Cheap cancer drugs: Novartis order is not a dead end of innovation

The supreme court finally denied Novartis, patent protection for Glivec, an anti-cancer drug. Six claims by the company – in my humble opinion, wrongly – state that this would discourage future innovation in India

rohit

Rohit Bansal | April 2, 2013


Novartis claims the SC order will stiffle pharma research
Novartis claims the SC order will stiffle pharma research

It is obvious that the folks at $57-billion Swiss pharma major Novartis are angry. Being denied a patent despite Glivec being a life-saving, breakthrough drug for certain forms of cancer like chronic myeloid leukaemia, in nearly 40 countries, albeit including Russia, China and Taiwan, must be hard.

The claim(s) and the math deserve a brief counterpoint each:

Novartis, Claim No.1: More than nine out of 10 patients currently taking Glivec in India will continue to receive the drug free of charge through Novartis Oncology Access programmes.

Counterpoint: While talk of “9/10 freeships” would impress anyone, Novartis doesn’t tell us the whole story in the fact that (only) 16,000 patients have benefitted. A case of statistical jugglery: understate the problem and then claim to have addressed it to the tune of 95 percent!

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Novartis, Claim No.2: Patents are the foundation of innovative drug discovery and essential to advancing medical science and treatment of patients. The breakthrough medicine, Glivec® (imatinibmesylate), provides clarification on the Indian patent law and discourages innovative drug discovery essential to advancing medical science for patients.

Counterpoint: The apex court refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound. The Indian law, rightly, bans firms from extending patents on their products by making slight changes to a compound, a practice known as "evergreening". Glivec was merely tweaking, and it does not satisfy a patent's "novelty" requirement.

Novartis, Claim No.3: The denial of the Glivec beta crystal form patent based on Sections 3(d) and 3(b) of the Indian patent law is wrong. Also, Novartis wasn’t granted an original patent for Glivec in India, when as the original innovator the company should be encouraged to invest in medical innovation especially for unmet medical needs. We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This (SC) ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.

Counterpoint: India’s legal provisions mandate the need for substantial innovation before new patents are issued on medicines. The case for that wasn’t satisfactorily made. As for need for patents, sure, they’re the bedrock of innovation. Which is why they usually protect the innovator companies for 20 years of exclusive sales. After that, they are open to other firms who can make cheaper copies of the original drug. Once the protection expires, the first company to challenge the patent gets an exclusive right to sell the copy for 180 days. After 180 days, more companies can sell the generic versions, potentially resulting in a further price drop. It is estimated that drugs with combined annual sales of $150 bn will go “off-patent” by 2015.

Novartis, Claim No.4: The primary concern of this case was with India's growing non-recognition of intellectual property rights that sustain research and development for innovative medicines. As a leader in both innovative and generic medicines, Novartis strongly supports the contribution of generics to improving public health once drug patents expire.

Counterpoint: Empty rhetoric. While Novartis claims to satisfy “95 percent of patients” by giving 16,000 of them free treatment, generic Glivec, manufactured among others by Cipla and Natco Pharma is apparently used by more than 3,00,000 patients. As for specifics, the beta crystalline form, Imatinib Mesylate (IM), is the salt form (mesylate) of an older medicine Imatinib. Novartis has wrongly claimed that this drug deserved a patent because of its 30 percent increase in the bio-availability — a measure of the absorption of the drug by the body. The bench of justices Aftab Alam and Ranjana Desai rightly rejected that IM is a new product and the outcome of an invention beyond what’s known as the Zimmermann patent. The judges held that IM is a known substance from the Zimmermann patent itself. Not only is IM known as a substance in the Zimmermann patent, but its pharmacological properties are also known in the Zimmermann patent and in the article published in Cancer Research.

Novartis, Claim No.5: The company has provided more than $1.7 billion worth of Glivec to patients in India.

Counterpoint: The math is based on an assumption that the price of Glivec is to be $2,600 (1,710 pounds) a month. The generic equivalent is currently available in India at one-tenth of this for $175. So, the Novartis claim of $1.7 billion should be deflated substantially.

Novartis, Claim No.6: In 2012, our contributions and programmes in this area were valued at $2 billion, providing medicine to more than 100 million patients, and health education, infrastructure development and other programmes to another 7.2 million people worldwide.

Counterpoint: If this were so, the corresponding numbers on India were not brought out before the SC and the Indian public. Companies which do will do better than Novartis did.

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