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In what is perhaps the first domestic patent for a new chemical entity (NCE) by an Indian company, drug research company Glenmark Pharmaceuticals has received a patent for its asthma molecule oglemilast from India’s patent office. The molecule is presently at advanced stages of clinical trials and the company plans to launch the drug in India by 2010-2011.

The company received the patent for the same molecule in the US in May this year. The Mumbai based company has entered into a drug development and marketing agreement with Forest Lab in 2004 for $190 million and an additional royalty payment (said to be in the mid-teens) on commercialisation in the US market, in one of the biggest drug development deals signed by an Indian company. For the Japan market, the company has entered into a similar arrangement with Teijin Pharma. The Indian company holds the marketing rights for the rest of the world (outside Japan and the US).

According to sources, oglemilast is an oral anti-asthma drug which could be the first in class in the category and could rake in sales of $2-$3 billion globally. Experts say the exact upside of Glenmark Pharmaceutical’s patent success can be ascertained when it is known if it is actually the best in class, and whether there will be similar drug alternatives available in the market. However, it is a significant step for the domestic pharma industry.

A Glenmark spokesperson said, “The patent 363/MUM/2003 protects GRC 3886 PDE IV molecule (for asthma and COPD). Also this is the first patent protection as regards to NCE for the company.” Once a company gets a patent, it will be able to market the drug with no competition from generic drugs.

The molecule has completed phase II(A) trials and will start Phase II(B) trials soon. The company’s other anti-diabetic molecule has received patent protection in the US and the Indian patent office is now examining the company’s application. Says Ernst & Young’s partner and national health sciences leader Utkarsh Palnitkar, “This shows the evolution and the ability of Indian companies to develop new drugs. Some Indian companies have taken this route since 1995 and have invested in discovery research and Indian companies can get similar patents in India.”

Since India became enacted legislation making it trade-related aspects of intellectual property rights compliant in 2005, both domestic and global pharma companies filed thousands of patent applications. Between, 1995 and 2004, the patent office had received around 8,000 applications.

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