Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity

In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..

The Fourth Circuit has recently reversed the district court’s decision, holding that each patent listed in the Orange Book—whether an original or a reissue patent—should be treated by the FDA as distinct when it comes to awarding 180-day exclusivity under the pre-MMA statute.

In the Fourth Circuit’s reversal, the Court found that (pre-MMA) 21 U.S.C. § 355(j)(5)(B)(iv)’s reference to “the patent” which is “the subject of the [Paragraph IV] certification” unambiguously allowed for separate 180-day exclusivity periods for each patent regardless of whether the patent was an original or reissue and therefore, the FDA was wrong not to consider a reissue patent to be “a new and distinct patent” for purposes of determining eligibility for 180-day exclusivity. The Fourth Circuit remanded to the district court to adjudicate the rights of ANDA applicants affected by the decision.

Gibbons will continue to monitor FDA decisions of interest to those in the Hatch-Waxman community.

Wendy R. Stein and George W. Johnston are Counsel to the Gibbons Intellectual Property Department.
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