Impact of Pharmaceutical Patent on Healthcare Sector in India



Intellectual property rights, or IPRs, are the rights that individuals have to protect their ideas, creations, inventions, and other forms of intellectual property. Creators are granted exclusive rights and financial benefits by these rights, which are essentially viewed as the property of the creator. This exclusivity both encourages others to concentrate on creating unique ideas or artwork and serves as a reward for their artistic endeavours. Monetary gain from these rights is restricted to the original creator or those duly authorised. The main goal of IPRs, is to reward creators and innovators with the temporary exclusive right to use their creations for commercial purposes. Encouraging innovation while protecting the creator's right to profit from their creation is the goal of this limited authorization.

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Pharmaceutical Patent

One unique feature of Indian patent law is Section 3(d) of The Patent (Amendment) Act, 2005. Maintaining access to medications, particularly for those from families with low incomes, while also adhering to the requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is accomplished successfully. India is now a leading country in the pharmaceutical sector because to this unique provision. After the TRIPS regime was put into effect, there have been significant changes to the dynamics within the pharmaceutical industry. The importance of pharmaceutical patenting in India is especially noteworthy when considering current public health concerns. India is a key supplier of affordable pharmaceutical products, especially in the form of generic pharmaceuticals, thanks to its sizable market and pharmaceutical companies. India's involvement in this subject acquired prominence with its participation in the 2001 Doha Declaration on the TRIPS Agreement and Public Health. The world has been concerned about access to medicines for more than a millennium. India has become the centre of attention for the worldwide movement supporting access to medicines, mostly due to its established and more export-oriented pharmaceutical sector and increased public awareness.

Evolution Of Patent Laws In India

Inventions are protected by the grant of patents. A patent is an exclusive right granted by the government to the person who files an innovative application. The inventor may file for a patent, as can any other individual or company they want. It is the right to stop others from developing, using, putting up for sale, importing, or selling the innovation without permission.

Patent Laws Under The British Rule

India approved its first patent laws in 1856, during the British colonial era, which ended in 1947 with the country's independence. Pharmaceutical items were always eligible for patents, even if the rules governing patents altered over the colonial era. Foreigners received the majority of the patents issued during this time.

Patent Laws After Independence (1947-1995)

The Patents Act of 1970 eventually came into effect in 1972. In an effort to support domestic inventions and ensure their commercial production in India, the Patents Act of 1970 placed severe restrictions on patent rights. First and foremost, medicinal items were not eligible for patent protection. Second, businesses could only patent one method of producing pharmaceuticals; they could not suppress competition by obtaining patents for every possible way to make medicine. Third, the fourteen-year period for patents pertaining to pharmaceutical processes was shortened to five years from the date of filing or seven years from the date of patent issue, whichever came first.

Post TRIPS Patent Laws In India

In 2002, India modified its patent laws to conform to the TRIPS agreement. After the transition period is over, all inventions—including patents for pharmaceutical products—would have a 20-year patent term. Additionally, additional wording about necessary licences was added in these modifications. In the event that the innovation is not developed or manufactured in India, does not satisfy the reasonable needs of the public, or is not reasonably priced, an application for a compulsory licence may be submitted within three years after the patent's issuance. Furthermore, when a public health emergency is declared by the government, the product may be used for non-commercial purposes in the public interest, or the product is intended for export to a nation whose manufacturing capacity is inadequate to address public health concerns, the law mandates an immediate, compulsory licencing.


Various perspectives appear to exist concerning its impact on the pharmaceutical industry in India and the availability of sufficient pharmaceutical items within and outside the country. India comes in at number four in terms of manufacturing volume, thanks to a huge number of pharmaceutical corporations. Even while patents for pharmaceutical drugs are a crucial component of the innovation system, the patent system as a whole can be confusing to those who lack knowledge of it. Drug companies routinely overcharge for patented goods and misuse their patent monopolies. The advent of product patents has reduced the accessibility of medicines. Currently, the majority of generic drugs, including vaccines, are patented in India, which makes it challenging for the pharmaceutical industry to develop necessary, life-saving drugs. Because prescription medicines are so expensive, ordinary people cannot afford to acquire medication, which is contrary to the state's assumption that it will protect its citizens' health. Particularly in India, where a sizable section of the populace still lives in poverty and health care costs are extremely high, it is clear that there is an immediate need for medication due to the shortage, high cost, and restricted availability of such supplies.

Government Policies to Regulate the Prices of Pharmaceutical Products in India

India has an extended history of imposing price limits on pharmaceuticals and their formulations. The Defence of India Act led to the introduction of the first price control order in 1963. Following that, price control orders were issued in accordance with the Essential Commodities Act, 1970. In order to safeguard customers and guarantee a limited but acceptable profit margin for producers, the Drug Price Control Order (DPCO) was enacted in 1970. This measure, which took effect in 1970 together with the removal of product patents, signalled the start of an era in which medicinal costs in India decreased. Unfortunately, intellectual property rights were compromised in order to achieve this affordability. A new balance that reduced producer returns in favour of greater access to pharmaceuticals was also adopted by the policy change, which aimed to safeguard consumer interests.

In 2005, the government unveiled a new pharmaceutical policy that called for adding 354 additional drugs to the National List of Essential Medicines (NLEM) and putting them under price regulation. Prior to receiving marketing approval, it is also suggested that patented drugs be the subject of price negotiations. For this, a pricing reference system based on the standards of other "comparable" nations will be developed.


Indian patent laws are seen as examples since they aim to reconcile the rights of creators with the interests of the public at large. A vast range of pharmaceutical items can now be granted patents in India as a result of the implementation of the product patent rule. This adaptability also applies to the transfer of patent rights, which can be granted and then assigned or licenced to different people or companies. Patents can be assigned or licenced, which is an effective means to transfer technology, especially for companies who don't have enough resources for marketing or manufacturing. In this sense, patents are an important tool for safeguarding the rights of inventors as well as promoting the sharing and exchange of technology across commercial sectors. However, circumstances change when it comes to prescription drugs that are necessary for almost everyone's health. In these situations, the country has the difficulty of achieving a positive balance. This entails figuring out how to leverage patent rules to encourage pharmaceutical companies to innovate and create novel treatments for diseases that are now incurable. In addition, it is critical that patients have access to these essential medicine combinations without experiencing financial hardship in order to protect their own finances as well as the financial resources of state and federal budgets.

Author : Chirayu Kshirsagar, in case of any query, contact us at Global Patent Filing or write back us via email at

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