March 2009

1. March 2009 Current Status of Biotech Patenting In India Kausalya Santhanam Ph.D Patent Agent USPTO, IPO Confidential

2. Commercial Attributes • Legal monopoly limited in scope and duration (20 years) • National in scope • Exclusionary in nature Patentability • Novelty • Inventive Step (Non-obviousness) • Industrial Application (utility) Patents Confidential

3. Protectable Inventions in Biotech Composition • Nucleic acid sequence • Protein sequences • Antibodies • Small Molecules Method of Use • Treatment • Diagnosis • Screening 3(d) Mere discovery of - a new form - a new property - a new use of a known compound not patentable unless differ significantly with regard to efficacy Tools • Machines • Devices Process • Method of Making • Synthesis Confidential

4. Biotech Inventions History and Facts • Article 27 of TRIPS provides the basis for patentability • US patent law grants patent to microorganisms when modified by human • intervention (Diamond v Chakraborty, US Supr. Court, 1980) • EPO has similar law with regard to patenting microorganisms • Patentability Criteria – Novelty, Inventive step (Non-Obvious in US), Industrial applicability (Utility in US) • Patenting of transgenic animals – Allowed in the US (ex: oncomouse); treated on a case by case basis elsewhere • Dimminaco A.G. v Controller of Patents & Designs (Calcutta High Court, 2002) Confidential

5. Biotech Inventions Indian Patent Act • Section 3 (Patent Amendment 2003) establishes Patentability Criteria for • microbiological processes • Microbiological process that can be established as ‘inventions’ are patentable • Patentability Criteria – Novelty, Inventive step, Industrial applicability • Biological material deposited at MTCC and Gene Bank, IMTech, Chandigarh • - all characteristics for identification of the microbial sample • - access to material allowed after publication of the application • - disclose the geographical source of the biological material • Indian law does not allow patenting of animal, whole or part Confidential

6. Biotech Inventions What is patentable? Purification from T. aquaticus Novel? Obvious? Useful? Taq polymerase PCR naturally-occurring Recombinant form of Taq polymerase Confidential

7. Biotech Inventions The catch… • Expressed Sequence Tags (ESTs) • Gene Fragments • SNPs • Genetic Tests (screening, diagnostic) • Proteins • Stem Cells Novel? Obvious? Useful? Enablement? Written Description? Confidential

8. Real World Well established OR Biotech Inventions Patentability Utility - US Specific Substantial Credible Industrial Applicability – EP and others Confidential

9. Patentability - US • 35 USC § 112, 1st paragraph The specification shall contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains…to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention Three Prong requirement in the specification • Written Description • Enablement • Best Mode Confidential

10. Patentability - US Written Description Requirement • A patent specification must describe an invention in sufficient detail that one skilled in the art can conclude that the inventor had possessionof the claimed invention • Possession can be shown by i. Actual reduction to practice ii. Reduction to drawings iii. Describe relevant identifying characteristics - structure - functional characteristics (with a correlation between structure and function) - physical characteristics - chemical characteristics - combination of the above Confidential

11. Patentability - US Enablement Requirement • Disclosure of information sufficient for the ordinary skilled person to make and use the full scope of the claimed invention • Disclosure should facilitate the making and using [of the invention] without undue experimentation Due to unpredictable nature of biotech, enablement requirement is high Confidential

12. Biotech Inventions Patentability Requirements Written Description and Enablement (35 USC § 112) • Ex: • The composition of claim 1 wherein said nucleotide sequences are selected • from the group consisting of: • the N. gonorroheae DNA insert of ATCC 53409, ATCC 53410 and • ATCC 53411 and discrete nucleotide subsequences thereof… • Yes • Ex: • An isolated polypeptide comprising an amino acid sequence of SEQ ID NO: XX • selected from the group consisting of: • a mature form of the amino acid sequence of SEQ ID NO: XX • a variant of the mature form of an amino acid sequence of SEQ ID NO: XX • a fragment of the mature form of the amino acid sequence of SEQ ID NO: XX • No Written Description can be satisfied by depositing the biological material (Enzo Biochem. Inc. v Gen-Probe Inc., Fed. Cir. 2002) Confidential

