Patenting the public good

The Madras High Court's dismissal of the Swiss pharmaceutical giant Novartis' patent plea has immediate implications for the company's key cancer drug, Glivec, but it also touches on the much bigger issue of trade and intellectual property protection. The court has held that Section 3 (d) of the amended Indian Patents Act, which bars the patenting of minor modifications to products, is valid. It has therefore rejected the Novartis contention that this provision is not compliant with the Trade-Related Intellectual Property Rights (TRIPs) regime of the World Trade Organisation (WTO). But this is not going to settle the controversy over the conformity of India's patenting provisions with global norms. Indeed, this was precisely the issue that was referred to the technical group headed by RA Mashelkar (then director general of the Council for Scientific and Industrial Research), which had opined in its controversial, and subsequently withdrawn, report that the Indian law is not wholly compliant with global provisions and hence needs to be amended so as to provide for the patenting of incremental innovations. What this controversy boils down to, especially from the trade viewpoint, is whether a company should be allowed to enjoy continued patent protection for its product simply by claiming enhancement of its efficacy or a minor innovation? The Indian pharmaceutical industry, sensing business opportunities in patent-expired products, is generally against such an extension, which it sees as being tantamount to the ever-greening of patents. However, most international companies view this as unfair (and possibly illegal) denial of protection to research-based products and their derivatives. The reactions to the Madras High Court's verdict are on these lines, giving the sense that the issue has not been settled.

Section 3 (d) was incorporated in the amended Indian Patents Act with a view primarily to providing citizens easy access to life-saving drugs by plugging the scope for the ever-greening of patents. Problems arose because of a lack of clarity on how to distinguish between ever-greening through minor improvements (including the development of new uses for old products) and genuinely significant and distinguishable incremental innovations. In this respect, the Mashelkar panel, too, had not approved of the ever-greening of patents, which would perpetuate a monopoly through trivial and insignificant modifications. Its objection was mainly to the denial of protection to such incremental innovations that build on the original patented product and are of genuine additional value. The difficulty, of course, lies in determining the value and distinctive significance of the incremental innovation, and this remains unresolved in the latest court verdict.

There are other issues relevant to this controversy. One pertains to the global perception of India's IPR regime. Some commentators have argued that the patent protection as it exists is more than enough to encourage new research and development. It has also been argued that excessive patent protection is responsible for the high and rising cost of drugs worldwide. Further, since most drug firms find it difficult to develop altogether new drugs, they are focusing increasingly on incremental changes to existing formulations. All this leans in favour of the Madras High Court judgment, but what matters also is whether research-based companies find the environment attractive enough to bring their new products to India. And it needs to be borne in mind that the US administration has kept India on the watch-list for intellectual data protection. If such perceptions are allowed to endure, the Indian public may be denied access to many a vital life-saving drug. Under the circumstances, the best approach would be to get the definition of incremental innovations and value enhancement peer-reviewed afresh; if need be, proper guidelines can be put in place to gauge the value of additions from the viewpoint of their patentability. In other words, have another go at a Mashelkar-style committee and hope that this time round, the committee does not get consumed by controversy.