Patent linkage is a system or process by which a country links drug marketing approval to the status of the patents corresponding to the originator’s product. Patent linkage is the establishment of relationship between market approval process of generic drug and the patent status of the originator product. It drawn the requirement of not allowing the grant of marketing approval to any generic drug manufacturer prior to the expiration of the patent term or determination by the competent authority that the patent will not be infringed or is invalid unless by consent of the patent owner. The most important part is that the obligation is placed on the applicants applying for marketing approval to prove that the drug is not protected by a patent. There is an obligation on national regulatory authorities to prevent the registration and marketing of a generic pharmaceutical in case the drug for which approval is sought is patented. It prevents the authorities from granting regulatory authorization to generic medicine where there is believed to be a relevant patent in existence.

Basically, patent linkage is the practice of linkage of drug marketing approval to the patent status of originator’s product and not allowing the grant of marketing approval of any third party prior to the expiration of the patent term unless consented by the patent owner. It is essential to obtain marketing approval from the drug regulator of their respective countries. The concept of patent linkage is very essential for the generic manufacturer to prove that the drug regulator that the drug, for which he seeks approval, is not covered by a valid patent.



The member countries required to follow the provision of World Trade Organization Trade Related Intellectual Property Rights Agreement[1] 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”[2]

Article 28 along with article 39.3[3]of TRIPS agreement provide some member states construe it to introduce the system of patent linkage. The concept of patent linkage fall under the scope of ‘TRIPS Plus’ concept which means that any intellectual property agreement negotiated subsequent to TRIPS among involving WTO members which can only create higher standard. 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.


The laws of the United State of America provide various provision of Patent linkage. Under the US laws, the Food and Drugs Administration grants marketing approval for pharmaceutical products. The Hatch-Waxman Amendments to the Federal Food Drug and Cosmetic Act in 1984 statutorily makes provisions for patent linkage. An Orange book is maintained by Food and Drug Administration which contain list of approved pharmaceutical drug production with therapeutic equation equivalent. The main function of the Act 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.


European Union does not support the concept of patent linkage. According to the European Generic Medicine Association the 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. Bolar provision was constituted with the mindset of speeding up generic entry into the market so as to provide with the availability of low cost drugs to the consumers. It permits any drug manufacturer to experiment with any patented drug, with a view of generating data that could be submitted to a drug control authority. The status of a patent application is not a ground for refusal, suspension or revocation of attaining marketing authorization.


In India marketing approval of pharmaceutical drug approved by Drug Controller General of India under the provision of The Drug and Cosmetic Act, 1940. The main function of Drug Controller is to look into whether the drug is fit for introduction into the market. The concept of patent linkage makes it essential for the generic manufacturer to prove to the Drugs Controller that the marketing approval seeked for their drug is not covered by a valid patent. This system of patent linkage is recognized in the United State and some other countries have not been expressly recognized in India by the legislature. Recently Delhi High Court provide a judgment that the patent linkage cannot inferred from the provision of Drug and Cosmetic Act, 1940[4].



Bristol-Myers Squibb vs. Hetero[5] Drug Ltd.

The US drug market, Bristol Myers Squibb Co. secured an ex-patre injunction from Delhi High Court on 19th December 2008 to preventing India’s drug regulator from approving an off-patent version of its cancer medicine ‘Dasatinib’the patented by Bristol Mayer in India is sold under the brand name sprycel and is prescribed for chronic myeloid leukemia. The Delhi High Court stayed Hetero Drug Ltd. Which had sought approval of marketing ‘Dasatinib’ from making, selling, distributing or exporting the medicine. The Court also stopped the drug controller from proceeding with hetero drugs application for approval of its generic version of medicine. The court observed: “It is expected that the DCGI while performing statutory functions will not allow any party to infringe any laws and if the party the drug for which approval has been sought by the defendant is in breach of the patent of plaintiff’s approval ought not to be granted to defendant.”


