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Judge Andrews denies motion to dismiss for lack of subject matter jurisdiction in ANDA litigation

In a recent Memorandum Order, Judge Richard G. Andrews denied defendant’s (“Sandoz”) motion to dismiss the case for lack of subject matter jurisdiction. Sanofi v. Lupin Atlantis Holdings, SA, C.A. No. 14-415-RGA (D. Del. Jan. 26, 2017). As Judge Andrews explained, Sandoz made a “Paragraph IV” certification in relation to plaintiff Sanofi’s ’900 patent on February 17, 2016. On October 28, 2016, Sandoz changed the Paragraph IV certification to a “Paragraph III” certification. As Judge Andrews explained, a “Paragraph IV certification creates subject matter jurisdiction,” but a Paragraph III certification does not create subject matter jurisdiction “because it represents that the generic will not market its product before the relevant patents expire.” Id. at 2. According to Judge Andrews, the “precise issue raised here is whether a generic who has filed a Paragraph IV certification divests the district court of jurisdiction by the mere act of converting the Paragraph IV certification to a Paragraph III certification.” Id.

In this instance, Judge Andrews found that such conversion did not divest the court of subject matter jurisdiction. First, Judge Andrews found that “I am not deprived of jurisdiction under 35 U.S.C. § 271(e)(2) and 35 U.S.C. § 1338(a) because it is sufficient that the case was initially certified under Paragraph IV.” Id. at 2-3. Judge Andrews also noted that “[i]t . . . appears that 28 U.S.C. § 2201 may confer jurisdiction.” Id. at 3. Second, Judge Andrews concluded that Sandoz’s mootness argument did not have any merit, finding that in this case there was a “reasonable expectation that the wrong will be repeated.” Id. at 3-5. Indeed, Sandoz conceded that it could “convert its Paragraph III certification back to a Paragraph IV at some future date under certain circumstances.” Id. at 3. Further, Judge Andrews noted that “Sanofi makes an adequately supported argument that Sandoz would reconvert back to Paragraph IV.”  Id. at 4. In reaching this conclusion, Judge Andrews distinguished Ferring B.V. Watson Labs, Inc.-Fla., 764 F.3d 1382 (Fed. Cir. 2014) and AstraZeneca AB v. Anchen Pharms Inc., 2014 WL 2611488 (D.N.J. June 11, 2014). Id. at 3-5.

Sanofi v. Lupin Atlantis Holdings, SA, C.A. No. 14-415-RGA (D. Del. Jan. 26, 2017).

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