Cipla is adopting every tactical strategy to compel Novartis to negotiate royalty agreement and give him license to manufacture “Onbrez Breezhaler” at low cost in India.

What is “Onbrez Breezhaler” ?

This drug is treatment for bronchitis. Inhalation device is designed to deliver the medicine contained in the capsules.The EU approved the Onbrez Breezhaler in November 2009.It is now approved in more than 50 countries and has been launched in 13 European countries. The application for U.S is under reviewed by an FDA advisory committee.

What steps Cipla ?

21st October 2014

Cipla filed petition to DIPP to revoke Novartis’ patent and asked Central Govt to exercise its power under compulsory license.

November 2014

Cipla launched generic version of Onbrez.
Cost – Rs. 130 per strip of 10, costs less than 1/4th the price of Novartis’ drug.

December 2014

Health ministry issued a statement stating that Cipla’s petition does not make a compelling case for revocation of Novartis’ Onbrez patents.

Delhi High Court granted injunction restraining Cipla.

January 2015

Cipla moved the Delhi High Court challenging its order.

April 2015

Cipla today suggested to the Delhi High Court that it was ready to pay “reasonable” royalty if it is allowed to manufacture respiratory disease drug, ‘Indaflo’, which could serve 66,000 patients in India at a cheaper rate.

Cipla told the bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva that public interest outweighs everything and if given the license, it will manufacture the drug as the Novartis’ drug was costlier and was not available in a majority of the medical stores in the country.

Currently Novartis has negatively responded and is unwilling to give license to Cipla to manufacture generic version of the drug.

In this Clash of Titans, important point is that

  • Why Cipla appealed to DIPP and not filed for compulsory license at Patent Office.
  • In the absence of compulsory licensing, isn’t it the right of patentee whether to agree for royalty agreement or not?