The country’s patent office has rejected an application by Hyderabad-based Lee Pharma seeking compulsory licence for making the diabetes medicine Saxagliptin, sold under the brand name Onglyza which was patented to international drug major AstraZeneca.
The Mumbai patent office, which heard the appeal, said it is not satisfied with the grounds raised by Lee Pharma for seeking compulsory licence.
OP Gupta, controller of patents, in an order of January 19, said, “As the applicant (Lee Pharma) has failed to provide evidence along with application or during hearing or by supplementary submission and failed to satisfy the controller regarding any of the grounds as specified in Section 84(1) of the Act, I am therefore of the view that a prima facie case has not been made out for making of an order under section 84 of the Act. Therefore, the application for grant of compulsory licence by the applicant is hereby rejected.”
The application was submitted on the grounds that the reasonable requirements of the public with respect to the patented invention have not been satisfied. It further pointed out that the patented invention was not available to the public at a reasonably affordable price and that the patented invention was not worked in the territory of India.
The controller observed that Lee Pharma’s submissions has not demonstrated the reasonable requirements of the public in respect of Saxagliptin. The exact quantity of the drug required in the context of number of patients and doctors’ prescription was not established for arriving at a figure. In the absence of a comparative study, it was difficult to conclude that Saxagliptin was the best and the latest option with no or comparatively less side effects over the others for treatment of Type-II diabetes patients in India. Apart from Saxagliptin, other drugs used to treat Type-II diabetes are Linagliptin, Sitagliptin and Vildagliptin.
The controller observed that prima facie case has not been made out to prove that the reasonable requirements of the public with respect to the patented invention are not being satisfied and to show that the patented invention is not available to the public at a reasonable affordable price. The company failed to establish patented invention is not worked in the territory of India, added the order.
Lee Pharma, a Rs 200-crore drug manufacturer, according to last year’s report, has filed an application on June 25 with the Controller of Patents, Mumbai, seeking a compulsory licence in its favour for Saxagliptin sold as Onglyza as a standalone drug and Kombiglyze as a combination with Metformin. The patent was granted to Bristol-Myers Squibb in April 2007 and was transferred to AstraZeneca AB.
According to section 84 of the Patents Act, 1970, any interested person may make an application for a compulsory licence to a patent on various grounds including that the patent owner had not taken adequate steps to manufacture the particular drug in India. It can also be argued that the product was not available at a reasonably affordable price, and that the public requirement was not being met, after three years from the date of its grant.