Novartis Awaits Landmark Drug Patenting Decision

Global drug-makers are eagerly awaiting the results of a landmark court ruling in India that will state whether drug makers can sell patented medicines in the country. The Supreme Court is set to decide whether or not Swiss pharma giant, Novartis AG’s cancer treatment, Glivec deserves a patent in the country.   

“Big Pharma is nervous because nothing has gone in their favour in the recent past,” Ajay Kumar Sharma, Associate Director of the Pharmaceutical and Biotech Practice at business consultancy Frost & Sullivan says.“With this verdict, at least, things will get clearer about what is the definition of patented medicines.”

Novartis has been fighting since 2006 to win a patent for Glivec, which many oncologists view as a major advance in treating chronic myeloid leukaemia, which kills 80-90 percent of sufferers, and some gastrointestinal cancers.

India has refused protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound - a decision consistent with domestic patent law, which sets tight restrictions on multiple patents for a drug.

By contrast, in the United States, amended versions can be patented.

Novartis is seeking to overturn a clause in Indian Patents Law that restricts patent protection for newer forms of existing molecules, and next week's ruling could set a precedent for how other similar patent claims are treated.

Ranjit Shahani, Vice Chairman and Managing Director of Novartis India Limited, said cheap generics had an important role to play once drug patents expired, but the company was concerned about the non-recognition of patents that were ultimately needed to sustain drug research.

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