 pm (ET).  A panel
    consisting of Margot Fröhlinger, Principal Director for patent law and
    international affairs at the European Patent Office; Paul Coletti, Assistant
    Patent Counsel for Johnson & Johnson; and John Pegram of Fish &
    Richardson will discuss how the new Unitary Patent for Europe and Unified Patent
    Court will work, and what the change is likely to mean for patent rights and
    litigation globally.

    The
    registration fee for the webinar is $120 (government and academic rates are
    available upon request).  Those
    interested in registering for the webinar can do so here.

  • D Young & CoD
    Young & Co will be offering its next European biotech patent law update on
    January 16, 2013.  The 45-minute webinar
    will be offered at three times: 4:00 am, 7:00 am, 12:00 pm (EDT).  Simon O'Brien and Robert Dempster will
    provide an essential update and live Q&A on EPO biotechnology case law.

    While
    there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • University of San_DiegoThe University of
    San Diego School of Law will be holding its 3rd annual Patent Law Conference
    on January 17-18, 2013 at the Joan B. Kroc Institute for Peace & Justice at
    the University of San Diego.  The Conference,
    which will address the Future of Patent Law Remedies, begins with an opening
    night reception for The Honorable Jimmie V. Reyna, Federal Circuit Court of
    Appeals, on January 17.  Professor John
    F. Duffy of the University of Virginia School of Law will provide remarks at
    the reception.  The Conference will offer
    the following sessions on January 18:

    • Judges Panel
    (Patent Pilot Judges) – including The Honorable Jimmie V. Reyna, Federal
    Circuit Court of Appeals; The Honorable Marilyn L. Huff, United States District
    Judge, Southern District of California; and The Honorable Janis L. Sammartino,
    United States District Judge, Southern District of California;
    • Attorneys Panel;
    • Keynote Address
    and Lunch — The Honorable Jimmie V. Reyna, Federal Circuit Court of Appeals;
    • Ethics Panel; and
    • Professors Panel.

    Additional
    information about the Conference and opening night reception, including a schedule,
    list of speakers, and directions can be found at the Conference's website.

    The registration
    fee for the Conference (excluding the reception) is $250 (general registration)
    or free (students and professors).  Those
    interested in registering for the Conference can do so here.

  • By Donald Zuhn

    New_Year_Ball_Drop_Event_for_2012_at_Times_SquareReflecting upon the events
    of the past twelve months, Patent Docs
    presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that
    were covered on Patent Docs last year
    that we believe had (or are likely to have) the greatest impact on
    biotech/pharma patent practitioners and applicants.  On Monday, Tuesday,
    and Wednesday we counted
    down stories #15 to #4, and today we count down the top three stories of
    2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as
    a few links to articles on related topics) have been provided in case you
    missed the articles the first time around or wish to go back and have another
    look.  As always, we love to hear from Patent Docs readers, so if you think we
    left something off the list or disagree with anything we included, please let
    us know.


    3. 
    Implementation of Leahy-Smith America Invents Act Continues

    The U.S. Patent and
    Trademark Office began the year by publishing five notices of proposed
    rulemaking in January to implement various provisions of the Leahy-Smith
    America Invents Act.  Another four
    notices of proposed rulemaking and a practice guide for proposed trial rules
    were published in February.  Over the
    summer, the Office issued three more notices of proposed rulemaking and a
    guidance document on the first-inventor-to-file (FITF) provisions of the AIA.  In July, the Office began issuing final rules
    to implement AIA provisions, with the final rules corresponding to the notices
    of proposed rulemaking issued earlier in the year.  By mid-August, the Office had issued eight
    final rules and a patent trial practice guide. 
    The Office also held a roundtable in September to obtain public input on
    issues relating to the Office's proposed rules to implement the
    first-inventor-to-file provisions of the AIA. 
    In February, the Office started to exercise its new fee setting
    authority under the AIA by submitting a proposed fee schedule to the Patent
    Public Advisory Committee (PPAC), with the PPAC holding two public hearings on the
    proposed schedule.  In September, the PPAC
    issued a report on the proposed schedule, which the Director considered before
    publishing a notice setting and adjusting certain patent fees.  The publication of the proposed fee schedule
    initiated a 45-day comment period, which ended in November.  The Office is expected to publish a final
    notice on fees in the coming weeks, with the fee schedule taking effect 45 days
    after publication (to provide Congress with an opportunity to review the
    schedule).  Earlier in the year, the
    Office issued AIA-mandated reports on the prior user rights defense provisions
    of the AIA and on international patent protections for small businesses.  While the Office collected public comments on
    genetic diagnostic testing and held two public hearings on the matter, the
    Office was unable to meet the deadline for submitting its AIA-mandated report
    on genetic diagnostic testing to Congress (and, in fact, has scheduled a
    roundtable on January 10 to discuss the topic further).  The Office also opened its first satellite
    office in Detroit, and after considering public input on locations for
    additional satellite offices, announced that it would be opening three
    additional offices in Dallas, TX; Denver, CO; and California's Silicon Valley.  Throw in a series of AIA roadshows, webinars,
    and a Twitter chat, and it has been a busy year for the Office as it implements changes brought about by the AIA, and for applicants and practitioners as
    they try to keep up with these changes. 
    And FITF is only 72 days away.

    For information regarding
    this and other related topics, please see:

