Novartis v. Union of India & Others is a landmark decision by a two-judge bench of the Indian Supreme Court on the issue of whether Novartis could patent Gleevec in India, and was the culmination of a seven-year-long litigation fought by Novartis. The Supreme Court upheld the Indian patent office's rejection of the patent application.

The patent application at the centre of the case was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement. As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition. India also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.

The patent application claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate). In 1993, during the time India did not allow patents on products, Novartis had patented imatinib, with salts vaguely specified, in many countries but could not patent it in India. The key differences between the two patent applications were that the 1998 patent application specified the counterion (Gleevec is a specific salt - imatinib mesylate) while the 1993 patent application did not claim any specific salts, nor did it mention mesylate, and the 1998 patent application specified the solid form of Gleevec - the way the individual molecules are packed together into a solid when the drug itself is manufactured (this is separate from processes by which the drug itself is formulated into pills or capsules) - while the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta crystalline.

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the EMR were granted in November 2003. Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India. Novartis set the price of Gleevec at USD 2666 per patient per month; generic companies were selling their versions at USD 177 to 266 per patient per month. Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.

When examination of Novartis' patent application began in 2005, it came under immediate attack from oppositions initiated by generic companies that were already selling Gleevec in India and by advocacy groups. The application was rejected by the patent office and by an appeal board. The key basis for the rejection was the part of Indian patent law that was created by amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. Section 3(d) of the amended Act, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy." At one point, Novartis went to court to try to invalidate section 3(d); it argued that the provision was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal. Novartis did appeal the rejection by the patent office to India's Supreme Court, which took the case.

The Supreme Court case hinged on the interpretation of section 3(d). The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts.

Although the court ruled narrowly, and took care to note that the subject application was filed during a time of transition in Indian patent law, the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing and innovation with affordability. Had Novartis won and got its patent issued, it could not have prevented generics companies in India from continuing to sell generic Gleevec, but it could have obligated them to pay a reasonable royalty under a grandfather clause included in India's patent law.

Background

History of Patent laws and pharma industry in India

As part of the Commonwealth, India inherited its intellectual property laws from Great Britain. However, after gaining independence in 1947, there was a growing consensus that to boost manufacturing, restrictive product patents must be temporarily removed. In 1970, amendments to the Indian Patents Act abolished product patents but retained process patents with a reduced span of protection.

During the absence of any product patent regime, the Indian pharmaceutical industry grew at a remarkable pace, ultimately becoming a net exporter, the world's third-largest by volume, and fourteenth-largest by value.

However, in the 1990s, during the Uruguay Round negotiations of the World Trade Organization (WTO), India pledged to bring its patent legislation in tune with the TRIPS mandate in a phased manner. Consequently, in 1999 India allowed for transitional filing of product patent applications, with retrospective effect from 1995. Full product and process patent protection was re-introduced beginning in 2005, when all transitional regulations ended.

India's patent law also contained a "grandfather clause" in section 11A, subsection (7),Controller General of Patents Designs and Trade Marks, Department of Industrial Policy and Promotion, Ministry of Commerce and Industry The Patents Act 1970 (incorporating all amendments till 26-01-2013) that created "a special regime for generic versions of medicines if the initial patent application was made between 1 January 1995 and 31 December 2004 and if these medicines were already on the Indian market before the 1st of January 2005.... Generics that enter into this category can stay on the Indian market even if their pharmaceutical substance is patented. However, the Indian law requires that the producers of those generics then pay a “reasonable royalty” to the patent holder."Erklärung von Bern. 8 May 2007 Short questions and answers about the court case initiated by Novartis in India Kevin Grogan for PharmaTimes. 27 February 2012 Novartis explains stance over India patent law challenge

The case hinged on a section of the new Indian patent law dealing with whether incremental inventions would be patentable, namely Section 3(d).

The initial version read as follows: "The mere discovery of any new property or new use of a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant."

This was amended twice, the last time in 2005. The final version reads as follows (amendments in italics):

"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 or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pureform, particle size isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy."

As discussed below, Novartis filed its initial patent application on imatinib (the raw material in Gleevec) in 1993, and at that time India did not confer product patents.Finally, the patients prevail, Sarah Hiddlestone, The Hindu, 7 April 2013 As mentioned above, in 1995 India joined the World Trade Organization and signed onto TRIPS; Switzerland joined the WTO later that same year.Switzerland page at WTONote: Further complicating matters, India's 1993 notification to the WTO indicating that it would join, included a list of countries whose priorities dates it would recognize for patenting, and Switzerland was not on the list as it was not a member of the WTO at that time.(Sudhir Ahuja, D P Ahuja & Co, Calcutta, India. India Decides to Join the Paris Convention and Ratify the Patent Cooperation Treaty. So What? Patent World Issue #106, October 1998). Additionally the EPO was not mentioned in the notification from India; it was not until 2003 that EPO became officially recognized by India, fully normalizing patent reciprocity between India and Europe. (G 0002/02 (Priorities from India/ASTRAZENECA) of 26.4.2004) Novartis filed its initial patent applications on Gleevec itself in 1997, after both India and Switzerland had joined the WTO but while both were still in transition.

Initial patent filings and product launches

In the early 1990s a number of derivatives of N-phenyl-2-pyrimidineamine were synthesized by scientists at Ciba-Geigy (now part of Novartis), one compound of which was CGP 57148 in free base form (later given the International Nonproprietary Name ‘imatinib’ by the World Health Organization (WHO)). A Swiss patent application was filed on 3 April 1992, which was then filed in the EU, the US, and other countries in March and April 1993US Patent Application No. 08/042,322). This application was abandoned and another continuation-in-part application was then filed on 28 April 1994 which matured into (US Patent 5,521,184).See here for worldwide filings] and in 1996 United States and European patent offices granted a patent to Novartis claiming imatinib and its derivatives, including salts thereof (but not mentioning mesylate). The patent does not specify any crystal forms of the compounds or discuss their relative advantages and disadvantages.US Patent 5,521,184EP0564409