India’s patent office has announced new rules for examining compulsory licence applications, which include allowing patent-holders to present their case before the office decides whether or not to grant the application.

Local generic drugmaker Natco Pharma has applied to manufacture Pfizer’s cancer drug Sutent (sunitinib) under compulsory license for export to Nepal. The Indian patent office decided to seek Pfizer’s opinion before granting the license, a move which was opposed by Natco on the grounds that this was not required under the legislation – Section 92 (A) of the Patent Act and the Patent Rules of 2006 – because, as compulsory licenses are intended to deal with public health emergencies, the law is not specific about how they are issued.

However, in a decision on July 4, the patent office rejected Natco’s claim, and has issued new rules stating that hearing the patent-holder’s arguments would be helpful in deciding the terms and conditions for granting a compulsory licence and could also be of use in avoiding abuses of the Act’s provisions.

Observers point out that Natco, which is the only Indian generic drugmaker so far to make use of the country’s compulsory license rules, had not provided evidence to the office that Nepal was facing a public emergency due to the fact Sutent is unavailable in the country. The firm is also applying for a compulsory license to manufacture and export Roche’s cancer drug Tarceva (erlotinib) to Nepal.

The patent office will now hear Pfizer’s views and enable Natco to respond.

Indian patent applications plummet

Meantime, it is reported that Indian drugmakers filed only 449 patent applications in 2007-8, a drop of 41% on the 765 filed in 2006-7 and the first decline in four years.

After the amended Indian Patent Act took effect at the beginning of 2005, requiring drugmakers to file product rather than process patents, many Indian firms began filing defensive patent applications, but these are expensive and time-consuming and the majority have not, so far, translated into granted patents. Also, the requirement to supply clinical trial data with patent applications is making the approval process much longer, while some firms have begun applying for patents overseas rather than India, industry sources point out.