Patent Law-II: Pharmaceutical Patents and the Novartis Case

There are three pre-requisites to grant a patent i.e. novelty, invention and utility. The journey of pharmaceutical patents in India has been through many ups and downs and the finally in 2005 India incorporated provisions of TRIPS Agreement in its Patent Laws. The pharmaceutical patents were denied before as they affect the Indian generic industry and results in price rise of medicines but the contention from the other side which kept pharmaceutical patents alive was that the manufacturers invest their money and resources in an invention and they need some return for continuing this work in future.

According to the section 3(b) of Indian Patent Act, those inventions are excluded from granting patent whose use could be done against public order, morality or prejudicial subject matter. For example, a powder made from the body of dead people was not accepted as it was immoral to use it. Section 3(c) of the act states that “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature would not be considered as an invention”. Section 3(d) of the Indian Patent Act restricts grant of patent for new form of known substances unless they show enhanced efficiency. It 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”.

The Supreme Court refused to grant a patent to Novartis, in the case of Novartis AG v. Union of India. Initially, Novartis claimed patent for beta crystalline form of Imatinib Mesylate but 5 opposition companies raised an objection stating that a very similar product was already patented, and hence, this particular drug could not be patented. Patent office rejected patent on 4 grounds i.e. anticipation, non-obviousness, not an invention under section 3(d) of Indian Patent Act and wrongful priority. Novartis reached Supreme Court and contended that it was a new invention since there were certain changes made to the drug. The Court stated that the drug did not pass the test laid down by Section 3 (d) of the Patents Act, and hence patent will not be granted. It also stated that just making some minor changes in a known product will not increase its efficiency and make it an invention.

Further under Indian Patent Law, a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not patentable. Section 3(j) of the act states that most of the lining things such as plants and animals in whole or any part thereof including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not patentable excluding microorganism and microbiological processes. Finally section 3(p) of the act says that an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components is not patentable. All the pharmaceutical innovations should adhere to these rules in order to be eligible to be granted a patent.

Aishwarya Says:

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