Brand companies have fewer tools to fight off generic challenges following a ruling that prevents them from reinstating a 30-month stay on FDA approvals if they initially lose the patent case in district court.

Sanofi-Aventis had argued that FDA should not have lifted the 30-month stay on generic versions of the colon cancer drug Eloxatin (oxaliplatin) after a district court ruled the patent had not been infringed. Sanofi appealed and the Federal Circuit eventually vacated and remanded the decision, but not before the generics had launched at risk.

As part of its efforts to block the generics, Sanofi sued FDA after the agency lifted the stay on approving oxaliplatin ANDAs, maintaining that FDA needed to wait until an appeals ruling to do so. But in a July 26 decision, the U.S. District Court for the District of Columbia Judge Ricardo Urbina said that the Food, Drug, and Cosmetic Act specifies that if the District Court determines that a valid patent has been infringed, then FDA's approval of the generic is not effective until the appeals court makes a final determination.

But he said the appeals process has no bearing on approval of generics if the district court finds the patent is invalid or not infringed.

Because appeals courts are specified in other scenarios outlined in the law, "omission of a discussion of the appellate process in the entry of judgment provisions is glaring," Urbina writes. "Accordingly, the court takes this omission to be intentional and concludes that Congress intended the 30-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."

Urbina has some history of pro-generic decisions that are eventually reversed on appeal, and it remains to be seen whether his ruling about the appeals process stands.

Sanofi led a fierce campaign to block generic versions of Eloxatin that embroiled four courts. Sanofi had requested that its suit against FDA be sealed, and even when it was unsealed, key documents, including the company's motion for a temporary restraining order and preliminary injunction, remained under wraps.

The legal maneuverings forced Teva and Hospira to briefly suspend marketing of their products (¹ Also see "Eloxatin's Wild Ride: Generics Back On The Market After Five-Day Stay Of Approval" - Pink Sheet, 20 August, 2009.). Teva and Hospira reached a settlement with Sanofi in April under which they withdrew their oxaliplatin products from the market on June 30 and are to relaunch in August 2012. A blockbuster drug, Eloxatin had U.S. sales of approximately $1.3 billion in 2008.

The Eloxatin decision was issued on the same day that Sanofi filed suit against FDA to rescind its approval of generic Lovenox (enoxaparin). The Lovenox suit is broader, claiming the agency should not have approved Sandoz's generic since there is no proof that it has the same active ingredient as Lovenox (see ² Also see "Lovenox Lawsuit May Be Omen For Biosimilar Battles" - Pink Sheet, 2 August, 2010.).

- Brenda Sandburg ( ³ b.sandburg@elsevier.com )

No Appeal: Eloxatin Decision Gives District Courts Primacy On 30-Month Stays

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