• Calendar

    November 12-14, 2012 – Fall Intellectual Property
    Counsels Committee (IPCC) Conference
    (Biotechnology
    Industry Organization) – Charleston, SC

    November 14, 2012 – Patents and
    the Public Good
    (Greater Washington, DC Chapter of the Licensing
    Executives Society) – Washington, DC

    November 15, 2012 – Successful Strategies for Overcoming Obviousness Rejections in the Patent
    Application Process
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 – 11:15 am
    (CT)

    November 27, 2012 – Patents and the Written Description Requirement: Navigating
    Section 112 Disclosure Obligations and Withstanding Invalidity Challenges
    (Strafford) – 1:00 – 2:30 pm (EST)

    November 28-29, 2012 – Biotech Patents*** (American Conference
    Institute) – Boston, MA

    November 28-29, 2012 – Orphan Drugs and Rare Diseases*** (American Conference
    Institute) – Boston, MA

    December 3-5, 2012 – Drug and Medical Device
    Litigation
    *** (American Conference
    Institute) – New York, NY

    December 4-5, 2012 – Paragraph IV Disputes*** (American Conference
    Institute) – San Francisco, CA

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

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

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

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

  • Strafford #1Strafford will be offering a webinar/teleconference
    entitled "Preissuance Prior Art Submissions at the USPTO — Best Practices
    for Third-Party Challenges to Patent Applications and Monitoring
    Competition" on December 11, 2012 from 1:00 – 2:30 pm (EST).  Clifton E. McCann and Thomas M. Haas of
    Thompson Hine will provide guidance to patent counsel on the new preissuance
    submission rules and offer best practices for deciding whether and how best to
    file a preissuance submission on a competitor’s or potential competitor’s
    patent application and for monitoring competitors.  The webinar will review the following
    questions:


    How do the new USPTO rules change the landscape for third-party intervenors?

    What are the key considerations for patent counsel when deciding whether to
    make preissuance submissions?

    What are the benefits and limitations of submitting prior art or printed
    publications on a pending patent application?

    The
    registration fee for the webinar is $297 ($362 for registration and CLE
    processing).  Those registering by
    November 16, 2012 will receive a $50 discount. 
    Those interested in registering for the webinar, can do so here.

  • AmsterdamC5 (UK) will be
    holding its 5th Forum on Biotech & Pharma Patent Litigation on January
    29-30, 2013 in Amsterdam, Netherlands. 
    The conference will cover the following topics:

    • View from the bench: Hear the perspectives of
    Judges on the latest developments;
    • SPCs: Implications of Neurim and how national courts are applying Medeva;
    • First hand
    perspectives on patent settlement agreements from the FTC in the US and
    European Commission: Find out what they are looking for;
    • Practical tips on planning your strategy when
    managing multi-jurisdictional litigation;
    • Assessing what is now patentable post-Prometheus — Find out the impact of the
    US Patent Reform on litigation in the US and Europe;
    • A Pan-European perspective on the latest
    developments affecting patent litigation in Germany, UK, Netherlands and
    France;
    • Business strategy considerations in response
    to the Unitary Patent Court developments; and
    • Understanding the implications of the Solvay case on cross-border injunctions.

    UntitledIn particular, C5
    faculty will offer presentations on the following topics:

    • In-house
    roundtable: How in-house counsel are selecting & evaluating their outside
    counsel, managing litigation, containing costs, and formulating their litigation
    strategies;
    • Implications of Neurim and aftermath of Medeva: How are national courts applying
    Medeva? — How likely is it that this
    will lead to further referrals to the CJEU?
    • A pan-European
    perspective on the latest developments affecting biotech & pharma patent
    litigation in Germany, UK, the Netherlands, and France;
    • Business strategy
    considerations in response to the unitary patent court developments
    — Part A: Update
    on the recent developments;
    — Part B: In-house
    counsel panel — How are in-house counsel altering their business strategies?
    — Part C: Private
    practice lawyers' perspective: Realignment of business units to capitalise on
    developments;
    • Assessing the
    implications of US patent reform on biotech & pharma patent litigation in the
    US and Europe — Tips on updating your litigation strategies;
    • Minimising costs
    by choosing the right alternatives to litigation for disputes in the biotech
    and pharmaceutical sector;
    • View from the
    bench: Judicial perspectives on the latest litigation, successful strategies,
    settlement considerations and more;
    • The implications
    of the latest patent settlement investigations in Europe & the US on your
    patent litigation strategy;
    • Understanding the
    implications of the Solvay case on
    cross-border injunctions;
    • Hints and tips
    from the coal face: Practical tips on planning your multi-national strategy
    when managing multi-jurisdictional litigation;
    • Biosimilars:
    Tailoring your litigation strategies to this emerging area;
    • How to
    successfully enforce your patents in China; and
    • Patent litigation
    strategies for Russia, India and Brazil.

