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Novartis wins its case against a generic producer in the United States

Novartis has once again won its case in the United States against the Chinese conglomerate HEC Pharm.

Novartis once again won its case in the United States against the Chinese conglomerate HEC Pharm, which, along with some twenty other generics producers, was contesting the validity of a patent granted to the Rhine pharmaceutical juggernaut on a dosage of its Gilenya treatment ( fingolimod hydrochlorate) for multiple sclerosis. The validity of the patent in question is due to expire in 2027.

As a corollary of this verdict of the United States Court of Appeal for the federal circuit, the filing by the Chinese firm of an application for approval of a generic version does indeed infringe the intellectual property of Novartis, according to the report of the decision taken on Monday.

The court recalls in its considerations that Novartis sued other companies for having sought to approve substitute versions of its Gilenya in daily dosage of 0.5 mg, without preliminary preparatory dosage. These cases had already been either settled or abandoned and only HEC was still appealing against a previous similar decision of a Delawarian district court rendered in August 2020.

Uncertainty removed

In a position paper on Tuesday, Novartis underlines that it does not anticipate any generic version of its sales engine subsequently for at least two years. The group generally conditions its forward-looking ambitions on the absence of competition from alternative versions for Gilenya, especially in Uncle Sam’s country.

Slowly slowing down, Gilenya’s revenue over the first nine months of 2021 still amounted to $ 2.13 billion (just under CHF 2 billion at the current rate).

At Vontobel, Stefan Schneider welcomes news that is certainly positive for Novartis, but probably anticipated by most stock market participants. The analyst now postpones the prospect of seeing a generic version of the aging sales engine across the Atlantic land until 2024, against the end of 2023 so far, without affecting its appreciation of the title.

Laurent Flamme, at the Cantonal Bank of Zurich broadly shares this interpretation and increases his projection of income from Gilenya in the United States to 1.3 or 1.4 billion dollars in 2024, against 1.1 billion previously. The annual rate of erosion anticipated beyond this deadline has been moderated below 30%.

At 9.45 am, the registered Novartis rose 0.44% to 80.66 francs, in the soft underbelly of an SMI down 0.24%.

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