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July 8 — Boehringer Ingelheim isn't entitled to a longer patent term extension for time it lost during the FDA's review and approval of its blood thinner Pradaxa, a federal court ruled July 6 ( Boehringer Ingelheim Pharma GmbH & CO. KG v. FDA, 2016 BL 216244, D.D.C., No. 15-656 (CKK), 7/6/16 ).
The FDA's calculation of the length of the patent term extension for Pradaxa was reasonable and owed deference, said Judge Colleen Kollar-Kotelly of the U.S. District Court for the District of Columbia.
Under the Hatch-Waxman Act, patent owners may apply for a patent extension on products to restore the time lost while awaiting FDA approval. Patent terms may be extended for up to five years, with the length determined in part by the length of the regulatory review period for that product.
The judge dismissed the entire case.
Boehringer Ingelheim told Bloomberg BNA July 8 that the company didn't have any comment on the ruling “at this time.”
In its suit against the FDA, Boehringer argued that the FDA's incorrectly determined the length of the patent term extension by slicing off about four months from the regulatory review period for Pradaxa (dabigatran etexilate mesylate capsules).
Boehringer argued that the approval phase for Pradaxa began on Dec. 15, 2009, not April 19, 2010, as the agency determined, and that the agency's contrary conclusion is legally flawed.
Specifically, Boehringer argued that the FDA's determination of the time the agency spent reviewing Pradaxa contradicted the terms of the Hatch-Waxman statute, violated the agency's own regulations and was inconsistent with the agency's past treatment of similarly situated applicants.
The judge disagreed with all of Boehringer's claims.
“[T]his is the type of case for which deference to the expert agency is particularly appropriate,” Kollar-Kotelly wrote. “The Court concludes that the relevant statutory provisions are ambiguous, that the agency's interpretation warrants deference and is reasonable, and that the agency's application of that interpretation in this case is reasonable.”
Among other things, the judge rejected Boehringer's argument that “no reasonable applicant would submit a purposefully deficient application in order to obtain a longer patent term extension.”
Contrary to Boehringer's claims, the court said, “it is reasonable for the agency, in light of its long experience in administering this complex statute, to arrive at a contrary assessment and to conclude that there is a risk of parties filing applications prematurely for strategic reasons.”
Moreover, the court said, “even if Plaintiffs were correct that strategic filing behavior is unlikely or infrequent, it is reasonable for the agency to interpret the statutory framework to encourage applicants to carefully ensure that their applications are complete and ready for substantive review prior to submitting them.”
“Any application that would not allow the FDA to begin a substantive review would not fulfill the purpose of the substantive review process. Therefore, it is proper not to consider any such deficient application to have been ‘initially submitted' ,” the opinion said.
On the issue of whether the agency had treated other similarly situated applicants differently, Kollar-Kotelly said “the agency has shown—and Plaintiffs have not rebutted—that the agency's determination in this case is consistent with numerous similar determinations made in other cases.”
“Accordingly,” she said, “the agency's determination of the patent term extension for Pradaxa survives this Court's deferential review under the Administrative Procedure Act.”
Boehringer Ingelheim, based in Germany, was represented by Hogan Lovells US LLP in Washington.
The government was represented by the Office of Consumer Litigation at the Justice Department in Washington.
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The opinion is at http://src.bna.com/gAX.
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