• BIO International ConventionThe Biotechnology Industry
    Organization (BIO) will be holding its annual BIO International Convention April
    22-25, 2013 in Chicago, IL.  Founded in
    1993, BIO is a nonprofit association seeking supportive biotechnology policies
    on behalf of more than 1,100 biotechnology companies, academic institutions,
    state biotechnology centers, and related organizations across the United States
    and in more than 30 other nations.  The
    BIO International Convention serves to educate the public and policymakers
    about biotechnology, while fostering partnering meetings and other business
    development activities to keep the biotech industry growing.

    An electronic version of
    the Convention program, including descriptions of the Convention's 125+
    Breakout Sessions and six Super Sessions, can be accessed here.  Among the sessions that may be of interest to
    Patent Docs readers are:

    April 22, 2013

    • How IP Issues Impact
    Innovations in Biomarker Diagnostics & Personalized Medicine — 10:15 AM –
    11:30 AM
    • Behind the Tech Transfer
    Headlines: What are You Missing? – 10:15 AM – 11:30 AM
    • Trends in Biotech IP Law
    in Canada and the U.S. — 2:30 PM – 3:30 PM
    • The Unitary Patent: How
    Will it Affect the Biotech Sector and Your Business? — 3:45 PM – 5:00 PM —
    panel moderated by Patent Docs author
    Donald Zuhn

    April 23, 2013

    • Multi-Party and
    Cross-Border Patent Issues Affecting Biotech Businesses — 9:00 AM – 10:15 AM
    • Ernst & Young’s
    Beyond Borders Report 2013 (Super Session) — 10:00 AM – 11:30 AM
    Myriad, Mayo, and Beyond:
    Developments in the Law of Patentable Subject Matter – 10:30 AM – 11:30 AM
    • Burrill
    State-of-the-Industry Report (Super Session) — 2:00 PM – 3:30 PM
    • The Compulsory Licensing
    Trend: Increased Access, or Lost Opportunities and Unintended Consequences? — 2:30
    PM – 3:30 PM
    • Biosimilars: Strategic
    Considerations for Regulatory Approval and Patents under the BPCIA –3:45 PM –
    5:00 PM

    April 24, 2013

    • IP Strategies for the
    Developing World — 9:00 AM – 10:15 AM
    • The Morning After!: What
    to Do in U.S. & European Patent Prosecution Following the Enactment of AIA
    — 10:30 AM – 11:30 AM
    • Finding Innovation in
    Emerging Markets — 10:30 AM – 11:30 AM
    • Emerging Markets: A
    Discussion with the Heads of Patent Offices — 3:45 PM – 5:00 PM
    • Scientific American
    WORLDVIEW (Super Session) — 3:45 PM – 5:15 PM

    As part of the Convention,
    more than 2,000 biotech companies, organizations, and institutions will
    participate in the BIO Exhibition.  A searchable
    list of exhibitors can be found here.  Information regarding registration and
    pricing can be obtained herePatent
    Docs
    Donald Zuhn, Kevin Noonan, Sherri Oslick, James DeGiulio, Andrew
    Williams, and Kwame Mensah will be attending BIO as part of the MBHB contingent,
    and will be reporting on a number of the sessions listed above.  Patent
    Docs
    readers who may be attending BIO are encouraged to stop by the MBHB
    booth (#3684).

  • Calendar

    March 25-27, 2013 – 2013 Spring Intellectual
    Property Counsels Committee (IPCC) Conference
    (Biotechnology
    Industry Organization) – San
    Diego, CA

    April 3-5, 2013 – 28th
    Annual Intellectual Property Law Conference
    (American Bar
    Association (ABA) Section of Intellectual Property Law) – Arlington,
    VA

    April 4,
    2013 – Double Patenting:
    Defeating Rejections and Avoiding Terminal Disclaimers
    (Strafford) – 1:00 – 2:30 pm (EDT)

    April 12-13, 2013 – PatCon 3 (University of
    Kansas School of Law, IIT Chicago-Kent College of Law, University of San Diego
    School of Law, and Boston College Law School) – Chicago, IL

    April 15-16, 2013 – China IP Counsel Forum (American Conference Institute) – Shanghai,
    China

    April 16, 2013 – 29th
    Annual Joint Patent Practice Seminar
    (Connecticut, New Jersey, New York, and
    Philadelphia Intellectual Property Law Associations) – New York, NY

    April 16, 2013 – Optimizing the Discovery Process:
    Home and Abroad
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    April
    18, 2013 – Advanced AIA Issues for Patent Claim
    Construction: Best Practices Absent Clear Court Guidance
    (Strafford) – 1:00 – 2:30 pm (EDT)

