• Boston Skyline American Conference
    Institute (ACI) will be holding its Hatch-Waxman Boot Camp conference on July
    19-20, 2010 in Boston, MA.  ACI
    faculty will help attendees:

    • Understand the
    interplay of the PTO and FDA in the patenting of drugs and biologics;
    • Learn about the
    essentials of the FDA approval process and its link to biopharmaceutical
    patents;
    • Develop an
    in-depth and practical knowledge of Hatch-Waxman protocols, including: Orange
    Book listings, bioequivalency, exclusivities, the 30-month stay, and the safe
    harbor;
    • Navigate the
    intricacies of patent term adjustment and patent term restoration;
    • Comprehend how
    the introduction of biosimilars will change industry dynamics; and
    • Recognize how
    pre-commercialization concerns relative to CMS approval and Medicare/Medicaid
    formulary selection are influencing the patenting and approval of drugs and
    biological products.


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

    • Key agencies
    overview:  Understanding the
    jurisdiction and interplay of the FDA and PTO in the patenting of drugs and
    biologics;
    • Identifying and
    comprehending pre-commercialization concerns relative to small molecules and
    biologics;
    • Exploring the
    link between the FDA approval process and the patenting of drugs and biologics;
    • Patent and IP
    overview for drugs and biologics: 
    Hatch-Waxman, trade dress, and more;
    • How the dynamics
    of follow-on biologics will change the Hatch-Waxman landscape;
    • Orange Book
    listings, de–listings, and related challenges;
    • Bioequivalence
    and the "same active ingredient" vis-a-vis patentability;
    • A in-depth look
    at 180-day exclusivity;
    • Comprehending the
    intricacies of non-patent/regulatory exclusivity;
    • Assessing patent
    protections afforded under the safe harbor; and
    • Examining
    pharmaceutical patent extensions: 
    Patent Term Adjustment and Patent Term Restoration.

    Two post-conference
    workshops will be offered on July 21, 2010.  The first, entitled "Follow–On Biologics: The Master
    Class," will be offered from 9:00 am to 12:00 pm, and will take attendees
    through every facet of this exciting and challenging new area.  The second workshop, entitled
    "Practical Considerations Surrounding Pre-Lawsuit Paragraph IV Diligence
    from Both a Brand and Generic Perspective," will delve into the practical
    side of the A to Z pre-lawsuit diligence necessary leading up to and including
    filing of the Paragraph IV lawsuit including, obviousness and non-obviousness
    searching, notice Letter preparation, brand response, offers of confidentiality,
    and venue.

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


    ACI - American Conference Institute The registration
    fee for this conference is $2,195 (conference alone), $2,795 (conference and
    one workshop), or $3,195 (conference and two workshops).  Those registering by June 11, 2010 will
    receive a $200 discount.  Those
    interested in registering for the conference can do so here,
    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 Hatch-Waxman Boot Camp conference.


  • New York #1 Practising
    Law Institute (PLI) will be holding a seminar entitled: "Markman Hearings and Claim Construction
    in Patent Litigation 2010" on June 30, 2009 in New York, NY.  Groupcasts of the New York session will
    also be held in Atlanta, GA; Mechanicsburg, PA; Philadelphia, PA; and
    Pittsburgh, PA. 
    The seminar will provide information on the
    following topics:


    Overview of Markman and its progeny;
    the promises and the realities of Markman
    in practice;

    Claim construction procedure, strategies, and tactics;

    How to prepare and prosecute patent applications to obtain appropriate claim
    construction;

    Discovery, timing, alternatives, and challenges in multi-patent and multi-party
    cases;

    Special claim construction problems;

    Use of experts, inventors, and masters;

    Claim construction from an appellate perspective; and

    After the Markman hearing — effect
    on further trial proceedings.

