Decoding India’s Section 3(d) Pharma Controversy

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call_outIndia owns the third largest pharmaceutical industry in the world in terms of volume and is the 14th largest in terms of value. It has joined hands with those of China, Brazil, Russia and 13 other countries to create a pool of pharmerging countries. This pool is expected to contribute nearly 50% of the world’s annual pharmaceutical market growth.

While India has grown dramatically in the supply of generic medicines, until 1995 the country did not allow patenting of product inventions in pharma. This allowed Indian pharma companies to produce generic drugs with ease at reduced costs. However, in 1995, India’s membership with the World Trade Organization (WTO) required it to revise its patent laws in accordance with the TRIPS Agreement. Until a decade ago process patents were encouraged to incentivize manufacturers in India to produce cost-effective methods of developing expensive patented products. However, from 1 January 2005, India started implementing substantial patent protection for pharmaceutical inventions that also included pharma products.

However, Section 3(d) of the India Patents Act 1970 detailing “What are not inventions” stood in stark contrast to the TRIPS provisions and boosted a controversy. Section 3(d) was created with an intention to balance pharmaceutical patent protection such that it provides access to affordable medicines and healthcare services to the common man.

Understanding Section 3(d)

Section 3(d) was introduced as part of India’s amendments to be compliant with TRIPS. It intends to prevent pharmaceutical companies from obtaining patents on old medicines. The section stipulates…

“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not patentable”

Mere discovery of a new form of known substance is not considered patentable. For instance, paracetamol has an antipyretic property. Further discovery of new property of paracetamol as an analgesic cannot be patented. Similarly, ethyl alcohol is used as solvent, but further discovery of a new property as anti-knocking as a fuel cannot be patented.

Mere discovery of any new use of known substance is not patentable. Aspirin is an analgesic. However, using it to treat cardiovascular diseases is not patentable. However, a new and alternative process for preparing Aspirin is patentable. Similarly, a new use of methyl alcohol as antifreeze in automobiles is not patentable. The use of methanol as a solvent is known in prior art. A new claim as ‘antifreeze’ is not allowable.

call_out_2Why the criticism of Section 3(d)?

The TRIPS agreement finds Section 3(d) violating on two grounds:

  • Section 3(d) does not provide patent protection for incremental innovation. TRIPS states there is a need to define incremental innovation.
  • TRIPS allows WTO members to be more liberal in providing patent rights over the TRIPS criteria, but not make them more stringent. However, Section 3(d) seems to lack standard protection for all categories that is mandated by TRIPS.

Impact on Inventions vs. Impact on Businesses

R&D in pharmaceuticals is risky, expensive and time-consuming. Changes to molecules that may seem trivial at one point in time, can showcase tremendous benefits to patients in another. Research in pharmaceuticals is done in incremental steps on platform technologies with fewer ‘eureka’ moments. Spectacular breakthroughs are few and far between. Extending the effectiveness of an existing medicine can, therefore, represent a significant innovation in itself.  For example, a medicine’s efficacy can be tested only therapeutically – not by claims based on its molecular set-up.  Claims on its physio-chemical properties such as beneficial flow, better thermodynamic stability and lower hygroscopicity, which may otherwise be beneficial, do not render the product therapeutically more efficacious unless tested on a patient. By not giving protection to these above mentioned physio-chemical properties, innovators are at a huge disadvantage in terms of marketing their medicines. Big Pharma could also be worried that the Indian example may be emulated by other developing countries such as Philippines and Argentina. These countries offer a huge marketing base for Big Pharma.

Best way forward

The sovereignty of a country includes its power to make laws. Any person who pursues commercial interests in another country must submit to these laws irrespective of whether the invention stands the test of that country’s legislation.  This is the argument put forwarded by India to defend its stand on introducing Section 3(d) in its patent laws.

A possible solution is to clearly define the concept of Efficacy. In my opinion, Efficacy boils down to a drug demonstrating a health benefit over and above the already approved medicine in relation to Section 3(d). Establishing a medicine’s efficacy can often be done relative to an already approved medicine. If it proves better beneficial effects, then Section 3(d) should not come in the way of a patent grant. Additionally it should also show enhance bioavailability, shelf life, heat stability, reduced side-effects, compatibility, safety etc.

Once a clear cut definition for efficacy such as this emerges, it can be incorporated in to the Patent Examiner’s manual. This will negate the issues of misapplication, arbitrariness and legal uncertainty, and bring peace between India’s patent laws and TRIPS.

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Dr. Nalini Mohan Koutha
Dr. Nalini Mohan Koutha

Dr. Nalini is a Pharmaceutical patent expert and has extensive experience as a technical and Intellectual Property Specialist in Generic Pharmaceutical manufacturing. His quest for analytical thinking extends to his deep interest in philately.


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