    • "USPTO Issues Final
    Rule Implementing Micro Entity Status
    ," December 26, 2012
    • "USPTO News
    Briefs
    ," December 20, 2012
    • "USPTO to Hold
    Roundtable on Genetic Diagnostic Testing
    ," December 4, 2012
    • "IPO Submits
    Comments on Proposed Fees
    ," November 14, 2012
    • "USPTO Holds Live
    Chat on AIA
    ," November 13, 2012
    • "USPTO News
    Briefs
    ," October 30, 2012
    • "PPAC Issues Report
    on USPTO Patent Fees Proposal
    ," October 9, 2012
    • "Rules Changes
    Implementing the Inventor's Oath or Declaration Provisions of the AIA
    ,"
    October 4, 2012
    • "More on USPTO's
    Proposed New Fees – Part II
    ," September 19, 2012
    • "More on USPTO's
    Proposed New Fees
    ," September 11, 2012
    • "USPTO Proposes New
    Patent Fees and CPI Adjustments to Certain Fees
    ," September 6, 2012
    • "USPTO News
    Briefs
    ," September 5, 2012
    • "USPTO News
    Briefs
    ," August 27, 2012
    • "USPTO Issues
    Several Final Rules for Implementing AIA Provisions
    ," August 15, 2012
    • "USPTO Issues Final
    Rule to Implement Miscellaneous Post Patent Provisions of AIA
    ," August 8,
    2012
    • "USPTO Issues Final
    Rule for Implementing Statute of Limitations Provisions for Office Disciplinary
    Proceedings
    ," July 31, 2012
    • "USPTO Issues Final
    Rule for Preissuance Submissions
    ," July 25, 2012
    • "USPTO to Open Three
    More Satellite Offices
    ," July 2, 2012
    • "Docs at BIO:
    Session on Prior User Rights as a New IP Option
    ," June 20, 2012
    • "USPTO Report on
    Genetic Testing Delayed
    ," June 18, 2012
    • "BIO International
    Convention 2012 Preview – Part III: BIO and the America Invents Act
    ," June
    14, 2012
    • "USPTO Issues
    Proposed Rules for Implementing Micro Entity Status
    ," June 4, 2012
    • "USPTO News
    Briefs
    ," May 23, 2012
    • "USPTO Posts
    Comments on Genetic Diagnostic Testing
    ," May 22, 2012
    • "USPTO Posts
    Comments on Proposed Fees Changes
    ," March 19, 2012
    • "A Glimpse under the
    Hood: How the USPTO Proposes to Adjust Patent Fees
    ," March 14, 2012
    • "USPTO Proposes Fees
    Changes
    ," March 1, 2012
    • "USPTO News
    Briefs
    ," February 20, 2012
    • "USPTO Holds First
    Hearing on "Second Opinion" Genetic Testing
    ," February 16, 2012
    • "Patent Docs Author
    Testifies at Genetic Diagnostic Testing Hearing
    ," February 16, 2012
    • "USPTO to Hold
    Hearing on Genetic Diagnostic Testing
    ," February 15, 2012
    • "USPTO Proposes More
    Rules for Implementing AIA Provisions
    ," February 13, 2012
    • "USPTO Issues
    Proposed Rulemaking for Supplemental Examination Provisions of AIA
    ,"
    February 8, 2012
    • "PPAC to Hold Public
    Hearings on Proposed Fee Schedule
    ," February 1, 2012
    • "Interpreting 35
    U.S.C. § 102 under the America Invents Act
    ," January 31, 2012
    • "USPTO Proposes
    Rules Changes for Implementing AIA Provisions — Oath or Declaration
    Provisions
    ," January 30, 2012
    • "USPTO News Briefs,"
    January 26, 2012
    • "USPTO News
    Briefs
    ," January 18, 2012
    • "USPTO Issues Report
    on Prior User Rights
    ," January 17, 2012
    • "USPTO Proposes
    Rules Changes for Implementing AIA Provisions — Statute of Limitations
    Provisions for Office Disciplinary Proceedings
    ," January 16, 2012
    • "USPTO Proposes
    Rules Changes for Implementing AIA Provisions — Preissuance Submissions
    Provision
    ," January 12, 2012
    • "USPTO Proposes
    Rules Changes for Implementing AIA Provisions — Miscellaneous Post Patent
    Provisions
    ," January 11, 2012


    2.  Supreme
    Court Grants Certiorari in AMP v. Myriad

    Six days after issuing its
    decision in Mayo Collaborative Services
    v. Prometheus Laboratories, Inc
    ., the Supreme Court issued an Order
    granting the petition for writ of certiorari
    in Association for Molecular Pathology v.
    Myriad
    , vacating the judgment, and remanding the case back to the Federal
    Circuit for further consideration in light of the Mayo decision.  As we noted
    yesterday, the Federal Circuit decided on remand that claims to isolated human
    DNA satisfy the requirements of 35 U.S.C. § 101, with each member of the panel
    issuing opinions that tracked their earlier opinions (the Federal Circuit's
    decision placed #5 on our 2012 list of top stories).  In September, the American Civil Liberties
    Union (ACLU) and Public Patent Foundation (PubPat) again filed a petition for certiorari with the Supreme Court, which
    the Court granted on November 30.  The
    Court's grant was limited to the first question presented — whether human genes
    are patent-eligible — and the Court denied certiorari
    on the other two questions (thus letting stand the Federal Circuit's
    determination that screening methods using genetically transformed cells are
    patent-eligible under the Court's Mayo v.
    Prometheus
    precedent, and that a declaratory judgment plaintiff must cite
    actual injury to have standing).  The Supreme Court's grant of certiorari in AMP v. Myriad ensures that this case will be a top story again in 2013.

    For information regarding
    this and other related topics, please see:

    • "Supreme Court
    Grants Cert in AMP v. Myriad
    ," November 30, 2012
    • "Myriad Files
    Responsive Brief Opposing Certiorari
    ,"
    November 29, 2012
    • "AMP v. Myriad Briefed and Distributed
    for Conference – Update
    ," November 19, 2012
    • "AMP v. Myriad Briefed and Distributed
    for Conference
    ," November 13, 2012
    • "Plaintiffs (Again)
    File Certiorari Petition in Myriad Case
    ," September 25, 2012
    • "Patent Eligibility
    and Biology
    ," August 23, 2012
    • "The Proper Scope of
    DNA (or 'Gene') Patent Claims
    ," August 1, 2012
    • "Myriad and Prometheus: Do Patents 'Preempt' Follow-On
    Research
    ?" July 29, 2012
    • "The Aussies Are At
    It Again
    ," June 14, 2012
    • "Supreme Court
    Remands Myriad Case
    ," March 26,
    2012


    1.  Supreme
    Court Issues Decision in Mayo v.
    Prometheus

    On March 20, the Supreme
    Court unanimously held in Mayo
    Collaborative Services v. Prometheus Laboratories, Inc.
    that claims
    directed to the relationship between the concentrations of blood metabolites
    and response to a therapeutic drug were invalid for "effectively claim[ing]
    underlying laws of nature themselves." 
    In the nine months since the Supreme Court issued its decision,
    applicants and practitioners have tried to gauge the impact of the decision and
    have asked whether claims perceived to be directed to "laws of
    nature" can, in fact, be written to pass Constitutional muster.  The U.S. Patent and Trademark Office
    responded to the Mayo decision by
    issuing preliminary guidance on the day after the decision, and then followed
    up with interim guidance in July.  It did
    not take the lower courts long to apply Mayo,
    with the District Court for the District of Columbia in SmartGene, Inc. v. Advanced Biological Laboratories SA invalidating
    diagnostic method claims in view of Mayo
    only ten days after the Supreme Court issued its decision.  In November, the Federal Circuit made its
    "first" attempt to implement the Supreme Court's jurisprudence
    on the scope of patent eligibility for diagnostic method claims in PerkinElmer, Inc. v. Intema Ltd. (we did not count the Federal Circuit's decision on remand in AMP v. Myriad, as the diagnostic method claims in that case had
    already been held patent-ineligible under the
    "machine-or-transformation" test set forth in In re Bilski).  As we wrote
    at the time, PerkinElmer stands as
    the most recent cautionary tale of how diagnostic methods claims must be
    crafted — narrow, specific, encompassing particular assaying and detection
    steps, and encompassing some (any) patentable feature other than the naturally
    occurring correlation between a marker and disease.  Whether this will be sufficient to render the subject matter of such
    claims as patent-eligible remains an open question.

