[Ip-health] Novartis drops AIDS drug plea

[Jean Blaylock]

Novartis drops AIDS drug plea
Joe C Mathew / New Delhi August 25, 2007
Move prompted by fears of Glivec-type rejection.
http://www.business-standard.com/common/storypage_c.php?leftnm=3D10&bKeyFla=
g=3DBO&autono=3D295782&chkFlg=3D


Swiss pharma major Novartis has chosen not to pursue the patent application=
 for its AIDS drug Atazanavir in India after the patent was declared =93aba=
ndoned=94 even as it continues to fight for the licence rights of its cance=
r drug Glivec in the Indian patent office.

The patent department made this declaration on August 16 after Novartis had=
 failed to respond to its queries within the prescribed time. The patent of=
fice declares an application abandoned if the company shows no interest in =
pursuing it even after intimations from the office over a specific period o=
f time.

Pharmaceutical firms normally opt to drop patent claims in this manner if t=
hey fear a negative verdict from the patent office.

Since patent offices in several countries seek the patent status of the sam=
e drug in other countries before giving a verdict on an application, a reje=
ction is not always in the applicant company=92s global interests, experts =
said.

=93The patent rejection of Novartis=92s Glivec (against which an appeal is =
pending with the appellate authority) in India could influence the patent e=
xamination in another country,=94 an expert told Business Standard.

Atazanavir is an important second-line AIDS drug, used by patients who deve=
lop resistance to first-line medicines over a period of time.

Though a majority of Indian HIV patients (estimated to be over 5 million) a=
re yet to receive the first-line treatment there are reports of deaths owin=
g to the lack of affordable second-line AIDS medicines.

NGOs active in AIDS treatment pointed out that any patent grant to Atazanav=
ir would have prevented the generic companies from introducing low-cost var=
iants of this medicine till 2017. The implication of a patent on this drug =
would not be limited to India since several developing countries are depend=
ent on Indian generic medicines, they say.

Global NGOs like the Clinton Foundation have committed $2 million to $3 mil=
lion for the first two years of second-line AIDS treatment in India. The av=
ailability of a generic version of Atazanavir was expected to bring down th=
e costs of these drugs significantly.

Novartis officials in Mumbai said the patent application was not filed by t=
he Indian subsidiary of the pharmaceutical major. =93Several patent applica=
tions have been filed by the company=92s international arms and an immediat=
e response on the issue would not be possible,=94 they said.

However, the Indian patent law provides an option for an appeal to reconsid=
er the application.

=93Though there is a provision for appeal the companies do not normally uti=
lise that option,=94 said Gopakumar Nair, a Mumbai-based patent expert.

He said when a company went for international patents, it would try to avoi=
d a negative response from smaller markets to protect its patents in bigger=
 markets.

=93There are several instances of multinational companies having decided to=
 forego the patent rights of their medicines in India when they were doubtf=
ul about the outcome of the patent examination,=94 Nair said.




--------------------------------------
Jean Blaylock
Trade Campaign Officer
- Ecumenical Advocacy Alliance
- Alliance oecum=E9nique agir ensemble
- Alianza Ecum=E9nica de Acci=F3n Mundial
- Globales =D6kumenisches Aktionsb=FCndnis
+41 (0)22 791 6080
jblaylock@e-alliance.ch
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          Trade Week of Action
           14-21 October 2007
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