Gleevec Updates: 5th March 2007 - 6th March 2007

The Novartis matter resumed today in the Madras High Court. Under the Order of the Chief Justice of the Madras High Court, the appeal of the Patent Controller’s order will be heard by the same bench of Justices Balasubramaniam and Prabha Sridevan.

Mr. Soli Sorabjee, counsel for Novartis, commenced his rejoinder arguments relating to Novartis’ claim that Section 3d is violative of Art. 14 of the Constitution. He contended that the manner in which the amendment to 3d was introduced, and the fact that India had undertaken a solemn obligation to comply with the TRIPS agreement, introduced an element of irrationality into the legislation, and therefore violated Art. 14. He further repeated his contention that India’s refusal to comply with TRIPS would lead to an erosion of India’s credibility internationally.

At this point, Justice Prabha Sridevan interjected and said that she understood the respondents’ arguments to say that whether 3d was TRIPS compliant or not was simply not a matter for judicial determination because TRIPS is not part of domestic law.

Sorabjee responded by claiming that the court had to look at the background surrounding the legislation. He claimed that the legislative history showed that Commerce Minister Kamal Nath disagreed with the TRIPS-compliance of 3d, and that while there was uncertainty in the government as to whether 3d was TRIPS compatible, Parliament went ahead and enacted 3d anyway.

Then he argued that the fact that “efficacy” and “significant enhancement” lacked any guidelines made it vague and arbitrary. Responding to the contention that a simple lack of definition did not render a statute invalid, he claimed that while other instances of broad undefined terms had acquired a well-understood judicial understanding, this was not the case with “efficacy” and “significant enhancement,” and thus made it vulnerable to varying interpretations that differ from individual to individual.

He pointed to a litany of Indian caselaw to advance the argument that where Parliament delegates unguided powers to the executive brance without laying down any clear legislative policy in the legislation itself, such delegation could be struck down by the courts as an excessive delegation of power.

At this point, Justice Balasubramaniam interjected and said that it was the case of the Respondents that “efficacy” was a concept known to those in the pharmaceutical field, including Novartis, and that the explanation only related to a requirement of significant increase in efficacy. Responding to this, Sorabjee admitted that the meaning of “efficacy” is known and that what was problematic was that section 3(d) did not explain what constituted a “significant enhancement.”

At this, Justice Prabha Sridevan observed that it appeared that Novartis’ grievance lay in the fact that section 3(d) did not provide a specific percentage for what constitutes “significant enhancement.” She said that it could be case that for a headache medicine, a 30% enhancement in efficacy may not amount to an increase in efficacy but that it could be amount to a significant increase in efficacy for an anti-cancer drug. She said that it would be incorrect to lay down the a specific percentage and that section 3(d) gave leeway to the Patent Controller to allow patentability of new forms of known substances. To this, Sorabjee replied that Novartis was not claiming that a rigid standard be defined.

Sorabjee argued that section 3(d) created an irrational legal fiction of deeming new forms of known substances to be the same substance. He said that he would refer to authorities to cite instances in which irrational legal fictions had been struck down. Sorabjee said that after creating such an irrational fiction, an attempt was made to provide an escape route by introducing the requirement of significant increase in efficacy. He said that it was important to have guidelines which were flexible.

Justice Balasubramaiam asked how Parliament could possibly anticipate all derivatives of known substances and list them. Responding to this, Sorabjee claimed that it was an irrational legal “fiction” to deem different substance to be the same substance. He argued that this legal “fiction” was arbitrary, and that this arbitrariness was not cured by allowing only certain new forms to be patented.

Admitting that Parliament could not lay down a rigid standard to determine what constituted an increase in efficacy, he argued that neither could Parliament leave section 3(d) without providing any guidance to the Patent Controller. He reiterated that a determination of what constituted a significant increase in efficacy would be a value judgment and that there was no guideline in section 3(d) that would guide the Patent Controller in arriving at this judgment.

To show how arbitrary 3(d) could be, he pointed to the affidavit filed by the Patent Controller, where he stated that a 30% increase in bioavailability “may or may not be statistically significant.” He argued that if even the patent controller did not know what constituted significance, then 3(d) surely was vague and ambiguous.

Mr. Shanti Bhushan, also appearing for Novartis, commenced his argument that 3(d) was incompatible with TRIPS. He claimed that the EU Directive, from which the language of 3(d) was borrowed, related to the drug regulatory review process, and such concepts, as applied to patentability criteria, would result in an absurdity. He claimed that the drug regulatory approval process generally took place years after a drug was patented, and that the clinical trials necessary to establish efficacy could not possibly be presented as evidence to satisfy the requirements of 3d during the patent examination stage.

At this point, Justices Balasubramaniam and Prabha Sridevan both interjected, observing that while this may be true in some circumstances, it was the case that Novartis actually knew and had data relating to the efficacy of imatinib mesylate during the patent examination stage. Mr. Bhushan admitted that this was the case, but this was only so because of the lag of several years between the filing of the application in the “mailbox” and the examination of the application in 2005. Justice Prabha Sridevan observed that whatever the reason for the lag, if Novartis did in fact have clinical trial data relating to imatinib mesylate’s efficacy, on what basis could Novartis claim that 3d imposed an unreasonable requirement?

Justice Prabha Sridevan also asked what the difference was between “invention” and “discovery.” She asked whether or not it was the case that only inventions needed to be patented, and discoveries did not need to be patented. Viewed in this light, she asked whether 3(d) is not a valid exclusion of all discoveries of new forms except for those with an increase in efficacy. To this, Mr. Bhushan replied that all “discoveries” become patentable “inventions” if such “discoveries” involve an inventive step.

Bhushan then continued with his argument that because section 3(d) imposes requirements above and beyond the basic requirements of novelty, inventive step and industrial application, it was in contravention to Art. 27 of TRIPS. He contended that Articles 7 and 8 provided for flexibilities only with respect to compulsory licensing, which India took advantage of in section 84, et seq of the Patents Act. He further argued that Article 27 only contemplates exclusions from patentability as laid out in Articles 65(4), 70(8), and subsections (2) and (3) of Article 27, and that no further exclusions are allowed under TRIPS. Justice Prabha Sridevan asked whether it was his contention that the exclusions contemplated under 27(2) and (3) formed an exhaustive list of valid exclusions from patentability, to which Bhushan replied in the affirmative.

At the conclusion of the day’s proceedings, Sorabjee indicated that he came to learn of the fact that the Additional Solicitor General, VT Gopalan, intended on filing some additional documents, one of which was the letter written by Henry Waxman to Novartis asking it to reconsider its position on the case. Sorabjee asked that the documents be filed today, so that Novartis could examine it and initiate contempt of court proceedings against Congressman Waxman.

To this, Grover responded that Novartis should examine its own website on which they were posting comments on the merits of the case, which also amounted to contempt of court.

Bhushan will complete his arguments relating to TRIPS tomorrow, at which point the Respondents will have the opportunity to respond to some of the new arguments that Novartis presented during its rejoinder. We will keep you posted.

In solidarity,
The Lawyers Collective HIV/AIDS Unit Team
Anand
Chan
Julie
Asha