The Supreme Court of India adjudicating on a special leave petition (SLP) by the Swiss drug major F. Hoffman-La Roche directed the Indian Patent Office to review the patent granted for Valganciclovir (trade name Valcyte) before January 31, 2009.

Roche had approached Supreme Court challenging the decision of the Madras High Court directing the Indian Patent Office to review the patent granted for Valcyte, an anti-infection drug used by HIV/AIDS patients. Madras High Court’s decision was in response to a writ petition filed by patient organizations who had petitioned that their opposition to the patent application was not given due consideration by the Controller before the grant of the patent for the drug.

The Division Bench of the Supreme Court along with the directive also observed that the Bombay High Court cannot dismiss the patent infringement suit filed by Roche against Cipla on Valcyte. The background to this observation is the patent infringement suit filed by Roche against Cipla for launching a generic version of Valganciclovir (trade name Valcept). In response to Roche’s patent infringement claim, Cipla made a counter-claim of patent invalidity.

The patent infringement suit now will be dependent on the outcome of the patent review. Though, as per a news report, counsels for Cipla pleaded the Bombay High Court to quash Roche’s claim for patent infringement based on the order of the Madras High Court, Bombay High Court has decided to consider the case only after the stipulated time given to the Patent Office to review the patent grant.

Opposition proceedings to grant of patents are bifurcated into pre-grant and post-grant opposition. Opposition to the patent as given under Section 25 of the Patents Act 1970 (as amended in 2005), is supplemented with Rule 55 of the Patent Rules 2003. Under section 25 sub-section 1 where an application for a patent has been published but a patent has not been granted i.e pre grant, any person, on any of the grounds enumerated therein, may represent by way of opposition to the Controller against the grant of patent. Post-grant opposition is provided under sub-section 2 of section 25 of the Patents Act, 1970. A notice of opposition may be given by any person to the Controller in the prescribed manner. The post-grant opposition may be filed at any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent on grounds enumerated therein.

The statutory provision is supplemented with Rule 55 of the Patent Rules 2003 according to which, the representation for opposition shall include a statement and evidence and a request for hearing if desired.