In a rather predictable move, Novartis, the swiss multinational company which holds patent for a many medicines used for treating camcer, leukemia, malaria and many others including the the anti retro-viral AIDS medicine has challenged the contentious Section 3(d) introduced via the 2005 Amendments to India’s Patent Act.

This unique section which has been specifically been introduced into the Indian Patent Acrt provides a part that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not patentable. While this clause has no precedent in any other patent laws in the world it was specifically drafted so as not to misuse the rediscovery of an already known item and patent it. The section then states (via an explanation to the section) that salts, esters, esthers, polymorphs, metabolites etc shall be considered as the same substance, unless they differ significantly in properties with regard to efficacy.

Previous history of ranting Novatis patents have shown that the last time a patent was granted on an EMR to Novartis in 2004 and it led to a consequent 20 times hike in the price of the drug. The financial express reported this a while .
The Financial Express reports:
“Novartis AG on Wednesday said that it has filed a petition in the Madras High Court seeking a stay on the Asst Controller of Patents and Designs’ order of January 25, 2006 invalidating its patent application for the beta crystalline form of Glivec (imatinib mesylate).
Novartis has also asked the court to declare section 3(d) of the Patents Amendment Act 15 of 2005 unconstitutional and in breach of India’s obligation under the TRIPS agreement. Ranjit Shahani, vice chairman & managing director, Novartis India, said in a statement, India needs to address some contentious issues before the patent law is fully aligned with TRIPs. We are strongly committed to defending international intellectual property rights for our most innovative medicines and ensuring that research to find new therapies for unmet medical needs continues.

In March 2005, India amended its Patents Act to comply with the 1995 World Trade Organisation’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which requires 20-year patent protection for innovative medicines while allowing for public health safeguards. This included Section 3(d), a provision that is unique to Indian law and was included to protect public health. It states that patents would not be given for new forms, uses or minor modifications of existing drugs unless they differ significantly with regard to efficacy. TRIPS only states that member states are to grant patents to all inventions that are “new”, “non obvious or inventive” and “have industrial utility”.

In the challenge to Section 3(d), Novartis argued that this aspect of the Indian patent law is arbitrary and illogical because it is not in compliance with the TRIPS agreement, particularly Article 27. It argued that this would undermine incentives for pharmaceutical innovation and that Section 3(d) was introduced in the Indian Parliament with the intent to disqualify Gleevec. Although Novartis recognised that TRIPS was a non-enforceable agreement and the Indian government was therefore free to repudiate its obligations under TRIPS, Novartis claimed that it was invalid and unconstitutional for Parliament to otherwise comply to all but one provision. It further claimed that the term efficacy was vague and discriminatory. It placed on record that it had a charitable programme Glivec International Patient Assistance Program (GIPAP), which disseminates medicines free of charge to those who were unable to afford them.

The CPAA and generic drug companies responded that it was not open to private companies or Indian courts to decide whether Indian patent laws were compliant with TRIPS. They contended that it did not violate the Indian Constitution and was passed by a competent legislature (the only two grounds for amending a statute in Indian law). They also argued that Section 3(d) was not vague and did comply with TRIPS. With regard to Article 27 they countered that Section 3d was valid because it did not discriminate as to the field of technology. They further made the case that 3(d) was a bona fide Act introduced to combat the problem of “evergreening”. This, they argued, was an abuse of the spirit of TRIPS, which sought to balance public health and intellectual property rights. Evergreening is a technique companies use to stagger patent applications so as to extend market monopoly and prevent the entry of generic drug competitors. This keeps medicines out of reach for the vast majority of Indians. Such a result would be in contravention of Article 21 of the Constitution and other international conventions on the right to health.

Reactions to the case have not been indifferent. This is not surprising as there is much at stake on several counts. Novartis will want to make the most of its blockbuster drug and may file for more patents under the same criteria. Other multinational companies are waiting in the wings for their cue. The well-fed debate about intellectual property rights versus rights to public health has found fresh pastures to graze on. As arguments intensify, it remains to be seen to what extent the government will stand by the amendments it made two years ago to the Patents Act.

Filed under: News, Patent Litigation, TRIPS