In a significant decision, The U.S. District Court for the District of New Jersey has granted summary judgment of non-infringement in favor of generic players Sandoz, Teva and Mayne Pharma (Hospira) on Oxaliplatin (Eloxatin) 50 mg/, 100 mg/vial, 200 mg/vial and 5 mg/ml injection.
Eloxatin is covered by following Orange Book listed patents:
US5338874 (Expiry Apr 07,2013): Which covers Optically pure cis-oxalato (trans- 1-1,2-cyclohexanediamine) Pt(II) wherein the melting point thereof is between 198.degree. C. and 292.degree. C
US5420319 (Expiry Aug 08,2016): Which covers a Cis-oxalato(trans-1-1,2-cyclohexanediamine) Pt(II) complex having high optical purity represented by Formula 1 which possesses optical purity of 99.94% or more and a melting point between 198.3.degree. C. and 199.7.degree. C
US5716988 (Expiry Aug 07,2015) : Which covers a pharmaceutically stable preparation of oxaliplatinum for the administration by the parenteral route, consisting of a solution of oxaliplatinum in water at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a pharmaceutically acceptable duration of time.
US5290961 (Expiry Jan 12, 2013): Which covers a process of preparing a cis-platinum (II) complex of a 1,2-cyclohexanediamine isomer
Sanofi-Aventis filed suit against Mayne Pharma (Hospira), Teva and Sandoz in June-July 2007 and their API supplier W.C. Heraeus GmbH in May 2008, for infringement of US5338874 which covers oxaliplatin as product.
The U.S. District Court for the District of New Jersey in it’s decision opined that although ‘874 patent covers optically pure oxaliplatin as product, however, the claim construction clearly suggest that claim in actual should be product by process claim. Also, court concluded that process limitation of ‘874 patent is separation of isomer using HPLC technique. Importantly, generic players are not using HPLC technique for resolution of isomer. Further, court upheld the validity of the patent but concluded no infringement of claim 1 by generic players Mayne Pharma (Hospira), Teva and Sandoz.
Oxaliplatin is a platinum-based chemotherapy drug in the same family as cisplatin and carboplatin. It is typically administered in combination with fluorouracil and leucovorin in a combination known as FOLFOX for the treatment of colorectal cancer. Compared to cisplatin the two ammine groups are replaced by cyclohexyldiamine for improved antitumour activity. The chlorine ligands are replaced by the oxalato bidentate derived from oxalic acid in order to improve water solubility.
Oxaliplatin was discovered in 1976 at Nagoya City University in Japan by Professor Yoshinori Kidani, who was granted US4169846 over the drug in 1979. Oxaliplatin was subsequently in-licensed by Debiopharm, a Swiss drug company headquartered in Lausanne and developed as an advanced colorectal cancer treatment. Debio licensed the drug to Sanofi-Aventis in 1994. Eloxatin gained European approval in 1999 and USFDA approval in 2004.
Press releaes
Hospira press release Here
Teva in a press release Here
Innovator Sanofi-Aventis press release Here
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