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  • Snatching Defeat from the Jaws of Victory?

    Obama Administration Pushes for Lower Data Exclusivity Period

        By Kevin E. Noonan —

    Obama Transition (Wikipedia Commons) The Obama administration is reported to be pushing
    for a lower data exclusivity period than the 12-year period contained in both the
    House and Senate versions of the 
    health care reform bill.  This latest twist was reported by Steve Usdin in BioCentury on Saturday.  According to the report, the President
    informed Congressional Democratic leaders of his opposition in a meeting at the
    White House last week.  Specifically, on Wednesday, Congresswoman Anna Eshoo (D-CA) asked the
    President whether he supported the 12-year data exclusivity period in the
    bill.  Characteristically
    forthright, the President is reported to have replied:  "As a matter of
    fact, I don't."  The
    Congresswoman, who succeeded in having the 12-year period added to the final bill
    over the objections of the Chairman of the House committee, fellow Californian
    Henry Waxman, is reported to have sharply responded to the news.  She particularly objected to having the
    "deal" brokered between the Obama Administration and the
    pharmaceutical industry (wherein the "contribution" of the industry
    to healthcare reform is capped at $80 billion) be "sacrosanct" while
    the administration objected to one of the few aspects of the reform measure where there is
    agreement between the House and Senate versions.  The President's answer was not specific, alluding to "good
    policy."

    Waxman, Henry The report contains speculation that Congressman
    Waxman (at left) is trying to get a victory on this issue at the 11th hour
    (having failed miserably during debate on the bill).  Other speculation includes that this is an issue where the
    President could assuage some of the criticism from the left that he had
    conceded too much to the pharmaceutical industry.  Or perhaps the President's stance comes from his inner
    policy wonk.

    Tauzin, Billy Regardless of motivation, the stance has raised a
    firestorm.  Billy Tauzin (at right), president
    and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) was
    motivated to threaten to withdraw "months of unstinting support" for the healthcare reform bill
    should the President prevail on Speaker Pelosi and Majority Leader Reid to
    reduce the data exclusivity term.  Mr. Tauzin also was reported to have notified PhRMA's board members that the group "could
    not support the bill [if the data exclusivity
    term was reduced]" (emphasis in original).  Congressman
    Waxman responded with characteristic combativeness, saying that "[t]he
    brand name drug companies are threatening to block health care reform for
    millions of Americans unless they receive virtually permanent immunity from
    generic competition."  Besides
    being deficient in mathematics ("12 years" can be the same as "permanent"
    only on Capitol Hill or to a politician trapped in 2-year re-election cycles),
    Congressman Waxman fails to consider that permanent immunity from generic
    competition is the status quo.  If
    he cares as much as he professes, he might consider that getting this
    health care bill passed should take priority; changes in data exclusivity term, if warranted, can wait for
    another day.  Congressman Waxman's
    position was echoed by Teva Pharmaceuticals (or, more precisely, by their
    lobbyists, Cuneo Gilbert & LaDuca), saying that "[a]ccess to affordable health care must not be held
    hostage by the pharmaceutical industry in this way."

    MassBio Perhaps the President should consider the likely,
    and threatened, consequences of his position.  For example, the Massachusetts Biotechnology Council (MassBio) is threatening to "attempt
    to derail Democrat Martha Coakley's bid to replace Edward Kennedy in the U.S.
    Senate" unless the Administration provided reassurances that the final
    version of the bill contains the 12-year data exclusivity period.  The article in BioCentury puts the number of biotech industry workers in
    Massachusetts at about 45,000, certainly enough to influence the election.  This position would be a
    reversal; recently, BIO President
    and CEO, Jim Greenwood, attended a fundraising dinner for Ms. Coakley, and
    Robert Coughlin, MassBio's president and CEO, was reported to have warned both
    Speaker Pelosi and Majority Leader Reid that MassBio would actively oppose Ms.
    Coakley's election if the data exclusivity term was lowered from the present 12
    years.  Failing to hold the
    Massachusetts Senate seat for the Democrats would wreck havoc on the
    legislative calculations for getting a health care bill passed.

