Abstract

India's laws, especially those that protect intellectual property (IPR), are having a hard time keeping up with the rapid development of biotechnology, which includes genetic engineering and genetically modified organisms. The Indian Patents Act, 1970 gives patents to biotechnological innovations that are novel, non-obvious, and industrially applicable. However, there are ethical concerns about genetic testing and personalized medicines. Patents can encourage people to invest in biotechnology, but they can also lead to monopolies that make it harder to get essential genetic tests and treatment. This could put individuals suffering from genetic disorders at risk and make it harder for them to get the care they need. This study looks at India's biotechnology patent rules and how they compare to global standards, such as the TRIPS Agreement, which says that innovations in all areas of technology must be eligible for patents, but exceptions can be made for reasons of public health or morals. The Indian Patents Act, 1970 has certain exceptions that do not apply to genetic innovations. India tries to find this balance by selectively patenting innovative concepts and following TRIPS flexibility provisions. New technologies like CRISPR-Cas9 gene editing are testing the limits of what is legal and ethical. International standards, like UNESCO's Universal Declaration on the Human Genome and Human Rights and the ICMR guidelines, stress patient rights, informed permission, and responsible innovation. The Indian Supreme Court has said that Article 21's right to health is an important part of the right to life. They have also said that any laws that deal with human genetic patents must take public health into account. This study takes a close look at how biotechnology, especially genetic innovations involving humans, interacts with Indian patent law. It also looks at how this affects public health and moral issues.

Keywords