{"id":26835,"date":"2015-09-04T11:36:43","date_gmt":"2015-09-04T06:06:43","guid":{"rendered":"http:\/\/localhost\/one\/sinapse\/?p=26835"},"modified":"2026-06-09T10:54:13","modified_gmt":"2026-06-09T05:24:13","slug":"lee-pharma-astrazeneca-compulsory-licensing-patent-india","status":"publish","type":"post","link":"https:\/\/www.bananaip.com\/intellepedia\/lee-pharma-astrazeneca-compulsory-licensing-patent-india\/","title":{"rendered":"Lee Pharma v. AstraZeneca- An unfinished Patent Story"},"content":{"rendered":"

Compulsory licensing under Section 84 of the Patents Act, 1970 has remained a subject of sustained debate in Indian intellectual property law. India issued its first compulsory licence to Natco Pharma, an Indian generic company, for Bayer’s anti-cancer drug Nexavar (Sorafenib) in March 2012. Two further compulsory licence applications followed \u2014 one relating to Roche’s Herceptin and another relating to Bristol Myers’ Dastanib \u2014 but in both cases the respondents prevailed and the drugs were not subjected to a compulsory licence. Section 84 returned to prominence in 2015 with a fresh application.<\/p>\n

Lee Pharma Ltd., an Indian generic company, filed an application [C.L.A. No. 1 of 2015] under Section 84(1) of the Patents Act (also referred to as ‘the Act’), 1970 on 29th<\/sup> June 2015, seeking the grant of a compulsory licence for manufacturing and selling the drug SAXAGLIPTIN, held by AstraZeneca. The drug is protected by patent number 206543, titled “A Cyclopropyl-fused pyrrolidine-based compound”, granted on 30th<\/sup> April 2007 to BMS (Bristol Myers Squibb). BMS assigned the ownership rights of Patent 206543 to AstraZeneca AB in February 2014, and AstraZeneca has held the rights to manufacture and sell the drug in India since then.<\/p>\n

SAXAGLIPTIN is used in the treatment of Type II Diabetes Mellitus, also known as Adult Onset Diabetes Mellitus, and is sold under the brand name ONGLYZA in dosages of 2.5mg and 5mg. It is also sold in combination with Metformin under the brand name KOMBIGLYZE XR.<\/p>\n

Grounds for the Application<\/h2>\n

Lee Pharma filed the application on the grounds that:<\/p>\n

    \n
  1. the reasonable requirements of the public with respect to the patented invention had not been satisfied; and<\/li>\n
  2. the patented invention was not available to the public at a reasonably affordable price; and<\/li>\n
  3. the patented invention was not worked in the territory of India.<\/li>\n<\/ol>\n

    Lee Pharma had made a request for a licence to AstraZeneca with respect to patent 206546 in May 2014. AstraZeneca replied seeking certain clarifications and disagreeing with Lee Pharma’s claim that SAXAGLIPTIN was not available at a reasonably affordable price. A period of one year elapsed without further progress, and Lee Pharma thereafter approached the Controller of Patents.<\/p>\n

    Based on the evidence submitted, the Controller found that Lee Pharma had made efforts to obtain a licence from the patentee on mutually agreeable terms and that a reasonable period as envisaged under Section 84(6) of the Act had elapsed without those efforts succeeding.<\/p>\n

    Controller’s Analysis<\/h2>\n

    In respect of clause (a) of sub-section (1) of Section 84 of the Patents Act, Lee Pharma submitted data and statistics to demonstrate that the reasonable requirements of the public had not been satisfied by the patented invention. However, given the availability of substitutes to the drug in question, the Controller found that a prima facie case could not be made out on this ground.<\/p>\n

    In respect of clause (b) of sub-section (1) of Section 84 of the Patents Act, the Controller observed that Lee Pharma’s proposal to sell the drug in the range of Rs 27 to 31.50 per tablet was paradoxical to its own claim that AstraZeneca’s drug was not available to the public at a reasonably affordable price, because the proposed selling price was several times the alleged cost of import. The applicant’s own argument thus undermined itself, and hence no case was made out in terms of clause (b) of sub-section (1) of Section 84 of the Patents Act.<\/p>\n

    In respect of clause (c) of sub-section (1) of Section 84 of the Patents Act, the Controller referred to the judgment of the Hon. Bombay High Court in the Bayer case<\/em> and the ruling of the IPAB in the same case, which held that:<\/p>\n

    “manufactured in India is not a necessary precondition in all cases to establish working in India and that the patent holder however is required to establish the reasons which make it impossible \/ prohibitive to manufacture the patented drug in India, particularly when the patentee has manufacturing facilities within the country”.<\/p><\/blockquote>\n

    In light of this standard, the Controller observed that Lee Pharma had not submitted any data relating to AstraZeneca’s manufacturing facilities within India, and had accordingly failed to establish that the invention was not being worked in the territory of India.<\/p>\n

    Outcome<\/h2>\n

    In view of these findings, the Controller found that a prima facie case could not be made out for making an order under Section 84 of the Patents Act and issued his decision on the 12th<\/sup> of August, 2015 in favour of AstraZeneca. The Controller’s original order is embedded below.<\/p>\n

    The Order<\/h2>\n