Balancing Innovation And Access: A Comparative Analysis Of Pharmaceutical Patent Regimes In The United States And India
- IJLLR Journal
- May 7
- 2 min read
Aanya Singh, Amity Law School, Amity University, Noida
ABSTRACT
A regulation of the patent rights over the medicines represents one of the most complex issues in intellectual property law due to its nature, which involves an intricate balance of stimulating innovations on the one hand and ensuring the availability of necessary drugs on the other. This research paper will examine the approaches applied in regulating pharmaceutical patents in the United States and India through the use of comparative analysis.
The analysis of the issue at hand will be conducted via the doctrine-based comparative methodology, relying on the examination of statutory provisions and court decisions. In the case of the United States, the pharmaceutical patent system represents a very sophisticated combination of patent monopolies, regulatory exclusivities, and litigation mechanisms provided for under the Hatch-Waxman Act and other legislative frameworks. While the system stimulates investments into pharmaceutical research and development on a high level, it can also be associated with several negative aspects, such as "patent thicket" and evergreening.
In the case of India, the public-oriented approach has been adopted with a number of instruments being provided for the prevention of patent abuse, including compulsory licenses and Section 3(d). Despite its effectiveness, this system is also associated with some issues, namely, the problem of low innovativeness and legal certainty. According to the analysis results, the difference between the two models is determined by the different approaches to the regulation of pharmaceutical patents, which are not sufficiently sufficient individually.
Thus, the introduction of a hybrid pharmaceutical patent system becomes critical for facing future problems in the area, including data-driven research and biologics.
Keywords: Pharmaceutical Patents, TRIPS Agreement, Evergreening, Section 3(d), HatchWaxman Act, Compulsory Licensing