Bayer v/s Cipla and Union of India&Ors..[6]


Indian patent office had granted a patent bearing number IN 215758 which covered Sorafenib tosylate. Bayer, the assignee of the patent filed a writ petition restraining DCGI from granting a license to Cipla “to manufacture and market, to imitate/ substitute sorafenib tosylate protected under this patent”. A further request was for a direction to Cipla to furnish an undertaking that the drug for which it has made an application before DCGI was not an imitation of or a substitute for Bayer’s patented drug “sorafenib tosylate” and consequently would not result in an infringement of subject patent. Further Cipla’s product was said to be a spurious drug under section 17 (b) and DCGI would exceed its jurisdiction in granting marketing approval to Cipla’s generic product. It was contended that since it was known at the time of Cipla’s application for marketing approval that Bayer held patent for Sorafenib tosylate, DCGI was under an obligation, flowing from collective reading of Section 2 of Drugs and Cosmetics Act (DCA) and Sections 48 and 156 of Patents Act, to decline Cipla’s application for marketing approval for Soranib.


The court rejected Bayer’s arguments and confirmed that there is no ‘patent linkage’ regulation in India. Parliament has not intended to link the two legislations. Further, an explicit legislation is required for patent linkage. DCGI can grant marketing approvals under DCA to generic versions of patented drugs. Determination of patent infringement is exclusive jurisdiction of Courts and this adjudication is beyond jurisdiction from DCGI. The court also rejected spurious drug argument stating if Bayer’s contention were to prevail, every generic drug would amount to be ‘spurious drug’.

Merk vs. Glenmark, 2013

This case is challenging the sale of generic diabetes drug, Januvia seems to have revived an oft-repeated demand by MNCs to link marketing approval of product to its patent status.

Mark subsidiary, MSD India had demanded an injunction order in the Delhi high court against the sale of generic Januvia launched by Glenmark. The plaintiff stated that it infringed the intellectual property right. The company seeks to block the sale of generic Januvia on the grounds of valid patent. Industry expert says that “patent linkage demand by MNCs seems to have been revived after the interim order of Delhi High Court in this case.”



The system of patent linkage in India creates various problems. It creates problem if national patent office grant low quality patent. Regulatory agencies may not be competent enough to determine validity and relevance of patents. This adds burden on them. Legally, only a court or tribunal, depending on a country’s law, can decide whether there is a patent for that particular medicine. The task of the regulatory bodies is to verify whether a medicinal product is safe, effective and of good quality. Their main function is to ensure that the pharmaceutical products reaching market are not harmful to public health. Other factors, such as the patent status of product, should therefore not be taken into account when assessing risk/benefit balance of medicine. Regulatory issues do not fall within the scope of definition of infringement. A generic medicine imported or manufactured under a compulsory license may not be able to get registered until the patent has expired.



If India implements the patent linkage regulation, then the system should make a balance of the interest of public health, domestic, pharmaceutical industry and multi-national pharmaceutical industry. It would be possible to make a balance in the system to protect interests of both Innovators and Generic industries. DCGI can list all new applications on its website. An aggrieved originator drug firm can track this database and move court if it apprehends that a generic product, for which a drug approval application has been filed, is likely to infringe its patent. Do note that originator would only be able to prevent introduction of a generic drug in the market not stop the drug regulator from processing application of the generic or even granting approval. The innovator can ask the court to declare that the generic product, if introduced, would infringe its patent. If court finds a prima facie case that the patent is valid and would be infringed by introduction of the generic product, it can issue a declaration to this effect. Importantly, issues of patent infringement can be decided solely by courts and DCGI is thus not involved.

[1] TRIPS Agreement

[2] Article 28.1(a) of TRIPS agreement

[3] which deals with protection of undisclosed information

[4] Bristol-Myers Squibb vs. Hetero Drug Ltd. 2009(41) PTC (Del)

[5] 2009(41) PTC (Del)

[6] August 2009


Article Written by: Aabha Saurav, Campus Associate at Legal Desire


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