    A pre-conference
    workshop, entitled "Successfully Obtaining Interim Injunctions in
    Europe," will be held from 1:30 to 4:30 pm on January 28, 2013.

    A complete brochure
    for the Biotech & Pharma Patent Litigation conference, including an agenda,
    detailed descriptions of conference sessions, list of speakers, and
    registration form can be obtained here.

    C5The registration
    fee is €1895 (conference alone) or €2594 (conference and pre-conference
    workshop).  Those registering on or
    before December 19, 2013 will receive a €100 discount.  A live webcast is also being offered for
    €1355.  Those interested in registering
    for the conference can do so here, by e-mailing
    registrations@C5-Online.com, by calling +44 20 7878 6888, or by faxing a
    registration form to +44 20 7878 6885.

    Patent Docs is a media partner of the C5 Biotech & Pharma Patent Litigation
    conference.

  • LESThe Greater Washington, DC Chapter of the Licensing
    Executives Society (LES) will be offering a program entitled "Patents and
    the Public Good" on November 14, 2012 from 5:30 – 8:00 pm (Eastern) at
    Sidley Austin LLP in Washington, DC. 
    Chief Judge Randall Rader of the U.S. Court of Appeals for the Federal
    Circuit, former Chief Judge Paul Michel of the U.S. Court of Appeals for the
    Federal Circuit, and Raymond Van Dyke of Van Dyke Law will review the positives
    of a strong patent system to our nation and the world.  A networking reception will be held from 5:30
    – 6:30 pm, and the presentation will be held from 6:30 – 8:00 pm.

    The
    registration fee for the program is $30 (LES members) or $40
    (non-members).  Those interested in
    registering for the program, can do so here.  The online registration deadline is November
    13, 2012.

  • Court Overrules PTO Interpretation of B-Delay Calculation

    By
    Kevin E. Noonan

    District Court for the Eastern District of VirginiaJudge
    T.S. Ellis III of the U.S. District Court for the Eastern
    District of Virginia wrote the latest chapter in the story of judicial review of (and,
    generally, disagreement with) how the Office has interpreted the patent term
    adjustment provisions of the 1999 America Inventors Protection Act (AIPA).  This case involves so-called "B delay,"
    corresponding to a date that is three years after an application's filing date
    and the date on which the Office actually grants a patent pursuant to 35 U.S.C.
    § 154(b)(1)(B).  The issue
    was whether the Office had correctly implemented the statute by negating B delay
    in circumstances where an applicant had responded to a final rejection by
    filing a request for continued examination (RCE) (also a provision newly added
    to U.S. patent law by the AIPA).

    ExelixisThe
    case involved an application filed by Exelixis that resulted in grant of U.S.
    Patent No. 7,989,622 entitled "Phosphatidylinositol 3-Kinase Inhibitors
    and Methods of their Use."  The
    application was filed on January 15, 2008 and a first Office Action promulgated
    by the Office on February 22, 2010, resulting in an "A delay" (the
    time from the filing date to the first substantive action in a case pursuant to
    35 U.S.C. § 154(b)(1)(A)) of 283
    days.  The PTO issued Final Rejection on
    March 9, 2011 (38 months, i.e., 2 months from the three-year date calculated
    from the filing date), to which the applicants responded on April 11, 2011;
    this response was filed with an RCE.  "Less
    than three weeks later" (a time the Court characterized as "commendable,
    if, with respect to this application, uncharacteristic alacrity"), the
    Office issued a Notice of Allowance.  Despite payment of the Issue Fee almost immediately (on April 28, 2011),
    the patent did not grant until August 2, 2011.  At that time, the Office notified Exelixis that the PTA for this patent
    was a total of 368 days, corresponding to 283 days of A delay, 85 days of B
    delay, 0 days of C delay under 35 U.S.C. § 154(b)(1)(C) and
    subtracting 61 days for applicant delay in prosecution ("C reduction"
    under 35 U.S.C. § 154(b)(2)(C)).  The Office's calculation of the B delay, the
    issue in the case, credited Exelixis for 85 days from the time between the date
    that was three years after the application was filed and the date the Final
    Rejection was mailed; the Office did not give this patent the benefit of
    another 114 days corresponding from the date the RCE was filed until the grant date,
    implementing Office policy that filing an RCE stops the accumulation of B delay
    in the Office's PTA calculation.  These
    114 days and the Office's policies that deprived the '622 patent of this
    additional PTA prompted the lawsuit.  The Court set forth a helpful timeline:

