There are many substances or chemical compositions that have more than one therapeutic effect or medical use. Where subsequent research brings forth the ‘second medical use’ that was not anticipated, such ‘second medical use’ of the substance already known to have a medical use is also protected in several national jurisdictions. Such types of claims are known as ‘Swiss claims’. Swiss claims can be defined as ‘the claim for the use of a substance or composition that has already been used for medical purpose for a ‘specified new medical purpose’.’ Swiss type of the claim may be illustrated as follows:
“The use of (substance X) in the manufacture of a medicament for the therapeutic and/or prophylactic treatment of (medical condition Y).”
Swiss type claims mark a digression from the absolute rule of ‘novelty’ in as much as here the substance or the composition in the claim already forms part of the ‘prior art’. The concept of novelty is not abandoned in toto but is modified to mean the novelty of ‘intended use’. Novelty here means discovery of the ‘previously unrecognized advantageous property’ of a chemical compound. Like claims for patent protection of new product, the ‘first medical use’ and Swiss type claims must also meet the criteria of patentability viz. they must be new, involve an inventive step and should be capable of industrial application.
Even though the conventional notion of novelty is not satisfied, Swiss Claims are protected as a matter of policy inasmuch as considerable efforts go into finding out new therapeutic use of known substances. Swiss claims are protected only if the national laws recognize them. There is no international obligation to give effect to such claims and therefore many national laws have excluded Swiss claims from patentability.
Indian Law on Swiss Type Claims
The Patents Act, 1970 as originally enacted did not recognize patent protection for the any substance intended to be used or capable of being used as a medicine or drug. In other words, even the first medical use of any chemical substance was not patentable. Therefore, the question of patent protection for the second medical use or the Swiss Claims was explicitly ruled out. Section 3(d) provided that mere discovery of any new property or new use for a known substance is not an invention. Further the process for the medicinal, surgical, curative, prophylactic or other treatment of the human beings was also kept outside the purview of term invention.
The Patents (Amendment) Ordinance, 2004 amended Section 3 (d) and substituted the words ‘new use’ with the words ‘mere new use’ of the known substance. The term ‘mere new use’ was thought to give way to Swiss claims in India as where the new use leads to a medically or therapeutically useful effect it may be patentable. The Patents (Amendment) Act, 2005 substituted the above section with a new one. It reverted to ‘new use’ from ‘mere new use’ of the known substance. Under the current law salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of the known substances are to be considered the same unless they differ significantly in properties with regard to efficacy.
However, under Section 3(d) any invention that enhances the known efficacy of the substance or results in a new product or employs at least one new reactant is patentable and that only the mere discovery of a new form or of any new property or new form of any new property or new use of a known substance or process is excluded.
The amended section makes it amply clear that Swiss type claims shall not be accepted for patent protection in India. Just about any improvement made to the known substance shall not merit protection. Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of the known substances shall be taken to be part of the ‘prior art’ unless they exhibit a higher degree of inventive step.
Rationale for Exclusion
Evergreening of the pharmaceutical products results where the incrementally modified (IMDs) are accepted for patent protection. IMD’s could be new formulations, new combinations of active ingredients or new salts or esters of approved compound. Evergreening of the patented pharmaceutical products will pose problems for India after the processing of the application in the mailbox system takes place. It is estimated that there are around 9000 patent applications in the mailbox system. It has been pointed out that between 1995 and 2003, only 274 new chemical entities have been granted marketing approval by the US FDA and this implies that an overwhelming majority of the applications in the mailbox covers IMDs.
The experience in Countries like U.S. reflects that Swiss type claims are used by the pharmaceutical giants as a strategy to evergreen their million dollar patented drugs. This strategy popularly known as ‘life-cycle management’ of drug entails making slight improvements on the basic invention by routes like new drug delivery system (NDDS), new dosage forms etc and claiming multiple patents on these insignificant improvements of the basic invention and thus extending the patent life of the drug from twenty years to forty years. The end results are-monopolization of the market, ousting of generics, and unavailability of cheaper drugs for a long period of time. The worst outcome would be the decrease in the innovation contrary to the spirit of patent law as course of working on Swiss claims it much time and money consuming.
Indian Perspective on acceptability of Swiss Claims
Pharmaceutical Research and Development Committee headed by Dr R A Mashelkar recommended that only ‘new chemical entity/ new medical entity’ should be given patented protection. Formulations – combinations of drugs, changes in dosage, new use, etc should not be patentable as there is no inventive step involved.
There are two competing opinions on the issue of whether India having already assumed the obligation to provide protection for pharmaceutical products, should also provide the protection to the Swiss type claims like European Union, United States, Australia etc. There is a set of people who strongly believes that recognition of Swiss type claims would tantamount to undertaking TRIPS Plus obligation by the developing countries. It would unnecessarily widen the scope of patent protection and would open floodgate of bogus and frivolous claims.
Other side of the line believes that recognition of Swiss Claim, though not mandatory, would bring Indian law in conformity with the international practice. As the Indian pharmaceutical industry is getting research oriented, recognition of Swiss claims would be beneficial for the industry in the long run.
From the perspective of the pharmaceutical industry exclusion of Swiss-type claims may not be a welcome step. Whereas their counterparts in developed countries enjoy the extended patented protection by developing their basic invention, they may not avail this benefit. Pharmaceutical research in India will not be inclined towards the further improvement of the already known chemical substance. This would also prevent discovery of new therapeutic uses of the known substances.
Instead of placing Swiss claims outside the purview of patent protection, it would have been better if such claims were allowed in limited circumstances. To thwart bogus claims, Indian Patent Office should have evolved elaborate guidelines for the acceptance of Swiss Claims. This measure would have galvanized research in the area of discovering new therapeutic uses on the known substances in India.