    April
    22-25, 2013 – 2013 BIO International Convention (Biotechnology Industry
    Organization) – Chicago, IL

    May
    7-8, 2013 – Paragraph IV Disputes (American Conference
    Institute) – New York, NY

    May 14, 2013 – Forum on Pharma & Biotech Collaborations (C5 (UK)) – Frankfurt, Germany

    May 15-16, 2013 – Forum on Freedom to Operate (C5 (UK)) – Frankfurt, Germany

    May 21-23,
    2013 – Pharma Legal Affairs (IBC Life Sciences) – Shanghai, China

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

  • PatCon3The University of
    Kansas School of Law, IIT Chicago-Kent College of Law, University of San Diego
    School of Law, and Boston College Law School will be holding the third annual
    Patent Conference — PatCon 3 — on April 12-13, 2013 at IIT Chicago-Kent
    College of Law in Chicago, IL.  The
    conference will consist of the following sessions:

    • The Changing
    Landscape of Patent Law: At the USPTO, the Supreme Court and the Federal
    Circuit? — to be presented by The
    Honorable Judge Richard Linn, U.S. Court of Appeals for the Federal
    Circuit

    • A Conversation with Industry — panel
    including corporate counsel from BP America, AbbVie, Bridgestone
    Americas and RR Donnelley

    • Plenary Session — to be presented by Prof.
    Mark Lemley of Stanford Law School; Alan Marco, Acting Chief Economist at the
    U.S. Patent and Trademark Office; and Prof. David Abrams of the University of
    Pennsylvania Law School

    • Debate About the Patent System — panel including The Honorable Judge
    Richard Posner, U.S. Court of Appeals for the Seventh Circuit; and Prof.
    Richard Epstein of the New York University School of Law and University of
    Chicago Law School

    A complete agenda for the PatCon 3 conference, including an agenda, list
    of speakers, and list of topics to be covered can be found here (Friday, April
    12)
    and here (Saturday, April 13).

    Additional
    information about the conference can be found here.  While Friday's sessions are open to anyone,
    Saturday's sessions are limited to academics. 
    Those interested in attending Friday's sessions can do so here.  The registration fee is $99 (practitioners
    and other members of the public) or free (full-time faculty and students).

  • Strafford #1Strafford
    will be offering a webinar/teleconference entitled "Advanced AIA Issues for Patent Claim
    Construction: Best Practices Absent Clear Court Guidance" on April
    18, 2013 from 1:00 – 2:30 pm (EDT). 
    Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner,
    Lauren L. Stevens of Foley & Lardner, and Colin G. Sandercock of Perkins
    Coie will provide guidance to patent counsel regarding the impact of the
    Leahy-Smith America Invents Act (AIA) on claim construction and offer best
    practices for addressing claim construction issues in light of the AIA.  The panel will review the following
    questions:


    What are the changes resulting from AIA and the implications for claim
    construction?
    • What is the impact of claim construction on choice of law?

    What are the benefits of new claims in a continuation application regarding
    choice of law in view of transitional applications?

    Can the choice of law change when a district court judge construes the claim in
    such a way that the EFD changes?

    What are the benefits and dangers of new claims, depending on their claim
    construction, in a continuation application filed after March 15, 2013?

    The
    registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by March 29, 2013 will
    receive a $50 discount.  Those interested
    in registering for the webinar, can do so here.

  • FTO BrochureC5 (UK) will be
    holding its 10th International Forum on Freedom to Operate on May 15-16, 2013
    in Frankfurt, Germany.  C5 faculty will
    offer presentations on the following topics:

    • A timeline of best
    practice at key milestones in the development pathway to ensure you develop
    & execute a robust and rigorous FTO search strategy;
    • Practical guidance for conducting your
    FTO searches more cost effectively and efficiently;
    • Overcoming challenges relating to
    privilege: How in-house counsel should communicate their FTO findings with the
    board to minimise risk;
    • Practical steps to take to identify
    & address the threat of potential blocking patents;
    • Refining and repositioning your FTO
    strategy in light of the latest case law on SPCs;
    • Update on the latest trends at the EPO:
    The views of the EPO and perspectives of users;
    • Tailoring your FTO strategy in response
    to the latest developments in litigation and interim injunctions in the
    Netherlands, Germany and the UK;
    • Tailoring your tactics for
    biosimilars: Analysing the regulatory risks & the impact on your FTO
    strategy;
    • Latest US case law developments
    impacting your FTO analysis;
    • The impact of US patent
    reform on European FTO analysis: What your peers are doing right now to ensure
    compliance;
    • Freedom to operate in China and India; and
    • What to do when your FTO assessment goes wrong:
    Key considerations relating to remedies and damages.