    The report notes that a compromise is possible,
    specifically a term of 10 years.  Earlier in the process, investors in the biotechnology sector and
    biotech company executives are said to have privately conceded that a 10-year
    term would be acceptable, similar to the term in Europe.  However, that was then, and it is
    possible (if not likely) that expectations have been raised sufficiently for a
    10-year term to no longer be possible.

    The report notes, ironically, that there are other
    provisions in the bill, such as ones involving how the Food and Drug
    Administration will review applications for biosimilar drugs (for example,
    involving formal rulemaking) that would delay institution of a biosimilar
    approval pathway for "a minimum of two to three years" after the
    legislation is enacted (if ever).

    While this may simply be a case of "politics
    as usual," it seems to be as
    inept as it is unnecessary.  After
    all the time and effort (as well as political capital) this administration and
    Congress have expended in trying to pass health care reform, it would be worse
    than a shame if the petty politics of political preference and prerogative were
    to prevent its passage.

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

    •
    "Follow-on Biologics News Briefs – No. 11," December 30, 2009
    •
    "Follow-on Biologics News Briefs – No. 10," November 30, 2009
    •
    "House Health Care Bill Includes Biosimilar Licensure Pathway,"
    November 3, 2009
    •
    "12 Senators Write in Support of 12-Year Data Exclusivity Period,"
    November 3, 2009
    •
    "Four Senators Write in Support of 12-Year Data Exclusivity Period,"
    October 19, 2009
    •
    "Governors Send Letter to Congressional Leaders in Support of 12-Year Data
    Exclusivity Period    ," October 2, 2009
    •
    "Follow-on Biologics News Briefs – No. 8," August 19, 2009
    •
    "House Committee Approves Health Care Reform Bill Calling for 12-Year
    Exclusivity Period    ," July 31, 2009
    •
    "Follow-on Biologics News Briefs – No. 5," July 19, 2009
    •
    "House Subcommittee Holds Hearing on Follow-on Biologics," July 14,
    2009
    •
    "Senators Champion 12-Year Data Exclusivity in Senate," July 14, 2009
    •
    "Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period,"
    July 9, 2009
    • "White House Recommends 7-Year Data Exclusivity Period for Follow-on
    Biologics    ," June 26, 2009
    •
    "No One Seems Happy with Follow-on Biologics According to the FTC,"
    June 14, 2009
    •
    "Third Follow-on Biologics Bill Introduced in 111th Congress," April
    1, 2009
    •
    "Second Follow-on Biologics Bill Is Introduced in House," March 18,
    2009
    •
    "Waxman Introduces Follow-on Biologics Bill," March 11, 2009
    •
    "Congressman Waxman Tells GPhA Meeting that Hatch-Waxman Model Will Work
    for Follow-on Biologics    ," February 25, 2009

  • Court Report

        By Sherri Oslick —

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


    Monsanto Co. et al. v. Slusser
    4:10-cv-00075; filed January 14, 2010 in the
    Eastern District of Missouri

    • Plaintiffs:  Monsanto Co.; Monsanto Technology,
    LLC
    •     Defendant:  Kevin Slusser

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


    Alza Corp. et al. v. Kremers Urban LLC et al.
    1:10-cv-00023; filed January 8, 2010 in the
    District Court of Delaware

    • Plaintiffs:  Alza Corp.; Ortho-McNeil-Janssen
    Pharmaceuticals Inc.
    •     Defendants:  Kremers Urban LLC; KUDCO Ireland
    Ltd.

    Infringement of U.S. Patent Nos. 6,919,373 ("Methods
    and Devices for Providing Prolonged Drug Therapy," issued July 19, 2005)
    and 6,930,129 (same title, issued August 16, 2005) following a Paragraph IV
    certification as part of Kremers' filing of an ANDA to manufacture a generic
    version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention
    deficit hyperactivity disorder).  View the complaint     here.


