shutterstock-145412341-web
wonderisland / Shutterstock.com
12 February 2015Americas

Novartis seeks injunction against proposed Zometa generic

Novartis has sued drug company BPI Labs for alleged patent infringement after it requested permission to market a generic version of Novartis’s bone cancer drug Zometa (zoledronic acid).

The Swiss pharmaceutical company filed the case on Monday (February 9) at the US District Court for the Middle District of Florida, Tampa Division. It came in response to BPI’s sending of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA).

BPI is seeking approval to make and sell a generic version of the drug before the patent covering it—US number 8,324,189—expires in 2025.

Zometa, which is used to treat cancer that has spread to the bones, was approved by the FDA in 2001.

According to the complaint, Novartis has already filed several other patent infringement lawsuits, at the US District Court for the District of New Jersey, which concern alleged infringement of the ‘189 patent. One is an action against pharma company Wockhardt USA.

The ‘189 patent, called “use of zoledronate for the manufacture of a medicament for the treatment of bone metabolism diseases”, covers the method of administration for Zometa. It is the only patent listed for Zometa in the Orange Book.

BPI previously argued in its notice letter to Novartis that the ‘189 patent is invalid and unenforceable.

Novartis has asked for a judgment that the patent is valid and enforceable, that it has been infringed by BPI’s submission of the ANDA, and for an order providing that the FDA will not approve BPI’s ANDA before the ‘189 patent expires.

The Swiss company has also asked for a permanent injunction stopping BPI from selling the proposed generic product in the US.

Novartis said it does not comment on pending litigation. BPI could not be reached for comment.