The information provided below is offered for consideration by the Council for TRIPS regarding practices in the United States related to patent protection concerning plants and animals, and plant variety protection. The information is limited to issues that are relevant to the subject matter of Article 27.3(b). In that regard, any information concerning animals is strictly confined to animal organisms other than a human being, as the latter was never considered patentable subject matter in any WTO Member. We offer this information in response to the invitation from the TRIPS Council expressed through the illustrative list of questions prepared and circulated by the WTO Secretariat. Please note that we have elected to phrase and respond to the issues in a slightly different form. We believe the information as provided below, and as contained in our response to a similar fact-finding exercise conducted in the OECD 2 , responds to those issues raised by the illustrative list of questions that are relevant to the review specified in Article 27.3(b). We also believe that the presentation of information in this form will facilitate preparation of a synoptic table that can simplify the review process by comparing relevant elements of patent and plant variety systems in WTO Members.
N.B. Please ensure that your responses to the questions above cover each category of subject matter specified in Article 27.3(b), namely micro-organisms, essentially biological processes for the production of plants or animals, microbiological processes, non-biological processes, plant varieties and other inventions concerning plants or animals.
Yes. To be patentable, every invention must also satisfy the requirement of utility set forth in Section 101 of title35, United States Code, as well as the requirement under Section 112 of title 35, United States Code, regarding that invention's written description and/or enablement.
No. Plants or animals are not excluded from being patentable if they are the subject of an invention. Of course, plants and animals occurring in their natural state are not inventions.
Yes. The same basis as recited in the answer to question 1 above.
[Answer A.1: Yes. To be patentable, every invention must also satisfy the requirement of utility set forth in Section 101 of title35, United States Code, as well as the requirement under Section 112 of title 35, United States Code, regarding that invention's written description and/or enablement.]
No, if the claim is limited to naturally occurring essentially biological processes comprising the steps for sexual or asexual reproduction of a plant or sexual reproduction of an animal. Such a claim would fail to meet one or more of the patentability requirements of novelty, non obviousness and utility under Sections 101, 102 and 103 of title 35, United States Code.
No. Under US law and practice, a patent may not be granted on a claim that is limited to subject matter indistinguishable from the form in which it is found in nature. For example, a claim drawn to a naturally occurring bacterium, per se, would fail to satisfy the requirements for novelty and utility (Section 101 of title 35, United States Code). However, these requirements, as well as the requirement of non obviousness, are considered to be met, when a claim is directed to an isolated and/or purified composition containing naturally occurring subject matter that exhibits new or unexpected properties.
Yes, for sexually reproduced and tuber propagated plant varieties, under the Plant Variety Protection Act (Section 2321 et seq. of title 7, United States Code).
The Plant Variety Protection Act conforms to the 1991 Act of UPOV.
No, with respect to plant variety protection certificates issued under the Plant Variety Protection Act. (With respect to utility patents issued under the general Patent Law, or plant patents issued under the Plant Patent Act, such acts would not require prior authorization from the holder of the patent if the acts were done for purely non commercial purposes. Acts with a commercial motivation or purpose however, would provide a basis for a finding of infringement of the patent, if done without prior authorization from the right holder).
No, with respect to plant variety protection certificates issued under the Plant Variety Protection Act. (With respect to plant patents issued under the Plant Patent Act, their protection extends only to specific acts of asexual reproduction of the protected variety, or sale or use of the plant that is the subject of the grant. Harvesting and reuse of seeds from such a plant involve sexual propagation of the plant, and as such would not be covered by the plant patent rights). (With respect to utility patents issued under the general patent law, such acts would require the prior authorization of the patent owner).
Yes, with respect to plant variety protection certificates issued under the Plant Variety Protection Act. The applicable periods of time are (a) for disclosures within the United States, one year, and (b) for disclosures outside the United States, (i) six years for new tree or vine varieties, and (ii) four years for all other types of varieties. (With respect to plant patents and utility patents, protection can be obtained, notwithstanding a disclosure of the plant variety or plant invention up to one year prior to the date of application for protection).
No, with respect to plant variety protection certificates. The determination of novelty for a variety is presently made through reference to the phenotype or expressed characteristics of the plant variety. No, with respect to plant patents, for the same reason (i.e., the evaluation of novelty and non obviousness of the plant variety is based on phenotypical or expressed characteristics of the plant variety). No, with respect to utility patents. If a gene is present in the plant in its natural state, its identification alone cannot be a basis for protection, regardless whether it is expressed or unexpressed. To rely on genes for patentability of a plant, they would have to be introduced into the plant by human intervention. Introduction of a gene that does not express a difference in the characteristics of the plant may render it novel and arguably non obvious under the general Patent Law. However, the criterion of utility would not be met, as the unexpressed gene did not change the original utility of the plant, as occurring in nature.
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