Pfizer’s Wyeth sues Novartis’ Sandoz over breast cancer drug patent
Pfizer subsidiary Wyeth Pharmaceuticals has filed a suit jointly with Puma Biotechnology against Sandoz over a patent related to breast cancer drug, Nerlynx (neratinib).
The companies filed the complaint at the District Court for the US District of Delaware, on Wednesday, November 10.
Puma Biotech and Wyeth held that the Novartis unit’s planned generic version of Nerlynx would infringe US patent number 7,399,865 B2.
The complaint further outlined that while the Orange Book currently lists the expiration of the ’865 patent as December 29, 2025, the patent will not actually expire until several years later.
This was because the US Patent and Trademark Office (USPTO) had issued a Notice Of Final Determination and Requirement for Election on the patent term extension (PTE) for the patent in February, according to the complaint.
Consequently, the companies argued that once the PTE certificate is issued, the expiration of the ’865 patent will be extended until December 29, 2030, and the Orange Book will be corrected accordingly.
The USPTO issues the ’865 patent, titled, “Protein Tyrosine Kinase Enzyme Inhibitors,” was to Wyeth in July 2008. Puma is currently the exclusive licensee of the patent-in-suit under a licence agreement with Wyeth.
The compound claimed in the ’865 patent, neratinib, was approved by the US Food and Drug Administration for the treatment of adult patients with early-stage breast cancer, following adjuvant trastuzumab-based therapy.
Puma began commercial sales of the drug in 2017, and it remains its only drug.
In February 2020, the FDA also approved Nerylyn in combination with capecitabine for the treatment of adult patients with advanced breast cancer.
In September 2021, Sandoz notified Wyeth and Puma that it had submitted A New Abbreviated Drug Application to the FDA for a generic version of neratinib tablets in a 40 mg dosage strength.
Puma and Wyeth are seeking a court order blocking the generic version until the patent-in-suit has expired in 2030 and cash compensation if copies are made before then.
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