The Indian Pharmaceutical Alliance (IPA) has cautioned against the possibility of a steep increase in the prices of several fast moving drugs if the Patent Amendment gets Parliamentary nod in its forthcoming session.

Rejecting the claims of the Central Government that patent amendment will not affect the availability and affordability of essential drugs, IPA has said that in the absence of a clear definition for patentability, evergreening of pre-1995 drugs would happen in the country.

As an example, IPA has highlighted the case of Aventis that got a second (US) patent for its "substantially pure" Fexofenadine hydrochloride in 1996, thereby extending its patent life to 2006. The IPA considers this as a case where first the patent is obtained (Aventis obtained first patent for the product in 1979) for the compound without any reference to purity. Thereafter, a patent is sought for a "substantially pure" compound. The second patent becomes a hurdle for generic products, as they are also "substantially pure". Under the present situation, where legislation is to permit patenting of trivial changes, this drug would become eligible for product patent as a post-1995 molecule. The sale of the product in India is Rs 30 crore.

The IPA also pointed out the case of Novartis obtaining a second patent for Oxcarbazeopine in 2003 claiming difference in the particle size of the new product. Here the first patent was obtained for the compound without any reference to particle size. Thereafter, a patent is sought for a particle size compound. The second patent becomes a hurdle for generic entry. Under the present conditions, this product can also become eligible for product patent in the coming days. The total sale of Oxcarbazepine in India is Rs 16 crore. IPA fears that of the 7000 odd mailbox applications, majority is of similar requests. According to D G Shah, secretary general IPA, the impact of patenting trivial changes could be severe with drugs worth Rs 3,000 crore coming under the cloud of compulsory withdrawal. The situation would harm both the drug companies as well as the patients. The patients who were on the drug regime for years, will soon find them off the shelves. For the industry, it is going to be a major economic loss," he said.

The two possible outcomes of the Patent Law Amendment would be the increased number of litigation, and the non-availability of drugs for long-term use, he warned. The official version that -only 3% of the drugs would be affected due to patent regime- was also countered by him. According to Shah, the US-based multinational companies had submitted their plea to USTR stating that they were losing US$ 1.8 billion annually from Indian market due to the process patent regime that exists here. "When US companies themselves claim that they were losing a business worth 40% of Indian domestic annual sales, how can the government say that it would be just 3%," he asked.

IPA felt that by their current actions, the government was alienating the entire developing nations. "The developing world feels betrayed by India as they are letting down developing world's right for access to low cost medicines for Indian interests in textile sector," he alleged.