Business

Novartis Challenges Indian Patent Law

By Dweep Chanana ⋅ December 22, 2006 ⋅  Email this post ⋅ Post a comment

I seem to have missed this. Since May, Novartis has been involved in a legal challenge to India’s Patent Act, which was changed in 2005 to make it TRIPS compliant (see Berne Declaration release for timeline, and coverage from IPMed).

The genesis of the issue is the rejection of Novartis’ patent application for its anti-cancer drug Gleevec (or Glivec). The Indian Patent Office rejected the application under section 3(d) of the Patent Act on grounds that the patented drug was not an invention but simply a minor modification of an existing drug (see legal analysis by Manisha S. Nair). Not only has Novartis challenged that decision, it has challenged the Patent Act itself:

Novartis has taken the “unprecedented action” of challenging India’s patent law in a high court, arguing that it is unconstitutional as well as in breach of international trade law, it said.

This is an important battle for Novartis because Gleevec is the top-selling drug for Novartis, with sales of $2.2 billion in 2005, and costing between $26,000-40,000 per patient. In comparison, generic treatment costs approximately $2,000 in India.

However, as Novartis’ statement points out, this is part of a wider war of the pharma industry to define the Intellectual Property regime. The TRIPS Agreement, which has been used as the global standard requires that applications be novel, commercially applicable, and non-obviousness.

The conflict arises in how India interprets those requirements in local law, making use of of flexibilities provided under the Doha Declaration on TRIPS and Public Health, which states that the TRIPS Agreement:

can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.

The Indian Patent Act, particularly section 3(d), goes further in its requirements for patentability than existing US and European law. This section states:

“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.

In plain english, this means that changing the taste of a drug, its color, or introducing it for a new use cannot be considered inventive.
The implications of this are huge, beyond Gleevec and even India. First, this case tests the legal standing of the Doha Declaration. Second, it is the first major test of the Indian Patent Act of 2005, and in particular its use of TRIPS flexibilities. These flexibilities are important if India is to continue to use generics. Finally, the outcome will define how other developing countries are allowed to create flexible patent regimes that suit their socio-economic context.