India: Pharmaceutical Products -What is not Patentable under Indian Law?

Preface

The determination of patentability of a particular invention is perhaps the most daunting and consuming task in the entire process of grant of a patent. For an innovation to qualify the criteria of invention it must be new, involve an inventive step and should be capable of industrial application. However, the existence of these preliminary requirements would not alone entitle an invention to claim patent protection. The invention must also escape the exclusionary clauses under the Patents Act.

Section 3 of the Patents Act, 1970 excludes certain inventions from the ambit of patentability. Though there is an exhaustive list of fifteen exclusions from patentability mentioned in the Act, only three exclusions enumerated in clauses (d), (e) and (i) of section 3 are relevant from the perspective of pharmaceutical products in India. These clauses exclude new use of the known substance, mere admixture of components and methods of treatment respectively from the ambit of term ‘invention’ and hence render them unpatentable. All these exceptions have been provided in conformity of the categories for exclusions mentioned in the TRIPS Agreement.

This article is an attempt to analyze these exclusions from a global perspective and study their ramifications on the Indian pharmaceutical companies.

It is a cardinal principle of patent law across all the national jurisdictions that for an invention to be patentable, it must be ‘new’, involve an ‘inventive step’ and should be capable of ‘industrial application’. Novelty is regarded as the most important criterion on which patentability hinges. Where a ‘new chemical entity, having therapeutic effect is discovered, it is per se entitled to patent protection. Where although the substance or chemical composition is known but its medical use is unknown, the ‘first medical use’ of such substance or chemical composition is also equally eligible for patent protection provided it fulfills the requisites for the same. The claim for the ‘first medical use’ is generally in the form ‘substance X for the use in the treatment of medical condition Y’.

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:

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.

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.

According to section 3(e), a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process of producing such substance is not an invention within the meaning of the Patent Act.

Thus section 3(e) of the Indian Patents Act denies claims to pharmaceutical composition with a single active ingredient, even if the active compound is novel, as it bars compositions obtained by mere admixture resulting only in the aggregation of the properties of the components thereof. In other words a novel pharmaceutical composition with a single active ingredient (known or novel) with an inert carrier is not patentable in India as there is no synergy between the components viz. the active compound and the inert carrier.

The rationale for excluding methods of treatment from patentability is that methods of treatment are not capable of industrial application. Another reason is the policy that the medical men who use methods as a part of their duties should not be inhibited by the existence of patent protection. The methods of treatment require medical skill of a medical practitioner and not merely intake of medicines by the patient and therefore the methods of treatment are not capable of manufacture unlike the pharmaceutical products or in other words are not capable of industrial application and hence cannot be patented.

In Bristol-Myers Squibb v Baker Norton Pharmaceuticals Inc, (1999), considered the purpose of exclusion of methods of treatments. Jacob J. observed:

Indian patent law expressly excludes methods of treatment of human beings and animals from patentability. Section 3(i) of the Patents Act 1970 as amended declares that the term invention does not encompass ‘any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for the similar treatment of animals to render them free of disease or to increase their economic value or that of their products’.

Under the original act of 1970 only process for medicinal, surgical, curative, prophylactic or other treatment were excluded from patent protection. Diagnostic and therapeutic treatment was included in this category by the Patent (Second Amendment) Act of 2002.

The Act does not define the meaning of the terms ‘medicinal’, ‘surgical’, ‘curative’, ‘prophylactic’, ‘diagnostic’, ‘therapeutic’ treatments. It is important to define the contours of these terms as those methods that do not fall in any of the specified categories would not be excluded from patentability.

In order to determine the exact scope of the exclusion it is necessary to understand the meaning of the terms-‘surgical’, ‘therapeutic’ and ‘diagnostic’ treatment. The term ‘therapy’ may be defined as ‘any treatment which is designed to cure, alleviate, remove or lessen the symptoms of, or to prevent or reduce the possibility of contracting any disorder or malfunction of the human or animal body. Therapeutic treatment may be defined as a course of treatment undertaken with the ‘intention to improve the health of the human or animal being treated’.

Surgery has been defined as ‘the field of medicines involving the healing of diseases or accident injuries, or remedies against physical defects by means of surgical intervention performed in a body’. Diagnostic methods generally include those methods "… in which the examination, i.e., both the determination of the present state of health and the symptoms of illness is carried out directly on body".

The Patent Act is silent on the point as to whether the new substances or compositions and apparatus used in such methods of treatment would be patentable or not. Drawing analogy from the law on the point in other jurisdictions such as EU, U.K. it may be assumed that though the process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment has been excluded, the products that are used in such treatment are patentable. Similarly the instruments and apparatus that are used in such treatment should also be patentable.

There are no judicial precedents in India on the patentability of methods of treatment so as to guide the interpretation of this exclusionary clause. The law on the ‘method of treatment’ has been extensively analyzed, explored and interpreted by the European Patent Office (EPO) and the national laws of the EU members. Elaborate guidelines are formulated by the EPO to aid the examination of the claims relating to the patent of ‘methods of treatment’. In order to understand the nuances of the nature and extent of exclusion, we have to study the legal provisions and the corresponding interpretations of the ‘methods of treatment’ in the other jurisdictions.

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.

Under the U.K and Australian law, purely cosmetic treatment of human and animals are patentable. Where a method of treatment involves both the therapeutic and cosmetic effects, the cosmetic effect would be patentable if it is distinct from the therapeutic effects. Whereas the exclusionary clause under the European law is exhaustive and excludes only therapeutic, diagnostic and surgerical methods of treatment, the Indian provisions is inclusive in nature and includes ‘other treatment’ also. It is not certain if purely cosmetic methods of treatment are patentable in India.

Many issues that have already confronted the courts of other countries regarding the scope and extent of exclusion of ‘methods of treatment’ shall confront Indian courts soon. Patenting of methods of treatments should not be given liberal construction in India. The medical costs are bound to escalate after the introduction of the product patent regime for pharmaceuticals; it should not be allowed to increase by patenting the methods of treatment.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.