Orange Book Blog

At the intersection of Patent and FDA Law

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  • District Court Dismisses Merck’s Fosamax Suit Against Apotex, Despite Apotex’s Opposition

    Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007)

    A year ago, Merck sued Apotex alleging that Apotex’s ANDA for generic Fosamax infringed nine patents on pharmaceutical formulations of alendronate, the active ingredient in Fosamax.  Apotex answered with counterclaims of patent invalidity and noninfringement.  Then, after Merck reviewed portions of Apotex’s ANDA, Merck granted Apotex a covenant not to sue on the patents and filed a motion to dismiss for lack of subject matter jurisdiction.  Last week, the U.S. District court for the District of Delaware granted the motion.

    Apotex had opposed Merck’s motion to dismiss because it sought a ruling that Merck’s patents were invalid and not infringed.  In its opposition brief, Apotex argued that dismissing its counterclaims would have "the collateral consequence of denying Apotex a court finding on invalidity or noninfringement that would trigger the first generic applicant’s 180-day period of exclusivity."  Merck replied that the collateral consequences doctrine does not apply and "[t]he fact that Apotex would be prevented from going to market by the 180-day exclusivity period that Barr and Teva have as first ANDA filers does not create a case or controversy between Merck and Apotex."

    After the Federal Circuit decided Teva v. Novartis last month, Apotex submitted a letter to the court arguing that the decision supported its position that Merck’s motion to dismiss should be denied.  Apotex argued that Merck’s actions, like Novartis’s, were meant to "frustrate the central purpose behind Hatch-Waxman, which was to enable competitors to bring cheaper, generic drugs to market as quickly as possible."  Merck replied with its own letter, arguing that Teva v. Novartis actually supported its motion to dismiss because "the Teva court specifically noted that Novartis declined to give Teva a covenant not to sue."

    Within days of receiving those letters, the district court granted Merck’s motion in a single-page order, stating that "it will grant Merck’s motion to dismiss for lack of subject matter jurisdiction in light of Merck’s covenant not to sue Apotex."  The court further indicated that an opinion "will follow at the court’s earliest convenience."

  • OBB News Briefs

  • Reminder: ACI’s Paragraph IV Litigation and Pharmaceutical Antitrust Conferences Are Approaching

    This is just a quick reminder of two upcoming conferences from ACI that should be of interest to Orange Book Blog readers: "Paragraph IV Disputes" and the "3rd Annual In-House Counsel Forum on Pharmaceutical Antitrust."

    "Paragraph IV Disputes," to be held April 23-24 in New York, will offer "expert insights on Hatch-Waxman litigation strategies for brand names and generics."  Several of the panels will touch on the Norvasc case (FDA decision expected this Wednesday!), including its pediatric and 180-day exclusivity issues.

    The "3rd Annual In-House Counsel Forum on Pharmaceutical Antitrust," to be held May 15-16 in New York, features addresses by FTC Chairman Majoras, Assistant AG Barnett, and nine other federal and state enforcement officials.  The Tamoxifen case in the Supreme Court and the pending legislation to ban "reverse payment" settlements will be hot topics of discussion.

    For more information or to register, click the links above.  When registering, use discount code 710OBB to receive $200 off tuition.

    Orange Book Blog is a media sponsor of these conferences.

  • Pfizer and Mylan Fight to Defend Norvasc Exclusivity; Apotex, Teva and Others Battle for FDA Approval

    A dozen companies have submitted letters in response to FDA’s March 29 request for "comments from interested parties" on Norvasc (amlodipine besylate) exclusivity issues.  Last week, as we reported here, FDA promised the U.S. District Court for the District of Columbia that by Wednesday, April 11, it will decide whether to approve any ANDAs for generic Norvasc besides Mylan’s.  Meanwhile, the district court has allowed Teva, Apotex and Mutual to intervene in the case for the limited purpose of responding, if necessary, to Mylan’s motion for a temporary restraining order against FDA.

