[Ip-health] India: Plan linking generics to patents is buried

[Sarah Rimmington]

http://www.livemint.com/2008/07/07211642/Plan-linking-generics-to-paten.htm=
l?atype=3Dtp

Plan linking generics to patents is buried
Tuesday July 8, 2008
Bhuma Shrivastava, bhuma.s@livemint.com
livemint.com/The Wall Street Journal (India)


India=92s drugs regulator has decided to abandon his own proposal to link
marketing approvals for non-patented versions of a drug to its patent
status, called patent linkage, dropping a plan that led to heated debate
and intense lobbying from industry factions and public health advocates.

The regulator told Mint he has come round to the view that such a
mechanism simply didn=92t fall in his agency=92s purview.

Indian drug makers, which had opposed the proposal and dubbed it =93patent
policing=94 by the office of the Drug Controller General of India (DCGI),
hailed the new stance.

=93In the light of renewed effort by brand name drug industry to obstruct
entry of generics, it is a welcome change. This will let the regulator
focus on evaluating safety, efficacy and quality of drugs as well as the
capacity-building of his own agency=94, which are the controller=92s primar=
y
responsibilities anyway, said D.G. Shah, secretary general of the Indian
Pharmaceutical Alliance (IPA), which represents large Indian generic
drug manufacturers.

DCGI=92s proposal, made in the wake of a controversy over the cancer drug
Tarceva, had the potential to hurt sales of generic or non-patented drug
makers and potentially could have delayed introduction of cheaper drug
copies in the market.

=93We will not base our regulatory approvals to the patent status of a
drug,=94 said DCGI Surinder Singh.
At an industry seminar in April, Singh had mooted the idea of rejecting
applications of generic drug makers for making copies of patent
protected drugs in India.

=93There will be no policy on this either. It is not in our purview to
stop a drug=92s marketing approval because of its patent status,=94 he said=
.
Patent infringement issues typically end up in Indian courts.

Singh=92s original plan came soon after Swiss drug maker F Hoffman-La
Roche Ltd sued Mumbai-based drug maker Cipla Ltd over generic copies of
Roche=92s Tarceva, alleging patent infringement.

The case is still in the Delhi high court.

Ranga Iyer, president of the Organisation of Pharmaceutical Producers of
India, an industry lobby of multinational drug makers in India and
convenor of the seminar in which the patent linkage announcement was
first made, declined to comment on Singh=92s change of mind, saying he had
not officially heard it from the regulator=92s office.

While patents are granted by the Indian Patent Office, marketing
approvals are sought from DCGI, who independently looks into the safety
and quality of drugs.

If the proposal were to become a reality, the controller=92s office would
have needed to track all listed, delisted, relisted, challenged or
revoked patents, something that fell outside the jurisdiction of the
Drugs and Cosmetics Act, 1940, which governed that office, said some
critics of the idea.

Singh said he is nowconsidering putting the regulatory stance of not
denying marketing approval to generic versions of patented drugs on
DCGI=92s website so that all global drug makers are aware of the way the
system worked, and also informing them if a generic version was going to
be approved.

Then =93let the companies slug it out between themselves=94, he said.

Drug access agency Medecins Sans Frontieres=92 campaigner in India, Leena
Menghaney, has expressed concern about DCGI=92s plan to inform the patent
holder if a generic version is being approved, which is similar to what
the US food and drug administration does, saying that it will block the
early entry of generic medicines in the market.

The controller =93should focus on ensuring provision of safer drugs for
the people rather than acting as de facto patent police=94, she said.

IPA=92s Shah, however, welcomed the sharing of such approval information.

The controller =93should put up a list or notify all new drugs approved
for marketing on its website, whether or not they are patented.

Thereafter, companies can keep tracking them=94 and deal within
themselves, he added.

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