    Timeline
    The Court recognized the context of the dispute being based in an assessment of
    Congressional intent in implementing the provisions of the General Agreement on
    Tariffs and Trade (GATT), which changed the term of U.S. patents from 17 years
    from issue to 20 years from the filing (or earliest priority) date, and the
    provisions of the AIPA apparently aimed at restoring term lost as the result of
    Patent Office delays in prosecution.  "Taken
    as a whole," the Court said:

    [T]he clear goal and purpose of these
    provisions is to provide a successful applicant with a patent that can be
    enforced against putative infringers for approximately 17 years — 20 years from
    the date of application less three years for prosecution and examination — and
    to reach this goal by providing applicants with day for day patent term
    extension for delays attributable to the PTO and day for day reductions for the
    patent term extension for delayed attributable to an applicant's failure to act
    with alacrity in certain circumstances.

    The Court characterizes the provisions of 35 U.S.C. § 154(b)
    as "guarantees" according to the titles of the three sections of § 154(b)
    relating to PTO delay, which is significant because the Court notes (in a
    footnote) that it is permissible for courts to use titles and headings in
    statutes in interpreting the meaning of the substantive provisions of law.

    On
    summary judgment, the Court ruled against the PTO's interpretation of the
    statute based on its construction of the statutory provisions and Congressional
    intent discerned inter alia from how Congress described and characterized those
    provisions in the statute.  The Court
    applied the deferential standard that agency action must be upheld unless it is
    "arbitrary, capricious, an abuse of discretion or otherwise not in
    accordance with law" under the Administrative
    Procedures Act (5 U.S.C. § 706(2)(A)), noting that an
    erroneous interpretation of the law satisfies this standard, citing Star Fruits S.N.C. v. U.S., 393 F.3d
    1277, 1281 (Fed. Cir. 2005), and Arnold
    Partnership v. Dudas
    , 362 F.3d 1338, 1340 (Fed. Cir. 2004).

    The Court's opinion begins with the "plain language of the statute," and
    the Court found that the meaning of the statute was "clear, unambiguous,
    and in accord with both the statute's structure and purpose."  Section 154(b)(2) clearly and "simply"
    is intended by its terms to provide a guarantee of no more than a three-year
    application pendency, according to the Court's opinion, and this goal is
    accomplished by "(i) starting a three year clock on the date the
    application is filed, (ii) tolling the running of this clock if, within the
    three year period, any of three events occur, including an RCE filing, and
    (iii) adding a day for day PTA to the patent term for any delay in the issuance
    of a patent after the three year clock, less any tolling, runs out."

    In
    the Court's view, the provisions of the statute involving RCEs have to do
    solely with tolling the clock with regard to the three-year date.  The opinion
    states that the portion of the statute concerning RCEs "clearly and
    unambiguously modifies and pertains to the three year period and does not apply
    to, or refer to, the day to day PTA remedy."  The Court characterizes as "[e]specially
    notable" that the statute "does not address the filing of an RCE after
    the expiration of the three year clock" (emphasis in original).  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.  The Court also notes that the filing of an
    RCE is not contained in the section setting forth the day to day reduction in
    PTA occasioned by applicant delay in prosecution, and concludes that the
    statute does not consider the filing of an RCE to be an action that warrants
    reduction in PTA under the statute.  The Court concludes that "RCE's gave no impact on the PTA after the three year
    deadline has passed."

