Introduction

• This case is the landmark case of Section 3(d) of the Patent Act, 1970.
• This case deals with the patent that can be granted to the product if it shows novelty and non-obviousness of the invention.

Facts

• A big pharmaceutical company called Novartis AG (Appellant) wanted to get a patent registered for a cancer drug named ‘Glivec’ or ‘Gleevec’ which they created using a specific form of a substance called “Imatinib mesylate”.
• The Assistant Controller determined that the appellant's claimed invention had been pre-emptively disclosed in a prior publication of a similar product named Zimmermann patent.
• At first, the request of the appellant was denied under a law called Section 5 of the Patents Act, 1970 which said, “Inventions were only methods or processes of manufacture patentable”.
• Later, when the law changed in 2005, the appellant tried again, but the Madras Patent office and the Intellectual Property Appellate Board rejected it.
• They said Glivec did not show better effectiveness than an earlier drug called 'Zimmermann' from the US.
• Because of this, it did not meet the requirements for a new invention under Section 3(d) of the Patent Act, 1970.
• Hence, the company appealed to the Supreme Court of India.

Issues Involved

• Whether the invention "Beta crystalline form of imatinib mesylate" claimed by Novartis is more efficacious than the substance that it was derived from i.e. "Imatinib mesylate"?
• What is the test of efficacy in the context of Section 3(d) of the Patent Act, 1970?

Observation

• The Court said the product is not a new substance, just a different version of an existing substance.
• To get a patent, it must meet the rules in Section 3(d) of the Patent Act, 1970 which says the new version must improve its "known efficacy."
  • They explained "efficacy" as meaning therapeutic effectiveness.
• So, in this case, the company should have proven that the new version works better for treating diseases than the old one. The term "efficacy" is crucial here.
• The SC said Section 3(d) aims to stop "evergreening," where companies try to extend their patent by making small changes.
• If a new invention does not pass the Section 3(d) test, it cannot get a patent. They also clarified that this case does not mean Section 3(d) blocks all small improvements.

Conclusion

• The Court finally held that beta crystalline form of Imatinib Mesylate is not a new form of known substance and dismissed the appeal by Novartis AG.

Note

• Section 3(d) of the Patents Act, 1970
  • 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.