Patentability of Seed Varieties

Report on variety registration, intellectual property rights and patenting of seeds.

Prepared by: James Mallet, Staff Counsel, Environmental Law Centre, Edmonton, Alberta (Oct. 15, 2003).

NOTE: The following is provided as a general introduction to Canadian patent law as it applies to seed varieties developed through traditional cross-breeding, and should not be relied upon as legal advice. For advice and further information, contact a lawyer experienced in intellectual property matters.

Issues:

1. Are seed varieties developed through traditional cross-breeding and selection patentable under Canadian patent law?

2. Will patent protection be available for such varieties in the future?

Summary of conclusions:

Seed varieties developed through traditional cross-breeding and selection are not currently patentable under the Patent Act .1 Reform of the Patent Act by Parliament would be required for any plant or seed to be patentable. The federal government has indicated it intends to introduce legislation to specifically address the patentability of higher life-forms, including plants and seeds.

Overview of the Canadian Patent Act

Under the Patent Act, an inventor may apply for patent protection of an “invention”, i.e.,

Any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.2

The applicant must submit a specification of his invention. The specification must constitute enabling disclosure, i.e., allow a person skilled in the art (e.g. cross-breeding and selection) to reproduce the invention.3 The purpose of this requirement is to ensure that, after the patent has expired (20 years from application), the public will have the benefit of the information necessary to reproduce and benefit from the invention. Once a patent has expired, the invention is said to have entered the public domain; no further protection of the invention is provided under the Patent Act.

A patent invests the inventor with the exclusive right to make and use the invention or sell it to others for use.4 Any person infringing this right is liable to the patent holder for lost profits resulting from the infringement.5 The protection granted under the Patent Act is far broader than that provided under the Plant Breeders’ Rights Act; under the latter Act, a farmer may retain and sow protected seed without permission.6 Under the Patent Act, these actions constitute infringement.

Are seed varieties developed through traditional cross-breeding and selection patentable under Canadian patent law?

Not under current law. The “process” of traditional cross-breeding cannot be patented; it is neither new nor an invention, but rather a natural biological process which occurs according to the laws of nature.7 With respect to the plants and seeds themselves, the Supreme Court of Canada has expressly rejected the patentability of higher life forms, including plants and seeds, under the Patent Act.8

In Pioneer Hi-Bred v. The Commissioner of Patents,9 a breeder had applied for a patent for a soybean variety developed through traditional cross-breeding and selection. The Federal Court of Appeal held that the development of the soybean variety involved too much luck to meet disclosure requirements, and too little human intervention to fall within the Patent Act definition of “invention”, which could not be extended to include essentially natural processes. The Supreme Court upheld the Commissioner’s rejection of the application on the basis that the applicant had not provided disclosure of how the variety was developed sufficient to allow its redevelopment by another skilled breeder. In this case, however, the Supreme Court did not rule on the broader, critical question as to whether plants or seeds were patentable subject matter.

In response to the Pioneer Hi-Bred decision, Parliament passed the Plant Breeders’ Rights Act. This Act imposes application requirements that are easier for plant breeders to satisfy, but also provides narrower protection than the Patent Act.

In the recent case of Harvard College v. Canada (Commissioner of Patents), the Supreme Court of Canada considered the patentability of a mouse foetus transgenically supplied with a gene that predisposed the animal to cancer.10 In its decision, the Court confirmed that higher forms of life, including plants and seeds, are not patentable under current Canadian law. Patents will thus continue to be restricted to uni-cellular organisms that are reproducible consistently, at will, and en masse.11 It is important to note, however, that the Court’s decision concerned only whether the current wording of the Patent Act could support the patenting of higher life-forms. The Court emphasized that the extension of patent protection to such life-forms is a matter to be determined by Parliament, and that the Court’s views on the utility or propriety of such an extension were irrelevant.12

Patentability of modified genes

Although the Supreme Court has rejected the patentability of higher-life forms under the Patent Act, patents for modified gene inserts have been upheld. In Monsanto Canada Inc. v. Schmeiser the Federal Court of Appeal confirmed that a patent for a modified gene inserted into plant material was enforceable against a farmer who had cultivated the seed without permission.13 On a practical level, a modified gene patent provides the patent-holder with significant rights over seed containing the modified gene, even though the seed itself is not patentable. However, the courts’ rulings on the patentability of modified genes do not directly affect the patentability of traditionally cross-bred plants and seeds.

Will patent protection be available for traditionally cross-bred plants and seeds in the future?

The major obstacles to patent protection for traditionally cross-bred plants and seeds since the Pioneer Hi-Bred decision - reliability of result and enabling disclosure - have been eclipsed by the outright rejection of higher life-form patentability set out in the Harvard College decision. For the time being, the only statutory rights available to plant breeders are those provided by the Plant Breeders’ Rights Act.

However, it is open to Parliament to reform Canadian patent law to allow the patenting of higher life-forms, and there are signs the federal government may be prepared to do so. The government is formulating a response to the Harvard College decision and a recent report of the Biotechnology Ministerial Coordinating Committee14 that recommends that limited patent protection be extended to higher life-forms, excluding human bodies.15 The government intends to introduce legislation to address this issue.16

1. R.S.C. 1985, c. P-4, as amended.
2. Ibid. s. 2 “invention”.
3. Ibid. s. 27(3).
4. Ibid. s. 42.
5. Ibid. s. 55.
6. Plant Breeders’ Rights Act, S.C. 1990, c. 20, s. 5.
7. Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1987] 3 F.C. 8 (C.A.), aff’d on other grounds [1989] 1 S.C.R. 1623, 60 D.L.R. (4th) 223. See also Canadian Patent Office, Manual of Patent Office Practice (Ottawa:
8. Supply and Service Canada, 1998) at 16.05.
9. Infra note 10.
10. Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623, 60 D.L.R. (4th) 223, aff’g [1987] 3 F.C. 8 (C.A.).
11. Harvard College v. Canada (Commissioner of Patents) (2002) 219 D.L.R. (4th) 577, 2002 SCC 76.
12. Abitibi Co., Re (1982), 62 C.P.R. (2d) 81 (Patent Appeal Board & Patent Commissioner); Harvard College v. Canada (Commissioner of Patents), supra note 10 at para 201.
13. Supra note 10 at para 153.
14. [2003] 2 F.C. 165, 2002 FCA 309 (Fed. C.A.), leave to appeal to the Supreme Court of Canada granted May 8, 2003.
15. Patenting Of Higher Life Forms And Related Issues: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee (Ottawa: Canadian Biotechnology Advisory Committee, 2002) online: Government of
16. Canada Depository Services Program .
17. House of Commons Debates, 039 (5 December 2002)(Hon. Allan Rock).
18. House of Commons Debates, 043 (11 December 2002)(Hon. Allan Rock).

BIBLIOGRAPHY

Reports

Patenting Of Higher Life Forms And Related Issues: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee (Ottawa: Canadian Biotechnology Advisory Committee, 2002) online: Government of Canada Depository Services Program .

Cases

Abitibi Co., Re (1982), 62 C.P.R. (2d) 81 (Patent Appeal Board & Patent Commissioner).

Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, 447 U.S. 303 (1980).

Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623, 60 D.L.R. (4th) 223, aff’g [1987] 3 F.C. 8 (C.A.).

Harvard College v. Canada (Commissioner of Patents), (2002) 219 D.L.R. (4th) 577, 2002 SCC 76.

Statute

Patent Act, R.S.C. 1985, c. P-4, as amended.

Plant Breeders’ Rights Act, S.C. 1990, c. 20.