Novartis sues Biocon for patent breach

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In what may turn out to be another major patent litigation between a multinational and a local pharmaceutical company, Swiss giant Novartis has dragged Biocon to court for allegedly infringing patent rights of its Galvus diabetes drug.

The multinational has filed infringement proceedings and is seeking an injunction against the Indian rival at the Delhi High Court, trying to block the Bangalore-based biotechnology firm from launching a generic version of Galvus, also known as vildagliptin.

According to industry estimates, Galvus, one of the best-selling medicines of Novartis, clocks Rs 200 crore of sales annually. Besides, Novartis also has a co-marketing tie-up with USV to sell the drug at a lower price under a different brand name, Jalra, in Tier-II and -III cities.

A Novartis spokesperson said: “During the hearing (at the high court) on March 28, a statement has been recorded by the court whereby Biocon will not manufacture, sell or export vildagliptin for commercial purposes till the next hearing.”

Biocon, however, maintained it had not been issued any injunction on vildagliptin; nor had it launched the product in India.

“There is no impact on our immediate plans for this product,” said the drug maker, adding it intended to operate within the parameters of applicable intellectual property laws.

According to Novartis, the basic compound patent on the vildagliptin molecule would expire in 2019 in India. Therefore, a launch by Biocon would infringe on its patent.

So far, in India, marketing approvals by the drug regulator have not been linked to intellectual property rights. Hence, even if a product is covered under patent, the regulator can approve its generic versions. However, the patent holder is free to challenge the generic maker, once the product is launched.