    For information regarding
    this and other related topics, please see:

    • "PerkinElmer Inc. v. Intema Ltd. (Fed.
    Cir. 2012)
    ," November 20, 2012
    • "Patent Eligibility
    and Biology
    ," August 23, 2012
    • "Chief Judge Rader
    (Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons
    ,'"
    August 6, 2012
    • "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29,
    2012
    • "USPTO Issues
    Interim Guidance Regarding Mayo v.
    Prometheus
    ," July 5, 2012
    • "BIO International
    Convention 2012 Preview: BIO and the Prometheus
    Supreme Court Case
    ," June 5, 2012
    • "Do Diagnostic
    Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)?
    " April 11,
    2012
    • "SmartGene, Inc. v. Advanced Biological
    Laboratories SA
    (D.D.C. 2012)
    ," April 10, 2012
    • "USPTO Issues
    Preliminary Guidance on Mayo v.
    Prometheus
    ," March 27, 2012
    • "Mayo Collaborative Services v. Prometheus
    Laboratories
    — What Should We Do? (or Can These Claims Be Saved?)
    ,"
    March 26, 2012
    • "Mayo Collaborative Services v. Prometheus
    Laboratories
    — What the Court's Decision Means
    ," March 22, 2012
    • "Mayo Collaborative Services v. Prometheus
    Laboratories
    — What the Supreme Court Said
    ," March 21, 2012
    • "Early Reaction to
    Supreme Court Decision in Mayo v.
    Prometheus
    ," March 20, 2012
    • "Mayo Collaborative Services v. Prometheus
    Laboratories, Inc.
    (2012)
    ," March 20, 2012

    Image of New Year's Eve
    ball drop for 2012 in Times Square

    (above) by Replytojain, from the Wikipedia Commons under the Creative Commons
    Attribution-ShareAlike 3.0 Unported
    license.

  • By Donald Zuhn

    New_Year_Ball_Drop_Event_for_2012_at_Times_SquareReflecting upon the events
    of the past twelve months, Patent Docs
    presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were
    covered on Patent Docs last year that
    we believe had (or are likely to have) the greatest impact on biotech/pharma
    patent practitioners and applicants.  On
    Monday
    and Tuesday,
    we counted down stories #15 to #8, and today we count down stories #7 to #4 as
    we work our way towards the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links
    to articles on related topics) have been provided in case you missed the
    articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we
    left something off the list or disagree with anything we included, please let
    us know.


    7.  Federal
    Circuit Interprets § 271(e)(1) Safe Harbor as Extending to Post-approval
    Activities

    In a case involving whether
    certain post-approval activities fall within the "safe harbor" of 35
    U.S.C. § 271(e)(1), a divided panel of the Federal Circuit in August vacated a
    preliminary injunction granted by the District Court, holding that acts taken
    after approval fell with the safe harbor. 
    According to the majority, it was significant that Congress had not
    (expressly) limited the scope of the safe harbor to the Food, Drug and Cosmetic
    Act but had "broadly" included within the scope of the safe harbor
    "any federal law" that "regulates the manufacture, use, or sale
    of drugs."  Thus, the majority
    rejected Momenta's contention that the process and quality control information
    obtained from Amphastar's infringement was not submitted to the FDA but was retained
    by defendants, as these "batch records" must be maintained "for
    at least one year after expiration of the batch" of generic enoxaparin and
    must be "readily available for authorized inspection" by the
    FDA." 
    The majority opinion states that "[w]e therefore hold that
    post-approval studies that are 'reasonably related to the development and
    submission of information under a Federal law which regulates the manufacture,
    use, or sale of drugs' fall within the scope of the § 271(e)(1) safe
    harbor."  Momenta's request for
    rehearing en banc was denied by the
    Federal Circuit in November.

    For information regarding
    this and other related topics, please see:

    • "Momenta Pharmaceuticals Inc. v. Amphastar
    Pharmaceuticals, Inc.
    : 'The Rest of the Story
    ,'" August 13, 2012
    • "Momenta Pharmaceuticals, Inc. v. Amphastar
    Pharmaceuticals, Inc
    . (Fed. Cir. 2012)
    ," August 9, 2012
    • "Chief Judge Rader
    (Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons
    ,'"
    August 6, 2012


    6. 
    Implementation of Biosimilar Regulatory Pathway Proceeds Despite
    Opposition

    In February, the U.S. Food
    and Drug Administration published its long-awaited draft guidance on the
    development of biosimilar products.  The FDA's guidance consisted
    of three documents:  Scientific
    Considerations in Demonstrating Biosimilarity to a Reference Product, Quality
    Considerations in Demonstrating Biosimilarity to a Reference Protein Product,
    and Biosimilars: Questions and Answers Regarding Implementation of the
    Biologics Price Competition and Innovation Act of 2009.  The FDA then spent the next few months
    collecting comments regarding the draft guidance, and in May held a hearing on
    the draft guidance, where researchers, payors, patient and physician groups,
    and industry advocates provided their thoughts on the FDA's first attempt to
    clarify the logistics as to the operation of the BPCIA.  The FDA's efforts to implement the BPCIA,
    however, did not push implementation of the biosimilar regulatory pathway up to #6
    on this year's list.  No, it was the
    Supreme Court's landmark decision in June upholding the Patient Protection and
    Affordable Care Act (PPACA) — of which the BPCIA is a part — as
    constitutional under the taxation clause of the Constitution that lifted this
    topic to #6.  While the Supreme Court's
    decision in National Federation of Independent Business v. Sebelius did
    not constitute a direct challenge to the BPCIA, there were a handful of direct
    challenges to aspects of the BPCIA.  For example,
    President Obama took yet another shot at the 12-year data exclusivity period
    specified under the BPCIA in his 2013 budget proposal, calling for a
    modification of the length of exclusivity to facilitate faster development of
    generic biologics by "award[ing] brand biologic manufacturers seven years
    of exclusivity rather than 12 years under current law."  The same modification had been included in
    the President's 2012 budget proposal.  In
    addition, Abbott filed a Citizen Petition with the FDA in April, requesting
    that the agency refrain from accepting biosimilar applications under the BPCIA
    that cite reference products (biologics) for which a biologics license
    application (BLA) was submitted to the FDA prior to March 23, 2010 (when the
    PPACA was signed into law). 
    Interestingly, in a letter to the FDA, Rep. Anna Eshoo (D-CA), who was one of the principal
    authors of the BPCIA, stated that "[w]hile Abbott's Citizen Petition
    argues that pre-BPCIA approved biologic products cannot be subject to the law,
    l want to state very emphatically that it was Congressional intent for the new
    pathway to apply to biologics approved before and after the passage of the
    Affordable Care Act."  In October,
    the FDA sent a letter to Abbott noting that the agency "has been unable to
    reach a decision on [Abbott's] petition because it raises complex issues
    requiring extensive review and analysis by Agency officials."  The agency did not provide a date by which it
    would respond.

