[Ip-health] INDIA: Novartis challenges Indian law - MSF Statement + Background document

Tue Sep 26 07:09:04 2006

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Today Novartis=E2=80=99 challenge against India=E2=80=99s patent law will  =
be heard in the=0D
Chennai High Court in India. As you may know in January this year,=0D
the Indian patent office rejected Novartis' request for a patent on the=0D
cancer drug Gleevec on the grounds that it was merely a new form of an old=
=0D
drug, which meant that under Indian law, it should not be patented=0D
But Novartis is now challenging the patent rejection and a crucial part of=
=0D
the Indian law that protects patients from the patenting of trivial=0D
improvements of known molecules.=0D
=0D
Please find below  the press release and a background document we prepared=
=0D
on the Novartis case.=0D
=0D
For further information do not hesitate to contact Ellen at  33 1 4021=0D
2836 , Leena  at  91 98 1136 5412 , or  Pascale  at  33 4  5025 8330.=0D
=0D
___________________________________________________________________________=
_______________________________=0D
=0D
=0D
As Novartis Challenges India=E2=80=99s Patent Law,=0D
=0D
MSF Warns Access to Medicines is Under Threat=0D
=0D
=0D
New Delhi/Geneva, 26 September 2006 =E2=80=93 A challenge against India=E2=
=80=99s patent=0D
law filed by the Swiss pharmaceutical company Novartis will be heard in=0D
the Chennai High Court in India today.  International medical humanitarian=
=0D
organisation M=C3=A9decins Sans Fronti=C3=A8res (MSF) warns that this case =
may have=0D
serious implications for future access to essential drugs worldwide.=0D
=0D
Novartis is challenging a crucial part of the Indian law that protects=0D
patients from the patenting of trivial improvements of known molecules.=0D
Novartis is also seeking to have the January 2006 decision to reject its=0D
patent application for the cancer drug Gleevec reversed and is seeking=0D
review by the Chennai High Court.=0D
=0D
=E2=80=9CIf Novartis=E2=80=99 challenge against the Indian patent law is su=
ccessful, a key=0D
safeguard that can protect the production of affordable medicines will be=
=0D
lost,=E2=80=9D said Ellen =E2=80=98t Hoen, Policy Director at MSF=E2=80=99s=
 Campaign for Access to=0D
Essential Medicines.  =E2=80=9CPeople the world over who rely on India as a=
 source=0D
of their medicines may be affected if Novartis gets its way.=E2=80=9D=0D
=0D
India has been a crucial source of affordable generic medicines, and 84%=0D
of the AIDS drugs MSF uses to treat over 60,000 patients in more than 30=0D
countries are generics from India.=0D
=0D
India began reviewing pharmaceutical product patent applications in 2005,=
=0D
when it was required to become fully compliant with World Trade=0D
Organization rules on intellectual property.  The Indian patent law has=0D
strict criteria regarding which inventions qualify for patenting, and=0D
allows for any party to oppose a patent before it is granted.  In 2005,=0D
cancer groups filed the first ever =E2=80=98pre-grant opposition=E2=80=99, =
against=0D
Novartis=E2=80=99 patent application for Gleevec.  MSF has supported simila=
r=0D
oppositions filed by patient groups in India against patent applications=0D
on key AIDS drugs.=0D
=0D
=E2=80=9CThe public health safeguards of the Indian Patent law have given h=
ope to=0D
many who depend on generics manufacture. The Novartis litigation is a=0D
direct challenge to those safeguards,=E2=80=9D said Leena Menghaney, MSF=0D
Campaigner in India.=0D
=0D
Novartis claims that Section 3(d) of the Indian Patents Act is not=0D
compliant with the WTO rules outlined in the agreement on Trade-related=0D
Aspects of Intellectual Property (TRIPS).  Section 3(d) formed a=0D
substantial part of the basis on which the Gleevec patent was originally=0D
denied.=0D
=0D
Many public interest and health groups will be watching the case closely,=
=0D
as the Gleevec patent order set an important precedent for the examination=
=0D
of other drug patent applications.=0D
=0D
=0D
Contact:=0D
Leena Menghaney, MSF Campaign for Access to Essential Medicines (India):=0D
+91.98.1136.5412=0D
=0D
=0D
=0D
=0D
Background=0D
=0D
NOVARTIS FILES CASE IN INDIA CHALLENGING PATENT OFFICE ORDER AND PATENT=0D
LAW=0D
=0D
CANCER PATIENTS DEMAND WITHRAWAL OF CASES=0D
=0D
On 17th May 2006 the Swiss pharmaceutical company Novartis Ltd. filed two=
=0D
cases,  challenging both the Indian patent office=E2=80=99s rejection of it=
s=0D
patent application for the cancer drug imatinib mesylate (brand name=0D
Gleevec), and  the section of the new Indian patent law which formed the=0D
basis of the patent office decision.=0D
=0D
Imatinib mesylate (Gleevec) =E2=80=93 A Drug for Cancer Treatment=0D
Imatinib mesylate (Gleevec) is a cancer drug used in the treatment of=0D
Myeloid Leukemia (cancer of the blood). It is produced and marketed=0D
internationally by the Swiss pharmaceutical company Novartis and various=0D
Indian pharmaceutical companies, such as Cipla, Hetero, Natco and Ranbaxy.=
=0D
Novartis sells Gleevec at Rs. 1,20,000 ($ 2500) per patient per month in=0D
India. Generic versions of the drug are priced at about Rs. 8,000 ($175)=0D
per patient per month on the Indian market.=0D
=0D
Novartis files patent application in India =E2=80=93 temporary monopoly gra=