    A pre-conference
    workshop, entitled "A Highly Practical and Hands-On Workshop Providing a
    Step by Step In-Depth Guide Through the Whole FTO Process" will be offered
    from 8:00 to 10:30 am on May 15, 2013, and a post-conference workshop, entitled
    "Reading and Analysing Claims in Patents and Patent Applications for
    Establishing FTO: EU and US Jurisdiction-Specific Issues," will be offered
    from 2:30 to 5:00 pm on May 16, 2013.

    A complete brochure
    for this conference, including an agenda, list of speakers, detailed
    descriptions of conference sessions, and registration form can be downloaded
    here.

    C5The registration
    fee is €1895
    (conference), €2495 (conference and one workshop), and €2695 (conference and both workshops).  Those
    registering by April 19, 2013 will receive a €100 discount.  A webcast of the conference is also available
    for €1355 (€1155 by April 19, 2013).  Those interested in registering for the conference can do so here, by calling +44
    20 7878 6888, by faxing a registration form to +44 20 7878 6885, or by
    e-mailing registrations@C5-Online.com.

    Patent Docs is a media partner of C5's Freedom to Operate Forum.

  • Collaborations BrochureC5 (UK) will be
    holding its 2nd Forum on Pharma & Biotech Collaborations on May 14, 2013 in
    Frankfurt, Germany.  C5 faculty will
    offer presentations on the following topics:

    • Identifying the current deal
    drivers and trends in deal-making: What it means for your next collaboration
    agreement;
    • How leading pharma & biotech choose
    the right partner and deal structure;
    • Executing robust agreements to underpin
    fruitful collaborations and limit the potential for future disputes and
    litigation;
    • Successfully negotiating and drafting
    collaborative research agreements with academic institutions;
    • Effective alliance management: Avoiding
    missteps and producing workable solutions for the inherent challenges of life
    sciences collaborations;
    • Putting the end first: Defining critical
    termination rights from the outset;
    • How much is it worth? Establishing the
    deal valuation; and
    • Overcoming
    defects in IP that have the potential to derail collaborations and safeguarding
    your rights during negotiations.

    A complete brochure
    for this conference, including an agenda, list of speakers, detailed
    descriptions of conference sessions, and registration form can be downloaded
    here.

    C5The registration
    fee is €1399
    (conference) or €995 (webinar).  Those
    registering by April 12, 2013 will receive a €200 discount.  Those interested in registering for the conference can do so here, by
    calling +44 20 7878 6888, by faxing a registration form to +44 20 7878 6885, or
    by e-mailing registrations@C5-Online.com.

    Patent Docs is a media partner of C5's Pharma & Biotech Collaborations Forum.

  • By Josh Rich

    Office of Management & Budget - OMBOn Tuesday, the U.S. Intellectual Property Enforcement
    Coordinator, Victoria Espinel, published a notice in the Federal Register "requesting
    any recommendations for legislative changes that would enhance enforcement
    against, or reduce the risk of, the misappropriation of trade secrets for the
    benefit of foreign competitors or foreign governments."  78 Fed. Reg. 16875 (Mar. 19, 2013).  Submissions are due by April 22, 2013.  The request for public submissions is one of the
    first steps in the implementation of the "Administration Strategy on
    Mitigating the Theft of U.S. Trade Secrets," issued on February 20, 2013 (see ""Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation").

    The Administration Strategy is a
    five-pronged approach, coordinated by the U.S. IP Enforcement Coordinator and
    involving many of the executive branch departments.

    First, the strategy calls for the White
    House to focus diplomatic efforts to protect trade secrets overseas.  Although the Administration Strategy does not
    expressly identify any specific countries on which it is focused, the examples
    of misappropriation of trade secrets for the benefit of foreign companies and
    countries are almost exclusively Chinese. 
    Consistent with this focus on China, National Security Advisor Tom
    Donilon later said that reports of cyber theft of confidential business
    information from entities in China were occurring "on a very large scale"
    and that the Chinese government "should take serious steps to investigate
    and put a stop to these activities" ("US calls for 'serious' action by China to stop cybertheft," The Washington Post, March 11, 2013).  However, a private U.S.-based cybersecurity
    firm had previously issued a report identifying the Chinese government
    (specifically, a military unit based in Shanghai) as being one of the causes of
    Chinese cyberattacks (see Mandiant Intelligence Center Report).  Thus, while the Strategy calls for sustained
    and coordinated international engagement with trading partners, such as China,
    it may be difficult for the Federal agencies charged with doing so (including
    the Departments of Commerce, Defense, Homeland Security, Justice, State, and
    Treasury, and the U.S. Trade Representative) to make much headway.  The Administration may find more success in
    the Department and PTO working with other countries through Intellectual
    Property Rights (IPR) working groups to fashion rules and policies to
    discourage trade secret theft.  The
    Strategy also calls for domestic law enforcement agencies to leverage
    international law enforcement cooperative agreements and arrangements to pursue
    investigations both in the U.S. and abroad.