    In particular,
    PLI's faculty will offer presentations on the following topics:

    1.  Markman
    law and claim construction procedures in litigation;
        a.  Overview of Markman and its progeny; the promises and the realities of Markman in practice;
        b.  Claim construction strategy and tactics
    in litigation;
    2.  How to present an effective Markman hearing;
        a.  The Markman
    hearing itself — Practical tips and strategies;
        b.  Special claim construction problems;
    3.  Claim construction from business and
    governmental perspectives;
        a.  Business perspective;
        b.  Government perspective;
    4.  Markman
    hearing presentation;
        a.  Patentee's presentation;
        b.
    Accused infringer's presentation;
        c.
    Discussion of Markman presentations;
    5.
     Markman judges'
    panel:  A symposium on the
    practice, procedure and perspectives of the judiciary and on bigger Markman issues.


    Practising Law Institute (PLI) #2 A
    program schedule and list of speakers for the seminar can be found here.  The registration fee for the conference
    is $1,495.  Those interested in
    registering for the New York seminar can do so here; those interested in
    registering for the Groupcasts can do so here (Atlanta), here (Mechanicsburg),
    here (Philadelphia) or here (Pittsburgh).


  • New York #3 Practising
    Law Institute (PLI) will be holding a seminar entitled: "Prior Art &
    Obviousness 2010:  Current Trends
    in Sections 102 & 103" on July 7, 2010 in New York, NY and on
    September 15, 2010 in San Francisco, CA. 
    The seminar will
    provide information on the following topics:


    When is a patent a "patent" under the statute?

    Public accessibility — on the web, on the shelf, in the mail,
    "routine" practices;

    Four steps to the abyss of 102(d);

    Ex parte 102(g); abandon, suppress, conceal;

    Actual vs. constructive reduction to practice (where 102(e) trumps 102(g));

    What have they done to 102(e)?

    The issues raised by successive common owner filings;

    A walk through the "guidelines" and "timelines"; and

    Impact of proper/improper benefit claims on:  a) prior art date of a reference, and b) effective filing
    date of the application being examined.


    San Francisco #4 In particular,
    PLI's faculty will offer presentations on the following topics:

    I. 
    Section 102 and the MPEP, from (a) to (g) (or what isn't in the statute but is
    in the law?);
    II. 
    Section 103 and the PTO KSR
    guidelines;
    III. 
    Section 102(a) – (d);
        A.  102(a) & (b) and the CAFC 2008;
        B.  102(c) & (d):  Abandonment and the "four
    steps";
    IV.  102(f) & (g):  Joint ventures and co-development;
    V.  35 U.S.C. 103 and the CAFC; and
    VI.  102(e) and the 9 most common
    timelines:  Effects of priority
    under 119, 120, 121, 365.

    A
    program schedule and list of speakers for the New York Patent Law Institute can
    be found here, and a
    program schedule and list of speakers for the San Franscisco Patent Law
    Institute can be found here.


    Practising Law Institute (PLI) #2 The
    registration fee for the conference is $1,495.  Those interested in registering for the conference can do so
    here (New York) or here (San Francisco).


  • Analysis Group The
    Analysis Group, Georgetown University's Center for Business and Public Policy,
    and McKool Smith will be offering a seminar entitled "Patent Reform 2010:
    What Shape Will It Finally Take?" on June 15, 2010 from 8:00 – 11:30
    AM (EST) in Washington, DC.  A panel of experts from
    industry, law, and politics will discuss the need for patent reform and the
    current legislative landscape, the pros and cons of bills under consideration,
    and the future implications for research, licensing, and litigation.  Panelists will include Federal Circuit
    Chief Judge Paul Michel (retiring); Representative Dana Rohrabacher (R-CA); Joe
    Matal, Republican General Counsel for the Senate Judiciary Committee; Cheryl
    Miller, Deputy Staff Director for Technology and Innovation for the Senate
    Committee on Small Business and
    Georgetown University Entrepreneurship; Philip Johnson, Chief
    Intellectual Property Counsel for Johnson & Johnson; Bernard Cassidy,
    Executive Vice President and General Counsel for Tessera Technologies; Hans
    Sauer, Deputy General Counsel for Intellectual Property of the Biotechnology
    Industry Organization (BIO); Jonathan Dudas, Partner at Foley & Lardner;
    Douglas Cawley, Principal at McKool Smith; Brian Riopelle, Partner at
    McGuireWoods; Pat Choate, Economist and Author; John Jarosz, Managing Principal
    for the Analysis Group; and Professor John Mayo, Georgetown University.

