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

1. INTRODUCTION The Patents Act Cap. 400 of the Laws of Zambia regulates the grant of protection for inventions in Zambia. The Act does not exclude any field of technology from protection. However, the Registrar has the discretion to deny protection to inventions deemed to be contrary to public morality or law. Further, substances used as food or medicine which are mere mixtures of known ingredients, or a process for obtaining such mixture are excluded from patentability. Section 38 herein refers. 2. PROTECTION OF PLANT VARIETIES As earlier indicated, Section 18 allows the Registrar on a discretionary basis to refuse certain classes of applications for a patent. However, plant varieties do not fall within any of the classes. Therefore by interpretation, it is possible for the Registrar to grant a patent for a plant variety, but only if it can meet the criteria of an invention and if the complete specification "fully described the invention and the manner in which it is to be performed". (Section 14(3) of the Act). What would need to be resolved, however, in such a situation would be the question of obviousness and reproducibility. Industrial property rights (IPRs) are private rights. This means that once a patent is granted the owner enjoys exclusive rights to his invention. Therefore, the grant of a patent for a plant variety would mean "to grant to the patentee, subject to the provisions of the Act and the conditions full power, sole privilege and authority by himself, his agents and licencee during the term of the patent, to make use, exercise and vend the invention within Zambia in such a manner as to him seems meet, so that he shall enjoy the whole profit and advantage accruing by reason of the invention during the term of the Patent". This would mean that the patentee would be empowered to control, totally, the use of his plant varieties including the saving of seed and its re-use on farms. The legislation does not provide for "farmers privilege". 3. TRIPS AGREEMENT: ARTICLES 27.3(b) This Article provides, inter alia, that only plants and animals and essentially biological processes for the production of plants or animals may be excluded from patentability. However, the same provision stipulates that micro-organisms, as well as micro-biological and non-biological processes are not covered. They have to be patented. However, Members are obliged to provide protection for plant varieties either by patents or by an effective sui-generis system or by a combination thereof. 4. IMPLICATIONS OF PATENTING PLANT VARIETIES AND LIFE FORMS Article 27.3(b) has been viewed as one that will make developing countries lose control over their own biodiversity and the benefits they derive therefrom. Developing countries are rich in biodiversity and giving of monopolies over these will curtail the enjoyment by communities. Opting to extend the patent laws to plant varieties will be setting up a system of private rights over individuals to prevent others from making, using or selling the protected variety or any product that might have patented genetic information. Consequently, farmers will not be able to freely access or re-use their seed, nor will they be able to save and/or exchange seed. Patenting of plant varieties does not provide for benefit sharing as this is a private right to the exclusion of anybody else. Major companies will have monopolies and secure ownership of plant varieties which contain genetic information obtained from the farmers own fields in the developing countries, which would then be sold back to them with a royalty charge added thereto. 5. SUI-GENERIS SYSTEM As already stated, Article 27.3(b) also provides for the protection of plant varieties through an "effective sui-generis system". This term has, however, not been defined sufficiently. It is difficult to determine what effective sui generis systems for plant varieties will entail. It is most likely that it might be on the lines of the UPOV inspired system. However, the sui-generis system allows developing countries to provide for the protection of plant resources by a model that is suitable with their culture. Legislation on protection of plant varieties should be developed which would accord recognition to innovations of indigenous peoples and local communities. In terms of definition, such statute should define innovation to include any inventive input done collectively, accretionally, intergenerationally and over time in relation to genetic resources. Such a system would effectively protect ownership rights of farmers and indigenous peoples over their plant varieties and seeds. Currently, Zambia has in place a draft Plant Breeders Rights Act. It would appear that the same is based on the principles of the 1991 Act of the UPOV Convention. Under UPOV 1991, parties are free to protect plant varieties by plant breeders rights. The Act works basically in the interest of the farmer at local community level. It would be advisable, therefore, if the Plant Breeders Rights Act was to be used in Zambia as an alternative to patenting of plant varieties in Zambia. 6. SUMMARY As the world integrates and calls for equitable sharing of benefits derived from the global trading system, and as it calls for the conservation and sustainable use of biological resources, countries world over are faced with a number of challenges as they strive to attain these objectives. Considering that Article 27 of the TRIPS Agreement hinges on matters that concern both the enhancement of trade, on the one hand, and conservation and preservation of the environment, on the other, it is imperative that the TRIPS review meeting take into account the concerns of the world. As a country whose rural community depends solely on agriculture the following concerns are expressed as regards the TRIPS Agreement in its present state:  Lack of recognition of indigenous knowledge within the provisions of the TRIPS Agreement;  No clear understanding within the provision of Articles 27.3(b) on the conservation and sustainable use of biological materials;  No clear understanding of what constitutes the sui generis system of protection. 7. RECOMMENDATIONS The review meeting should ensure that the TRIPS Agreement provides for a clear understanding within the provisions of Articles 27.3(b) on the conservation and sustainable use of biological materials. It should also endeavour to provide for a clear understanding of the coverage of a sui generis system, whether indigenous knowledge and eco-system protection fall within its coverage. Since most least developed countries depend much on farming, there is need to recognize the contribution of farming and indigenous communities to genetic resource conservation and enhancement. As rapid changes take place in plant varieties much of the diversity contained in landraces and farmers' varieties are under great threat from their replacement by new varieties. It should also be borne in mind that genetic engineering, and its products in food, has its own consequences, whose full impact on the health of human beings has not fully been assessed. This poses the danger of causing unrepairable damage. Moreover, many developing countries do not even have the capacity to conduct such assessment. The plant variety protection route should not deprive farmers of their own rights and, therefore, whatever sui generis system is adopted, it should include provisions to either protect the farmer's privilege, or provide wider space in the plant variety protection law for farmers as breeders and/or conservers (the right to compensation for the commercial use of their materials).

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?

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.

(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.

(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.

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.

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

(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.

(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.

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.

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.

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)?

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?

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)?

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).

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;

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

(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.

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?

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).

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?