Context: Between July and November last year, AstraZeneca filed a wave of patent infringement suits against four generic drugmakers in the United States District Court for the District of New Jersey. The companies it has been targeting include Cipla Limited, Sandoz Inc., Natco Pharma Limited, and Zydus Lifesciences, and the complaints all allege that the defendants submitted Abbreviated New Drug Applications (ANDA) to the U.S. Food and Drug Administration (FDA) for generic versions of its cancer treatment drug Lynparza ahead of its patents’ expirations. The oral medication in question is used to treat ovarian, breast, pancreatic and prostate cancer.
What’s new: AstraZeneca has filed complaints against Cipla, Sandoz, Natco and Zydus over the infringement of a Lynparza patent. This time, the patent-in-suit covers its active pharmaceutical ingredient olaparib and the plaintiff is seeking preliminary and permanent injunctions against all four companies. The U.S. Patent and Trademark Office issued an issue notification for the patent-in-suit on December 11, 2024. All four defendants indicated they were aware of the patent six days later but have not withdrawn their applications, the complaint stipulates.
Direct impact and wider ramifications: This brings the number of patents over which AstraZeneca has filed lawsuits related to Lynparza up to nine. But this should not come as a surprise as the UK-based biotech giant is not holding back on any of its drugs – these cases join several others it is currently embroiled in. For example, it is fighting a lawsuit against 13 Chinese generic manufacturers over its diabetes drug Farxiga in which the plaintiff successfully defended a record 33 individual patent invalidation claims last summer (December 13, 2024 ip fray article).
Cipla, Natco and Zydus are all Indian-headquartered pharmaceutical organisations, while Sandoz is based in Switzerland.
AstraZeneca is being represented by Charles H. Chevalier at Gibbons P.C., who helped Catalyst Pharmaceuticals Inc. settle a two-year orphan drug patent dispute with Teva Pharmaceuticals Ltd. earlier this month (January 9, 2025 ip fray article). Mr. Chevalier is joined by Williams & Connolly LLP’s David I. Berl, Elise M. Baumgarten, Kevin Hoagland-Hanson, Max Accardi, Nicholas Vincent, and Falicia Elenberg.
AstraZeneca has sued all four generic drugmakers over the same patent, which is related to its olaparib (Lynparza) tablets:
- US Patent No. 12,178,816 (“Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one”)
The four complaints can be found at the bottom of this article.
Pending Lynparza disputes
Prior to this suit, the company already had cases pending in the District of New Jersey against the four defendants, all of which involved the alleged infringement of Lynparza-related patents.
Each of Natco, Sandoz, Cipla, and Zydus had sent AstraZeneca notice letters informing it that they had sought approval from the FDA to manufacture and sell generic Lynparza tablets in December 2022, December 2023, May 2024 and November 2024, respectively.
AstraZeneca filed complaints against the four drugmakers, alleging that their ANDAs would infringe on the following patents:
| Cipla | Natco | Sandoz | Zydus | |
| US Patent No. 8,475,842 | Settled | Settled | Pending | Pending |
| US Patent No. 11,633,396 | Settled | Settled | Pending | Pending |
| US Patent No. 11,970,530 | Settled | Settled | Settled | N/A |
| US Patent No. 7,449,464 | N/A | N/A | Settled | N/A |
| US Patent No. 11,975,001 | Pending | Settled | Pending | Pending |
| US Patent No. 8,859,562 | Pending | Pending | Pending | Pending |
| US Patent No. 12,048,695 | Pending | Pending | Pending | Pending |
| US Patent No. 12,144,810 | Pending | Pending | Pending | Pending |
Here, finally, are the complaints AstraZeneca filed against the four drugmakers last week:
Cipla:
Sandoz:
Natco:
Zydus: