Pfizer in News

Data Exclusivity may be capped at 4 years
Publication : Financial Express, August 25, 2004

Sanjay Sardana
The Union government is mulling the option of not enacting data exclusivity for a period beyond four years. It believes that once product patent comes into force, the protection of a product is for 20 years.

The government feels that enforcing data exclusivity again will tantamount to further greening of the patent for a product.

The government is also keen to make provisions of compulsory licencing (CL) less stringent so that it can be used to manufacture cheaper drugs in case of national emergencies.

Secretary, chemicals, Pratyush Sinha, is heading the inter-ministerial committee, constituted by the ministry of chemicals and fertilisers, which is in the process of finalising a report on data protection. But the government's thinking goes against the thinking of some of the multinational and domestic research-based pharmaceutical companies, which are in favour of data protection so that it cannot be misused.

The committee will be meeting on August 25 to take the issue further. Mr Sinha had earlier sought suggestions from various ministries including science and technology, agriculture and commerce & industry.

The 14-member committee has been set up to examine whether data protection can be offered under the existing legal provisions. The ministry of health, in its recommendations, has said that India already has necessary legal provisions to protect the data submitted by the innovator companies and hence there is no need for any further protection.

Nicholas Piramal president Harinder Sikka told FE, "It is very important to provide a five-year data protection as is done by all countries. It will also help research in India and increase substantial investments in clinical
research."

"I feel that the five-year data protection must mandatorily lapse within the 20-year patent life of a product. It will give enormous amount of comfort level to the investors," he added. "CL provisions need to be aligned to its initial
spirit. It must empower government to trigger or enact CL when faced with the need of invoking CL provisions under true health emergencies," Hocine Sidi Said, managing director, Pfizer, said while speaking at a seminar. He added that there was a need to remove commercial motivation and low thresholds.

The industry too is divided on the issue of data protection. While the majority of the home-grown pharma companies are not in favour of data protection, the multinationals and some of the research-based domestic companies like Nicholas Piramal favour it.

Multinational pharma companies feel that while India should be looking at new research, the government instead is concerned about copycats engaged in reverse engineering."A protectionist approach is likely to hurt. Bigger sufferer will be clinical research and tinkering with intellectual property will restrict foreign direct investment and may even push clinical research into countries like China," said an industry source favouring data protection.