In an earlier post, I argued that an Indian supreme court decision may have unwittingly unleashed a Chinese blockbuster. As promised, here is a bit more on this stupendous Supreme court (SC) ruling that effectively denied Novartis a patent over its blockbuster anticancer drug, Glivec. And raised the bar for pharma patents in the bargain!
For those interested, here are some excerpts from a recently published piece of mine in the Oxford University Commonwealth Law Journal (OUCLJ) capturing the core of this decision and situating it within the larger theme of India acquiring more patent proficiency over the years. Paradoxically enough, at the time of deciding the Novartis case, the Supreme Court lacked patent proficiency. However, I argue that this deficit may have actually helped it question well entrenched patent dogma. And infuse some common sensical wisdom into an otherwise isolated and esoteric legal regime. In particular, the court applies general legal concepts (such as evidentiary principles) and catches Novartis on the wrong foot (having it hoist on its own petard, so to speak). The take home lesson for me at least: always important to have some “generalists” too in the patent firmament. Else we risk the tyranny of specialists: those that know more and more about less and less! Or as the talented Taleb is wont to say: “The problem with experts is that they do not know what they do not know”.
In any case, with the advent of Artificial Intelligence (AI) and all, specialists may soon get replaced by machines. But a generalist who is able to cross pollinate and create (through hunches etc) may be more difficult for a machine to replicate, no matter how “artificially” intelligent it is.
Anyway, here are some short extracts from the piece. Situating the Supreme Court decision within the larger history of Indian patent law and the making of section 3(d), reflecting on what transpired in court and the various pros and cons of the ultimate decision. Come to think of it, the making of a law (or decision) is always so much more interesting than the final product itself!
Excerpts as below. Grateful for feedback (caustic comments also welcome, but in somewhat civil language please).
Courts’ Take on Section 3(d): Therapeutic Efficacy?
Novartis claimed that the active ingredient in Glivec was more effective than the imatinib free base, since it displayed better properties, such as solubility and bioavailability (the potential of a substance to be absorbed into the bloodstream). To this effect, Novartis submitted evidence demonstrating an increase in bioavailability of up to 30%.
The Supreme Court, however, was not impressed. First, it held that Novartis had used the wrong comparators: given that imatinib mesylate (in amorphous form) was the closest known prior art, the comparison ought to have been between this ‘known’ substance and the beta-crystalline form, not between imatinib (free base) and the beta-crystalline form. The court noted that Novartis itself had admitted that the claimed invention was ‘two stages removed from imatinib in free base’ and that ‘the substance immediately preceding the subject product is imatinib mesylate (non-crystalline)’. Second, the court held that the claimed advantages for the beta-crystalline version did not constitute a significant enhancement in efficacy.
In order to arrive at this conclusion, the court had to interpret section 3(d) and distil the meaning of the term ‘efficacy’. The court appears to have drawn from my submissions (as intervenor cum amicus) in this regard, where I had argued:
“The structure of section 3(d) as also its legislative history supports a narrow reading of the term ‘efficacy’. Illustratively, the Explanation to section 3(d) clearly states that all pharmaceutical derivatives would be considered the same ‘substance’, unless ‘they differ significantly in properties with regard to efficacy.’ The above clause refers to only those ‘properties’ that have some bearing on ‘efficacy’ and not all properties. If ‘all properties’ were to qualify, it would effectively render the term ‘efficacy’ redundant.”
On this strict construction of the term ‘efficacy’, the Supreme Court held that Novartis’ alleged invention failed to qualify, since it merely enhanced physical properties such as bioavailability and solubility. The court, however, qualified this by suggesting that bioavailability could in certain cases amount to enhanced therapeutic efficacy, provided the patent applicant empirically demonstrated the causal link between the two. While the court interpreted ‘efficacy’ to mean ‘therapeutic efficacy’, it refused to define the contours of this term. This failure to provide definitional guidance will necessarily mean that future cases on this count will find their way back to the apex court.
Apart from the above, the court’s decision and decision-making process would appear to suffer a few other infirmities. Firstly, the court spent a significant amount of time (more than 100 hours at least) and heard each counsel (over 10 of them representing various parties to the litigation) patiently. Given the court’s overburdened docket, this would, at first glance, appear to be a greatly disproportionate amount of time spent on a patent case. However, given that this was the first pharmaceutical patent case to be decided by the Supreme Court in the post-TRIPS era, involving a provision that had no precise parallel anywhere in the world, it was to be expected that the court would take a longer period of time to adjudicate this than a regular dispute in one of the more traditional legal disciplines such as contract or property law.
In particular, a significant portion of the court’s time was spent in making technical or factual assessments (eg the nature of the ‘known substance’ for the purpose of section 3(d)), despite the fact that the apex court is meant to focus on the law more than facts. This extensive fact-finding mission by the court may well have detracted from its ability to offer more interpretative clarity around legal concepts, beyond the confines of the narrow set of facts before it.
The apex court refused to lend any deference to findings by the lower fora, namely the patent office and the IPAB. Rather, it went on to reassess the facts and other technical findings afresh. This might have stemmed from the fact that the lower fora had not adequately reasoned out their decisions. In particular, the patent office decision was very sketchy and failed even to mention what it considered to be the ‘known’ substance against which the efficacy comparison for Novartis’ claimed pharmaceutical substance was made. Given the shoddiness of the decisions below, the court may have thought it better to make this assessment itself, without necessarily remanding it back to the lower fora.
