The Indian government last week set up a four-minister committee to examine the more controversial aspects of the country's draft Patent Bill, as the deadline for implementing India's obligations under the TRIPs Agreement draws closer.

Pharmaceutical companies in India are gearing up for last-ditch lobbying over the new law. India has pledged to put in place a product patent regime for pharmaceuticals by January 1 2005.

At present drugs can only be protected by process patents, a situation that has allowed local generic drugs makers that specialize in reverse engineering pharmaceuticals to flourish.

Now generic and originator companies are fighting over the details of proposals to bring India's drug patent regime closer in line with those of developed countries.

Last week DG Shah, secretary general of the Indian Pharmaceutical Alliance – which represents many of the country's generic drugs companies – warned that plans to reintroduce the same Patent (Amendment) Bill originally tabled by the former BJP government could raise drugs prices in India and encourage frivolous litigation.

The clash between largely foreign originator companies and their generic rivals is centered on the sections of the bill dealing with patentability, compulsory licensing and patent opposition procedures.

Generic drugs companies are calling for the government to add a new clause to the bill, that would expand the list of non-patentable inventions.

In a letter to Kamal Nath, the minister of commerce and industry, the Indian Pharmaceutical Alliance said that "the patenting of marginal changes or improvements to the form of previously patented compounds would promote evergreening of patents, delaying the entry of generics; encourage abuse by patent holders to the detriment of consumers; and deprive domestic industry of a potential advantage to push exports of drugs and pharmaceuticals".

But Ajit Dangi, director-general of OPPI, the Organization of Pharmaceutical Producers of India, which is dominated by foreign originator companies, told MIP Week that there should be no carve-out for drugs when it comes to deciding what is patentable and what is not.

"We think that the normal criteria – whether an invention is novel, non-obvious and useful – should be applied to pharmaceuticals just like any other invention," said Dangi.

Dangi's organization has also urged the government to rewrite sections in the draft bill dealing with compulsory licensing. Originator companies say that as drafted, the government has retained discretion to grant compulsory licences when the reasonable requirements of the public are not satisfied or the patented invention is not available to the public at a reasonably affordable price – measures that they say go above and beyond what governments can do under the TRIPs Agreement.

On patent opposition, the Indian Pharmaceutical Alliance has appealed to the government to retain a pre-grant opposition system – a system that would be ditched under the bill drafted by the previous government. In his letter to the commerce minister, DG Shah said that abolishing pre-grant opposition would remove a check on the grant of frivolous patents and avoidable litigation and could lead to foreign companies claiming patents on several products, including HIV/AIDS medicines that are already in the Indian market, and forcing their withdrawal through court injunctions.

"Thus, suddenly a large chunk of the pharmaceutical market will be turned into a patent protected market. The consequential sharp increase in their prices could be an embarrassment for the Government," said Shah.

The two sides are also divided on the cabinet decision to refer the draft legislation to a ministerial committee. Yogin Majmudar, president of the Indian Drug Manufacturers' Association, which represents domestic drugs companies, said the bill should be discussed fully by all sections of the population and stakeholders before it is introduced in the Parliament, because it "would affect the right of access to medicine of the people at large in this billion-plus country."

"Within the Parliament also, it should be fully debated by representatives from all regions and parties before it is turned into a law. In this sense, we feel that reference of the Bill to a ministerial committee of the cabinet is a step in the right direction," added Majmudar.

But Ajit Dangi of OPPI said that there had already been extensive consultation on the decision to introduce a product patent regime for drugs. "The Joint Parliamentary Committee had two years of debate all across India and reviewed all the objectives. This exercise has already been done."

The ministerial group is expected to report back to the cabinet on its recommendations for the Patent (Amendment) Act by the end of the month.

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