The High Court of Madras (Chennai) has rejected a challenge to India’s patent laws this week from the Swiss pharmaceutical company Novartis, paving the way for Indian drug manufacturers to continue to produce low cost generic drugs. The battle over the case has been long and complex, with Novartis arguing that the landmark ruling would discourage investments in innovation and would undermine attempts to improve products or heavily invest in much needed medical research. IP and Patent protection issues, according to Novartis, have now been weakened internationally and this would now lead to long term negative consequences for R&D into better medicines.

On the other hand, organisations such as Medecins Sans Frontieres, state that the ruling is “a huge relief for patients and doctors in developing countries who depend upon affordable medicines from India”, and have long campaigned for access to essential medicines. Aid organisations worldwide have hailed the ruling as “a victory for the rights of patients over patents”.

The case, keenly monitored by the international pharmaceutical industry, centered on Novartis requesting the court to clarify significant parts of the Indian Patent Legislation, arguing that it breached the Indian Constitution, and in particular the granting of patents for incremental developments. Although the full judgment has not been publically released, it is believed the judge was of the opinion that the court had no jurisdiction to rule over whether Indian patent law complied with WTO guidelines on Intellectual Property. The issue arose over a seperate case last year in which Novartis has been denied a patent in India on a freshly modified form of its leukemia drug Glivec. The decision had been made on the basis that the new drug was insufficiently innovative, as Indian patent legislation does not permit the practice of ‘evergreening’ - issuing patents for already known drugs that have undergone modification. Novartis comments however “medical progress occurs through incremental innovation. If Indian patent law does not recognize these important advances, patients will be denied new and better medicines”.

If the court had ruled in favor of Novartis, the decision would have allowed international pharmaceutical companies to receive patents on modifications of already known drugs, thus extending the time frame of their sole rights to produce them. Concerning the Glivec drug alone, this would have prevented Indian companies from manufacturing generic versions of the drug, which they sell for about a tenth of the price of the Novartis product, leading to large nunbers of cancer patients worldwide without access to any treatment. Indian companies provide 84% of the drugs to fight AIDS that Medicins Sans Frontieres supplies to patients worldwide, and more than 25% of other essential drugs used by them. Other relief agencies are equally dependent upon Indian pharmaceutical manufacturers generic brands.

Novartis have said it is ‘unlikely’ they will appeal to the Supreme Court.

Y.K Sapru, head of the Mumbai Cancer Patients Support Group commented “This is a major decision domestically in India and internationally. India has a USD5 billion value pharmaceutical industry and 65% of those drugs are sold to the developed world and it’s patients. All that would have been suspended if the judgement had gone the other way and there would have been a dearth of affordable drugs for the worlds poor. That potential calamity has now been prevented”.

In terms of our own viewpoint, it appears an obvious moral choice taken by the court, although the global drugs manufacturers - and possibly the WTO - have strategic issues now to decide upon in terms of patent laws infringing upon the overall benefit to mankind of permitting low cost essential products. Drug companies are in a commercial environment; and they are going to have to restructure their business models in order to maintain the ability to conduct research. If Novartis, in such an environment, claim they cannot maintain the necessary R&D if patent protection is not forthcoming to allow them to make back the enormous cost of such facilities, then their competitors will. In this case, common sense and a recognition of the moral requirement to limit profiteering at the expense of the poor has been timely, and reflects well upon the Indian legal system and the governments commitment to obligations to lift the worlds poor out of misery and disease.

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