    For information regarding
    this and other related topics, please see:

    • "Rep. Eshoo Expresses
    Views on Abbott's Biosimilars Petition in Letter to FDA
    ," October 25, 2012
    • "FDA Continues to
    Review Abbott Petition on Biosimilars
    ," October 24, 2012
    • "Affordable Care Act
    Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars
    ,"
    June 28, 2012
    • "BIO International
    Convention 2012 Preview – Part II: BIO and Biosimilar Regulations throughout
    the World
    ," June 12, 2012
    • "House Passes User
    Fee Bill
    ," May 31, 2012
    • "Senate Passes User
    Fee Bill
    ," May 29, 2012
    • "FDA Holds Public
    Hearing on Biosimilar Draft Guidance
    ," May 20, 2012
    • "BIO Comments on FDA
    Biosimilars Guidance: Demand More Testing, Permit Fewer Differences
    ,"
    April 25, 2012
    • "Abbott Asks FDA to
    Refuse Certain Biosimilar Applications
    ," April 23, 2012
    • "FDA Discusses
    Initial Considerations for Biosimilar Guidance Documents
    ," February 27,
    2012
    • "President's Latest
    Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of
    Pay-for-Delay Agreements
    ," February 21, 2012
    • "More on FDA Draft
    Guidelines for 'Follow-on' Biologic Drug Approval Pathway
    ,"
    February 14, 2012
    • "FDA Publishes Draft
    Guidelines for Biosimilar Product Development
    ," February 9, 2012


    5.  Federal
    Circuit Confirms Patent Eligibility of Isolated DNA

    In August, the Federal
    Circuit in Association for Molecular
    Pathology v. U.S. Patent and Trademark Office
    , decided on remand that, the Supreme Court's decision in Mayo v. Prometheus notwithstanding, claims to isolated human DNA
    satisfy the requirements of 35 U.S.C. § 101. 
    Each of Judge Lourie's majority opinion, Judge Moore's concurring
    opinion, and Judge Bryson's opinion concurring in part and dissenting in part
    substantially tracked their opinions when the panel first decided AMP v. USPTO
    Had the case ended here, the Federal Circuit's decision would have
    placed higher on our list (perhaps foreshadowing one of the stories to be discussed in the final installment of our Top Stories series).

    For information regarding
    this and other related topics, please see:

    • "Patent Eligibility
    and Biology
    ," August 23, 2012
    • "Association for Molecular Pathology v.
    United States Patent and Trademark Office
    (Fed. Cir. 2012)
    ," August
    16, 2012
    • "AMP v. USPTO — Federal Circuit Confirms
    Patent Eligibility of Isolated DNA
    ," August 16, 2012
    • "The Proper Scope of
    DNA (or "Gene") Patent Claims
    ," August 1, 2012
    • "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29,
    2012
    • "Federal Circuit
    Hears Oral Argument in AMP v. USPTO
    Remand
    ," July 23, 2012
    • "Myriad Genetics
    Files Supplemental Brief in AMP v. USPTO
    ,"
    July 19, 2012
    • "Supplemental Brief
    for Appellees in AMP v. USPTO
    ,"
    July 19, 2012
    • "Biopharmaceutical
    Companies Weigh-In on Myriad
    Case
    ," July 17, 2012
    • "Health Care
    Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible
    ,"
    July 16, 2012
    • "Coalition of Amici File Brief in Support of
    Myriad
    ," July 15, 2012
    • "Dr. James Watson:
    Human Genes Should Not Be Patented
    ," July 12, 2012
    • "Scientist-Law
    Professor Files Amicus Brief in Myriad Case
    ," July 11, 2012
    • "U.S. Government: Mayo Decision Supports Prior Argument
    That Isolated Genomic DNA Is Not Patent Eligible
    ," July 10, 2012
    • "IPO Amicus Brief Argues for Patent
    Eligibility of Myriad's Isolated DNA Claims and Method Claim 20
    ," July 9,
    2012
    • "Eli Lilly & Co.
    File Amicus Brief in AMP v. Myriad
    ," June 27, 2012
    • "Biotech Companies
    Send Letter on Myriad Case to
    Attorney General and Solicitor General
    ," June 19, 2012
    • "Parties and Amici File Briefs in Myriad Case," June 17, 2012
    • "The Aussies Are At
    It Again
    ," June 14, 2012
    • "Federal Circuit
    Declines Invitation to Reconsider Standing Question
    ," June 13, 2012
    • "Plaintiffs Respond
    to Myriad's 'Suggestion' of Mootness or, Alternatively, Motion for Remand in AMP v. USPTO
    ," June 10, 2012
    • "Myriad Files Motion
    'Suggesting' Mootness or Seeking Remand in AMP
    v. USPTO
    ," May 30, 2012
    • "Federal Circuit
    Sets Schedule for AMP v. USPTO
    ,"
    April 30, 2012
    • "Supreme Court
    Remands Myriad Case
    ," March 26,
    2012


    4.  Supreme
    Court Grants Certiorari in Monsanto v.
    Bowman

    In October, the Supreme
    Court granted certiorari in Monsanto v. Bowman, against the advice
    of the U.S. Solicitor General.  In Bowman, Monsanto's complaint arose from
    farmer Bowman's "second planting" of herbicide resistant seed that
    was made using so-called "commodity seed" (seed sold by farmers to
    local grain elevators for commodity use, for example, as cattle feed).  After planting this seed, which was
    significantly cheaper than Roundup Ready® seed, farmer Bowman tested the crop
    for Roundup® resistance and found that substantial amounts of the seed were
    resistant.  He used Roundup® on these
    plantings and then replanted the seed. 
    The District Court granted summary judgment of patent infringement and
    entered judgment against farmer Bowman, and the Federal Circuit affirmed.  The question presented to the Supreme Court
    is:

    Whether the Federal Circuit erred by (1)
    refusing to find patent exhaustion in patented seeds even after an authorized
    sale and by (2) creating an exception to the doctrine of patent exhaustion for
    self-replicating technologies?

    For information regarding
    this and other related topics, please see:

    • "Supreme Court
    Grants Certiorari in Monsanto v. Bowman
    ,"
    October 22, 2012
    • "Bowman Responds to
    Solicitor General
    ," September 12, 2012
    • "Solicitor General
    Recommends the Supreme Court Deny Cert in Bowman
    v. Monsanto
    ," August 30, 2012

    Image of New Year's Eve
    ball drop for 2012 in Times Square

    (above) by Replytojain, from the Wikipedia Commons under the Creative Commons
    Attribution-ShareAlike 3.0 Unported
    license.

