The Hindu Business Line : Drug `efficacy' may be open to interpretation

According to Section 3(d), 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 shall not be an invention (and therefore shall not be patentable).

MR RAHUL CHERIAN JACOB

Novartis, created in 1996 through the merger of Ciba-Geigy and Sandoz, derives its name from Latin novae artes, meaning `new skills'. To reflect the company's `commitment to focus on research and development to bring new healthcare products', explains Mr Daniel Vasella, CEO, on www.novartis.com.

What's new, though, about Novartis is the legal action it is pursuing in India `following the patent office's decision to decline the patent' for Glivec/Gleevec, a cancer treatment.

"We also are challenging the establishment of additional hurdles to patentability in India that discourage the development of better medicines,'' declares a recent press release on the site.

Meanwhile, the Communist Party of India (Marxist) has called upon the Government `to vigorously defend the Indian Patents Act'.

To discuss the issue, Business Line contacted Mr Rahul Cherian Jacob, Partner at IndoJuris Law Offices, Chennai. He completed his law from the National Law School, Bangalore with a B.A.LLB (Hons) Degree in 1998.

Mr Jacob practises intellectual property law, media and entertainment law, and technology law.

Here are his answers to a few urgent questions.

First, what is the dispute about?

The Novartis issue in short is this: Is the `increase in efficacy' test for new forms and derivatives of known chemical substances under the amended Patents Act in line with TRIPS (Trade-Related Aspects of Intellectual Property Rights), which requires that patents be granted for inventions capable of industrial application in all fields of technology, provided that they are new and involve an inventive step?

We adhere to TRIPS, don't we?

As per India's commitment to TRIPS, the country is required to provide patents for all inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. India is required to ensure that patents shall be available and patent rights enjoyable without discrimination as to the field of technology. (Article 27 of TRIPS)

What can be patented under our law?

As per Indian patent law only `inventions' are patentable. As per the Patents Act, `invention' means a new product or process involving an inventive step and capable of industrial application. `Inventive step' means a feature of an invention that involves technical advance compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

Is there any contradiction between our law and TRIPS?

On reading of the definition of `invention' it appears that there is no contradiction between TRIPS and the Indian Patent Act. In this context, it is necessary to study Section 3(d) of the Indian Patents Act.

According to this section, 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 shall not be an invention (and therefore shall not be patentable). The explanation to this section states that salts, esters, esthers, polymorphs, metabolites, pure form, particle size, isomers etc. and other derivatives of known substances shall be considered as the same substance, unless they differ significantly in properties with regard to efficacy.

On the rationale of the section?

Apparently Section 3(d) was drafted to prevent pharmaceutical companies from getting perpetual rights by merely recombining known substances. In my opinion, while the legislature has not laid down the guidelines relating to the novelty and inventive step requirements for inventions in other fields of technology in the Patents Act, keeping in mind the substantial political and social issues involved in the case of pharmaceuticals, the legislature thought it prudent to lay down certain guidelines as to what would constitute novelty with respect to drugs and chemical compounds. The result was Section 3(d).

On first look, this seems to provide a different standard for patentability of chemical compounds, from other fields of technology. It is therefore contended by Novartis that the Indian Patents Act discriminates between inventions in other fields of technology and chemical compounds and that therefore the Patents Act does not comply with TRIPS.

Does TRIPS offer any leeway?

Signatories to TRIPS are free to decide what guidelines should be adopted to decide whether a product is `new' and has an 'inventive step' (i.e. whether there is a technical advance compared to existing knowledge etc. and whether there is non-obviousness in the invention) for it to be an `invention' and therefore capable of patent protection.

The way forward, as you see it?

My understanding is that Section 3(d) is intended to say that known substances and their derivatives shall not be considered `new' unless they differ significantly in properties with regard to efficacy.

At the end of the day, a chemical substance (especially a drug) is judged on the basis of its efficacy. Unless a product is `new' it will not as per the Patents Act be an `invention' capable of being patented.

To this extent I feel that Section 3(d) is in line with TRIPS since it merely lays down a guideline as to what constitutes novelty for substances, drugs etc. The legislature felt that novelty in this case must be tested on the basis of efficacy as well. It is of course, left to interpretation as to what would constitute `efficacy'. This I expect would vary from case to case depending on the nature of the substance.

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