AstraZeneca and Merck Sue to Block Generic Lynparza

On the same day AstraZeneca and Merck & Co. received a new patent for their cancer drug Lynparza (olaparib), the companies initiated fresh legal actions against Natco Pharma and Sandoz. These lawsuits allege that the generic versions of olaparib being developed by Natco Pharma and Sandoz infringe on existing patents for Lynparza, a PARP inhibitor used in cancer treatment.

AstraZeneca and Merck claim that Natco Pharma submitted a regulatory application to the FDA at the end of 2022 seeking approval for its generic version of olaparib. Similarly, Sandoz filed its application with the FDA in December 2023. Upon acceptance of these applications for FDA review, AstraZeneca and Merck responded by filing lawsuits against both companies. These initial lawsuits allege that the generic products infringe on four specific Lynparza patents: 7,449,464; 8,475,842; 11,633,396; and 8,859,562. These cases are still under judicial consideration.

The recent legal complaints, filed this week in the New Jersey District Court, were prompted by the issuance of two new patents. The United States Patent and Trademark Office granted the 11,970,530 patent on April 30, and the 11,975,001 patent on May 7. The first patent (11,970,530) pertains to a method for treating homologous recombination deficient cancers, such as ovarian and pancreatic cancers, by combining Roche's anti-VEGF antibody Avastin (bevacizumab) with Lynparza. The second patent (11,975,001) covers an immediate release formulation of Lynparza.

These new patents bolster AstraZeneca and Merck’s ability to protect their intellectual property and the market position of Lynparza. By securing patents that cover both novel treatment methods and formulations, they aim to extend the exclusivity period of Lynparza, which is crucial for their commercial strategy.

The legal actions against Natco Pharma and Sandoz underscore the ongoing battle between brand-name drug manufacturers and generic drug makers. Generic manufacturers aim to create affordable versions of popular drugs, while original developers strive to protect their innovations through patents, which can delay the entry of cheaper alternatives into the market.

The outcomes of these lawsuits could have significant implications for the pharmaceutical industry, particularly concerning the balance between fostering innovation and ensuring access to affordable medication. If AstraZeneca and Merck succeed in their lawsuits, it could delay the introduction of generic versions of olaparib, thereby maintaining Lynparza’s market exclusivity for a longer period. Conversely, if Natco Pharma and Sandoz prevail, it could pave the way for more affordable generic options for patients needing this cancer treatment.

In summary, the recent legal developments highlight the complexities of patent law in the pharmaceutical sector, as major companies like AstraZeneca and Merck seek to protect their intellectual property against generic competitors. The ongoing litigation will be closely watched, given its potential to impact drug pricing and availability, as well as its broader ramifications for innovation in the healthcare industry.