AstraZeneca, MSD sue MSN and Sandoz over Calquence generics
AstraZeneca and Merck, Sharp & Dohme (MSD) have filed a pair of lawsuits against MSN and Sandoz, claiming their planned generic versions of its leukaemia treatment Calquence (acalabrutinib) infringe six patents.
The lawsuits, filed Friday, November 4, in the US District Court for the District of Delaware, ask the court to halt the release of both MSN and Sandoz’s generics until the six patents have expired.
Calquence is AstraZeneca’s blockbuster cancer drug which was first approved by the Food and Drug Administration (FDA) five years ago and is currently protected by the patents through to 2036.
AstraZeneca has teamed up with MSD for the proceedings as MSD is the current owner and assignee of one of the patents core to Calquence, with AstraZeneca being the exclusive licensee.
Both MSN and Sandoz notified the plaintiffs that it had filed for Paragraph IV certification and was seeking approval from the FDA to manufacture and sell their Abbreviated New Drug Application (ANDA) prior to the expiration of five of the patents.
Both companies alleged that their generics would not infringe on the five patents, or that the patents were either invalid or unenforceable.
Also, MSN and Sandoz specified that they wanted to create an acalabrutinib oral capsule at a 100mg dosage, the same dosage as AstraZeneca’s variant.
AstraZeneca and MSD are seeking a declaratory judgment that its patents are infringed by Sandoz’s ANDA and requests a preliminary and permanent injunction barring them from releasing the ANDA prior to the expiration of its key patents.
Calquence was first approved for the treatment of chronic lymphocytic leukaemia in the US in November 2019, with EU approval for the same treatment following in November 2020. It is currently approved for the treatment of CLL and small lymphocytic lymphoma in both jurisdictions and several other countries worldwide.
According to AstraZeneca’s 2020 annual report, Calquence generated $522 million in revenue for the pharmaceutical giant last year, up 219% from the year prior.
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