Legal Blog

District of New Jersey Follows Federal Circuit Law on Subject Matter Jurisdiction

Celgene Corporation v. Sun Pharma Global FZE et al.,

Civil Action No. 19-10099 (D. N.J. Apr. 6, 2020) (SDW) (LDW) Unpublished

Generic manufacturer Sun raised a subject matter jurisdiction challenge when non-Orange Book listed patents were asserted against it as a result of it filing an Abbreviated New Drug Application for Celgene’s blockbuster Revlimid®.

Sun filed its ANDA including Paragraph IV certifications to three Orange Book listed patents. Celgene timely sued Sun for patent infringement under 271(e)(2) asserting those three patents. Then not quite a year later, Celgene again sued Sun asserting infringement of three additional patents claiming crystalline forms lenalidomide, the active ingredient in Revlimid®, that were not listed in the Orange Book. Sun moved to dismiss the complaint for lack of subject matter jurisdiction over the three new patents citing their absence from the Orange Book and from Paragraph IV certifications.

The Court seemed to wave-away the jurisdictional challenge, citing ample authority. A prior District of New Jersey ruling seemed particularly apt. Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 12-3289, 2013 WL 591976, at *3–4 (D.N.J. Feb. 14, 2013) (“Defendants’ arguments that paragraph IV certifications are needed with respect to the [asserted] patent are belied by the plain language of 35 U.S.C. § 271” and that “[n]othing in the plain language [of § 271] suggests that infringement actions against ANDA filers must be based only on Orange Book listed patents….”). The Court also cited prior Federal Circuit cases denying similar defenses. Id. at 4 (“[S]ubsequent decisions from the Federal Circuit have explicitly held that a Paragraph IV certification is not necessary to confer subject matter jurisdiction under § 271(e)(2).”) citing Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) and AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1377 (Fed. Cir. 2012).

The question of whether a patent need be in the Orange Book or subject to a Paragraph IV certification for subject matter jurisdiction to lie in a Hatch Waxman case appears a settled issue. Barring a truly unusual fact pattern, when a case is brought relying on 35 U.S.C. subject matter jurisdiction will likely be found. Generic drug manufacturers would do well to choose their issues carefully and conserve resources for issues with a better likelihood of success. And so subject matter jurisdiction challenges must wait for another fact pattern.


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