Astellas, University of California Sue Sandoz Over Prostate Cancer Treatment ANDA

Astellas Pharma Inc., Astellas US LLC, Astellas Pharma US, Inc., Medivation LLC, Medivation Prostate Therapeutics LLC, and the Regents of the University of California (collectively, the plaintiffs) have filed suit against defendant Sandoz Inc. (Sandoz) over alleged infringement of two patents – the ‘517 and the ‘274 patents. The suit, filed Wednesday in the District of New Jersey, comes after Sandoz informed the plaintiffs of their intent to produce a generic version of Xtandi tablets pending approval from the United States Food and Drug Administration (FDA).

Xtandi tablets are intended to treat patients with resistant forms of prostate cancer. The FDA previously granted the plaintiffs exclusive license to both the ‘517 and ‘274 patents and included the right to sue in the event of patent infringement. Sandoz recently filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking their approval to produce and sell generic versions of the patent protected Xtandi tablets.

Sandoz gave notice of their ANDA submission to the plaintiffs on May 18, the complaint said. In the letter they explained that they filed the ANDA to gain FDA approval to manufacture, use, and sell generic versions of the Xtandi tablets prior to the expiration of the patents that were protecting the drug. They also expressed their belief that claims of the Xtandi patents are “invalid, unenforceable, and/or not infringed.”

The ‘517 and ‘274 patents protect the pharmaceutical compound enzalutamide that is used in Xtandi. The plaintiffs argued that Sandoz’s generic products will contain this compound and the compound will be used in the treatment of patients, therefore constituting infringement. They also contend that Sandoz’s allegations of patent invalidity are “devoid of an objective good faith basis in either the facts or the law.” The plaintiffs assert that they will be “substantially and irreparably harmed” by the patent infringement.

Ultimately, the plaintiffs are seeking a favorable judgement regarding patent infringement on both the ‘517 and ‘274 patents, a permanent injunction enjoining Sandoz from further pursuing the product prior to patent expiration, litigation costs, and any other relief deemed proper by the Court.

The plaintiffs are represented by Walsh Pizzi O’Reilly Falanga LLP.