    Allergan Inc. v. Sandoz Inc.
    1:10-cv-00024; filed January 8, 2010 in the
    District Court of Delaware

    Infringement of U.S. Patent Nos. 5,688,819 ("Cyclopentane
    Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents,"
    issued November 18, 1997) and 6,403,649 ("Non-acidic Cyclopentane
    Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents,"
    issued June 11, 2002) following a Paragraph IV certification as part of Barr's
    filing of an ANDA to manufacture a generic version of Allergan's Lumigan®
    (0.03% bimatoprost ophthalmic solution, used to treat lower intraocular eye
    pressure in people with open-angle glaucoma or ocular hypertension).  View the complaint     here.


    AstraZeneca Pharmaceuticals LP et al. v. Teva
    Parenteral Medicines Inc. et al.
    1:10-cv-00018; filed January 7, 2010 in the
    District Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP;
    AstraZeneca UK Ltd.; AstraZeneca AB
    •     Defendants:  Teva Parenteral Medicines Inc.; Teva
    Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

    Infringement of U.S. Patent Nos. 6,744,122 ("Formulation,"
    issued August 10, 2004) and 7,456,160 (same title, issued November 25, 2008) following
    a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture
    a generic version of AstraZeneca's Faslodex® (fulvestrant, used to treat metastatic
    hormone receptor-positive breast cancer).  View the complaint     here.


    Teva Women's Health, Inc. v. Lupin, Ltd. et al.
    2:10-cv-00080; filed January 6, 2010 in the District
    Court of New Jersey

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

    Infringement of U.S. Patent No. 7,615,545 ("Oral
    Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology,"
    issued November 10, 2009) following a Paragraph IV certification as part of Lupin's
    filing of an ANDA to manufacture a generic version of Teva's LoSeasonique®
    (ethinyl estradiol and levonorgestrel, used as oral contraception).  View the complaint     here.

  • Conference & CLE Calendar

    Calendar

    January 20, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Los Angeles & San Francisco

    January 21, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Birmingham, Boston, Philadelphia & Pittsburgh

    January 20-21, 2010 – Life Sciences IP
    Due Diligence     (American Conference
    Institute) – New York, NY

    January 25, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Atlanta & Seattle

    January 25-26, 2010 – European Pharmaceutical Regulatory Law Boot
    Camp         (American Conference
    Institute) – New York, NY

    January 26-27,
    2010 –     Advanced In-House Counsel Forum on China IP Law (C5) – Shanghai, China

    January 27-30, 2010 – Mid-Winter Institute (American
    Intellectual Property Law Association) –     La Quinta, CA

    January 27-28, 2010 – Pharma & Biotech Patent Litigation (C5) – Amsterdam, Netherlands

    January 28, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Memphis

    January 29, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Wilmington

    February 4, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Chicago

    February 4, 2010 – Bay Area Pharma and Life Sciences IP Summit (Fish
    & Richardson and Berkeley Center for Law & Technology) –     San Mateo, CA

    February 9, 2010 – Patent
    Prosecution: Best Practices for Reducing Costs While Improving Patent
    Quality     (    Technology
    Transfer Tactics) –     1:00 – 2:30 PM (EST)

    February
    17-18, 2010 –     Biotech & Pharmaceutical Patenting (IIR) – Munich, Germany

    February 24-25, 2010 – 2nd Expert Forum on ITC Litigation &
    Enforcement     (    American Conference
    Institute) –     New York, NY

    March 1-2, 2010 – 4th Annual Patent Law Institute (Practising
    Law Institute) –     New York, NY

    March 2-4, 2010 – 6th Annual Biosimilars Conference (Visiongain) – Boston,
    MA

    March 18-19, 2010 – 4th Summit on Biosimilars and
    Follow-on Biologics    *** (    Center for
    Business Intelligence) –     Washington, DC

    March 22-23, 2010 – 4th Annual Patent Law Institute (Practising
    Law Institute) –     San Francisco,
    CA

