FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOS

August 15, 2012

By Kurt R. Karst –      

It’s been nearly nine years since the enactment of the Medicare Modernization Act (“MMA”), which, among other things, changed the regime for 180-day generic drug marketing exclusivity from a “patent-by-patent” approach (under which shared exclusivity can exist for cross-Paragraph IV filers to different patents) to a “first applicant to any patent” approach.  Yet, the lawsuits against FDA involving pre-MMA 180-day exclusivity keep popping up.  Last year, there was the controversy over generic LIPITOR (atorvastatin calcium) Tablets.  Earlier this year there was the case involving generic PROVIGIL (modafinil) Tablets (see here).  The latest case, filed on August 15th in the U.S. District Court for the District of Columbia by Watson Laboratories, Inc. (“Watson”), involves generic versions of Takeda Global Research & Development Center, Inc.’s (“Takeda’s”) diabetes drug ACTOS (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg.  Watson, through its Complaint and Motion for a Temporary Restraining Order and a Preliminary Injunction, seeks to enjoin FDA from granting final approval (or causing or allowing final approval to be granted) to any ANDA for generic ACTOS prior to granting final approval to Watson’s ANDA No. 076798, or, alternatively, to require FDA to approve ANDA No. 076798 if FDA grants final approval to any other ANDA for generic ACTOS.

Like almost all pre-MMA 180-day exclusivity cases, this case is complicated; but we’ll try to be brief.  FDA approved ACTOS on July 15, 1999 under NDA No. 021073 and granted a period of 5-year new chemical entity exclusivity.  At the time the first ANDA containing a Paragraph IV certification could be submitted to FDA on July 15, 2003, the Orange Book listed several patents for ACTOS.  One of those patents expired in 2006, and the others, which are referred to by Watson in its court filings as the Composition Patents and the Combination Therapy Patents, expire in 2016. 

Watson, and apparently Mylan (ANDA No. 076801) and Ranbaxy (ANDA No. 076800), all submitted ANDAs to FDA on July 15, 2003 containing Paragraph IV certifications to the Composition Patents and to the Combination Therapy Patents.  Prior to “receiving” (i.e., filing) the Watson ANDA on September 9, 2003, FDA instructed Watson (and presumably the others ANDA sponsors as well) to amend its proposed labeling and to change its Paragraph IV certifications to the Combination Therapy Patents to section viii statements (i.e., for labeling carve-out purposes).  Watson disagreed with FDA’s position, but made the certification change. 

After FDA received ANDA No. 076798, Watson provided notice of the Paragraph IV certifications as to the Composition Patents to Takeda and was sued for patent infringement, as were other ANDA sponsors.  Ultimately, the patent infringement litigation was settled and Takeda granted Watson, Mylan, and Ranbaxy a non-exclusive license to the Composition Patents and to the Combination Therapy Patents as of August 17, 2012.  Under FDA’s regulation at 21 C.F.R. § 314.94(a)(12)(v), “if the [ANDA] is for a drug or method of using a drug claimed by a patent and the applicant has a licensing agreement with the patent owner,” the application must contain a Paragraph IV certification as to that patent “and a statement that it has been granted a patent license.”  All three ANDA sponsors apparently amended their respective ANDAs to include Paragraph IV certifications Combination Therapy Patents.  But it is unclear when this happened exactly.  Timing is, of course, critical for 180-day exclusivity purposes.

According to Watson, “[b]ased on the simultaneous filing of the Watson ANDA with Mylan and Ranbaxy’s ANDAs, Watson has expected to share the period of 180-day exclusivity with Mylan and Ranbaxy (as well as with a fourth generic manufacturer, Teva Pharmaceuticals (‘Teva’), that has been granted a license by Takeda).”  In August 2012, however, Watsons says that “FDA informed Watson for the first time that approval of the Watson ANDA would be delayed.  FDA informed Watson it had reached a decision to award another filer or filers a period of 180-day exclusivity, to the exclusion of Watson’s ANDA, and to delay approval of Watson’s ANDA until the expiration of that exclusivity period.”  In other words, FDA presumably determined that one (or more) ANDA sponsor was first to convert its section viii statements to the Combination Therapy Patents to Paragraph IV certifications as a result of the settlement agreement, and that Watson subsequently converted.

