The Mayor Inc. is a company incorporated under the laws of United States of America (U.S.A.) consequent to its Research and Development (R&D) activities the company invented and developed its patented drugs to enable

The matter of dispute between Mayor Inc. vs Kipla pharmaceuticals is related to grant of Compulsory license under the Indian Patent Act, 1970. Compulsory licenses are sovereign state authorizations which enable a third party to make, use, or sell a patented product without the consent of the patent holder. Provisions pertaining to compulsory licensing are provided for under both the Indian Patent Act, 1970, as well as the international legal agreement between all the member nations of WTO - the TRIPS. In India, Chapter XVI of the Indian Patent Act, 1970 deals with compulsory licensing while the conditions which need to be fulfilled for the grant of a compulsory license are laid down under Sections 84 and 92 of the Act. In accordance with Section 84(1) of the Indian Patent Act, 1970, after three years from the grant of a patent, any interested person may make an application for a compulsory license on the grounds that the patented invention: Does not satisfy the reasonable requirements of the public; Is not available to the public at a reasonably affordable price; and Is not worked in the territory of India. In addition to the aforementioned grounds, according to Section 92 of the Act, compulsory licenses can also be issued suomotu by the Controller of Patents pursuant to a notification issued by the Central Government if there is either a "national emergency" or "extreme urgency" or in cases of "public non-commercial use". The said section enables the Government of India to notify to the public of such extreme circumstances, whereupon, any person interested can apply for a compulsory license and the Controller in such case may grant to the applicant a license over the patent on such terms and conditions as he thinks fit. Natco v. Bayer case On March 9, 2012, the Controller of Patents issued the first compulsory license for patents in India. The compulsory license was issued to NatcoPharma Ltd. This patent relates to drug Sorafenibtosylate sold under the brand name Nexavar by Bayer. For liver cancer. The Controller granted the compulsory license to Natco to manufacture and sell a generic version of Nexavar. The decision of the Controller was based on section 84 of the Patents Act. The Controller found that the reasonable requirements of the public with respect to the patented invention had not been satisfied, since only 2% of the total kidney and liver cancer patients were able to access the Bayer's drug. The Controller determined that the patented invention was not available to the public at a reasonably affordable price, because Bayer was charging about ₹ 2.8 lakhs for a therapy of one month of the drug. Lee Pharma v. AstraZeneca The following case illustrates license sought for Saxagliptin® which is used in the treatment of Type-II Diabetes Mellitus On June 29, 2015, Lee Pharma filed an application for compulsory license for patent covering Astra Zeneca's diabetes management drug Saxagliptin®. The application was rejected stating that no prima facie case had been made out on any of the three grounds under section 84 (1) of the Indian Patent Act. Reasonable requirements of the public had not been satisfied: Lee Pharma failed to demonstrate reasonable requirements of the public with respect to Saxagliptin® and further failed to demonstrate the comparative requirements of the drug Saxagliptin® vis-à-vis other drugs. The patented invention was not available to the public at a reasonably affordable price: It was held that all related drugs were in the same price range and that Saxagliptin® being sold at unaffordable price was not justified. The patented invention had not been worked in the territory of India: Lee Pharma also failed to show the exact quantitative requirements of Saxagliptin® in India. Therefore, it could not be concluded whether manufacturing of the drug in India was necessary or not. BDR Pharmaceuticals International Pvt Ltd. v. Bristol-Myers Squibb Co In BDR Pharmaceuticals the controller rejected BDR's application for a compulsory licence (4 March 2013) for the Bristol-Myers Squibb cancer drug SPRYCEL. The controller rejected the compulsory licence application made by BDR by stating that BDR had failed to make a prima facie case for the grant of the compulsory licence. The controller observed that BDR had made no credible attempt to procure a licence from the patent holder and the applicant had also not acquired the ability to work the invention to public advantage. Thus, the request for grant of the compulsory licence was refused. Under the Indian Patent Act, the reasonable requirements of the public are deemed not to have been satisfied where: The patentee refuses to grant a license or licenses on reasonable terms; and a trade or industry is prejudiced; or demand for the patented article has not been met to an adequate extent; or a market for exportation of the patented article manufactured in India is not being supplied or developed; or the establishment or development of commercial activities in India is prejudiced. The patentee imposes a condition on the patented invention; Non-working of the patent in the territory of India; Working of the patented invention in India on a commercial scale is prevented by the importation from abroad. Section 146 (2) of the Indian Patent Act requires every patentee and licensee to provide information on the extent to which the patented invention has been worked on a commercial scale in India. Relevant information is submitted by patentees and licensees with Form 27. It is required to be filed every calendar year, within three months of the end of each year. The information includes the following: Whether the invention has been worked; If not worked, the reasons for non-working, and steps being taken to work the invention; If worked, quantum and value of the patented product; If manufactured in India; Whether imported from other countries, giving details of the countries concerned; Licenses and sub-licenses granted during the year.