nted=0D
In 1998, Novartis filed an application in the Chennai Patent Office for a=
=0D
patent on imatinib mesylate (Gleevec). At that time, India did not yet=0D
grant patents on medicines but in November 2003, Novartis was still able=0D
to obtain exclusive marketing rights (EMR) for a period of five years,=0D
based on a temporary provision of the previous Indian Patents Act. The=0D
granting of EMR was a TRIPS obligation for countries like India, which did=
=0D
not grant patents for pharmaceutical products before 2005 (subject to a=0D
number of conditions). After 2005, when the Indian patent office began=0D
examining pharmaceutical product patent applications, EMRs would either be=
=0D
replaced by patents (if granted) or cancelled (if patents were rejected).=
=0D
The latter scenario applies to the Gleevec patent application.=0D
=0D
Cancer patient=E2=80=99s access to generic Gleevec affected=0D
The EMR operated like a patent monopoly, preventing Indian pharmaceutical=
=0D
companies from producing affordable generic versions of imatinib mesylate.=
=0D
Producers of generics were forced to withdraw the production and sale of=0D
generic versions of the drug in India and other developing countries.=0D
=0D
Cancer Patient Group files Patent Opposition=0D
In 2005, India changed its patent law to become fully TRIPS compliant and=
=0D
Novartis=E2=80=99 patent application on Gleevec came up for examination by =
the=0D
Indian patent office of Chennai. The Indian Patents Act allows for any=0D
person or group to oppose a patent application before it is granted and=0D
the Cancer Patients Aid Association filed an opposition on behalf of=0D
cancer patients in the Chennai patent office=0D
=0D
Chennai Patent Office rejects Gleevec patent application=0D
In January 2006, the Chennai Patent office rejected Novartis=E2=80=99 paten=
t=0D
application on the grounds that the application claimed 'only a new form=0D
of a known substance.=E2=80=99  This order of the Chennai patent office bro=
ught=0D
relief to thousands of cancer patients as it not only prevented a patent=0D
monopoly until 2018, but also automatically cancelled the EMR Affordable=0D
versions of imatinib mesylate became unavailable after Novartis was=0D
granted the EMR.. The Gleevec patent order rejecting a 'new form of a=0D
known substance' also set an important precedent for the examination of=0D
other patent applications claiming only improvements of known molecules,=0D
including antiretroviral medicines to treat AIDS.=0D
=0D
Novartis challenges Patent Order and Indian Patent Law=0D
On 17 May 2006, Novartis filed two sets of cases in the Chennai High=0D
Court.=0D
=0D
The first case challenges the order of the Chennai Patent office, which=0D
rejected the Gleevec patent application of Novartis, following a pre-grant=
=0D
opposition by the Cancer Patients Aid Association. Legal representatives=0D
of the Cancer Patients Aid Association will appear on their behalf before=
=0D
the Chennai High Court. Novartis' constant litigation renews fears about=0D
the future availability of drugs if the patent case of Gleevec is=0D
reopened. Further, it has raised serious concerns among other patient=0D
groups, as the Gleevec patent order set an important precedent for the=0D
examination of crucial drug patent applications including those for AIDS=0D
treatment.=0D
=0D
The second case filed by Novartis challenges the constitutionality of=0D
section 3(d) of the 2005 Indian Patents Act, which was specifically=0D
introduced by the Indian parliament as a safeguard against the misuse of=0D
the product patent regime. Novartis in its petition is claiming that the=0D
section is not in compliance with the TRIPS Agreement and hence should be=
=0D
declared unconstitutional.=0D
=0D
Section 3 (d) of the Indian Patent Law - an important public health=0D
safeguard=0D
The section is aimed at preventing pharmaceutical companies from obtaining=
=0D
patents on trivial improvements or new medical uses of known molecules.=0D
=0D
When India became fully compliant with the TRIPS Agreement and introduced=
=0D
a product patent regime in 2005, it coupled its law with a critical=0D
safeguard of refusing patents on discoveries of new forms or new uses of=0D
known substances. The Indian patent law does not consider such discoveries=
=0D
as inventions, unless an enhancement in efficacy is proven, and therefore=
=0D
patents should not be granted. This is in accordance with the TRIPS=0D
Agreement which does not define what an invention is and allows WTO=0D
countries to freely =E2=80=9Cdetermine the appropriate method of implementi=
ng the=0D
provisions=E2=80=9D TRIPS Article 1. of TRIPS. Indeed the Doha declaration=
=0D
requires that the TRIPS Agreement is implemented in such a manner that it=
=0D
allows for measures to ensure access to medicines for all. Section 3 (d)=0D
is an example of such a provision.=0D
=0D
For more information contact:=0D
=0D
Leena Menghaney, MSF Campaign for Access to Essential Medicines: +=0D
91.98.1136.5412=0D
=0D
Anand Grover, Director, Lawyers Collective HIV/AIDS Unit, Phone:=0D
+91.22.2287.5482 aidslaw@lawyerscollective.org=0D
=0D
Ellen 't Hoen, MSF Campaign for Access to Essential Medicines: + 33 6 223=
=0D
758 71=0D
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=0D