The Hindu Business Line : Concern rises within Govt over default on patents deadline

WITH only a few days to go for the patents deadline to lapse, the Government has expressed serious apprehensions on the fallout of any default in its commitment to introduce a product patent regime by January 1, 2005.

The Ministry of Commerce and Industry, which is piloting the Patents (Third Amendment) Bill, has said that besides raising a question mark over the country's credibility in the international arena, there could be "serious legal implications" if the laws are not made World Trade Organisation (WTO) compliant within the deadline.

In a comprehensive note on the issue, the Ministry has pointed out that the Government would have no legal basis to defend the default as the country had already exhausted the 10-year transition period provided to move from a process-patent regime to a product-patent regime.

It further said that India could throw itself open for being dragged to the international legal forum by other WTO member countries.

The non-compliance with the WTO commitment would directly impact the medicines or drugs industry, the food sector and other substances produced by chemical processes.

The note indicates that a major area of concern for the Government is the over 4,500 applications currently posted by various pharmaceutical companies in the Mail Box facility.

This could lead to a legal vacuum, as there is no clarity on whether the Mail Box facility would continue to exist or cease to do so.

Also, there would be uncertainty on how new patent applications would be treated after January 1, 2005.

Meanwhile, as the ambiguity surrounding the Ordinance on the Patents Bill continues, sources said that deletion of Section 5 of the Act would be the key. The deletion of this would enable the Patent Office to grant both process and product patents in all fields as per the TRIPs (Trade-Related Intellectual Property Rights) agreement.

The Group of Ministers (GoM), constituted in August this year, had agreed to both pre-and post-grant opposition hearing of patents.

While a window of 90 days would be provided for companies to challenge patent applications is proposed before a patent is granted, post grant opposition would be allowed any time during the lifetime of a patent.

These safeguards are present in countries such as China, Brazil, Japan, Korea, USA and the European Union.

Also, safeguards have been proposed to prevent evergreening of patents. Patents would be granted to inventions and not to discoveries, said sources.

The GoM has also been in favour of scrutinising all the Mail Box applications and has rejected the request by domestic companies seeking waiver from patent infringement.

It felt that such a move would go against the TRIPs agreement and would infringe the rights of the patentee.

The GoM also felt that safeguards already exist to ensure the availability of drugs.

In case of a national emergency, the Government could in public interest, go in for parallel imports and import medicines for distribution.

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