Access to Medicines for the World’s Poor: Novartis Case - ECLT - Università di Pavia

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Access to Medicines for the World’s Poor: Novartis Case


Access to Medicines for the World’s Poor: Novartis Case
by Avgi Kaisi

There were several reactions to the judgment of the Supreme Court of India, issued on  1 April 2013 and refusing Novartis patent protection for its cancer drug under the commercial name Gleevec. On the one hand Novartis and other pharmaceutical companies consider that this decision will discourage future innovation in India. On the other  NGOs advocating for public health praised the decision of the Court, stating that it was an important victory not only for the people of India but for the world’s poor.

Gleevec is used to treat chronic myeloid leukemia and other cancers. Novartis filed an initial patent application in 1992 in the U.S. covering the drug “imatinib mesylate” (Gleevec), for which it received a patent (Zimmermann patent). In 1997 Novartis filed a second application for a variation of the imatinib mesylate salt, the “beta crystalline form”. A patent for this second form was also granted in the U.S..

In 1998 Novartis filed an application in India for the second form of imatinib. At that moment India’s law on product patenting was at a transitional stage, and the application remained dormant under an arrangement called the “mailbox procedure” until 2005, according to Art.65 (4) of the TRIPS Agreement. The application was initially rejected by the Indian Patent office on the grounds that it was considered a new form of the existing “imatinib”.

The Supreme Court followed the same line as that of the patent office stating that “imatinib mesylate” was a known substance of the previous Zimmermann patent.

The Court based its judgment on Art. 3(d) of the new Indian Patents Act whereby 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” cannot be considered an invention and is therefore not patentable.

The Court interpreted the term efficacy in the case of medicines as “therapeutic efficacy” which should receive narrow and strict interpretation. According to the Court, not all advantageous and beneficial properties are relevant to such efficacy and therefore the advantages relating to the storage and production of the medicine should not be taken into consideration.

The Court underscored the initial intention of the Parliament when adopting section 3(d) of the new patent act. According to the Court, the Parliament aimed at setting up “ a second tier of qualifying standards for chemical substances/ pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds”.

The decision of the Supreme Court opens the way for generic competition and a subsequent reduction in prices. It is enough to note that the price charged by Novartis while enjoying exclusive marketing rights is Rs 120. 000 per month, approximately €1680. This  price is unaffordable for the majority of Indian patients, in a country in which 40% of the population earns approximately one euro per day.

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