Mylan Pharms., Inc. v. FDA (N.D.W.V.)

FDA’s decision to treat an original and its reissued patent as having a single bundle of rights for purposes of generic exclusivity was reasonable, therefore Mylan’s motion for preliminary injunction was denied.

Summer 2014

GENERICally Speaking

Case Name: Mylan Pharms., Inc. v. FDA, Case No. 14-cv-75, 2014 U.S. Dist. LEXIS 73448 (N.D.W.V. May 29, 2014) (Keeley, J.)

Drug Product and Patent(s)-in-Suit: Celebrex® (celecoxib); U.S. Patent No. RE44,048 (“the ’048 patent”)

Nature of the Case and Issue(s) Presented: Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for preliminary injunction on April 28, 2014, seeking an injunction to enjoin the FDA from withholding final approval on May, 30, 2014 to any first-to-file celecoxib ANDA applicant, pending either the Court’s decision on the merits of this case or expiration of the 180-day celecoxib marketing exclusivity period. In its motion, Mylan argued that FDA’s decision erroneously concluded a reissued patent does not give rise to eligibility for a period of marketing exclusivity that is separate and distinct from the period of exclusivity arising from the original patent. According to Mylan, original and reissued patents should be treated as two distinct patents, thereby triggering separate periods of exclusivity. The district court disagreed, and denied Mylan’s motion. 

Why FDA Prevailed: After determining that the issue presented was ripe for decision and that jurisdiction was proper, the court first addressed Mylan’s likelihood of success on the merits. Mylan argued that the plain language of the Hatch-Waxman Act’s court decision trigger clause, 21 U.S.C. § 355(j)(5)(B)(iv), governs the instant action. The FDA, however, argues that neither the court decision trigger clause nor the remainder of the Hatch-Waxman Act addresses exclusivity periods for reissued patents, and consequently, it has the authority to provide its own interpretation of the matter. The court agreed with FDA. It found that ambiguity existed with respect to the court decision trigger clause’s treatment of exclusivity periods for reissued patents. The language of the clause does not necessarily define what causes the exclusivity entitlement to arise, nor does anything in the court decision trigger clause of the statute foreclose the FDA’s single bundle of patent rights interpretation that, in the case of reissued patents, periods of exclusivity do not arise until after a court decision issues on the reissued patent. While acknowledging that there is also little to suggest that Mylan’s interpretation of the matter—that the exclusivity period is triggered at the time a court decision issues on the original patent—is inaccurate, the court held that the court decision trigger clause is subject to more than one interpretation as to the exclusivity rights of reissued patents and it is therefore ambiguous. After analyzing the “broader context of the relevant statutory scheme,” the court held that Congress left it for the FDA to decide how reissued patents affect generic exclusivity rights. Next, the court found that FDA’s decision to treat an original and its reissued patent as having a single bundle of rights is reasonable and allows the agency to administer the Hatch-Waxman Act in a predictable manner. This interpretation satisfied the APA’s arbitrary and capricious standard of review, and was therefore permissible under Chevron Step Two. Thus, the court found that Mylan was unlikely to succeed on the merits of this case.

Mylan next argued that it would lose “millions of dollars in lost profits” if it is not one of the first generic celecoxib manufacturers to go to the market. But purely economic injury and economic loss alone, however substantial, does not constitute irreparable harm. The court, citing to several other decisions, held that the financial harm to one generic manufacturer resulting from the FDA’s award of exclusivity to another manufacturer is not irreparable. Accordingly, the court found that Mylan failed to satisfy its burden of establishing that it would suffer irreparable harm by not receiving preliminary injunctive relief.

The remaining factors of balance of equities and public interest either weighed against Mylan or were neutral. Thus, the court denied Mylan’s request.

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