Sanofi-Aventis U.S. LLC and Sanofi Mature IP have sued India’s Aurobindo Pharma Limited and two of its domestic subsidiaries (collectively, APL) over their purported intention to make and sell a generic version of Sanofi’s drug Jevtana. Tuesdays’ District of Delaware lawsuit says that APL’s Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval prior to the expiration of its three drug patents infringes one or more of each of the asserted patents’ claims.
The filing explains that Jevtana has been “approved for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.” Sanofi reportedly developed the drug and obtained its new drug application in June 2010.
The plaintiff’s underlying patents relate to both the drug’s composition as well as its administration. For example, the complaint says that two are “directed to methods for increasing survival of certain prostate cancer patients with cabazitaxel, including the use of JEVTANA® in accordance with the labeling approved by the FDA.”
The defendants reportedly seek to engage in the commercial manufacture, use, or sale of cabazitaxel injection, for intravenous infusion, a generic version of Sanofi’s Jevtana kit in violation of Sanofi’s intellectual property rights. As such, the lawsuit states six claims for patent infringement.
For each of the three asserted patents, Sanofi brings one claim for “actively induc[ing] direct infringement” and one claim for declaratory judgment. The latter type of claims assert that if APL “is not permanently enjoined, Plaintiffs will suffer substantial and irreparable harm for which there is no remedy at law.”Sanofi is represented by Morris, Nichols, Arsht & Tunnell LLP and of-counsel Venable LLP.