Novartis A.G. v. UOI & Ors. – Hon’ble Justice Aftab Alam’s Swansong

By Rudrajyoti Nath Ray, Associate

The act of an “invention” precedes the act of making an application for a “patent” under the Patents Act, 1970 (“Act”). Simply put, no invention – no patent! In the recent decision of the Hon’ble Supreme Court of India (“SC”) in Novartis A.G. v. UOI & Ors. (Civil Appeal Nos. 2706-2716 of 2013 arising out of SLP (C) Nos. 20539-20549 of 2009) (“Novartis”) it was discussed, at length, whether  the Appellant  is entitled to get a patent for the beta crystalline form of a chemical compound called Imatinib Mesylate – that is marketed as “Glivec” and is considered a therapeutic drug for chronic myeloid leukemia. Naturally the first question that was asked was: does the production of the beta crystalline form of the chemical compound called Imatinib Mesylate (“the beta form”) qualify as an “invention”.

The appellants contended that indeed Jürg Zimmermann invented a number of derivatives of N-phenyl-2-pyrimidine-amine, one of which is Imantib. These derivatives were granted a patent in the U.S. (“the Zimmerman Patent”). Beginning with Imatinib, the subject product, i.e., the beta form, was brought to being by not one but two inventions. The first invention involved the coming to being of Imantib Mesylate from Imantib in its free base form (“the first alleged invention”). The second invention was the process by which the appellant arrived at the beta form (“the second alleged invention”). These contentions were however not accepted by the SC.

Sub-Clauses (ac), (j) and (ja) of Section 2(1) of  the Patents Act, 1970 (“Act”) read as, “In this Act, unless the context otherwise requires,- (ac) “capable of industrial application”, in relation to an invention, means that the invention is capable of being made or used in an industry; (j) “invention” means a new product or process involving an inventive step and capable of industrial application; (ja) “inventive step” means a feature of an invention that involves technical advance as 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; On a combined reading of the aforesaid clauses, the SC held that,  it is evident that a product, in order to qualify as an ‘invention’, must satisfy the following tests: i) It must be “new“; ii) It must be “capable of being made or used in an industry” iii) It must come into being as a result of an invention which has a feature that: a) entails “technical advance over existing knowledge”; Or b) has an “economic significanceAnd c) makes the invention “not obvious to a person skilled in the art”.

It was however pointed out that in case of chemicals and especially pharmaceuticals, if the product for which the patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to the clauses of section 2(1), the tests provided in section 3(d) read with its explanation. Section 3(d) of the Act, for the purposes of our understanding, is reproduced below: “ What are not inventions.- The following are not inventions within the meaning of this Act,- (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 purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of 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.”

Within the framework of these laws – it was concluded – as regards the first alleged invention that, Imantib Mesylate was a known substance from the Zimmerman Patent. The Zimmerman Patent had, in fact, the teaching for the making of Imatinib Mesylate from Imatinib, and for its use in a pharmacological compositions for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. In view of that fact, it could not be said that Imantib Mesylate was a “new product” or that it came into being through an “invention” that involved a “technical advance over existing knowledge” or was “not obvious to a person skilled in the art.” The consequential finding, therefore, was that the production of Imatinib Mesylate does not qualify the test of “invention” as laid down in section 2(1)(j) and section2(1)(ja) of the Act.

As regards the second alleged invention – it was found by the SC that the beta form, being a pharmaceutical substance and moreover a polymorph of Imatinib Mesylate, directly ran into section 3(d) of the Act with the explanation appended to the provision. Within the meaning of that Section therefore it was obligatory for the Appellant to show the “enhanced efficacy” of the beta form over the known substance, i.e., Imantib Mesylate (non-crystalline) Of course, efficacy is measured differently for different things. In the case of medicine, the SC held, the test of efficacy could only be “therapeutic efficacy”. But, on the basis of the material brought before the Court it could not be concluded that the beta from had any enhanced or superior therapeutic efficacy.

In view of the finding that the beta from failed both the tests of invention and patentability as provided in clauses (j), (ja) of section 2(1) and section 3(d) respectively – the appeals were dismissed. Interestingly, right at the end of the judgment it was noted that, “In the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form. On the package there is no reference at all to Imatinib Mesylate in beta crystalline form. What appears, therefore, is that what was sold as Gleevec was Imatinib Mesylate and not the subject product, the beta crystalline form of Imatinib Mesylate. If that be so, then the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.”

For the courage of his convictions and for the forcefulness of his speech – Novartis shall always be remembered as Hon’ble Justice Aftab Alam’s swansong. He is scheduled to retire on 18th April, 2013.

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