    The Court rejected PTO arguments in favor of the Office's interpretation.  Specifically, the opinion swiftly dismissed
    the argument that the statute must be interpreted as if it included the word "then"
    in such a way that would support its interpretation by simply noting that the
    word "then" did not appear in the statute and on the grounds that the
    Office's interpretation would effectively treat the filing of an RCE as a failure
    to "engage in reasonable efforts to conclude prosecution of the
    application," i.e., the grounds for applicant delay where the Court had
    expressly found RCE filings were not included.  If this is the interpretation the Office wants to apply to RCEs, the Court tartly recommends that the Office should be sure to "issue any
    notice of rejection prior to the expiration of the three year period" as
    well as require prompt filing of an RCE.  The Court also rejects the Office's position that it should be accorded
    deference, saying that "deference is unwarranted when [] the statute is
    unambiguous."  In this regard the Court notes that the Federal Circuit had rejected this level of deference in
    the last case decided on PTA issues, Wyeth
    v. Kappos
    .  Finally, the Court noted
    that any disparate treatment that might result one application to the next
    (depending on whether an RCE was filed before or after the 3-year anniversary
    date) was something within the Office's power to control or minimize.

    It
    is likely that the government will appeal to the Federal Circuit, and thus that
    the finality of this interpretation of the statute will remain delayed until
    that review of complete.  This means that
    there is time for prudent patent practitioners to review the PTA status of their
    clients' patents to determine where there are instances where the PTA was "improperly"
    calculated under the interpretation set forth in this opinion.  But time may be of the essence for some because
    the statute also imposes a 180-day statute of limitations on filing challenges
    to Office PTA determinations (see "USPTO Posts Notice Regarding Wyeth Decision"), and while an
    intervening change in the law may permit challenges outside that period it
    makes better sense to identify important patents and file a lawsuit based on
    this interpretation of the B delay statutory provisions to best protect both
    clients and practitioners.

    Exelixis, Inc. v. Kappos (E.D. Va. 2012)
    Memorandum Opinion by Judge T.S. Ellis, III

  • By Donald Zuhn

    California FlagOn Tuesday, while California
    voters were helping President Obama secure a second term in the White House, picking the President over Republican challenger Mitt Romney by a 59.1% to 38.6%
    margin, they were also responsible for defeating a ballot initiative, Proposition 37, that would have required raw or processed food to be
    labeled if such food was made from plants or animals having genetic material
    changed in specified ways.  The
    initiative measure, entitled "The California Right to Know Genetically
    Engineered Food Act," would have amended the California Health and Safety
    Code such that "any food offered for retail sale in California [would be considered to be] misbranded if it is or may
    have been entirely or partially produced with genetic engineering and that fact
    is not disclosed."  The margin of
    defeat for Proposition 37 was somewhat narrower than that in the Presidential
    race, with voters rejecting the ballot initiative 53.7% to 46.3%.

    According to Proposition
    37, "genetically engineered" food was defined as:

    [A]ny food that is produced from an organism or
    organisms in which the genetic material has been changed through the
    application of:
        (A)
    In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid
    (DNA) techniques and the direct injection of nucleic acid into cells or
    organelles, or
        (B)
    Fusion of cells, including protoplast fusion, or hybridization techniques that
    overcome natural physiological, reproductive, or recombination barriers, where
    the donor cells/protoplasts do not fall within the same taxonomic family, in a
    way that does not occur by natural multiplication or natural recombination.

    Right to KnowUnder the Act, raw
    agricultural food that was genetically engineered would have to be labeled as
    "Genetically Engineered," and processed food ("any food produced from a raw agricultural
    commodity that has been subject to processing such as canning, smoking,
    pressing, cooking, freezing, dehydration, fermentation, or milling") would have to be
    labeled as "Partially Produced with Genetic Engineering."

    At
    the California Secretary of State website,
    arguments in favor of and against the ballot initiative were presented.  In addition, voters were directed by the
    website to the groups California Right to Know
    (in favor of the initiative) and NO on 37 (against
    the initiative) for additional information.

    No on 37Interestingly,
    the Ballotpedia webpage for Proposition 37
    listed the California Democratic Party and the Green Party of California as
    supporters of the failed ballot initiative and the California Republican Party as
    being opposed to the initiative.  Donors
    to the "No on 37" campaign included Monsanto, E.I. Dupont De Nemours
    & Co., DOW Agrisciences, Bayer Cropscience, BASF Plant Science, Syngenta
    Corporation, and the Biotechnology Industry Organization (BIO).

