The same day AstraZeneca and Merck & Co. were granted a new patent for their cancer drug Lynparza (olaparib), the partners filed new suits against Natco Pharma and Sandoz that allege the manufacturers’ respective generic compounds infringe on the PARP inhibitor’s patents.
According to the plaintiffs, Natco Pharma submitted a regulatory application to the FDA at the end of 2022 seeking approval of its generic olaparib, and Sandoz filed an application with the US agency for its product in December 2023. After each submission was accepted for FDA review, AstraZeneca and Merck first filed suit against the companies claiming infringement against four Lynparza patents; namely, 7,449,464; 8,475,842; 11,633,396; and 8,859,562. Both suits are still pending.
The fresh lawsuits, filed this week in New Jersey District Court, were triggered after the pharma partners were issued two new patents.
The US Patent and Trademark office granted the 11,970,530 patent on April 30 and the 11,975,001 patent on May 7. The former is for a method of treating homologous recombination deficient cancers, such as ovarian and pancreatic cancer, that combines Roche's anti-VEGF antibody Avastin (bevacizumab) with Lynparza. The latter covers an immediate release formulation Lynparza.