Despite official claims on the contrary, the Trade and Economic Partnership Agreement (TEPA) signed by India and the four country bloc that consists of Switzerland, Norway, Iceland and Liechtenstein on Sunday may dilute the spirit of the public interest clauses provided within the existing Indian intellectual property (IP) laws, patient and public interest groups fear.
They point out that the IP provisions in the agreement's annex, the power to prima facie reject patent oppositions on the vague ground by the patent office undermines pre-grant opposition provision under the existing law - a public health tool used by patients to challenge evergreening patent claims. These provisions, included in the draft patent 2023 amendment rules were criticized by patient and public interest groups they say.
Another concern of the groups is related to the need to share information about the working of the patent in India. "Since patents are a social contract – monopoly In exchange of working the patent, the legal requirements to work the patent are important. However, the IP text undermines the requirement for providing data annually on the working of a patent on medicines and in the name of confidential information tries to curtail information on licensing and other aspects that are needed to assess whether a patent is being worked. Currently, mere importation is not sufficient under Indian law to meet the requirement of working of a patent and also includes a test based on whether the needs of the public have been met at a reasonable price, and whether it is licensed and manufactured in India," says Leena Menghaney of Medicines Sans Frontiers (MSF).
The IP annex of the agreement permits the member countries to adopt enforcement measures at a level that is beyond what is provided in the TRIPS Agreement. Menghaney says this provision requires more analysis as it could lead to impacting judicial discretion, heightened damages against generic manufacturers and promoting interim injunctions at the cost of access to medicines for patients who cannot afford the patented medicine.
The decision to set up a Joint EFTA-India Committee comprising senior government officials under the agreement to consider the possibility of further removal of barriers to trade and other restrictive measures concerning trade between the EFTA States and India has also been highlighted by the civil society groups as a potential way of putting continuous pressure on India to make further changes in EFTA bloc's favour.
The partner countries however, consider the joint committee mechanism as an important tool to assess the implementation of the agreement as TEPA also involves an investment commitment worth $ 100 billion to India from EFTA nations and the creation of 1 million jobs in India by those countries in the next 15 years as part of the agreement.