    Second, the Strategy calls for the U.S. IP
    Coordinator to promote voluntary best practices by private industry to protect
    trade secrets.  While the IP Enforcement Coordinator
    will work with the Departments of Justice and State (among other agencies) to
    encourage companies and industry groups to develop and implement voluntary best
    practices, the Administration Strategy expressly indicates that those best
    practices must be consistent with antitrust laws.  Among the areas in which the Strategy
    suggests focus are R&D compartmentalization, information security, physical
    security, and human resources policies. 
    But the Strategy makes it clear that compliance with best practices must
    be voluntary, and any identified best practices may not be suitable for all
    companies.

    Third, the Strategy calls for the
    enhancement of domestic law enforcement operations.  Spearheaded by the Attorney General's Task
    Force on Intellectual Property and the FBI, the Department of Justice is making
    the investigation and prosecution of corporate and state-sponsored trade secret
    theft a higher priority.  The Office of
    the Director of National Intelligence will also coordinate the sharing of
    intelligence among the intelligence and law enforcement communities in order to
    monitor foreign government activity and prevent international trade secret
    misappropriation, and will also work with the private sector to warn of
    potential threats.

    Fourth, the Strategy calls for the
    Administration to improve domestic legislation. 
    This is the prong to which the U.S. IP Coordinator's Federal Register notice is directed, and
    one area where there has been concrete (although incremental) progress in
    recent months.  The Strategy highlighted
    two acts passed at the conclusion of the last Congress.  First, the "Theft of Trade Secrets
    Clarification Act of 2012" was intended to reverse the outcome of cases
    like United States v. Aleynikov, 676
    F.3d 71 (2d Cir. 2012), in which the defendant stole the source code for a
    proprietary high-frequency trading system from his former employer to provide
    it to a new employer, but was acquitted because the source code was intended to
    remain secret and therefore not "related to or included in a product that
    is produced for or placed in interstate or foreign commerce."  That Act modified the Economic Espionage Act
    (EEA) to make it cover trade secrets "related to a product or service used
    in or intended for use in interstate or foreign commerce."  Second, the "Foreign and Economic
    Espionage Penalty Act of 2012" did exactly that: increased potential
    sentences and fines for violations of the EEA. 
    The U.S. IP Enforcement Coordinator is charged with coordinating an
    initial review of existing Federal laws within 120 days of the release of the
    Administration Strategy, by June 20, 2013.

    Finally, the Strategy calls for various
    departments in the Administration to increase efforts to develop public
    awareness and engage in stakeholder outreach. 
    For example, the FBI and Department of Commerce are to continue and
    expand their efforts to inform the public about the threat and cost of trade
    secret misappropriation, using existing public awareness programs.  In addition, the PTO will include discussion
    of the economic implications of trade secret misappropriation in its "road
    show" events.

    All in all, the Administration Strategy
    suggests a greater focus on protection of trade secrets against foreign
    misappropriation, as well as a more coordinated effort than in the past.  But the next steps, both in discussions with
    China and shaping of Federal legislation, may be critical in determining
    whether that effort provides greater security for domestic companies.  We will continue to monitor developments and
    will report back on suggested legislative changes.

  • By Donald Zuhn

    GENEarlier
    this month, Genetic Engineering &
    Biotechnology News
    published its list of the top 20 best-selling
    prescription drugs worldwide for 2012 (see
    "GEN Compiles List of Top Selling
    Drugs for 2012
    ").  The biotech publication has followed that
    effort with a list of the top 20 biopharma companies in terms of research and
    development spending.  GEN's latest list,
    which the journal released on March 12 (see
    "Top 20 Biopharma R&D Spenders"),
    was based on figures disclosed by the companies in annual reports and quarterly
    results press releases.  For each company
    making its list, GEN has provided spending totals for 2008, 2011, and 2012,
    R&D spending as a percentage of sales for 2008, 2011, and 2012, and the
    percent change in R&D spending from 2011 to 2012.  2012 R&D spending for the top 20 companies
    ranged from $1.156 billion to $9.332 billion.

