Pfizer Sues to Block Generic Version of Breast Cancer Drugs

Pfizer, Inc. (Pfizer), Warner-Lambert Company LLC, and PF Prison IMB B.V. filed suit on Tuesday against Qilu Pharmaceutical Co., LTD, and Qilu Pharma, Inc. (Qilu) in the District of Delaware. The plaintiffs are seeking a declaratory judgement of patent infringement and an order enjoining Qilu from further infringement. The case concerns the patent for Ibrance, used to treat breast cancer.

Qilu, the complaint said, is a pharmaceutical company that manufactures and sells “generic versions of branded pharmaceutical drugs through various operating subsidiaries.” Qilu recently filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) in an effort to gain their approval to produce and sell generic versions of the drug. They informed Pfizer of their intention to produce the drug pending FDA approval and explained in the letter that they had submitted an ANDA seeking permission to produce the drug prior to the expiration of the ‘730 patent which covers the drug.

Within their notice letter that they sent to Pfizer, Qilu included an “Offer of Confidential Access.” The offer contained a host of conditions that the plaintiffs describe as “unreasonably restrictive.” The respective parties agreed to proceed by filing a complaint and handling “the production of Qilu’s confidential information in a post-filing discovery.”

The plaintiffs said they believe Qilu will commence production and manufacturing of the generic drug immediately upon approval of their ANDA, and that this would be an infringement of the ‘730 patent, which they assert is valid and enforceable. They further contended that an infringement of the ‘730 patent by Qilu would “substantially and irreparably” harm the plaintiffs. They claimed that “Qilu has acted with full knowledge of the ‘730 patent and without a reasonable basis for believing that it would not be liable for the infringement of the ‘730 patent.”

Pfizer and its accompanying plaintiffs are requesting a favorable judgement regarding the invalidity of Qilu’s ANDA, a statement that Qilu may not partake in any generic drug production of Ibrance prior to patent ‘730’s expiration, litigation costs, and any other relief deemed just and proper by the court.

Pfizer is represented by Morris, Nichols, Arsht & Tunnell.