    Those
    interested in registering for the seminar, can do so here.


  • ABA The
    American Bar Association (ABA) Center for Continuing Legal Education and ABA
    Section of Science & Technology Law will be offering a teleconference and
    live audio webcast entitled "Navigating the U.S. Biosimilar Pathway"
    on June 29, 2010 from 1:00 – 2:30 PM (EST).  Dr. William Simmons of Sughrue Mion, PLLC; Kenneth Burchfiel
    of Sughrue Mion, PLLC; Krista Hessler Carver of Covington & Burling LLP;
    and Michael Dzwonczyk of Sughrue Mion, PLLC will explore the new U.S.
    biosimilars pathway, including risks confronting biosimilar producers.

    The
    registration fee for the webcast is $85 for Section of Science & Technology
    Law members, $150 for ABA members, and $185 for the general public (for
    additional fee options, please visit the event website).  Those interested in registering for the
    webcast, can do so here.


  • ABA The
    American Bar Association (ABA) Center for Continuing Legal Education and ABA
    Section of International Law will be offering a teleconference and live audio
    webcast entitled "Regulatory and Intellectual Property Opportunities and
    Challenges for Life Science Companies Entering the U.S. Market" on June
    23, 2010 from 12:00 – 1:30 PM (EST).  Dr. MaryAnne Armstrong of Birch, Stewart, Kolasch and Birch,
    LLP; Alan Minsk of Arnall Golden Gregory LLP; and Dr. Steven K. Stranne of
    Polsinelli Shughart PC will discuss potential opportunities and challenges and
    offer recommendations to protect company interests and maximize product
    benefits for life sciences companies, particularly early-stage companies.  The panel will focus on patent
    considerations, regulatory issues with the Food and Drug Administration, and
    reimbursement strategies focusing primarily on medical devices.

    The
    registration fee for the webcast is $85 for Section of International Law
    members, $125 for ABA members, and $150 for the general public (for additional
    fee options, please visit the event website).  Those interested in registering for the webcast, can do so
    here.

  •     By James DeGiulio —

    AstraZeneca Settles Entocort Patent Suit with Teva,
    Stipulates with Mylan


    AstraZeneca_small AstraZeneca has settled its infringement claims
    against Teva over its Crohn's disease treatment Entocort, striking a deal that
    grants Teva an exclusive license to market a generic oral budesonide capsule on
    Feb. 15, 2012.  The companies will seek approval for the deal through a consent
    judgment in the U.S. District Court for the District of Delaware.


    Barr Pharmaceuticals AstraZeneca brought suit against Barr in May 2008
    following Barr's January ANDA filing, claiming Barr's generic budesonide
    infringed U.S. Patent Nos. 6,423,340 and 5,643,602.  AstraZeneca later brought a similar suit against Mylan,
    alleging infringement of the same Entocort patents (see "Court Report," July 27, 2008).  The Barr and Mylan suits, though initially separate, were
    consolidated in early 2009.

    On May 19, AstraZeneca and Mylan stipulated to a
    judgment against Mylan, agreeing that both Entocort patents are valid and that
    Mylan infringed the '340 patent.  The only remaining issue in that case is
    whether the '340 patent is enforceable.

    AstraZeneca's settlement terms with Teva were not
    available.  The stipulation in the
    Mylan case can be found
    here.


