First Dust Up Over Generic PROVIGIL 180-Day Exclusivity Quickly Put on Hold With TRO/PI Motion Withdrawal, But is Followed Up With a Second Lawsuit

April 5, 2012

By Kurt R. Karst –      

It was yet another exciting day in the Hatch-Waxman world when news broke Wednesday morning that Teva Pharmaceuticals USA, Inc. (“Teva”) and Cephalon, Inc. (“Cephalon”) filed a Complaint and Motions for a Temporary Restraining Order and Preliminary Injunction against FDA in the U.S. District Court for the District of Columbia “to vindicate their statutory rights” under the FDC Act with respect to Teva’s claim to 180-day marketing exclusivity for a generic version of Cephalon’s PROVIGIL (modafinil) Tablets, 100 mg and 200 mg, which is approved under NDA No. No. 020717 to improve wakefulness due to narcolepsy, obstructive sleep apnea, and shift work disorder.  The companies filed the lawsuit after FDA “signaled that it may seek to approve competing applicants for generic modafinil products as early as April 6 and notwithstanding Teva USA’s right to sole marketing exclusivity.”  Among other things, Teva and Cephalon requested in their lawsuit that the court enter a TRO “preventing FDA from approving any ANDA referencing PROVIGIL® other than Teva USA’s ANDA [No. 076596] until the Court resolves Plaintiffs’ motion for preliminary injunctive relief” and “order FDA to produce its decision regarding Teva USA’s exclusivity.”

180-day exclusivity for generic PROVIGIL is governed by the pre-Medicare Modernization Act (“MMA”) version of the FDC Act, under which exclusivity is patent-by-patent, thereby giving rise to the possibility of shared 180-day exclusivity.   That is, where there are, for example, two Orange Book-listed patents for a drug and different ANDA sponsors are first-to-file a Paragraph IV certification as to each patent, FDA has said that there is an “exclusivity standoff” (i.e., “whereby each ANDA applicant’s approval is delayed indefinitely” – see, e.g., here and here).  To resolve this “exclusivity standoff,”  FDA has determined that “when approval of an ANDA eligible for exclusivity is blocked by another applicant’s eligibility for exclusivity, the applicants that are eligible for the 180-day period of generic drug exclusivity may share the same exclusivity period.”  More recently (see here), FDA has clarified that pre-MMA, shared exclusivity is appropriate only where “two applicants have submitted paragraph IV certifications to two different patents, and one applicant was first to file a paragraph IV certification on one patent and the other was first to file on a different patent.”

PROVIGIL is listed in the Orange Book with information on two patents: (1) U.S. Patent No. RE37516 (“the ‘516 patent”), which expires on April 6, 2015; and (2) U.S. Patent No. 7,297,346 (“the ‘346 patent”), which which expires on May 29, 2024.  The ‘346 patent is a later-listed patent that did not appear in the Orange Book until December 2007.  On December 24, 2002, Teva and several other generic drug manufacturers submitted the first ANDAs to FDA containing Paragraph IV certifications to the ‘516 patent.  With respect to the ‘346 patent, Teva says that it alone was first-to-file a Paragraph IV certification on December 14, 2007, and that because shared 180-day exclusivity applies only in the circumstances discussed above, Teva alone has 180-day exclusivity. 

When Teva went to FDA to seek clarification as to 180-day exclusivity for generic PROVIGIL, however, Teva says that the Agency “signaled its belief that Teva USA may not be entitled to such exclusivity.”  That prompted the lawsuit.  But later in the day on Wednesday, Teva and Cephalon filed a notice with the D.C. District Court withdrawing their Motions for a Temporary Restraining Order and Preliminary Injunction, but reserving the right to renew them “as circumstances dictate.”

On Thurday morning, the circumstances that prompted the withdrawal notice became clear.  According to a Teva press release: “FDA has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil® (modafinil) and therefore Teva’s ANDA alone is entitled to 180-day exclusivity.  Cephalon launched generic Provigil® on March 29, 2012 and the FDA has also decided that such launch triggered the exclusivity.”  That last sentence caught our attention, as it raises the possibility of a future fight over the circumstances under which the marketing of an authorized generic might trigger 180-day exclusivity. 


    “The Complaint alleges that Teva did not maintain valid paragraph IV (PIV) certifications as a result of its acquisition of Cephalon. The Complaint states that, once Teva became the owner of Cephalon, Teva could no longer infringe its own patents through a PIV certification and that Teva therefore is not entitled to exclusivity based on patent certifications. Mylan also alleges that FDA should have found that Mylan is the sole first filer on one of the Orange Book Patents for Provigil, that Teva abandoned its abbreviated new drug application (ANDA), and that FDA should have approved Mylan's ANDA for this product. Mylan is seeking an immediate order from the Court entitling it to exclusivity and immediate approval for its ANDA.

The Complaint also alleges that FDA's decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful. Mylan believes the Federal Trade Commission did not contemplate the current outcome when it imposed its conditions on the Teva/Cephalon merger. As a result of FDA's decision, only one party—Teva/Cephalon—is controlling 100% of the supply of product in the marketplace. This is despite the fact that Cephalon previously agreed to a Mylan launch of its generic product no later than April 6, 2012.”