Watson argues in its court papers that at the very least the company is entitled to shared exclusivity.  Watson’s primary arguments, however, are that FDA’s decision in this case that Watson’s ANDA cannot be approved as a result of another sponsor’s 180-day exclusivity “(i) contravenes the plain language of the statute and regulations, which only bars approval of later filed applications; and (ii) is contrary to FDA’s regulations and past practice, which deny exclusivity to any ANDA applicant for patents that are the subject of withdrawn or amended Paragraph IV certifications” (emphasis in original).  Accordingly, Watson says that the company is “entitled to an order requiring FDA not to approve any other pioglitazone ANDAs before it approves Watson’s ANDA.”

The case number is 12-cv-01344-ABJ. A hearing has been scheduled for August 15th.  We'll update this post with additional information.


  • August 15, 2012 Minute Entry: "Motion Hearing held on 8/15/2012 re [3] MOTION for Temporary Restraining [Order]; Motion heard and denied without prejudice."
  • August 17, 2012 Minute Order: "As stated by the Court in its August 16, 2012 oral ruling, plaintiff's renewed motion for a temporary restraining order is denied. To demonstrate entitlement to a temporary restraining order or preliminary injunction, a litigant must show 1) a substantial likelihood of success on the merits; 2) that it would suffer irreparable injury if the injunction is not granted; 3) that an injunction would not substantially injure other interested parties; and 4) that the public interest would be furthered by the injunction. See Mova Pharm. Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998) (setting forth standard for a preliminary injunction); Sterling Commercial Credit–Michigan LLC v. Phoenix Indus. I, LLC, 762 F. Supp. 2d 8, 78 (D.D.C. 2011) (stating that the same standard applies to temporary restraining orders and preliminary injunctions). For the reasons explained at the August 16, 2012 hearing, the Court finds that plaintiff did not show a substantial likelihood of success on the merits in its motion for a temporary restraining order concerning its abbreviated new drug application ("ANDA") for generic pioglitazone hydrochloride 15 mg, 30 mg, and 45 mg tablets ("Generic Pioglitazone"). Specifically, plaintiff was told by the Food and Drug Administration ("FDA") on August 15, 2012 that its application was deficient and that it was required to submit additional information. The Court denied plaintiff's initial motion for a temporary restraining order without prejudice in view of the FDA's request. Plaintiff then responded to the FDA's request and renewed its motion. During the August 16 hearing on plaintiff's renewed motion, the FDA informed plaintiff that it had not submitted sufficient information in response to the August 15 request. Accordingly, at that time, plaintiff's application was still deemed deficient by the FDA and plaintiff was unable to demonstrate a likelihood of success on the merits; indeed, plaintiff's counsel conceded that the Court could not grant injunctive relief if its application was deemed deficient. Even if plaintiff had provided sufficient information to the FDA prior to the August 17, 2012 release date of Generic Pioglitazone, however, the Court finds that plaintiff did not present the Court with any case law or other legal authority that would persuade the Court that it has the authority to compel the FDA to immediately process and approve Watson's ANDA under the facts of this case. Plaintiff's alternative requests for relief also fail. Plaintiff requested, inter alia, that the Court enjoin the FDA from approving any other company's ANDA for Generic Pioglitazone if the FDA were not to approve Watson's ANDA on August 17, 2012. This request fails because such relief would plainly cause substantial injury to the other providers of Generic Pioglitazone who would have been approved on August 17, 2012. Furthermore, the public interest would not be furthered by an injunction that prevents approved companies from selling a generic drug. Accordingly, for the reasons stated by the Court on August 16, 2012 and for the reasons explained above, plaintiff's motion for a temporary restraining order is DENIED. Signed by Judge Emmet G. Sullivan on August 17, 2012."