Novartis loses in patent appeal over multiple sclerosis drug Gilenya

Novartis has settled patent cases with several other generic drugmakers, paving the way for some Gilenya generics to be introduced before the patent’s 2027 expiration.

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On Tuesday, a split panel with two of the same judges reversed the decision.

Swiss drugmaker Novartis AG lost in a patent infringement dispute case over its multiple sclerosis drug, Gilenya. On Tuesday, a US appeals court ruled against the Swiss drugmaker and reversed its own earlier ruling in the case.

According to a report by the news agency Reuters, a divided panel found Novartis’ patent was invalid, reviving Chinese drugmaker HEC Pharm Co’s bid to make a generic version of the medicine.

Moreover, Novartis reported nearly $2.8 billion in Gilenya sales last year, making it the Swiss company’s third-highest-selling drug. The companies and their attorneys did not immediately respond to requests for comment on the decision.

In January this year, the Federal Circuit upheld a Delaware court’s ruling that Novartis’ patent was valid and that HEC’s proposed generic infringed it. The patent covers the use of a specific dosage of Gilenya, known chemically as fingolimod, to treat relapsing multiple sclerosis.

On Tuesday, a split panel with two of the same judges reversed the decision.

Novartis has settled patent cases with several other generic drugmakers, paving the way for some Gilenya generics to be introduced before the patent’s 2027 expiration.

Novartis said after the January decision that it did not expect any Gilenya generics on the U.S. market for at least the next two years.

(With inputs from Reuters)

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