Over the past years, the developing, as well as developed States, have come forward with various new initiatives for strengthening the existing IPR regime. The stringent cover of IPR was initially made applicable in order to promote the domestic interest of the Nation. Accordingly, the concept of MFN (Most Favored Nations) and National Treatment was brought into existence to benefit Free Trade Agreement entered at regional, bilateral, and multilateral contracting Nation parties without any discrimination to promote their domestic interest first. The concept of FTA was adopted with an objective to water down impediments to imports and exports. Nation parties come together for various trade-related aspects in the global village to foster their economic growth.
INTERPRETATION OF TRIPS AND FTA
- The liberal reading should be given to all FTA in nexus with TRIPS so that no conflicting situation can blossom. Article 31-33 of the Vienna Convention on the Law of Treaties (VCLT) lays down rules to facilitate liberal interpretation of the international treaties. Whether or not, such flexible interpretation between TRIPS and FTA is possible, is very circumstantial. However, there may be certain TRIPS-plus treaties also in the form of FTA, which restricts what has been allowed by the TRIPS.
- Concerning TRIPS, choosing a narrow or wide understanding of conflict is particularly relevant. Under the narrow approach, extra Intellectual Property protection flowing from FTAs, whose application does not necessitate the violation of a TRIPS obligation, constitutes no conflict. Under the wider approach, a TRIPS-plus rule in FTA may be in contradiction with an optional TRIPS provision as soon as it limits the ability of a WTO Member to exercise a ‘right’ or flexibility TRIPS provides for. If in such a situation TRIPS were to prevail, it will make TRIPS flexibilities unavoidable and untouchable i.e., almost as nullify rights of WTO Members, which cannot be taken away.
- The main core of the international IP regime, which governs the relationships amongst different agreements addressing the same subject matter, is that of ‘minimum standards.’ In principle, the subsequent treaties can build up extra protection for IP, but might not curtail the protection provided in previous treaties. In the second sentence of Article 1 (1), TRIPS address this issue of additional protection. However not in relation to (subsequent) international agreements, but to the domestic IP laws of WTO member States. The second sentence of Art.1 (1) TRIPS authorizes member nations to grant more extensive protection than the required by TRIPS, with the qualification that such protection ‘does not contravene the provisions of the Agreement.’ Hence, taking TRIPS provision for a ride should not be allowed for furthering TRIPS-plus FTA.
- Ostensibly, the new set of IPR policies poses threat to public health/welfare in terms of eliminating the relaxations given under the regime of TRIPS. However, the US has responded to this by claiming side letters in the FTAs contain a waiver for public health purposes. Like the US–CAFTA–DR letter which says that the obligations that were put in the FTA do not affect the ability of either Party to take requisite measures to protect public health from promoting access to medicines for those in need, in particular, the concerning cases like HIV/AIDS, malaria, TB and other epidemics diseases, as well as circumstances which are of national emergency. Also, FTA does not preclude the effective use of the TRIPS or health solution. While the USTR claims that the side letter will have interpretative value and that ‘the United States has no intention of using dispute resolution to challenge any country’s actions that are in accordance with that solution’, such statements cannot be sole to be relied upon as side letters are not the part of the actual context and therefore will likely carry little legal weight in a dispute settlement proceeding. In any event, the side letter lends itself to interpretative complexities, as some disagreement may still exist as to what is a ‘TRIPS/health solution’. Thus, the US could still use pressure partners to submit to its understanding or initiate dispute settlement proceedings for clariﬁcation of the understanding among them.
THE PRESSURE EXERTED UNDER THE UMBRELLA OF TRIPS PLUS TO SIDELINE TRIPS
- On many occasions, sincere efforts have been made to allow patenting of substances that might create a threat of evergreening of the pharma products by slight molecular modification, in absence of improved therapeutic effect over medicines.
- Sometimes TRIPS-plus provision leads to the monopoly in favour of patent holders, by erecting walls for the generic companies to enter into the market. Several Nations have unjustifiably used the weapon of FTA to increase patent protection beyond 20 years.
- Patent opposition act as a tool to stop bogus patent applications that do not fulfil the requirement of national legislations. Some FTA parties try to suppress the ability of pre-grant opposition. E.g., the US-Bahrain FTA under Article 14.8 (4).
- In the past, various concluded FTA’s has overreached the minimum standards prescribed by TRIPS. “A practical example of how increased intellectual property enforcement can impede treatment access is the seizure of essential medicines from India to various developing countries including Mexico, Brazil etc. Infect, the same was done by European customs authorities on an average 17 times, while in transit, through the EU in the year 2008- 2009. The seizures took place on the suspicion that medicines violated a fictional patent and/or trademark rights even though the medicines were lawfully produced in India and could be lawfully sold and consumed in destination countries.”
- Article 39.3 of the TRIPS Agreement has never mandated test data exclusivity but it protects undisclosed data’s unfair commercial use. Many recent FTAs carries a provision for patent registration linkages, to preclude approval to new medicines by the national drug regulatory authorities when they can infringe existing patents. Consequently, national authorities may be reluctant in registering new medicines, even in absence of concrete evidence of a violation of the patent in question. Such instance will have a negative impact on public health. The negative impact of patent linkage was established in Nations with high HIV cases, like Ukraine.
We must calibrate the impact of robust FTA on the Indian Territory. India is a signatory member of the TRIPS. It has to follow the minimum threshold set by TRIPS. It may not afford to deviate from these standards.
- If we take of glimpse of the EU and India FTA, the EU persuaded India, under Article 2 (2), to embark on the protection of non-original databases. Seemingly, the same was rejected by the Indian Govt. because the sue generis protection of such databases (contained in directive 96/9/EC of the European Parliament and of the council of 11th March 1996 on the legal protection of databases) gives birth to such rights that may act as an obstacle to access to knowledge in the public domain. Article 8(3) expects India to give patent insurance to databases. It has been learnt that India as of now gives copyright security to PC programs. Be that as it may, India must be constrained to give copyright assurance to databases as it will be a huge obstruction to the entrance to learning in people in general space, which is critical in a data-based society. Indeed, even the USA which is all the more ostensibly the most genius copyright and patent nation on the planet has not given patent insurance concerning databases. Through Article 11 (1), India is required to agree to different worldwide IPR traditions which India has not approved up until now. Contaminate, TRIPS don’t commit India to sanction the Rome Convention which was in presence before the TRIPS itself. Likewise, the WIPO arrangements thoroughly have not yet been approved by India.
- The issue of patent administrative endorsement linkage has as of late made basic reactions in many developing nations including India. The fundamental articulation of this issue is shown in many facilitated commerce assertions which incorporate the USA and critics generally view it as a TRIPS-in addition to commitment directed through bilateralism. Multi-level control is a typical wonder in the pharmaceutical division and diverse parts of medications are directed by unmistakable government bodies and services. The safety and adequacy parts of medications are observed by safety divisions and no Information and Communications Technology Law item is enrolled for advertising unless a recommended methodology is fastidiously taken after. Licensed innovation parts of a similar item are independently managed by the patent workplaces and these streams to a great extent work autonomously.
The review of the existing IPR state of affairs establishes that we must owe our allegiance to minimum standards find mention in TRIPS. The lacunas in the existing TRIPS needs to be overcome to lower down instances of developed countries exploiting developing and least-developed Nations for minting currencies out of IP protection. FTA needs to be in line with what was envisaged in Uruguay Round. Ambiguous TRIPS-plus agreements must be kept in abeyance till they amplify the common good of the global community.
Author(s) Name: Saksham Bhardwaj (Advocate, Supreme Court of India)