Patent Evergreening And Access To Medicines: A Legal Dilemma
- IJLLR Journal
- 9 hours ago
- 2 min read
Nuzhat Nazir Malik, Jamia Hamdard Shariqa Mehmood, Jamia Hamdard
ABSTRACT
One of the most disputed problems in modern pharmaceutical patent law has become the socalled patent evergreening, especially in developing nations such as India when the access to affordable medicaments is one of the burning issues of the population. Evergreening is the practice used by pharmaceutical firms to make a minor modification on a previously existing drug, whether in form, dose or combination; without any significant breakthrough in its therapeutic effect in order to keep the patent alive. On the one hand, the idea of patent protection is meant to encourage innovation by giving a person a 20-year monopoly, but on the other hand, this concept may be applied to withhold the introduction of effective generic medicines due to the necessity to secure patent protection.
This paper is a critical analysis of the legal issue on drug innovation versus access of essential drugs by the people in the Indian context. It discusses the legal context of the Patents Act, 1970, especially the Section 3(d) that aims at eliminating patenting of minor modifications unless they can prove an improved therapeutic effect. This is an exclusive provision by India in balancing the rights of the individual and the objective of the health of the population.
The paper also examines some of the landmark judicial decisions that have informed the debate on evergreening. In Novartis AG v. Union of India. The Supreme Court took a very stringent view on efficacy and established a world-wide precedent against non-serious patent extensions. Likewise, Bayer Corporation v. Natco Pharma ltd. emphasized the importance of the compulsory licensing as a means of accessing life-saving drugs, and Roche ltd v. Cipla ltd emphasised the role of the public in the enforcement of patents.
Arguments of evergreening and anti-evergreening have also been put forward in the paper. In its proponents believe that incremental innovations should be offered protection, and help recuperate high research and development expenditures. However, critics see evergreening as an artificial expansion of monopolies and thus limiting access to affordable medicines and ethical issues particularly in low- and middle-income countries.
Placing the problem in a comparative context, the article shows that India has a tighter patent system than other countries of the United States and the European Union in terms of its adherence to the concept of public health. Finally, the article proposes a moderate legal solution that could nourish outstanding innovation but will eliminate the exploitation of patent rights. It points out why the judicial vigilance and consistent policy action are necessary to make sure that the patent system benefits the commercial interest as well as the larger aim of fair healthcare access.
