It has been recently reported in Economic times that Cipla has
filed representation with the government (Department of Industrial
Policy & Promotion) seeking revocation of five patents of
Novartis on indacaterol, a respiratory drug for the treatment of
chronic obstructive pulmonary disease (COPD) and marketed as Onbrez
by Novartis. The central government, under section 66 of the Indian
Patent Act, has the power to revoke patent in public interest,
after giving patentee an opportunity to be heard.
According to section 66,
"Where the Central Government is of opinion that a patent
or the mode in which it is exercised is mischievous to the State or
generally prejudicial to the public, it may, after giving the
patentee an opportunity to be heard, make a declaration to that
effect in the Official Gazette and thereupon the patent shall be
deemed to be revoked."
Cipla has launched its generic version of indacaterol and
alleged that Novartis held patents on indacaterol since 2008-09
without manufacturing in India and importing only in negligible
amounts, as a result of which there is an urgent and unmet need to
provide this drug to patients at affordable prices. According to
Cipla, it has potential to manufacture adequate quantities of the
drug to make available in the country. Cipla's launched generic
version of indaceterol is reported to be 1/5th of the price of
This is the first time that an Indian generic company has asked
the government to revoke patents on the ground of public interest
under section 66. Otherwise, the revocation has always been sought
on grounds under section 64 (for example obviousness, anticipation,
insufficient disclosure, violation of section 8, 3d etc.), whether
an Indian company has filed a revocation petition or a counter
claim in an infringement suit. However, public health and drug
price play significant role in deciding a patent's fate in
India especially in context of Compulsory Licensing of patent as it
happened in Natco's case. Even in Roche v. Cipla, public health
and pricing issues were considered by the India courts, although
the decision at the High Court was based on merits of the case and
not in public interest.
It is highly expected that Novartis will take a legal course to
challenge Cipla's launch. Novartis has been very active to
protect patents for its one of the blockbuster anti-diabetic drugs
vildaglipton in India. Novartis has sought, just a few months ago,
quia timet interim injunctions against several Indian
generic companies including Glenmark generics, Bajaj healthcare,
Cadila healthcare, Alembic pharmaceuticals against alleged patent
infringement of vildaglipton even before they actually launched
their generic versions and after they obtained marketing approvals
Thus Novartis will most likely file patent infringement suits
seeking interim/permanent injunctions restraining Cipla from
manufacturing and selling generic version of indacaterol in
On another note, Cipla could also have applied to obtain a
compulsory license to manufacture and sell indacaterol before
launching the drug. All three grounds of granting compulsory
license under section 84(1) viz. reasonable requirements of public
not being met, drug non-affordability and non-working of patent in
India could have been proved by Cipla. According to Cipla, Novartis
declared import of meagre 53,844 units for the year 2013 which do
not satisfy even 4500 patients annually where there are more than
1.5 crore patients in need of the drug. Cipla also urged the
government to consider COPD as an epidemic worthy of being
qualified as a "public health crisis" as it claims 50
lakh lives annually in India, which is more than the toll from
HIV-AIDS, malaria, cancer and tuberculosis.
Till now, we are not aware of any case in India wherein the
government has revoked the patent in public interest under section
66. The outcome of government opinion to revoke said patents is
thus eagerly awaited. This would act as precedent for all similar
future cases. And if the government decides to revoke the patent
under this section, the ongoing conflict between multinational
innovator companies and Indian generic companies is going to
intensify. Innovator companies criticize that India has weak patent
laws not in compliance with international standards, whereas Indian
government takes a stand that its patent laws are in compliance
with TRIPs standards and are designed to meet the objectives of
drug availability, affordability and accessibility.
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