    In its March 29 request for comments, FDA presented the following questions:

    1. What date controls FDA’s giving effect to the decision in Pfizer v. Apotex holding that Pfizer’s patent on Norvasc is invalid?
    2. If FDA must await the issuance of the Federal Circuit mandate, does pediatric exclusivity bar approval of all unapproved ANDAs in the meantime?
    3. If and when the Apotex decision is implemented, what is the effect of the decision on the obligation of an ANDA applicant to change its patent certification?
    4. If and when the Apotex decision is implemented and the patent is treated as invalid, does pediatric exclusivity attach to Pfizer’s patent with respect to any unapproved ANDAs?
    5. Does 180-day exclusivity triggered before a patent expires continue to bar approvals of other ANDAs after the patent expires?

    The letters submitted in response are posted at this FDA web-page.  The positions are summarized very briefly below:

    • Pfizer was awarded pediatric exclusivity on Norvasc and argues that all unapproved amlodipine ANDAs (i.e., all ANDAs besides Mylan’s) remain subject to that exclusivity.
    • Mylan was the first to file a Norvasc ANDA with a paragraph IV certification and claims it is entitled to 180-day exclusivity.
    • Apotex argues it is the only company not subject to Pfizer’s pediatric exclusivity because it is the only company having a Federal Circuit decision in its favor.
    • Teva argues that neither Pfizer nor Mylan is entitled to exclusivity.
    • Mutual argues that no other ANDAs may be approved until Pfizer’s pediatric exclusivity or Mylan’s 180-day exclusivity expires in September.
    • Caraco argues that Mylan’s 180-day exclusivity was triggered upon launch and extends to September 23, 2007.
    • Roxane suggests that all tentatively approved ANDAs should be granted final approval when the Federal Circuit issues a mandate.
    • Watson argues that Mylan’s 180-day exclusivity ended when Pfizer’s patent expired, and that Pfizer is not entitled to pediatric exclusivity.
    • Daiichi Sankyo filed a paragraph III certification in its 505(b)(2) application and says it is subject to Pfizer’s pediatric exclusivity.
    • Aurobindo, an API supplier, argues that the Federal Circuit decision triggered Mylan’s 180-day exclusivity period.
    • Orchid filed a paragraph III certification in its ANDA and takes no position on the questions.
    • Medco, a pharmacy benefit manager, argues that FDA should grant final approval to all tentatively approved amlodipine ANDAs now.

    FDA Law Blog is expected to have more information on this interesting case.

  • Federal Circuit Allows Declaratory Judgment Jurisdiction for Generic Drug Patent Challenges

    Teva Pharms. USA v. Novartis Pharms. et al., No. 06-1181 (Fed. Cir. 2007)

    For the second time in as many days, the Federal Circuit has decided a case with broad implications for innovator and generic drug companies.  The decision today, in Teva v. Novartis, opens the door to many more lawsuits by generic drug companies seeking declarations of patent invalidity or noninfringement.

    The Federal Circuit held as follows:

    A justiciable declaratory judgment controversy arises for an ANDA filer when a patentee lists patents in the Orange Book, the ANDA applicant files its ANDA certifying the listed patents under paragraph IV, and the patentee brings an action against the submitted ANDA on one or more of the patents.  The combination of these three circumstances is dispositive in establishing an actual declaratory judgment controversy as to all the paragraph IV certified patents, whether the patentee has sued on all or only some of the paragraph IV certified patents.

    In the case, Teva filed an ANDA to market a generic version of Famvir, an antiviral medication.  Novartis then sued Teva for infringing U.S. Patent No. 5,246,937, which covers the active ingredient in Famvir, famciclovir.  Novartis chose not to sue Teva on any of its other four Orange Book-listed patents for Famvir, each of which covers methods of use.  Teva then brought a declaratory judgment action on the four remaining method patents under a provision of the 2003 Medicare Modernization Act entitled "civil action to obtain patent certainty."  The district court dismissed Teva’s complaint, and the Federal Circuit has now reversed the dismissal.

    The district court dismissed the case pursuant to the Federal Circuit’s application of its "reasonable apprehension of suit" test in Teva v. Pfizer.  The Supreme Court’s recent decision in MedImmune, however, has forced the Federal Circuit to revisit that test.  Indeed, in today’s opinion the Federal Circuit expressly acknowledged that MedImmune overruled the test.

    Today’s decision eliminates a powerful weapon innovator drug companies had in their ongoing battle against generics: the uncertainty and risk that generics face when considering whether to launch their drug products before patent expiration.  Now, generics in Teva’s position will be able to file a declaratory judgment action and obtain a court decision on the validity or infringement of Orange Book-listed patents before deciding whether to launch.

