The Supreme Court of India gave the landmark judgment in Novartis AG & Ors. v Union of India & Ors. AIR 2013 SC 1311, a case that dealt with the patenting of a polymorphic form of the anti-cancer drug Imatinib mesylate, created a furore at the international level, particularly within the pharmaceutical and drug discovery communities. This furore and confusion have only been aggravated by subsequent decisions by Indian courts rejecting patents for a series of pharmaceutical substances. Maximum decisions were focussed on section 3(d) of the Indian Patent Act, which was introduced in 2005.
Amidst these judicial controversies, we don’t take cognizance that patented drugs are becoming more frequent and established at the commercial level in India. India is steadily becoming an exclusive patent regime for new drug substances similar to that of major markets such as the United States and Europe. Perception of India becoming the exclusive patent regime has been obfuscated by the judicial controversies over section 3(d).
An unsubstantial Fear
The fright and suspicion various pharmaceutical companies are encountering around the section 3(d) is misconceived and is due to misinterpretation of the scope and meaning of this provision of the section 3(d) of the Indian Patent Act.
The section 3(d) reads as follows:
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;
The Indian patent act does not distinctly expound terms like ‘enhancement of known efficacy;’ ‘derivatives;’ or ‘differ significantly in properties with regard to efficacy.’ The dearth and insufficiency of interpretation, explanation and instruction for these terms and the line of action for evaluating ‘efficacy’ has led to an improper understanding of the substances that are eligible for patent protection.
Scrutinizing the Case Law
The Supreme Court of India had the opportunity to expound and interpret section 3(d) in the Novartis v Union of India case, nonetheless the outcome of the judgment was primarily confined to the term “efficacy.” This has left many questions unanswered.
Following the Supreme Court’s Novartis decision, various drug product patents have been denied under section 3(d) by the Indian patent office. These include enantiomer for Tofacitinib (2015), Enzalutamide, a derivative (2016), Epothilone B, a polymorph (2018), Tiotropium bromide, a polymorph (2015) at the patent office, and Valganciclovir, a prodrug (2015) and Lapatinib ditosylate salt (2013) by the IPAB.
The interpretation of section 3(d) by the patent office, IPAB, and Indian courts has primarily focused on direct evidence for the enhancement of known efficacy of the drugs—indirect evidence in terms of improved bioavailability has not been taken into consideration.
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