[Ip-health] Novartis Persists With Challenge To Indian Patent Law Despite Adversity

[Joana Ramos]

( FYI, you can link out to documents cited in this article, by going to
original IPW article at the URL below)
JR


http://www.ip-watch.org/weblog/index.php?p=3D430&res=3D1024_ff&print=3D0

19/10/2006
Intellectual Property Watch
Novartis Persists With Challenge To Indian Patent Law Despite Adversity

By Tove Iren S. Gerhardsen
Following the rejection of a patent application for one of its
medicines, Swiss pharmaceutical company Novartis has taken the
=93unprecedented action=94 of challenging India=92s patent law in a high
court, arguing that it is unconstitutional as well as in breach of
international trade law, it said.

=93The filing of writ petitions with the Indian High Court demonstrates
Novartis=92 strong commitment to defending international intellectual
property standards and its right to obtain patents for its innovative
compounds under the World Trade Organization Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS),=94 a Novartis press
officer told Intellectual Property Watch.

It is a =93question of principle,=94 Novartis CEO Daniel Vasella told
Intellectual Property Watch, adding that =93we would undermine the whole
system=94 if the company gave in.

The drug in question has been approved by patent offices in 40
countries, Novartis said, but at the moment there are only some 40
patients paying for its drug in India.

Another South Africa?

The matter has invoked comparisons to a hotly contested case in South
Africa a few years ago which led to a withdrawal of the case. =93This has
South Africa written all over it,=94 said Ellen =91t Hoen of M=E9dicins San=
s
Fronti=E8res=92 Access to Essential Medicines Campaign. The only difference=
,
she said, is that this time it only involves one company instead of 39.

The South Africa case dates back to 18 February 1998 when 39 companies
took the South African government to court for its Medicines and Related
Substances Act, which would allow for compulsory licenses and parallel
import of medicines to South Africa, allegedly in violation of patent
rights, sources said. After pressure, the group withdrew its case on 19
April 2001.

This time it is about Novartis=92s cancer drug, Gleevec (imatinib
mesylate). After Novartis was denied a patent on the drug, it first
challenged the decision of the India Controller General of Patents and
Designs (which administers the patent office) in court, and then argued
that aspects of the Indian Patents Act infringe international trade law
relating to intellectual property rights.

The case has raised concerns among non-governmental groups. =93We are very
concerned that the changes sought by Novartis [to] the Indian Patents
Act could negatively affect access to essential generic medicines not
only in India but also in all the developing countries that import
Indian generic medicines,=94 the Berne Declaration, a Swiss
nongovernmental organisation, wrote in an open letter to Vasella.

The 19,000-member Berne Declaration has worked since 1968 to create
sustainable and democratic North-South relations through the use of
research, public education and advocacy work, it said.

The letter is signed by, among others, former Swiss president Ruth
Dreifuss, who also chaired the World Health Organization Commission on
Intellectual Property Rights, Innovation and Public Health (CIPIH) that
published its report in April 2006. The letter also is signed by the
Association of European Cancer Leagues, the Swiss Cancer League, and 16
other organisations. Novartis has not replied to the letter and is not
withdrawing the case, sources said.

=93[We] act in the long-term interest of patients,=94 Vasella said, adding
that =93only a handful,=94 meaning some 40 patients, pay for Gleevec in
India, while =93several thousands [we] give out for free.=94 A Novartis
spokesperson said that 99 percent of patients, or some 6,000 patients,
receive the drug for free in India through Novartis=92 Glivec
International Patient Assistance Program.

It is =93really frightening=94 that =93five years after the South Africa ca=
se,
Novartis has not learned anything,=94 Berne Declaration Campaign Director
Julien Reinhard told Intellectual Property Watch.

The Chain of Events

In 1998, Novartis filed a patent application for Gleevec in one of
India=92s four patent offices, the Chennai Patent Office. Based on the
patent application and a particular provision of the Indian Patents Act,
Novartis at the end of 2003 obtained exclusive marketing rights until
the patent was granted, according to the Berne Convention.