    According
    to a report
    in the San Jose Mercury News, proponents of the initiative, including
    California Right to Know, will now turn their efforts towards getting similar initiatives
    on the ballot in Washington and Oregon.

  •     By Andrew Williams

    USPTO SealLast month, on October 18,
    2012, the U.S. Patent and Trademark Office published a notice of
    proposed rulemaking (77 Fed. Reg. 64190) to finally update its rules of professional conduct by conforming
    them to the ABA Model Rule of Professional Conduct.  The ABA Model Rules have been adopted in some
    form by every state (except California) and the District of Columbia.  These USPTO proposed rules are welcome news
    for patent practitioners that are also attorneys, because currently, such
    individuals are required to know and abide by the ethics rules of the state in
    which they practice, as well as the Patent and Trademark Office Code of
    Professional Conduct, which is based on the former ABA Model Code from
    1980.  Of course, there are differences
    between the ABA Model Rules and the proposed USPTO Rules, just are there are
    differences between the current USPTO Code and the proposed Rules of
    professional.  In highlighting any
    differences, this post will refer to the ABA Model Rules and not to the
    specific rules of any particular jurisdiction, because to do so would be too
    onerous (in other words, if you are an attorney licensed in a U.S.
    jurisdiction, do not rely on any statements found below regarding what ethical
    rules are required in your jurisdiction, but instead please consult the
    particular rules of the state in which you practice).  If you would like to provide any comments to
    the Patent Office regarding these proposed rules, they must be submitted to the Office on or before December 17, 2012.

    The Patent Office detailed its
    reasoning for proposing these rules at this time in the Federal Register
    notice, and these reasons were reiterated by David Kappos on his Public Blog.  The Office recognized that adopting
    harmonized rules of ethical and professional conduct is consistent with the
    mandate of the Leahy-Smith America Invents Act of 2011.  There are almost 42,000 registered patent
    practitioners, and at least 75% of them are attorneys.  Without the new rules, these patent attorneys
    are required to go back and forth between the old Model Code and the newer
    Model Rules.  More importantly, the
    amount of authority referring to or interpreting the Model Code is, at best,
    limited.  Instead, a practitioner has the
    benefit of comments, annotations, and case law interpreting the Model Rules
    which, even if not binding on the Patent Office, will be useful until a larger
    body of USTPO-specific precedent is established.  Finally, the Office pointed out that the new
    rules do not deviate significantly from the current rules of professional
    conduct, and largely codify obligations or professional and fiduciary duties
    that already exist.

    The differences between the
    current PTO Code of Professional Conduct, the ABA Model Rules of Professional
    Conduct, and the proposed USPTO Rules are highlighted in the Federal Register
    notice, as well as on the Patent Office website.  One of the more significant changes from the
    current Patent Office rules is the removal of the ability of the Patent Office
    to collect an annual practitioner maintenance fee, and the removal of the
    ability of the Patent Office to require continuing legal education reporting
    of all registered agents or attorneys.  Of course, these provisions were never enforced, but the new rules
    remove any threat of potential enforcement in the future.  There are also examples of differences
    between the ABA Model Rules of Professional Conduct and the proposed USPTO
    Rules that include the inclusion of ex
    parte
    proceedings in the section that requires candor towards the tribunal
    (proposed § 11.303) and the removal of the sections in the ABA Model Rules that
    deal exclusively with criminal proceedings.  However, probably the most important section to which patent attorneys need
    to pay attention is proposed § 11.106, dealing with the confidentiality of
    information.