What was surprising, however, was the Supreme Court’s failure to utilise a statutory provision that might have aided it in its factual assessment of the various technical issues before it. Section 115 of the Act provides:
“In any suit for infringement or in any proceeding before a court under this Act, the court may at any time … appoint an independent scientific adviser, to assist the court or to inquire and report upon any such question of fact or of opinion (not involving a question of interpretation of law) as it may formulate for the purpose.”
During the course of the proceedings, the court posed a technical question to me in my capacity as intervenor cum amicus. The court wanted to know if a skilled person in the art could have arrived at Novartis’ claimed invention (the beta-crystalline version of imatinib mesylate) without undue experimentation from the teachings of the earlier patent specification filed by Novartis over the imatinib free base (and the common general knowledge up to 1997, which is the priority date for Novartis’ secondary patent application covering the beta-crystalline form). I pleaded my incompetence in addressing this issue, as I was not a chemistry expert and suggested that the court invoke section 115 and appoint an independent expert to help determine this. Thereupon, the court requested all those present in court to suggest the names of competent independent experts, who could be approached. Unfortunately, one of the counsels objected, stating that most academic experts in India were compromised and could not be relied upon. Without bothering to interrogate this assumption, the court immediately dropped the promise of this prospect, and went on to make a factual finding, relying largely on party submissions and without the benefit of independent technical expertise.
Notwithstanding the above infirmities, the court needs to be appreciated for demonstrating a far higher degree of adjudicatory competence than one might have come to expect from a country whose judiciary had seen very few patent disputes.
In fact, neither of the judges deciding the dispute had any significant prior patent experience. The court also deserves praise for refusing to wed itself to a Western patent construct that entails clever claim drafting and the propensity to claim more than what was disclosed. Rejecting this well-entrenched norm, the court held that patent coverage had to be commensurate with disclosure and that any claim that did not find adequate disclosure in the patent specification would be axed. In a sardonic statement, the court held:
“We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”
A specialised court firmly entrenched in the global narrative around patents might not have reacted this sharply to a practice that is at odds with the primary purpose of the patent system: to reward inventors for that which they specifically disclose to the public, enabling interested competent members to work out the invention on their own and study from it.
Similarly, the benefits of having a generalist Supreme Court bench (with no prior entrenchment in the practice of patents) might have helped the court draw on common legal precepts to hold against Novartis. Illustratively, the court’s determination that imatinib mesylate’s non-crystal form was the ‘known substance’ for the purpose of a section 3(d) analysis was based inter alia on the finding that Novartis’ earlier patent (referred to as the ‘Zimmermann’ patent) covering the imatinib free base referred to this potential salt form, stating that it could be prepared using ‘known’ processes. The court went on to note:
“That imatinib mesylate is fully part of the Zimmermann patent is also borne out from another circumstance. It may be noted that after the Zimmermann patent, the appellant applied for, and in several cases obtained, patent[s] in the US not only for the beta and alpha crystalline forms of imatinib mesylate, but also for Imatinib in a number of different forms. The appellant, however, never asked for any patent for imatinib mesylate in non-crystalline form, for the simple reason that it had always maintained that imatinib mesylate is fully a part of the Zimmermann patent and does not call for any separate patent.”
The court relied on this conduct to ultimately hold that it would be incongruous for Novartis to now claim that its earlier patent did not anticipate imatinib mesylate. The court was careful to note, though, that it was only ruling on the limited set of facts before it. It cautioned that its decision should not be taken as sounding the death knell of all secondary pharmaceutical patents:
“We have held that the subject product, the beta crystalline form of imatinib mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances.”
The 2005 amendments marked a watershed in Indian IP history. Not only were they informed by a level of public debate and political contestation never witnessed before in the annals of Indian IP history, it heralded India as a pioneer in the patent doctrine space. The lack of drafting finesse notwithstanding, section 3(d) played a critical role in this new transformative phase. Unlike the mid-1990s, when India’s disdain for what it thought to be an inequitable treaty led to rash non-compliance, the year 2005 marked an innovative phase, with India creatively leveraging TRIPS’s flexibilities to further its own national interest.
Section 3(d) faced its toughest litmus test in the aftermath of Novartis’ patent challenge. Not only did the Indian judiciary endorse the legality of section 3(d), it insisted on a rigorous ‘therapeutic efficacy’ threshold. In doing so, it complemented the efforts of the Indian legislature in refusing to co-opt itself into a cosy patent construct engineered by the allegedly more sophisticated patent regimes of developed countries. Notwithstanding some of the infirmities in the decision, the court still demonstrated a fair degree of patent proficiency, given that neither of its judges came with any prior patent adjudicatory expertise.
The innovative advantage of section 3(d) lies in its potential to serve as a more definite rule, legal heuristic, or shortcut to the obviousness enquiry, by examining the merit of a pharmaceutical invention from the perspective of its ex post utility or impact—as opposed to an extensive ex ante analysis of how the invention was conceived in the first place, which is often what the standard convention inventive step enquiry entails. As such, section 3(d) makes for a speedier and less resource-intensive decision-making process for developing country institutions (such as the Indian patent office) which face severe resource constraints.
In the overall analysis, the Indian example is a striking one for the IP and development debates, where a developing country with allegedly less patent expertise than its developed counterparts pioneered patent norms to suit its own national interest, and did it with a fair degree of proficiency.
ps: Image from here.