Lead Author: Munnazzar Ahmed
Organization: Symbiosis Law School
Country: India


Issues in Compulsory Licensing: Since Natco v Bayer
Access= Affordability + Availability, the access to medicine is not guaranteed if any of the either is missing. India has been one of the countries among the developing nations, which has ensured the presence of both leading to the positive results. The task is not that easy how it looks as there is role of different stakeholders as well as Government authorities to be played to achieve the above task. To ensure the TRIPS compatibility and to ensure the access of medicines specifically patented in the country is very critical task for the Government authorities as it also leads to the International Relations among the nations involved in the transaction. When India granted its first compulsory license to Natco for drug named Nexaver to cure of liver & kidney cancer, India was under the critical debate for such step. But India has done nothing else but just exercising the flexibilities under Article 31 TRIPS, so he question comes that then what did India do wrong. Now this is not the case Of India alone but of all developing countries and under developed countries. The access of the medicines to developing countries and under developed countries is under the challenge if such provisions are not allowed to exercise under TRIPS. Indian IP regime was highly criticised soon after the grant of first compulsory license granted. But it is evident through 2 cases where the applications for the compulsory license has been rejected too by the India Patent office because not due to pressure from developed nations but only that they couldn’t comply with requirements. Research intends to enlighten the panel about these developments in India so limelight the fair practice of IP in Indian Jurisdiction.


Issues in Compulsory Licensing & Access to Medicine: Since Natco v Bayer
Munnazzar Ahmed

The meaning of the words Accessibility of patented drugs has a very limited scope under the India Patent regime. It is directly proportional to the cost and the in numbers available in the market or affordability and availability of the medicine. Now this we cannot say is uniform for all the medicines but is applicable to only life saving drugs, for example a medicine used to cure wrinkles cannot be brought under the purview of such medicines, which are life savings.
On March 9, 2012 P.H. Kurien, Controller, Patent & Trademark office, Mumbai issued the first compulsory license to Natco, a Hyderabad based generic medicine manufacturing company for the drug named Nexavar, which was manufactured by Bayer, a German pharmaceutical company. The Controller was satisfied that the conditions under Section 84(1) are eligible in the current case to grant for the compulsory license. Soon after this order there was huge criticism about the India’s IP regime and also India was included in the US priority list. Since then the Indian IP regime is under huge debate among the developed nations and also been the party to the complaint by US in WTO. Now the question arose that time that India abused its rights under TRIPS but India only exercised the right of having flexibility under Article 31 TRIPS in the respective National Legislation. The biggest achievement under the order was that the cost of the drug was brought down from almost 3 Lakh to only 8 thousand required for one month of treatment. No doubt the object of the decision was to benefit the masses in comparison to the individual interest following utilitarian approach.

Impact of Compulsory Licensing
The very impact that could be guessed just after the decision was the lowering of the process of the drugs similar to Nexavar in nature to escape the grant of compulsory license on them too. It was very much evident that many companies brought the rates of the medicine to a low rate and also an active role of Department of Industry & policy in bringing the price of such drugs in control. The very second impact was also visualized that there will be more cases of compulsory licensing by different other generic companies against the different companies having patent over such medicines in India. It happened too. Soon after the order and pendency of the case by Intellectual Appellate Board a new application for the grant of compulsory was filed by BDR Pharmaceutical International Ltd for the drug DASATINIB manufactured and sold by Bristol Mayers. BDR Pharmaceutical stated that the price of each tablet sold by patentee is INR 2761, which will further will be calculated, as INR 1,65,680/- for 60 tablets for 1 month as tables is required to be taken twice a day as per the prescription. BDR pharmaceutical further claimed to sell the same medicine for INR 8100 for 1 moth of treatment.

Researcher just wants to focus on the facts that the objective of policies adopted by developing countries in dealing Intellectual Property is to maintain a balance between the interests of the stakeholders and consumers. Lessons have been learned that until such balance is not achieved it will act as hindrance to developments on any nation which is the prime objective of millennium goals by UN.

Bibliography and References

All the content is authors own analysis with experience in the relevant subject matter