    GEN's
    top 20 rankings are shown below, with GEN's figures for 2012 and 2008 R&D
    spending.  We have also included the
    number of biopharm patents for which the company was listed as an assignee in
    2012.  Biopharm patents were determined to
    be those patents designated as belonging to the following classes (each having
    an assigned art unit in Technology Center 1600, which encompasses biotechnology
    and organic chemistry):  260 (Chemistry of Carbon Compounds), 424 (Drug,
    Bio-Affecting and Body Treating Compositions), 435 (Chemistry: Molecular
    Biology and Microbiology), 436 (Chemistry: Analytical and Immunological
    Testing), 504 (Plant Protecting and Regulating Compositions), 506 (Combinatorial
    Chemistry Technology: Method, Library, Apparatus), 514 (Drug, Bio-Affecting and
    Body Treating Compositions), 518 (Chemistry: Fischer-Tropsch Processes; or
    Purification or Recovery of Products Thereof), 530 (Chemistry: Natural Resins
    or Derivatives; Peptides or Proteins; Lignins or Reaction Products Thereof),
    532, 534, 536, 540, 546, 548, 549, 552, 554, 556, 558, 560, 562, 564, 568, 570
    (Organic Compounds — Part of the Class 532-570 Series), 730 (Data Processing:
    Structural Design, Modeling, Simulation, And Emulation), 800 (Multicellular
    Living Organisms and Unmodified Parts Thereof and Related Processes), and/or
    930 (Peptide or Protein Sequence), 987 (Organic Compounds Containing a Bi, Sb,
    As, or P Atom or Containing a Metal Atom of the 6th to 8th Group of the Periodic
    System).  Note: The identification of
    biopharm patents in the table below may be limited in some respects.  For
    example, to the extent that biopharm patents were designated in some other
    class, such patents will be omitted from the number of biopharm patents. 
    In addition, to the extent that a subsidiary of a given company contributed to
    that company's patent count and the subsidiary had a distinct name, such
    patents will be omitted from the number of biopharm patents.  Moreover, if
    the company was not indicated on the face of the patent as an assignee, that
    patent will be omitted from the number of biopharm patents.

    Genetic Engineering &
    Biotechnology News

    Top 20 Biopharma R&D Spenders for
    2012

    Table
    Genetic Engineering & Biotechnology News
    , "Top 20 Biopharma R&D Spenders,"
    March 12, 2013.

  • By Donald Zuhn

    IPO #2In an amicus brief
    filed last week in support of respondents Myriad Genetics, Inc. et al., the Intellectual Property Owners
    Association (IPO) asked the Supreme Court to affirm the Federal Circuit's
    decision in Association for Molecular Pathology
    v. Myriad Genetics, Inc
    . that claims to isolated human DNA are patent-eligible.  The IPO brief opens by noting that
    "[w]hile Petitioners and their amici
    provocatively refer to the subject matter at issue in this case as 'human gene
    patenting,' this term inaccurately characterizes the claims in Myriad's
    patent," and that "what is claimed is a specific sequence of isolated
    human DNA."

    The IPO argues first that
    isolated human DNA constitutes patent-eligible subject matter.  Citing Diamond
    v. Chakrabarty
    , the brief reminds the Court that it "fashioned a
    straightforward test of whether a manufacture or composition of matter was patent-eligible:
    it must demonstrate the 'hand of man,' something that is 'a product of human
    ingenuity 'having a distinctive name, character [and] use.''"  The IPO argues that "[t]he Court's Chakrabarty test is the proper standard for
    patent-eligibility, not the imposition of bright line, categorical rules
    applying broad, categorical prohibitions such as that advanced by Plaintiffs
    and their amici," and thus,
    "[a]nything that evinces the 'hand
    of man' is patent-eligible" (emphasis in brief).

    MyriadAccording to the IPO,
    isolated human DNA satisfies the requirement in Chakrabarty that claimed subject matter show "the hand of
    man," and therefore is patent-eligible. 
    With respect to the characteristic of being "isolated," the
    brief notes that "the entire genetic complement (or genome) in the cell
    comprises about six billion nucleotides of DNA," and that "[a]n individual
    gene typically comprises about 1,000 of these nucleotides."  The brief points out that "to isolate a
    gene requires these specific 1,000 nucleotides to be separated from the remaining
    (approximately) 5,999,999,000 nucleotides in the cellular genome."

