Patent law again

The revised report of the technical expert group on patent law issues is not very different from the one that the group had to withdraw in 2007

The revised report of the technical expert group (TEG) on patent law issues, headed by R A Mashelkar, is not very different from the one that the group had to withdraw in 2007, following controversy over a part of the text having been lifted verbatim from elsewhere. On the key issues referred to the group — that of limiting patents to only new chemical entities (NCEs), and the patentability of micro-organisms — the fresh report maintains the same stance as the earlier version. It has held that confining the granting of patents for pharmaceutical substances to NCEs alone and excluding microbes per se from patent protection would not be compatible with the provisions of the trade-related intellectual property rights (TRIPs) agreement of the World Trade Organisation (WTO). These conclusions had left many industrial sections dissatisfied, including some in the fast-growing pharmaceutical industry, though there were also voices in support of the group’s opinion. The simple fact is that, if one is to go by the Mashelkar report, the new patent law as amended in 2005 in order to align it with global norms, still does not fully conform to TRIPs provisions, as it bars the patenting of a new form of a known substance unless it differs significantly in properties with regard to efficacy. On microbes, on the other hand, the expert group has endorsed the present law, which allows their patenting although public opinion largely holds microbes as non-patentable as these are the creation of nature and not human inventions.

Among the arguments given by the expert group in support of its contention on NCEs, one says that it will amount to statutory exclusion of a field of technology, which violates TRIPs; a second is that the entirely new chemical structures with new mechanisms of action are a rarity and, therefore, incremental innovations need to be encouraged. At the same time, however, the group’s plea that the Indian patent office is capable of determining what is patentable and what constitutes only a trivial change of an existing technology, does not seem tenable; there is plenty of room for arbitrary and subjective judgment that could, therefore, lead to a spate of litigation.

In the case of the microbes, too, the expert group’s conclusion is far from incontrovertible as microbes have now become one of the key resources for evolving new biotechnology-based drugs; their patenting would limit their use to a few multinational companies which have already acquired various kinds of patents on microbes in the countries where such patent protection is legally available. The predominant scientific opinion in India is that microbes per se should not be patentable unless these are radically altered through human intervention, such as transgenic biological products, and satisfy the criteria of novelty, non-obviousness and commercial utility. The sovereign rights over microbes granted to the countries of their origin under the Convention on Bio-diversity need also to be respected.

Considering the lack of consensus on the findings of the expert group on both the key issues, the new report needs to be property debated, keeping in view the wider national interest, the flexibilities allowed under TRIPs, and the Doha declaration, before accepting and implementing it in its present form.