First Publication Date: 11th December 2010.
A person falling within the scope of a defense will not be liable for infringement though his product or process is infringing. Some of the defenses to patent infringement recognized under the Indiann Patent Law are:A. Experiment, Research or Education;
B. Bolar Exemption;
C. Government use; and
D. Parallel Imports.
A. Experiment, Research or Education
Use of a patented invention for experimentation or research is a defense to patent infringement. The provision relating to experiment and research under the Indian law uses expansive language and can be interpreted to have a very broad scope. Economic objectives of the research or experiment are not considered for ascertaining whether an activity falls within the scope of this exemption. As the exemption is much narrower in USA and other countries, many companies have set up R and D centers in India to carry out research without patent hurdles.
In addition to research, use of a patented invention for education to pupils is also a defense to patent infringement.
B. Bolar Exemption
A patented drug may be used without any infringement liability for conducting studies, experiments and trials to get authorization from the drug approval authorities. This defense is called as the Bolar Exemption because it was enacted in USA after the decision in the case of Roche v. Bolar. In India, the provision is worded in very broad language and may be extended to government approval for any invention and not just drug related inventions.
C. Government use
Importation, manufacture or use of a patented invention by or on behalf of the government is another defense to patent infringement. Such a defense is available only if the activity is merely related to purposes of government’s own use. Initially, the scope of the defense for government use was expounded by the courts to be limited to use by government officers and government departments only. However, the Delhi High Court in a recent decision stated that the government use exemption to infringement will extend to contractors of the government as well.
D. Parallel Imports
The exclusive rights with respect to a product are exhausted on sale of the product by the patent holder. Exhaustion applies to a process patent also on sale of a product made by the process. This is also called as the first sale doctrine in USA.
Exhaustion of patent rights may be national, international or regional. In case of national exhaustion, the rights of a patent holder are exhausted within a country on sale of a patented product in that country. International exhaustion is a scenario where rights of a patent holder are exhausted within a country on sale of the patented product in any country. With respect to regional exhaustion, the rights of a patent holder are exhausted in region if the patented product is sold in any country within the region. The European Union follows the system of regional exhaustion.
India follows the principle of international exhaustion. As per the Patents Act in India, the rights of a patent holder will be exhausted if the sale of the product in another country is duly authorized under the law of that country. If a person purchases the product in a country from a person authorized to sell in that country and imports the same into India, he would not be liable for patent infringement. This exemption is also called as Parallel Imports exemption because it allows parallel imports of a product without liability. In addition to the afore-said defenses, equitable defenses such as inequitable conduct, patent misuse and so on may also be used for shielding patent infringement suits.
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