The multinational drug lobby has succeeded in incorporating several clauses to protect their interests in the patent bill and when the government actually starts implementing it the left parties should be alert to form an alliance with the concerned health and legal experts to monitor the implementation according to Dr B Ekbal, renowned left health activist and National Convener of Jan Swasthiya Abhiyan (JSA).

The wording of some of the clauses of the bill is as vague and ambiguous with room for interpretations, to help the interests of the multinational drug lobby.

The bill permits generic manufacturers to continue producing generic version of new drugs, which are in the mailbox. However, this only applies where the generic producer has made a 'significant investment' and will have to pay a reasonable royalty. The question of 'significant investment' poses a threat of potential infringement suits as the generic producer would have to clearly show that it has made what would be considered a significant investment in producing and marketing the generic drugs. With respect to the `reasonable royalty' it creates the problem of excessive demands from the patent holder and litigation. The reasonable royalty rate should have been fixed at a particular percentage, the norm being 4 per cent, opined Dr Ekbal, in an e-forum communication.

The Bill demands the patentee to show that the invention includes a `technical advance' or has economic significance, or both. The provision should have required the applicant to comply with both requirements for an inventive step, namely existing knowledge and having economic significance. Otherwise, the requirement of technical advance is compromised and diluted by the fact that a patent could be simply granted on economic significance alone, which should not determine the inventive step of a patentable invention.

Similarly, in the case of compulsory licensing, the amendment does not remove the existing requirement that only after three years after the grant of a patent, can a person make an application to the controller for the grant of a compulsory license.

The provisions of the final bill, was accepted in the parliament, needs detailed examination by health and legal experts since a number of litigations are likely to come up in future. The main opposition against the bill were related to the criteria for patentability, patenting of life forms, granting of compulsory licensing, pre-grant opposition to the patent applications, continued production of the drugs patented after 1995 in the generic sector, and the export of cheap Indian drugs to the less developed countries.

In all these issues the rules in the ordinance were clearly in favour of the multinational drugs companies and against the interest of the Indian people and the poor in the less developed countries. The left parties brought in 12 amendments to the bill. The government with some modifications accepted most of the amendments of the left parties and two contentious issues i.e. the granting of patents to microorganism and the definition of news chemicals were left to expert committees for detailed study.

There were provisions in the ordinance to grant "secondary patents" lead to the perpetuation of Patents monopoly beyond the stipulated 20 years by repeated Patent grants based on small changes made to the original molecule. The amendments to the Ordinance tabled by the Government has now restricted the scope for the granting of patents on frivolous claims to some extend. Similarly, the bill had restricted the provisions to oppose the grant of a patent on various grounds. The new amendments have now restored all the original grounds in the previous Act of 1970 for opposing grant. The time for filing such opposition has also been extended from 3 months to six months.

The ordinance had a provision that the importing country would have to obtain a compulsory license before they can import drugs from India. It would have been impossible for the developing countries to import drugs from India because they can invoke compulsory licensing only after 2016 the date stipulated for these countries to implement the product patent regime. The amendments now clarify that the country can import from India without going in for compulsory licensing.

The major concern of many was that once patents and hence exclusive marketing rights are granted to drugs for which patent applications are already filed as per the "mail box" facility provided by the first amendment in 1999, the cheap generic varieties of these drugs produced by Indian companies cannot be marketed. The new amendments have now clarified that such Indian companies who are already producing these drugs can continue to produce them after payment of a royalty even if the drug is placed under patent.

There have been widespread concerns that the process of grant of compulsory licenses to counter the monopoly of patents may take too long and thus defeat the whole purpose for the application for compulsory licensing. This has been addressed by the amendments by specifying that the reasonable time period before the Patents Controller consider issuance of a compulsory license when the patent holder denies such a license shall not ordinarily exceed six months.