Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • DOJ Advises Supreme Court Not To Grant FTC’s Cert Petition in FTC v. Schering

    As Patently-O reported early this morning, the Solicitor General has filed an amicus brief in FTC v. Schering.  The Supreme Court, while considering whether to grant certiorari in the case, had asked for the views of the Solicitor General last fall.  The Solicitor General’s brief advises the Court not to grant the FTC’s cert petition.

    If the Court denies certiorari, that would leave standing the 11th Circuit’s decision that a settlement of a patent infringement lawsuit between Schering-Plough and Upsher-Smith did not violate the antitrust laws.  The patent infringement suit concerned Upsher’s generic version of Schering’s K-Dur 20 drug product, a treatment for high blood pressure and heart disease.  The settlement agreement between Schering and Upsher included a cash payment from Schering to Upsher in exchange for Upsher’s promise not to launch its generic version of K-Dur 20 for six more years—close to the end of Schering’s patent term.

    The FTC’s petition for certiorari presents the following questions for review:

    1. Whether the antitrust laws prohibit a brand name drug patent holder and a prospective generic competitor from settling patent infringement litigation by agreeing that the generic manufacturer will not enter the market before a future date within the term of the patent and that the patent holder will make a substantial payment to the generic manufacturer.
    2. Whether the court of appeals erred in concluding that "substantial evidence" did not support the Federal Trade Commission’s factual finding that a payment from a patent holder to an allegedly infringing generic manufacturer was consideration for the generic manufacturer’s delayed entry into the market rather than a separate royalty for a license concerning a different product.

    The following briefs have been filed:

    Thanks to Dennis Crouch for sending me copies of the briefs!

    RELATED READING:

  • Ivax and Ranbaxy Successfully Appeal FDA’s Delisting of Merck’s Zocor Patents

    In a recent decision, Ranbaxy v. Leavitt, the federal district court for the District of Columbia held that the FDA improperly denied Ivax’s (a division of Teva) and Ranbaxy’s citizen petitions to relist two Merck patents on Zocor.  According to the court, by denying the citizen petitions, the FDA effectively nullified Ivax’s and Ranbaxy’s rights to 180-day exclusivity periods, contrary to the clear intent of Congress.

    In 2000 and 2001, Ivax and Ranbaxy filed ANDA’s for generic versions of Zocor, a blockbuster statin drug, certifying under paragraph iv that two of Merck’s Orange Book listed patents were invalid, unenforceable, or not infringed.  However, Merck chose not to sue the generic drug companies for patent infringement.  In 2003, Merck sent a letter to the FDA requesting that the two patents be removed from the Orange Book.  The next year, the FDA delisted the two patents.

    In 2005, Ivax and Ranbaxy submitted citizen petitions asking the FDA to relist the patents, and for confirmation that, as the first ANDA filers, they were still entitled to 180 days of marketing exclusivity for generic Zocor.  In October, 2005, the FDA denied the petitions, stating that it would not relist the patents and that no generic applicant would be entitled to a 180-day exclusivity period.  In denying the citizen petitions, the FDA asserted that the statute was ambiguous, and therefore it was free to choose how to handle delisting requests.

    On summary judgment, the U.S. District Court for the District of Columbia, Judge Richard W. Roberts, held that the FDA was wrong to deny the citizen petitions.  According to the court, the issue in the case was "whether the FDA can effectively restrict the reward [of a 180-day exclusivity period] to only a sued ANDA holder by delisting a patent after the ANDA holder successfully avoided suit."  The court observed that if the FDA had not delisted the patents, Ivax and Ranbaxy would have been entitled to the exclusivity period, triggered by their commercial marketing of generic Zocor.  Additionally, the court noted that pursuant to FDA regulations the FDA will not delist a patent once litigation has ensued.  The court concluded as follows:

    If Merck had sued plaintiffs because of their paragraph IV certifications, plaintiffs would have been in danger of losing their right to a 180-day exclusivity period upon final FDA approval only if the patents were found to be enforceable or infringed.  In this case, however, the FDA delisted the patents from the Orange Book, disregarding the plaintiffs’ success in avoiding suit.  That disparate treatment here contravened the plain and undisputed intent of Congress.  The delisting practice as applied here effectively eliminated Congress’s "first commercial marketing" trigger, in violation of the clear command of Congress.

    The FDA has not yet indicated whether it will appeal the decision to the D.C. Circuit.

    RELATED READING:

  • Supreme Court Asks Solicitor General for Views on Whether Orange Book Listing Creates Justiciable Controversy

    Generic drug companies may finally hear from the Supreme Court on whether merely listing a patent in the Orange Book creates a sufficient basis for a declaratory judgment action.  Last October, the Supreme Court denied cert in Teva v. Pfizer, in which the Federal Circuit held that listing a patent in the Orange Book does not create a justiciable controversy.  On Monday, in a move that may foreshawdow a grant of certiorari, the Supreme Court asked the Solicitor General for his views on a similar case, Apotex v. Pfizer.  Both cases concern generic challenges to Pfizer’s patent on Zoloft.

    In its cert petition, Apotex framed the question for review as follows:  whether, in cases where a generic drug maker seeks a declaratory judgment of noninfringement, a justiciable controversy is presented when "the failure to secure a court judgment prohibits the federal government from approving the generic equivalent and the prospect of massive patent liability deters the generic manufacturer from entering the marketplace."  Apotex argued in its petition that Teva v. Pfizer was wrongly decided because the Federal Circuit improperly elevated its "reasonable apprehension" test for declaratory judgment jurisdiction to a "constitutional requirement"–in direct conflict with Supreme Court precedents.  Apotex further argued that cert should be granted because the Federal Circuit’s decision to deny declaratory judgment jursidiction "effectively nullifies an entire statutory scheme," the Hatch-Waxman Amendments.

    In its opposition brief, Pfizer argued that the petition should be denied because:  (a) the case is so fact-intensive that it doesn’t raise a recurring issue; (b) the reasonable apprehension test is consistent with Supreme Court precedents and creates no split among the circuits; and (c) the lower court decision is correct on the merits.  Apotex answered each of these arguments in its reply brief.

    The Generic Pharmaceutical Association filed an amicus brief in support of Apotex.

    Related postings:

  • 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.

    RELATED READING:

  • 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.