Sanofi-Aventis settles colorectal cancer drug oxaliplatin (Eloxatin) litigation with Sun Pharma

Sanofi-Aventis has settled the patent infringement lawsuit against Indian firm Sun Pharma pertaining to a generic version of its colon cancer drug Eloxatin.

The U.S. District Court for the District of New Jersey has signed off settlement agreement between Sanofi-Aventis and Sun Pharma on Eloxatin patent litigation.

Eloxatin which contains oxaliplatin, combined with infusional administration of 2 other chemotherapy drugs, 5-fluorouracil/leucovorin (5-FU/LV), is approved by the Food and Drug Administration (FDA) for adjuvant treatment of people with stage III colon cancer who have had their primary tumors surgically removed.

Eloxatin  (oxaliplatin) plus 5-FU/LV has been shown to increase overall survival rates by 5.5% when the recommended dose of 12 cycles of therapy is completed in clinical studies in people with stage III colon cancer who had their primary tumours surgically removed.

Eloxatin (oxaliplatin) also cut down the risk of colon cancer coming back.

Eloxatin (oxaliplatin) has been proven as safe and effective in patients over age 65 as it is in younger patients with advanced colorectal cancer.

Sanofi originally filed suit against generic makers including Sun Pharma, Sandoz, Actavis Inc, and Par Pharmaceutical Inc in June 2007

Sanofi-Aventis accused Sun Pharma of infringing Sanofi’s patent covering Eloxatin, U.S. Patent No. 5,338,874.

Debiopharma is the owner of patent No.5,338,874. Sanofi-Aventis is the exclusive licensee of the patent.

However, Sanofi and Sun began negotiating for a settlement during the course of litigation

Sanofi-Aventis and Sun have finally arrived at an agreement in May 2009.

On June 16, Sanofi summarily verified to Sun that Sun had fully executed and signed Sun’s portions of the agreement and that Sanofi had obtained almost all of the signatures required for the settlement.

Sanofi was also expected to send out the final completed document to Sun on June 17.

However, on June 17 the District Court decided that different generic makers involved in the lawsuit  used a different method for the formulation of Eloxatin’s active ingredient and  granted motions for summary judgment of non-infringement for Sandoz, Mayne Pharma, Teva Pharmaceutical Industries, Ltd., and Hospira, Inc.

But Sanofi refused to turn over a signed copy of the settlement, following the Court’s ruling.

Sanofi maintained the view that the District Court’s ruling had diminished the value of any such settlement agreement.

However, the Court ruled that because of the essential terms of the agreement were set forth in both the letter of intent and the term sheets, the agreement was enforceable regardless of whether all required signatures had been obtained.

In its most recent ruling,  the Court also concluded that both parties, before its ruling on June 17, had considered the settlement complete, with no further revisions required

In July Sanofi Aventis reached a similar settlement agreement with Austrian pharmaceutical company Ebewe Pharma Ges.m.b.H. Ebewe agreed to stipulate that it infringed the patents covering Sanofi-Aventis’ colon cancer drug Eloxatin.

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes
therapeutic solutions . Sanofi-Aventis is listed in Paris.