Should India allow data exclusivity, or just stick to data protection?

An interesting article on date exclusivity pulished in September 2006 issue of Business World by Gina S. Krishnan. Read on

Patently Contentious

Should India allow data exclusivity, or just stick to data protection?

GINA S. KRISHNAN

Interest groups are into their last round of hectic lobbying before the Satwant Reddy panel set up by the government decides on 6 September whether India should adopt data protection or data exclusivity in its patents regime under TRIPS Article 39.3. Reddy is the secretary, Ministry of Chemicals and Fertilisers.

The battle lines are clearly drawn between the lobby of innovator companies, mostly multinationals, and that of generics companies, largely Indian. They range from the Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers Association (IDMA), and the Organisation of Pharmaceutical Producers of India (OPPI, representing the MNC lobby), US pharma lobby PhRMA, to individual companies, interest groups and NGOs.

“According to TRIPS, India needs to ensure protection of data during the life of the patent. There’s no clause which restricts the exclusivity of use of innovators data beyond the life of the patent,” says D.G. Shah, secretary general, IPA.


It is vital to innovators that India goes for data exclusivity because that would allow them to make it difficult for generics companies to make and sell a drug profitably even after the patent on it has expired. Generics companies, however, contend that such a regime would allow innovator companies to extend patent life beyond 20 years.
The price fall after patent expiry, as seen in the US, has been anywhere between 40 per cent and 80 per cent, depending on the size of the market and the number of companies that want to enter with generics. With the number of blockbuster innovator drugs coming to the market falling off in recent times, MNCs want to milk drugs they have discovered even after their patents expire.
As a member of the World Trade Organisation (WTO), India allows data protection. Patents are filed on a new chemical entity (NCE), or molecule, after it shows possibilities of developing into a usable drug. Thereafter, it has to go through development and trials and may, finally, get marketing approval, often more than a decade after the patent is filed. Data protection ensures that no other company can use the data generated to prove the usability of the drug during this period. Exclusivity ensures that this data cannot be used by others for 3-5 years after the concerned drug gets marketing approval.

Companies take the marketing approval for a specific country when they want to launch a drug there. It may be staggered across countries, and, therefore, may be valid even if the patent has expired elsewhere. Says Ramesh Adige, executive director, Ranbaxy Laboratories: “We support data protection. It should apply only to NCEs. Under no circumstance should it exceed the life of the patent.”

WTO members are divided over data exclusivity. While China has adopted it, Brazil has not. Nor have about 62 other WTO countries. “Data exclusivity is becoming such a contentious issue as it is not about respecting intellectual property, but about marketing exclusivity,” says an Indian industry insider.

Data exclusivity could also be used to carry out additional studies on a molecule beyond the life of the patent. Exclusivity or patent term extension could be sought and granted for isomers, new uses of existing products, and pediatric use of an old product. This is possible in the US and EU, which allow exclusivity.

India has to balance the interests of innovator and generic firms, keeping spiralling healthcare costs in mind. After all, it has one of the strongest generics drug industries in the world.