March 2009 Current Status of Biotech Patenting In India Kausalya Santhanam Ph.D Patent Agent USPTO, IPO Confidential Patents 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) Confidential Protectable Inventions in Biotech Composition Method of Use Treatment Nucleic acid sequence Diagnosis Protein sequences Screening Antibodies 3(d) Mere discovery of Small Molecules - a new form - a new property - a new use of a known compound not patentable Tools unless Machines differ significantly with regard to efficacy Devices Process Method of Making Synthesis Confidential 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 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 Biotech Inventions What is patentable? Purification from T. aquaticus Novel? Taq polymerase PCR Obvious? naturally-occurring Useful? Recombinant form of Taq polymerase Confidential Biotech Inventions The catch… Expressed Sequence Novel? Tags (ESTs) Obvious? Gene Fragments SNPs Useful? Genetic Tests (screening, diagnostic) Proteins Enablement? Stem Cells Written Description? Confidential Biotech Inventions Patentability Utility - US Specific Substantial Credible Real World OR Well established Industrial Applicability – EP and others Confidential 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 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 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 Confidential 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 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 x No Written Description can be satisfied by depositing the biological material (Enzo Biochem. Inc. v Gen-Probe Inc., Fed. Cir. 2002) 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 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 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 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 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 Biotech Inventions Bioinformatics Genomics Proteomics Clinical/Regulatory Highthroughput Tools Data Mining Data Analysis Pattern Molecular Recognition Modeling Data Storage Predictive Tools Confidential 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 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 Biotech Patents - India Indian Patent Applications Filed/Granted between 2000 to 2005 in allied areas Year Biotech Chemical Drug 2000-01 4/0 787/353 883/276 2001-02 2/0 778/483 879/320 2002-03 46/0 776/399 966/312 2003-04 23/0 2952/609 2525/419 2004-05 1214/71 3916/573 2316192 Source: Indian Patent Office , Annual Report 2004-2005 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 Integration of IP and Research Goal: Tie Applications to Appropriate Process Points Drug Discovery Product Identification Cell Validation Animal Validation/ Clinical Preclinical Provisional Updated Provisional/Utility Utility/CIP Utility 12 months 12 months Composition and MOU Formulation and Dose Confidential Portfolio Management Identification of >25 Compounds Biology IP Disease Groups IP Chemistry Validation In vitro Studies Project Management Preclinical Animal Studies, Pk, Tox Regulatory Marketing Affairs Clinical Formulation/ Phase I, II Manufacturing Licensing or Partnering deals IP Audits <2 Products - Patent Application Confidential IP Strategies – Related Applications Gillette Building a fortress around the basic Invention/ technology Vacuum chamber in which Use of 3 staggered the DLC blade Blade getting progressively coating was applied closer to skin Single point cartridge Mach 3 Core Technology New forward pivot design loading system - Avoiding positioning the blades in upside down attachment (Diamond like Coating) an optimal shaving position Indicator strip signaling Rubberized contour grip when the shaver is no for better handling longer experiencing ‘the optimal shave’ Confidential March, 2009 Thank You!
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