[Ip-health] DNA India: Data exclusivity, a Trojan horse?

[Mike Palmedo]

http://www.dnaindia.com/report.asp?NewsID=3D1041730

Data exclusivity, a Trojan horse?

DNA India
Reghu Balakrishnan
Friday, July 14, 2006

IPA sees hidden agenda in MNC demand for extension of data exclusivity =96
delaying the launch of new products in India

MUMBAI: Data exclusivity (DE) has been a hot issue in the pharmaceutical
industry since India entered the new product patent regime in 2005. If
DE is implemented, the domestic manufacturers, who have been raising a
hue and cry against it, have to face another hidden problem in the issue
- extension of DE.

DE assures that the information submitted by the innovator while seeking
an approval for marketing will be kept confidential by the government
for a fixed period of time, especially from the generic drug
manufacturers who could make copycat versions using the data.

As the MNCs are pushing the government to implement DE for a minimum of
5 years, experts point out that the exclusivity may be continued even
after the patent has expired. In other words, Indian generics
manufacturers will not be able to manufacture or export the generic
version even after the patent is expired.

DG Shah, secretary general, Indian Pharmaceutical Alliance (IPA), says,
=93If a drug which has been granted 20 years of patent protection in the
US gets marketing nod in India in the 17th year and also gets a
five-year DE, it prevents the generic version of the drug from being
launched in India as well exported outside India after the patent
protection has expired.=94

Secondly, if a period of DE is also granted when an existing medicine
obtains marketing authorisation for a second or new indication, DE could
be extended beyond the period of exclusivity of the originator product.

PhRMA (Pharmaceutical Research and Manufacturers of America), which has
been lobbying with the government to implement the data exclusivity
clause, is learnt to have asked the government to grant DE from the date
of first commercial sale, not the date of marketing approval in India.

In a letter addressed to the secretary, department of chemicals and
petrochemicals, IPA has demanded the need for data protection instead of
DE. The data should be protected from the competitor companies for using
to make generic version and whoever uses the data for =91unfair commercial
use=92 should be punished, IPA demands.

IPA says, =93The PhRMA demand for 5-11 years of DE from the date of
commercial launch is part of the hidden agenda for delaying the launch
of new products in India, which deprive patients of access to new
medicines.=94