Nithya Subramanian

New Delhi , Jan. 10

WITH the product patent regime in place, all eyes are on how the Government grants patents to the over 4,500 applications pending in the mail box.

While the domestic pharmaceutical industry has been maintaining that the Ordinance does not clearly define patentability, Government officials acknowledged that this has deliberately been kept open-ended.

"The Commerce Ministry had some problems in coming up with a clear definition of patentability and, therefore, it has been left to interpretation. While there could be huge litigations when the first few patents are granted, a clearer picture would emerge subsequently," said a senior Government official.

The Act says inventions cannot be defined as a mere discovery of a new property or new use for a known substance or of a mere use of a known process, machine or apparatus unless such a known process results in a new product or employs at least one new reactant.

Also, a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such a substance cannot be called an invention.

According to Mr D.G. Shah, Secretary-General, Indian Pharmaceutical Alliance , "There could be applications for generic versions of drugs for which pharmaceutical companies could have received their first patents in the late 1970s or early 1980s in the US. On expiry of the first patent, a second patent could have been granted for trivial changes made by them. How would the Patents Office treat these applications?"

For example, Aventis was granted a patent for Fexofenadine Hydrochloride, an antihistamine, in 1979 in the US. The first patent in the normal course would have expired after a 20-year period, in 1999. But the company obtained a second patent in 1996 claiming that it was a "substantially pure compound", extending the patent life to 2006.

"The second patent becomes a hurdle for generic products, as they are also substantially pure," said industry sources.

Similarly, Oxcarbazepine (a central nervous system (CNS) drug) patent was granted to Novartis in 1970 for 20 years. Subsequently, the company obtained a second patent in 2003 claiming "particle size" of certain specifications.

Currently, generic versions of both these drugs are available in the country. The total market for the antihistamine drug till November 2004 has been pegged at Rs 30 crore with companies such as Ranbaxy and Dabur manufacturing them, while the total sales of the CNS drug is estimated to be at Rs 15.7 crore with Wockhardt, Sun Pharmaceuticals and Cadila selling generic versions.

Mr Harinder S. Sikka, senior President, Corporate Affairs, Nicholas Piramal India Ltd, said, " The Government, in its Ordinance, has provided a clear definition of what can be patented and what cannot be. Only invention, and not discovery, will be patented and there is unnecessary speculation in the industry."

© Copyright 2000 - 2009 The Hindu Business Line