Novartis tries to block generic versions of Gilenya, enforces new patent

Swiss pharmaceutical giant Novartis is trying to stop an array of drugmakers manufacturing and selling generic versions of its newly-patented multiple sclerosis treatment, Gilenya.

In court documents filed in Delaware’s District Court on January 28, 2020, Novartis is claiming an infringement of US patent 10,543,179, after the defendants filed applications with the US Food and Drug Administration (FDA) for approval to “engage in the commercial manufacture, use, or sale of Fingolimod 0.5mg capsules, generic versions of Novartis’s Gilenya capsules, 0.5mg”, prior to expiration of the patent.

The defendants are Apotex, Bionpharma, Emcure Pharmaceuticals, Heritage Pharmaceuticals, Ezra Ventures, Glenmark Pharmaceuticals, HEC Pharm, Hetero, Prinston Pharmaceuticals, Strides Global Pharma, Zydus Pharmaceuticals, and Cadila Healthcare.

According to the complaint, Novartis is the holder of abbreviated new drug application (ANDA) No. 022527, by which the FDA granted approval for the “commercial manufacturing, marketing, sale, and use of Gilenya (fingolimod) capsules.”

Novartis was also recently granted a new patent for Gilenya, a treatment for relapsing forms of multiple sclerosis, the most common form of the condition that sees sufferers experiencing relapses or flare-ups, when new symptoms can often appear.

The filing also indicated that “upon information and belief, each defendant has made, and continues to make, substantial preparation to engage in the commercial manufacture, use, offer to sell, or sale of its ANDA product,” prior to the expiration of Novartis’s patent, in 25 years’ time.

Novartis is one of the largest pharmaceutical companies in the world, by both market capitalisation and sales. It reported net sales of $12.2 billion in the third quarter of 2019, driven by strong growth in shipments of Cosentyx (arthritis treatment), Entresto (heart failure prevention), and Zolgensma (spinal muscular atrophy).

Novartis is seeking an immediate stop to each defendant “making, using, offering to sell, or selling in the US, or importing into the US, or inducing or contributing to the same, of its ANDA product that will infringe the patent”, as well as a judgment that one or more claims of the patent is not invalid.

It is also seeking damages, “including monetary and other relief, if any defendant engages in commercial manufacture, use, offers to sell, sale, or importation in or into the US of its ANDA product, prior to the expiration date of the patent”.

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