    Sanofi-Aventis' Uroxatral Patent Valid, Mylan's
    Generic Infringes


    Sanofi-Aventis_large On May 14, Mylan's generic alfuzosin drug was
    confirmed as infringing Sanofi's patent covering the prostate treatment Uroxatral
    after Mylan's contention that the patent was invalid for obviousness was
    rejected.  Sanofi brought an
    infringement suit against Mylan in 2007 following Mylan's ANDA filing, alleging
    Mylan's generic alfuzosin hydrochloride infringes U.S. Patent No. 4,661,491 (see "Court Report," October 14, 2007)  Mylan asserted that the '491 patent
    was obvious in view of three pieces of prior art.


    Mylan In his May 14 order, Judge Sleet of the U.S.
    District Court for the District of Delaware held that the three prior art
    references asserted by Mylan fail to invalidate the '491 patent because they do
    not suggest that alfuzosin would prove an effective treatment for frequent
    urination and other symptoms of benign prostatic hyperplasia.  Judge Sleet then finalized an earlier
    bench ruling that Mylan's generic alfuzosin hydrochloride would infringe Sanofi's
    '491 patent.  However, Judge Sleet
    refused to award attorneys' fees to Sanofi, finding no bad faith or vexatious
    litigation on the part of Mylan.

    Judge Sleet's order can be found here.


    Mylan's Antitrust Claims Dismissed In AstraZeneca
    Prilosec Suit


    AstraZeneca Logo In the latest development in AstraZeneca's
    long-running Prilosec infringement suit, AstraZeneca's motion to dismiss Mylan's
    antitrust counterclaims was granted and Mylan's motion for attorney's fees was
    denied.

    AstraZeneca first sued several generic-drug makers
    in 2000, accusing them of infringing patents
    4,786,505 and 4,853,230, covering
    the gastric-acid inhibitor Prilosec.  Mylan joined the litigation after releasing a generic version of omeprazole
    in August 2003.  At the May 2006
    trial, Judge Barbara Jones of the U.S. District Court for the Southern District
    of New York found that AstraZeneca's two patents were valid, but defendants
    Mylan, LDE, and Lek did not infringe.  Other defendants Apotex and Impax were
    found liable for infringement.  The U.S.
    Court of Appeals for the Federal Circuit upheld the finding of noninfringement
    with respect to Mylan in June 2008 (
    as reported by Patent Docs on June 11,
    2008
    ).

    Mylan On May 18, Judge Jones granted AstraZeneca's motion
    to dismiss with prejudice Mylan's counterclaims that AstraZeneca forced generic
    manufacturers out of the omeprazole market by launching sham patent litigation
    to delay the release of generic versions of the drug.  Judge Jones agreed with AstraZeneca's contention that its
    patent infringement litigation cannot give rise to antitrust liability under
    the Sherman Act because its claims were supported by probable cause.

    Mylan also moved for attorneys' fees on the grounds
    that AstraZenca's infringement suit was meritless.  Judge Jones denied Mylan's motion for attorney's fees,
    finding that the case is not exceptional.

    Judge Jones' May 18 order can be found here.

    James
    DeGiulio has a doctorate in molecular biology and genetics from
    Northwestern University and
    is a third-year law
    student at the Northwestern University School of Law.  Dr. DeGiulio
    was a member of MBHB's 2009 class of summer associates, and he can be
    contacted at degiulio@mbhb.com.

  • "Biotech/Pharma"
    Top 47"

        By
    Donald Zuhn

    The
    Intellectual Property Owners Association (IPO) released its 27th annual list of
    the top 300 organizations receiving U.S. patents.  Patent Docs
    Readers may recall that the U.S. Patent & Trademark Office stopped
    releasing its annual list of top patent recipients in 2006 in order to
    "discourag[e] any perception that we believe more is better."

