India government seeds stronger IP protection with agrochemicals

Signalling a policy shift that would allay the global concern that India’s intellectual property rights (IPR) regime is not strong enough, the Narendra Modi government is set to give statutory backing to “data exclusivity” (DE) for agrochemical innovations and lengthen the period of protection to five years from three now. Sources said the Cabinet would soon consider a proposal to include the stronger DE regime for agrochemicals in the Pesticides Management Bill, 2008, which is pending in the Rajya Sabha.

While the move would benefit global chemical giants like Bayer, Syngenta, BASF, Dow, Monsanto and DuPont, it is also seen as a precursor to similar exclusivity for pharmaceutical majors. The DE for agrochemicals was first granted in India in 2007, through an executive order. This followed recommendations from a high-level inter-ministerial committee.

Big Pharma has long lobbied for data exclusivity, that is,a guarantee that the valuable test and other data they submit to the regulators for marketing and pre-marketing (clinical trials) approvals for new chemical entities (NCEs) won’t be disclosed to a third party who can potentially put it to unfair commercial use. Once DE , which is arguably a TRIPS obligation and has examples in many countries including the US, Canada, China and South Korea, is granted, the regulator will be barred from not only disclosure of the data, but also from relying on the innovator data for giving approvals for copycat versions.

The US government has consistently backed this claim, and the issue repeatedly surfaced in high-level meetings between the two countries.

Local drug companies have, however, opposed data exclusivity and got the backing of various wings of the government including the health ministry, which wants to promote cheaper generic drugs. According to generic drug companies, although the demand for DE would, on the face of it, appear justified, it could be misused by the patent holders to prolong the patent life of a product.

To illustrate, after a patent on an NCE is granted, it could take eight to nine years on average for the firm to take the product (medicine or agrochemical) to the market after completion of all regulatory tests. If a new drug, for instance, is launched in the western markets in the 12th year of patent, its launch in India could get delayed further to, say, the 17th year of the patent, whose usual term is 20 years. In such cases, a five-year data protection could undermine generic ventures and the patent owner could enjoy an extended period of marketing exclusivity, the generic companies argue. However, the innovator pharma companies refute this saying drug launches in India are no longer delayed. The actual commercial exploitation of patents, they add, is for periods much shorter than 20 years.

DG Shah, secretary general, Indian Pharmaceutical Alliance, said: “We will soon write to the ministries concerned and the prime minister against the move to introduce DE in Indian law. We will join issue with Swadeshi Jagaran Manch.”

A parliamentary standing committee on agriculture has favoured enhancing DE for agrochemicals to five years, a position that the government has now supported, sources said, adding that a Cabinet note is in circulation to modify the relevant Bill.