Fed. Circ. Hands Sanofi Victory In Eloxatin Spat

By Elaine Meyer

Law360, New York (September 10, 2009) -- A federal appeals court has struck down a ruling in an infringement suit brought by Sanofi-Aventis US LLC against a slew of generics makers, saying the lower court erred when it said the generics manufacturers had not infringed on Sanofi’s patent for popular colon cancer drug Eloxatin.

The U.S. Court of Appeals for the Federal Circuit on Wednesday vacated and remanded a summary judgment ruling back to the U.S. District Court for the District of New Jersey.

Sanofi filed the suit in June 2007, accusing generic-drug makers Sandoz AG, Hospira Inc.’s Mayne Pharma, Barr Laboratories and Teva Pharmaceutical Industries, among others, of infringing Eloxatin in producing oxaliplatin, the generic version of the drug.

Judge Joel A. Pisano erred when he ruled that the generics used a different process to formulate the drug's active ingredient in his claims interpretation of Sanofi-held U.S. Patent Number 5,338,874, the appeals court said.

The district court judge wrongly interpreted composition claims as product-by-process claims, according to the Federal Circuit.

The case will be sent back to the district court for a new claims interpretation.

Judge Pisano had agreed with the defendants in his June opinion that the generics did not contain oxaliplatin derived by the method described in the '874 patent.

Sanofi’s method of achieving optically pure oxaliplatin uses high-performance liquid chromatography, a patented process for separating oxaliplatin from an undesired enantiomer.

The pharmaceutical giant argued that the generics violated its patent by using the same process.

Sanofi licenses the patent from Switzerland-based Debiopharm SA, which was also a plaintiff in the suit.

Sanofi initiated the suit after Sandoz filed an abbreviated new drug application with the U.S. Food and Drug Administration for a generic version of Eloxatin in 2006.

Sandoz's ANDA called the Sanofi patents — the '874 patent and U.S. Patent Number 5,716,988 — invalid and therefore noninfringed, the complaint said. Sanofi disputed that claim, however, seeking judgment that the patents were valid and enforceable, as well as damages.

Sanofi has sought to protect the cancer treatment through numerous lawsuits against generics makers over the '874 patent, including the most recent, an August 2008 filing against Apotex Inc.

In May 2008, Sanofi attacked W.C. Heraeus GmbH, claiming the German precious metals company aided infringement of the '874 patent by providing an important active pharmaceutical ingredient to three generics makers, including Sandoz and Mayne.

Eloxatin received approval to be marketed in France more than a decade ago. The drug is now sold in more than 60 countries for the treatment of metastatic colorectal cancer.

Sanofi-Aventis said in a statement Thursday that it was pleased with the ruling.

Representatives for Sandoz said the companz does not comment on pending litigation.

The patent-in-suit is U.S. Patent Number 5,338,874.

Sanofi is represented by Fitzpatrick Cella Harper & Scinto.

Sandoz is represented by Schiff Hardin LLP.

Mayne Pharma is represented by Winston & Strawn LLP. Teva Parenetral Medicines Inc. and Barr Laboratories are represented by Goodwin Procter LLP. Fresenius Kabi Oncology PLC is represented by Rothwell Figg Ernst & Manbeck PC.

The case is Sanofi-Aventis U.S. LLC v. Sandoz Inc. et al., case numbers 09-1427 and 09-1444, in the U.S. Court of Appeals for the Federal Circuit.

--Additional reporting by Shannon Henson and Jocelyn Allison