The recent Indian Supreme Court’s dismissal of Swiss multinational pharma major Novartis’s application for patent for its anticancer medicine, Glivec, is hailed worldwide as a victory of public health. After failing to get patent at several stages in India, disappointed Novartis finally knocked the door of Supreme Court of India and even questions the very provision of a special section in Patent Act, Section 3(d). The seven-year-old battle finally won by India with a strong message that India does not allow patent leniently but for real innovations and has a concern for public health too.

Glivec (outside USA Gleevec) is chemically imatinib mesylate, a breakthrough medicine in myelogenous leukemia and other forms of cancer. The story of Glivec controversy in India began with rejection of patent application of Novartis, a Swiss based multinational pharmaceutical company, in 2006. When the patent application was rejected by the patent office, Chennai; Novartis approached the Madras High Court claiming that the Indian Patent Act is not in consistent with World Trade Organization (WTO) Rules. It urged the Court to invalidate the Section 3(d). While rejecting the Novartis’s claim, the Court referred the case to the Intellectual Property Appellate Board (IPAB), which in turn rejected the application. IPAB hears the appeal of aggrieved patent applicant who failed to get patent. The rejected Novartis finally approached Supreme Court of the country in 2009 and the Supreme Court in its recent judgment dismissed Novartis’s challenge. Dismissing the petition with cost the Supreme Court clarified that applicants of patent have to meet the standards of Section 3(d) of Indian Patent Act before they can get the patent under Indian law.”

Patent Act 1970 allowed only process patent. There was no provision of product patent for pharma and food products. After signing the Trade Related Intellectual Property Rights (TRIPS), India joined WTO. The effective date of TRIPS is 01 January 1995. India amended its Patent Act in 2005 to meet its obligation to provide product patents, a requirement of WTO. Patent coverage for pharmaceutical products applies prospectively to application filed with Indian patent office on or after the effective date of TRIPS, 01st January 1995. The law also has a powerful limitations for patents applied between the TRIPS effective date and the commencement of product patent, 01 January 1995 to 31 December 2004. Any Indian Company that has began manufacturing a drug which is subsequently covered under Indian patent can continue to manufacture and sell. However, such company has to pay royalty to the patent holder as recommended by the government. Besides, Indian Parliament in its wisdom inserted a provision called 3(d) while amending the Patent Act in 2005. The section is intended to prevent undue patent exploitation when there is no real innovation. The section 3(d) states 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 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. It further clarified that for the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, 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.

The present Novartis case falls in the above category. The pharma giant’s patent application for beta form of crystalline imatinib mesylate is rejected at different levels in India. The company claims that the beta form is superior to imatinib mesylate and has in fact obtained patent in several countries including USA, China and Russia. India interpreted this beta form is just another form of known substance, imatinib mesylate. As the company filed its first patent for imatinib and imatinib mesylate in USA in 1994, this is already in public domain and generic version of the drug is available. At that time India was in no obligation to provide product patent. Section 3(d) does not allow patentability of derivative or form of known substances unless there is significant improvement in therapeutic efficacy. By the time Novartis’s patent application reviewed, India had a new law with Section 3(d).

The company pleaded that beta crystalline form of the imatinib mesylate has better physic-chemical properties: improved flow properties, less hygroscopicity, improved thermal stability. Later it has claimed of improved bioavailability. The bioavailability comparison is made with imatinib and not the mesylate salt which would have been more appropriate. All these factors amount to improved efficacy. The apex court observed that these may be beneficial to the patient but does not qualify as standard of efficacy as specified in Section 3(d). In fact while maintaining high standard of patentability for innovative products, Indian patent law prohibits ever greening of patents as attempted by Novartis.

In a country where access of essential medicines is much lower than global average, affordability is a big issue. Two thirds of India’s population is reported to have no access to essential medicines against the one-thirds of global population not having access. A month’s treatment costs around Rs. 8000/- with generic versions manufactured by Indian generic pharmas while the cost of Glivec is Rs. 1,20,000/- for the same period. Had the Section 3 (d) loosely interpreted and patent granted, there would have been altogether different situations where people cannot afford to have this costly medicine. However, Novartis through its charitable scheme offering free Glivec to many cancer patients is just to show that the interpretation of law if made in its favour, is not going to influence access of medicines. But this is not just the case of Glivec alone; it is the interpretation of law which has much global implications.

The industries claim that the investment made is huge during development drug and this need to be recovered with profits; failing which the companies may not venture into this risky business. But in the case of Glivec the company has not invested much as the initial development costs were funded from National Institute of Health, Leukemia society and others. Even the clinical trial period was also short: testing started in 1998 and approval obtained on May 10, 2001.

Many developing and poor countries rely on cheaper but quality generic medicines from India. The weakening of 3(d) would have delayed the generic availability of medicines for HIV and other diseases. Thus India can continue the production and export of generics while other countries continue to import from India. Other companies would not involve unnecessarily in ever greening patent persuasion and devote in innovative research. Even other developing countries can cite this precedence and amend their IPR laws to protect public health from undue exploitation of patents. This historic judgment of Indian Supreme Court against the Swiss pharma major Novartis ever greening patent attempt is a victory of millions and millions patients of the world.