Aurobindo Sued for Patent Infringement After Seeking FDA Approval for Generic Version of Merz Drug

Merz Pharmaceuticals, LLC and Merz North America, Inc. (together Merz) filed a civil complaint against defendants Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. (together Aurobindo) on Wednesday. The action relates to Aurobindo’s filing of an Abbreviated New Drug Application (ANDA) seeking Food and Drug Administration (FDA) approval to manufacture and sell a generic version of the plaintiffs’ trademarked Cuvposa, a drug that treats sialorrhea, a condition which causes drooling or excessive salivation. Merz seeks a permanent injunction blocking Aurobindo from bringing the generic to market before the expiration of the two patents-in-suit.

According to the complaint, the Merz plaintiffs are North Carolina businesses that hold intellectual property and regulatory approval rights for “innovative pharmaceutical products,” and also develop, market, and sell them. The filing states that generic manufacturer Aurobindo Pharma Ltd. is believed to be a foreign corporation based in Hyderabad, India, and Aurobindo Pharma USA Inc. is its wholly-owned American subsidiary. In support of its contention that jurisdiction is proper, Merz points to several District of Delaware cases where Aurobindo has submitted to jurisdiction by filing counterclaims.

Merz explained that Cuvposa was first approved by the FDA in 2010. It reportedly holds the rights to the two underlying patents-in-suit by assignment. In mid-November, the filing states, Aurobindo submitted its ANDA and notified Merz via letter of its submission. Aurobindo’s letter also included a “Paragraph IV certification,” stating Aurobindo’s opinion that the patents-in-suit are invalid, unenforceable, or will not be infringed by the development of its generic equivalent.

In response, Merz filed the instant action. The plaintiffs contend that if not enjoined, Aurobindo will infringe, contributorily infringe, and induce infringement by intentionally encouraging medical personnel to treat patients with sialorrhea using patented methods. For the alleged harm, Merz requests declaratory and injunctive relief.

The plaintiffs are represented by McCarter & English, LLP and of counsel Hogan Lovells US LLP.