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

  • Summit on Biosimilars and Follow-on Biologics

    Washington Monument #2 The Center for
    Business Intelligence (CBI) will be holding its 4th Summit on Biosimilars and
    Follow-on Biologics on March 18-19, 2010 in Washington, DC.  At the Summit, CBI's faculty will offer
    presentations on the following topics:

    • Understand the developing biosimilars
    framework in the United States and European Union;
    • Biologics similarity — How will this
    be defined? (panel discussion);
    • FDA update on the scientific issues
    associated with evaluating FOB submissions;
    • Update on healthcare reform policy
    and implications for bio/pharma;
    • From the Hill — Biosimilars
    legislative perspectives (panel discussion);
    • European monoclonal antibody draft
    guidance — What will this mean for the U.S.?
    • Update on reimbursement systems,
    benefit design implications and clinical/patient safety considerations for
    biosimilars;
    • Understand provider perspectives on
    the use of biosimilars;
    • Lessons learned from Hospira's EU
    biosimilar experiences;
    • Partnering with biobetters to
    facilitate approval and increase product update;
    • The biosimilars business model —
    Opportunities and pitfalls;
    • Follow-on perspective; and
    • Innovator perspective.

    A complete agenda
    for the Summit on Biosimilars and Follow-on Biologics can be found here (Day
    One    )
    and here (Day Two).  A brochure for this conference can be
    requested here.

    Center for Business Intelligence (CBI) The registration
    fee for the conference is $2,095. 
    Attendees registering on or before January 22, 2010 will receive a $400
    discount off the registration fee, and attendees registering a group of three
    individuals will receive a fourth registration for free.  Those interested in registering for the
    conference can do so here,
    by calling 1-800-817-8601, or by e-mail at cbireg@cbinet.com.

    Patent Docs is a media partner of CBI's Summit on Biosimilars and Follow-on
    Biologics.

  • ABA IP Roundtables on Gene Patenting

    ABA The
    Intellectual Property Litigation Committee of the American Bar Association
    (ABA) Section of Litigation will be holding a number of luncheon roundtable
    discussions at various locations around the country to address the
    question:  "Are Genes
    Patentable?"  Roundtables have
    been scheduled on the following dates at the following locations:

    • January
    20, 2010 – Los Angeles & San Francisco
    • January
    21, 2010 – Birmingham, Boston, Philadelphia & Pittsburgh
    • January
    25, 2010 – Atlanta & Seattle
    • January
    28, 2010 – Memphis
    • January
    29, 2010 – Wilmington
    • February
    4, 2010 – Chicago
    • Date
    to be determined – Houston, Minneapolis, Nashville, Palo Alto & Washington,
    DC

    Patent Docs author Kevin
    Noonan     will be moderating the Chicago roundtable.  The hosts and moderators for the other roundtables can be
    found here.  Information regarding the site, time,
    possibility of securing CLE credit, and whether lunch is being provided at each
    roundtable can also be obtained at the above link.  A 17-page program discussion outline for the roundtable can
    be obtained here.

  • Bay Area Pharma and Life Sciences IP Summit

    Fish & Richardson Fish
    & Richardson and the Berkeley Center for Law & Technology will be
    holding the Bay Area Pharma and Life Sciences IP Summit in San Mateo, CA on
    February 4, 2010.  Registration for
    the event opens at 11:30 am (PT), and at noon, Suzanne Michel, Deputy Director
    for the Office of Policy Planning at the Federal Trade Commission, will give a
    keynote luncheon presentation entitled: 
    "Impact of Healthcare Legislation on Pharmaceutical Patent
    Litigation Settlements and Follow-on Biologics."  Following the keynote, a series of panel discussions will
    address the following topics:

    •
    Hot Topics in Bio/Pharma Litigation
    •
    Product Life Cycle Management
    •
    Early Stage IP Strategies

    Panelists
    will include:

    •
    Debra Condino, Vice President and Chief Intellectual Property Counsel,
    Allergan, Inc.
    •
    Frank Grassler, Vice President – Intellectual Property, Gilead Sciences, Inc.
    •
    Kurtis MacFerrin, Lead IP Counsel – Litigation, Life Technologies
    •
    Gerald Suh, Chief Patent Counsel, Metabolex, Inc.
    •
    D. Jeffery Grimes, General Counsel, Aradigm Corp.

