The Hindu Business Line : Data Exclusivity law brooks no delay

India is a rule-of-law country. As the Commerce and Industry Minister, Mr Kamal Nath, has noted, the ethos of India is a great respect for intellectual property. It is important, he added, for India to have a good data exclusivity (DE) law.

India is globally competitive and has no more reason to resist its obligation in this area than in the area of patents, where it adopted product protection last year. Bringing the DE debate to a positive conclusion would be good news for India's patients, drugs producers, and civil society.

Benefits for Patients

DE will bring more, newer drugs to the market faster by ensuring a return on investment to the innovator. In developing countries including Mexico and Jordan, DE has improved access to new medicines, increased clinical research opportunities for patients, and resulted in safer administration of drugs.

Benefits to industry

Data Exclusivity protects the incremental innovation — new drug delivery systems (NDDS) and improved formulations at which Indian companies excel — whether or not they are considered patentable. Undoubtedly, Indian companies such as Ranbaxy, Nicholas Piramal Labs and Dr Reddy's Labs will bring pioneering compounds to the market on time and under budget. But it is likely that many more Indian firms will come up with an NDDS or once-daily dosage, just as Ranbaxy did years ago for Bayer's Cipro. It is important for Indian companies to be protected against unfair use of their clinical dossiers.

Incentives for FDI

With so many MNC innovators now in tie-ups with Indian firms, both sides will benefit from improved IP protection making India's knowledge economy more appealing to foreign investors.

The line between an innovator and a generic company is blurring. Ranbaxy is just one example of a generic company increasingly focused on innovative research, both in bio-pharmaceuticals and chemically-synthesised molecules. Novartis has been successful in developing innovative drugs even while competing with Teva as the global leader in generics. Merck has launched an authorised generic version of its own post-patent Zocor, while Pfizer has done the same with Zoloft, for which the patent just expired.

No Evergreening

Ninety-nine times out of hundred, Data Exclusivity does not extend the life of a patent. This makes sense because DE runs at the same time as the patent, from the date of marketing approval, and nearly always expires before the end of the 20-year patent.

No Threat to Civil Society

Countries that rely heavily on lower-cost generic products have successfully implemented DE, including Central European nations, where generic pharmaceutical industries supply up to 70 per centof all drugs. Central European states now provide at least six years of exclusivity from unfair commercial use, with no reported significant impact on the cost of healthcare, or the health of their important generic companies. Turkey, which enjoys a very strong generic sector, also provides a six-year term of data exclusivity. Israel, home to Teva and stringent price controls, implemented a Data Exclusivity period of five years for innovative products on the Israeli market.

As Opposition Leader, Dr Manmohan Singh, had said that he saw protection of clinical dossiers as a moral issue, noting that it was simply wrong for one party to gain from another's time and effort to generate the clinical research submitted to the health regulatory authorities. So positive resolution of DE is overdue.

(The author, founding Executive Director of the American BioIndustry Alliance, heads Finston Consulting, LLC and recently founded BayhDole25, an NGO focused on technology transfer.)