Understanding the Patent Linkage Process
The denial of the market entry often concerns the access to essential and cheaper medicines and in a larger picture, the public health issue. The availability of generic drugs being subjected to any such preceding condition irrespective of any infringement does affect the larger issues of access to medicine. Patent linkage is perhaps one of the most debatable aspects of patent regulation around the world. Various countries have often tried to explain different ambits of patent linkage following the situation prevailing. The system of ‘patent linkage’ refers to the practice of linking the market approval of the generic product to the status of the patent of the innovator’s product. This way, the patent linkage has the involvement of two different authorities, one being the regulatory body which grants the market access to the pharmaceutical industry and the other is the patent office which grants the patent rights to the patentee. If there being an existing patent on the subject drug then the regulatory authority can refrain from providing market approval to the generic manufacturer as per the regulation.
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Free Trade Agreement & TRIPs
The US-South Korea Free Trade Agreement, commonly known as KORUS FTA, is one of the examples where due to this agreement; South Korea changed its domestic laws to insert the notion of Patent Linkage. Trans-Pacific Partnership is another agreement that did not come to force, due to US withdrawal primarily because the measures were inconsistent with that of US commitments of free and fair trade as notified by the US government. The US wanted to implement TRIPs-plus provisions which were countered by different developing countries on board. Consequently, the remaining members re-negotiated the draft and entered into a new agreement known as Comprehensive and Progressive Agreement for Trans-Pacific Partnership. Similarly, the Regional Comprehensive Economic Partnership (RCEP) too witnessed India’s walkover owing to the requirement of adopting TRIPS-plus provisions by countries. India rejected this requirement on grounds of under-developed IP laws of various countries, including India’s.
TRIPS provisions do not talk about any linkage regulation. The countries supporting this regulation, however, adopted a literal interpretation of the TRIPS agreement resulting in the TRIPs-plus regime, as mentioned above. In the TRIPs Agreement, if anywhere the rights of the patentee are elaborated; it is Article 28.1(a) which provides that “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 with 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. Also, Members shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data are protected against “unfair commercial use”.
Critique
Why this clause is generally added to the various agreements might also be because this shifts the onus of regulating the infringement from the patent holder to the authority. This way the authorities take the responsibility of a patent office to which they don’t have any expertise. This linkage also gives the power to the patent holder to have an injunction on the claim without evaluating the merit of the same. Even previous research has concluded that even in the US, this clause is moreover used in avoiding the competition among the products with the originator drug and delaying the very entry of generic drugs. Undoubtedly, pharmaceuticals companies will be the major supporter of the linkage framework to be adopted by countries, especially developing countries. If we try to analyze the economic perspective of this framework, most of the justification follows the tendency to respond to positive incentives and rewards. But these incentives must be ‘locked’ up at least ‘temporarily’, for the primary purpose of providing a net benefit to society, in the time of the pandemic.
The linkage framework will be inconsistent with the double benefits that pharmaceutical companies are getting with the prolonged market exclusivity for the drug. All scientific development is built upon a pre-existing knowledge and concept. This framework kills the substantial interest of the developing countries with weak IP regulations for their much-needed purpose of access to medicine. The automatic stay over the market approval is an unintended consequence of this regime. It is imperative to analyze two cases that are very important for this discussion. The Delhi High Court in the case of Bristol-Myers Squibb Co. vs. Hetero Drugs gave an ex parte injunction to Bristol, preventing the Drug controller to approve the generic version by Hetero, which created a lot of distress among generic manufacturer. In the 2010 landmark decision of Delhi HC in Bayer Corporation vs. Cipla, the court made it clear that patent linkage is impermissible in India.
Originally retrieved from – global patent filing
Author: Saransh Chaturvedi (Advocate, LLM (IIT Kharagpur) – an associate at Khurana & Khurana, Advocates and IP Attorney, in case of any queries please write back us via email at support@ipandlegalfilings.com or contact us at IP And Legal Filings.
