“Friends, Indians, Countrymen, lend me your ears;
I come to bury the Madras High Court judgment, not to praise it.
The Madras High Court decided a landmark case involving Novartis’ famed anti- cancer drug, Glivec. Ignoring the bard’s dictum that brevity is the soul of wit, the court in a tryingly long decision held that section 3(d) of the Indian Patents Act was constitutional. It also held that it had no jurisdiction to adjudicate on the TRIPS issue i.e. whether or not section 3(d) (the section in the Indian patents act under which Novartis’ application claiming Glivec was rejected), was compliant with TRIPS. Several commentators lauded the judgment and rightly so⎯it’s conclusions cannot be faulted. However, there is much to be said for the manner in which they were arrived at.
What is perhaps most surprising is that Novartis issued a statement that although it disagrees with the judgment, it will not appeal to the Supreme Court. This note points out why it is imperative for Novartis to challenge this judgment.
Section 3(d) essentially states that new forms of existing chemical substances do not merit patent protection, unless they demonstrate significantly enhanced “efficacy” over the previously known substance. The Madras High court defended the constitutionality of section 3(d) by holding that the terms “enhancement of known efficacy” and “significant differences in properties with regard to efficacy” were neither vague, arbitrary nor discriminatory. Nor did the inclusion of such terms in section 3(d) without accompanying definitions amount to a delegation of an essential legislative function.
Although the conclusions are correct, the reasoning leaves much to be desired. Indeed, the judgment is a convoluted morass of mutually conflicting propositions. Illustratively, the court is not clear whether section 3(d) embodies an ‘economic’ rationale or whether it encapsulates ‘social welfare’ goals or both. Paradoxically, while the court demonstrates a hands-off approach to TRIPS by claiming that it has no jurisdiction to adjudicate on it, it discusses TRIPS provisions in an effort to defend the constitutionality of section 3(d). Most surprisingly perhaps, the court denies any scope for vagueness and uncertainty in the term “enhancement of known efficacy” by claiming that Novartis, being a pharmaceutical giant, knows what this means. This proposition strikes me as puzzling⎯is the court suggesting that Novartis self certify the increase in efficacy demonstrated by its drug? In which case, do we need to waste the time of the patent office and courts over this issue? Important flashback⎯Novartis assumed that its demonstration of a 30% in bio-availability would be sufficient to procure the patent—unfortunately, the patent office didn’t think so!
Had this been a case that turned purely on the esoteric nuances of patent law, one might have forgiven the court. After all, for a country that is coming to grips with pharmaceutical product patents after a long hiatus and has thus far been exposed to a mere 80 odd patent cases, one cannot expect sophisticated legal reasoning. However, for a country that is lauded for producing some of the most sophisticated constitutional law jurisprudence, this is shameful!
Novartis may or may not be interested in the finer aspects of constitutional law. However, it ought to be concerned with the court’s pronouncement on the term “efficacy”. A medical dictionary definition was relied upon to hold that the term “efficacy” in section 3(d) meant “therapeutic” efficacy and therefore “what the patent applicant is expected to show is, how effective the new discovery made would be in healing a disease”.
Under such a definition, the kind of derivatives that qualify for patent protection are likely to be severely limited. For instance, increased “bio-availability” (which is what Novartis claims in its application for Glivec) may not count as “therapeutic” efficacy. The court makes this clear by stating that an increase in the potency of the drug does not amount to an increase in efficacy. However, Novartis could easily challenge the court’s assumption that section 3(d) is limited to drugs and therefore “efficacy” ought to be construed as “therapeutic efficacy”. A plain reading of section 3(d) would make clear that the section also applies to other “chemicals” such as agro-chemicals. A pesticide or fertilizer cannot be tested for patentability on the basis of whether it enhances a “therapeutic” effect on the human body!
If Novartis does not challenge this portion of the Madras High Court judgment, and if the IPAB follows this dictum (as to whether the IPAB is bound by this ruling of the Madras High Court is a moot issue), then Novartis effectively loses the case. It may as well withdraw its appeal from the IPAB! It is paradoxical that Novartis would continue to threaten to move investments to China, despite being called on their bluff—whilst at the same time desisting from fighting where it really matters.
Amidst several calls that Novartis withdraw its case, it bears reiteration that we must let this case run its course, so that we get more clarity on section 3(d). Let me close by paraphrasing the Bard of Avon:
O judgement! thou art fled to brutish beasts,
And men have lost their reason…. Bear with me;
My heart is in the coffin there with the HC judgment,
And I must pause till it come back to me”