In a 112 page judgment delivered earlier this morning, a Bench of the Supreme Court, comprising of Mr. Justice Aftab Alam and Ms. Justice Ranjana Prakash Desai have upheld the rejection of the patent application (1602/MAS/1998) filed by Novartis for Glivec in 1998 before the Indian Patent Office. The judgment can be accessed over here. If not, please download the judgment from here.
The patent application had initially been rejected by the Controller of Patents in 2006, after hearing 5 pre-grant oppositions filed by various generic pharmaceutical companies including Ranbaxy, Cipla, Hetero and one patients group – the Cancer Patient Aid Association (CPAA). Novartis had initially filed an appeal with the Madras High Court which subsequently transferred the appeal to the Intellectual Property Appellate Board (IPAB). In a separate petition Novartis had also unsuccessfully challenged Section 3(d) of the Patents Act before the Madras High Court. In 2009, the IPAB upheld the rejection by the Controller. Later in the same year, Novartis appealed directly to the Supreme Court and after a game of ‘musical chairs’ the present bench heard extensive arguments from both sides and Shamnad, who had intervened as an amicus. (His post on his intervention can be accessed over here)
From a reading of the judgment, it appears that the Supreme Court had considered the entire case de novo despite it being an appeal from the IPAB, which had itself delivered a lengthy judgment.
On the merits, not only did Novartis lose its main ground of appeal regarding Section 3(d) but it also lost the points raised by the generics in their cross-appeals against certain aspects of the IPAB’s judgment. I’ll deal with the most important points below and we’ll carry a more detailed analysis of the case later this week.
(i) Section 3(d): As you all know, this case was a ‘test case for Section 3(d). This provision is aimed at curbing ‘evergreening’ by preventing the grant of a patent for new forms of known substances, unless the applicant can establish the new form demonstrates an increased efficacy.
Two questions arise in this context:
(a) How should efficacy be defined?
The Madras High Court while deciding the constitutional validity of Section 3(d) had interpreted “efficacy” as therapeutic efficacy, as opposed to including even non-therapeutic efficacy. This was a narrow interpretation of efficacy and would have substantially reduced the scope of certain pharmaceutical patents.
In pertinent part, the Supreme Court, answered the above question with the following:
“180. What is efficacy? Efficacy means“the ability to produce a desired or intended result. Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be“therapeutic efficacy.”
Interpreting, therapeutic efficacy, the Supreme Court contrasted, what it termed as a “rigid position” taken by Mr. Anand Grover, appearing for CPAA and the “less rigid” position taken by Shamnad.
Mr. Grover’s line of arguments on “therapeutic efficacy” was not only targeted at knocking out Novartis’s claim, that the increased bio-availability of the beta-crystalline form would qualify as increased efficacy under Section 3(d), but to also restrict the scope of “efficacy” to a set of factors so narrow that it would seriously affect the patentability of incremental innovation in the pharmaceutical sector.
On the other hand the Supreme Court describes Shamnad’s position as follows “However, taking a less rigid position than Mr. Grover, Prof. Basheer argued that safety or significantly reduced toxicity should also be taken into consideration to judge enhanced therapeutic efficacy of a pharmaceutical product in terms of section 3(d)”.
The court however refuses to rule on the exact scope of “therapeutic efficacy” and leaves it to be determined by future courts.
Although the Court refused to rule on the larger points, regarding the scope of therapeutic efficacy, as raised by Mr. Grover and Shamnad, it did depend on an authority provided by Shamnad, to conclude the following:
“the position that emerges is that just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data.”
The SC points out that Novartis had not filed any such data which described the effects of bioavailability on the therapeutic efficacy of the drug.
(b) What is the “known substance” for the purposes of Section 3(d)?
For the purposes of comparing efficacy under Section 3(d), it was necessary for the Supreme Court to compare the claimed invention to a “known substance” and there has always been a disagreement between both parties on what constituted the “known substance” i.e. the “imatinib free base” or the “beta-crystalline form of imatinib mesylate”. Novartis had sought comparison with the “imatinib free base” while the opposing side sought a comparison with the “beta-crystalline form of imatinib mesylate”. The Supreme Court followed the sequence of innovation leading to the claimed invention and held that imatinib mesylate was the “known form” for the purposes of Section 3(d). In pertinent part, it held the following:
“174. We have so far considered the issue of enhanced efficacy of the subject product in light of the finding recorded earlier in this Judgment that Imatinib Mesylate (non-crystalline) is a known substance from the Zimmermann patent and is also the substance immediately preceding the patent product, that is, Imatinib Mesylate in beta crystalline form.”
(ii) Novelty & Obviousness: The Zimmerman patent was the main piece of prior art cited against the Glivec patent and the Supreme Court appears to have used this piece of art as the main document in invalidating Novartis’s patent.
“131. In the face of the materials referred to above, we are completely unable to see how Imatinib Mesylate can be said to be a new product, having come into being through an invention” that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art. Imatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent.”
“132. 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 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.”
Did the Supreme Court ban incremental innovation?
Given the media coverage of the last few days, it is probably pertinent to mention the Supreme Court’s clarification on the impact of its judgment on incremental innovation. In pertinent part, the Court states:
“191. 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. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.”
So, there you have it, Section 3(d) permits incremental innovation.
What happened to the Section 3(b) argument?
As readers may remember, the IPAB had come to the ridiculous conclusion that the Novartis patent would not be allowed since the claimed invention, Glivec, was so expensive, that it offended Section 3(b) which forbids patents for inventions that offended public ordre or morality. It appears that this holding was too ridiculous for the Supreme Court to even consider it. Well, that is generally good news for patent law.
Conclusion: Novartis is not happy.
Together with the first order on Compulsory licensing, hats off to the Indian judicial system for upholding public interest. I am sure this judgement will come as a relief to many.
The SC points out that Novartis had not filed any such data which described the effects of bioavailability on the therapeutic efficacy of the drug. Since it failed to place on record any research data which could prove that there was 30% increase in Bio availabilty of the Beta Crystalline Form as claimed orally. In the event when Novartis failed the test of Section 3(D) of the Act on technical grounds without contest, there was no need of going through other provisions and history of Patent Act in 112 Page Judgment.
Can you describe more of the procedural history of this case? I have read the opinion and I am unclear how a Section 3(d) appeal turned into a complete de novo review of all the patentability requirements. Thank you.