BIOTECHNOLOGY PATENTING IN CANADA

MICHAEL F . GILLEN, Ph . D .

Senior Patent Examiner

Biotechnology Section, Patent Branch

Canadian Intellectual Property Office

Hull, Quebec, CANADA

K1A OC9

Canada's patent system has undergone significant change over the past eight years. Canada has moved from a "first-to-invent" .system to a "first-to-file" system, has adhered to the Patent Cooperation Treaty, has adopted the International Patent Classification (IPC) system for classifying documents, and is now a member of the Budapest Treaty on the International Recognition of the Deposit of microorganisms for the Purposes of Patent Procedure (The Budapest Treaty). In addition, in 1990, Canada enacted a Plant Breeders' Rights Act (PBRA) for the protection of new plant varieties, and in 1991, ratified the Convention of the International Union for the Protection of New Varieties of Plants (UPOV).

Canada became a "first-to-file" country on October 1, 1989 with the coming into force of a new Patent Act.

Patents in Canada are now granted to the first inventor to file an application. The new Act also introduced the concept of absolute novelty, replacing the two year grace period under the old Act. An invention described in a patent application i~ considered "old" if there has been public disclosure anywhere in the world before the filing date, or before the priority date if convention priority rights are being claimed. An exception to the absolute novelty provision, is disclosure to the public by an applicant or by a person who obtained knowledge of the invention from the applicant, directly or indirectly. Such a disclosure can be made up to a year before the Canadian filing date.

The 1989 amendments to the Patent Act also provide for (a) applications being "laid open' to public inspection 18 months after the earlier of the filing date and the priority date, (b) a patent term which ends 20 years after the filing date of an application, (c) the filing of ‘prior art" which a third party believes to be pertinent to the patentability of a claim in a pending application or in an issued patent, (d) examination of an application only after an applicant has made a request for examination and paid a prescribed fee, and (e) yearly fees to maintain an application in effect or to maintain patent rights.

Further amendments to the Patent Act and Patent Rules which came into force on October 1, 1996 are particularly relevant to biotechnology inventions. Thus, patent specifications which disclose nucleotide and/or amino acid sequences which are not prior art sequences, must now include a "sequence listing" and be accompanied by a copy of the listing in electronic format, i.e., on diskette. A "sequence listing" includes the actual sequence(s) and associated information and is part of the description section of the specification. Applicants can also now rely on a reference in a specification to a deposit of biological material to supplement the written description of an invention. Where an invention is biological material or where the invention relies on biological material, words alone may not be sufficient to fully describe the invention and therefor to satisfy the disclosure requirements of the Act. Access to the biological material may also be necessary. The deposit must have been made before the filing date of the application and in an International Depository Authority (IDA) under the Budapest Treaty. The Patent Rules also provide for limiting access to a sample of deposited material. An applicant can elect, prior to an application being "laid open", that until a patent issues on the basis of the application, or until the application is withdrawn, abandoned and no longer subject to reinstatement, or finally refused, that a sample of deposited biological material referred to in the application be furnished only to an independent expert nominated by the Commissioner of Patents.

While the Patent Act and Patent Rules have undergone significant revision over the years, the definition of invention in the Act has remained unchanged and is essentially the same as that found in the United States statute. Section 2 defines "invention" as "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". The requirement, imposed by the courts, that an invention also be non-obvious to one of skill in the art, is now part of the Act (section 28.3) as a result of the 1996 amendments. Thus, by statute, patents are granted for what is new, useful and the result of inventive ingenuity. However, not "anything under the sun" is patentable subject matter. Some things are excluded.

Exclusions from patentability have been based on an interpretation of the definition of "invention". With respect to inventions in biotechnology, section 2 of the Patent Act has been interpreted to exclude multicellular differentiated organisms (i.e., higher life forms like animals, plants and seeds), methods which occur essentially according to the laws of nature without any significant human technical intervention, and methods of medical or surgical treatment of humans and animals, including methods of preventive medicine (e.g. vaccination) but excluding non-surgical methods which are purely diagnostic or are solely for deriving some economic benefit from an otherwise healthy animal (e.g., a method to increase milk production in a cow).

