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

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

Composition  Nucleic acid sequence  Protein sequences  Antibodies  Small Molecules Protectable Inventions in Biotech Method of Use  Treatment  Diagnosis  Screening Tools  Machines  Devices Process  Method of Making  Synthesis Confidential 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

 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) History and Facts Biotech Inventions Confidential

 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 Indian Patent Act Biotech Inventions Confidential

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

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

SpecificSubstantial Credible Utility - US Industrial Applicability – EP and others Real WorldWell established OR Biotech Inventions Patentability Confidential

35 USC § 112, 1 st 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 Patentability - US Confidential

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 possession of 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 Patentability - US Confidential

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 Patentability - US Confidential

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 and ATCC and discrete nucleotide subsequences thereof… 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 Written Description can be satisfied by depositing the biological material (Enzo Biochem. Inc. v Gen-Probe Inc., Fed. Cir. 2002) Biotech Inventions Patentability Requirements Yes x No Confidential

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

 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 Outcome…  Those skilled in the art can readily use various cell cultures (vertebrate) to produce human EPO  Publications (in the given area) that demonstrate the extent of the enabling disclosure Biotech Inventions Patentability Requirements Confidential

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 Biotech Inventions Patentability Requirements Confidential

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

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

Bioinformatics GenomicsProteomicsClinical/Regulatory Highthroughput Tools Data Mining Data Storage Data AnalysisPattern Recognition Molecular Modeling Predictive Tools Biotech Inventions Confidential

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

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) Biotech Patenting Confidential

Source: Indian Patent Office, Annual Report Biotech Patents - India Indian Patent Applications Filed/Granted between 2000 to 2005 in allied areas YearBiotechChemicalDrug /0787/353883/ /0778/483879/ /0776/399966/ /02952/ / /713916/

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 Dwindling  Patent Examining Process Training in specific fields/art  Oppositions

Goal: Tie Applications to Appropriate Process Points Identification Cell ValidationAnimal Validation/ Preclinical Clinical Drug Discovery ProvisionalUpdated Provisional/UtilityUtility/CIPUtility Composition and MOU Formulation and Dose 12 months Integration of IP and Research Product Confidential

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

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

Thank You! March, 2009