NOVARTIS AG VS UNION OF INDIA: CASE SUMMARY
The Supreme Court in Novartis AG Vs Union of India (2013) 13 SCR 148 held that the beta crystalline form of Imatinib Mesylate (patent product) fails in both the tests of invention and patentability as provided under clauses (j), (ja) of Section 2 (1) and Section 3 (d) of Patent Act, 1970.
FACTS OF THE CASE
Novartis AG has filed application for patent for Imatinib Mesylate in beta crystalline form at Chennai Patent Office in July 1998. The Patent Office refused to grant patent on the ground that invention claimed by Novartis is anticipated by prior publication Zimmermann Patent, invention is obvious to a person skilled in the art in view of disclosure in Zimmermann Patent etc. Novartis aggrieved by the refusal by Patent Office filed Writ Petition before the Chennai High Court. After constitution of IPAB, Writ Petitions were transferred to it. IPAB held that Novartis invention satisfied test of novelty and non-obviousness but was hit by Section 3 (d) of Patent Act, 1970 which requires higher standard of inventive step. Novartis has also filed Writ Petitions challenging the constitutional validity of Section 3 (d) of Patent Act, 1970 which was dismissed by High Court.
Against the order of IPAB, Novartis filed Special Leave Petition to the Supreme Court under Article 136 of the Constitution.
FINDINGS OF THE SUPREME COURT
The Supreme Court took notice of development of patent law in India. The Court noted that Patent Act, 1970 provided for only process patent. Product patent was not available under the said Act. After India became member of WTO and signed TRIPS agreement, India had to comprehensively amend Patent Act, 1970 in 2005 and provision for product patent was also made.
The Supreme Court observed that three conditions have to be fulfilled to qualify as an invention under Section 2 (1) (j) – Firstly, It must be “new”, secondly, it should involve “inventive step”, and thirdly, it must be capable of industrial application.
Inventive Step has been defined under Section 2 (ja) to mean 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.
The Supreme Court noted that “invention and patentability” are two separate concepts. Something may be “invention” in general understanding but the same may not be “invention” for purposes of the Act. Something may be “invention” for the purposes of the Act but may not be “patentable” under the Act.
The critical issue in the matter was whether patent application was hit by Section 3 (d) of the Act. Section 3 (d) of the Act reads as under :
Section 3 – What are not inventions – the following are not inventions within 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 employes 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 substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
The Court held that Section 3 (d) is meant specially for chemical substances and more particularly pharmaceutical products. It sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave door open for true and genuine products but at the same time to check any attempt at repetitive patenting or extension of the patent on spurious grounds.
The Supreme Court found no force in submission that development of Imatinib Mesylate from Imatinib is outside the Zimmermann Patent and constitutes an invention as understood in the law of patent in India.
As far as beta crystalline form of Imatinib Mesylate was concerned, the Supreme Court observed that it was a new form of a known substance, i.e. Imatinib Mesylate, efficacy of which was known. As such it will attract explanation to Section 3 (d). The Supreme Court observed that the pharmacological effects of Imatinib Mesylate in beta crystalline form are equally possessed by Imatinib in free base form.
The Supreme Court observed that no material has been placed on record to indicate that beta crystalline form of Imatinib Mesylate will produce enhanced or superior efficiency on molecular basis than what could be achieved with imatinib free base in vivo animal model.
The Court held that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja), of Section 2 (1) and Section 3 (d) respectively as such appeal filed by Novartis AG was dismissed with costs.
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Mukesh Kumar Suman is an advocate and legal author based at Delhi. He regularly appears before various Judicial Forums including NCLT, NCLAT, High Courts and the Supreme Court. He can be approached at mukesh_suman@outlook.com or +91 9717864570.