With the application pending, and once the Indian patent law was amended
in March 2005 to be TRIPS compliant and the =93mailbox facility=94 opened
(it had accepted applications during the 10 years since India joined
TRIPS), a number of Indian patient groups filed a =93pre-grant
opposition,=94 which is possible under the Indian patent law (IPW, Public
Health, 30 March 2006).

The patent office refused Novartis=92 application in January 2006 on the
grounds that the product was not innovative enough.

Patents may be granted for the active substance in a medicine or the
process by which it is made. =93However, whether a form of the product or
a new use or combination (salt or isomer) should also be patented is
left to each country under the TRIPS agreement=94 to decide, Anand Grover,
an Indian lawyer of Lawyers Collective, who has been involved in the
case on the patient side, told Intellectual Property Watch.

=93By Section 3(d) of the Indian Patents Act such forms are not patentable
unless they differ significantly in properties with regard to efficacy,=94
he said.

The Chennai Patent Office rejected the Gleevec patent application on the
grounds that =93(both the salt and the chrystalline) form was not new and
did not involve an inventive step,=94 Grover said.

Section 3(d) states: =93the mere discovery of a new form of a known
substance which does not result in the enhancement of the known efficacy
of that substance or the mere discovery of any new property or new use
for a known substance or of the mere use of a known process, machine or
apparatus unless such known process results in a new product or employs
at least one new reactant,=94 is not patentable.

But Novartis takes issue with this section. =93India should not establish
additional requirements for patentability beyond novelty, commercial
applicability and non-obviousness,=94 Novartis said.

Novartis then took the cases to the High Court in Chennai (new name for
Madras) in May 2006, challenging the order of the Chennai patent
controller but also challenging the validity of Section 3(d) of the
Indian Patent Act (from 1970 but amended in 2005) is not compliant with
the TRIPS agreement, according to sources.

The case is now in the high court at Madras. More hearings are planned,
a source said. Novartis AG (the holding company) and Novartis India have
filed separate cases, which Grover did not know why, but he suggested it
was to add more money as they have =93a lot of money to waste.=94

The Cheaper Version

On the basis of the exclusive marketing rights granted to it in 2003,
Novartis filed infringement suits in the Madras High Court and got
injunctions restraining all but one of six generic companies from
producing cheaper versions of the product for the Indian market as well
as for export, Grover said.

=93As against the other generic company, Novartis filed the infringements
case in the Bombay High Court. It interpreted the case differently and
refused to grant the injunction to Novartis. As a result, that one
company continued its production,=94 Grover said.

The Berne Convention points to the fact that the annual price of generic
treatment per patient for Gleevec used to be $2,100, while Novartis=92s
price is $26,000. But Novartis has a different view.

=93Generics will not solve the challenges of access for those who cannot
afford drugs at any cost, and this applies to the majority of patients
in India. Based on data from the World Bank, the cost of one year of
treatment with generic imatinib alone is four to five times a person=92s
annual average income,=94 the spokesperson said.

Vasella said that generic companies are often behind patient groups in
India, and said he would not be surprised if they gave money to the groups.

Allowed Under TRIPS?

The Doha Declaration, agreed to at the 2001 WTO ministerial meeting in
Doha, Qatar, says (paragraph 4 under public health) that the TRIPS
agreement =93can and should be interpreted and implemented in a manner
supportive of WTO members=92 right to protect public health and, in
particular, to promote access to medicines for all.=94

The Berne Declaration said that this is one of the recognised
flexibilities of the TRIPS agreement, which have been highlighted by,
among other things, the 2001 United Kingdom Commission on Intellectual
Property Rights report and the CIPIH report.

The Indian government has maintained that its section is compliant with
TRIPS, a source said.

=93As a manufacturer of generics, Novartis understands and recognises the
contribution of generics once drug patents expire,=94 Novartis said. =93Our
concern is with the non-recognition of intellectual property rights that
ultimately help sustain and advance pharmaceutical research and
development.=94

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.

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--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
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