Pharmaceutical Patents: Exploring beyond the scope of section 3 (d)

Verdict is loud and clear after the Patents Amendment 2005. No patents for trivial pharmaceutical inventions. Mere discovery of polymorphic forms, resolution of racemic mixtures, new salts, esters and ethers of known substances, particle size, pure form, metabolites and combinations of known substance are considered to be quite obvious to overcome patentability bar. This legislative march is meant to prevent ever-greening of patents in the field of pharmaceuticals and to make sure only well merit inventions see the light of patent protections. This is what the patents are all about. Newly amended section 3 (d) of the Patents Act, 1970 has come into action after the post-2005 era, drawing the attention of both domestic and global pharmaceutical players towards the scope of section 3 (d). Patent applications filed during the transitional period (“mail-box applications”) are now undertaken for examination, paving way to product patents in the field of pharmaceuticals and drugs after a long gap of 35 years. Sooner or later, global pharma players will introduce their patented drugs in Indian market, putting end to the long era of launching re-engineered generic drugs in India. Attention is definitely mounting on the scope of section 3 (d) that is limited, not unlimited. Section 3 (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 same substance, unless they differ significantly in properties with regard to efficacy;” Drawing a Silver Lining Section 3 (d) excludes majority of pharmaceutical inventions from patent protection, particularly new forms of known substance and new use for known substance. Unlike in US and Europe, new polymorphic forms and method of use (Swiss-type) claims will not be eligible for patent protection in India. This is not the end, there is silver lining too. It is a matter of reading between the lines and interpreting the hidden catch. What stands between in and out is the word ‘mere’. Section 3 (d) diminishes the fate of trivial inventions but at the same time keeps the thumb up for well merit inventions. Interpreting the hidden catch According to section 3 (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 will not be considered as a patentable invention. This is a conditional statement, purporting that if a new form of a known substance is the mere discovery using conventionally known practices and devoid of any inventive feature then the new form will be not patentable unless the new form results in the enhancement of the known efficacy. This means that the mere discovery of a new form with improved efficacy will be enough to overcome patentability bar. For example, if a new polymorphic form is having substantially improved thermal stability as compared to earlier known efficacy then the stated improved thermal stability will be enough to stand the requirement of inventive-step under section 2 (1) (ja), and thereby overcome the barrier of section 3 (d). This, however, clearly connotes that the mere discovery of a new form of a known substance can be patentable subject to improved efficacy. Now let us consider the second “hidden” interpretation where the discovery of a new form involves substantive technical input, enough, to overcome the scope of word ‘mere’ and meet the requirement of inventive-step under the Patents Act, 1970 then in that case condition of enhancement of the known efficacy is not mandatory to meet patentability criteria. This situation falls beyond the scope of section 3 (d), clearly overcoming the barrier of section 3. This ‘hidden’ interpretation implies that a new form of a known substance which involves a technical merit sufficient to meet inventive-step under section 2 (1) (ja) of the Patents Act, 1970 can be patentable irrespective of any enhancement of the known efficacy. Show Technical Merit Usually Swiss-type or method of use claims is not eligible for patent protection in India. According to section 3 (d), the mere discovery of any new property or new use for a known substance will not be considered as a patentable invention. Here the use of conjunction ‘or’ between ‘new property’ and ‘new use’ is conjunctive. A close interpretation of section 3 (d) connotes that the mere discovery, such as scientific observation, of any new property or new use for a known substance will not be patentable. But if the discovery of any new property or new use is result of technical expertise coupled with technical solution/utility to stand the requirement of inventive-step under section 2 (1) (ja) of the Patents Act, 1970 then the discovery of any new property or new use for a known substance may overcome the scope of section 3 (d). The scope of section 3 (d) ends with the scope of word ‘mere’, suggesting that second and subsequent use for a known substance may also be patentable if their discovery involves technical merit to overcome the scope of ‘mere’ and stand the condition of inventive-step under section 2 (1) (ja) of the Patents Act, 1970. Game of Interpretation Statutory provisions are always open for interpretation, leading to numerous remarkable precedents by highest level of Courts and further paving way to jurisprudential interpretation. Patent law is not exception to that. A plain reading of section 3 (d) may look straight forward, ruling out the patentability of new form and new use of a known substance but a bird-eye view of it may invoke various interpretations. Weighing every single word of the provision and thereby interpreting it will be the key to patenting and future appeals against patent office both in Courts and Appellate Board. There is a bright silver lining hidden in section 3 (d) which needs to be discovered. To end with, it is all about knowing and doing, and doing and knowing.