The Hindu Business Line : No spiralling of drug prices, says Kamal Nath

THE Government has promulgated an Ordinance to amend the Patents Act paving the way for a product patent regime applicable to the drugs, food and chemicals sector in accordance with the commitment made to the World Trade Organisation (WTO).

This makes the Indian patents laws WTO-compliant within the stipulated January 1 deadline.

At a news conference, the Commerce and Industry Minister, Mr Kamal Nath, sought to allay fears of spiralling prices of medicines and said that 97 per cent of all drugs manufactured in India are off-patent and will remain unaffected.

"A feature of patent protection is that it spurs research so that constantly alternatives keep appearing in the market. Thus price control is inherently built in," he elaborated.

The ordinance will delete the provisions related to the exclusive marketing rights (EMRs) as this would become redundant and introduce a transitional clause for safeguarding EMRs that have already been granted.

The Government has also initiated modifications in the provisions related to pre-grant and post-grant opposition to patent applications in the Patent Office.

The processing time for grant of patents would also be reduced drastically from the earlier nine years to about four years now, Mr Kamal Nath said.

The ordinance seeks to protect Indian industry from infringement proceedings for any violation of patents prior to the ordinance.

"We have specifically provided that patent rights for mail box applications will only be made prospectively," said the Minister.

"This would mean that patent holders can seek damages for generic versions of products only from the day the patent is granted and not from the time the drug was introduced in the market. This is in accordance with provisions under the Article 70 of TRIPs, wherein, countries can safeguard their domestic interest," said Mr D.G. Shah, Secretary General, Indian Pharmaceutical Alliance (IPA).

In order to prevent evergreening of patents, Mr Nath said that new use of the existing products or any new property of known substance would not be patentable.

Other safeguards such as conditional grant of patents that will allow for imports of drugs for public health distribution, revocation of patent in public interest, grant of compulsory licence, acquisition of invention and patent for public purpose by the Government and allowing parallel imports are being allowed.

Also a clarification of the provisions relating to patenting of software related inventions when they have technical application to industry or are in combination with hardware.

Elaborating on the ordinance, the Minister said that this was only an interim measure and the Bill would be discussed in the Budget session.

Admitting that the decision on patents was a "difficult" one, the Finance Minister, Mr P. Chidamabaram, said in his address at the FICCI AGM that the move would enable industry to remain competitive and also help Indian scientists to reap the advantages of patent protection.