Trade-Related Aspects of Intellectual Property Rights - Information for Review of Art. 27.3(b) (Patentable Subject Matter)

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.

4. Notes

List of Questions

Illustrative List of Questions Prepared by the Secretariat.

A. Patent Protection of Plant and Animal Inventions

1. To what extent are inventions concerning plants or animals, whether products or processes, patentable under your country's law, if they meet the conditions for patentability stipulated in Article 27.1 of the TRIPS Agreement?

2. Where any such inventions are not patentable, even if they meet these conditions:

To what extent is this due to per se exclusions from patentability?

To what extent is this based on other grounds (for example because conditions for patentability other than those stipulated in Article 27.1 are not met or in order to protect ordre public or morality (see Article 27.2 of the Agreement))?

3. Please describe any specific provisions, guidelines, final judicial decisions and administrative rulings of general application concerning the application of the conditions for patentability stipulated in Article 27.1 to subject matter addressed by Article 27.3(b).

4. Where plant varieties are not as such patentable subject matter under your country's law, please indicate the extent to which the scope of protection under patents for inventions concerning plants can nevertheless embrace plant varieties or a botanical taxon whose plants express a trait covered by the claims of a patent.

5. Please provide any definitions used under your country's law with regard to subject matter specifically excluded from patentability or specifically patentable (e.g. micro-organisms, microbiological processes, non-biological processes, plant varieties).

6. To what extent is subject matter that is identical to what occurs in nature patentable under your country's law?

7. Explain the requirements under your country's law for ensuring adequate disclosure of the patentable inventions referred to above.

8. What rights are conferred upon owners of the patents referred to above? Are product and process patents subject to the same rules as other patents? Do they benefit from the same protection as stipulated in Article 28 of the TRIPS Agreement?

9. Are there any specific exceptions to these rights (affecting the scope or duration of the patents referred to above)? To what extent are exceptions, available in respect of plant variety rights (e.g. those referred to under question B.4(i) below), available in respect of rights conferred upon patent owners?

10. Are there any specific provisions under your country's law for compulsory licensing in respect of the patents referred to above?

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.

B. Protection of Plant Varieties

1. Does your country's law provide for the protection of plant varieties by plant breeder's rights, plant patents or any other sui generis system for the protection of plant varieties?

2. (a) If your country is a party to the International Convention for the Protection of New Varieties of Plants (UPOV), please indicate which Act or Acts of the UPOV Convention your country has signed; which it has ratified; to which it has acceded; and to the standards of which its law conforms but to which it has not (yet) adhered.

(b) If your country is not a party to the UPOV Convention, does the protection offered to plant varieties under your country's law conform to the standards of any of the Acts of the UPOV Convention and, if so, which?

3. Please indicate whether concurrent protection under your country's plant variety protection law and its patent law is available (see also question A.4 above).

4. Please provide the following details of your country's sui generis system for the protection of plant varieties:
(a) the relevant laws and regulations and, if they have been notified to the Council for TRIPS, a reference to the relevant WTO documents;

(b) the definition of "plant variety";

(d) the extent to which subject matter that is already known to the public or identical to what occurs in nature is protectable under your country's sui generis system for the protection of plant varieties;

(e) the extent to which protection can be based on characteristics of germplasm, as opposed to characteristics of plant varieties derived from such germplasm;

(f) who is entitled to the rights;

(g) the procedure for the acquisition of rights, including the authority in charge of administering the rights;

(h) the rights conferred;

(i) exceptions to the rights conferred;

acts performed for research or experimental purposes;
acts performed to develop new varieties of plants;
acts performed to commercialize such newly developed varieties;
any "farmer's privilege" (e.g. acts performed by a farmer on his own land in respect of seed saved from the previous harvest);
acts done privately and for non-commercial purposes;
compulsory licensing.

(j) the duration of protection;

(k) transfer of rights;

(l) enforcement of the rights.

