Dates: Friday, July 15, 2011
Venue: AIPS, Goregaon (W), Mumbai
Background: Patent applicants are often faced with the unenviable task of proving efficacy vis-a-vis section 3(d) of the Indian Patents Act, 1970. The Seminar provides an opportunity to discuss and analyze recent important decisions at the Patent Office in this regard, and learn from the practice of the patent office as to what needs to be done to prove enhanced efficacy of a known drug.
Theme: The focus will be on understanding the requirements of section 3(d), to know how efficacy is understood, what needs to be shown to prove or disprove enhanced efficacy, and on how to get over the common pitfalls that result in the failure to prove efficacy.
Discussion Topics:
- Can section 3(d), arguably a regulatory import, be an index of pharmaceutical innovation?
- If section 3(d) covers patenting bioequivalents, can the regulatory data submitted to prove bioequivalence be used to show that there is no significant difference in efficacy?
- Is it reasonable to expect proof of enhanced therapeutic efficacy at the time of making the patent application?Does proof of efficacy require regulatory-type testing or do they need different tests?
- Is section 3(d) open to further challenge after Novartis?
Queries & Registration: Please write to info [at] aips [dot] ac [dot] in