13. Biotech Inventions Patentability Requirements Enablement (35 USC § 112) Ex: US5,756,349 Vertebrate cells which can be propagated in vitro and which are capable upon growth in culture of producing erythropoietin in the medium of their growth in excess of 100 U of erythropoietin per 10.sup.6 cells in 48 hours as determined by radioimmunoassay, said cells comprising non-human DNA sequences which control transcription of DNA encoding human erythropoietin Enabled? By Describing ‘a way’ to make EPO… Can Amgen claim all cells that propagate in vitro comprising non-human DNA sequence that control transcription of DNA encoding human erythropoietin? Amgen v Hoechst (Fed. Cir. 2003) Confidential

14. Biotech Inventions Patentability Requirements Outcome… • Those skilled in the art can readily use various cell cultures (vertebrate) to • produce human EPO • For those skilled in the art it is relatively simple to determine • - whether a certain promoter will work within a specific vertebrate cell • - whether a particular vertebrate cell will produce human EPO in culture • - whether a particular promoter could be operatively linked to control the • transcription • Publications (in the given area) that demonstrate the extent of the enabling disclosure Confidential

15. Biotech Inventions Patentability Requirements Enablement Wands Factors (In re Wands, Fed. Cir. 1988) • Nature of the invention • State of the Prior Art • Level of ordinary skill in the art • Level of predictability • Amount of Direction • Presence of working examples • Breadth of claims • Quantity of experimentation Confidential

16. Biotech Inventions Gene Inventions and exemplary claims • Nucleotide, Protein sequences • Promoters • Vectors • Epitope sequences and Antibodies • Processes used for making the protein • Method of Use(s): diagnostic, treatment, screening • Pharmaceutical Product Confidential

17. Biotech Inventions Enabling Technologies • Improvement Strategies (ex: transgenics, knock-outs) • Gene expression methodology (ex: antisense, target specific expression) • Gene expression materials (ex: specific promoters) • Gene Constructs Confidential

18. Biotech Inventions Bioinformatics Genomics Proteomics Clinical/Regulatory Highthroughput Tools Data Mining Data Analysis Pattern Recognition Molecular Modeling Data Storage Predictive Tools Confidential

19. Biotech Inventions Bioinformatics – Challenges in Patenting • Client oriented – Diverse needs: breadth of claims? • Anticipate and prevent competition is difficult • Scarce judicial precedent • Invention obsolete? Confidential

20. Biotech Patenting Other Issues… • Bits and pieces: Allowing a single genomic gene to be patented in several ways (ex: fragments, SNPs, peptides) • Preventing knowledge sharing (decrease in publications) and impeding research activities • Social, ethical and religious issues (ex: stem cell research) Confidential

21. Biotech Patents - India Indian Patent Applications Filed/Granted between 2000 to 2005 in allied areas Source: Indian Patent Office , Annual Report 2004-2005

22. Biotech Patents - India • First Product Patent Granted (post 2005 era) Pegasys (Roche) – Pegylated IFNα 2a • Increase in no. of Biotech Application Filings Homegrown company filings less in no.? Homegrown companies filed outside India pre-2005? • Product vs Process Applications Process Product • Patent Examiners About 130-150 Dwindling • Patent Examining Process Training in specific fields/art • Oppositions

23. Integration of IP and Research • Goal: Tie Applications to Appropriate Process Points Drug Discovery Product Identification Cell Validation Animal Validation/ Preclinical Clinical Provisional Updated Provisional/Utility Utility/CIP Utility 12 months 12 months Composition and MOU Formulation and Dose Confidential

24. Disease Groups IP Project Management Regulatory Affairs Marketing Formulation/ Manufacturing Portfolio Management Identification of >25 Compounds Biology IP Chemistry Validation In vitro Studies Preclinical Animal Studies, Pk, Tox Clinical Phase I, II Licensing or Partnering deals IP Audits <2 Products - Patent Application Confidential

25. IP Strategies – Related Applications Gillette Building a fortress around the basic Invention/ technology Vacuum chamber in which the DLC blade coating was applied Use of 3 staggered Blade getting progressively closer to skin Single point cartridge loading system - Avoiding upside down attachment Mach 3 Core Technology (Diamond like Coating) New forward pivot design positioning the blades in an optimal shaving position Indicator strip signaling when the shaver is no longer experiencing ‘the optimal shave’ Rubberized contour grip for better handling Confidential

26. March, 2009 Thank You!