18/08/2015
India has decided against giving the compulsory licence for Anglo-Swedish drugmaker AstraZeneca’s key antidiabetes compound Saxagliptin sought by Hyderabad-based Lee Pharma.NEW DELHI: India has decided against giving the compulsory licence for Anglo-Swedish drugmaker AstraZeneca's key antidiabetes compound Saxagliptin sought by Hyderabad-based Lee Pharma. The Controller of Patents office rejected the application on the grounds that substitutes to the drug are readily available in the market and Lee Pharma's claim that requirements of public with respect to the patented invention are not being satisfied has not been proven.Saxagliptin, sold under the brand name Onglyza and Kombiglyze, is prescribed for type-IIdiabetesmellitus, which occurs when the pancreas does not produce enough insulin or when body does not effectively utilise the insulin produced.The patent for manufacturing and selling Saxagliptin compound was granted toBristol Myers Squibbon April 30, 2007 and then transferred to London-headquartered AstraZeneca. The renewal fee for the patent has been paid till March 5, 2016.Section 84(1) of Patents Act 1970 states that after the expiration of three years from the date of grant of patent any person may make an application for grant of compulsory licence on three grounds - the reasonable requirements of the public have not been satisfied or the patented invention is not available to the public at an affordable price or the patented invention is not worked in the territory of India.The Controller of Patents office turned down Lee Pharma's application on all the three grounds.Rajiv Aggarwal, controller of patents, said that manufacture in India is not a necessary precondition in all cases to establish working in India."The applicant has failed to prima facie show that the patented invention is not worked in the territory of India...I am therefore of the view that case has not been made out for the making of an order under Section 84," Aggarwal said in his order, a copy of which was seen by ET.AlthoughLee Pharmahad contended thatAstraZenecahad fixed a high price for tablets of the two medicines, Onglyza and Kombiglyze, the controller of patents found Lee Pharma's proposed selling price several times the import cost and only marginally below that of AstraZeneca. Thisalso prompted the controller to turn down the application