  • By Donald Zuhn

    New_Year_Ball_Drop_Event_for_2012_at_Times_SquareReflecting upon the events
    of the past twelve months, Patent Docs
    presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that
    were covered on Patent Docs last year
    that we believe had (or are likely to have) the greatest impact on
    biotech/pharma patent practitioners and applicants.  Yesterday, we counted down stories #15 to
    #12
    , and today we count down stories #11 to #8 as we work our way towards the
    top three stories of 2012.  As with our
    other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these
    stories (as well as a few links to articles on related topics) have been
    provided in case you missed the articles the first time around or wish to go
    back and have another look.  As always,
    we love to hear from Patent Docs
    readers, so if you think we left something off the list or disagree with
    anything we included, please let us know.


    11.  Patent Law Changes Abroad

    In December, the European
    Parliament adopted two draft regulations on the creation of the unitary patent,
    and an agreement establishing the Unified Patent Court (UPC), a specialized
    court having exclusive jurisdiction over infringement and validity questions
    related to unitary patents, is expected to be signed next month.  The European Union, however, was not the only
    governing body making patent news abroad. 
    In Australia, significant amendments were made to that
    country's patent laws through enactment of the Intellectual Property Laws
    Amendment (Raising the Bar) Act
    2012, with the new provisions scheduled to
    take effect on April 15, 2013.  Those
    provisions will raise Australia's patentability threshold and specification
    requirements, and are intended to raise the quality of granted patents in
    Australia to a level that is more consistent with the standards set in the
    U.S., Japan, and Europe.  In Israel, the
    adoption of a set of amendments to the Israel patent statute establish 18-month
    publication, submission of prior art by third parties, and third party requests
    for expedited examination of patent applications.

    For information regarding
    this and other related topics, please see:

    • "Parliament Approves
    EU Unitary Patent Package
    ," December 17, 2012
    • "European Parliament
    Adopts Draft Regulations on Unitary Patent
    ," December 12, 2012
    • "Unitary Patent
    & Unified Patent Court
    ," December 12, 2012
    • "Progress for Single
    European Patent and Litigation System
    ," November 12, 2012
    • "Australia Reforms
    Its Patents Act 1990
    ," August 29, 2012
    • "Recent Amendments
    to the Israel Patent Statute: Pulling the Pace of Prosecution from the Purview
    of the Applicant
    ," August 7, 2012
    • "EU Patent Is
    Finally Born
    ," July 2, 2012


    10.  Federal Circuit Issues Fractured En Banc
    Decision on Divided Infringement Cases

    On August 31, the
    Federal Circuit issued its en banc decision in Akamai Technologies,
    Inc. v. Limelight Networks, Inc.
    and McKesson Technologies, Inc. v. Epic
    Systems Corp.
    , reversing the
    District Court in both cases and remanding for reconsideration.  A majority consisting of Chief Judge Rader
    and Circuit Judges Lourie, Bryson, Moore, Reyna, and Wallach (with Circuit
    Judges Newman, Linn, Dyk, Prost, and O'Malley dissenting) expressly overruled BMC
    Resources, Inc. v. Paymentech, L.P.
    , 498 F.3d 1373 (Fed. Cir. 2007), which
    held that there must be a single actor (or a second actor acting under the
    control of another) for infringement to lie. 
    According to the majority, all the steps of the claimed method still
    need to be performed, but it is not necessary to prove a "single
    entity" performed them.  The
    majority opinion, if upheld, would be a boon for biotechnology, if only because
    it would provide another way for claim drafters to protect diagnostic method
    claims.  However, it is unlikely that the
    Supreme Court will deny certiorari in a case of statutory construction where
    the Federal Circuit is so plainly fractured.  (According to the Supreme Court's
    website, the deadline for filing a petition for a writ of certiorari was
    December 28, 2012.)

    For information regarding
    this and other related topics, please see:

    • "Akamai
    Technologies, Inc. v. Limelight Networks, Inc.
    and McKesson Technologies, Inc.
    v. Epic Systems Corp
    . (Fed. Cir. 2012) (en banc)
    ," September 4, 2012


    9.  More USPTO PTA Interpretations Questioned

    In 2012, the District
    Courts for the District of Columbia and the Eastern District of Virginia sided
    with a number of patentees in determining that certain practices used by the U.S.
    Patent and Trademark Office in determining Patent Term Adjustment (PTA) were
    improper.  In ArQule, Inc. v. Kappos, the District Court for the District of
    Columbia found that the Office's practice of counting weekends and holidays as
    applicant delay under 37 C.F.R. § 1.704(b) (while permitting responses filed by
    the next business day to be considered timely under 35 U.S.C. § 21(b)) was improper.  In Exelixis, Inc. v. Kappos, the Eastern
    District of Virginia disagreed with the Office's practice of negating B delay
    in circumstances where an applicant had responded to a final rejection by
    filing a request for continued examination (RCE).  According to the District Court, the statute
    "makes [it] clear that once the three year clock has run, PTA is to be
    awarded on a day for day basis regardless of subsequent events" in the
    Court's view.  As a result, RCEs filed
    after the three-year date should not toll the amount of B-Delay to be awarded to the patentee.  The District Court for the District of
    Columbia adopted the rationale of the Eastern District of Virginia in Novartis AG v. Kappos, finding that PTA
    should not be reduced by time attributable to an RCE where the RCE is filed after
    the expiration of the three year guarantee period specified in the statute.  The Court in Novartis, however, refused to toll the 180-day after issuance deadline for filing suit
    against the USPTO Director to challenge a PTA determination (for one of 23 patents at issue in the case, where the Office had failed to issue a
    determination on reconsideration within the 180-day period of 35 U.S.C. §
    154(b)(4)(A), but Novartis had filed suit within 180 days of the Office's
    determination on reconsideration, the Court did toll the start of the 180-day period).  The
    Court issued a warning to patentees that may be dissatisfied with PTA
    determinations by the Office that are based on different theories than those
    presented in Wyeth, ArQule, or Exelixis, stating that "Novartis was free to raise the same
    issues that Wyeth and Abbott Laboratories raised in their lawsuits within the
    180 days after their patents were granted."