    Confidentiality of Information

    One of the most significant
    changes found in the proposed USPTO Rules in terms of what is currently required
    by the Patent Office, and in terms of how it differs from the ABA Model Rules,
    is that relating to the handling of a client's confidential information.  This new rule differs from that currently in
    place by changing what is defined as confidential information.  The current USPTO Code defines "Confidence"
    as "information protected by the attorney-client or agent privilege under
    applicable law," and "Secret" as "other information gained
    in the professional relationship that the client had requested by held in
    inviolate of the disclosure of which would be embarrassing or would be likely
    to be detrimental to the client."  USPTO Code § 10.57(a).  As can be
    seen, and has been noted by commentators for years, this definition is somewhat
    limiting.  Most confidential information
    of a client does not fall under this definition of confidence, and information
    is only secret under this definition if the client has expressly stated that it
    is so (or if its disclosure would be embarrassing or detrimental).  Instead, the ABA Model Rules and the proposed
    USPTO Rules expand the scope of this term, defining confidential information as
    any "information relating to the representation of a client . . . ."  See, e.g., Proposed USPTO Rule §
    11.106(b).  Of course, this definition is
    provided in the context of what information a practitioner can or cannot
    (technically may or shall not) reveal, and it is important to note that this
    information can include information that is publically available.  In fact, the ABA rules have been interpreted
    to mean that it is possible for an attorney to be prohibited from revealing
    information related to his or her representation of a client even though such
    information could have otherwise been obtained from a publically available
    source.  As a result, it can be a
    difficult question figuring out whether something is truly "confidential"
    under this Rule.  Thus, this is a perfect
    example of a rule for which there is a lot of non-USPTO commentary, and
    hopefully the Patent Office will either provide its own guidance of the extent
    of "confidential" information, or will accepted this preexisting (and
    future) commentary as persuasive on the issue.

    The more troubling aspect
    of the proposed rule is where it deviates from the ABA Model Rules.  As with the Model rule, the proposed USPTO
    Rule explains what information a practitioner "shall not" reveal without
    informed consent, implied authorization, or permission under rules.  In addition, both sets of rules explain what
    information a practitioner "may" reveal, including such things as
    information that may prevent death, bodily harm, or fraud.  Of note, however, even in the cases where
    death, bodily harm, or fraud may be result, the practitioner is not required to
    reveal such information, but rather the practitioner has permission to do
    so.  The proposed USPTO Rules and the ABA
    Model Rules nevertheless diverge in one important respect:  the proposed USPTO
    Rules include a type of information that is mandatory to reveal:  "A
    practitioner shall disclose to the Office information necessary to comply with
    applicable duty of disclosure provisions." 
    In other words, under this proposed rule, a finding that relevant
    information was intentionally withheld by a practitioner involved in the
    prosecution of an application will not only cause a patent to become
    unenforceable, it will result in an ethical violation by the practitioner.

    This requirement to
    disclose information even though it may be confidential also has the
    possibility to trap a patent practitioner between two ethical obligations.  Importantly, this obligation to disclose
    information necessary to comply with the duty of disclosure is not limited to
    confidential information from that particular prosecution client.  Instead, it is possible under the rule that a
    patent attorney could be aware of confidential information belonging to another
    client that is nevertheless relevant, and he would therefore be ethically
    required to submit it with the prosecution client's application.  The Patent Office apparently considered this
    potential ethical quandary, and as a result, removed this type of disclosure
    from the types of information that are prohibited from being revealed.  Of course, try explaining to your other
    client why you revealed its confidential information and made it publically
    accessible in another client's patent file. 
    Moreover, any patent attorney in a jurisdiction that has adopted some
    form of the ABA Model Rules is subject to rules of professional conduct that do
    not have such a permissive cut-out. 
    Therefore, such a patent attorney would be required by the proposed
    USPTO Rules to reveal such third-party confidential information to satisfy the
    duty of disclosure, but would be prohibited from doing so by the professional
    rules of conduct of their state.

    To be fair, a similar
    quandary probably already exists, because if a patent attorney is aware of such
    third-party confidential information, that attorney is already required to disclose it
    to prevent the patent from becoming unenforceable (and therefore withholding it
    would violate the duty to act competently for your client).  Nevertheless, the proposed rules would
    explicitly make such action unethical, and subject to potential disciplinary
    proceedings.  What is unclear from the
    proposed USPTO rules is whether an attorney in such an ethical quandary could
    noisily withdraw from the case, thereby removing the problem.  However, if not, such an attorney would face
    certain disciplinary proceedings (either in their state or at the Patent Office), because it is impossible to "not reveal" information and, at
    the same time, submit it to the Patent Office in an information disclose
    statement.  Yet, this is what the
    proposed rule, in conjunction with the ABA Model Rules would require.

    Anyone wishing to provide comments regarding
    the new rules regarding confidential information, or provide comments to any
    other of the proposed rules, can do so by submitting them by e-mail to ethicsrules.comments@uspto.gov; by
    regular mail addressed to:  Mail Stop OED-Ethics Rules, United States
    Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450, marked
    to the attention of William R. Covey, Deputy General Counsel for Enrollment and
    Discipline and Director of the Office of Enrollment and Discipline; or via the
    Federal eRulemaking Portal.  Again, the deadline for submitting comments
    is December 17, 2012.  Additional information regarding the submission of
    comments can be found in the Office's Federal Register notice (77 Fed. Reg. 64190).

