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

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?

Section 7(2)6 of the Patents Act stipulates that "biotechnological inventions that can be used solely for one particular plan to animal variety" shall not be protected with patents.

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.

See the answer to question 1 above.

[Answer A.1: Section 7(2)6 of the Patents Act stipulates that "biotechnological inventions that can be used solely for one particular plan to animal variety" shall not be protected with patents.]

(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.

Section 6(2)8 of the Patents Act indicates that plant and animal varieties are not regarded as the subject of an invention.

(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.

According to Sections 7(1)1 and 7(2)4 of the Patents Act, patent protection shall not apply to: - inventions contrary to ordre public and morality; and - processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to the health care of human beings or animals, and also animals resulting from the use of such processes.

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.

No.

(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.

The concept of "plant variety" is defined by Section 2 of the Plant Varieties Act: "§2. Variety and essentially derived variety. (1) "Variety" means a plant grouping within a single botanical taxon of the lowest known rank which is defined by the expression of the characteristics resulting from a given genotype or combination of genotypes, is distinguished from other plant groupings by the expression of at least one of the said characteristics and is considered as a unit with regard to its suitability for being propagated unchanged. Such plant grouping is deemed to be a variety irrespective of whether the conditions for the grant of a plant variety right are fulfilled or not. (2) A plant grouping consists of entire plants or parts of plants (hereinafter variety constituents) which are capable of producing entire plants with the same characteristics. (3) A variety is deemed to be essentially derived from another variety if it is predominantly derived from the initial variety or a variety that is itself predominantly derived from the initial variety, it is clearly distinguishable from the initial variety, and, except for the differences which result from the act of derivation, conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety. (4) Essentially derived varieties may be obtained by the selection of a mutant or a variant individual of the initial variety, by back-crossing, transformation by genetic engineering, somatic cloning, or other such method." The concept of an animal breed is defined in Section 2(9) of the Farm Animal Breed Act: ""Breed" means a group of animals of the same species, with similar parentage, conformation and economic utility, whose number is sufficient for breeding purposes."

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, as far as biological material can be the subject of an invention (Section 6(1) of the Patents Act).

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.

It is not possible to obtain a patent on an essentially biological process for the production of a plant or animal. Under Section 7(2)5 of the Patents Act, processes are unpatentable which are biological in essence and are used for deriving biological materials, producing plant or animal varieties, except microbiological processes for deriving micro-organisms. An essentially biological process for the derivation of a biological material or production of plant or animal varieties is defined in Section 7(3) as a process which consists entirely of natural phenomena, including crossing and selection.

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)?

Yes (artificial re creation and clones are permitted).

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. The Plant Varieties Act provides for a sui generis form of protection for new plant varieties.

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).

Estonian legislation is based on the 1991 Act of the UPOV Convention.

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. Section 40 of the Plant Variety Rights Act stipulates: "A protected variety may be used without a licence issued by the holder of the plant variety right: 1) in scientific research and in official trials conducted for the purposes of comparison; 2) as parental material for the purpose of breeding new varieties; 3) privately, and for non-profit purposes."

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

Yes, if the exploited variety is essentially derived from the protected initial variety or from a variety that is itself predominantly derived from that initial variety.

(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, but at the request of the right holder or his representative the farmer must provide information about the quantities of the seed harvested. A licence fee has to be paid if the protected variety is grown for personal purposes on a territory bigger than 10 ha.

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?

Yes (see the response to question 10(c)).

[Answer B.10(c): No, but at the request of the right holder or his representative the farmer must provide information about the quantities of the seed harvested. A licence fee has to be paid if the protected variety is grown for personal purposes on a territory bigger than 10 ha.]

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, protection can 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. In the case of availability of a plant variety in Estonia, the time-limit is one year. In the case of availability in the territory of another state, the time-limit is four years and in the case of trees and grapevines, the time-period is not longer than six years.

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?

The issue is currently under consultation with the UPOV.