    For information regarding
    this and other related topics, please see:

    • "Novartis AG v.
    Kappos
    (D.D.C. 2012)
    ," November 27, 2012
    • "Exelixis, Inc. v.
    Kappos
    (E.D. Va. 2012)
    ," November 8, 2012
    • "ArQule v. Kappos:
    Enjoy Your Weekend, or What a Difference a Day (or Two or Three) of PTA Can
    Make
    ," October 1, 2012
    • "USPTO Proposes
    Change to PTA Provisions Regarding Appellate Review
    ," January 9, 2012


    8.  Supreme Court to Resolve Circuit Split on
    Reverse Payment Settlement (Pay-for-Delay) Agreements

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

    For information regarding
    this and other related topics, please see:

    • "Supreme Court to
    Review Reverse Payment Settlement Agreements
    ," December 9, 2012
    • "FTC Moves as Amicus
    in Effexor Litigation, and Gets Its (Well-Earned) Comeuppance
    ," October
    18, 2012
    • "FTC Asks Supreme
    Court to Play Favorites in Reverse Payment Settlement Agreement Cases
    ,"
    October 16, 2012
    • "Amici File Briefs
    Supporting Certiorari in K-Dur Case — Part II
    ," October 10, 2012
    • "Amici File Briefs
    Supporting Certiorari in K-Dur Case
    ," October 8, 2012
    • "GPhA Files Amicus
    Brief in K-Dur Case
    ," October 3, 2012
    • "Bayer Files Amicus
    Brief in K-Dur Case
    ," September 27, 2012
    • "PhRMA Files Amicus
    Brief in K-Dur Case
    ," September 26, 2012
    • "Should Presumptions
    Be Avoided in the Reverse Payment Debate?
    " September 21, 2012
    • "Generic Defendant
    Petitions for Certiorari in K-Dur Litigation
    ," September 17, 2012
    • "Merck Asks Supreme
    Court to Review Third Circuit K–Dur Decision
    ," August 28, 2012
    • "The Federal Trade
    Commission Finally Wins One
    ," July 18, 2012
    • "Federal Trade
    Commission v. Watson Pharmaceuticals, Inc.
    (11th Cir. 2012)
    ," April 30,
    2012
    • "Latest Legislative
    Attempt on Reverse Payment ANDA Settlements
    ," February 27, 2012

    Image of New Year's Eve
    ball drop for 2012 in Times Square

    (above) by Replytojain, from the Wikipedia Commons under the Creative Commons
    Attribution-ShareAlike 3.0 Unported
    license.

  • By Donald Zuhn

    New_Year_Ball_Drop_Event_for_2012_at_Times_SquareReflecting upon the events
    of the past twelve months, Patent Docs
    presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that
    were covered on Patent Docs last year
    that we believe had (or are likely to have) the greatest impact on
    biotech/pharma patent practitioners and applicants.  Today, we count down stories #15 to #12, and
    then throughout the week, we will work our way towards the top three stories of
    2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage
    of these stories (as well as a few links to articles on related topics) have
    been provided in case you missed the articles the first time around or wish to
    go back and have another look.  As always,
    we love to hear from Patent Docs
    readers, so if you think we left something off the list or disagree with
    anything we included, please let us know.


    15.  USPTO
    Continues Efforts to Cut Application Backlog and Pendency

    In November, the U.S.
    Patent and Trademark Office released its Performance and Accountability Report
    for Fiscal Year (FY) 2012, which indicated that the Office had met all of its
    annual performance targets.  For one of
    those targets — average total pendency — the Office not only hit its target
    by achieving a 32.4-month pendency (versus the target of 34.7 months), but it
    surpassed the average pendency achieved in each of the three previous fiscal
    years.  The Office also noted that
    despite an increase in application filings (565,566 in FY 2012 versus 537,171
    in FY 2011), the number of applications awaiting action dropped from 690,967 in
    FY 2011 to 633,812 in FY 2012 (the fourth consecutive year that the number of applications
    awaiting action had dropped) and the total number of pending applications decreased
    from 1,168,928 in FY 2011 to 1,157,147 in FY 2012.  However, despite the improving numbers, the
    Office has continued to seek ways in which to cut the application backlog and
    application pendency.  One issue on which the Office has focused its attention recently is the rising number of Requests for Continued
    Examination (RCEs).  Earlier this month,
    the Office published a notice in the Federal Register (77 Fed. Reg. 72830)
    seeking public feedback on RCE practice. 
    The notice, which indicated that the Office has a backlog of
    more than 90,000 applications that have not been examined since an RCE was
    filed, described some of the Office's efforts to reduce the RCE backlog, including
    the Quick Path Information Disclosure Statement (QPIDS) pilot program and the
    After Final Consideration Pilot (AFCP). 
    Not surprisingly, the notice does not discuss the Office's efforts to
    decrease RCE filings by raising the cost of filing a first RCE to $1,200 (from
    the current fee of $930), and further raise the cost of filing subsequent RCEs
    to $1,700, a proposal that the Patent Public Advisory Committee (PPAC) has
    called "illogical."  Comments to
    the Office's notice can be submitted until February 4, 2013 (see link below for information regarding
    the submission of comments).

    For information regarding
    this and other related topics, please see:

    • "USPTO Seeks Public
    Feedback on RCE Practice
    ," December 13, 2012
    • "USPTO News Briefs,"
    June 21, 2012
    • "USPTO Announces
    Quick Path Information Disclosure Statement (QPIDS) Pilot Program
    ," May
    10, 2012
    • "USPTO to Assess
    After Final Consideration Pilot Program
    ," April 5, 2012


    14.  USPTO
    and Applicants Deal with Intersection of Patent and Copyright Law

    In January, the Office of
    the General Counsel for the U.S. Patent and Trademark Office issued a
    memorandum in
    response to several inquiries the Office had received concerning copyright
    infringement and the use of non-patent literature (NPL) in the examination
    process.  In that memo, USPTO General
    Counsel Bernard Knight, Jr. deemed the following practices to be protected by
    the doctrine of fair use:  (1) the Office's
    practice of making copies of copyrighted NPL and providing such copies to an
    applicant in the course of patent examination; (2) the Office's practice of providing
    certified copies of entire file histories, including copyrighted NPL, to
    members of the public for a fee; and (3) the copying of copyrighted NPL by
    patent applicants and their attorneys and the submission of those copies to the
    USPTO pursuant to the USPTO's disclosure requirements.  The memo was timely given separate lawsuits
    brought by a publishing company against two law firms in February.  (Because one of the firms is McDonnell Boehnen
    Hulbert & Berghoff LLP, where the Patent
    Docs
    authors and contributors work, Patent
    Docs
    has not provided any coverage of these cases.  However, former MBHB attorney Dennis Crouch
    has covered the cases on his Patently-O weblog; see here
    and here,
    for example.)

    For information regarding
    this and other related topics, please see:

    • "USPTO Issues Memo
    on Use of Non-Patent Literature During Examination
    ," January 23, 2012


    13.  Congress
    Works to "Correct and Improve" Leahy-Smith America Invents Act

    On November 30, Rep. Lamar
    Smith (R-TX) introduced a bill (H.R. 6621) entitled "To correct and
    improve certain provisions of the Leahy-Smith America Invents Act and title 35,
    United States Code."  Demonstrating
    that you cannot judge a bill by its title, the legislation contained provisions having
    nothing to do with any of the AIA's provisions, including one that would have
    effectively eliminated patent rights for the ~200 pending U.S. patent
    applications having a filing date prior to June 7, 1995 (when legislation
    enabling the provisions to the Uruguay Rounds of the General Agreement on
    Tariffs and Trade (GATT) were enacted). 
    This section, however, was replaced with a provision requiring a report
    to Congress on the status of pre-GATT applications before the House passed the
    bill by a 308-89 vote, and even that changed section was replaced with a
    clerical amendment in the Senate version of the bill.  Following passage of the further amended bill
    by the Senate, the bill stalled back at the House when Rep. Bobby Scott (D-VA)
    objected to a vote on the grounds that a quorum was not present.

