1. EXPERIMENTAL DATA STANDARD REQUIRED FOR PATENTING BIOLOGICAL PHARMA MATERIAL IN INDIA © SNA-2011 Hari Subramaniam Subramaniam, Nataraj & Associates New Delhi India Fax: (+91 11) 2922 6005/2922 6012 E-mail: sna@vsnl.com

2. WHAT IS PATENTABLE n In the context of pharma only the following are patentable n i) new molecule per se n ii) new form of known substance provided there is a significant increase in efficacy n Iii) synergistic compositions made of two or more actives.

3. NOT PATENTABLE (Section 3-Negative list) n i) new forms of known substances not having significant increase in efficacy (S. 3(d)) n ii) simple admixtures (S. 3(e)) n iii) methods of treatment (S. 3(i)) n iv) medical uses (S. 3(d))

4. Evidence Required n NEW MOLECULE- A FIRST TIME DRUG n No special evidence required n In vivo (animal model studies) or even in vitro tests considered sufficient.

5. Evidence Required n NEW DERIVATIVES OF KNOWN DRUGS n Esters, ethers, salts, new forms, polymorphs, pure forms….. n Significant increase in efficacy as compared to parent compound to be demonstrated.

6. Evidence Required n NEW DERIVATIVES OF KNOWN DRUGS n Raises two issues: n What is efficacy n What is “significant”

7. Evidence Required n NEW DERIVATIVES OF KNOWN DRUGS n Novartis case n Increase in bioavailability not considered to be increase in efficacy. n Also 30% increase not considered to be significant. n Efficacy should be therapeutic efficacy.

8. Evidence Required n NEW DERIVATIVES OF KNOWN DRUGS n Efficacy should ideally find support in working examples in the description. n Comparative examples to establish significant efficacy over parent compound. n Patent Office has accepted extrinsic evidence. n Expert evidence from an independent lab, with affidavit will be useful.

9. Evidence Required n Nevertheless, more patent applications have been refused in the last five years under Section 3(d) than any other ground. Elaborate comparative examples in the original specification advisable.

10. Evidence Required n Where possible test results on human patient. n If not, at least accepted animal models. In vivo experimental data would be strongest. In vitro would be acceptable.

11. RECENT CASES n Novartis (Glevac) n Gilead (Bis boc pmpa, tamiflu) n Cadila (Crystalline clopidogrel besylate)

12. CONCLUSION n Clear comparative examples in the specification-best form of evidence. n Extrinsic evidence supported by experimental data-next best In vivo experimental data stronger than in vitro Comparison with immediate parent compound and closest prior art highly desirable

13. THANK YOU