The term patent was defined under the patents act, in the year 1970 and then it was amended thrice in the years 1999, 2002 & 2005. The main reason behind this amendment was to add the basic criteria and terminology of compulsory licensing under sections 84 & 92 of the patents act. As we all know that patent is a right that is granted for any sort of invention or creation whether it is made by thought or a product or even a process that raises a new technical solution into a problem. Patent rights are very important in our country because even though there are so many inventions in our country, they are not given basic rights which leads to less innovation by the creator. In this particular article, I am going to discuss the term compulsory licensing as well as the provisions governing it.
WHAT IS COMPULSORY LICENSING?
The term compulsory licensing under the patents act comes under sections 84 to 92 of the Patents Act. In simple terms, it can be defined as a sort of authorization that is given to a third party by the government which is in intention to create or use or to sell a product or any sort of model which has been granted patent. This provision works best against the patent holder because there is no permission needed to sell a particular product.
There are certain conditions which are needed to be fulfilled by the greater if the government wants to grant a compulsory license. India has granted its first compulsory license in the year 2012 to an Indian company known as Natco Pharma for its genetic production Nexa Var.
It was found that the particular production did not meet the criteria because of which it was unable to be sold as Market and the particular production was unsuccessful in India. The particular product was formed to cure liver and kidney cancer and the cost for that was 2,80,000 rupees. Therefore, in the year 2013, the government granted licenses to 3 important medicines which created a lot of progress for the country. Various sections speak about compulsory licensing under patents act as mentioned above such as section 84 where it is said that it is not important for a particular person to be the holder of the patent, he is just required to follow a few conditions after 3 years has passed from the day the patent was granted –
- If any of the requirements of the people are not met by the patented inventions.
- Sometimes particular inventions may be expensive and in that car, compulsory licensing can be granted.
- Similarly, if any patent has not been used or is unable to be used by people in India.
PROCEDURE FOR FILING COMPULSORY LICENSING
After the conditions have been met by the person opting for compulsory licensing a particular procedure is followed.
The first thing that comes under this is that a proper application has to be filed which consists of all the facts, evidence, as well as all other required aspects concerning the invention, after which a person who has been appointed to look after all the documents goes through it to find if everything is proper or not and only after being sure that the document is proper, he can grant the license of the particular patent. After this step if the controller is not satisfied with the application, then a notice is issued to the applicant stating that the application has been rejected for getting a compulsory license after getting the notice the applicant sets up a meeting with the controller, and during this time it is unto the controller’s discretion whether the license should be accepted.
- Lee Pharma v Astra Zeneca
In this particular case, Lee Pharma, a Hyderabad Based Indian Pharma Giant filed a compulsory license for a patent which was there for a diabetes management drug known as Saxagliptin prepared by none other than Astra Zeneca. But the main point which arose over here was that Astra Zeneca was not at all agreeing to the terms and conditions and hence a conflict of interest started among both of them. Therefore, so as to make this particular matter prima facie one, a case was filed in the court stating that the patent owner i.e., the respondent failed to respond within a reasonable period. There were certain grounds which were as follows:
The petitioner actually failed to meet the important requirements of the public, the invention was also unavailable at an affordable price and the invention was not at all used in the country.
In the end based on these grounds, the application filed for compulsory licensing of the drug was rejected by the controller. It was also rejected on the basis that it was not even proper with respect to benefit of the public and there was no sort of comparative requirement too.
- BDR Pharmaceuticals International Pvt Ltd v Bristol-Myers Squibb Co
In this particular case, a compulsory license application was rejected by the controller for the petitioner BDR Pharmaceuticals regarding a cancer treatment drug made by Bristol Myers Squibb Co. SPRYCEL. The application was rejected on the grounds that BDR failed to make a prima facie case which is required in order to grant the patent.
It is felt that there will be certain issues and problems regarding compulsory licensing in our country because of the fact the laws are not clear enough. The functioning of the Indian Patent office will bring more clarity and also it will decide the future of compulsory licensing in India.
The main reason why it has still not managed to get much importance is because of the economic condition of the people and also because our country needs to strictly comply with the rules of patent protection and safeguard public health at large. Though some people might find compulsory licensing to be a devil I feel that to some extent it is required and is the need of the hour as it will sort of help to protect the excessive use of the power provided to monopoly and help to keep the rights of humans safe, however, this remains a topic of debate that whether we require compulsory licensing or not. Also, it has been observed that compulsory licensing is almost a fairly new term to which people are yet getting used to there are certain places where it has left its impression such as in case of any kind of innovations or in cases of competition and cost also it has helped to impact the patients.
Author’s Name: Akanksha Chowdhury (Amity University, Kolkata)