Skip to content

CS Professional · Intellectual Property Rights - Law and Practice · Indian Patent Law and its Developments

Zenith Pharma Ltd, Hyderabad, holds an Indian patent on a cardiac drug. Before the patent expires, Kiran Labs makes small batches of the drug in India solely to generate data required to be submitted to a drug regulator, in India or abroad, for marketing approval. Under the Patents Act, 1970, how is Kiran Labs' act treated?

Kiran Labs' act is not an infringement. The Act provides that making a patented invention solely for uses reasonably related to developing and submitting information required under a law regulating the product, in India or another country, is not infringement. The regulator's location and any royalty are irrelevant.

  1. AInfringement, because any making of the patented product without the patentee's consent is infringement
  2. BInfringement, unless Kiran Labs pays royalty to Zenith Pharma
  3. CNot an infringement, because it is solely for uses reasonably related to developing and submitting information required under a law regulating the productCorrect
  4. DNot an infringement only if the regulator is an Indian authority

Explanation

Section 107A(a) says making, constructing, using, selling or importing a patented invention solely for uses reasonably related to development and submission of information required under any law in India or in a country other than India is not infringement. Option D is wrong because the provision covers laws in India or elsewhere. No royalty condition appears.

Did you get it right without looking?

One question tells you little. A timed set on Indian Patent Law and its Developments shows your real accuracy, how long you take and where you lose marks.

Practise Indian Patent Law and its DevelopmentsFree diagnostic mock

More Indian Patent Law and its Developments questions