The Madras High Court today allowed amendment on the much-controversial Novartis legal challenge against the orders of the Patent Controller invalidating the patent claim on Novartis' blockbuster anti-cancer drug Glivec (Imatinib Mesvlate).
The Court today ultimately allowed the amendment, but ruled that all of the objections would be noted and heard during the hearing which will begin tomorrow. The parties were also given the opportunity to file affidavits on Novartis' amended petition challenging 3(d) on the ground of Article 14.
As the members of the Madras Advocates Association had abstained from work today as a result of an altercation between a senior lawyer and a senior police officer, the hearing was adjourned for tomorrow.
The court will decide tomorrow on another preliminary issue of whether Novartis may convert its challenge to the Patent Controller's order from a writ petition to an appeal. This determination 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. After this issue is decided, the arguments regarding Novartis' challenge to section 3(d) will begin.
Novartis India and Novartis AG had filed applications to amend their petitions to ask for a declaration from the Court that section 3(d) of the Indian Patent Act was not in compliance with TRIPS and that it violates Article 14 of the Indian Constitution, which prohibits discriminatory and arbitrary state action.
The Cancer Patients Aid Association (CPAA), an NGO working in the health sector, and the generic companies had opposed the applications to amend on the ground that Novartis had not specifically claimed a violation of Article 14 in the original petitions. Also, the CPAA and the generic companies claimed that as far as TRIPS non-compliance was concerned, a domestic court did not have the jurisdiction to decide the matter.
The Novartis petition questions the constitutional validity of Section 3(d) of the Patents Act 1970 and pleads that any decision considered under Section 3 (d) should be considered legally non-tenable. The Glivec was the only drug that had received exclusive marketing rights (EMR) during the mailbox period. Further examination of the patent application showed that the patent specification of Novartis AG does not bring out any improvement in the efficacy of the beta-crystal form over the known substances.
As per Section 3(d) of the patents act, any salt, polymorph or derivative of known substance is not patentable unless such salt, polymorph or other substance shows enhanced efficacy of the substance. Giving its ruling in January 2006, patent office had stated that Glivec is only a new form of a known substance. Further, stating that Novartis AG failed to prove enhanced efficacy of the beta-isomer over the known substance, the patent office had concluded that, the subject matter of this (patent) application (filed by Novartis AG) is not patentable under Section 3(d) of the Patents Act 1970 as amended by the Patents (Amendment) Act, 2005.