Judge Stark Explains Remedies for an Infringing ANDA

In the ongoing litigation between Mylan Pharmaceuticals and Galderma Laboratories over the branded product Oracea, Judge Stark has issued an opinion on remedies for Mylan’s infringement of one patent covering that drug.  Judge Stark had previously found after a bench trial that Mylan infringed a patent—the Chang Patent—that was added to the Orange Book after Mylan’s generic product had received FDA approval.  Consequently, Mylan’s ANDA did not include a Paragraph IV certification for the Chang Patent.  In the recent remedies opinion, Judge Stark ordered a permanent injunction against any drug described in Mylan’s ANDA until the expiration of the Chang Patent.  He also ordered the FDA to withdraw approval of Mylan’s ANDA and delay the effective date of approval to no earlier than December 19, 2027, the expiration date of the Chang Patent.  The Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc., C.A. No. 09-184-LPS, at 3 (D. Del. May 18, 2012).

After considering remedies briefing from the parties, Judge Stark rejected Mylan’s argument that 35 U.S.C. § 271(e)(4)(A) did not entitle Galderma to a change in the effective date of Mylan’s ANDA because Mylan had not filed a Paragraph IV certification for the patent which Mylan was found to infringe.  The Court found that “a Paragraph IV certification against the Chang Patent was not required for Galderma to bring suit under Section 271(e)(2).”  Id. at 9.  Judge Stark cited the Federal Circuit’s recent decision in AstraZeneca Pharmaceuticals LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir. 2012) that a Paragraph IV certification was not required for subject matter jurisdiction over a patentee’s Section 271(e)(2) claims.  Because Galderma had alleged that Mylan’s ANDA filing infringed the Chang Patent, the Court had subject matter jurisdiction over the infringement claim despite the lack of a Paragraph IV certification for that patent.  As Judge Stark stated, a Paragraph IV certification is not a “necessary predicate” to an infringement claim under §271(e)(2)(A).  Id. at 7-10.

In AstraZeneca, however, the plaintiffs failed to state a viable Section 271(e)(2) claim because the defendant generic manufacturer had carved out patented methods of treatment from their ANDA.  By contrast, Mylan’s ANDA product was directly covered by the Chang patent and therefore infringed the Chang Patent under Section 271(e)(2).  Accordingly, “because Galderma properly invoked the Court’s subject matter jurisdiction, stated a claim pursuant to Section 271(e)(2), and ultimately prevailed on the merits at trial, the Court . . . grant[ed] Galderma’s request for [an order that the FDA delay approval of the ANDA] under Section 271(e)(4)(A).”  Id. at 9-10.

The Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc., C.A. No. 09-184-LPS,…

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