DC District Court Denies Sanofi Summary Judgment Motion in Generic ELOXATIN Case; Refuses to Reinstate 30-Month Stay on ANDA Approvals

By Kurt R. Karst –   

Earlier this week, the U.S. District Court for the District of Columbia denied Sanofi-Aventis’s Motion for Summary Judgment and granted Cross-Motions for Summary Judgment (here and here) filed by FDA and intervenor-defendants last fall in a dispute over FDA’s approval of applications for generic versions of Sanofi’s drug ELOXATIN (oxaliplatin).  In our previous post on the litigation over generic ELOXATIN – The Oxaliplatin Controversy – a Tale of Intrigue, Secrecy, and Suspense – we reported on the various twists and turns that eventually resulted in the approvals.  The most recent decision affirms what court decision terminates a 30-month stay of ANDA (and 505(b)(2) application) approval in Paragraph IV patent infringement litigation.

When we last left you, FDA had reinstated the approvals for generic ELOXATIN after the U.S. Court of Appeals for the District of Columbia Circuit ordered the dissolution of an administrative injunction suspending the approvals.  Shortly thereafter, on September 10, 2009, the U.S Court of Appeals for the Federal Circuit vacated a judgment (which the Court had previously stayed) from the U.S. District Court for the District of New Jersey that U.S. Patent No.5,338,874 (“the ‘874 patent”) covering ELOXATIN was not  infringed by certain generic applicants.  Just a few days later, Sanofi filed a Motion for Summary Judgment in the U.S. District Court for the District of Columbia in the case it had filed against FDA in August 2009 (Sanofi-Aventis et al. v. Food & Drug Admin. et al., No. 2009-1495) arguing that a stayed judgment is not a “judgment” within the meaning of FDC Act § 505(j)(5)(B)(iii)(I)(aa) (ANDA) and FDC Act § 505(c)(3)(C)(i) (505(b)(2)) terminating the 30-month stay on approval, and that as a result of the Federal Circuit’s September 10th decision vacating the New Jersey district court’s judgment, the 30-month stay on ANDA/505(b)(2) approval was effectively reinstated.  FDA and the intervenor-defendants argued in their Cross-Motions for Summary Judgment that regardless of the Federal Circuit’s stay and subsequent vacatur of the New Jersey district court’s decision, the FDC Act required the Agency to approve the applications once the New Jersey district court entered its judgment with respect to the ‘874 patent.

In ruling on the “purely legal issue of whether a vacatur entered by an appellate court overrides the terminating effect that the entry of a district court judgment has on the thirty-month stay under the FDCA,” the D.C. district court turned its attention to the text of FDC Act § 505(j)(5)(B)(iii) and § 505(c)(3)(C):

In short, there are two ways the thirty-month stay can terminate prematurely.  The first – addressed in the entry of judgment provisions [at FDC Act §§ 505(c)(3)(C)(i) and (j)(5)(B)(iii)(I)] – arises when the district court rules that the patent is invalid or not infringed or endorses a settlement agreement stating that the patent is invalid or not infringed prior to entering judgment.  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 [under FDC Act §§ 505(c)(3)(C)(ii) and (j)(5)(B)(iii)(II)(aa)] occurs when the district court determines that the patent is valid and infringed, the judgment is appealed and the court of appeals either reverses the district court judgment and determines that the patent is invalid or not infringed or endorses a settlement agreement stating that the patent is invalid or not infringed before issuing an opinion.  When viewed in context, the omission of a discussion of the appellate process in the entry of judgment provisions 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.

Although not implicated in the litigation, the court noted that Congress made reference to the appellate process in the ANDA 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(AA).  This provision states that in a failure-to-market forfeiture analysis one event that is considered is when “a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has or can be taken.”  Thus, the court determined that “the lack of limiting language in the entry of judgment provisions – in contrast to the successive sections and the forfeiture provision – is sufficient to demonstrate Congress’s intent that the entry of judgment by the district court be the event that triggers the termination of the thirty-month stay notwithstanding any subsequent appeal or ruling by the appellate court.”

Presumably the district court’s decision will put this matter to bed, but an appeal is always possible.