    The
    IPO stated that while it does not intend for the report to "encourage or
    discourage patenting," it would continue to publish its annual list of top
    recipients because "the number of patents granted is one of the few
    objective measures of the patent system as a whole and the patenting activities
    of individual industries and companies."  The IPO compiled its list by counting the number of utility
    patents granted during 2009 on which an organization or its subsidiary was
    listed as the owner on the face of the patent.  However, the IPO attributed patents that were granted to two
    or more organizations jointly to the organization listed first on the
    patent.  The IPO noted that 165,213
    patents were issued in 2009, which was an increase from the 154,699 patents
    that issued in 2008.  The top
    fifteen companies on the IPO Top 300 are listed below


    2009 Top 15
    As
    in past years, we used the IPO's list of top patent holders to compile a list
    of the top "biotech and pharma" companies and organizations receiving
    U.S. patents in 2009.  This year's
    list of 47 biotech and pharma companies and organizations reverses a downward
    trend that saw the number of biotech and pharma companies and organizations go
    from 51 in 2006 to 47 in 2007 to 43 last year.  Each organization's IPO top 300 ranking for 2009 is
    indicated in the "'09 IPO Rank" column; the IPO top 300 ranking for
    2008 (if available) is indicated in the "'08 IPO Rank" column.  Please note that some of the companies
    and organizations listed below may be involved in non-biotech or non-pharma
    work, and therefore, a portion of the patents granted to these companies and
    organizations may be directed to other than biotech and pharma-related
    inventions.  In addition, our list
    is a little inclusive in that we included medical device companies.

     
    2009 Top 47

    For
    additional information regarding this topic, please see:


    "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
    • "IPO
    Releases List of Top 300 Patent Holders
    ," May 22, 2008
    • "IPO
    Posts List of Top 300 Patent Holders
    ," April 20, 2007

  •     By
    James DeGiulio —


    GlaxoSmithKline - GSK Earlier this year, GlaxoSmithKline announced an "open
    innovation" strategy to help deliver new and better medicines for diseases
    disproportionately affecting people living in the world's poorest countries.  Making good on that promise, GSK has
    teamed up with the European Bioinformatics Institute (EMBL-EBI), the U.S.
    National Library of Medicine (NLM), and Collaborative Drug Discovery (CDD) to
    make freely available more than 13,500 compounds that could ultimately lead to
    new treatments for malaria.


    Cover_nature The
    data was generated by screening GSK's library of 2 million compounds for those
    that demonstrate potent inhibition of the most deadly malaria parasite, Plasmodium falciparum, found primarily in
    sub-Saharan Africa.  Kinase
    inhibitors constituted a large proportion of the most potent compounds.  The
    full results of the study are part of the cover story published in the May 20
    issue of Nature ("
    Thousands of chemical starting points for antimalarial lead identification")

    According
    to the GSK press release, the release of
    this data marks the first time that a pharmaceutical company has made the
    structures of so many compounds available at no cost to researchers.  With the
    structure of the compounds and information about how they affect the malaria
    parasite, scientists can utilize these compounds for drug discovery or to study
    their mechanism of parasite inhibition.


    CDD The
    sharing of this data is an example of recent "open source" tactics
    being applied to drug discovery.  EMBL-EBI
    will act as the primary repository for the data on this compound set, and will
    index further information that is deposited.  GSK will add more data as it is generated
    and external scientists researching these compounds will be asked do the same.  The
    data on the compounds can be found at the following links:

    European
    Bioinformatics Institute
    (EMBL-EBI)
    Pubchem
    Collaborative Drug
    Discovery

    James
    DeGiulio has a doctorate in molecular biology and genetics from
    Northwestern University and
    is a third-year law
    student at the Northwestern University School of Law.  Dr. DeGiulio
    was a member of MBHB's 2009 class of summer associates, and he can be
    contacted at degiulio@mbhb.com.

