“Accessibility of Protected Inventions and Plant varieties for Further Innovations” Victoria Henson-Apollonio, Ph.D.,Manager, the CGIAR Central Advisory Service on IP 7/16/2019

Introduction Patent Protection for Plant Inventions Exceptions to Infringement 7/16/2019

Patent options for protection of plant material Plant Patents Utility Patents Standard Patents 7/16/2019

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). 7/16/2019

Plant Patent option One claim, describing unique new characteristics Protects asexually reproduced plants Favored for protection of new horticultural varieties, as well as fruit and nut trees No Tuberous plants 7/16/2019

Utility Patent option Original Patent Act, 1790 U.S. option for inventions- process, machine, manufacture, composition of matter Right to exclude others from making, using, selling, (importing), the claimed invention –in/into the U.S. 7/16/2019

Utility Patent option Invention must be novel, non-obvious and useful Inventions involving living material, --Chakrabarty case –U.S. Supreme Court ruling in 1980, –”..anything under the sun that is made by man.” 7/16/2019

Utility Patent option Multiple aspects of a plant invention can be claimed “Best mode disclosure” and “enablement” requirements Often met by deposit of propagative material into a “Budapest” –certified depository 7/16/2019

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 7/16/2019

Standard Patent option- EPO European Patent Office practice (European Patent Convention) National laws interpret European Parliament Directives 7/16/2019

Standard Patent option-EPO Original EPO interpretation of Directive 98/44/EC –no basis for patents on living plants Overturned 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. 7/16/2019

Standard Patent option-Japan Japan allows claims directed to plants and to the genetic engineering of plants Claims tend to be very narrow 7/16/2019

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 7/16/2019

Standard/Utility Patent –New Zealand Claims can be directed to new transgenic plant varieties, plants components 7/16/2019

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 7/16/2019

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 7/16/2019

Exceptions to Infringement-EU Community 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.” 7/16/2019

Exceptions to Infringement-EU Standard 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 7/16/2019

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 7/16/2019

Contract options for “enlarging” research exemption Through collaborative agreements–Collaborator may have license Bilateral contract/license with patent owner 7/16/2019

Contract options for “enlarging” research exemption Cross-licensing “Patent Pooling”/”Clearing-House” mechanisms 7/16/2019

Summary Several patent instruments covering plant inventions – Primarily used by inventors in developed countries Experimental use/Research exceptions to infringement do exist 7/16/2019

Summary Exceptions is U.S. are mainly judicially created U.S. exceptions are very narrow European and Japanese exceptions tend to be legislated and are interpreted fairly broadly 7/16/2019

Summary “Research only” licenses are usually, but not always, available to public institutions Other contract options/arrangements have been used 7/16/2019

The CGIAR Central Advisory Service on Intellectual Property, Housed at ISNAR in The Hague v.henson-apollonio@cgiar.org 7/16/2019