    The IPO next addresses the
    impact of other Supreme Court decisions on the Myriad case, arguing that no other precedent controverts
    Chakrabarty.  Noting that the Court recently addressed the
    issue of patent eligibility in Mayo
    Collaborative Services v. Prometheus Labs., Inc.
    , the brief states that the
    Court's concerns about the scope of patent eligibility "arise when the
    claims produce no more than information (inform a relevant audience about
    certain laws of nature)."  Citing
    the Court's decisions in O'Reilly v.
    Morse
    , Gottschalk v. Benson, Parker v. Flook, and Bilski v. Kappos, the brief contends
    that "[i]n each of these decisions, the Court found a lack of patentable subject
    matter because the claimed method provided little (or nothing) more than
    abstract information as opposed to concrete inventions that 'promote the
    Progress of . . . the useful Arts.'" 
    Contrasting these cases with Myriad,
    the brief states that:

    Unlike the method claims in Mayo, Benson, Flook and Bilski, Myriad's composition of matter
    claims at issue here are not broadly preemptive. They are both specific and
    concrete and as such do not implicate the policy concerns enunciated by this
    Court in those cases where preemption rendered claims patient-ineligible.  Rather than being directed to mere
    information, the claims at issue are drawn to a useful and concrete composition
    of matter that falls within the statutory classes of patentable subject matter
    defined by Congress in Section 101 of the patent statute.  Since Myriad's claimed inventions "evince
    the hand of man," they are directed to patentable subject matter per Chakrabarty.

    Turning to Petitioners'
    argument that isolated human DNA is patent ineligible because it constitutes a
    product of nature, the IPO counters that "[t]his contention is incorrect as
    a matter of law and as a matter of fact." 
    The brief explains that:

    The claimed
    isolated human BCRA1 and BCRA2 DNA are not "products of nature"
    because, as claimed, they are not found in nature.  These isolated human DNAs are never found
    "isolated" in nature.  First,
    they are not merely associated with contaminants (like the "intracellular
    material" contaminating cellulose in the Wood Paper Patent Cases); they are intrinsically (and covalently)
    attached to and are a part of the physical and chemical structure of the
    chromosomal DNA, and their isolation requires them to be separated from this
    DNA, i.e., to be present in an
    entirely new chemical structure.  . .
    .  [I]n other (cDNA) embodiments the claimed
    isolated human DNA is also not merely "isolated" but chemically
    changed in the process, first by the cell in making mRNA, and again by the
    inventor in converting the mRNA into cDNA. 
    Thus, the claimed subject matter is different, physically and
    chemically, from the DNA present in nature.

    The brief continues by
    arguing that:

    [Another] line of
    reasoning, enunciated by the Court in Funk
    Brothers
    and recited with approval in Chakrabarty
    and more recently in Mayo, is that
    claims cannot encompass a "natural law" or "phenomenon of
    nature."  Myriad's claims to
    isolated human DNA do neither.  These
    claims recite man-made manufactures or compositions of matter, not
    phenomena.  They are tangible, physical
    compounds, having particular and specific structures capable of being
    elucidated and described.  They do not
    foreclose anything other than making, using, selling, offering to sell, or
    importing these specific and particular chemical compounds.

    The IPO also takes the
    Petitioners to task for "wrongly equat[ing]" the patenting of
    isolated human DNA with the patenting genetic information.  While acknowledging that "[t]here is no dispute
    that genetic information, standing alone, is not patentable subject matter and
    does not belong to one of the statutory categories required for
    patent-eligibility," the IPO argues that "[p]atent claims to isolated
    DNA only cover the isolated DNA itself, and not the genetic information per se."  The brief also argues that:

    The dichotomy between patent-eligible
    isolated human DNA and patent-ineligible genetic information is consistent with
    precedent.  For example, in O'Reilly v. Morse, 56 U.S. 62, 63
    (1853), the ability to use electricity for communication was found to be
    patent-ineligible, but the specific telegraph invented by Morse was determined
    to be patent-eligible.  Algorithms per se have also been held to be
    patent-ineligible, Parker v. Flook,
    437 U.S. 584, 585 (1978); Gottschalk v.
    Benson
    , 409 U.S. 63, 64 (1972), while the use of an algorithm (an equation)
    in a patented process has been found to be patent-eligible, Diamond v. Diehr, 450 U.S. 175, 177
    (1981).

    The brief next discusses
    the adverse impact that a ban on isolated human DNA patenting would have on the
    development of biologic drugs and personalized medicine.  The brief also suggests that "[a]bsent
    patent protection, and under the circumstances of multigenic causation (or at
    least association) of common diseases, the impetus will be to develop and
    protect this nascent technology using, inter
    alia
    , trade secret protection." 
    The brief predicts that "[u]nder these circumstances, innovation in
    genetic-based diagnostics would be severely limited, since there would be no
    incentive (indeed, there would be strong disincentives) to disclose the genetic
    basis of the diagnostic assay," and that as a result, genetic information
    "as a trade secret, could be kept out of the public domain indefinitely."