    For information regarding
    this and other related topics, please see:

    • "The Status Quo
    Reigns in Senate's Version of H.R. 6621
    ," December 30, 2012
    • "Congressional
    Corrections Regarding H.R. 6621
    ," December 20, 2012
    • "Congressional Misunderstandings
    (Apparently) Motivate H.R. 6621
    ," December 20, 2012
    • "The Plot Thickens
    around H.R. 6621
    ," December 18, 2012
    • "Pre-GATT Patent
    Applications Threatened by Lamar Smith's H.R. 6621
    ," December 6, 2012


    12.  Federal
    Circuit Defines Presumption of Enablement for Prior Publications

    On July 27, the Federal
    Circuit issued a decision in In re Antor
    Corp
    . that increased the burden on proving patentability created by prior
    art references for patent applicants and patentees by defining a presumption of
    enablement not only for prior patents and published patent applications but
    also for all prior printed publications, regardless of source of provenance.  The Antor
    decision is likely to have important implications for practitioners attempting
    to provide patent protection for biotechnology-based inventions.  This is because the inventiveness of
    biotechnology inventions is often assessed in view of prior art produced by
    university researchers, and it is a feature of some of this art that portions
    therein are reserved for what can most kindly be called discussions of possible
    future implications and applications of a scientific result (or unkindly, unsupported flights of fancy).  However, the presence of such language in
    scientific references such as journal articles not expressly provides a much
    more robust source of prior art, insofar as anything said in a prior art
    printed publication now falls expressly within the presumption that it is
    enabled.  While in many cases this will
    not pose an insurmountable challenge, it can be expected at the very least to
    increase the difficulties and cost of obtaining patents, and to open up a host
    of new prior art for use in invalidity defenses.

    For information regarding
    this and other related topics, please see:

    • "In re Antor Media
    Corp.
    (Fed. Cir. 2012)
    ," August 20, 2012

    Image of New Year's Eve
    ball drop for 2012 in Times Square

    (above) by Replytojain, from the Wikipedia Commons under the Creative Commons
    Attribution-ShareAlike 3.0 Unported
    license.

  • By Kevin E. Noonan

    Washington - Capitol #2The
    Senate on Saturday passed an amended version (S. Amendment 3344) of H.R. 6621,
    Rep. Lamar Smith's bill "To correct and
    improve certain provisions of the Leahy-Smith America Invents Act and title 35,
    United States Code.
    "  In this
    version, the (in)famous, controversial and unnecessary provisions relating to
    so-called pending "pre-GATT" patent applications have been eliminated
    in favor of a totally unrelated clerical correction.

    To recap, the original version contained
    the following provision in Section 1(m):

    (m) Effective Date of Uruguay
    Round Agreements Act –
        (1) CERTAIN PATENT
    APPLICATIONS
    – Notwithstanding section 534(b)(1) of the
    Uruguay Round Agreements Act (35 U.S.C. 154 note), section 154(a) of title 35,
    United States Code, as amended by section 532 of the Uruguay Round Agreements
    Act (Public Law 103-465; 108 Stat. 4809), shall apply, and section 154(c)(1) of
    title 35, United States Code, shall not apply, to any application that is –
            (A) filed before the date that is 6 months
    after the date of the enactment of the Uruguay Round Agreements Act; and
            (B) pending on a date that is 1 year or
    more after the date of the enactment of this Act.
        (2) EFFECTIVE DATE
    – This subsection shall take effect on the date that is 1 year
    after the date of the enactment of this Act and shall apply to any original
    plant or utility patent application that is pending on or after that effective
    date.

    In
    order to garner the support of certain House members, particularly Rep.
    Dana Rohrabacher (R-CA), this provision was amended to require a PTO "Report"
    on these applications in an amended version of the provision:

    (m) REPORT ON PRE-GATT APPLICATIONS.– Using
    existing resources, not later than four months after the date of the enactment
    of this Act, the Director of the United States Patent and Trademark Office
    shall submit a report to the Committees on the Judiciary of the United States
    House of Representatives and the Senate that describes–

        (1) the total
    number of pending United States applications for patent
    that–

            (A) are not
    subject to an order under section 181 of title 35, United States Code;
    and

            (B) were filed
    before the effective date of the amendments made by section 532 of the Uruguay
    Round Agreements Act (Public Law 103–465; 108 Stat.
    4983);


        (2) the filing date of each such
    application;


        (3) the filing date of the earliest
    application for which each such application claims the benefit of or a right of
    priority to its filing date;

        (4) the inventor and assignee named on
    each such application;

        (5) the amount of time that examination of
    each such application has been delayed because of a proceeding under section
    135(a) of title 35, United States Code, an appeal to the Patent Trial and
    Appeal Board under section 134(a) of such title, a civil action in a United
    States District Court under section 145 or 146 of such title, or an appeal to
    the United States Court of Appeals for the Federal Circuit under section 141 of
    such title; and

        (6) other information about such
    applications that the Director believes is relevant to their pendency.

    The bill passed the House on a vote of
    308-89 on December 18th (see "Congressional Misunderstandings (Apparently) Motivate H.R. 6621").

    The Senate version of the bill contains
    this language in Section 1(m):

    (m) Clerical Amendment.–Section 123(a) of title
    35, United States Code, is amended in the matter preceding paragraph (1) by
    inserting "of this title'' after "For purposes''.

    The House was slated to pass this amended
    version of the bill late Sunday evening but did not; the bill may make it to
    the House floor on Monday.

    Pre-GATT
    application owners are not out of the woods yet, however.  During remarks made on the Senate floor, Sen.
    Patrick Leahy (D-VT) said the following:

    We must also continue to focus on the troubling
    problem of several hundred "pre-GATT" patent applications that have now been
    pending before the Patent Office for over 18 years.  The original version of
    this legislation in the House addressed that problem by providing a 1-year
    window for the pending applications to be processed.

    Unfortunately, that language was removed before final
    passage in the House and replaced with a provision requiring the Patent Office
    to prepare a report.  The amended bill the Senate has passed today strikes the
    report, but I will work closely with the PTO to identify the cause of the delays
    and ensure that the PTO has the tools it needs to address any abuses by those
    who may be trying to game the system and use the patent laws to impede, rather
    than encourage innovation.

    It should come as no surprise to anyone who has followed Sen.
    Leahy's many pronouncements on his AIA and the patent system that he shares
    with his colleagues in the House some of the misunderstandings of the laws he
    is creating.  It
    is up to members of the patent community to do what they can to correct these
    misperceptions if effective patent reform can be achieved.

    Hat tip to
    Hal Wegner for details of these legislative machinations.

