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May 29, 2015
WASHINGTON, DC, May 29, 2015 — Covington scored a victory for Amarin Pharmaceuticals Ireland Limited this week when a federal judge vacated the U.S. Food and Drug Administration’s earlier decision that Amarin’s new drug Vascepa was not entitled to a five-year period of market exclusivity. It is the first known successful challenge to FDA’s denial of five-year-exclusivity to a drug maker since the Hatch-Waxman Act was passed in 1984.
“The [c]court concludes that the FDA’s decision must be set aside,” U.S. District Judge Randolph D. Moss of the District of Columbia wrote in a 40-page opinion.
On July 26, 2012, FDA approved Amarin’s new drug application for Vascepa, a prescription medicine used along with a low-fat and low-cholesterol diet to lower high levels of triglycerides in adults. On Feb. 21, 2014, however, the agency concluded that the drug is not entitled to five-year exclusivity because Vascepa’s active ingredient—a single molecule—is one component of a mixture that makes up the “active ingredient” of another FDA-approved drug. Under the Hatch-Waxman Act, a drug manufacturer is entitled to five-year exclusivity if its newly-approved drug does not contain an “active ingredient” that was previously approved in another drug application.
Judge Moss ruled that “FDA’s ‘active moiety’ approach cannot be reconciled with the statutory text.” Granting Amarin’s motion for summary judgment, Judge Moss ruled that FDA’s administrative decision denying Amarin’s request for exclusivity failed under Chevron U.S.A. v. Natural Resources Defense Council. That case, decided by the U.S. Supreme Court in 1984, set forth the legal test for determining whether to grant deference to a government agency's interpretation of a statute which it administers.
Judge Moss remanded the case to the FDA for proceedings consistent with the opinion.
The Covington team included Christopher Sipes, Benjamin Block and Bradley Ervin.