Aurobindo sued by Pfizer over skin antibiotic

Pfizer has launched a lawsuit against Aurobindo Pharma accusing the Indian pharmaceutical company of infringing patents related to an antibiotic used to treat skin infections.

US-based Pfizer said Aurobindo had attempted to market a generic version of Tygacil (tigecycline) and would, as a result, infringe two of its patents prior to their expiry date.

The lawsuit, filed at the US District Court for the District of Delaware, was in response to Aurobindo’s Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration.

In its complaint, filed on July 2, Pfizer said it became aware of Aurobindo’s application after the company wrote to it on May 19 this year.

Pfizer said Aurobindo claimed in its ANDA application that the two patents, US numbers: 7,879,828 and 8,372,995, were invalid and would not be infringed if its ANDA application was approved.

But Pfizer said it was not able to agree terms under which it could review Aurobindo’s application.

The patents, which expire in 2029, are both related to the composition of the drug.

“Aurobindo’s ANDA, for the purpose of obtaining approval to engage in the commercial manufacture, use and offer for sale prior to the expiration of the patent was an act of infringement,” Pfizer said.

“Aurobindo will actively induce infringement when the ANDA is approved and will do after approval,” it added.

Pfizer is seeking a judgment that any FDA approval of Aurobindo’s ANDA be denied until after the expiration date of both patents and that a permanent injunction banning it, and others, from marketing generics related to Tygacil be granted.

Pfizer is also seeking damages and attorney’s fees.

Aurobindo did not immediately respond to a request for comment.