Patent Dynamics: Unveiling Novelty in Known Substances and Processes

 

Introduction

Section 3 of The Patents Act, 1970 describes what inventions or discoveries will not be patented. From clauses 3(a) to 3(p), eligibility criteria for patentability is given. The most controversial and tricky clause is 3(d). Clause 3(d) states that 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.  Specifically means that, 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;

This new clause was added by the 2005 amendment, which clearly states that inventions cannot be patentable.

Essentials

Main findings from the clause that amount to essential are – Known substance, New form of known substance and new use of known substance.

A.Known substance

There is no particular parameter to find what is known substance. However, In a very recent ruling in the case of DS Biopharma Limited v. The Controller of Patents and Designs, a single bench of the Delhi High Court held that, in order to raise an objection under Section 3(d), the specific known substance must be identified, and the Patent Office must at the very least mention, in brief, how the claimed compounds are new forms.

1. mere discovery of a new form of a known substance

The mere identification of a novel attribute in a known substance, like the revelation of paracetamol's analgesic quality or the recognition of ethyl alcohol as a fuel due to its anti-knocking properties, does not meet the criteria for obtaining a patent. The novelty must extend beyond known applications to meet the patentability criteria.

 

1. mere discovery of any new property or new use for a known substance

An insignificant discovery of new property of recognized substance isn't always taken into consideration patentable. A brand new use for a acknowledged substance always falls outside the purview of patent safety for the prime reason that the discovery of new residences, from regarded substances, are not taken into consideration ‘inventive’. The safety of second or in addition uses are also dependent on what's disclosed to the public when in comparison with prior artwork.

EXCEPTION

There is no proper clause for the exception of section 3(d) as such. In the provision, the only exception mentioned is that it should –

1. Result in the enhancement of the known efficacy of that substance
2. Results in a new product or employs at least one new reactant

In very famous case of F. Hoffmann-La Roche Ltd. &Anr. v Cipla Ltd, the division bench gave the parameter to judge if there has been made any infringement under section 3(d) of the Patent act.

CONCLUSION

The 2005 reforms ensured that India adopted an intellectual property system that was in line with the spirit of the WTO, but also aimed at “Ever greening"—making  expensive drugs available at nominal prices by promoting market competition. . It was also shown to maintain this ban what the Indian Judiciary has shown through cases like Novartis and Cipla is that Section 3(d) does not apply to patents, which means it acts as a defence against greening. Reviewing product effectiveness and resubmitting products basically limits the speed of research and development and leads to the downfall of the country. Second, these cases have made it clear that the public interest as a whole is paramount when granting and examining patent applications.

Indian patent laws encourage invention but are opposed to granting absolute rights and provide limited rights that encourage further research and development and the development of better drugs in the market.