    The brief concludes by arguing
    that isolated human DNA patenting does not impede research.  In support of this conclusion, the brief
    cites a study performed by the American Association for the Advancement of
    Science on the effects of isolated human DNA patenting on basic research in the
    U.S., Germany, the U.K, and Japan, the study finding that "intellectual
    property rights had little negative impact on the practice of science."  Suggesting that "[p]erhaps the best
    measure of [research] activity is the number of research reports in public
    databases that reflect ongoing basic scientific research in peer-reviewed scientific
    journals," the brief notes that "[w]hile reported estimates differ depending
    on the search term used, a simple search of 'brca1 or brca2' resulted in 10,652
    publications [in the scientific literature]."  The brief then adds that:

    If [Myriad's]
    patents had a chilling effect on basic research, the expectation would be that
    the number of scientific research reports would have declined in the face of
    these patents.  On the contrary, the
    number of such publications has steadily increased each year, which is
    precisely what would be expected if these patents had no significant effect on
    basic scientific research.

    What these patents
    do, of course, is prevent commercial activity — using the patented isolated
    human DNA or performing the patented methods for profit.  This is a legitimate exercise of the patent
    grant.

    Note: the IPO brief was
    co-authored by Patent Docs author Dr.
    Kevin Noonan.

  • By Donald Zuhn

    USPTO Extends Comment
    Period on Notice Regarding Preparation of Patent Applications

    USPTO SealIn January, the U.S. Patent
    and Trademark Office published a notice in the Federal Register (78 Fed. Reg.
    2960
    ) requesting
    public comment regarding potential practices that applicants can employ in the
    drafting of patent applications to facilitate examination and bring more
    certainty to the scope of issued patents. 
    The notice set forth a list of nine "potential practice changes
    that applicants can employ to augment the quality of issued patents" and
    sought input as to whether any of the practices should be used by applicants
    during the preparation of an application to place the application in a better
    condition for examination.

    On March 15, the Office
    published a new notice in the Federal Register (78 Fed. Reg. 16474)
    extending the comment period by one month from March 15, 2013 (when many
    application drafters were likely preoccupied with a more significant deadline)
    to April 15, 2013.  Comments can be sent
    by e-mail to QualityApplications_Comments@uspto.gov, or by regular mail
    addressed to:  Mail Stop Comments —
    Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450,
    marked to the attention of Nicole D. Haines.

    In the Office's initial
    notice, the potential practice changes were divided into two groups, one group
    related to clarifying the scope of the claims and one group related to
    clarifying the meaning of claim terms in the specification.  The first group of potential practices
    included:

    1.  Presenting claims in a multi-part format by
    way of a standardized template that places each claim component in separate,
    clearly marked, and designated fields (e.g., preamble, transitional phrase, and
    individual claim limitations).

    2.  Identifying corresponding support in the
    specification for each of the claim limitations (e.g., using a claim chart).

    3. Indicating whether
    examples in the specification are intended to be limiting or merely
    illustrative.

    4.  Identifying whether the claim preamble is intended
    to be a limitation on claim scope.

    5.  Expressly identifying clauses within
    particular claim limitations for which the inventor intends to invoke 35 U.S.C.
    § 112(f) (which pertains to means-plus-function limitations for applications
    filed on or after September 16, 2012) and pointing out where in the
    specification corresponding structures, materials, or acts are disclosed that
    are linked to the identified § 112(f) claim limitations.

    6.  Using textual and graphical notation systems
    known in the art to disclose algorithms in support of computer-implemented
    claim limitations, such as C-like pseudo-code or XML-like schemas for textual
    notation and Unified Modeling Language (UML) for graphical notation.

    The second group of
    practices included:

    1.  Indicating whether terms of degree — such as
    substantially, approximately, about, essentially — have a lay or technical
    meaning and explaining the scope of such terms.

    2.  Including in the specification a glossary of
    potentially ambiguous, distinctive, and specialized terms used in the
    specification and/or claims.

    3.  Designating, at the time of filing the
    application, a default dictionary or dictionaries to be used in ascertaining
    the meaning of the claim terms.