    Berkeley Center for Law & Technology A
    cocktail reception will follow the panel discussions at 5:00 pm.  While there is no registration fee,
    those interested in attending the Summit should e-mail Roxanne Smith by January
    28, 2010 at rks@fr.com.  Additional information regarding the
    Summit can be obtained here.

  • AIPR Reiterates Opposition to Patent Reform Legislation

        By
    Donald Zuhn —

    American Innovators for Patent Reform On
    Tuesday, the American Innovators for Patent Reform
    (AIPR) announced
    that it was joining with the Small Business Coalition on Patent Legislation in
    opposing patent reform legislation currently before Congress.  The AIPR specifically opposes the
    inclusion of apportionment of damages, post-grant opposition, and first-to-file
    provisions in any patent reform bill that might make its way to the Senate or
    House floor for a vote.  Last fall,
    the AIPR had issued a statement
    regarding its opposition to the post-grant review provision in particular.

    In
    December, the Small Business Coalition on Patent Legislation sent a letter to
    the U.S. Small Business Administration stating its opposition to the
    first-to-file, post-grant review, and USPTO rulemaking provisions in pending
    patent reform legislation (see "Patent
    Reform Efforts Opposed by Small Business Group    ").  Only a few weeks earlier, in a letter
    to The New York Times, Senate
    Judiciary Chairman Patrick Leahy (D-VT) asserted that "[w]e need to create
    the legal landscape that allows our innovators to flourish in the new economy,
    and we need to do it now" (see "Senator Leahy: 'Time Is Now' for
    Patent Reform    ").  Senator Leahy added that "Congress should not let the controversial issue
    of how damages are calculated bog down needed reforms," and noted that
    with regard to patent reform, Congress "will make this happen, and America
    will invent its way back to prosperity."

    Washington - Capitol #3 In
    the AIPR release, the group's founder and President Alexander Poltorak
    noted that while Congress had been consumed by the health care reform debate
    for most of the past year, and both the Senate (S. 515)
    and House (H.R. 1260)
    patent reform bills had been put on hold, "there is no doubt that Congress
    will again address the Patent Reform Act in 2010, and those who believe that
    only strong U.S. patents will insure and protect American innovation must stand
    united in opposition to this ill-conceived legislation!"  Referring to the letter sent by the the
    Small Business Coalition last month, Dr. Poltorak
    applauded the group for its efforts "in getting the voice of small business
    — traditionally the largest source of new job creation and new technologies —
    heard in the halls of Government."

    According
    to the AIPR website, the group represents a broad constituency of American
    innovators and innovation stakeholders, including inventors, engineers,
    researchers, entrepreneurs, patent owners, investors, small businesses, and
    intellectual property professionals such as patent attorneys, patent agents,
    tech transfer managers, and licensing executives.

  • USPTO to Hold Public Meeting on January 20th to Discuss Appeals Rules Changes

        By
    Sarah Fendrick —

    USPTO Seal The
    U.S. Patent and Trademark Office published a notice in the Federal Register last month (    74 Fed.
    Reg. 67987    ) in which the Office announced that it is
    considering modifications to rules governing the practice before the Board of
    Patent Appeals and Interferences (BPAI) in ex parte patent appeals.  The USPTO had previously solicited
    public comment in 2007 regarding a proposed rule change for practices before
    the BPAI in ex parte patent appeals, and the resulting final rule was to become
    effective on December 10, 2008.  Due to a number of factors, the final rule was never implemented (see "    Patent Office Announces Delay for New Appeals Rules" and "Patent Office to Publish Notice Delaying New Appeals Rules").

