Sanofi-Aventis, et al. v. Food and Drug Administration, et al., No. 09-1495 (D.D.C. 2010)
The question in this case is "whether a vacatur entered by an appellate court overrides the terminating effect that the entry of district court judgment has on the thirty-month stay under the FDCA." The answer is "no" -- the thirty-month stay is not reinstated. Sanofi-Aventis filed the case against the FDA last summer, amid a flurry of activity in its ANDA litigation over Eloxatin (oxaliplatin), a $1.4 billion/year cancer drug. Here is an abbreviated timeline of that activity:
- June 18, 2009: New Jersey district court files Opinion granting Hospira's and Teva's motions for summary judgment of noninfringement of U.S. Patent No. 5,338,874, claiming optically pure oxaliplatin
- June 30, 2009: New Jersey district court enters Final Judgment
- June 30, 2009: Sanofi files notice of appeal, motion for stay pending appeal, and petition for writ of mandamus to vacate the district court's judgment with the Federal Circuit
- July 10, 2009: Federal Circuit files Order granting Sanofi's motion for stay, pending appeal
- August 7, 2009: FDA grants final approval of Hospira's ANDA for oxaliplatin
- August 7, 2009: FDA grants final approval of Teva's 505(b)(2) application for oxaliplatin
- August 10, 2009: Sanofi files emergency motion in Federal Circuit to enforce the July 10 Order granting stay
- August 10, 2009: Sanofi files suit against FDA in D.C. district court, seeking declaratory and injunctive relief requiring FDA to rescind final approval of applications for generic oxaliplatin, and a motion for temporary restraining order and preliminary injunction against FDA
- August 11, 2009: Federal Circuit files Order denying Sanofi's emergency motion
- August 11, 2009: D.C. district court denies Sanofi's motion for temporary restraining order and preliminary injunction (opinion here)
- August 11, 2009: Hospira announces launch of oxaliplatin; Teva announces launch of oxaliplatin shortly thereafter
- August 13, 2009: Federal Circuit files Order denying Sanofi's motion for panel or en banc review of its August 11 Order denying Sanofi's emergency motion
- September 10, 2009: Federal Circuit files Opinion vacating district court's June 20 final judgment of noninfringement and remanding to district court
- September 14, 2009: Sanofi files Motion for Summary Judgment in D.C. district court, seeking an injunction ordering FDA to rescind all final approvals of generic oxaliplatin products
- April 1, 2010: Hospira and Teva announce settlements of Eloxatin patent litigation with Sanofi
- July 26, 2010: D.C. district court files Opinion denying Sanofi's motion for summary judgment
The relevant statute in this case provides that if, before the expiration of the automatic thirty-month stay in a Paragraph IV case, "the district court decides that the patent is invalid or not infringed . . . the [FDA] approval [of the generic drug application] shall be made effective on . . . the date on which the court enters judgment reflecting the decision." In its summary judgment motion filed last September, Sanofi argued that FDA was wrong to conclude that a stayed judgment (which existed at the time FDA granted final approval to Hospira and Teva) is a "judgment" within the meaning of the statute. The court disagreed.
In denying Sanofi's motion, the court explained that when read in context, the statute is clear:
In short, there are two ways the thirty-month stay can terminate prematurely. The first -- addressed in the "entry of judgment" provision -- arises when the district court rules that the patent is invalid or not infringed. . . . That scenario ends with the district court; there is no provision for what happens if the district court's judgment is appealed. The other scenario occurs when the district court determines that the patent is valid and infringed, the judgment is appealed and the court of appeals reverses the district court judgment and determines that the patent is invalid or not infringed . . . . When viewed in context, the omission of a discussion of the appellate process in the entry of judgment provision is glaring. Accordingly, the court takes this omission to be intentional and concludes that Congress intended the thirty-month stay to terminate upon the entry of judgment by a district court that a patent is invalid or not infringed without regard to the appellate process.
The court concluded:
Given that the entry of judgment provisions have a plain meaning, the court will not read into the statute any implication a vacated judgment might have on those provisions. . . . The court thus determines that plain language of the statute dictates that the thirty-month stay terminates upon entry of judgment by a district court that a patent is invalid or not infringed, regardless of any subsequent appeal, and that the FDA was bound to follow this directive.
In view of the fact that Sanofi has settled its Eloxatin patent litigation, it is unclear whether Sanofi will appeal the decision to the D.C. Circuit.
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