Managing Intellectual Property Rights in Indian Pharmaceutical Companies -Innovative Techniques for In‑House Legal Teams

The pharmaceutical sector in India is a high‑rewarding sector where protection and management of intellectual property rights (“IPR”) is imperative to maintain novelty, profitability and competitiveness in the market – and mitigate risks of infringement and dilution of ones IP. 

Protection of IPR provides fair incentives to innovations, helps prevent potential IP infringement and enables inventors from defending infringement cases. Specifically in the pharma sector, the process of identifying ones IP, protecting ones IP and commercialising the asset provides exclusive rights to inventors of life-saving drugs to market their products openly, reap profits from their R&D efforts and also prevent others from unauthorized manufacturing or sale of these products.

IP protection in the pharmaceutical sector holds significant importance, as it provides commercial advantages and also holds public health considerations. Some key ways in which the Indian pharmaceutical industry can effectively manage its IPRs are outlined below 

1. Patent registration

It is imperative for pharmaceutical companies to obtain a registration for its novel drug or medical equipment or process. For obtaining a patent, the drug/ equipment/ medical process must be novelty, inventive and have industrial applicability. [1]A patent registration encourages inventors by maintaining exclusivity and reap the benefits of their investments in research and development. Moreover, registration of patent is required for consumer safety since it enables customers to make informed decisions, maintains quality control over infringed drugs, and ensure that the market is clear of fake, infringed drugs and medical equipment/ processes.

For successful patent registration, companies should draft patent claims clearly specifying the inventive step and sufficient disclosure to withstand obviousness scrutiny. In-house counsels must prioritise early filing for core molecule patents, then file robust, technically substantive secondary patents. At the R&D stage, companies should maintain documentation to describe the journey of the invention.

2. Trademark registration 

Per the act, a trademark should be devoid of generic, descriptive or suggestive terms. Achieving this is particularly difficult in the pharma sector given that pharma manufacturers would like to specify the salt composition of the drug, a medical term related to the drug or the treatment performed - however these are prohibited under the Trade Marks Act, 1999 (“Trade Marks Act”)[2]. Moreover, inclusion of chemical elements and compounds is also prohibited under the Trade Marks Act, 1999 (“Trade Marks Act”)[3]. 

Therefore, companies must focus on picking a brand name that is not only catchy and easily memorable for consumers, but is also capable of registration under the Trade Marks Act. A successful trademark registration adds tremendous value to a product in the market.

3. Protection of undisclosed Information

Undisclosed information encompasses trade secrets and confidential information such as drug formulae, drug patterns; compilation of related data; details of a medical equipment; and the method and technique of a medical process, to name a few. 

The Delhi High Court in the case of American Express Bank v. Priya Puri, trade secret is information which, if disclosed, will cause real or significant harm to the owner. Any type of information can be protected as a trade secret, with the only criterion being that the information has potential economic worth and that the owner took reasonable steps to keep it secret.

India doesn't have a single written trade secret law, but a mix of common law, contract law, and equity are used to build the framework. Trade secrets are protected via criminal proceedings under the Companies Act, 2013 and the Information Technology Act, 2000 as well as action under the Indian Contracts Act, 1972. Additionally, obligations through non-disclosure agreements, restricted access to information, partnership agreements, employee confidentiality clauses, etc remedy trade secret theft by way of injunctions, monetary damages and return of confidential material.

4. Patent Pools, Cross‑Licensing and Pro‑Active Licensing Models

Flexible licensing models such as Patent pools, wherein multiple patent holders agree to license their technologies as a package, Cross-licensing whereby companies exchange IP rights in complementary technologies, Field-of-use licences that license limited technologies, such as specific therapeutic areas; Royalty-stack management whereby  a licensee is bound to pay royalties to multiple licensors in order to commercialise an end product, and Non-assert covenants, that sets conditions under which an IP holder commits to never enforce their IP rights against certain parties.

5. Compulsory Licensing and Public Health Options 

For Indian pharmaceutical companies, a strategic understanding of compulsory licensing (CL) mechanisms under the Patents Act, 1970, is essential for effective IP management. Compulsory licences, which allow third parties to manufacture a patented product without the consent of the patent holder under specific conditions—such as public health emergencies or unreasonable pricing—play a crucial role in balancing innovation with access to medicines. In-house legal teams should proactively analyse the circumstances under which CLs may be invoked, both domestically and internationally, to anticipate potential risks and opportunities. Being well-versed in these provisions can strengthen a company’s bargaining position during licensing negotiations, technology transfer discussions, and collaborations with multinational partners. Moreover, engaging constructively in policy dialogues on CL frameworks enables companies to shape a fair and predictable IP environment. By integrating CL preparedness into overall IP strategy, Indian pharma firms can safeguard innovation while aligning with public interest imperatives.

Evidently, safeguarding a company’s IPR is a multifaceted task that requires strategic planning and proactive management. The IPR management methods specified above require pharmaceutical in‑house legal teams to blend successful IP registration, active prosecution, vigorous enforcement as well regulatory strategies such as trade secret governance, flexible licensing and selective litigation. These efforts, as has been proven via several real‑world examples have time and again demonstrated that IP protection and enforcement is indeed the most valuable investment in a business to protect revenues and expand its markets.

This Content is originally posted on: https://www.maheshwariandco.com/blog/intellectual-property-in-indian-pharma/