    USPTO Implements PCT-PPH
    with IPOPHL

    IPOPHOn March 5, the U.S. Patent
    and Trademark Office announced that it was
    establishing a patent prosecution highway (PPH) pilot program based on Patent
    Cooperation Treaty (PCT) work products (PCT-PPH) with the Intellectual Property
    Office of the Philippines (IPOPHL).  Under
    the new pilot program, which went into effect on January 29, an applicant
    receiving a written opinion or international preliminary examination report in
    a PCT application that indicates at least one claim in the PCT application has
    novelty, inventive step, and industrial applicability, where the USPTO was the
    International Searching Authority or the International Preliminary Examining
    Authority, may request that the IPOPHL fast track the examination of
    corresponding claims in an application filed with the IPOPHL.  The USPTO- IPOPHL PCT-PPH pilot program is
    scheduled to expire on January 28, 2014, but may be extended if necessary to
    adequately assess the feasibility of the program.


    USPTO Upgrades to PPH 2.0
    with IPOPHL

    On the same day that the
    U.S. Patent and Trademark Office announced the implementation of a PCT-PPH with
    the IPOPHL, the USPTO announced
    that it was upgrading its PPH with the IPOPHL to a PPH 2.0 program, with the
    upgrade commencing on January 29.  The
    PPH 2.0 program with IPOPHL supersedes the prior PPH program with that office.  The upgrade with the IPOPHL brings the number
    of PPH 2.0 participating offices to twelve, including the USPTO, Canadian
    Intellectual Property Office (CIPO), European Patent Office (EPO), Japan Patent
    Office (JPO), IP Australia (IPAU), Korean Intellectual Property Office (KIPO),
    National Board of Patents and Registration of Finland (NBPR), Portugal National
    Institute of Industrial Property (INPI-PT), Federal Service on Intellectual
    Property, Patents & Trademarks of Russia (Rospatent), Spanish Patent and
    Trademark Office (SPTO), and United Kingdom Intellectual Property Office
    (UKIPO).

    In order to participate in
    any of the PPH 2.0 programs in the USPTO, applicants must satisfy the following
    requirements:

    1.  One of the other PPH 2.0 participating
    offices has determined that at least one claim is allowable/patentable (under
    the PPH 2.0 program, applicants no longer need to submit a copy of the allowed
    claim or any English translation thereof).

    2.  The application before the PPH 2.0
    participating office (i.e., containing the allowable/patentable claim) and the
    U.S. application for which participation in the PPH 2.0 program is being
    requested must have the same priority/filing date (the Annex to the USPTO's
    notice on the PPH 2.0 program provides fifteen schematics outlining situations
    in which this requirement would be satisfied).

    3.  All claims on file, as originally filed, or
    as amended in the U.S. application must sufficiently correspond to one or more
    of the claims indicated as allowable in the application filed in the PPH 2.0
    participating office (the USPTO notice states that "[a] claim is
    considered to 'sufficiently correspond' where, accounting for differences due
    to translations and claim format, the claim in the U.S. application is of the
    same or similar scope as a claim indicated as allowable in the application filed
    in the PPH 2.0 participating office"). 
    Under the PPH 2.0 program, applicants must submit a claims
    correspondence table (in English), indicating how all the claims in the U.S.
    application correspond to the allowable/patentable claims in the application
    filed in the PPH 2.0 participating office.

    4.  Examination of the U.S. application for which
    participation in the PPH 2.0 program is being requested has not yet begun.

    5.  The applicant has filed a request to
    participate in the PPH 2.0 program.

    6.  The applicant must submit a copy of the
    office action issued just prior to the "Decision to Grant a Patent"
    (along with an English translation, which may be a machine translation) for the
    application before the PPH 2.0 participating office (under the PPH 2.0 program,
    applicants no longer need to submit a statement that the English translation is
    accurate).

    7.  The applicant must submit an information
    disclosure statement listing all documents cited in the office action of the
    PPH 2.0 participating office.

    8.  All of the documents described above must be
    filed via the EFS-Web and indexed using the document description:  "Petition to make special under Patent
    Pros Hwy."

    Additional information
    regarding the PPH 2.0 program with the IPOPHL can be found here.


    USPTO Continues PPH with
    SIPO

    SIPOEarlier this month, the
    U.S. Patent and Trademark Office announced the
    continuation of the PPH pilot program with the State Intellectual Property
    Office of the People's Republic of China (SIPO).  As with other PPH programs, the USPTO-SIPO
    PPH permits an applicant having an application whose claims have been allowed
    in one of the offices to fast track the examination of an application in the
    other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a
    ruling from either the USPTO or SIPO that at least one claim in an application
    is patentable may request that the other office fast track the examination of
    corresponding claims in the corresponding application in that office.  The USPTO-SIPO PPH pilot program is now
    scheduled to expire on November 30, 2013, but may be extended thereafter.