Pre-grant opposition to drug patents likely to be restored
Domestic pharma companies can breathe easy. The Group of Ministers (GoM) on Patent Law may restore the facility of pre-grant opposition to patents, which the previous NDA government allegedly proposed to withdraw.

The scrapping of the pre-grant objection provision in the Patent Amendment Bill 2003 caused a lot of heartburn amongst the domestic pharma companies which saw that it would lead to grant of frivolous patents.

The commerce and industry ministry is piloting a proposal to the GoM. It will propose making it obligatory on the patents controller to issue a "speaking order" before disposing of a pre-grant representation.

This means a person will have the right to challenge the controller's order in the court and withhold grant of the patent. The proposal for mandatory speaking order is expected to address the concerns over the changes in provisions for contesting a patent, mooted in the bill drafted by the NDA government, officials said. The bill will be modified accordingly. "The bill will have no provision to fetter the authority of the courts," clarified a senior official

On September 21, chairman of the GoM, defence minister Pranab Mukherjee had detailed discussions with commerce and industry minister Kamal Nath on the issues relating to the proposed amendment to the Patents Act.

Government sources clarified that the proposed amendments would not dilute the scope for contesting possible grant of a "bad patent". "After the mandatory publication of the patent application, there will be a minimum period of seven months to make a representation, disputing the patentability of the relevant invention. In the proposed system, the application would be published even prior to the notification of acceptance," sources said.

Following the proposed changes in the bill moved by the previous NDA government, domestic pharma majors had pointed out that facility for pre-grant opposition is crucial in a patent system. Patent examiners are not infallible. If a bad patent is granted, a post-grant legal resolution may take years, and by the time, the holder of the patent will have enjoyed the exclusivity.

The government, on the other hand, thinks that the time taken for processing and grant of patents has been a matter of concern. The delays, the government argued, were also substantially due to statutory provisions, which prescribe lengthy time lines for each stage/level of processing.

In respect of existing provisions relating to opposition, it has been noted that a notice of opposition, when filed, becomes a quasi-judicial proceeding and hold up the processing of patent application till the proceedings are finalised.

The government had pointed out that bill provided opportunities for representation against patent applications by third party and opposition and revocation of patents under section 25 (1) (a) and (b) and Section 25 (3). However, of these sections, pre-grant opposition pertains to only Section 25 (1) (a) and (b).