    As
    a result of the previously submitted comments, the USPTO is considering further
    change to the final rule to reduce any additional burden introduced by the
    final rule.  During this
    consideration period, the USPTO is seeking public comment on potential
    modifications to the final rule.  In addition to public comment, the USPTO is conducting a public session
    and roundtable on January 20, 2010 from 9:30 a.m. to 12:30 p.m. in connection
    with the final rule modification.

    Several modifications to
    the final rule as published in 73 Fed. Reg. 32937 are being considered.  These modifications include:

    (1) Deleting portions
    of the rule that require the filing of a petition to the Chief Administrative
    Patent Judge seeking extensions of time to file certain papers after an appeal
    brief is filed in an ex parte appeal or seeking to exceed a page limit; (2)
    deleting portions of the rule that require the filing of a jurisdictional statement,
    table of contents, table of authorities, and statement of facts in appeal
    briefs, a table of contents, table of authorities, and statement of additional
    facts in reply briefs, and a table of contents and table of authorities     in
    requests for rehearing filed in ex parte appeals; (3) deleting portions of     the rule that require an
    appellant to     specifically identify which arguments
    were
    previously presented to the     Examiner and which arguments are new; (4)
    deleting portions of the rule     that require specific formatting requirements
    and page limits for appeal briefs, reply briefs, and requests for rehearing;
    and (5) deleting portions of the rule that require appellants to provide a list
    of technical terms and other unusual words for an oral hearing.

    Written
    comments on potential modifications to the final rule can be submitted to the
    USPTO until February 12, 2010.  Comments can be submitted by electronic mail to BPAI.Rules@uspto.gov or by regular mail
    addressed to:  Mail Stop Interference, Director of the United States Patent and
    Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the
    attention of "Linda Horner, BPAI Rules.

    For additional information regarding this topic, please see:

    • "Patent Office Announces Delay for New Appeals Rules," December 10, 2008
    • "Patent Office to Publish Notice Delaying New Appeals Rules," December 9, 2008
    • "Patent Office Issues Appeals Rules Clarification," November 21, 2008
    • "More on Ex parte Appeal Rule," October 10, 2008
    • "Unhappy with the Ex parte Appeal Rule?  Read This Now," October 8, 2008
    • "Patent Office Posts Comments on New Appeals Rules," September 11, 2008
    • "More on USPTO Rulemaking Practices,"July 21, 2008
    • "USPTO Rulemaking Practices Being Called into Question (Again)," July 20, 2008
    • "New Appeals Rules Published," June 10, 2008
    • "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008

  • Consumer Groups Ask Congress to Add Pay-for-Delay Provision to Health Care Bill

        By
    Donald Zuhn —

    American Antitrust Institute On
    Monday, the American Antitrust Institute
    (AAI) sent a letter
    to Speaker of the House Nancy Pelosi (D-CA) and Senate Majority Leader Harry
    Reid (D-NV), urging the House and Senate to include provisions in their health
    care reform bills that would prohibit exclusion payments in pharmaceutical
    patent settlements.  These
    payments, also known as pay-for delay settlements or reverse payments, are made
    by brand name drug companies to generic drug companies in order to delay the
    entry of a generic drug into the market. 
    Co-signatories on the letter included Families USA,
    U.S. PIRG, the Consumer Federation of America,
    Consumers Union, Community Catalyst,
    and the National Legislative Association on Prescription Drug Prices.

    Kohl, Senator In
    a press release issued on Monday, the AAI noted that a group of Senators, led
    by Sen. Herb Kohl (D-WI) (at left), had tried unsuccessfully to add a pay-for-delay
    provision to the Senate health care bill last month.  The proposed amendment was based on a bill (S. 369)
    Sen. Kohl introduced in February 2009, which would "prohibit payments from
    brand name to generic drug manufacturers with the purpose to prevent or delay
    the entry of competition from generic drugs" (see "Bill to Prohibit Reverse Payments Introduced in the
    Senate    ").  Last fall, the bill was passed out of
    Senate Judiciary Committee by a 12-7 vote (see
    "Anti-Reverse Payment Legislation Introduced in the House").

