Sanofi v. Lupin Atlantis Holdings SA

A generic manufacturer’s conversion from a PIV certification to a PIII, by itself, does not deprive the court of jurisdiction.

April 26, 2017

GENERICally Speaking

Case Name: Sanofi v. Lupin Atlantis Holdings SA, Civ. No. 15-415-RGA, 2017 U.S. Dist. LEXIS 10653 (D. Del. Jan. 26, 2017) (Andrews, J.) 

Drug Product and U.S. Patent: Multaq® (dronedarone tablets); U.S. Patent No. 9,107,900 (“the 900 patent”)

Nature of the Case and Issue(s) Presented: Sanofi asserted against Sandoz various Orange Book-listed patents covering Multaq. At trial, the court found in favor of Sanofi, and against Sandoz, and enjoined Sandoz from commercializing its ANDA product before Apr. 16, 2029. That decision was on appeal. On Aug. 18, 2015, Sanofi was issued another patent, the ’900 patent, which Sanofi also listed in the Orange Book as covering Multaq. Again, Sanofi filed suit against Sandoz, asserting the ’900 patent, which also expired on Apr. 16, 2029.

At first, Sandoz had submitted a Paragraph IV certification against the ’900 patent. Sandoz had then requested a stay—which the court had denied—of this case pending resolution of the multiple appeals from the earlier trial. On Oct. 28, 2016, Sandoz changed its Paragraph IV certification to a Paragraph III certification, and filed the instant motion to dismiss. Sandoz argued that a Paragraph IV certification created subject-matter jurisdiction, while a Paragraph III certification did not. Thus, the issue presented was whether a generic that has filed a Paragraph IV certification divests the district court of jurisdiction by converting to a Paragraph III certification. The court denied Sandoz’s motion.

Why Sanofi Prevailed: The court addressed two arguments: (i) what exactly is the basis for subject matter jurisdiction in the first place; and (ii) in what circumstances can the unilateral actions of one party divest a court of jurisdiction?

In response to the first, statutory interpretation, argument, the court found that it was not deprived of jurisdiction under 35 U.S.C. § 271(e)(2) and 28 U.S.C. § 1338(a) because it was sufficient that the case was initially certified under Paragraph IV. Moreover, 28 U.S.C. § 2201 may confer jurisdiction so long as there is sufficient allegation of immediacy and reality such that the exercise of jurisdiction over such an action was within the discretion of the district court.

In response to Sandoz’s mootness argument, the court found that Sandoz’s Paragraph III certification was a matter of convenience and expedience, and wholly revocable. The court found this to be “a concession that the case is not moot.” The statutory structure shows that there is no jurisdiction over an initial Paragraph III certifier, whereas there is jurisdiction over an initial Paragraph IV certifier. Moreover, Sandoz cited to only one case where a court had decided the instant issue in favor of the generic. But because mootness was a fact-bound issue, the court noted that the decision relied on by Sandoz was not inconsistent with the case at bar. Finally, the case law relied on by Sanofi was more binding on the court given that it was also a D. Del. Case. 

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