Compulsory
licensing originates when government allows someone else to produce the
patented product or process without the consent of the patent owner. In
current public discussion, this is usually associated with pharmaceuticals, but
it could also apply to patents in any field.
The TRIPS Agreement allows compulsory licensing as part of the agreement’s
overall attempt to strike a balance between promoting access to existing drugs
and promoting research and development into new drugs.
But the term compulsory licensing does not appear in the TRIPS Agreement.
Instead, the phrase “other use without authorization of the right holder”
appears in the title of Article 31.
Compulsory licensing is only part of this, since the other use includes use by
the government for their own purposes. Compulsory licensing and government use
of a patent without the authorization of its owner can only be done under a
number of conditions aimed at protecting the legitimate interests of the patent
holder.
For example, normally, the person or company applying for a license must first
attempt, unsuccessfully, to obtain a voluntary license from the right holder on
reasonable commercial terms (Article 31h). However, for “national urgencies”,
“other circumstances of extreme urgency” or “public non-commercial use” (or
government use) or anti competitive practices, there is no need to try for a
voluntary license (Article 31b). Compulsory
licensing must meet certain additional requirements. In
particular, it cannot be given exclusively to licensees and usually it must be
granted mainly to supply the domestic market. The TRIPS Agreement does not
specifically list the reasons that might be used to justify compulsory
licensing. In
Article 31, it does mention national emergencies, other circumstances of
extreme urgency and anti-competitive practices- but only as grounds when some
of the normal requirements for compulsory licensing do not apply, such as the
need to try for a voluntary license first (Doha Declaration 5(b) and (c)).
Each member has the right to determine what constitutes national emergency or
other circumstances of extreme urgency. It is generally understood that public
health crisis, including those relating to HIV/AIDS, tuberculosis, malaria, and
other epidemics like Anthrax, Dingy fever and Chicken Gunny affecting major
part of the country, can represent a national emergency or other circumstances
of extreme urgency.
Therefore
we can say that, Compulsory Licensing is a system whereby the government allows
third parties (other than patent holder) to produce and market a patented
product or process without the consent of the patent owner. This mechanism
enables timely intervention by the government to achieve equilibrium between
two objectives rewarding inventions and in case of need, making them available
to the public during the term of the patent. The following are the provisions
relating to compulsory license in the Indian Patent Act.
SECTION
84: COMPPULSORY LICENSE:
As
per this provision of the Patents Act of India,, at any time after the
expiration of three years from the date of the grant of patent, any person
interested, may make an application to
the controller for grant of compulsory license on patent on any of the
following grounds, namely:-
·
That the reasonable
requirements of the public with respect to the patent invention have not been
satisfied, or
·
That the patented
invention is not available to the public at a reasonably affordable price, or
·
That the patented
invention is not worked in the territory of India.
SECTION
92: SPECIAL PROVISION FOR COMPULSORY LICENSES ON NOTIFICATION BBY THE CENTRAL
GOVERNMENT:
As per the section 92 of the Indian Patent Act,
if the central government is satisfied, in respect of any patent in force, in
circumstances of national emergency or in circumstance of extreme urgency or in
case of public non- commercial use, that it is necessary that compulsory
license should be granted at any time after the sealing thereof to work the
invention, it may make a declaration to the effect, by notification in the
official gazette, and thereupon following provisions shall have effect, that is
to say:
·
The controller shall on application
made, at any time after the notification, by any person interested grant to the
applicant a license under the patent on such terms and conditions as he thinks
fit.
·
In setting the terms and
conditions of a license granted under this section, the controller shall
endeavor to secure that the articles manufactured under the patent shall be
available to the public at the lowest price consistent with the patentees
deriving a reasonable advantage from the patent right.
SECTION 92A: COMPULSORY LICENSE FOR EXPORT OF PATENTED
PHARMACEUTICAL PRODUCTS IN CERTAIN EXCEPTIONAL CIRCUMSTANCES:
As per the section 92A of the Indian Patent Act,
Compulsory License shall be available for manufacture and export of patented
pharmaceutical products to any country having insufficient or no manufacturing
capacity in the pharmaceutical sector for the concerned product to address
public health problems, provided compulsory license has been granted by such
country or such country has, by notification or otherwise, allowed importation
of the patented pharmaceutical product from India.
SECTION 100: POWER OF CENTRAL GOVERNMENT TO USE
INVENTION FOR PURPOSES OF GOVERNMENT:
As per the section 100 of Indian Patent Act, Central
Government has the power to use inventions for the purposes of Government. The
provision states that after an application for a patent has been filed at the
patent office or a patent has been granted, the central government and any
person authorized in writing by it may use the invention for the purposes of government
in accordance with the provisions of chapter XVII of the Patent Act, 1970 (as
amended in 2005).