Multinational drug makers seem hell bent upon forcing the government to alter the patent regulations in their favour.

In the latest move, a study funded by the Innovation, Development, and Employment Alliance of the US Chamber of Commerce has called for dropping Section 3 (d) of the Indian Patents Act, 1970, which has been a protective shield against frivolous patenting, much to the chagrin of Big Pharma.

The report, titled the value of incremental pharmaceutical innovation: benefits for Indian patients and Indian business, extols the virtues of patenting of "incremental innovations," and reasons that it benefits Indian drugmakers and patients just as well.

Incremental innovation refers to innovations based on existing knowledge and existing products.
"Incremental innovation is just a glorified term for ever greening — extending the patent monopoly by bringing out trivial changes to an already existing patented product," says a New Delhi-based healthcare and international law expert.

Section 3 (d) of the Indian Patents Act holds that mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance shall not be treated as an invention within the meaning of the Act.

The clause has been crucial in preventing patent grants to a slew of applications by multinational companies recently.

Patent applications by US-based Pfizer (for cholesterol and blood pressure drug Caduet), UK-based GlaxoSmithKline (for rosiglitazone salt, used for treating diabetes), Swiss major Novartis (for alpha crystalline form of leukaemia drug Glivec), and US-based Gilead Sciences (for bird flu drug Tamiflu) were all rejected by the Delhi Patent Office for being mere modifications or extensions of known salts.

The US study, a copy of which is with this newspaper, argues that incremental innovations can lead to a decrease in costs and increased access to drugs by reducing overall treatment costs and hospitalisation.

It specifically states that removing Section 3 (d) would allow all incremental innovation, including pharma innovations, to undergo examination and be treated in the same manner regardless of industry, field, or technology.

IP experts counter this argument.

"Section 3 (d) has often been a cover against frivolous patenting of drugs. The developed world and MNCs were never comfortable with it. All this is part of a larger ploy to monopolise the medicine market in India," says a leading Mumbai-based intellectual property (IP) expert."Patenting means giving monopoly to the inventor; and monopoly means sole right to determine pricing. How can it lead to a decrease in costs and increase access to drugs?" the expert asks.

The study goes on to state that a removal of Section 3 (d) would spur foreign direct investment as MNCs look upon India as an ideal location for clinical trials due to low costs and large patient pool.

Incremental innovations would also be good for local Indian companies who don't have the capability of developing entirely new drugs, it holds. Amit Sengupta, secretary of All India People's Sciences Network, who also feels that an increase in grant of patents leads to a rise in monopoly and thus a rise in the prices of drugs, offers a counter argument. "Patenting incremental innovations does not encourage innovation as, instead of coming out with truly novel products targeting diseases which don't have enough drugs, companies will try and keep coming out with different versions of existing molecules."

For all that, however, this is not the first time Section 3 (d) has been questioned. Around three years back, Novartis had challenged the validity of the clause, which provided one of the grounds for rejection of the Swiss company's patent application for the beta crystalline form of imatinib mesylate (Glivec).