Pfizer Alleges Patent Infringement Against Natco Pharma

On Tuesday in the District of Delaware, Pfizer filed a complaint against Natco Pharma alleging infringement of Pfizer’s patent for drug Ibrance.

Pfizer owns U.S. Patent No. 10,723,730 (the ’730 patent) for Ibrance, a drug approved to treat certain types of breast cancer. Natco sent notice to Pfizer on Dec. 15, 2020, that it had filed abbreviated new drug application (ANDA) No. 213089 with the Food and Drug Administration (FDA) to manufacture and sell palbociclib, the generic version of Ibrance.

The letter also alleged that Pfizer’s ’730 patent is “invalid, unenforceable, and will not be infringed” by the market entry of the ANDA product, according to the complaint. Pfizer disagrees, arguing that the ANDA product infringes claims 1, 7, and 15 of the ’730 patent.

Pfizer argued that Natco is knowingly and intentionally continuing in its intent to manufacture, sell, and distribute its ANDA product before the ’730 patent expires, constituting infringement, inducement of infringement, and contribution to the infringement by others of the ’730 patent, the complaint alleges.

Infringement of the ’730 patent will render Pfizer “substantially and irreparably damaged,” the complaint argues.

Pfizer requests judgment that its patent has indeed been infringed through the submission of Natco’s ANDA, a judgment that the date of any FDA approval of Natco’s ANDA product or other allegedly infringing products is no earlier than the ’730 patent’s expiration date, an injunction to bar Natco from manufacturing, using, selling, or importing the ANDA product in the U.S., costs and fees, and other relief.

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