There is no ambiguity in Indian legislation

Font Size

Print

Feedback

Email

Discuss

: use this flexibility.

This entire dispute arose merely because of a lack of clarity on how to determine the “enhancement of a substance”. This was not addressed by the high court in its verdict, giving ample scope for future litigation in this area. But the growing fear that the decision would have an impact on future R&D within the country is a pettifogging ploy.

Under our Act, patents are granted for 20 years according to the WTO’s timeframe to sufficiently remunerate an inventor. Even after this, if an inventor creates a modified version of the original product with improved efficacy then the law explicitly recognises it under Section 3(d).

What it restrains is the practice of extending the patent term beyond 20 years by tweaking the composition of the original product without any enhanced efficacy. In other words, it tries to restrain the firm’s monopoly.

What the current situation demands most is minor clarification of this controversial provision to avoid future challenges. The ideal situation would have been for the Madras High Court to come out with its own interpretation, after due consultation with the patent and health authorities, of Section 3(d) in its verdict. However, it has not done so. On the contrary, in its verdict, it claimed that the provision does not suffer from vagueness, ambiguity or arbitrariness and contains reasonable in-built protection for patent applicants—a statement which cannot be denied.

But, for a better understanding, either we can wait for a similar dispute to be raised in court, or could come up with an addendum in the law giving greater clarity to the provision by setting up some criteria for judging the enhanced efficacy of a new drug. Nevertheless, none of these steps are imperative as the provision is consistent with the Trips agreement.