 "Patent Office refuses Lee Pharma's application for Astrazeneca's diabetes drug")
The Indian Patent Office has rejected an application submitted by Hyderabad-based Lee Pharma seeking Compulsory License of international drug major AstraZeneca's patented diabetes medicine Saxagliptin, which is sold under the brand name Onglyza. Lee Pharma's counsel has said that the company has decided to appeal against the order in the appellate authority, soon.
In an order issued on Tuesday, O P Gupta, controller of Patents 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 license by the Applicant is hereby rejected," said the order.
The application was submitted on the grounds that 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 and that the patented invention is 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 is not established for arriving at a figure and in the absence of a comparative study, it is difficult to conclude that Saxagliptin is 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 esablish patented invention is not worked in the territory of India, added the order.
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Afzal Hasan of Hasan and Singh, counsel appearing for Lee Pharma, said that the company would go for an appeal against the controller's decision. He added that Lee Pharma is able to provide the drug at Rs 11 per tablet, while AstraZeneca's price is Rs 43 per tablet, with a difference of around 300 %.
Lee Pharma, a Rs 200 crore drug manufacturer as per reports last year, 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.
In August, this year, Rajiv Aggarwal, the then Controller of Patents, concluded in a notice that a prima facie case has not been made out for the making of an order under Section 84 of the Act, for issuance of CL. The Official also said that Lee Pharma can request for a hearing within a month, failing which the application shall be refused. Following this, Lee Pharma requested for a hearing. Fresh hearing was held before Gupta, who took charge as the controller of Patents later.
As reported earlier, this is the third application for a compulsory licence in India, the first being one by Natco Pharma for Bayer's cancer drug Sorafenib (brand name Nexavar) and the second by BDR Pharma for Bristol-Myers Squibb's cancer drug Dasatinib (Sprycel). While the first application was granted, the second was rejected by the authority.
According to Section 84 of the Patents Act, 1970, any interested person may make an application for a compulsory license to a patent on various grounds including that the patent owner had not taken adequate steps to manufacture the particular drug in India, 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.