- Court
- Madras High Court
- Date of judgment
- Judge
- Senthilkumar Ramamoorthy
- Outcome
- Remanded
Headnote
Refusal of a hemisulphate salt claim under section 3(d) set aside and the application remanded. The Court held that Novartis left the door open for incremental inventions based on enhanced bioavailability, the Supreme Court having noticed but not decided the contention that therapeutic efficacy can be established only on pharmacodynamic properties. Enhanced therapeutic efficacy founded on bioavailability must therefore be tested on its own criteria and not on enhanced intrinsic pharmacological activity per unit of active ingredient, which is the test the Controller had applied. The specification disclosed bioavailability of 34.73% for the salt against 4.54% for the base compound in dogs, together with recitals on therapeutic benefit, and those aspects had never been considered.
Headnote by BRB Legal, written from the judgment: a summary for reference, not legal advice. Read the judgment itself before relying on it.