[Ip-health] Mint: Controller orders inquiry into Chennai office patent for Roche

[chan park]

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C.H. Unnikrishnan

Mumbai: The office of India=92s controller general of patents has ordered a=
n inquiry into the decision of the Chennai patent office to grant a patent =
to F Hoffman-La Roche Ltd, for its drug valganciclovir, which the Swiss dru=
g maker sells under the brand Valcyte, without hearing an opposition filed =
by a patient group as mandated under Indian patent rules.

The drug is used to treat infection related to HIV/AIDS and organ transplan=
ts.

The inquiry will study whether procedures were flouted by officials in gran=
ting the patent. The Chennai patent office had in September granted a paten=
t for Roche=92s drug, despite a pre-grant opposition filed by the Mumbai-ba=
sed lawyers body, Lawyers Collective, on behalf of its clients. The patent =
awarded to Roche in September prevents makers of off-patent or generic drug=
s in India from copying it. Lawyers Collective had filed a pre-grant opposi=
tion to the valganciclovir patent application of Roche in 2006 on the groun=
d that the drug was a pre-1995 molecule. Drugs patented elsewhere 10 years =
before the Indian Patents Act of 2005 are not eligible for patent protectio=
n in India.

A person familiar with the development, who didn=92t want to be identified,=
 said: =93A departmental enquiry, ordered on the basis of newspaper reports=
, is currently on and the officials concerned at the Chennai patent office =
have been questioned.=94

V. Rangaswami, chief patent controller at Chennai, confirmed discussions at=
 his office =93after the centre asked for an explanation for not giving a h=
earing to the opponents=94.

Mint on 26 September first reported that the Chennai patent office had gran=
ted a patent to Roche without hearing groups opposed to it; this was a firs=
t time ever a patent had been granted without listening to the opposition.

Lawyers Collective plans to legally challenge the decision. =93We are filin=
g a petition in the Madras High Court against the Chennai patent office as =
it failed to give us an explanation for granting the patent without hearing=
 us,=94 said Chan Park, a senior technical and policy adviser at the lawyer=
 group, adding it had written to the patent officer for an explanation soon=
 after the Chennai office published the Roche patent, but was yet to receiv=
e a response.

Domestic drug maker Cipla Ltd plans to challenge the patent by filing a pos=
t-grant opposition.

=93Denying the opponent an opportunity to present his/her objection is a vi=
olation of fundamental rights,=94 said Mumbai patent attorney Gopakumar Nai=
r. =93In the case of a pre-grant opposition of patents, it is a violation o=
f patent law, provided the opponent had asked for a hearing.=94

Although there are no local generic versions of this drug yet launched here=
, Cipla is currently developing a copy of valganciclovir, which, according =
to its managing director Amar Lulla =93is expected to get a marketing appro=
val from the drug controller shortly and ...be available in the market by e=
arly 2008.=94

Girish Talang, managing director, Roche Scientific Co. (India) Pvt. Ltd, th=
e Indian subsidiary of Roche, said on phone that =93all questions (put to R=
oche) by the Chennai patent officer were answered before the patent grant=
=94 and declined further comment.