    Rush, Bobby In
    its letter to the Speaker and Senate Majority Leader, the consumer advocacy groups seek support
    for the pay-for-delay legislation being proposed by Rep. Bobby Rush (D-IL) (at right).  The anti-reverse payment provision
    being proposed by Rep. Rush is presumably similar to the bill (H.R. 1706) he
    introduced in April 2009, which would prohibit brand name drug companies from
    compensating generic drug companies for delaying the entry of generic drugs
    into the market (see "Senate
    Judiciary Committee Acts on Reverse Payments    ").

    Nelson, Bill The
    groups also seek support for a bill (S. 1315)
    introduced by Sen. Bill Nelson (D-FL) (at left), which would provide an incentive for multiple
    generic manufacturers to challenge patents.  The bill, which was introduced in June and then referred to
    the Senate Committee on Health, Education, Labor, and Pensions (HELP), would
    amend the Federal Food, Drug, and Cosmetic Act to expand the definition of
    "first applicant" under the Act to allow a generic drug manufacturer
    that is currently considered an applicant subsequent to a brand-name
    manufacturer's 180-day exclusivity period to qualify as a first applicant for
    purposes of filing an abbreviated application for a new drug.  Currently, Sen. Nelson's bill has only
    one co-sponsor:  Sen. Kohl.

    The
    AAI letter states that Rep. Rush's and Sen. Nelson's provisions "will help
    open up the market for affordable prescription drugs."  The letter notes that "[w]hen
    patents are weak or illegitimate, drug manufacturers have the opportunity to
    challenge those patents and, if successful, to introduce affordable generics to
    the market in a shorter timeframe than they otherwise would."  However, when a first-to-challenge
    generic manufacturer is "paid off by the branded drug manufacturer to stay
    out of the market," the generic manufacturer gets to keep its 180-day
    exclusivity period, thereby preventing other manufacturers from bringing the
    same generic drug to market. 
    According to the letter, this results in consumer harm.  As a result, the letter contends that
    reverse payments "should be considered per se illegal:  they prevent any generic manufacturer with a legitimate challenge to a patent
    from potentially entering the market."

    With
    regard Sen. Nelson's modification of the 180-day exclusivity period, the letter
    argues that "[e]xpanding the exclusivity period is vitally important,
    since it removes the barrier to entry that has protected collusive settlements
    between brands and first-filing generics."  The letter contends that including Sen. Nelson's provision
    in the final health reform legislation "would provide a strong complement
    to Representative Rush's per se ban on these payments."

  • Partnerships Between Startup Firms and Big Pharma Fueled 85% Increase in Biotech Funding in 2009

        By
    James DeGiulio —

    Burrilll, Steven Industry
    investor and analyst Steven Burrill (at right), CEO of Burrill & Co., reports that a record
    $55.8 billion was raised by the biotech industry in 2009, which constitutes an 85 percent
    increase over the $30.1 billion recorded in 2008.  Mr. Burrill noted that these results were driven by $37 billion
    in financial partnerships between large drug companies and biotech startups,
    but warned startups that licensing their most promising developments will
    ultimately lead to long-term limits on company growth.  "You're not going to
    grow a lot more Genentechs or Amgens," Mr. Burrill said.  His comments regarding 2009 biotech funding were reported in an article appearing in the San Francisco Chronicle ("'Big Pharma' feed biotech startups record funds").

    Smaller
    biotech firms hope to use partnerships to fund the development of a biomedical
    breakthrough while retaining enough control to preserve the growth potential of
    the company.  In order to survive a
    tough year, biotech startups have increasingly been forced to turn to
    partnerships and licensing for revenue production.  Though smaller biotech firms
    have had success in developing marketable drugs, these firms have typically
    struggled to meet the cost of developing drug sales efforts.  Partnerships and buyouts have become an
    easier way to raise the necessary capital than initial stock offerings.

    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.