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22 March 2018Americas

Novartis sues Regeneron over eye treatment

Novartis has accused competitor Regeneron of patent infringement through the latter’s sale of Eylea (aflibercept) and Zaltrap (ziv-aflibercept).

The Swiss pharmaceutical company filed its patent infringement complaint at the US District Court for the Southern District of New York, White Plains Division, on Monday, March 19.

In 1997, US patent number 5,688,688 was issued to biopharmaceutical company Chiron, which Novartis acquired in 2006. The patent discloses and claims “gene expression constructs for the expression of polypeptides in mammalian cells”, a method of producing products for use in eye disorders.

Novartis uses the ‘688 patent to develop Lucentis (ranibizumab injection), a prescription medication used to treat diseases related to the retina.

Regeneron manufactures and sells Eylea, a product which is injected to treat diseases related to the retina. It owns US patent number 7,070,959, which discloses the production of aflibercept.

In addition, Regeneron produces and sells Zaltrap, a cancer drug administered by intravenous infusion. According to Novartis, the active ingredient in Zaltrap is “identical” to the one used in Eylea.

Novartis said the method of manufacturing aflibercept includes the use of a gene expression system owned by biotech company Lonza Group. According to the complaint, the system infringes the technology claimed by the ‘688 patent.

As the allegedly infringing technology is used to manufacture Eylea and Zaltrap, the production of the treatments also infringes the patent, claimed Novartis.

Lucentis and Eylea are competing products in the market of vitreoretinal eye disorder therapies. Novartis said that, prior to Eylea’s entry into the market, Lucentis was the only approved protein-based therapy for the treatment of such disorders.

In a statement, Regeneron said that it intends to “vigorously defend” itself and that it has “strong defences that will prevent Novartis from enforcing the ‘688 patent”. For example according to Regeneron, the ‘688 patent expired in 2014, and is therefore no longer the proprietary technology of Novartis.

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More on this story

Big Pharma
27 March 2018   GSK has revealed that it will buy Novartis out of their joint consumer healthcare business.
Americas
4 May 2021   Pharmaceutical company Novartis has abandoned its attempt to halt US imports of Regeneron’s Eylea pre-filled syringes amid concerns that such a ban could hinder public access to essential treatments.

More on this story

Big Pharma
27 March 2018   GSK has revealed that it will buy Novartis out of their joint consumer healthcare business.
Americas
4 May 2021   Pharmaceutical company Novartis has abandoned its attempt to halt US imports of Regeneron’s Eylea pre-filled syringes amid concerns that such a ban could hinder public access to essential treatments.