  • By Kevin E. Noonan

    Mimicry
    is a classic (and classical) biological phenomenon, the appreciation of which
    dates to the time when biology was more accurately called "natural history"
    and was more diversion for English country gentlemen than proper science.  Perhaps
    the most well-known form of mimicry is Müllerian mimicry, and the
    best example of that is the viceroy butterfly (Limenitis
    archippus
    ),
    which although tasty to avian predators displays markings almost
    indistiguishable from the monarch butterfly (Danaus
    plexippus
    ),
    which is not only unpalatable but actually toxic to birds (see below).  Anyone with even a rudimentary appreciation
    of Linnean classification will recognize another interesting feature of
    mimicry:  despite their visual similarities, the monarch and viceroy butterflies
    are not only different species but members of different genera, suggesting that
    genetic inheritance cannot account for the convergence in wing pattern
    phenotype.

    Butterflies
    Heliconius melpomeneRecent
    work employing genomic sequencing and linkage analysis (from the Heliconius
    Genome Project) has begun to shed light on the genetic bases for Müllerian
    mimicry.  This work was performed on a
    South American butterfly species, Heliconius
    melpomene
    (at right).  As reported in Nature (doi:10.1038/nature11041), naturally occurring species of Heliconius show significant
    introgression in regions related to color pattern development.  Heliconius butterflies comprise 43 species and
    hundreds of races and make up rapidly radiating butterfly species in South
    America; certain of these species exhibit classic Müllerian mimicry, wherein palatable species adopt the
    color pattern of other species that are unpalatable to bird predators.  The
    authors sequenced almost 13,000 genes (12,669 open reading frames) in the 269
    megabase (Mb) butterfly genomic DNA and mapped the majority (~83%) of these
    genes to the 21 Heliconius chromosomes using a modern
    version of RFLP analysis termed restriction site DNA linkage mapping.  This work
    found that the chromosomal organization of Heliconius butterfly genomic DNA was "broadly
    conserved"
    since the evolutionary split from a common ancestor shared with Bombyx (silkmoth) species in the
    Cretaceous (~100 million years ago).  Comparison
    with the Bombyx mori (silkmoth) genome
    identified 6,010 orthologues and previously unidentified chromosomal fusions in
    the Heliconius chromosomal
    complement.  Biologically important expansion was found in families of
    genes related to chemosensation and body shape and form (homeobox, or Hox, genes).  The Heliconius genome showed an
    expected increase in ultraviolet opsins (due to the diurnal lifestyle adopted
    by butterflies) and an unexpected genetic complexity in olfactory genes (33 Heliconius
    olfaction genes, similar to what was found in monarch butterfly species having
    34 olfactory genes).  The researchers also
    found additional Hox genes related to body shape and form, similar to
    what is found in other butterflies and related dipteran species.

    The
    researchers compared genomic DNA from three co-mimicry species, Heliconius melpomene, Heliconius timareta, and Heliconius
    elevatus
    and produced a genetic tree between 84 individuals from H.
    melpomene
    and related species (see below).  In
    this comparison, the researchers found hybrid exchange especially at two genomic regions that control mimicry
    pattern based on ~4% (12Mb) of the
    genome.  The results obtained from Heliconius melpomene amaryllis
    and H.timareta ssp. were
    compared and the researchers report evidence of greater hybrid interbreeding
    between these species when compared with H.
    melpomene aglaope
    and H.timareta ssp, which do not
    have overlapping spatial ranges.  The
    researchers estimated 2-5% exchange of the genome; the introgression was not
    uniformly distributed over the 21 chromosomes but seems to be limited to 11
    chromosomes with two chromosomes showing the strongest frequency of
    introgression.  These regions, comprising loci known to be associated with red pattern (B/D) and yellow (N/Yb) pattern loci, showed blocks of sequence (~100 kb in size) that are
    shared between species and exchanged in hybrids.  The genetic makeup of these shared blocks of
    sequence were more consistent with hybrid introgression (and fixation) than in
    other alternatives, such as convergent evolution.