  •     By
    James DeGiulio —


    Mc_logo Despite
    the global economic outlook improving considerably over the last year, an
    industry survey by international intellectual property group Marks & Clerk
    suggests that the biotech and pharmaceutical industry may be entering a
    critical phase in terms of drug innovation and development.  The research identifies a number of
    industry-specific problems, the most urgent being the patent cliff facing
    innovator pharmaceutical companies, where a large number of blockbuster drugs
    are set to come off patent between now and 2014.  The Marks & Clerk survey indicates that biotech/pharma
    companies intend to overcome this obstacle through strategic mergers and
    acquisitions, while increasingly relying on patent term extensions to safeguard
    essential blockbuster revenue.  Interestingly, the survey further suggests that members of the
    biotech/pharma industry favor recent U.S. healthcare reforms.

    Marks
    & Clerk conducted the survey of 381 executives across the biotech/pharma
    sector.  The study involved respondents from the U.S., U.K., Europe, and Asia.  Over
    half of those responding were from commercial pharmaceutical and biotechnology
    companies, with the remainder coming from academic and R&D environments.  A
    small number were from the venture capital industry with a specialty interest
    in life sciences angel investment.

    Overall,
    the outlook within the industry has improved since last year, with 63% of
    respondents indicating that the climate for doing business and access to
    funding has improved in the past 12 months.  However, the results of the survey indicate a pessimistic
    outlook towards the innovation capabilities of big pharma.  The research reveals that 82% of
    respondents predict that big pharma will be unable to innovate sufficiently
    from within to replenish dwindling drug pipelines.  Thus, many predict a
    substantial increase in acquisitions to augment this insufficiency.  68%
    forecast substantial acquisition activity within the next two years, with 19%
    anticipating major activity within the next year.  Further, 65% believe the improved economic situation means
    the industry now has the confidence to go ahead with those mergers.

    Marks
    & Clerk predict that large innovator companies will begin to look to
    biotechnology startups as the source for drug development pipelines of the
    future.  Marks & Clerk also predicts that the industry is likely to observe
    innovator companies move into some areas of generic competition, particularly
    in the area of biosimilars where they identify considerable commercial
    opportunity or threat.

    The
    study also confirmed the increased importance of patent term
    extensions within the biotech/pharma industry.  Previously viewed as merely one tool among many for securing
    future revenue, 97% of respondents believe that the industry's reliance on
    patent term extensions, or supplementary protection certificates (SPCs) in
    Europe, will intensify as blockbuster drugs near the end of their patent life.  87% of respondents believe that dwindling drug pipelines at innovator companies
    drives this reliance.

    This
    reliance on patent term extensions has fueled the push for reform in
    Europe.  The biotech/pharma
    industry is calling for reform of the European system, since SPC protection is
    only granted to the product subject to initial marketing approval.  Incremental improvements to the drug
    are not eligible for SPC protection.  82% of respondents believe innovators
    ought to be given a longer term in which they can market their products
    exclusively due to the increasing cost of R&D.  Further, 79% favor reform
    where SPC protection is broadened to protect the underlying invention, as in
    the U.S., rather than the more narrow protection of the active ingredient the SPC
    provides now.

    Interestingly,
    the Marks & Clerk research shows the biotech/pharma sector has a much more
    favorable view of the intellectual property system in the United States than it
    does of the European system.  62% of survey respondents felt that the U.S.
    intellectual property system has better managed to reward innovation and meet
    the changing needs of the industry than that in Europe.  Further, despite the recent healthcare
    reform in the U.S., the clear majority rejects the notion that healthcare reform
    will ultimately harm drug innovation in the U.S.  Indeed, 65% of the respondents believe that the reforms will
    benefit U.S. innovation in the long run.  The findings display considerable
    confidence in the U.S. regime overall, with 89% of respondents believing lasting
    capital will be attracted back into the U.S. market for the long term as a result
    of the reforms.

    The
    Marks & Clerk press release discussing the research can be found here.

    James
    DeGiulio has a doctorate in molecular biology and genetics from
    Northwestern University and
    is a third-year law
    student at the Northwestern University School of Law.  Dr. DeGiulio
    was a member of MBHB's 2009 class of summer associates, and he can be
    contacted at degiulio@mbhb.com.