AstraZeneca Sues Alembic Over Generic Blood Thinner Notice

On Friday, pharmaceutical company AstraZeneca filed a lawsuit against Alembic Pharmaceuticals for allegedly infringing on their drug patent.

This suit comes in response to a letter sent by Alembic notifying AstraZeneca that they have submitted an abbreviated new drug application (ANDA) to the FDA in an attempt to get approval for the commercial manufacturing of generic Ticagrelor tablets. Ticagrelor is a blood thinner used to prevent stroke, heart attack, and other heart problems. This letter is pursuant with the Hatch-Waxman act, which sets forth the procedure for regulatory approval and commercial marketing of pharmaceuticals, including generic drugs. 

Under Hatch-Waxman, each ANDA must include a certification or statement for each patent listed in the Orange Book. In this case, the defendant is citing paragraph IV of 21 U.S.C. Sec. 355(j)(2)(a)(vii), which states that the patent is not valid or will not be infringed by the new drug. After receiving the notice, AstraZeneca, the  holder  of  New  Drug  Application (NDA) on ticagrelor since April of 2013, decided to exercise their right to sue as they believe that their patent is valid and enforceable. They believe that if not enforced, it would result in significant monetary damages.

The plaintiff stated that contrary to the claims made in the notice letter, the defendant’s generic version of the drug does directly infringe upon claims within its patent and its relation to their brand name drug BRILINTA. AstraZeneca argued that this ANDA was filed for the specific purpose of infringing upon the patent and will do so immediately once it is approved. They also assert that the notice letter provides no factual basis for contending that its ticagrelor ANDA product will not infringe the claims of the patent, and that the defendant’s product has no non-infringing uses and had no reason to think that it did.

If the defendant’s marketing and sale of generic ticagrelor tablets prior to expiration of  the patent  and all other relevant exclusivities is not enjoined, AstraZeneca said it will suffer substantial and irreparable harm. The plaintiff is requesting that their accusation of infringement be affirmed and that they be granted an injunction blocking Alembic and all persons acting in concert with Alembic from the commercial manufacture, use, sale, offer for sale, or importation into the United States of Alembic’s ANDA Products, or any other drug product whose use is covered by the patent until that patent has reached its expiration.

The plaintiff is represented by McCarter & English.