ipr aspects of herbal drugs
DESCRIPTION
IPR Aspects of Herbal DrugsTRANSCRIPT
IPR ASPECTS OF HERBAL DRUGS
Supriya Ramacha
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AGENDA
1. Analyzing patentability of an invention
Patentability Criteria
Patent searching
2. Obtaining patent rights.
Overview: patent process- patent filing.
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BACKGROUND- PATENT RIGHTS
Rights of patentee Make Use Sell Offer for sale Import
Negative rights
Term
Jurisdiction
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ANALYZING PATENTABILITY OF AN INVENTION
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PATENTABILITY REQUIREMENTS
Patentable subject matter
Utility
Novelty
Non-obviousness / Inventive step
Specification
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SUBJECT MATTER
Inclusion list – herbal drugs
Product
Process
Apparatus
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Exclusion list Section 3 and 4
Not patentable examples Medical methods (sec. 3(i)) New form/ new property/ new use of known
substance (sec. 3(d)) Mere admixture (sec. 3(e)) Plants, animals, seeds, varieties, species or any
parts (excl. microbes) (sec. 3(j)) Traditional knowledge (sec. 3(p))
TKDL
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UTILITY / INDUSTRIAL APPLICABILITY
Industrial application Capable of being made or used in an industry Present use
Relatively one of the easiest requirement to fulfill.
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NOVELTY
New in light of prior art Prior art: known prior to filing anywhere
Rule - compare one prior art at a time
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INVENTIVE STEP / NON OBVIOUSNESS
Inventive step Technically advanced / economic significance;
and Not obvious to a person skilled in the art
Person skilled in the art
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CONT...
Problem-solution approach Identify the problem Proposed solution obvious in light of existing ones
Secondary indications Teaching away Commercial success Copying Praise by experts Unexpected results Long felt need
Rule - combine all relevant prior art references
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SPECIFICATION
Meet all the guidelines specified in the act
Written description Describe in a detail manner
Best mode Best method of performing the invention
Enablement Capable of being worked independently by a
person having skill in the art
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EXAMPLE
Invention
Chair with wheels
Prior art
1. Chair
2. Wheels for toys
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EXAMPLE
Invention
Door knob-porcelain
Prior art
1. Door knob-metal
2. Kitchen utensils- porcelain
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EXAMPLE
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Invention
thiazolidinedione compound-maleic acid salt
hydrate form
Prior art
thiazolidinedione compound
pharmaceutically acceptable acids (such as
Hydrobromic acid, Hydrochloric acids, methanesulphonic, maleic acids,)
• Patent application No. IN/PCT/2000/00080/MUM M/s. Smithkline Beecham Plc
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Patentable ?
Efficacy ?
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EXAMPLE
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Mr. Golu files an application in India for a herbal composition used to treat obesity and ulcers :
Caralluma fimbriata extract
Liquorice extract
Priort art 1 A extract for reducing
body weight comprising Caralluma fimbriata extract.
Prior art 2 A method for treating
peptic ulcers by administering liquorice extract
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Patentable? © 2
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TURMERIC CASE
US5401504 Claim: A method of promoting healing of a wound in
a patient, which consists essentially of administering a wound-healing agent consisting of an effective amount of turmeric powder to said patient.
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PATENTABILITY CRITERIA MET
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Fig: Kalyan’s Patent filter model
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PRACTICAL PERSPECTIVE – OBTAINING A PATENT All requirements can broadly be classified under 3 stages
Stage 1 – Pre-search stage Subject matter Utility
Stage 2 - Patentability assessment-Patent search and analysis Novelty Non-obviousness
Stage 3 - Application drafting and filing Specification
Written description Enablement
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PATENT SEARCH
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PRACTICAL SCENARIO
Patentability Analysis invention in hand
Landscape Analysis conceptualization
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Resources: Patent databases
Methodology Keyword search Classification search
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OBTAINING A PATENT PATENT PROCESS - OVERVIEW
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PATENT FILING
Patent Application Provisional application Complete application
Priority date-filing date of the first application in the chain of applications
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Filing in India
Was the filing a complete or a provisional?
File the complete specification (12 months)
Provisional
Complete
Publishing (18 months*)
Request for examination (48 months)
Examination
Examiner decision (grant/refusal)
Indian Patent Process
*Can be reduced to 2 months by filing a RFP
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Thank You
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