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12 May 2022Big PharmaAlex Baldwin

Novartis' Gilenya patent survives invalidity bid

Novartis has convinced a Delaware court that a patent for its flagship multiple sclerosis treatment Gilenya (fingolimod) is directed at patent-eligible matter, dismissing a challenge from Handa Pharmaceuticals that the patent is directed at natural phenomena and invalid.

Gilenya is the brand name of Novartis’ 0.5mg daily dose fingolimod treatment. The flagship drug is used to treat multiple sclerosis.

Judge Maryellen Noreika gave an oral order denying Handa’s motion for judgment attempting to invalidate the patent.

“The court does not view the claims to be directed to a patent-ineligible observation of a natural phenomenon. Rather, the claims appear to be directed to a method of treating multiple sclerosis in certain patients by administration of a specific amount of a specific compound (fingolimod),” Noreika ruled.

Handa still has the opportunity to “obtain additional evidence” to pursue patent ineligibility arguments at trial, she added.

Novartis launched several patent infringement proceedings against Handa in the US District Court for the District of Delaware, claiming that Handa’s planned fingolimod 0.5mg tablets infringe on existing Gilenya patents.

Handa filed a New Drug Application with the US Food and Drug Administration to develop its fingolimod drug, but the application was opposed by Novartis.

Novartis initially alleged that Handa infringed two patents, US Patent 9,187,405 and 10,543,179.

Handa challenged the validity of the ‘179 patent in a motion for judgment submitted in June last year, arguing that the claims of the patent, and the related ‘405 patent do not “shift the focus” away from natural phenomenon to a patent-eligible invention.

It argued that the invention “merely observed” adverse effects of treatment with fingolimod, which could lead to patients contracting “serious” varicella zoster virus (VZV) infections. Novartis’ patentable invention was to immunise individuals against VZV, “an entirely natural and well-known phenomenon that results from vaccination”, prior to the dose of fingolimod.

However, judge Noreika appeared to disagree with this assessment, stating that the patents seemed to be directed at patent-eligible subject matter.

Novartis recently prevailed in another challenge to its ‘405 patent from China’s HEC Pharm in proceedings before the US Court of Appeals for the Federal Circuit.

The precedential decision handed down in January saw the majority of the panel uphold the validity of the patent, which Novartis has been enforcing across several high-profile generic drug manufacturers including Apotex, Bionpharma, Emcure Pharmaceuticals, Heritage Pharmaceuticals, and Glenmark Pharmaceuticals.

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