Novartis sues Zydus over Alzheimer and Parkinson’s disease drug

Novartis Pharmaceuticals has launched a lawsuit against generics company Zydus Noveltech and its subsidiaries, accusing them of infringing patents relating to a drug used to treat Alzheimer’s and Parkinson’s disease.

In a lawsuit filed at the US District Court for the District of Delaware, Switzerland-based Novartis accused Zydus and its subsidiaries Zydus Pharmaceuticals and Cadila Healthcare of infringing two of its patents.

Novartis said an Abbreviated New Drug Application (ANDA) submitted by Zydus to the US Food and Drug Administration (FDA) would infringe its US patents 6,316,023 (‘023) and 6,335,031 (‘031).

Both centre on the drug rivastigmine, used to treat the two diseases.

“Defendant Zydus submitted to the FDA an ANDA seeking approval to engage in the commercial manufacture, use, and sale of a rivastigmine transdermal system, before the expiration of the ‘023 and ‘031 patents [in 2019],” the complaint said.

It added that Zydus’s application said the patents are invalid and or will not be infringed but did not allege that any of the claims were unenforceable.

“By filing its ANDA before the expiration of the ‘023 and ‘031 patents, Zydus has committed an act of infringement,” the complaint added.

“There is a substantial and immediate controversy between plaintiffs and Zydus concerning the ‘023 and ‘031 patents,” the Novartis complaint alleged, adding that it was entitled to a declaratory judgment that Zydus will infringe and or induce infringement of one or more claims of the patents.

Novartis is also seeking a permanent injunction preventing Zydus from engaging in the commercial manufacture or use of a drug that will infringe the patents, as well as damages and attorneys’ fees.