[Ip-health] Paediatric nevirapine application rejected by Indian Patent Office

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INDIAN PATENT OFFICE REJECTS AIDS DRUG PATENT APPLICATION
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Adopts strict interpretations of patentability criteria in rejecting applic=
ation for critical AIDS drug
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New Delhi, 19 June 2008 - The Indian Patent Office in New Delhi has rejecte=
d a patent application filed by the multinational pharmaceutical company Bo=
ehringer Ingelheim claiming a paediatric form of the anti-AIDS drug nevirap=
ine.=A0 In May 2006, the Indian Network of People Living with HIV/AIDS (INP=
+) and the Positive Women's Network (PWN) had filed a pre-grant opposition =
against this application.=A0 The rejected patent application covers the syr=
up form of nevirapine, which is particularly important for children living =
with HIV who are unable to swallow tablets.=A0 This is the first decision f=
rom the Patent Offices on 13 patent oppositions filed by Indian civil socie=
ty groups against HIV-related patent applications, and will set an importan=
t precedent for the others that are still pending.
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=93PWN has been involved in looking at the issues of women and children in =
the context of HIV. We opposed the patent application on nevirapine hemihyd=
rate to ensure that it remains available for our children and to make sure =
that the government doesn=92t say it is too expensive to provide. This is i=
mportant not just for us but for PLHIV across the world,=94 said P. Kousaly=
a, president of PWN.=A0 "Accessing appropriate paediatric formulations of A=
IDS drugs has been a particular problem around the world, and we hope that =
this decision can be a step towards making them more available."
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The Indian Patents Act contains some important safeguards designed to ensur=
e that frivolous patent applications are not granted at the cost of public =
health.=A0 These include section 3(d) of the Patents Act, which prevents ma=
ny "new forms" of known substances from being patented unless there is a si=
gnificant improvement in efficacy, and section 3(e) of the Act, which preve=
nts "mere admixtures" of substances from being patented.
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The opposition filed by INP+ and PWN had argued, among other things, that t=
he particular application was not patentable under Indian law because the h=
emi-hydrate form of nevirapine was obvious to a person skilled in the art; =
that it was just a "new form" of an already known substance without any inc=
reased efficacy; and that the manufacture of nevirapine hemihydrate in an a=
queous solution was just a "mere admixture" of ingredients that did not dem=
onstrate any synergistic effects.
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The Patent Office agreed with INP+ and PWN on all these grounds.=A0 In cons=
idering these arguments, the Patent Office considered as a=A0"fact of law" =
the need to "give a strict interpretation of patentability criteria, as dec=
ision=85thereof shall affect the fate of people suffering from HIV/AIDS for=
 want of essential medicine."=A0 The Patent Office also cited approvingly t=
o the Madras High Court's judgment in Novartis v. Union of India, which had=
 observed that the "object which the [Patents (Amendment) Act, 2005] wanted=
 to achieve [was] to=85provide easy access to the citizens of this country =
to life saving drugs and to discharge their Constitutional obligation of pr=
oviding good health care to its citizens."
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"For many of us living with HIV/AIDS, low cost generic antiretrovirals offe=
r hope of continuing treatment. With patents interfering with our lives we =
have no choice but to oppose them.=A0 The patent order sets an important pr=
ecedent for the examination of other drug patent applications," said K.K. A=
braham, President of INP+.=A0 "We hope that the other Patent Offices in Che=
nnai, Kolkata and Mumbai will take note of this decision, and subject other=
 patent applications on important medicines to strict scrutiny," he continu=
ed.
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The hearing on the opposition had been held in August 2007, and the parties=
 were directed to submit written submissions to the Patent Office shortly t=
hereafter.=A0 In its Decision, the Patent Office adopted large portions of =
the Opponents' legal arguments.=A0 For instance, the Patent Office agreed w=
ith the Opponents that under section 3(d) of the Indian Patents Act, which =
states that "new forms" of known substances may not be patented unless ther=
e is a significant enhancement of "efficacy," the burden is upon the patent=
 applicant to put forth evidence of the therapeutic efficacy of both the kn=
own substance and the "new form" of the known substance. =A0In doing so, th=
e Patent Office made clear that other "improvements" to an existing drug, s=
uch as improved stability, would not be sufficient to meet the standards of=
 section 3(d) of the Indian Patents Act.
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A copy of the Opponents' Written Submissions and the Patent Office's Decisi=
on can be found at:
http://www.lawyerscollective.org/content/patent-nevirapine-rejected
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For more information, contact Anand Grover at +91.9820184788, KK Abraham at=
 +91.9840066386, P. Kousalya at +91.9444035203, and Prathibha Siva at +91.9=
968050357.