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The multinational company was not able to meet the demand for Saxagliptin, sources at Lee Pharma said. Lee Pharma, a Rs 200 crore drug manufacturer, 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.
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.
“AstraZeneca is aware of Lee Pharma’s application filed with the Indian Patent Office and we are reviewing our options. AstraZeneca has complete confidence in its intellectual property and does not believe that such intellectual property is a barrier to access to medicines in developing countries,” AstraZeneca said in a statement.
Lee Pharma contended the patent owner had not taken adequate steps to manufacture Saxagliptin in India, the product was not available at a reasonably affordable price, and that the public requirement was not being met.
According to Section 84 of the Patents Act, 1970, any interested person may make an application for a compulsory licence to a patent on these grounds after three years from the date of its grant.
Lee Pharma alleged the cost of importing one tablet of Onglyza was Rs 0.80 but it was sold at Rs 41-45 and the cost of importing one tablet of Kombiglyze was Re0.92 and it was sold at Rs 49.
Lee Pharma claimed it had the capacity to manufacture 1 million Saxagliptin and Saxagliptin-Metformin combination tablets a day. It proposed a price of Rs 27 per Saxagliptin 2.5 mg tablet and Rs 29 per Saxagliptin 5 mg tablet. It also proposed the combination of Saxagliptin and Metformin extended release be priced at Rs 30 a tablet for 5/500 mg strength and Rs 31.50 per tablet for 5/1000 mg strength.
Onglyza 2.5 mg costs Rs 43.2 per tablet and a strip of 14 tablets costs Rs 605, making the monthly cost Rs 1,269.4. Onglyza 5 mg — for which Lee Pharma says prices are expected to increase with the new batch — costs Rs 41.5 per tablet and Rs 1,245 per month. The combination drugs Kombiglyze XR (5/500 and 5/1000 mg), are priced at Rs 49 per tablet and Rs 1,470 per month. Both are once-daily dosage.
Lee Pharma said the population of Type II diabetes in India was around 60 million, and there were four key medicines available for treatment: Linagliptin (Trazenta), Sitabliptin (Januvia), Vildagliptin (Galvus), and Saxagliptin. It added if 1 million patients were prescribed Saxagliptin, it would require 365 million tablets a year, whereas imports for 2013 were 8,23,855 tablets, about 0.23 per cent of the requirement. "Thus there is more than 99 per cent shortage of Saxagliptin in the Indian market," Lee Pharma said.
Company sources said in the case of Nexavar, the difference between the price of the originator's drug and the price quoted in the compulsory licence application was huge, but the patient population was less. In the case of Saxagliptin, the patient population was huge and a smaller difference in price would also result in several crore rupees collectively, they added.
Lee Pharma, incorporated in 1997, has three manufacturing units in Hyderabad and Visakhapatnam. Its medicines are sold locally and are exported to 48 countries.
While the application for Saxagliptin was only the third in the country so far, the move was a sign of the evolution of compulsory licensing in India, said Swaraj Paul Barooah, editor-in-chief of intellectual property blog Spicy IP and visiting faculty at Nalsar University of Law, Hyderabad.
“The emergence of Lee Pharma, which seems to be new to the patent litigation field, indicates some generics manufacturers may be willing to test the boundaries of what the law recognises as abuse of patents. There are several drugs on the market that appear susceptible to compulsory licences, so regardless of the outcome of this application, this seems to be good. As long as the Patent Office continues to take a balanced approach, these developments will help improve the compulsory licensing scenario in India,” he said.
Another expert said it must be seen whether there were other drugs available at an affordable price before concluding that a compulsory licence was required. Similar diabetes medicines are available in the market, including generic versions of Saxagliptin.
