Cancer Patients Aid Association challenged
the grant of exclusive marketing rights (EMR) through a writ
petition in the Supreme Court of India. The Petitioners filed
this petition in public interest under Article 32 of the
Constitution of India on account of the violation of the right
to health and equality of cancer patients suffering from Chronic
Myeloid Leukemia (CML). The Patent Controller of India granted
EMR to Novartis AG, for the drug called Gleevec,
containing
b-crystalline form of the compound
Imatinib Mesylate, used for the treatment of patients suffering
from CML, a life threatening form of cancer. According to the
petitioners the grant of EMR to the life saving drug containing
the b-crystalline
form of the compound Imatinib Mesylate, resulted in the denial
of access to the drug. Gleevec is sold by Novartis AG at Rs.
1,20,000 (Rupees one lakh twenty thousand) per month. There were
nine generic manufactures producing the drug that treats CML, at
rates lower than that of Gleevec. The generic version of
the drug was otherwise available to CML patients at Rs
9000-12,000. Consequently the overwhelming majority of patients
that suffer from CML every year in India will die. The Madras
High Court issued an interim injunction against 6 generic
manufactures preventing them from producing the drug. Another
petition filed by Novartis seeking a similar injunction is
pending against a major generic manufacturer in the Bombay High
Court. Even the prices of the generic manufacturers’ drugs were
beyond the reach of majority of the 24,000 new CML patients per
year and the 18,000 CML patients that die each year, due to the
un-affordability of this life saving drug. According to the
petitioners, this would result in the denial of right to health
and life as enshrined in the Article 21 of the Constitution. The
right to health is also guaranteed under Article 12 of the
International Covenant on Economic Social Cultural Rights (ICESCR),
which is ratified by India.
The Petitioners, in particular, challenged
the grant of EMR to Novartis for the drug Gleevec.
Generally, for the grant of patents three major steps are
required, viz. (a) inquiry under sections 2, 3 and 4 of the
Patents Act, 1970; (b) report under section 12 resulting in
acceptance of complete specification, after which the Applicant
for patent has the same rights as that of a patent holder,
except the right to sue for infringement; and (c) consideration
of opposition to grant of patent under Chapter V of the Act.
Only thereafter the does Applicant for patents have the right to
sue for infringement. However, an EMR can be granted after a
simple consideration vis-à-vis sections 3 and 4 and compliance
with grounds under section 24-B (grant of patent and marketing
approval in respect of the same article or substance in a
convention country to be the same). An EMR entitles the holder
of EMR the right to sue for infringement under section 24-E.
Section 24-A postpones the examination and
report under section 12 of the Act till 31.12.2004. By virtue of
sections 24-B, EMRs can be granted without examination and
report under section 12 or without following the procedure
prescribed for opposition to grant of a patent under Chapter V.
As a result, a person who is granted an EMR is entitled to sue
for infringement under section 24-E. This is permitted despite
the fact that on following the procedure for the report under
section 12 and/ or the opposition to grant patent application
may ultimately be rejected. Hence, the petition seeks to declare
the provisions of sections 24-A, 24-B and 24-E of the Patents
Act to the extent it postpones the procedure under sections12
and 13 of the Patents Act before granting EMRs, and does not
provide for opposition or revocation of EMR and the EMR holder
to sue for infringement are violative of Articles 14 and 21 of
the Constitution of India
The Petition also challenges Patent Rule 53,
which restricts the interpretation of public interest in the EMR
context, hence it is violative of Articles 14 and 21 of the
Constitution of India.
Further, the petition seeks an order or
direction from the Court directing the National Pharmaceutical
Pricing Authority to exercise its power under the DPCO (Drug
Price Control Order) and fix the prices of the drugs containing
the b-crystalline
form of compound Imatinib Mesylate at affordable prices;
The petition also seeks a relief from the
Court to direct Novartis to deposit an amount as a security to
compensate patients illegally deprived of the drugs containing
the b-crystalline
form of Imatinib Meyslate equivalent to the sales of the drug
Gleevec in India for a period of 5 years for which they have
been given the EMR in case the patent is not granted to them.
As an interim relief, the petition seeks
an interim stay on the operation of EMR granted to Novartis.
The petition
also raises the following interesting legal questions.
Whether, the provisions of ICESCR and in
particular Article 15(1)(b), which provides everyone the right
to enjoy the benefits of scientific progress and its
applications, have to be read into Article 21 of the
Constitution of India?
Whether the intellectual property rights (IPRs)
can override the right to life and health, particularly in view
of the Articles 7 and 8 of the Agreement on Trade-Related
Aspects of Intellectual Property Rights (hereinafter TRIPS) and
the Doha Declaration that interpreted it. This has been
recognized in Section 83 of the Patents Act, 1970.
Petitioners
Cancer Patients Aid Association, 5, Malhotra House Opp. G.P.O.
Mumbai – 400 001 and Mr. Y.K. Sapru, Founder Chairman of the
Cancer Patients Aid Association.
Respondents
Union of India, (a) Through the Secretary,Ministry of Commerce
and Industry Udyog Bhavan, New Delhi and (b) Through the
Secretary, Ministry of Health and Family Welfare, irman Bhavan,
New Delhi – 110 011
The Controller General of Patents, Designs and Trade Marks, the
Patent Office, Nizam Place, 2nd MSO Building, 5th
to 7th Floor, 234/4, Acharya Jagdish Bose Road,
Kolkatta – 700 020.
Drug Controller General of India, Directorate General Health and
Services, Room No. 342, A- wing, Nirman Bhavan, Maulana Azad
Road, New Delhi – 110 011.
Novartis AG, Schwarzwaldallee 215, 4058 Basel, Switzerland.
Novartis India Limited, Sandoz House, Shivsagar Estate, Dr.
Annie Besant Road, Worli, Mumbai – 400 018.
National Pharmaceutical Pricing Authority, 5th/ 3rd
Floor, YMCA Cultural Centre, Building, 1 Jaisingh Rd, New Delhi
110001
