The Challenges of Governing Public Interest and Intellectual Property Together

In one line

The difficulties are institutional, evidential, temporal, political and conceptual, and none of them is solved by writing a better statute.

Why the question is put this way

MU asked candidates to critically analyse the challenges faced while governing public interest and intellectual property together. The word is challenges, not criticisms.

So the answer must identify difficulties that a well intentioned government would still face, rather than list objections to the system.

Five kinds, and each has a worked example in Indian law.

The institutional difficulty

The functions are split across bodies that do not answer to one another.

The Controller General of Patents, Designs and Trade Marks grants rights, under the Department for Promotion of Industry and Internal Trade.

The Competition Commission of India polices their exercise.

The National Pharmaceutical Pricing Authority caps prices under the Drugs (Prices Control) Order.

The Central Drugs Standard Control Organisation approves medicines.

The National Biodiversity Authority approves access and intellectual property applications over biological resources.

The Protection of Plant Varieties and Farmers' Rights Authority registers varieties.

And the High Courts hear revocation and infringement, the Intellectual Property Appellate Board having been abolished by the Tribunals Reforms Act, 2021.

The consequence. A single question, whether a medicine is available at a reasonably affordable price, may be before the Controller under section 84, the pricing authority under the Order, and a High Court in an infringement suit, with no mechanism for a common answer.

And the abolition of the Appellate Board in 2021 returned a specialised jurisdiction to generalist courts, which improved constitutional propriety and worsened the availability of technical expertise. Both propositions are true and an answer should say so.

The evidential difficulty

Every public interest provision turns on facts the State does not hold.

Section 84(1)(a) asks whether the reasonable requirements of the public are satisfied. That requires knowing how many patients need the medicine and how many receive it.

Section 84(1)(b) asks whether the price is reasonably affordable, which requires knowing purchasing power and the cost of supply.

Section 84(1)(c) asks whether the invention is worked in India, which requires knowing what the patentee manufactures and imports.

The statutory answer is section 146 and Form 27, requiring every patentee and licensee to file an annual statement of working. Compliance has been incomplete, the form was simplified in 2020, and the information it yields is thinner than the statutory tests require.

The same difficulty appears elsewhere. Whether a licensing condition unreasonably restrains trade under section 140 requires market data. Whether a traditional knowledge claim is anticipated requires prior art that may be oral. Whether benefit sharing is fair and equitable under section 21 of the Biological Diversity Act requires knowing what the resource contributed to a product's value.