In a landmark move, Natco Pharma has filed India’s first compulsory licensing application against Bayer’s patented drug Nexavar, which is used to treat liver and kidney cancer. The full ET Report which covers this is available here.
Nexavar is presently available in the market for Rs. 2.85 lakhs for a one month’s course, against this Natco plans to sell its generic version, sorafenib tosylate, for just Rs. 8,900 for the same course i.e. at almost 1/32 of the cost. Approximately 25 lakh cancer patients in India stand to benefit from this generic drug.
This is not the first challenge to Bayer’s Nexavar patent. We had earlier blogged about Cipla’s challenge to Bayer’s patent and the subsequent infringement suit filed by Bayer against Cipla here. The latest developments on this case can be found here. The suit is pending before the Delhi High Court.
S.84 of the Indian Patents Act deals with compulsory licences; it states that an application can be made to the Controller for grant of a compulsory licence, at any time after 3 years from the date of grant of a patent on any of the following grounds:
- the reasonable requirements of the public with respect to the patented invention have not been satisfied
- the patented invention is not available to the public at a reasonably affordable price
- the patented invention is not worked in India
Natco has filed the application on the second ground that the drug is not affordable by the average Indian person.
In accordance with S. 84(6) (iv) of the Patents Act, Natco had in December approached Bayer for a voluntary licence for its generic version, sorafenib tosylate. S. 84 (6) (iv) states that while considering an application for a compulsory licence, one of the factors the Controller will take into account is whether the applicant has made reasonable efforts to obtain a licence from the patent holder. Bayer refused to grant the licence as a consequence Natco has now approached the Controller for grant of a compulsory licence.
Interestingly Bayer has also filed an infringement suit against Natco’s generic version of Nexavar, in the Delhi High Court on 6th May this year. The suit is pending before the Delhi High Court.
Experts from the industry believe that the compulsory licensing application filed by Natco is set to face a long drawn battle and the loser is likely to challenge the decision in court. A decision in favour of Natco however would be a milestone for generic drugs since it would encourage other firms to apply for compulsory licences for costly medicines as well.
Currently two other voluntary licensing applications are pending, Natco’s with a GSK-Pfizer joint venture, in relation to a generic HIV drug, which we had blogged about here and Cipla’s with US based Merck and Co. also in relation to an anti-HIV drug, which we had blogged about here and can be read about here as well. Only time will tell whether these too will go the Natco way, and whether we will see more such compulsory licensing applications being filed in the future as well.