Life Sciences & Healthcare

Pharmaceuticals, biotech, medical devices, diagnostics and digital health, where patents, licensing and data decide market access.

India is both a major producer of generic medicines and a growing centre of research, so life sciences IP here is contested from both sides. Section 3(d) of the Patents Act, which bars new forms of known substances that do not show enhanced therapeutic efficacy, shapes how pharmaceutical claims are drafted and challenged. Pre-grant and post-grant oppositions are common, and so are infringement actions on launch.

Where IP creates value

• Patents for new chemical entities, formulations, processes, biologics and devices, drafted with Indian exclusions in mind.
• Licensing and technology transfer for in-licensing, contract manufacturing, voluntary licences and research collaborations with institutions.
• Brands. Pharmaceutical trade marks face a stricter test of confusion because of the risk to health.
• Know-how in manufacturing processes, protected as trade secrets.

Regulation to build around

The Drugs and Cosmetics Act and the New Drugs and Clinical Trials Rules, 2019, the Medical Devices Rules, 2017, and the DPDP Act for patient and trial data, which the Act treats with particular care where children are involved.