In the much awaited decision of the Supreme Court of India in the case of Novartis AG vs. Union of India and others, the Supreme Court upheld the decision of the Indian Patent Office which refused to grant a patent on the beta crystalline form of the imatinib mesylatechemical compound, a therapeutic drug for chronic myeloid leukemia and specific types of tumours that is marketed under the names “Glivec” or “Gleevec”.
There were several issues before the Supreme Court such as whether the amended Patents Act 1970 of India was constitutional; whether the amendments were outside the TRIPS Agreement to which India is a signatory; and whether the beta crystalline form of imatinib mesylate was new and inventive over what was already known in the prior art.
It is a basic requirement of the Patent Laws of almost all countries that for a claimed invention to be patentable, the claimed features must be:
- Inventive (in that the claimed features are not obvious to another person skilled in the art); and
- Industrially applicable
The Supreme Court had to decide based on the evidence before it whether the beta crystalline form of imatinib mesylate was new and inventive.
The Supreme Court focused on the question of obviousness:
Does the product for which Novartis claims a patent qualify as a “new product” which comes by through an invention that has a feature that involves technical advance over the existing knowledge that makes the invention “not obvious” to a person skilled in the art?
India recognizes that its inventive step is a higher standard than that of different countries especially in the area of pharmaceuticals and other chemical compounds. India’s amended Patents Act provides that:
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 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.
Explanation: For the purpose of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy.
The Supreme Court found that section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions, but at the same time to check any attempt at repetitive patenting or extension of the patent term on spurious grounds (a method known as “evergreening of patents”).
The active ingredient in Gleevec is a beta crystal form of imatinib mesylate, which was already known for inhibiting tumours (the function of Gleevec). The Court found the difference between the prior art chemical and the chemical in the current patent application insufficient to allow the new patent.
The decision is important to the Indian pharma industry while the amended Patent Act of India is also TRIPS compliant.
It is interesting to note how other countries which have a substantial generic pharma industry could consider the commercial implications of this landmark decision of the Supreme Court of India.
A moot point: If Novartis were to apply for a patent in Malaysia for the beta crystalline form of imatinib mesylate, would the Malaysian Patent Office grant a patent for the product?