[Ip-health] Opposition filed against Roche's Patent on Valganciclovir in India

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New Delhi, 27 June 2008 - The Delhi Network of Positive People (DNP+), an o=
rganization run by and representing the needs of people living with HIV/AID=
S (PLHAs), filed a post-grant opposition against a patent for valganciclovi=
r, a treatment for a common infection that can cause blindness or death to =
people living with HIV/AIDS.=A0 Roche, a Swiss multinational pharmaceutical=
 company was granted the patent last year by the Chennai Patent Office.
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Valganciclovir is a treatment for cytomegalovirus (CMV), a virus that often=
 attacks the retina of people with compromised immune systems, such as PLHA=
s.=A0 Left untreated, CMV retinitis leads to irreversible blindness.=A0 CMV=
 infection can also attack other parts of the person's body, such as the ga=
stro-intestinal system or brain. Such systemic CMV infection is serious, an=
d without treatment, will progress and invariably result in death in a pers=
on whose immune system is weakened by HIV.=A0
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CMV can be effectively treated with oral doses of valganciclovir.=A0 Howeve=
r, Roche, which owns the patent on valganciclovir in India and other countr=
ies, charges as much as US$ 10,000 for a four-month supply of oral valganci=
clovir.=A0 In India, the price for a full course of treatment is over Rs. 2=
,70,000.=A0 Due to the patent that was granted in India, Indian companies a=
re blocked from manufacturing generic versions of the drug.=A0
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Due in part to the high costs, for most people in India and throughout the =
developing world, no treatment for CMV is available at all, or is substitut=
ed with invasive and extremely painful injections of other drugs directly i=
nto eye or through intravenous, twice-daily treatment requiring a long stay=
 in the hospital.
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"The exorbitant price that Roche is charging for valganciclovir shows how t=
he patent system has failed in making treatments accessible for those most =
in need," said Loon Gangte, President of DNP+.=A0 "Thousands of people are =
unnecessarily losing their vision and their livelihoods - or worse - as a r=
esult of what is otherwise a treatable condition, simply because the treatm=
ent is too expensive," he continued.
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In December 2006, two other patient groups had filed a "pre-grant" oppositi=
on against the patent application for valganciclovir.=A0 Despite this, the =
Chennai Patent Office granted the patent to Roche, even without giving the =
patients groups an opportunity to present their arguments to the Patent Con=
troller.=A0
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"Indian law requires that the Patent Controller provide the opponents an op=
portunity to be heard," said Anand Grover, Director of the Lawyers Collecti=
ve HIV/AIDS Unit.=A0 "We still have not received a clear explanation from t=
he Chennai Patent Office as to how they proceeded to grant this patent with=
out giving the opponents a fair hearing."=A0
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The opposition filed by DNP+ argues that valganciclovir is a known compound=
, that it is insufficiently inventive, and that it is, at most, a "new form=
" of an already known substance that shows no improvement in efficacy.=A0 R=
emarkably, the opposition also points out that many of the claims that the =
Chennai Patent Office granted were rejected by the United States Patent Off=
ice, which operates under laws that are generally considered to be far more=
 liberal than the standards in India.
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[A copy of the=A0opposition will be made available on=A0www.lawyerscollecti=
ve.org shortly]=A0
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For more information, contact Anand Grover at +91.9820184788, and Loon Gang=
te at +91.9871029514.