Patent Linkage in India- Present and Future

This article proposes to analyze the current status of patent linkage in India, in light of the Hon’ble Delhi High Court and Supreme Court’s judgment in the case of Bayer Corporation and Others v Cipla, Union of India (UOI) and Others^[1]. At the outset, the article explains the concept of patent linkage and proceeds to throw light on the existing system in United States and the European Union. It further reviews the judicial history of patent linkage in India and the reasons for not permitting the same. The paper concludes with the future of patent linkage in India outlining the pros and cons.

The system of ‘patent linkage’ refers to the practice of linking drug marketing approval to the status of the patent of the originator’s product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term, unless consented to by the patent owner^[2]. For a pharmaceutical drug to be introduced in the market, either by the originator company (i.e a company that invents a new drug, gets a patent, conducts clinical trials, and introduces the drug in the market for the first time), or by generic^[3] manufacturers (i.e those producing ‘bio-equivalents’ of the originator’s drugs), it is essential to obtain marketing approval from the drug regulator of their respective countries. The concept of patent linkage essentially requires the generic manufacturer to prove to the drug regulator that the drug, for which he seeks approval, is not covered by a valid patent.

The member countries are required to abide by the provisions of the World Trade Organization Trade Related Intellectual Property Rights Agreement (hereinafter referred as ‘TRIPS’), which under Article 28 ensures exclusive rights to the patent holder for a limited period. Article 28.1 (a) of TRIPS agreement reads as follows:-

“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 imposing for these purposes that product”

Reading Article 28 along with Article 39.3^[4] (which deals with protection of undisclosed information), some member states construe it to introduce the system of patent linkage. But it is not specifically covered under TRIPS. Patent linkage falls under the umbrella of ‘TRIPS Plus’ concept, this principle means that any intellectual property agreement negotiated subsequent to TRIPS among and/or involving WTO members which can only create higher standards.

The TRIPS-plus concept covers both those activities aimed at increasing the level of protection for right holders beyond that which is given in the TRIPS Agreement and those measures aimed at reducing the scope or effectiveness of limitations on rights and exceptions.^[5]

Patent linkage in United States

As under the US laws, the Food and Drug Administration (hereinafter referred as ‘FDA’) grants marketing approval for pharmaceutical products[6]. The Hatch-Waxman Amendments to the Federal Food Drug and Cosmetic Act in 1984 statutorily makes provisions for patent linkage. The FDA maintains an ‘Orange Book’ which has a list of approved pharmaceutical drug products with therapeutic equation equivalents[7]. The Act aims to allow speedier introduction of generic competition, increased rights for drug companies to recoup patent terms that had been shortened by clinical trials and regulatory delays, and a linkage system conditionally allowing registration of generic equivalents in the absence of patent claims.

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