  • By Sherri Oslick

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

    Eli Lilly and Company v.
    Kappos et al.

    1:12-cv-01491; filed December
    26, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 7,498,414 ("Human Antibodies Specific to KDR and Uses
    Thereof," issued March 3, 2009). 
    View the complaint here.


    Millennium Pharmaceuticals
    Inc. v. Actavis Inc.

    1:12-cv-01750; filed December
    21, 2012 in the District Court of Delaware

    Infringement of U.S. Patent
    Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March
    30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed
    exclusively to Millennium, following a Paragraph IV certification as part of
    Actavis' filing of an ANDA to manufacture a generic version of Millenium's
    Velcade® (bortezomib, used to treat multiple myeloma).  View the complaint here.


    UCB, Inc. et al. v. Teva
    Pharmaceuticals USA, Inc. et al.

    1:12-cv-04420; filed December
    21, 2012 in the Northern District of Georgia

    • Plaintiffs:  UCB, Inc.; UCB
    Manufacturing, Inc.
    • Defendants:  Teva
    Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

    Infringement of U.S. Patent
    No. 6,344,215 ("Methylphenidate Modified Release Formulations,"
    issued February 5, 2005) based on Teva's manufacture and sale of a generic
    version of UCB's Metadate CD® (methylphenidate hydrochloride, used to treat
    attention deficit hyperactivity disorder). 
    View the complaint here.


    Bristol-Myers Squibb Co.
    v. Dr. Reddy's Laboratories, Ltd. et al.

    3:12-cv-07800; filed December
    21, 2012 in the District Court of New Jersey

    • Plaintiff:  Bristol-Myers
    Squibb Co.
    • Defendants:  Dr. Reddy's
    Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

    Infringement of U.S. Patent
    Nos. 6,670,384 ("Methods of Administering Epothilone Analogs for the
    Treatment of Cancer," issued December 30, 2003), 7,022,330 ("Parenteral
    Formulation for Epothilone Analogs," issued April 4, 2006), and RE41,393 ("Treatment
    of Refractory Tumors Using Epothilone Derivatives," reissued June 22,
    2010) following a Paragraph IV certification as part of Dr. Reddy's filing of
    an ANDA to manufacture a generic version of BMS's Ixempra® kit product
    (ixabepilone), used to treat breast cancer). 
    View the complaint here.


    BioGeneriX GmbH v. Kappos

    1:12-cv-01484; filed December
    21, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 8,207,112 ("Liquid Formulation of G-CSF Conjugate,"
    issued June 26, 2012).  View the
    complaint here.


    Cerenis Therapeutics Holding
    SA v. Kappos

    1:12-cv-01488; filed December
    21, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 8,206,750 ("Charged Lipoprotein Complexes and Their
    Uses," issued June 26, 2012).  View
    the complaint here.


    Glaxo Group Ltd. et al. v.
    Kappos

    1:12-cv-01481; filed December
    21, 2012 in the Eastern District of Virginia

    • Plaintiffs:  Glaxo Group
    Ltd.; SmithKline Beecham Ltd.; Glaxosmithkline Consumer Healthcare GmbH
    & Co. KG
    • Defendant:  David J. Kappos

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent Nos. 8,207,176 ("Compounds," issued June 16, 2012),
    8,216,576 ("Method for Inhibiting Binding to B-cell Receptor," issued
    July 10, 2012), 8,236,345 ("Composition and Use," issued August 7,
    2012), and 8,220,102 ("Toothbrush" issued July 17, 2012).  View the complaint here.


    Millennium Pharmaceuticals,
    Inc. v. Kappos

    1:12-cv-01479; filed December
    21, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 8,207,177 ("Inhibitors of E1 Activating Enzymes,"
    issued June 26, 2012).  View the
    complaint here.


    Conaris Research Institute AG
    v. Kappos

    1:12-cv-01482; filed
    December 21, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 8,206,948 ("Optimized Nucleotide Sequences Encoding
    SGP130," issued June 26, 2012). 
    View the complaint here.


    Supernus Pharmaceuticals, Inc.
    v. Kappos

    1:12-cv-01485; filed December
    21, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 8,206,740 ("Once Daily Formulations of Tetracyclines,"
    issued June 26, 2012).  View the
    complaint here.


    DSM I.P. Assets B.V. v. Kappos

    1:12-cv-01490; filed December
    21, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 8,206,981 ("Process for Cell Culturing by Continuous
    Perfusion and Alternating Tangential Flow," issued June 26, 2012).  View the complaint here.


    Genetic Technologies Ltd.
    v. Laboratory Corp. of America Holdings et al.

    1:12-cv-01736; filed December
    20, 2012 in the District Court of Delaware

    • Plaintiff:  Genetic
    Technologies Ltd.
    • Defendants:  Laboratory Corp.
    of America Holdings; Laboratory Corp. of America; 23andMe Inc.

    Infringement of U.S. Patent
    No. 7,615,342 ("ACTN3 Genotype Screen for Athletic Performance,"
    issued November 10, 2009) based on Laboratory Corporation's genomic testing and
    analysis services, including ACTN3 gene testing and analysis.  View the complaint here.


    Genetic Technologies Ltd.
    v. Natera Inc.

    1:12-cv-01737; filed December
    20, 2012 in the District Court of Delaware

    Infringement of U.S. Patent
    No. 5,612,179 ("Intron Sequence Analysis Method for Detection of Adjacent
    Locus Alleles as Haplotypes," issued March 18, 1997) based on Natera's
    manufacture, use, sale, and offer for sale of DNA testing services, including
    preimplantation genetic diagnosis for in vitro fertilization.  View the complaint here.


    Genetic Technologies Ltd.
    v. HistoGenetics LLC

    1:12-cv-01738; filed December
    20, 2012 in the District Court of Delaware

    Infringement of U.S. Patent
    No. 5,612,179 ("Intron Sequence Analysis Method for Detection of Adjacent
    Locus Alleles as Haplotypes," issued March 18, 1997) based on HistoGenetic's
    provision of tissue-typing services, including human leukocyte antigen typing
    services by sequenced-based typing for blood stem cell transplants.  View the complaint here.


    Endo Pharmaceuticals Inc. et
    al. v. Par Pharmaceutical Companies, Inc. et al.

    1:12-cv-09261; filed
    December 19, 2012 in the Southern District of New York

    • Plaintiffs:  Endo
    Pharmaceuticals Inc.; Grunenthal GmbH
    • Defendants:  Par
    Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

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


    Intrexon Corp. v. Kappos

    1:12-cv-01451; filed December
    17, 2012 in the Eastern District of Virginia

    Review and correction of the
    patent term adjustment calculation made by the U.S. Patent and Trademark Office
    for U.S. Patent No. 8,236,556 ("Method of Modulating Gene Expression Using
    and Ecdysone Receptor-Based Inducible Gene Expression System," issued
    August 7, 2012).  View the complaint here.