AstraZeneca Sues Generic Drugmakers Over Cancer Drug Patents

AstraZeneca has launched new lawsuits against four generic drug manufacturers in an ongoing patent battle over its cancer drug Lynparza (olaparib), approved to treat ovarian, pancreatic, prostate, and breast cancers.

In the new complaints issued January 9, AstraZeneca claims that generic drug companies Sandoz, Cipla, Natco Pharma, and Zydus Pharmaceuticals are planning to make and sell generic versions of Lynparza, which infringes on a new patent that covers the active pharmaceutical ingredient, olaparib.

The recent wave of lawsuits follows several years of litigation against the generic companies related to Lynparza’s patents. In February 2023, AstraZeneca filed the original suit against Natco Pharma, alleging that the generic company was seeking US Food and Drug Administration (FDA) approval to commercially manufacture, use, offer for sale, sell, and/or import generic versions of Lynparza and thus would be infringing on several existing patents for AstraZeneca’s Lynparza before the patents expired. That litigation, which involves patents expiring in 2027, is still pending, according to court records. 

In late 2024, AstraZeneca filed lawsuits against Sandoz, Cipla, and Zydus Pharmaceuticals alleging the same infringement claims pertaining to its existing patents over Lynparza.

In the most recent filings, attorneys for AstraZeneca said they received notice in December 2024 that the US Patent and Trademark Office would be issuing a new patent covering Lynparza. Despite being aware of the new patent, AstraZeneca alleged that the generic drugmakers are still moving forward with plans for their generic products upon FDA approval, in violation of the new patent. Unless the court enjoins the drugmakers from infringing on the new patent, AstraZeneca will “suffer irreparable injury,” according to its complaint.

The latest suits, filed in New Jersey District Court, asked a judge to immediately stop the generic drug companies from any manufacturing, use, or sale of generic products of Lynparza.

A spokesperson for AstraZeneca told Medscape Medical News that AstraZeneca “is confident in the strength of its intellectual property covering Lynparza and is prepared to vigorously defend its intellectual property.”

Cipla, Natco, and Zydus did not return messages seeking comment. A spokesman for Sandoz said the company does not comment on pending litigation. 

At least three of the generic drugmakers have countersued AstraZeneca. In separate countersuits filed between 2023 and 2024, Cipla, Natco Pharma, and Sandoz argued that they are not infringing on AstraZeneca’s existing patents over Lynparza and that AstraZeneca’s claims are invalid. The drugmakers are requesting a “judicial declaration” that their actions involving Lynparza do not and “would not infringe any valid and enforceable claim of the ‘695 patent,” one of the older patents.

The countersuits say AstraZeneca’s ‘695 patent is invalid for failure to satisfy one or more federal law requirements and/or because of double patenting. Double patenting refers to attempting to secure multiple patents for the same product to extend its patent protection beyond what’s legally permitted. 

Intellectual property expert Richard Gold said the patent litigation involving the back-and-forth between AstraZeneca and the drugmakers is generally “the normal litigation process surrounding drug patents.”

“Unfortunately, given the high costs of this type of litigation — costs starting at $2.5 million per side if this goes to trial — it is the consumer who ultimately suffers by paying higher drug prices,” said Gold, director of the Centre for Intellectual Property Policy at McGill University in Montreal. “I don’t know the patents enough to know who will win. Usually, the patent holder wins, but up to 42%-46% of overall US patents are held invalid in the US, so” it’s anyone’s call.