On 1 May 2023, Amgen instigated proceedings in the US District Court of New Jersey against Sandoz, Novartis and Lek, alleging infringement of 21 patents relating to Amgen’s Prolia® and Xgeva® (denosumab) products. Sandoz submitted its aBLA to the FDA in December 2022 (which was accepted on 6 February 2023) seeking approval of its anti-RANKL mAb Prolia® and Xgeva® biosimilar.
Amgen is asserting that Sandoz/Novartis/Lek failed to comply with the BPCIA 42 U.S.C. § 262(l)(2)(A) “patent dance” requirements, and is seeking declaratory judgement under § 262(l)(9)(C).
Interestingly, of the 21 patents in suit, there are 2 product patents, and 19 process patents including many to media related “inventions”.
The asserted patents (and the nature of the patent, according to Amgen) are:
- 7,364,736 (“the ’736 Patent”) – denosumab sequence patent
- 7,928,205 (“the ’205 Patent”) – process (reduction/oxidation reagent + (optionally) a chaotopric agent)
- 8,058,418 (“the ’418 Patent”) – product patent;
- 9,012,178 (“the ’178 Patent”) – methods of culturing mammalian cells to express protein in a serum free media
- 9,133,493 (“the ’493 Patent”) – methods of culturing mammalian cells (tyrosine and cysteine feeds)
- 9,228,168 (“the ’168 Patent”) – methods of stabilizing feed media (pyruvate)
- 9,320,816 (“the ’816 Patent”) – methods of treating cell culture media (UV C light and filtration)
- 9,328,134 (“the ’134 Patent”) – methods of making proteins with modified glycosylation profile
- 9,359,435 (“the ’435 Patent”) – methods of modulating glycoform content (mannose)
- 9,481,901 (“the ’901 Patent”) – methods of influencing high mannose glycoform content (mannose sugars)
- 10,167,492 (“the ’492 Patent”) – methods of influencing fucosylated glycan content
- 10,513,723 (“the ’723 Patent”) – methods of influencing high mannose glycoform content
- 10,583,397 (“the ’397 Patent”) – systems and methods to control filtration
- 10,822,630 (“the ’630 Patent”) – methods of influencing fucosylated glycan content
- 10,894,972 (“the ’972 Patent”) – methods of influencing high mannose glycoform content (mannose sugars)
- 11,077,404 (“the ’404 Patent”) – systems and methods to control filtration
- 11,098,079 (“the ’079 Patent”) – methods of using a charged depth filter
- 11,130,980 (“the ’980 Patent”) – methods of regulating high mannose glycoform content (monensin)
- 11,254,963 (“the ’963 Patent”) – methods of influencing high mannose glycoform content
- 11,299,760 (“the ’760 Patent”) – methods of regulating high mannose glycoform content (monensin)
- 11,434,514 (“the ’514 Patent”) – methods of influencing high mannose glycoform content (mannose sugars).
Given the timing of Sandoz’s submission, in the ordinary course of events its approval will precede expiry of US patent no. 7364736 to the denosumab antibody in February 2025.
Prolia® is indicated for the treatment of osteoporosis, and Xgeva® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumours; and treatment of giant cell tumour of bone.