AstraZeneca is suing generic drug manufacturer Zydus Pharmaceuticals Inc. and its parent company over alleged infringement of its patent covering Tagrisso for the second time in a little over a year in the District of Delaware.
AstraZeneca AB and AstraZeneca Pharmaceuticals LP previously brought an infringement suit against India-based Cadila Healthcare Ltd. and its United States subsidiary, Zydus over the same patent, U.S. Patent No. 10,183,020, covering Tagrisso, which treats certain mutations in lung cancer. While those original proceedings have continued, the defendants notified AstraZeneca on March 3 that they amended their Abbreviated New Drug Application (ANDA) No. 214263 with the U.S. Food and Drug Administration (FDA) that proposed the manufacturing and selling of the generic version of Tagrisso, osimertinib mesylate, in 40 and 80 mg strengths.
The operative suit, brought Friday, came after the second notice letter by the defendants. In the defendants’ second notice letter, they claimed that they remedied the alleged issue with their original ANDA that prompted the first suit and argued that the patent-in-suit “is invalid, unenforceable, and/or will not be infringed” by Zydus’ ANDA product.
AstraZeneca disagreed, claiming that the defendants’ proposed product still infringes on its patent, per the description of the proposed drug in the notice letter, and that the defendants plan to circulate their ANDA product before the patent-in-suit expires.
“The proposed amended product labeling for Zydus’s ANDA Products thus directs, encourages, and induces a method of treating cancer in a patient in need thereof … wherein the cancer is non-small cell lung cancer,” according to the complaint.
AstraZeneca claimed that if the defendants are not enjoined from continuing their alleged plans to circulate their ANDA product, it “will suffer irreparable injury.” AstraZeneca also requested attorneys’ fees, costs, and other relief.
McCarter & English LLP represents AstraZeneca.
