Other than the Novartis case, what are some of the other important intellectual property cases that you have handled during your time with the Supreme Court?
Novartis was the first and the last patent case that I heard and decided in my 23-year tenure as a judge. In the Patna High Court where I was a judge from 1990 to 2006, no IP rights cases came to the court either before me or before any other judge to the best of my knowledge. Then, I was the Acting Chief Justice of the Jammu and Kashmir High Court for five months. There too I did not come across any IPR case.
My introduction to IP laws took place only when I came to the Supreme Court in November 2007. Here, some small trade mark cases first passed through my hands that had come at the interlocutory stage from the trial court. And then Novartis landed! As the hearing of the case commenced I had no expertise or special knowledge of the law of patents in India but my inadequacy was more than compensated by the excellent assistance rendered by the bar. Some of the lawyers appearing in the case were truly outstanding. Hence, whatever worth there is in the judgment, the credit should go to the lawyers.
Given that you had no experience with patent law before the Novartis case, did you do any special preparation either for the hearing or for your drafting of the opinion?
I read the brief, especially the order of the Intellectual Property Appellate Board. But unfortunately that wasn't of much help. The order was very long, repetitive, unfocused and I am sorry to say, in parts self-contradictory. From the order under appeal I was unable to form a clear idea of the real issues involved in the case. I, of course, also went through the Patents Act. But to tell the truth the case really unfolded for me in course of the oral hearing.
Once the hearing was over I was very clear in my mind and knew exactly how I was going to decide the case. There was, therefore, no need for any special preparation for the drafting of the judgment.
But let me confide in you and tell something about the writing of the judgment that you may find interesting. For the Novartis judgment, I did not dictate to the secretary which is the usual mode of writing judgments, not only for me but almost all the judges in the Supreme Court. The Novartis judgment is one of maybe one dozen, out of nearly three hundred that I wrote in the Supreme Court, that I myself typed on an ancient laptop that my youngest daughter had junked about 10 years ago.
I can only type with one finger but that gives me sufficient time to think even while I am writing. I find the process very relaxing too; after finishing the day's regular work I would pick up the laptop and almost caressingly go over the earlier parts of the judgment and then slowly start moving ahead. The writing of the judgment thus went on for nearly a month. On two occasions I found that what I had written the previous evening, about fifteen to twenty pages on each occasion, was not saved and was completely missing from the laptop. I cannot describe my frustration and anger but on each occasion I had to simply re-write what was written the previous evening.
Section 3(d) has become a hot topic of discussion since the Novartis matter. What other issues in Indian IP law do you think will be important in the next year or two?
The Novartis judgment deals with only some of the facets of section 3(d). The other facets and the full rigour of section 3(d) are yet to be explored and those will be dealt with in future cases. Apart from section 3(d), I think provisions concerning compulsory licensing are likely to come as other important issues before the court.
How would you respond to those who claim that India's system does not do enough to protect intellectual property and promote innovation?
I think it is incorrect to say that the patent law in India does not do enough to protect intellectual property and promote innovation. Any such accusation is misconceived and based on the view that even a trifling change in the earlier known product, regardless of its properties and functions should qualify as innovation or invention and should be accorded patent protection. Indian law puts the threshold for invention, especially in the case of pharmaceuticals and chemicals much higher, and I think very rightly so. A true and genuine invention is entitled to the fullest protection in India. Indian law thus encourages and promotes true inventions and not spurious innovations.
Now that you have moved on to the role of the chairperson of the Telecom Disputes Settlement Appellate Tribunal, is there anything you will miss about your time with the Supreme Court?
Strangely, what I miss is what I used to complain about the most when on the Supreme Court: the great stress. I now realise that the stress had coupled with it a palpable excitement. In no other Court and in no other work have I felt the same kind of excitement as in working in the Supreme Court. I think I have started missing the excitement of working on the very wide range of cases there.
The Novartis decision
The Indian Supreme Court's rejection of the Novartis's Glivec patent renewed the debate surrounding section 3(d), one of the most controversial parts of the India Patents Act. Section 3(d) states that "a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" is not patentable.
Novartis's patent involved Glivec, the beta crystalline form of Imatinib Mesylate, a molecule invented in the 1990s with a US patent application from April 1994. The original molecule was not patented in India because under Indian law, substances invented before 1995 could not receive patent protection.
One of the main issues in the Novartis case is whether Glivec represented a significant enhancement in efficacy over earlier forms. Here, the Supreme Court establishes that enhanced efficacy means enhanced therapeutic efficacy.
Novartis had argued that the beta crystalline form of the molecule demonstrated enhanced bioavailability (the extent to which a drug reaches its intended site of action), but the Court found that this was not enough.
The court noted that enhanced bioavailability can be one factor contributing to better therapeutic efficacy, but enhanced bioavailability alone is insufficient. The court found that Novartis had not submitted data to establish improved therapeutic efficacy.
The judgment also explained that improvements inherent to the physical form would not qualify as enhanced efficacy.
"Any scientist will tell you that the salt form of a substance will be more soluble, and that a polymorphic form like a beta form will be more stable," says Prathiba Singh of Singh and Singh, who represented the generic manufacturers opposing the patent. The benefits of Glivec over other forms of the molecule were inherent to its beta crystalline form, and thus not considered enhanced efficacy.
Despite the heated responses to the decision, lawyers say that the court's interpretation of section 3(d) is straightforward, and fairly limited in its holding. They note that section 3(d) must still be evaluated on a case-by-case basis, and that further cases are needed to flesh it out.
