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www.expresspharmaonline.com FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS
1-15 September 2006  
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Home - Management - Article

Patent Post

Compulsory licensing under the Indian Patent Law

Suresh Sukheja throws light on compulsory licensing under the Indian Patent Law to deal with extreme or urgent situations.

The Indian Patent Law has provided for adequate powers to the Controller of Patents to issue compulsory licenses to deal with the following extreme and/or urgent situations.

A) Section 84—To prevent the abuse of patent as a monopoly and to make way for commercial exploitation of invention by an interested person.

B) Sections 92 (1) and 92 (3)—Circumstances of national emergency or extreme urgency.

C) Section 92 A—For exports of pharmaceutical products to foreign countries with public health problems.

(A) Section 84—The law provides for compulsory license under section 84 of the Indian Patent Act, to prevent the abuse of patent as a monopoly and to make way for commercial exploitation of invention by an interested person. Under this section, any person can make an application for grant of compulsory licence for a patent after three years, from the date of grant of that patent, on any of the following grounds:

(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.

Moreover, Section 89 specifies and explains the general purposes of granting compulsory license under Section 84 as:

(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.

Further, the subsection 6 of Section 84 elaborates that the Controller shall take into account the following 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. Notably, Section 90 of the Act also empowers the controllers to settle the terms and conditions for compulsory licences.

(B) Sections 92 (1) and 92 (3)—Both these sections enable the Central Government and the Controller, respectively, to deal with circumstances of national emergency or circumstance of extreme urgency related to public health crises by granting relevant compulsory licences.

(C) Section 92 A—Provides for compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. Thus, this section is an "enabling provision" for export of pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector in certain exceptional circumstances, to address public health problems. Such country has either to grant compulsory license for importation or issue a notification for importation into that country.

 


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