In this section, I am trying to comprehend about the patent compulsory license and the purpose behind granting it. As per the section 84 of the Indian Patent Act, 1970, after three years from the grant of patent any person interested or a license holder of the patent can make an application to the Controller for grant of compulsory license on the following grounds:
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- That the reasonable requirement of public has not been satisfied;
- The patented invention is not available at a reasonable price to the public;
- The patented invention is not worked in the territory of India.
The application made under this section should contain a statement reflecting the nature of the applicant’s interest and the facts on which it is based. While considering the application under this section the Controller shall take into account
- The nature of invention
- Time elapsed since the sealing of the patent and the measures taken by the patentee or licensee to make full use of the invention.
- The ability of the applicant to work the invention to the public advantage
- Capacity of the applicant to undertake the risk in providing capital and working the invention, if application is granted.
- If the applicant has tried to obtain a license from the patentee on reasonable terms and conditions within the prescribed period of not more than 6 months.
Patent Compulsory License
A compulsory license is granted by the Indian government to an applicant or a third person to make, use, and sell a patented invention without the consent of the patentee on certain grounds. The grounds are mentioned above. The sole objective behind introducing the provision of compulsory licensing was to
- Prevent the abuse of the patent by forming a monopoly;
- To address the public health concerns in India;
- To make use of the patented invention by commercially exploiting it.
Further, section 92 of the Indian Patent Act, 1970 talks about grant of a compulsory license by the Controller, on issuance of a notice by the Central Government in the Official Gazette, in certain special circumstances i.e either national emergency, extreme urgency or public non-commercial use. Section 92 (A) talks about granting of compulsory license for manufacture and export of patented pharmaceutical product to other countries which have insufficient supply of the said patented product to address their public health problems, provided such countries also provides similar provision to India and has allowed importation from India.
India’s first compulsory license was granted by the Indian Patent Office to Natco Pharma Ltd for producing generic version of Nexavar (Bayer corporation’s patented drug), used for the treatment of Liver and kidney cancer. Recently, on 20 January 2016, the Indian Patent Office had rejected Lee Pharma’s application for compulsory licensing of Astra Zeneca’s patented drug Saxagliptin, an anti diabetic drug.