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3 June 2015Asia

Celgene company suffers Abraxane patent rejection in India

The Indian Patent Office has reportedly rejected an application covering US company Abraxis BioScience’s cancer drug Abraxane (paclitaxel).

The decision, handed down on Monday (June 1), means that Indian generic drug makers can now produce their own version of the product.

Biopharmaceutical company Abraxis BioScience is a wholly-owned subsidiary of Celgene.

Its Abraxane injection is used to treat advanced forms of breast cancer, non-small cell lung cancer and pancreatic cancer. In 2014, it generated worldwide sales of $848.2 million.

According to the Times of India newspaper, Abraxis’s application to patent the drug was refused for lacking inventive step. Legal sources told the paper that the invention was also found to be obvious.

The office said the application violated section 3(d) of the Indian Patents Act, which seeks to curb the practice of ‘evergreening’ by prohibiting patents that seek to protect new forms of known substances unless they are proven to have enhanced efficacy.

In 2013, Novartis lost its plea to patent its cancer drug Glivec (imatinib) in India because of the section 3(d) provision.

The Times of India report said that Abraxis applied for the patent in 2006, and that in 2008 domestic drug maker Natco Pharma filed an opposition against the application.

Neither Celgene nor Natco had responded to a request for comment at the time of publication.

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