“To patent or not to patent? the case of Novartis’ cancer drug Glivec in India”

Globalization and Health

Jillian Clare Kohler¹  Ravinder Gabble² 

[1] Associate Professor and Director Global Health, Leslie Dan Faculty of Pharmacy, & Munk School of Global Affairs, University of Toronto, 144 College Street, Toronto, Ontario M5S 3 M2, Canada;Dalla Lana School of Public Health, University of Toronto, 155 College Street, 6th floor, Toronto, Ontario M5T 3 M7, Canada

关键词: Pharmaceuticals;    Drug industry;    TRIPS agreement;    Generic drugs;    Patents;    Glivec;    Novartis;    India;   

Others  :  805096
DOI  :  10.1186/1744-8603-10-3

 received in 2013-06-19, accepted in 2013-11-11,  发布年份 2014

【 摘 要 】

Background

Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in the case of Chronic Myeloid Leukemia, one of the most common blood cancers in eastern countries. After more than a decade of legal battles surrounding its patentability, the Supreme Court of India gave its final decision on April 1st of 2013, rejecting the appeal of the Swiss giant drug manufacturer. In 2006, the Indian Patent Office first refused Glivec’s patent under Section 3(d) of the Indian Patent Act arguing that it was only a modified version of an existing drug, Imatinib, and therefore that the drug was not innovative. Novartis replied filing legal challenges against the Indian government but the final verdict in April of 2013 ends the battle. Indeed, the Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Glivec was not patentable.

Methods

The research primarily focused on journal, newspaper and magazine articles relevant to the time frame of the lawsuit (from 1994 to 2013) as well as news searches through Google, Factiva, ProQuest, PubMed, and YouTube where press articles from court verdicts were obtained by using the following keywords: “India”, “Novartis”, “Glivec”, “Patent”, “Novartis Case”, and “Supreme Court of India”. The data sources were interpreted and analyzed according to the authors’ own prior knowledge and understanding of the exigencies of the TRIPS Agreement.

Results

This case illuminates how India is interpreting international law to fit domestic public health needs.

Conclusions

The Novartis case arguably sets an important precedent for the global pharmaceutical industry and ideally will help improve access to lifesaving medicines in the developing world by demanding that patient health needs supersede commercial interests. The Supreme Court of India’s decision may affect the interpretation of the article of the TRIPS Agreement, which states members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

【 授权许可】

   
2014 Gabble and Kohler; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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