July 24, 1998

180-Day Exclusivity Decision

Arnold & Porter Article

A Federal District Court has now upheld FDA’s implementation of the Hatch-Waxman Act’s 180-day exclusivity provision (21 U.S.C. 355(j)(5)(B)(iv)). As you know, that provision provides a 180-day headstart to the first ANDA applicant to challenge a patent, with the 180 days beginning on the earlier of the date of first marketing under the first ANDA or the date of the first decision holding the patent invalid or not infringed. We have previously distributed copies of the FDA’s guidance in which it announced that, in response to the Mova and Granutec decisions, it would no longer condition the grant of exclusivity on the first ANDA applicant having successfully defended a patent suit. That guidance also said, in effect, that FDA would not require that the first ANDA applicant even be sued for patent infringement in order to qualify for exclusivity.
This past Tuesday, July 21, Judge Royce Lamberth of the D.C. District Court denied a TRO and preliminary injunction sought by an ANDA applicant that is being kept off the market because of 180-day exclusivity granted to an earlier ANDA applicant that had not been sued for patent infringement. Purepac Pharmaceutical Co. v. Friedman, Civ. No. 98-1780 (D.D.C. July 21, 1998). No written opinion was issued, and the oral explanation of the decision simply explained that the court accepted FDA’s view that FDA’s current regulation did not have a "must be sued" requirement independent of the "successful defense" requirement struck down in Mova. The court did not rule out the possibility that FDA might later adopt a "must be sued" requirement through rulemaking, though it noted that there was a fair question about whether such a position could be adopted.
The drug involved was ticlopidine, a Roche product. We represented Roche, which intervened and opposed the TRO and preliminary injunction. Appeals have been noticed and the appellants have asked for expedited briefing. An appellate decision is not, however, expected until sometime this fall at the earliest.

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