Representative Questions for TRIPS 27.3(b) Review Submitted by the Delegations of Canada, the European Union (formerly European Communities), Japan and the United States

A. Patent System Questions

1. In your territory, is there any basis for denying a patent on an invention consisting of an entire plant or animal that is novel and involves an inventive step?

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.

2. If the answer to question 1 is yes, please respond to the following questions:
(a) Does your patent system exclude entire plants or animals as inventions? If it does, please cite the legal basis for this.

No.

(b) If your patent system does recognize entire plants and animals as inventions, does it exclude all such inventions from being patentable subject matter, or does it only exclude certain types of plants or animals? If it excludes all, please cite the legal basis for their exclusion (e.g. lack of industrial applicability). If it excludes only certain types, please identify the categories or characteristics of inventions that are excluded and cite the legal basis for their exclusion.

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.

(c) Is there any other basis in your law that precludes the grant of a patent on any categories of plant or animal inventions that otherwise are novel, involve an inventive step and are capable of industrial application? If so, please cite the legal basis for that exclusion from patent eligibility.

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.]

3. Other than with respect to subject matter you defined as being ineligible to be patented under question (2), is it possible in your territory to obtain a patent claim defined in any of the following ways?
(a) A patent claim that is not limited to a specific plant or animal variety.

Yes.

(b) A patent claim that is expressly limited to a plant or animal variety.

Yes.

(c) A patent claim that is expressly limited to a group of plants or animals, where the group is defined through reference to a shared characteristic such as incorporation of a particular gene.

Yes.

(d) If the answers you provide to question (3)(a) to (c) vary, please provide the definitions of a "plant variety" and an "animal variety" that are used by your examining authority.

Not applicable.

4. Is it possible to obtain a patent in your territory on a microorganism that is novel, involves an inventive step and is capable of industrial application? If not, please identify the legal basis under which these inventions are deemed ineligible to be patented.

Yes.

5. Is it possible to obtain a patent in your territory on an essentially biological process for the production of a plant or animal (i.e. a process limited to those acts that are necessary for sexual or asexual reproduction of a plant or animal)? If not, please identify the legal basis under which a patent on such a process would be denied.

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.

6. Is it possible to obtain a patent in your territory covering subject matter that is identical to that found in nature (e.g. a plant or animal in its natural state)?

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.

B. Plant Variety Protection Systems

7. Do the laws applicable to your territory provide for a sui generis form of protection for a new plant variety?

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).

8. If the answer to question 7 is "yes", does that protection conform to the standards defined in one of the Acts of the International Convention for the Protection of New Varieties of Plants (UPOV)?

Yes.

9. If the answer to question 8 is "yes", please specify the Act of the UPOV Convention upon which your legislation is based (i.e. the 1991 Act, the 1978 Act or the 1961/1972 Act).

The Plant Variety Protection Act conforms to the 1991 Act of UPOV.

10. If sui generis protection for plant varieties is provided in your territory, would any of the following acts require the prior authorization of the right holder:
(a) acts performed for research or experimental purposes, or to develop new varieties of plants;

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).

(b) acts performed to commercially exploit a variety distinct from the protected variety but sharing its essential characteristics;

Yes.

(c) acts performed by a farmer of harvesting seed from his planting of a protected variety legitimately obtained, storage of that seed, and replanting of that seed on the farmer’s land.

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).

If prior authorization is not required for any of the above examples of activities, is there any requirement that the party undertaking the specified actions provide the right holder with remuneration in any form?

No.

11. Can protection be obtained for a plant variety that was known to the public, or was publicly available, prior to the application for sui generis protection for that plant variety, and, if so, under what conditions (i.e. what are the time-limits during which public disclosure or availability will not preclude the grant of protection).

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).

12. Can protection be predicated on identification of an unexpressed gene, on an unexpressed set of genes present in the genome of the plant variety, or on the characteristics of germplasm, rather than the expressed characteristics of plant varieties derived from such genes or germplasm?

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.