On the heels of several drug patent applications facing pre-grant oppositions from local drug makers and non-governmental agencies, the Organization of Pharmaceutical Producers of India, or Oppi, an industry body representing the foreign-owned drug firms here, has reiterated its demand for removal of this provision in the Indian patent law.
The association, which has been lobbying for a review of the newly amended rules to make it more compatible with the international patent laws, says this provision has been widely misused by interested parties to unnecessarily delay the application process.
Ranga Iyer, managing director, Wyeth Ltd, and the newly elected president of Oppi, said the Indian intellectual property protection law has already incorporated “enough precautions against frivolous patenting...By including this unique provision for pre-grant opposition, which allows anyone to oppose the patent claims before the grant, are mainly used here to delay the process one after another.”
Pre-grant opposition is not a common provision in many countries. India amended its intellectual property law pertaining to pharmaceuticals and agrochemicals in 2004 to comply with its commitment to World Trade Organization to commence product patent regime in these two areas in the country by January 2005.
The amended law provides opportunity for opponents to file objections to patent claims by drug firms before and after granting the patent. Known as pre-grant and post-grant oppositions, these provisions are being largely used by local drug companies who make generic or copy versions of drugs invented by others.
The Indian law also has an additional rule, which prevents patent protection to minor modifications or innovations of known or existing drugs, unless the efficacy of the drug is enhanced significantly by the innovation. Iyer says, “This provision is also not very clear as there is no parameter fixed to measure efficacy.”
There are at least 150 pre-grant oppositions and a dozen of post-grant oppositions pending with the Indian patent offices. Gopakumar Nair, a patent attorney in Mumbai, says that the pre-grant oppositions was allowed in the Indian patent law because it gives an opportunity to a citizen of the country to present his/her objection to claims in patent application before the patent office takes a decision on granting the patent. Suresh Kare, president, Indian Drug Manufactures’ Association, which represents local drug makers, said, “Since majority of the 9,000 drug patent applications filed in India are not exactly on genuine innovations, strong provisions for opposing and scrutinizing them are imperative here.”