On Jun 13, 2017 a Virginia federal judge handed Alembic Pharmaceuticals Ltd. a win saying the Indian pharmaceutical company’s generic alternative to
Novartis AG and Mitsubishi Tanabe Pharma Corp.'s multiple sclerosis drug Gilenya does not infringe their patent.
Alembic pharma filed complaint for Declaratory Judgment on
Mar 13, 2017 seeking a declaration that Alembic has not infringed, does not
infringe, and will not infringe any valid claim of U.S. Patent No. 8,324,283
(“the ’283 patent”). Alembic sought a declaratory judgment of non-infringement
and/or invalidity of the ’283 patent that would free the FDA to approve
Alembic’s generic drug application at the earliest possible date, thereby
allowing Alembic to market its low-cost, generic fingolimod drug product.
On Apr 12, 2017, the Federal Circuit affirmed the Patent
Trial and Appeal Board's decision invalidating a US’283 patent (expiring on Mar
29, 2026) in a win for generics makers Apotex, Mylan and Torrent pharma. The
‘283 patent covers a solid combination of a sphingosine-1 phosphate (S1P)
receptor agonist (fingolimod) and a sugar alcohol (mannitol).
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