In a significant development in the Novartis case, the Madras High Court today ordered that it has converted the writ petition of the Novartis into an appeal, on the condition that no new grounds are added in the converted appeal. The hearing, which started yesterday, continued for the second day today and has been adjourned to March 5.
The order to convert the writ petition into appeal was passed today by a bench comprising Justice Balasubrahmaniam and Justice Prabha Sridevan. In today's order, Justices said that the appeal will be placed before Chief Justice AP Shah for appropriate order to be placed before appropriate bench.
Today's decision will have a bearing on the scope of review allowed by the High Court. While a review under a writ petition is limited to clear mistakes in the law, the review available under an "appeal" is broader, and the Court may look into mistakes in both fact and law. All the parties, including the Cancer Patients Aid Association (CPAA), the generic companies and Novartis have agreed to the order.
The hearing, which started yesterday, continued for the second day today. The court during the last two days heard the arguments of the CPAA and the generic companies. The court will hear the arguments of Novartis on March 5 from Soli Sorabjee and Shanti Bhushan.
Additional Solicitor General VT Gopalan appeared for the Union of India and the Patent Controller.
Gopalan responded to two of Novartis' claims: (1) that 3d was arbitrary and (2) that 3d violated TRIPS. He argued that the amendment was not arbitrary and in violation of Article 14 because the concepts of "efficacy" and "significant efficacy" are well known and definite in the field. He pointed out that TRIPS allowed flexibilities for member countries and allowed to prevent the abuse of intellectual property rights, including ever-greening.
On constitutional validity of 3d in light of Article 14, he pointed out that there are only two grounds available for challenging a statute in India: (1) that the law violates the fundamental rights guaranteed in the constitution, or (2) Parliament lacked the authority to enact the law in question. Given that Novartis had failed to state either ground, it had no basis for bringing this issue before the Court.
Gopalan pointed out that the Patent Controller's order denying Novartis a patent on Glivec was based on other issues besides 3d, including lack of novelty and obviousness. Simply because Novartis had not been granted a patent did not give it a legal basis for challenging the statute. Even assuming that, in this instance, the Patent Controller had arbitrarily applied section 3d, this only provided Novartis with a basis for challenging the Patent Controller's Order, but not the statute itself.
Lakshmikumaran, counsel for Ranbaxy and Hetero, argued that the Court cannot strike down a law on the ground that it violates an international treaty. He showed that the settled law in India was that a treaty does not become law on its own; it can only be used as an interpretive tool used in the case of ambiguity.
Addressing Novartis' request for a declaration that section 3d was incompatible with TRIPS, Lakshmikumaran asserted that if the Court did make such a declaration, without granting any further relief, Novartis would use it as ammunition to convince Switzerland to take India to the WTO Dispute Panel. There, if the dispute panel ultimately decided that section 3d was in fact compatible with TRIPS, it would have the effect of placing the Court in an embarrassing situation in which it had been effectively overruled by a foreign body. To avoid this embarrassing situation, he pleaded with the Court not to engage in such a purely academic exercise.
Arvind Datar, counsel for Cipla, again raised the issue that international treaties must be specifically incorporated into Indian law for it to have domestic effect, and that once Parliament has spoken, the Courts must give effect to it, regardless of any international law to the contrary. Datar asserted that 3d complies with TRIPS and was in fact a "golden mean."
Anand Grover, counsel for Cancer Patients Aid Association, reinforced the theory that Novartis could not maintain its request for a declaration of TRIPS non-compliance.