PondPond /
2 February 2015Americas

AstraZeneca sues Glenmark to defend breast cancer drug

AstraZeneca has sued Glenmark Pharmaceuticals for allegedly infringing four patents protecting its breast cancer drug Faslodex (fulvestrant).

The Anglo-Swedish pharmaceutical company filed the case at the US District Court for the District of New Jersey last Monday (January 26).

The case follows Glenmark’s filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration to make and sell a generic version of Faslodex in a 250mg/5ml strength before four patents protecting the drug expire.

AstraZeneca’s Faslodex patents are due to expire in 2021.

Faslodex is an oestrogen receptor antagonist used to treat hormone receptor-positive metastatic breast cancer that has spread in postmenopausal women.

In a letter to AstraZeneca notifying the company of its ANDA filing, Glenmark claimed that the four patents are invalid, unenforceable and would not be infringed by the generic product.

AstraZeneca has asked for a judgment that the four patents are valid and enforceable, that Glenmark’s submission of its ANDA was an act of infringement, and that Glenmark’s proposed generic product would infringe its patents.

The Anglo-Swedish company has also asked for an order that any FDA approval of Glenmark’s ANDA will not be provided until after the four patents expire, as well as a permanent injunction stopping Glenmark from making or selling its proposed product before the patents expire.

Last June, AstraZeneca sued Sandoz, and then in September it took action against Illinois-based Sagent Pharmaceuticals, to protect the same patents. Both cases were filed in the New Jersey district court, while AstraZeneca also filed a lawsuit against Sagent in Illinois.

Both companies had filed ANDAs before AstraZeneca took action. The lawsuits have not yet been resolved.

A spokesperson for AstraZeneca told LSIPRAstraZeneca contends that generic fulvestrant injection products and their use will infringe the claims of AstraZeneca’s patents. We have full confidence in and are vigorously defending and enforcing our intellectual property protecting Faslodex.

Glenmark did not respond to a request for comment.

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