Cracks have surfaced again in the Indian Pharmaceutical Alliance (IPA), the exclusive club of top domestic pharma companies, on the contentious patent issue.

After Nicholas Piramal, which walked out earlier, it's now Ranbaxy Laboratories - the largest constituent of the alliance- which is singing a different tune. In what could be music to the ears of multinationals, the domestic major has favoured granting patents to even derivatives and sundry other offshoots of a new chemical entity (NCE). On the other hand, IPA is pushing for a much stricter definition, ie restricting patents only to NCEs.

Significantly, the latest spat in IPA comes when the Group of Ministers (GoM) under defence minister Pranab Mukherjee is in the process of finalising the third amendment to the Patents Act.

According to government sources, Ranbaxy has shot off a missive on patentability to the GoM, expressing its view which is divergent with IPA's. The company wants to retain Section 3 of the Patent Act as it is in the draft at hand, and avoid any expansion of the exclusion criteria on patentability.

The company, which sees opportunity for itself rather than threat from multinationals in a liberal patenting regime, repudiated IPA's allegedly protectionist view that salts, isomers, metabolites, polymers, solvents or such modifications of an already patented NCE should not be patentable.

When contacted, Ramesh Adige, vice president, Ranbaxy said, "Being a big spender in R&D, Ranbaxy is of the view that all products which are novel, innovative and of commercial utility can be patented. This would mean that a new drug delivery system (NDDS) should become eligible for patent."

By '07, Ranbaxy's R&D investment (above 6% of the turnover at present) is expected to touch Rs 900-1,000 crore, or 10% of the turnoverThough IPA and Ranbaxy are for retention of pre-grant opposition, the latter is pitching for a clause in the Act for time-bound completion of the proceedings.

However, despite the difference of opinion, sources said Ranbaxy is unlikely to desert IPA. Apart from Ranbaxy, ten other domestic pharma biggies including Dr Reddy's, Sun Pharma, Torrent, Wockhardt, Glenmark, Cadila Healthcare and Lupin are members of the IPA. Cipla had earlier walked out of the alliance as the generic drug major felt that IPA's combativeness would not help.

On the patentability issue, IPA stands for tightening of the criteria so that "ever-greening" of patents cannot take place. As per the TRIPS agreement, a patentable invention should be the one "involving an inventive step" and "capable of industrial application."

The draft for third amendment to the patent act which the GoM is discussing, does not deconstruct these terms to the satisfaction of IPA. The alliance's fear is that leaving the patentability criteria ambiguous could lead to grant of bad patents, at the cost of the generic industry. Consequently, the consumers will have to pay higher prices for the patented products.
In the US, where the law is more liberal on patentability, a large number of frivolous patents happen to be issued, resulting in tortuous litigation, points out IPA.