Finally, the patients prevail

April 07, 2013 12:12 am | Updated December 04, 2021 11:39 pm IST

The Supreme Court has denied Novartis a patent for its anti-cancer drug Gleevec. This leaves the door open for Indian pharmaceutical companies to produce their own versions of the drug. Since these are sold at roughly one tenth of the patented brand price, for thousands of cancer patients it means the difference between medicine and no medicine at all.

It is not just cancer patients that will benefit, but millions of people dependent on medicines for survival, including those with HIV, diabetes, hepatitis and more. Had the judgement gone the other way, it would have set a precedent for other big pharmaceutical companies to simply make minor modifications to any existing medicines to receive fresh patents. The message from the court is clear: India will grant pharmaceutical companies extended market monopoly only if a medicine is genuinely innovative.

It’s not that Gleevec is not an excellent medicine. It is a lifesaving medicine for those who suffer with chronic myeloid leukaemia. But the key ingredient, Imatinib, was patented in 1993 before India accepted product patents. All salt forms, including Imatinib Mesylate (IM), were covered. So, IM was never eligible for a patent in the first place. Like many others, local companies produced their own quality-assured versions at much lower prices.

In 2005 India conformed to the World Trade Organisation’s intellectual property standards (1995 TRIPS Agreement), and retroactively accepted applications for product patents from 1995 for scrutiny. What Novartis was seeking was a patent on a slightly altered version (beta-crystalline form of the imatinib mesylate compound) that was developed in this window.

Determination of standards

Under the flexibilities granted to countries accepting the WTO TRIPS agreement, India had the right to determine its own standards for novelty, inventive step and industrial application. In doing so, section 3(d) of Indian patent law excludes new forms of known substances unless they exhibit enhanced efficacy. For seven years Novartis tried and failed to challenge this provision.

Novartis’s first application was filed before the Chennai Patent Office in 2005. It was rejected a year later on several grounds, including under section 3(d).

Not to be deterred, Novartis challenged the law in the Madras High Court, arguing that the patent law provision broke the WTO agreement and that the term ‘efficacy’ was vague. The court pointed out that the correct forum for the dispute was the WTO disputes settlement board (to which only nations are eligible to apply, not companies). It dismissed the company’s claim saying that efficacy was understood in the pharmaceutical industry as therapeutic efficacy.

In 2009 The Intellectual Property Appellate Board rejected the Novartis appeal on its patent refusal not only because it did not meet the patentability requirements of section 3(d) but because it was priced too high compared with the income of the average citizen.

Novartis then approached the Supreme Court. It argued that certain properties of the new form of the drug, including greater solubility, better stability under heat, counted as improved efficacy. But the Court did not agree: if improved efficacy meant therapeutic efficacy, patent applicants must prove so based on research conducted both in the lab and in trials on animals.

Novartis could only prove therapeutic efficacy of its new formulation by referring to tests conducted on the original model drug. It still counted as new, the company said, because although it was ‘covered’ by the patent it was not ‘disclosed’ in it. For the court this amounted to an attempt to encash the same million dollar note twice. The result is that 3 (d) is a more robust provision than perhaps it was before the case was brought. The court has termed section 3(d) a “second tier of qualifying standards” for patentability. This will be binding on every patent office, local IP tribunal or High Court for every patent consideration for a medicine. Patients may, under the new patent system, have to wait 20 years for a branded medicine to come off-patent before it becomes affordable. But it is now clear that they will not be forced to wait indefinitely.

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