Earlier in the month of November, Indian generic drug maker
Cipla Ltd. had requested the Central government to revoke five
patents held by Swiss firm Novartis AG on respiratory drug
Indacetorol, used for the treatment of Chronic Obstructive
Pulmonary Disease (COPD) under the brand name 'ONBREZ'.
Cipla had filed a representation before the Department of
Industrial Policy & Promotion (DIPP) to cancel the patents on
the ground that the Swiss company had held them for six years
without making the medicine locally or importing it in the quantity
which is required.
The representation was filed under section 66 and section 92 of
the Indian Patents Act, 1970.
Section 66 empowers Central Government to revoke a patent on the
grounds of it being mischievous to the State or prejudicial to the
public. The power given to the Government of India under section 66
of the Indian Patents Act has been exercised only twice so far. The
first was when a process patent had been granted to Agracetus, a
U.S. based company for genetically engineered cotton cell lines.
This patent was revoked on the ground that it was against the
public interest, cotton being an important source of India's
national economy. The second case was when the Avesthagen patent
for "synergistic ayurvedic/functional food bioactive
composition" was revoked. On an application by the Traditional
Knowledge Digital Library, this patent was revoked by the DIPP for
"generally being prejudicial to the public". In the
present case Cipla had applied for revocation on the ground of
non-working of patent and sheer obviousness.
Section 66 of the Indian Patents Law acts as a correctional
provision and the Government is considered as the adjudicating
authority, which ensures that interest of public is given more
priority than personal or commercial interests.
Under Section 92, the Central Government has the power to grant
Compulsory License if it is satisfied that there is a circumstance
of national emergency or of extreme urgency or in case of public
non-commercial use. Cipla believed that COPD is one of the major
causes of fatalities in India and therefore, proper treatment is
essential. COPD has, in recent years, assumed epidemic proportions
as it is prevalent in people residing in urban, semi-urban and
rural areas. The causes of COPD are several and the sheer magnitude
of the disease as per the publicly available data is sufficient for
the Central Government to invoke the provisions of Section 92 and
to treat it as an "epidemic" or a "public health
crisis". Such exercise of power in the present case would be
in consonance with the avowed purpose for which Section 92 has been
Cipla had already launched the generic version of Novartis'
Indacetorol, under the brand name UNIBREZ.
However, Central Government after examining Cipla's petition
considered it of minimal merit. The Health Ministry also suggested
that Cipla's proposal for a compulsory license for the
medicines under section 92 of the Patents Act a rarest of rare
provision to be used in case of national emergency or in extreme
urgency or for public non-commercial use may not be "fit"
to pass legal scrutiny and if at all there is a chance for the
grant of Compulsory License Cipla should opt for the route provided
under section 84 of the Patents Act.
In a blow to Cipla, Novartis approached the Delhi High Court in
a patent as well as trademark dispute in this regard.
Novartis filed a trademark suit on November 7, 2014 against
Cipla for using the impugned mark UNIBREZ for pharmaceutical
products which is deceptively similar to its mark ONBREZ used for
pharma products. The Delhi High Court vide its order dated November
17, 2014 passed the order in favor of Novartis permanently
restraining Cipla from using the impugned mark.
Novartis also petitioned before the Delhi High Court to
permanently restrain Cipla from manufacturing Indacaterol
in any form and selling it in India, claiming its patent rights and
also sought damages and payment for infringing the patented
Cipla stated in its reply the court that the drug sold by
Novartis is way too expensive for the general public in India and
is only available to government hospitals and this led Cipla to
file a representation before the DIPP, to revoke exclusive patent
rights granted to Novartis, claiming non-working of Novartis'
patents in India.
After hearing the detailed arguments of both the parties, the
Delhi High Court reserved its judgment.
Keeping in view the stand of the Health Ministry and the Delhi
High Court in this issue, it is undoubtedly evident that a
stringent approach is followed in matters relating to IP protection
now, as the USTR had already blamed India for its lenient stand
over approval to generic drug makers in regard to patented
pharmaceutical products, posing serious challenges to the
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