10,000 product patents for drugs awaiting nod

With the introduction of the third amendment to the Indian Patents Law on January 1, the Indian pharmaceutical industry is set for an overhaul with the product patent laws being enforced.

Pharma majors in the country have accelerated filing applications for product patents. So far the Indian Patent Office is estimated to have received over 10,000 applications for product patents since the second amendment in the Indian patent law brought in 1995 and the first product patent is expected to be granted by the end of 2005.

"Pharma majors in the country such as Ranbaxy, Dr Reddy's, Cipla, Zydus Cadila Healthcare, among others have already filed product patents since the second amendment in the Indian Patent Law in 1995. Various companies are also working to oppose as many patents as possible on account of prior public information. However, the patent office has started processing the applications and the first patent will take at least a year's time to be granted," said Manoj Pillai, partner, Lex Orbis, to Business Standard on Wednesday. Lex Orbis, based in New Delhi, is a legal firm specialising in intellectual property practice.

Of the 10,000 plus applications, over 70 per cent are from foreign multinational companies and the remaining 30 per cent are from the Indian pharma majors.

The product patent applications received by the patent office are however not necessarily for the new chemical entities (NCEs) or new drugs.

Pharma formulations, compositions, synergistic combinations, new drug delivery systems (NDDS), novel dosage forms, herbal extracts among others (any claims other than for processes) are also covered in this list of applications.

"The Indian patent authority is going to have a tough job to examine these product patents. The patent office needs to be aggressively geared up to examine over 10,000 pending patent applications. In 2005, more new applications are expected to be filed, and the corporates are going to be the most demanding. However, we believe that the first product patent will be granted by the end of the current calendar year," said Gopakumar Nair, of Gopakumar Nair Associates, one of the leading patent and trademark agents based in Mumbai.

"The office of the Patent Controller General of India (PCGI) is located in Mumbai and its associated offices are in Chennai, Kolkata and Delhi. The infrastructure at the patent office lacks in technology and personnel. The government has allocated resources for development of patent offices, however, these need to be taken up speedily," said Pillai.

However, according to industry sources, the significance of an increased number of pharma-related applications for product patents is that more drugs would come under an exclusive umbrella, which would block local generic companies from making chemically-similar versions of these drugs. With this practice, the domestic drug industry feels that the drug prices are set to go up sharply.