Shionogi sues Aurobindo to halt Doribax generic

Japanese pharmaceutical company Shionogi has sued Aurobindo Pharma in an attempt to stop the Indian generic drug maker from marketing a version of its antibiotic drug Doribax (doripenem) in the US.

Shionogi’s complaint, filed on Friday (January 16) at the US District Court for the Northern District of Illinois, came in response to Aurobindo’s filing of an Abbreviated New Drug Application (ANDA).

The ANDA, filed with the US Food and Drug Administration (FDA) in December last year, sought approval to market a generic version of Doribax before a patent covering the drug expired.

Doribax is used to treat adults with “complicated intra-abdominal infections and complicated urinary tract infects including pyelonephritis” or infection of the kidney, the complaint said. The FDA approved Shionogi’s drug in 2007.

In its complaint, Shionogi argued that Aurobindo had infringed US patent 8,247,402, entitled “crystal form of pyrrolidylthiocarbapenem derivative”, which was issued by the US Patent and Trademark Office in 2012. According to the Orange Book, the patent is due to expire in 2021.

“Upon information and belief, Aurobindo’s generic doripenem for injection products will contain a copy of the active ingredient in Doribax. That active ingredient is covered by the ’402 patent,” Shionogi wrote in the complaint.

It continued: “Aurobindo’s generic doripenem for injection products will be sold with a product label that will contain substantially the same instructions for administration and use as the Doribax product label. The administration and use of doripenem is covered by the ’402 patent.”

Shionogi said it would be “irreparably harmed” if Aurobindo’s ANDA is not rejected by the court.

The Japanese company has asked for a judgment confirming that the ‘402 patent is valid and enforceable and that it has been infringed by Aurobindo, and for an injunction stopping Aurobindo from marketing its drug before the patent expires.

Aurobindo did not respond immediately to a request for comment.