Understanding India's New Patent Laws - Did the 2005 Patents Act engender a Western intellectual property rights culture in the country? - BioPharm International


Understanding India's New Patent Laws
Did the 2005 Patents Act engender a Western intellectual property rights culture in the country?

BioPharm International
Volume 21, Issue 4

"Patent and copyright laws in India are old and [out]dated, and they nowhere match the world standards," according to Franklin Lavin, US undersecretary of commerce for international trade, as quoted in the journal Managing Intellectual Property.13

Western firms doing business in India have a rather broad set of complaints over IPR issues there, extending beyond the weakness of India's patent law to include the patent office's growing backlog, India's slow judiciary process, and the theft of proprietary information.14,15

Alluding among other things to "unfair commercial use of undisclosed test and other data submitted by pharmaceutical companies seeking marketing approval for their products," and also to "weak enforcement" against IPR violations, the Office of the US Trade Representative (USTR) retained India on its IPR "watch list" in 2006, despite the country's patent law changes. India was placed on the USTR's "priority watch list" in early 2007.16–18

Will such measures force a deeper transformation in India's IPR processes? The need to maintain access to medicines for a large and relatively poor population, the need to keep local generics producers happy, and perhaps the general feeling that local businesses deserve a helping hand, all suggest that it would be politically problematic for India to adopt a fully Western IPR regime too quickly.

Moreover, there is no real economic pressure to back up those words. Far from curtailing trade with India, the West is outsourcing services and consuming Indian export goods at a prodigious rate—and the consumption of Indian pharmaceuticals is no exception. According to Milind Antani of Nishith Desai Associates, a legal counseling firm in Mumbai, "Even though we're seeing R&D and CRO outsourcing being done in India today, until data exclusion and IP protection laws are enacted and enforced, multinational corporations will need to think twice about entering into large-scale CMO relationships in India."


There is no obvious solution here, other than perhaps to wait for India to expand economically so that its citizens are sufficiently wealthy to manage within a more Westernized IPR system. Meanwhile, pharmaceuticals patents in such a country may be of limited use to Western innovators, who find they may have to sell their drugs much more cheaply than they do in the West, and more often by licensing them to the same Indian companies that contest their patents.11 When it comes to obtaining and enforcing drug patents in India, it may be that Indian drug companies have the advantage, being less likely to attract NGO opposition to their lower-priced drugs, and perhaps less likely, by virtue of their connections, to encounter delays in the patent application process. In this sense, the primary beneficiaries of India's new patent laws are the very Indian companies the laws were originally thought to threaten.?

Eric Langer is president and managing partner at BioPlan Associates,Inc., Rockville, MD. He is also the editor of Advances in Biopharmaceutical Technology in India, 301.921.9074,

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