Patent No. EP3999643 (titled "Methods Of Treating Or Preventing Spinal Muscular Atrophy") was filed by Biogen MA on Jul 16, 2020. The application was issued on Nov 22, 2023.
A treatment regimen for spinal muscular atrophy (SMA) that rapidly achieves and maintains higher concentrations of antisense compound in patients with SMA. The regimen involves administering a loading dose of the antisense compound at a concentration of 50 mg/mL followed by maintenance doses of 28 mg/mL. This approach enables patients to achieve therapeutic levels of the antisense compound earlier than the approved 12 mg dose of nusinersen, thereby enhancing treatment efficacy. The regimen can be administered intrathecally or intrathecal bolus injections.

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.
| Company | Opposition Date | Representative |
|---|---|---|
| ADALVO | Aug 22, 2024 | CASALPRIM CASTELLA |
| GENERICS UK | Aug 21, 2024 | TER MEER STEINMEISTER & PARTNER |
| TEVA PHARMACEUTICALS | Aug 21, 2024 | VON KAUFFMANN |
| POLPHARMA | Aug 20, 2024 | ELKINGTON AND FIFE |
| SANDOZ | Aug 13, 2024 | ELKINGTON AND FIFE |
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