    In fact, the court’s opinion today suggests that unless an innovator grants a covenant not to sue, the mere listing of a patent in the Orange Book coupled with a paragraph IV certification may be sufficient to establish declaratory judgment jurisdiction.  In other words, generic drug companies may be able to pursue declaratory judgment actions even if the innovator declines to file suit on any of its Orange Book-listed patents.

    If that turns out to be true, it would go a long way toward solving a "bottleneck problem," where delay by a 180-day generic exclusivity holder prevents subsequent ANDA filers from launching their generic drugs.

    RELATED READING:

    UPDATES:

    • The holding of this case does not bode well for Forest Labs’ March 13 motion to dismiss Caraco’s DJ complaint in the Lexapro case.

  • Merck Prevails in Patent Term Extension Case at Federal Circuit

    Merck & Co. v. Hi-Tech Pharmacal, No. 06-1401 (Fed. Cir. 2007)

    The U.S. Court of Appeals for the Federal Circuit held today
    that a patent term extension under 35 USC 156 may be applied to a
    patent that is subject to a terminal disclaimer under 35 USC 253, handing a
    victory to Merck in its battle with Hi-Tech Pharmacal over generic
    Trusopt (dorzolamide HCl opthalmic solution).  Hi-Tech had argued that
    Merck's patent on Trusopt expired in 2004 because a patent term
    extension on the patent was invalid.

    As we reported last month,
    a loss for Merck in this case would have had drastic effects on
    pharmaceutical companies and patent owners, since the Patent Office has
    routinely granted patent term extensions on patents that are subject to
    a terminal disclaimer.  Brand-name drug companies would have lost years
    of patent protection on some of their best-selling drugs if the Federal
    Circuit had decided that a terminal disclaimer precludes a patent term
    extension.

    Section 156 was enacted as part of the Hatch-Waxman Act in 1984 to
    allow restoration of part of a pharmaceutical patent's term "lost" due
    to lengthy FDA review of a new drug application.  Section 253, on the
    other hand, applies to all kinds of patent applications–not only those
    relating to pharmaceuticals–and allows the filing of a terminal
    disclaimer to overcome "obviousness-type double patenting" rejections
    made by the Patent Office.

    In reaching its decision today, the Federal Circuit properly
    recognized that "the language of Section 156 is unambiguous and
    fulfills a purpose unrelated to and not in conflict with that of
    Section 253."  The court observed: (1) according to Section 156, a
    patent term "shall be extended" if five enumerated conditions, none of
    which concern terminal disclaimers, are met; (2) the legislative
    history is consistent with the mandatory language of the statute; and
    (3) Section 154 excludes patents in which a terminal disclaimer has
    been filed from the benefit of a term adjustment for PTO delays, but
    Section 156 contains no such exclusion for patents eligible for term
    extensions for FDA delays, which further supports the court's interpretation of Section 156.

    Additionally, the court explained why Section 156 and Section 253 are compatible:

    The purpose of the terminal disclaimer–to prevent extension of
    patent term for subject matter that would have been obvious over an
    earlier filed patent–remains fulfilled by virtue of the fact that the
    date from which any Hatch-Waxman extension is computed is the
    terminally disclaimed date.  At the same time, the purpose of the
    patent term extension–to restore some of the patent term lost due to
    regulatory review–is also satisfied.

    Hi-Tech will now have to wait until at least April 28, 2008, when
    Merck's patent expires, before it can launch its generic version of
    Trusopt.

    RELATED READING:

  • OBB News Briefs

    • Adams Respiratory and Mutual Pharma settle guaifenesin patent litigation: press release
    • FTC subpoenas Cephalon over Provigil patent litigation settlements: AP; Phil. Bus. J.
    • Glenmark first to file Zetia ANDA with paragraph IV certification: Bloomberg
    • Senate holds hearing on pediatric exclusivity: Reuters
    • Takeda awarded $16.8 million in fees in pioglitazone patent case: NY Law J.; Reuters

  • Mylan Obtains Injunction Preventing FDA from Approving Any Other Generic Norvasc Until April 13

    Mylan Laboratories announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007.  Mylan launched its generic Norvasc last week and, with the exception of Pfizer’s authorized generic, currently has the only generic on the market.

