By, Saransh Chaturvedi


The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which formed part of the Agreement Establishing the World Trade Organization, established a minimum level of protection with respect to various forms of Intellectual Property Rights. The varieties of provisions in WTO have given rise to various Free-Trade Agreements (hereafter, FTAs) for the purpose of enhanced trade regime. There are various provisions which take the route of these FTAs to enter the domestic market. One of the prominent provisions is that of Patent Linkage. The concept of Patent Linkage (hereinafter, Linkage) lies in this very domain. This concept takes into consideration two bodies. One is the regulatory body which grant the market access to the pharmaceutical industry (hereinafter, Industry) and other is the patent office which grant the patent rights to the patentee. The whole concept of Linkage deals with the link between these two authorities. This linking helps the two authorities to work in consonance. Therefore, under this process, the regulatory authority, before granting the market approval, will take into consideration the patent office. Now what this linkage aims for, is to protect the right of the patentee. If the regulatory authority, through the patent office, got to know that there is a patent already in existence and the patent term has not been expired, then the regulatory authority can refrain from providing with the market approval to the industry or until the consent has been taken from the patentee.

Very interestingly, the concept of the Patent Linkage is not even defined in the TRIPS Agreement and it is left to the Domestic Countries to regulate the same. Article 28.1(a) states “where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product”. Also one article that deals in this domain is Article 39.3 which says Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.

In the United States, the concept of Patent Linkage is statutorily mentioned in Drug Price Competition and Patent Term Restoration Act, a major amendment of the Federal Food, Drug and Cosmetic Act, enacted in 1984. This legislation is commonly known as the Hatch Waxman Act. Through this the US publishes the Orange Book which contains all the approved drugs in the US which are having the same Therapeutic Evaluation. Through this, the Food and Drug Administration updates the list of all the drugs and provides the exclusivity information and all the industry while filing for the Abbreviated New Drug Application must show which drug has been used and what is the expiration of the same. If there is any infringement then the FDA can also grant a stay over the approval for 30 months, if within 45 days the patentee submits the infringement. After 30 months the FDA is free to grant marketing approval of the generic but if the rights holder’s litigation subsequently succeeds, the generic may be removed from the market and will be required to pay damages.

In EU, the domestic law which deals with that of Intellectual Property and its varied interpretation is named as Bolar Provision. Too much surprise, the European Union does not have a system of patent linkage. There were instances where various industries have tried to introduce such provision but they failed and even in a 2006 press release, the European Generic Medicines Association had stated that patent linkage is contrary to EU regulatory law as it undermined the Bolar provision, which sought to encourage quick access to the post-patent market for EU generic medicines.

In the domain of patent linkage, some of the important agreement we have, such as US Korea Bilateral Agreements, the Trans-Pacific Partnership Agreement and also the latest RCEP, Regional Comprehensive Economic Partnership. Mostly, those agreements which had US on either side, the Patent Linkage has been taken into the clause. In almost all IP law jurisdictions, the protection is provided to the IP holder that if in case of infringement the IP holder can bring the suit against infringement provided under the law. Even in USA, the same clause is available, provided the IP holder has to demonstrate the nature of infringement before any injunction if granted. Meaning thereby, that the even in the absence of the Linkage clause, there are sufficient rights to the patent holder to seek an injunction.

If this was the case, still what was the need to insert this clause in the FTAs? The pharmaceuticals industry often alleges inadequacy in measures to affect potential infringer which ultimately. Why this clause is generally added to the agreement might also be because this shifts the onus of regulating the infringement from the patent holder to the authority. As already mentioned that linkage is nowhere mentioned in TRIPs, this often purports to be a new regime in TRIPs mainly TRIPs Plus provisions, mostly advanced by USA.

The US- South Korea Free Trade Agreement, commonly known as KORUS FTA, was one of the examples where due to this agreement; South Korea changed their domestic Laws to insert the notion of Patent Linkage. Eventually Trans-Pacific Partnership was also the proposed agreement which did not come to force primarily due to USA’s withdrawal. The remaining members re-negotiated the draft and entered into new agreement known as Comprehensive and Progressive Agreement for Trans-Pacific Partnership. USA wanted to have a robust IP Law mechanism which included Linkage also to which no consensus was made. Similar was the case of recently debated agreement of Regional Comprehensive Economic Partnership, RCEP. India put itself out of it. One of the reasons to not enter in this was Patent Linkage. India’s contention, against putting up with this Linkage mechanism was due to less development of IP law in various countries including India too.

The proliferation of Linkage mechanism giving route to TRIPs-plus provision must be seen in three dimensions. Firstly, the impact on Domestic Market must be assessed. Secondly, the impact on Global market must be ascertained. And thirdly, rather going on to the TRIPs-plus, there must be research over new avenues of TRIPs. Instead of only coming up with TRIPs-Plus, the country must delineate them and move onto the new areas where the interest of both the developed and developing country is maintained



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