Is Section 3(d) Separating Wheat from the Chaff?

Prior to the third amendment, the Indian patent law categorically barred patent protection not only to chemical and drug compounds and intermediates but also to pharmaceutical compositions, drug combinations, drug deliveries and any physical/chemical modification to chemical/drug compounds (such as polymorph, co-crystals, complexes, enantiomers and so on). However, ten-year transitional period provided by TRIPS agreement mandated India to allow patent protection to all fields of technology that included drug and chemical products. This mandate was met with strong resistance and protest from local pharmaceutical companies and public health NGOs, and one of the most heated issues was ever-greening. Acknowledging industry concerns about ever-greening and weighing flexibilities provided under TRIPS agreement, the Government of India diligently amended section 3(d) to separate wheat from the chaff. In other words, section 3(d) was amended to separate genuine inventions from frivolous inventions. In patent law, a frivolous invention is an invention which fails any of three criteria of patentability, that is, novelty, inventive step and utility. But if an invention satisfies all three criteria of patentability then it is not frivolous and is patentable until and unless categorically excluded under the law (such as section 4). Notably, the criteria of patentability are same in almost every country having patent law but the benchmark to judge those criteria may differ country to country (such as judicially evolved doctrine).

What differentiate patent law from other disciplines of law is that this is the only subject of law that specifically and particularly deals with advance science and latest technology. Obviously with the advancement of scientific research and technology, certain practices that may have well thought-out inventive almost a decade back has now become more or less a customary practice to a person skilled in the art. For example, almost 10-15 years back resolution of racemic mixture into isomers/enantiomers was novel and inventive practice considering the state of technology and scientific practice prevailing at that particular point of time but now it has become known and customary to an ordinary person skilled in the art. Similarly, concepts such as bilayer tablet or controlled release formulation using HPMC that may obviously thought inventive almost a decade (or two) back is now a common formulation practice. However, despite such practices becoming customary and obvious in state-of-the-art, patents are regularly been issued for inventions using /based on such practices. Unfortunately, the patent law is not able to keep in race with the changing technology and scientific practices and in many cases still scrutinizing inventions keeping in account decade old scientific practice. Such patents are now a major point of concern in healthcare industry, which not only hamper healthy competition but also create litigious market, and is often used as a part of business strategy positively referred as Product LifeCycle Management and negatively referred as Ever-greening.

History is witness that many countries in past, from time to time, amended their patent law to support their social and economic development and India is no exception to that. In 1970, following observations and recommendations made by Ayyenger Committee, the Government of India abolished patent protection to chemical, drug and food products which was a well-thought recommendation to support social and economic situation of India. The impact of that recommendation resulted into strong indigenous generic drug industry which not only supported widely-concern public health issue but also brought new business and employment opportunities for India. In 2005, India again carefully brought changes to its patent law not only in conformity to TRIPS agreement but also to support its socio-economic development. Inclusion of amended section 3 (d) is an example of such diligent approach to balance social and economic development and at the same time keeping patent law in pace with changing technology and scientific practices.

In our continuing post, we will particularly discuss section 3(d) in detail and will also try to rationalize the spirit and scope of section 3(d). However, we will be happy to welcome comments from our readers on this post and their opinion on section 3(d). Hope we can bring some value and clarity to section 3(d).