[Ip-health] India to let Pharma Challenge Compulsory Licenses

[Sarah Rimmington]

www.pharmalot.com/2008/07/india-lets-pharma-challenge-compulsory-licenses/

India Lets Pharma Challenge Compulsory Licenses
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By Ed Silverman // July 7th, 2008 // 7:33 am

The Indian patent office will provide brand-name drugmakers a chance to exp=
lain their views before a decision to grant compulsory licenses against the=
ir patented medicines is taken, The Business Standard reports. In doing so,=
 the patent office is, for the first time, setting rules for examining comp=
ulsory license applications from local companies against multinational drug=
 majors like Pfizer and Roche.

The patent office on July 4 dismissed a petition filed by Natco Pharma oppo=
sing its move to seek Pfizer=92s opinion before granting a compulsory licen=
se to Natco, which wants to make and export a generic version of Pfizer=92s=
 patented cancer med, Sunitinib, to Nepal. The application was made under a=
 provision of the patent law that allows the government to issue compulsory=
 licenses to local generic drugmakers to export patented meds to countries =
that don=92t have the capability to make drugs.

Since such licenses are meant to be issued at the time of public health cri=
sis, India=92s patent law don=92t spell out the specifics. Natco had argued=
 that inviting Pfizer to appear at the hearing to contest the grant of comp=
ulsory license was not required under the patent law. The patent office, ho=
wever, felt that the arguments of the patent holder would be helpful in dec=
iding the terms and conditions for granting such a license, and avoiding ab=
use of patent laws.

=93I think Natco=92s application itself is a weak one as they did not submi=
t proof to suggest that there is a public health emergency in Nepal due to =
lack of availability of the drug. The patent controller, therefore, states =
in his order that one of the reasons for the =91hearing=92 is to ensure tha=
t the provisions=85are not =91abused=92. This is a sound order and helps th=
e patent office take a better decision on a complicated area of law,=94 Sha=
mnad Basheer, a patent expert, tells the paper.

Natco is the first and the only Indian generic drugmaker to seek a compulso=
ry license to supply meds to a least-developing country. Natco has two pend=
ing requests for compulsory licenses to supply cancer meds to Nepal; the ot=
her request is for permission to export Roche=92s cancer medicine, Erlotini=
b.

The patent office decision will enable Pfizer to express its views on the c=
ompulsory license application. Natco will be given time to respond to Pfize=
r=92s submission before the patent office takes up the case for final heari=
ng.

Source: The Business Standard


--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/