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CS Executive · Economic, Commercial and Intellectual Property Laws · Law relating to Patents

Sunrise Pharma Ltd, Hyderabad, makes small batches of a patented drug owned by Veda Labs solely to generate data needed for submitting to a drug regulator, in India or abroad, under the law regulating manufacture and sale of the product. Veda Labs sues for infringement. What is the position under the Patents Act, 1970?

It is not infringement. Section 107A provides that acts of making, using, selling or importing a patented invention solely for uses reasonably related to developing and submitting information required under a law, in India or elsewhere, regulating the product, are not infringement of patent rights.

  1. AIt is infringement, because only the patentee may make the invention
  2. BIt is not infringement, because the acts are solely for uses reasonably related to development and submission of information required under lawCorrect
  3. CIt is infringement unless Veda Labs gives written consent
  4. DIt is not infringement only if the regulator is in India

Explanation

Section 107A says making, using, selling or importing a patented invention solely for uses reasonably related to developing and submitting information required under any law in India or another country is not infringement. The regulator's location is irrelevant, so the option limiting it to India is wrong.

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