Five years after the Indian Supreme Court’s Novartis verdict

On 1 April 2013, in a packed room inside India’s Supreme Court, India’s apex court delivered a 112-page landmark judgment which dismissed Swiss pharma giant Novartis AG’s appeal for a patent for its life-saving cancer drug marketed under brand name Glivec in most parts of the world.

The Novartis case triggered a hugely polarising discourse around the world about a key feature of India’s patent regime.

Intellectual Property Watch was in the Supreme Court covering the famous case, which at it its core was about the interpretation of a specific clause (Section 3(d) of India’s patent law), which explains what does and does not constitute “invention” under India’s patent regime.

Section 3(d), States that :

” 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 .”

Five years after Novartis’ challenge to India’s anti-evergreening safeguard — section 3(d) – was struck down by India’s Supreme Court, it is time for stock-taking. Clearly, the famous clause in India’s patent law, aimed at preventing ‘evergreening’ or not allowing patents on new forms of existing medicines unless they demonstrate a significant increase in efficacy, remains a thorny issue, admired and hated equally.

Leena Menghaney, South Asia head for Médecins Sans Frontières’  access campaign says there is the greater global awareness that the patent system is being abused by the pharmaceutical industry to block the early entry of competition that drives medicine prices down.

“The campaign that civil society led in this case against evergreening played a role in the genesis of this debate. During the Campaign, we saw elements of the debate on the impact of patents on high prices emerging in the United States. Today, you can see the steps being taken in the European Union, South Africa, and Argentina – which offer the beginning of a new approach to examining patents and preventing unnecessary extensions of monopolies in the pharmaceutical markets.”

“The majority (72%) of granted patents for pharmaceuticals are secondary patents, granted for marginal improvements over previously known drugs for which primary patents exist,” Menghaney told Intellectual Property Watch. “As MSF, we have observed this trend in new TB drugs where a number of weak secondary patents granted could impact early entry of alternative suppliers from India.”

Domestic Impact

In India, two of the key civil society groups that were present at the Supreme Court almost through the entire litigation were Delhi Network of HIV positive people (DNP+) and Cancer Patients Aid Association (CPAA).

Says Loon Gangte, an Indian activist living with HIV, regional coordinator, South Asia, of the International Treatment Preparedness Coalition (ITPC) and one of the founders of the DNP+, “The Indian Supreme Court’s decision on Section 3(d) in the famous Novartis case created a precedent and has helped us in our campaign for affordable medicines.”

  1. Sapru, who heads the Cancer Patients Aid Association (CPAA), which took on Novartis, expressed similar sentiments. “As a result of the 2013 Supreme Court judgement, the price of Glivec was reduced from INR 150,000 (approximately USD 2,200, for one month’s treatment) to INR 6,000 (USD 88) in the generic drugs market.” Sapru said. “The drastically reduced price of the generic version of Glivec has helped saved the lives of around 500,000 patients of Chronic Myloid Leukaemia in the last five years.”

While activists on the frontline of the battle for affordable medicines in India, like Sapru, Gangte and others, typically point out the positive fallout of the landmark judgment, pressures and challenges continue.

In the last five years, there have been two important studies which have gone into the issue of how India’s patent office has been granting and rejecting patents.

The report, authored by Dr. Feroz Ali, Dr. Sudarsan Rajagopal, Mohamed Mustafa and Chinnasamy Prabhu said: “The increased application of Section 3(d) by the IPO soon after the Novartis case could be due to the legal certainty provided by the decision of the Supreme Court in upholding the rejection of a patent application rejected under that section.”

Challenges Remain to continue further……….

However, a subsequent report by the same group of authors which studied the patents granted by the IPO found that section 3(d) has not been effectively utilised in preventing secondary patents from being granted. The study, released in an

Feroz Ali, IPR chair professor at the Indian Institute of Technology, Madras, and a practising advocate who was involved with both the reports, stresses that there have been inconsistencies in the way the ‘Novartis standard’ is dealt with by the Indian Patent Office.

“One of the reasons we identified for not following of the Novartis standard was that the pharma guidelines developed by the IPO (Indian Patent Office) do not spell out the details of the Novartis Standard,” Ali said. “The standard developed by the Supreme Court, which lists various steps to determine whether an invention falls within the ambit of Section 3(d), has not been captured in the pharma guidelines prepared by the IPO. Rather they merely quote paragraphs from the Novartis decision without indicating how the lessons from the decision can be put into practice.”.

However, he said, “Despite the fact that Section 3(d) is useful, it appears that 3(d) is being deliberately ignored by the patent controller’s office. As a result, it is not being applied correctly always. This is evident from the recent study of Firoz Ali et al: If 3(d) had been correctly applied, there would have been less patents.

“There is a need for the Government to get an independent audit done of the patents granted to ensure that undeserving patents are not granted,” Grover said.

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