The Telegraph
Friday , April 4 , 2014
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Novartis, Biocon lock horns

Mumbai, April 3: Novartis has taken Bangalore-based Biocon Ltd to court for allegedly infringing its patent on an anti-diabetes drug.

The Swiss pharmaceutical giant filed a case in the Delhi high court against Biocon last month, seeking to stop Biocon from coming out with a generic version of its anti-diabetes drug Galvus.

Galvus (vildagliptin), used to treat type-2 diabetes, is one of the major drugs for Novartis. According to its annual report for 2013, the “blockbuster” drug recorded sales of $1.2 billion for the year,marking a growth of 40 per cent.

Novartis contends that a generic version of the drug cannot be launched in the country as the patent for the basic compound, which was registered in 1999, is valid till 2019.

The Delhi high court will hear the matter on April 28 and has ordered that Biocon cannot manufacture or sell generic Galvus till the next court hearing.

Biocon, however, contends that while it has not been issued any injunction, it has also not launched the product here in the country and that it respects all valid patents.

Incidentally, this is the second patent battle that Novartis is fighting with regard to Galvus.

Last month, the Delhi high court issued an injunction against Wockhardt, which had challenged the validity of the Galvus patent at the Intellectual Property Appellate Board. The Delhi high court will hear the dispute between Wockhardt and Novartis on May 20.

India is known as the diabetes capital of the world and, therefore, the segment is fiercely competitive with domestic players seeking to make generic versions of popular drugs.

This is not the first time that the domestic pharmaceutical industry is witnessing patent fights between local players and the innovators. Last year, Glenmark had launched a generic version of Merck’s anti-diabetes drug Januvia.

This had led the overseas company to file a suit in the Delhi high court against Glenmark for patent violation.

Multinational pharma companies have often in the past complained about India’s weak intellectual property regime and pointed out that if the situation continues, they may be forced to hold back investments. Some of the laws that have made them uncomfortable include that relating to compulsory licensing.

Under the law, the government can permit third party manufacturers to make a particular drug if that is unaffordable or in short supply. This can be done even if the patent in that drug is in force. It may be recalled that in 2012, Natco Pharma was granted a compulsory licence for Sorafenib Tosylate (Nexavar owned by Bayer). Nexavar is the first-line treatment for liver and kidney cancer.

The compulsory licence enabled Natco to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets (one month’s therapy) against Rs 284,428 being the cost of Naxavar sold by Bayer.

Novartis was in the news last year when its attempt to win patent protection for an anti-cancer drug Glivec failed after the Supreme Court ruled that it did not see it as a new drug.

The Biocon share today closed lower at Rs 434.35 on the Bombay Stock Exchange against Wednesday’s close of Rs 439.50.