Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • Merck Seeks to Reverse Loss in Federal Circuit, Alleging Teva Committed Litigation Fraud

    Merck has asked the federal district court in Delaware to vacate a judgment that Merck’s patent on its Fosamax Once Weekly drug product is invalid, alleging that Teva committed fraud in the previous litigation.  In its 2003 decision, the district court upheld Merck’s patent.  However, in a 2005 decision, the Federal Circuit reversed the district court when it found, by a 2-1 vote, that Merck’s patent was invalid as obvious.

    According to Merck’s new complaint, filed last Wednesday, Teva withheld key documents in the previous litigation that would have convinced the Federal Circuit to affirm, rather than reverse, the district court.  More specifically, Merck alleges that Teva failed to produce documents that would have supported Merck’s claim that it had sufficient evidence of unexpected results to defeat Teva’s obviousness argument.

    A Dow Jones article relating to the litigation can be found here.

  • Eli Lilly Files Suit Against Barr Labs to Protect Prozac Weekly

    Barr Labs announced that yesterday, Eli Lilly filed a patent infringement lawsuit against Barr relating to Lilly’s Prozac Weekly drug product.  Lilly filed suit in the Southern District of Indiana, alleging infringement of U.S. reissue patent RE39,030.  According to Barr’s press release, Barr filed its ANDA seeking approval of a generic version of Prozac Weekly in September, 2001, and filed a paragraph iv certification to the Orange Book listed patents at that time.  Lilly, however, chose not to file suit against Barr until its reissue patent was granted.

    Previously, Barr successfully challenged other Lilly patents covering its daily Prozac drug product.  The 2001 en banc Federal Circuit decision invalided Lilly’s patents on double-patenting grounds.  Lilly appealed to the Supreme Court, but cert was denied.

  • Public Comment Period on FTC’s Authorized Generics Study Ends June 5, 2006

    Authorized generic drugs are essentially brand name drugs packaged and sold as generics by an innovator drug company under its own NDA, through either the innovator’s generic subsidiary or an independent generic drug company.  With increasing frequency, innovator drug companies are launching authorized generics simultaneously with the first ANDA filer’s launch of its generic drug product, thereby limiting the value of the 180-day exclusivity period.  Last year, in Teva v. Crawford, the D.C. Circuit held that the practice of selling authorized generics during the 180-day exclusivity period is perfectly legal.

    The FTC announced in March that it is initiating a study of the effects of authorized generics in the prescription drug marketplace.  The FTC plans to use its subpoena power to obtain information from 80 brand name drug makers, 10 authorized generic companies, and 100 independent generic companies.  According to the FTC’s news release:

    The goal of the Commission’s study will be to assess the likely short- and long-run effects of market entry by authorized generics on generic drug competition.  Among other things, the study will examine actual wholesale prices (including rebates, discounts, etc.) for brand-name and generic drugs, both with and without competition from authorized generics; business reasons that support authorized generic entry; factors relevant to the decisions of generic firms about whether and under what circumstances to seek entry prior to patent expiration; and licensing agreements with authorized generics.  The data collected will enable the FTC to advance the understanding of the effects of generic entry on prescription drug prices – in particular, the role of the 180-day exclusivity period in generic competition prior to patent expiration – beyond what is available in the economic literature today.

    The FTC is accepting public comments regarding its study until June 5, 2006.  During the public comment period the Commission seeks information on the following:

    1. whether the proposed information collection is needed for the proper performance of the agency’s functions and whether what is collected will have practical utility;
    2. the accuracy of the FTC’s estimate of the burden of the information collection;
    3. ways to limit the number of companies included in the study without undermining the validity and reliability of the study results;
    4. ways to enhance the quality, utility, and clarity of the information to be collected; and
    5. ways to minimize the burden of collecting the information on companies asked to respond.

    The Federal Register notice regarding the FTC’s study includes detailed information for submitting comments.  The FTC expects to issue its final report sometime in 2007.

  • FTC Commissioner Speaks on Settlements in Pharmaceutical Patent Cases

    The Federal Trade Commission recently published the remarks of Commissioner Jon Leibowitz regarding trends in settlements of patent lawsuits between innovator and generic drug companies.  Commissioner Leibowitz made his remarks in a speech at the 2nd Annual In-House Counsel’s Forum on Pharmaceutical Antitrust, on April 24th in Philadelphia.  On the same day, the FTC released its latest annual report on patent settlements between innovators and generics.  While the entire speech is well worth reading, the following comments are especially interesting:

    • until the Schering and Tamoxifen cases, almost no settlements involved a cash payment from the innovator to the generic; since those cases, more than two-thirds of settlements have included such payments;
    • unless the Supreme Court reverses the Schering and Tamoxifen decisions, the innovator and generic drug companies "will have carte blanche to avoid competition and share resulting profits, and we will see minimal competition before patent expiration";
    • rather than settling with only the first ANDA filer, in some cases the innovator company is settling with all ANDA filers to guarantee no generic entry until a date that’s usually very near patent expiration;
    • since the Federal Circuit decision in Teva v. Pfizer, some innovators have been pursuing a strategy of settling with the first ANDA filer and declining to sue any subsequent filers, which could effectively block all generic entry until patent expiration.

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  • Welcome to Orange Book Blog!

    This weblog will focus on issues at the intersection of patent law and FDA law.  For example, I aim to discuss drug development and patenting; Hatch-Waxman litigation; and antitrust issues in pharmaceutical patent cases.  I am a patent lawyer, and therefore I will be looking at these topics from that perspective.  Others, such as those more involved in regulatory issues, may bring different perspectives; comments on posts are always welcome.  Thank you for visiting.  And thanks to Dennis Crouch for inspiring me to start a blog and for his assistance setting it up.