Novartis Case Study

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The case of rejection of Novartis’ patent application for its cancer drug ‘Glivec’ is a classic example of the way India has incorporated appropriate safeguards in its patent laws to subdue the harmful effects of medical patents on accessibility of essential medicines. In this case, the safeguard is in the form on Section 3(d) of the Indian Patents Act, 1970.

Novartis had filed an application with the Indian Patent Office in 1998 for inventing a new form ‘Imatinib Mesylate’ of its earlier molecule ‘Imatinib’. It failed to prove increased pharmacological efficacy. The Indian Patent Office rejected the application.

In 2013, the Supreme Court upheld the rejection of the patent application filed by Novartis for Glivec before the
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NATCO Pharma was granted the Compulsory Licence to produce the drug Nexavar that was patented by Bayer. In a significant decision that would have long-lasting consequences for availability of essential medicines, the Supreme Court of India refused to entertain Bayer’s Special Leave Petition to scrap CL on Nexavar granted to NATCO Pharma. The highest court upheld the Bombay High Court’s decision to uphold the CL. This is the first ever CL granted to any company in India.

The litigation ensuing around the Compulsory Licence application for Sorafenib tosylate (Nexavar), its grant, the petition to scrap it and the subsequent rejection of the petition, was the first of its kind in India. Sorafenib tosylate is a drug to cure kidney and liver cancer. The price that Bayer was charging for the drug under the trade name Nexavar was Rs. 2,84,000 per patient per month which is exorbitant for majority of the patients in India. In March 2012, the Patent Controller granted a CL to NATCO Pharma to manufacture and market a cheaper generic version of Nexavar at around Rs. 8,800 per person per year. Bayer subsequently appealed against the grant before the Intellectual Property Appellate Board (IPAB) and later before the Bombay High
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