Breather for Cipla as SC lifts bar on cancer generic

In a big relief to generic drug major Cipla, the Supreme Court has stayed the Delhi High Court's order that restrained the Indian company from marketing generic version of its anti-cancer drug Sunitinib, which is being developed by US pharmaceutical firms Sugen and Pharmacia & Upjohn Company.

The Indian drug major had sought permission from the apex court to market the drug in view of the revocation of patent rights by Intellectual Property Appellate Board (IPAB) to Sugen.

A bench headed by justice KS Radhakrishnan, while putting on hold the operations of the HC October order till December 6 also sought replies from the ministry of commerce and the two US drug companies.

Cipla had challenged the HC order that restrained it from launching its "life-saving drug" Sunitinib, which is used to treat renal cancer until December 6, despite the Sugen's patent for the drug having been revoked by the patent office.

Sunitinib was being sold by Cipla at one-fourth the price charged by the US companies.

On September 24, the patent office had revoked Sugen's patent under Section 3(d) of the Indian Patents Act of 1970, which bars patent for incremental changes that fall short of being inventive.

Arguing for Cipla, senior advocate Harish Salve said once the patent has been revoked, it is non-existent in the eyes of the law; hence, there can be no question of infringing it.

Till the time such patent stands revoked, no restraint order could have been passed against it any other party thereby restraining them from manufacturing its drug, he told the apex court.

Cipla had moved the IPAB challenging the local patent for Sutent, a liver and kidney cancer drug sold by Pfizer worldwide, on grounds that the invention was publicly used in India before the priority date of claim and did not include any inventive step. Natco Pharma and other local drug makers had also opposed the patent. Subsequently, the Assistant Controller of Patents and Designs had revoked Pfizer's local patent for its cancer drug Sutent or 'Sunitinib Malate', developed by drug maker Sugen. The patent for the drug was granted to the US firm in India in 2007.

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