Page 193 - DMGT401Business Environment

Business Environment

Notes Due to the existence of bolar provision in Section 107A of the Act, an organisation will be
able to make, use, sell or import the patented product for uses related to development and
submission under Indian or foreign law.
3. Exclusive Marketing Right (EMR): Product patent was also applicable to those applications,
which were made since 1995 using the 'mailbox' provisions. The 'mailbox' provision was
introduced in the Patent Act through the first amendment undertaken in 1999 in order to
fulfil the condition imposed in Article of the TRIPs Agreement (the so-called Transitional
Arrangement). The "Transitional Arrangement" required India to introduce two provisions
in its Patent Act.

Article 70.8 of the TRIPs Agreement required India to provide 'a means' by which product
patent application can be filed from January 1, 1995. If the products figuring in these
applications were granted a patent in any of the WTO member countries were granted
marketing approvals in any of the WTO member countries, then according to Article 70.9,
five years Exclusive Marketing Rights (EMR) had to be granted by India before the patent
on the product was either granted or rejected in India.
According to the new ordinance, holders of EMRs will continue to enjoy their EMR till the
patent is granted or rejected.
4. Compulsory License: Article 31 of TRIPs provides the provision of compulsory license
which means a situation where a government allows an agent to produce a patented
product without the consent of the original patent owner. If attempts to obtain the right to
produce a patented product from patentee fail and if a compulsory license is issued, then
adequate remuneration will be paid to the original rights holder. These requirements are
waived or diluted when these are issued for public and non-commercial use or for other
circumstances of extreme urgency.
Unit XVI of the Act deals with the provision of compulsory license in India. Section 92A
allows the grant of compulsory license to manufacture and export a patented product to
any country having insufficient or no manufacturing capacity in the pharmaceutical sector
for the purpose of addressing public health problems, provided a compulsory license has
been granted in that country. The amendment seeks to implement the agreement on Para
6 of the Doha Declaration on TRIPS and public health. This will allow Indian companies to
produce and export AIDS drugs to the African and South East Asian countries.

Due to the existence of compulsory license provisions, MNCs will be forced to work their
inventions in India in case they obtain an Indian patent. In the event of the patented
invention not having been worked on India for a period of more than three years, (e.g. the
product is only imported and not manufactured in India) the Controller General of patents
can issue a compulsory license to any one interested in exploiting the patent. Three other
conditions are to be satisfied in this regard:
(a) Reasonable requirements of the public are not satisfied;

(b) The patented invention is not worked in the country and;
(c) The patented invention is not available to the public at a reasonably affordable
price.

The last mentioned provision is aimed at ensuring that India has the option to export
products that have been produced using the license from the patent holders. A major
impact will be on the pharmaceuticals sector, where India could well emerge as a major
supplier of pharmaceuticals to the developing countries that do not have adequate domestic
manufacturing facilities.

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