March 2009
Current Status of Biotech PatentingIn India
Kausalya Santhanam Ph.DPatent 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
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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
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3(d) Mere discovery of - a new form - a new property - a new use of a known compound not patentable unlessdiffer 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
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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
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Biotech Inventions
What is patentable?
Taq polymerasenaturally-occurring
Purification from T. aquaticus
PCR
Recombinant form of Taq polymerase
Novel?Obvious? Useful?
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Biotech Inventions
The catch… Expressed Sequence Tags (ESTs)
Gene Fragments
SNPs
Genetic Tests (screening, diagnostic)
Proteins
Stem Cells
Novel?Obvious?
Enablement? Written Description?
Useful?
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Specific Substantial Credible
Utility - US
Industrial Applicability – EP and others
Real World Well establishedOR
Biotech Inventions
Patentability
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35 USC § 112, 1st paragraph The specification shall contain a written description of the invention and of themanner and process of making and using it, in such full, clear, concise, andexact terms as to enable any person skilled in the art to which it pertains…tomake and use the same, and shall set forth the best mode contemplated by theinventor of carrying out his invention
Three Prong requirement in the specification
Written Description
Enablement
Best Mode
Patentability - US
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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
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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
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Written Description and Enablement (35 USC § 112)
Ex:The composition of claim 1 wherein said nucleotide sequences are selectedfrom the group consisting of:- the N. gonorroheae DNA insert of ATCC 53409, ATCC 53410 and ATCC 53411 and discrete nucleotide subsequences thereof…
Ex:An isolated polypeptide comprising an amino acid sequence of SEQ ID NO: XXselected 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 InventionsPatentability Requirements
Yes
x No
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Biotech InventionsPatentability 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)
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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 InventionsPatentability Requirements
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EnablementWands 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 InventionsPatentability Requirements
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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
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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
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Bioinformatics
Genomics Proteomics Clinical/Regulatory
HighthroughputTools
Data Mining
Data Storage
Data Analysis Pattern Recognition
MolecularModeling
Predictive Tools
Biotech Inventions
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Biotech Inventions
Client oriented – Diverse needs: breadth of claims?
Anticipate and prevent competition is difficult Scarce judicial precedent
Invention obsolete?
Bioinformatics – Challenges in Patenting
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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
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Source: Indian Patent Office , Annual Report 2004-2005
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
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
Goal: Tie Applications to Appropriate Process Points
Identification Cell Validation Animal Validation/Preclinical
Clinical
Drug Discovery
Provisional Updated Provisional/Utility Utility/CIP Utility
Composition and MOU Formulation and Dose
12 months
12 months
Integration of IP and Research
Product
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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 dealsIP Audits
Project Management
Disease Groups IP
RegulatoryAffairs
Formulation/Manufacturing
Marketing
- Patent Application
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IP Strategies – Related Applications
Building a fortress around the basic Invention/ technology
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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