In a landmark judgment that has the potential to change the direction of India’s pharmaceutical business, The Supreme Court denied that the drug Glivec  manufactured by the pharma giant Novartis is qualified for getting patent in India.

Novartis a Swiss based pharmaceutical company filed a patent application in the year 1997 to grant patent to its drug named Glivec which was a critical drug used for the treatment of leukaemia on the ground that it invented the beta crystalline salt form (imatinib mesylate) of the free base, imatinib.

However at that time India was not in a position to grant patent to pharmaceutical products and agrochemical products, In the year 2005 in compliance with the TRIPS agreement India thereon started to grant patents in pharmaceutical drugs. Parliament introduced a significant and important provision to prevent ever greening and granting of frivolous patents— section 3(d).

Subsequently the matter of Novartis was taken up by the patent controller, CPAA and other generic companies filed pre-grant oppositions against Novartis patent application for imatinib mesylate, claiming, among other things, that Novartis alleged “invention” lacked novelty, was obvious to a person skilled in the art, and that it was merely a “new form” of a “known substance” that did not enhance the substance’s efficacy, and was thus not patentable under section 3(d).

Novartis was already granted Patent for the salt imatinib in the year 1993 in United States itself and the present application was based on one of the specific compound of the already invented salt.

The Application was rejected by the patent controller as the invention failed to comply with condition laid down by section 3(d) of the patent act.

This meant that the generic manufacturers were now free to manufacture the generic version of the drug.

But Novartis challenged the decision of patent controller in Madras High court in the year 2006 by filing number of writ petitions. Challenging to the constitutional validity of section 3(d) was that the use of the term “efficacy” in section 3(d) is vague and ambiguous, and therefore violates the equality provision (Article 14) of the Indian Constitution.

While dismissing Novartis’ writ petitions, the Madras High Court held: “We have borne in mind the object which the Amending Act wanted to achieve namely, to prevent ever greening; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to it’s citizens”.

Also held that the term “efficacy” was known in the pharmaceutical field to mean “therapeutic efficacy”. Therefore rejected the contention that it was vague.

After this the next phase of Litigation started in IPAB an appellate body of patent controller.

However IPAB overturned the Patent Controller’s findings on novelty and inventive step and held that the beta-crystalline form of imatinib mesylate was new and involved an inventive step.

But refused to grant patent as the Novartis failed to establish beta-crystalline form of imatinib mesylate exhibited significantly enhanced therapeutic efficacy over imatinib mesylate, the known substance .In contravention to section 3(d) of the act.

Challenging the IPAB’s order, Novartis approached the Supreme Court directly by filing a special leave petition challenging the IPAB’s interpretation and application of section 3(d) to its patent application. Subsequently, CPAA and Natco filed cross-petitions challenging the IPAB’s findings on other issues including novelty and inventive step.

The main question before the Supreme Court was that

1. Whether the invention qualifies the section 3(d) of the patent act?

2. Interpretation of section 3(d) of patent act?

3. Whether the invention qualifies for the test of novelty and inventive for the alleged product?

The main contention of Novartis was that IPAB admitted that the substance is an invention in its impugned order and then applied section 3d of the act, It was contended that if it is admitted that the product is an invention then section 3d would not be applicable as section 3d is applicable to incremental inventions or discovery and not on new invention.

It was also contended that ‘efficacy‘ test is only applied on known substance but not in the case of beta-crystalline form of imatinib mesylate which is a new substance.

The approach of Supreme Court was simple in this case-:

1. Court observed that the product was a new form of substance not an entire new substance.  It has always existed in the original amorphous form. The product thus qualifies for the test laid by section 3d of the patent act.

2. This section says that just discovering a new form of a substance is not enough to grant a patent, if it does not enhance its “known efficacy”.

3. On interpretation of section 3d of the act, Novartis tried to argue that the physico-chemical properties of the polymorph form of the imatinib molecule, i.e. better flow properties, better thermodynamic stability and lower hygroscopicity, resulted in improved efficacy. The Supreme Court firmly rejected this contention holding that in the case of medicines, efficacy means “therapeutic efficacy” and these properties while they may be beneficial to some patients do not meet this standard. The Supreme Court also held that patent applicants must prove the increase in therapeutic efficacy based on research data in vivo in animals.

4. Simply if the invention does not qualify the test of Therapeutic efficacy the invention can’t be granted patent, Thereby the true intention of the section 3d of patent act is fulfilled by stopping the concept of ever greening in critical sectors, moreover the supreme court held the strict view that patent in the field of medicine specially in the cases of life saving drug must be granted with

full caution so that larger interest of the masses are not affected to an extent that they lose right to live.

The SC judgement is a big relief for those people who can’t afford the lifesaving drugs manufactured by profit guzzling big pharma giants, there is a simple sense of humanity which needs to be preserved by the human race only. I say what is the purpose of an invention  when it is not affordable to the masses and cannot do good for mankind. Here we are talking about a drug which is a life saving drug priced way above the per capita income of the country. The Company in the name of patent prohibits those generic firms who are selling the generic version at an affordable rate, These Pharma big giants are corporates and claimed to have already made billion dollars and are becoming selfish thereby prohibiting people to buy the cheaper version and leaving only option to die because of the fact they are poor as if these Big pharma giants have a patent rights over their lives. I agree with the fact that patent is necessary to preserve one’s invention but that invention must be available to all at a rate reasonable to the masses then only the purpose of the invention would be fulfilled.

On the other hand the companies like Novartis, are doing just tweaking a single molecule call that whole thing as an invention and thus trying to obtain the monopoly over the lives of millions of masses.

The Supreme Court was clear that India is a developing country and cheap medicines are an essence for healthcare of 1 billion people. The Supreme Court has taken a right step and thereby prohibited the liberal approach in granting patents and thus filtering the genuine inventions with frivolous inventions. which allows these companies to make huge amount of inventions

Regarding the investment in innovation in India, This decision is a huge setback to the investors who are interested in investing in India for R&D, I say that they must be cautious that whatever they are inventing should be as per the Indian market conditions or else they will face great amount of dissatisfaction as in the cases of Novartis, Bayer etc. Indian patent environment is not like US and the EU, Rather it is more society dependent than inventor dependent which is exactly the way should be. Following the judgement Novartis had withdrew all its investments of research in India.

By-:

Nitish Banka

Legal consultant

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