Economic times reports
that Natco Pharma has applied for a
compulsory license to sell a generic version of Bayer`s drug Nexavar. Nexavar
is used for treating liver and kidney cancer and costs about Rs 2.85 lakhs
(10lakhs = 1 million) for a month`s course in India. The high cost of Rs 2.85
lakhs for a month`s course is un-affordable for an average Indian. Natco has
claimed that it can sell its generic version of Nexavar, sorafenib
tosylate for Rs. 8, 900 for the same course.
Natco had
sought a voluntary license from Bayer in December, 2010. However, the
request to grant the Voluntary license to Natco was refused by Bayer.
Consequently, Natco went ahead and applied for a compulsory license. The
Indian Patent law (Section 89(4)) allows an interested party to apply for a
compulsory license when a voluntary license has been refused to the interested
party by the company holding the patent. On grant of a compulsory license, the
licensee has to pay some royalty (usually 5% of sales) to the patent owner.
Further
information about compulsory license in India
Under the provisions
of Indian Patent Act, an interested party may apply for a compulsory license
after expiry of 3 years from grant of patent. The request for compulsory
license can also be made by a party that has availed a license for the patent
from the patent owner. The conditions under which a compulsory license is
granted by the controller of Indian Patent office is covered under section 84,
section 92(1) and 92(3), and section 92(A). Section 84 is related to
preventing the abuse of patent as monopoly and to make way for commercial
exploitation. Section 92(1) and 92(3) are related to situations calling for
national emergency and section 92(A) is related to export of drugs/medicines to
foreign countries with public health problems and lack of resources and infrastructure
to produce the necessary drugs required by the public. Article 30 and 31 cover
compulsory licensing provisions in TRIPS. The relevant sections have been added
at the end of the article from the Indian Patent Act.
This is the
first instance of a company applying for compulsory license in India. Till
date, no compulsory license has been issued by the controller or the government
of India. There have
been a few occasions (three) where parties have applied for compulsory license
under section 92(A); however, such applications were withdrawn later by the
parties themselves.
Section 84
(a) The
reasonable requirements of the public with respect to the patented invention
have not been satisfied;
(b) The
patented invention is not available to the public at a reasonably affordable
price.
(c) The
patented invention is not worked in the territory of India.
Section 89
further explains the rationale of granting compulsory license under Section 84.
Section 89
(i) That the
patented inventions are worked on a commercial scale in the territory of India
without undue delay and to the fullest extent that is reasonably practicable;
(ii) That the
interests of any person for the time being working or developing an invention
in the territory of India under the protection of a patent are not unfairly
prejudiced.
Subsection 6 of
Section 84 specifies the factors while considering the
application under section 84.
(1) The nature
of the invention, the time which has elapsed since the sealing of the patent
and the measures already taken by the patent or licensee to make full use of
the invention;
(2) The ability
of the applicant to work the invention to the public advantage;
(3) The
capacity of the applicant to undertake the risk in providing capital and
working the invention, if the application were granted;
(4) As to
whether the applicant has made efforts to obtain a license from the patentee on
reasonable terms and conditions and such efforts have not been successful
within a reasonable period as the Controller may deem fit.
Sections 92 (1)
and 92 (3)
These sections
enable the Central Government and the Controller to deal with situations
demanding national emergency related to public health crises by granting
relevant compulsory licenses.
Section 92 A
Provides for compulsory
licensing of patents relating to the manufacture of pharmaceutical products for
export to countries with public health problems.
Keywords: Natco / Pharma / India / Compulsory
License
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