Patents are granted with claims to the following kinds of biotechnology products and processes:

(a) DNA, RNA and oligonucleotides, whether naturally occurring or synthetic, including protein-encoding sequences, promoters, linkers, probes and vectors;

(b) proteins and polypeptides, whether naturally occurring or synthetic, including structural proteins, enzymes and antibodies;

(c) unicellular life forms and viruses, including naturally occurring bacteria, yeast and certain fungi, transformed host cells, cells in culture and hybridomas;

(d) diagnostic methods and kits;

(e) cell culture media;

(f) processes to prepare, isolate, modify or manipulate biotechnology products and living matter, including plants and seeds, provided the processes involve significant human technical intervention;

(g) processes which rely on living matter, including processes which use microorganisms to produce known or novel products, and processes where living organisms are used in bioremediation or in the control of agricultural diseases and pests;

(h) apparatuses designed to carry out biological processes, including those with a medical application.

Naturally occurring gene sequences, proteins and microorganisms can be patented provided they are newly discovered, have a utility, and are claimed not as they occur in nature, but as isolated and characterized products. Claims are rejected which extend to these products in their natural environment. DNA, RNA and proteins are considered as chemical compounds and not as living matter. No distinction is made between substances isolated from human sources and substances isolated from non-human sources. Patents are also granted with claims directed to the use of biological products including new uses of known products.

Prior to 1982, patents were not granted in Canada with claims to living matter. In that year, a Commissioner's Decision (Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81) led to the granting of patents with claims to unicellular life forms, including microorganisms and cells in culture. The Commissioner’s Decision established the patentability of lower life forms ‘produced en masse as chemical compounds are produced" and "formed in such large numbers that any measurable quantity will possess uniform properties and characteristics. ‘ The Abitibi application was directed only to microorganisms and the patentability of higher life forms, like plants and animals, was not at issue in this case.

In the years following the Abitibi decision, the Commissioner refused to grant a patent for a plant and its seed (Re Application for Patent of Pioneer Hi-Bred Ltd. (1986), 11 C.P.R. (3d) 311', and for a genetically engineered mouse (Commissioner' B Decision re application no. 484, 723, available from the Federal Court of Canada under Court no. T-275-96). In each case, applications were refused on the grounds that the claimed subject matter was outside the definition of "invention".

Specifically, the Commissioner did not consider that a life form, like a plant or an animal, was a "manufacture" or a "composition of matter" for the purposes of section 2 of the Patent Act. The "plant" application claimed a new variety of soybean produced by crossing-breeding. On appeal, the Federal Court upheld the Commissioner's ruling (Pioneer Hi-Bred Ltd. v. Commissioner of Patents (1987), 14 C.P.R. (3d) 491). An appeal to the Supreme Court resulted in a refusal of the patent application for lack of sufficient disclosure. The question of patentable subject matter was not considered by this Court (Pioneer Hi-Bred Ltd. v. Commissioner of Patents (1989), 25 C.P.R. (3d) 257). The "mouse" case is now under appeal before the Federal Court and the fate of this application will not be known until the Court has rendered a decision.

While patents are not granted with claims to plants, protection for new plant varieties which are distinct, uniform and stable is available under the Plant Breeders' Rights Act which i8 administered by the Federal Department of Agriculture and Agri-Food. Canada is bound by the 1978 revision of the UPOV Convention and currently provides protection for varieties of 39 crop categories. Plant breeders' rights include the exclusive right to sell propagating material, as such, to produce a protected variety in Canada for the purpose of selling the propagating material, and to make repeated use of the protected variety to commercially produce another variety or to Produce ornamental or cut flowers.

There are no provisions in the Patent Act or Patent Rules for third parties to object to a pending patent application or to an issued patent on religious, ethical or social grounds. Canada's statute does not include a section similar to Article 53(a) of the European Patent Convention relating to "ordre public". However, either while an application is pending, or after a patent has issued, anyone can file "prior art" to show that an invention was old or would have been obvious to one of skill in the art on the filing date or priority date of the application for patent. With an issued patent, the filing of "prior art" is accompanied by a request for re- examination and a re-examination fee is required. Re-examination is based solely on the "prior art" submitted and does not take into consideration any religious, ethical or social concerns.

Individuals and groups within society have already begun to ask questions of a moral or ethical nature vis-a-vis biotechnology. As the science continues to evolve and to cross new frontiers, it will come under increased public scrutiny. It remains to be seen how patent law and statutes governing the environment, animal rights, and human dignity in jurisdictions throughout the world will change in answer to public concerns with respect to biotechnology.

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