Fingolimod – USA

Fingolimod – USA

IPR decision (Jul 11, 2018):

AIA Review
Filing Date
Institution Date
Petitioner
Patent No.
Final Written Decision
IPR2017-00854*
02/03/2017
07/18/2017
Apotex
9,187,405
Claims 1–6 are patentable
*Cases IPR2017-01550 (Argentum), IPR2017-01946 (Actavis), and IPR2017-01929 (Sun Pharma) have been joined with this proceeding.

US 9,187,405 (Novartis; Exp: 12/25/2027 with PED)

1. A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.
3. A method for treating Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.
5. A method for slowing progression of Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.

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