    Mylan was the first generic drug maker to file an ANDA for generic Norvasc, and is therefore entitled to a 180-day generic exclusivity period.  However, FDA’s policy for pre-Medicare Modernization Act ("MMA") ANDAs (like Mylan’s) is that the 180-day exclusivity period cannot extend beyond patent expiration.  Pfizer’s patent on Norvasc expired on Sunday, and therefore without the injunction Mylan’s 180-day exclusivity period might have been cut short.  (The MMA introduced numerous 180-day exclusivity "forfeiture provisions," one of which is that 180-day exclusivity ends upon patent expiration.  Since Mylan’s ANDA was filed before December 8, 2003, however, the MMA does not apply.)

    Mylan filed its Complaint against the FDA and Emergency Application for a Temporary Restraining Order and/or Preliminary Injunction
    yesterday, and the district court ruled on it the same day.  According to the district court’s Order, the "FDA will now solicit the views of other interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007."  The FDA is to notify the court of its decision no later than April 11 and is enjoined from taking final agency action "until April 13, 2007 at 5:00 pm to enable the court to rule formally on the plaintiff’s application for a TRO."

    Presumably, such interested parties include Apotex, Dr. Reddy’s, Gedeon Richter USA, Kali Labs, Matrix, Roxane, Teva, and Watson, each of which has been granted tentative approval to market generic Norvasc and is awaiting only resolution of the exclusivity issues.

    The other party with a huge stake in this case is Pfizer–the innovator who developed Norvasc and whose patent the Federal Circuit declared invalid last Thursday.  Pfizer has 6 months of pediatric exclusivity on Norvasc and indicated last week that it will "pursue all available legal remedies" to protect that exclusivity.

    This case is far from over.  We’ll post additional briefs and submissions as they become available.

    RELATED READING:

    UPDATES:

    • FDA Law Blog reports that Mylan filed a citizen petition with the FDA on Monday to enforce its 180-day exclusivity period.

  • ACI “Paragraph IV Disputes” Conference, April 23-24, New York City

    American Conference Institute has announced that its first ever conference devoted entirely to Hatch-Waxman litigation will take place April 23-24, 2007, at the Sheraton New York Hotel and Towers in New York City.

    The conference promises “expert insights on Hatch-Waxman litigation strategies for brand names and generics.”  Speakers will include leading patent litigators who specialize in Paragraph IV litigation.  Additionally, an optional half-day Master Class, “Settling Paragraph IV Disputes: Brand Name and Generic Perspectives,” is offered on April 25.

    The following presentations sound especially interesting:

    • Pre-Suit Due Diligence: Anticipating the Paragraph IV Challenge
    • Assessing the ANDA Applicant’s Pre-Litigation Strategy and Initial Obligations
    • Litigating with Multiple ANDA Filers: Brand Name and Generic Perspectives
    • Exploring 180-Day Exclusivity Dilemmas Relative to Paragraph IV Litigation
    • Injunctions and At-Risk Launches: Considerations and Options During Litigation and Appeal
    • Settling a Paragraph IV Action

    The co-chairs for the conference are Brian P. Murphy of Morgan Lewis & Bockius LLP and Barry S. White of Frommer, Lawrence & Haug LLP.  Additional details and registration information are available at the conference website.

    Orange Book Blog is a media partner of this conference.

  • House Oversight Committee to Hold Hearing on Follow-on Biologics

    On March 8, the Senate held a hearing on follow-on biologics.  Now it’s the House’s turn.  Tomorrow morning, the House Oversight Committee, chaired by Rep. Henry A. Waxman (D-CA), will hold a hearing entitled “Safe and Affordable Biotech Drugs–The Need for a Generic Pathway.”

    Rep. Waxman is the sponsor of the “Access to Life-Saving Medicine Act” (H.R. 1038) in the House.  A nearly identical bill (S. 623) has been introduced in the Senate.  If passed, the bill would establish an abbreviated pathway for FDA approval of follow-on biologics.  Democrats in both chambers have indicated that passage of the bill is a top priority for the new Congress.

    Witnesses called to testify tomorrow include Dr. Janet Woodcock, Deputy FDA Commissioner, representatives from the pharmaceutical industry and third-party payors, and consumer advocates.

    UPDATES: