“accessibility of protected inventions and plant varieties for further innovations”
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“Accessibility of Protected Inventions and Plant varieties for Further Innovations”. Victoria Henson-Apollonio, Ph.D.,Manager, the CGIAR Central Advisory Service on IP. Introduction. Patent Protection for Plant Inventions Exceptions to Infringement. - PowerPoint PPT PresentationTRANSCRIPT
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“Accessibility of Protected Inventions and Plant varieties for Further Innovations”
Victoria Henson-Apollonio, Ph.D.,Manager, the CGIAR Central Advisory Service on IP
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Introduction
Patent Protection for Plant InventionsExceptions to Infringement
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Patent options for protection of plant material
Plant PatentsUtility PatentsStandard Patents
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Plant Patent option
Unique to U.S.Oldest type of statutory IP protection for living material, --Townsend-Parnell Plant Patent Act, 46 Stat. 376 (May 23, 1930, ch. 312, §1).
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Plant Patent optionOne claim, describing unique new characteristicsProtects asexually reproduced plantsFavored for protection of new horticultural varieties, as well as fruit and nut treesNo Tuberous plants
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Utility Patent optionOriginal Patent Act, 1790U.S. option for inventions- process, machine, manufacture, composition of matterRight to exclude others from making, using, selling, (importing), the claimed invention –in/into the U.S.
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Utility Patent option
Invention must be novel, non-obvious and usefulInventions involving living material, --Chakrabarty case –U.S. Supreme Court ruling in 1980, –”..anything under the sun that is made by man.”
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Utility Patent optionMultiple aspects of a plant invention can be claimed“Best mode disclosure” and “enablement” requirementsOften met by deposit of propagative material into a “Budapest” –certified depository
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Utility Patent option
Applicant can file applications for rights on the same variety, under both the utility patent regulations as well as under the Plant Variety Protection Act
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Standard Patent option- EPO
European Patent Office practice (European Patent Convention)National laws interpret European Parliament Directives
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Standard Patent option-EPOOriginal EPO interpretation of Directive 98/44/EC –no basis for patents on living plantsOverturned by decision in late 1999, that a claim directed to transgenic plants of more that one variety, that does not claim an individual plant variety, is permissible.
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Standard Patent option-Japan
Japan allows claims directed to plants and to the genetic engineering of plantsClaims tend to be very narrow
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Standard Patent --Australia
Claims can be directed to new plant varieties, plants components, reproductive material, products from plants and plant materials used in industrial processes
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Standard/Utility Patent –New Zealand
Claims can be directed to new transgenic plant varieties, plants components
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Exceptions to Infringement-U.S.
Plant Patents (U.S.) —can be used as breeding material (Judicial)Utility Patents (U.S.) –Very narrow interpretation
Further-narrowed by recent (Oct 10, 2002) ruling --Madey v Duke University
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Exceptions to Infringement—U.S.Madey v. Duke University also narrowed the definition of “non-commercial”Pharmaceutical industry in U.S. enjoys a “safe harbor” provided by the U.S. Legislature–the Bolar Amendment (Section 271(e))—allows generic drug makers to test versions of patented drug for regulatory approval
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Exceptions to Infringement-EUCommunity Patent Convention Article 27(b) (currently, non-binding),provides that, “the rights conferred by a patent shall not extend to acts done for experimental purposes relating to the subject matter of the patented invention.”
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Exceptions to Infringement-EUStandard Patents- Experimental use exception in U.K. patent law (Section 60(5)(b)German Courts have interpreted the experimental use clause in the patent law, quite liberally –at least in pharma cases
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Exceptions to Infringement-Japan
Experimental use exception provided by Section 69 (1) of the Japanese Patent Law.Scant case law, so far, to aid in interpretation of experimental use exception dealing with plants
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Contract options for “enlarging” research exemption
Through collaborative agreements–Collaborator may have licenseBilateral contract/license with patent owner
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Contract options for “enlarging” research exemption
Cross-licensing“Patent Pooling”/”Clearing-House” mechanisms
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Summary
Several patent instruments covering plant inventions –Primarily used by inventors in developed countriesExperimental use/Research exceptions to infringement do exist
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Summary
Exceptions is U.S. are mainly judicially createdU.S. exceptions are very narrowEuropean and Japanese exceptions tend to be legislated and are interpreted fairly broadly
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Summary
“Research only” licenses are usually, but not always, available to public institutionsOther contract options/arrangements have been used
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The CGIAR Central Advisory Service on Intellectual Property,Housed at ISNAR in The Hague