    Genetic Tree
    The researchers concluded that these species
    exchange protective color pattern genes promiscuously and that their evidence
    of hybrid exchange and fixation indicates that this mode of gene transfer
    between diverse species may be a more important mechanism for explaining
    phenomena like mimicry than had been previously appreciated.  The authors propose that hybridization
    between mimicking species is a plausible explanation for "parallel
    evolution of multiple mimetic patterns" in these species.

    Supplemental
    experimental details can be found here.

    Image of Heliconius melpomene by Greg Hume, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

  • By Sherri Oslick

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

    Acura Pharmaceuticals Inc. v.
    Impax Laboratories Inc.

    1:12-cv-01371; filed October
    31, 2012 in the District Court of Delaware

    Acura Pharmaceuticals Inc. v.
    Par Pharmaceutical Inc.

    1:12-cv-01372; filed October
    31, 2012 in the District Court of Delaware

    Acura Pharmaceuticals Inc. v.
    Sandoz Inc.

    1:12-cv-01373; filed October
    31, 2012 in the District Court of Delaware

    Acura Pharmaceuticals Inc. v.
    Watson Laboratories Inc.-Florida et al.

    1:12-cv-01374; filed October
    31, 2012 in the District Court of Delaware

    • Plaintiff:  Acura
    Pharmaceuticals Inc.
    • Defendants:  Watson
    Laboratories Inc. – Florida; Watson Pharmaceuticals Inc.; Watson Pharma
    Inc.

    The complaints in these cases
    are substantially identical.  Infringement of U.S. Patent No. 7,510,726 ("Methods and
    Compositions for Deterring Abuse of Opioid Containing Dosage Forms,"  issued March 31, 2009) following a Paragraph
    IV certification as part of defendants' filing of an ANDA to manufacture a
    generic version of Oxecta® (oxycodone hydrochloride, used for the management of
    acute and chronic moderate to severe pain where the use of an opioid analgesic
    is appropriate, marketed by Pfizer). 
    View the Impax complaint here.


    Esoterix Genetic Laboratories,
    LLC et al. v. Life Technologies Corp., et al.

    1:12-cv-01173; filed October
    31, 2012 in the Middle District of North Carolina

    • Plaintiffs:  Esoterix Genetic
    Laboratories, LLC; The Johns Hopkins University
    • Defendants:   Life Technologies Corp.; Applied
    Biosystems, LLC; Ion Torrent Systems, Inc.

    Infringement of U.S. Patent
    Nos. 6,440,706 (" Digital Amplification,"  issued August 27, 2002), 7,824,889 (same
    title, issued November 2, 2010), and 7,915,015 (same title, issued March 29,
    2011) based on defendants' manufacture and sale of products, kits, and devices
    used in methods for the detection of ratios of genetic sequences in a
    biological sample and/or for the detection of allelic imbalances in a biological
    sample.  View the complaint here.


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

    2:12-cv-06761; filed October
    26, 2012 in the District Court of New Jersey

    Infringement of U.S. Patent
    No. 8,263,650 (" Microbiologically
    Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of
    Narcolepsy,"  issued September 11, 2012) following a
    Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture
    a generic version of Jazz's Xyrem® (sodium oxybate, used to treat
    narcolepsy).  View the complaint here.

  • Calendar

    November 12-14, 2012 – Fall Intellectual Property
    Counsels Committee (IPCC) Conference
    (Biotechnology
    Industry Organization) – Charleston, SC

    November 15, 2012 – Successful Strategies for Overcoming Obviousness Rejections in the Patent
    Application Process
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 – 11:15 am
    (CT)

    November 27, 2012 – Patents and the Written Description Requirement: Navigating
    Section 112 Disclosure Obligations and Withstanding Invalidity Challenges
    (Strafford) – 1:00 – 2:30 pm (EST)

    November 28-29, 2012 – Biotech Patents*** (American Conference
    Institute) – Boston, MA

    November 28-29, 2012 – Orphan Drugs and Rare Diseases*** (American Conference
    Institute) – Boston, MA

    December 3-5, 2012 – Drug and Medical Device
    Litigation
    *** (American Conference
    Institute) – New York, NY

    December 4-5, 2012 – Paragraph IV Disputes*** (American Conference
    Institute) – San Francisco, CA

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

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