India proved patent laws not cast in stone

India has remarkably shown the way forward in
India has remarkably shown the way forward in IP and development. FILE PHOTO | NMG 

Three weeks ago, I wrote an article titled, ‘‘How State intervention could boost the fortunes of Kenya's pharmaceutical sector’’, for the Daily Nation newspaper in which I detailed the potential in the pharmaceutical industry if we balanced international obligations and our national interest.

I argued that Kenya should emulate India in suspending the intellectual property law in at least health and agricultural sectors since these two are the cornerstones of the Kenyan economy. I received rather unexpected responses. While some people thought I was ignorant, others argued that I was misleading the country into violating World Trade Organisation’s (WTO) Trade Related Intellectual Property Rights (TRIPS). They were wrong.

In essence I was urging the country to fight in the interest of people and secure the best outcome possible for affordable medicines. In my view, India is the best case study for Kenya to move beyond rhetoric and put together the building blocks of affordable healthcare.

Provisions of TRIPS are not cast in stone. They are subject to interpretation and this where most developing countries fail. India cleverly drafted their Intellectual Property law by providing for local examination of patent application. Virtually all other developing countries assume that any medicine with an approved patent in developed countries should automatically be granted domestic IP rights without examination.

In a paper titled, ‘‘Trumping TRIPS: Indian Patent Proficiency and the Evolution of an Evergreening Enigma’’, Shamnad Basheer says, Section 3(d) of India’s Patents Act forbids patents on pharmaceutical substances that do not demonstrate a significantly enhanced efficacy over and above prior known substances.This enigmatic provision was transplanted from a European drug regulatory directive and finds no precise parallel in any other part of the world.


To make this really work the Indian law allowed third parties into the process of granting local IP rights. If an informed patient feels that by approving a new patent it will affect their medicine then they have a right to object in public interest – meaning any person can raise an objection to granting of patent (pre-grant opposition of patent).

In effect, this amounted to giving the public (even more so the patients) the right to oppose granting of patents without incurring cost to their objection.These provisions were put to test in a famous case between Novartis (Glivec) and the government of India specifically on Section 3(d).

On this matter, Basheer noted: “Not only did the Indian judiciary endorse the legality of Section 3(d), it insisted on a rigorous ‘therapeutic efficacy’ threshold.In doing so, it complemented the efforts of the Indian legislature in refusing to co-opt itself into a patent construct engineered by the allegedly more sophisticated patent regimes of developed countries.

Notwithstanding some of the infirmities in the decision, the court still demonstrated a fair degree of patent proficiency, given that neither of its judges came with any prior patent adjudicatory expertise.”To the surprise of many, Novartis did not contest the ruling or take the matter to WTO perhaps for fear that it will be replicated in other countries like Thailand and South Africa that have an advancing pharmaceutical industry.

Another important practice that India has used for national interest is compulsory licensing as done with ARV drugs. It was similarly taken to the Supreme Court where the Indian government once again won (the compulsory licensing step was taken by the government as the pharma company was not selling it at an affordable price to the patients even after granting a patent).

India acted within the provisions of TRIPS adopted in Morocco in April 1994, that although it reflected a substantial victory for developed countries and their positions, it had some wins for developing countries, too, most notably the retention of flexibilities in compulsory licensing. In the overall analysis, developing countries like Kenya must see beyond the ambiguities in TRIPS and interpret it for the purpose of national interests. India has remarkably shown the way forward in IP and development.

To restate Basheer, India, with less patent expertise than its developed counterparts, pioneered patent norms to suit its own national interest, and did it with a fair degree of proficiency.