Patent Linkage: A Marketing Approval Barrier Suffered By the Generic Drug Manufacturers

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Patent Linkage: A Marketing Approval Barrier Suffered By the Generic Drug Manufacturers, And Its Impact on Access to Medicines

Written By: Sreshta Satpathy


Under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights, access to vital medicines is a developmental concern for poor countries (TRIPs). The primary goals of any developing country’s public health strategy are to make medicines more accessible, affordable, and available (medicines and medications are used interchangeably in this work). Drug access is critical given that, after food, medication is the second-largest family expenditure, and it is paid out of pocket in these nations due to a lack of adequate public health systems. Many countries’ drug policies were established with this issue in mind. The difficult aspect is that pandemics have increased the demand for cost-effective medications in emerging and least developed countries. Previously, countries such as India have addressed this growing need by delivering low-cost generic pharmaceuticals to the world and assisting in the fight against pandemics. There is no necessity for WTO Member States to acknowledge this practice under the TRIPS Agreement. It does, however, ensure that one government agency does not undermine another’s attempts to offer effective patent protection. A successful linkage system reduces wasteful and unnecessary litigation by requiring third parties to assess whether their drug product is subject to a patent prior to seeking drug approval and ensuring that the drug approving authority does not approve the product until any patent issues are resolved. The purpose of patent linking is to provide a second layer of protection to patent monopolies.

What is Patent Linkage?

The practice of national pharmaceutical registration authorities “linking” marketing authorization – that is, the right to commercialize a drug – with the patent status of an originator drug is known as patent linkage. The most prevalent type of patent linkage bans the relevant registration authority from obtaining marketing authorization (i.e., registering a generic drug for sale on the market) while the drug is still covered by a valid patent. The registration authority’s examination is limited to determining whether the medication under consideration is safe and effective in the absence of a patent relationship. Simply put, without patent linking, a drug’s patent status has no bearing on the marketing approval process. The registration authority verifies the drug’s safety and efficacy, whereas the patent act establishes the patent holder’s rights. Of course, marketing authorization does not supersede patent rights in any way, and a generic pharmaceutical business would be infringing on those rights by bringing the drug to market while a valid patent is still active.

What is Generic Drug

A generic drug is a pharmaceutical that is designed to be identical to a brand-name drug in terms of dose form, strength, mode of administration, quality, performance characteristics, and intended use. Generic medications have the same active components as brand-name drugs and have the same strength. The pharmaceutical business that finds and markets a novel drug acquires a patent on it when it is first developed. The patent normally lasts for 20 years to allow the original company to recoup its research costs. A generic version of the medicine may become accessible when the patent expires. Generics are sold under the drug’s chemical name, or “generic,” and must fulfill the same FDA quality and efficacy standards as the brand-name version.

Situation in India

India’s patent legislation does not now allow for patent linking. With 20 percent (value) of all generics and 75 percent of the Indian market share, India’s drug business is one of the world’s largest. India’s generic exports are primarily destined towards the United States. In 2008, the Department of Pharmaceuticals launched a scheme called “Jan Aushadhi” (people’s medicine) shops to provide unbranded generic pharmaceuticals to the country’s poor people at a decent and cheap price. Until June 30, 2019, 5300+ “Pradhan Mantri Bhartiya Janaushadhi Kendras” are operational in 35 states and territories in the United States.  More than 900 pharmaceuticals and 154 surgical and consumables have been supplied under the “Bureau of Pharma PSUs of India” umbrella, spanning practically all important therapeutic areas. The primary goal of India’s Draft Pharmaceutical Policy, 2017, is to “make vital pharmaceuticals accessible to the ordinary masses at affordable pricing.” To achieve the policy goal, the government created a price-control system known as the National List of Essential Medicines.

 One of the primary themes of the 2017 National Health Policy is affordability. “Achieve the highest feasible level of excellent health and well-being for all Indians through a preventive and promotive healthcare orientation in all developmental initiatives,” the policy states. Without a thriving generic medicine business, these policy goals will be impossible to attain. The Pharma Vision 2020 initiative of the Indian government intends to make India a global leader in end-to-end medication manufacturing. By 2020, pharmaceutical exports are estimated to reach $20 billion, with a total market of USD$55 billion. India meets 20% of the global demand for generic drugs. It’s also worth noting that Indian pharmaceutical companies offer more than 80% of the antiretroviral medications used to fight AIDS around the world (Acquired Immune Deficiency Syndrome). Even 30 percent of the generic medicine market in the United States is supplied by the Indian business. Changes in global and regional policies will have a significant impact on the Indian generic business. There is a direct link between the cost of generic medications and their affordability. However, there is a conflict of interest between patented medicine makers and generic drug manufacturers, and patent infringement allegations are prevalent. The original drug industry is accused of charging high costs for their copyrighted pharmaceuticals, which are out of proportion to their investments. In India, the Madras High Court addressed this problem in the well-known Novartis case.

The Indian case of Bayer v Union of India examines the drug authority’s institutional inefficiency and power to investigate patent validity. Even in the United States, where patents are linked, the FDA is not authorized to examine the validity of patents. Furthermore, such authority is undesirable since it will lead to confusion between the two authorities and will unnecessarily postpone the introduction of generics. The lack of a legislative foundation and policy is the primary reason for India’s lack of patent linkage. Even if the patent linkage is established, countries like India will need to improve their institutional capacity.


In practically all countries, drug accessibility and availability are the primary goals of public health policy. The Indian Draft National Pharmaceutical Policy, 2006, for example, has as its goals ensuring accessibility, availability of pharmaceuticals at acceptable prices, and encouraging further research and development. There is currently no law in India that acknowledges patent linkage. As previously stated, the high court has already concluded that there is no patent relationship. If India implements patent linkage regulations, the system should strike a balance between public health, indigenous pharmaceutical industry, and global pharmaceutical business interests. Given the stakes in this debate in the Indian context, which include health concerns, the business of multinational companies, and the domestic pharmaceutical industry, deciding whether patent linkage regulation should be implemented in India or not is a difficult decision. However, a systemic equilibrium might be achieved to preserve the interests of both innovators and generic manufacturers.


Sreshta Satpathy - The Law Communicants

Sreshta Satpathy

Student at Adv. Balasaheb Apte college of Law , Mumbai 

I am 20 years old and I belong to Orissa. I’m currently a third-year student pursuing BLS LL.B from Mumbai University. I intend to pursue corporate law in the future.

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