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Comité consultatif canadien de la biotechnologie
Accueil Publications Recherche 2001

Intellectual Property Protection for Biological Innovations (disponible en anglais seulement)

Ce document est présenté dans la langue dans laquelle il a été fourni par l'auteur ou la source

Prepared for

The Canadian Biotechnology Advisory Committee Project Steering Committee on Intellectual Property and the Patenting of Higher Life Forms

By Mona Frendo
January 2001

Table of Contents

  1. Introduction
  2. Patent Act
    1. What is a Patent and What is the Role of the Patent System in Canada?
    2. What is included/excluded from patentability in Canada in terms of biotechnological innovations?
      1. Products
        1. Genetic Material
        2. Unicellular Organisms
        3. Non-Human Multicellular Organisms
        4. Human Body Parts
        5. Human Body
      2. Processes
        1. Non-Biological and Essentially Biological Processes
        2. Gene Therapies
        3. Cloning
      3. Methods of Medical Treatment
  3. Plant Breeders’ Rights Act
    1. What is the purpose and the application of the Plant Breeders’ Rights Act?
  4. Conclusion

  1. Introduction

    Biotechnology is expected to become a leading driver for technological innovation in this century. It has the potential to improve the quality of our health care, the environment and our agriculture, mining and manufacturing practices. It also has the potential to become an engine for job creation and economic growth in the global economy. Public opinion research indicates that Canadians want to reap the economic and social benefits of biotechnology; nonetheless, they want government controls in place to temper the impact of biotechnology upon their daily lives. As GPC Communications stated in their recent report to the Biotechnology Ministerial Coordinating Committee:
    there is a fear that certain applications of biotechnology, such as genetically modified foods, plants and animals, being introduced [into society] without a complete understanding of their long-term effects and in the absence of an agreed, contemporary and all-encompassing government policy and regulatory system.

    As a result, one of the challenges Canada will face in the 21st century is to develop a socially, economically and politically acceptable policy on the patenting of biotechnological products and processes, especially with regards to multicellular organisms or higher life forms. This paper seeks to aid in the effort to formulate such a policy by examining the legal foundation upon which it must be built. There are numerous provisions in the Patent Act and the Plant Breeders’ Rights Act which dictate the nature of intellectual property protection presently accorded to biotechnological products and processes in Canada. These provisions will be discussed in depth in the following paragraphs.

    This paper is divided in two main sections. The first focuses on the Patent Act. It discusses the definition of a patent, the role of the patent system in Canada and the process for receiving and appealing a patent decision. In addition, it contains a detailed analysis of what types of biotechnological products and processes are currently included or excluded from patentability in Canada. The second section focuses on the Plant Breeders’ Rights Act. It elaborates on the purpose and application of the Plant Breeders’ Rights Act as well as the differences between this Act and the Patent Act. The second section also discusses the subject of farmer’s privilege and how this privilege functions in relation to the Plant Breeders’ Rights Act.

  2. Patent Act

    1. What is a Patent and What is the Role of the Patent System in Canada?

      A patent is an exclusive property right in a new invention. The Patent Act states that the federally appointed Commissioner of Patents (“Commissioner”) shall grant a patent in a new product or process to the inventor or the inventor’s legal representative if the patent application meets all the requirements of the Act (section 27(1)). The holder of a Canadian patent receives the right to prevent all others in this country from manufacturing, using or selling the patented invention for a period of twenty years from the date of filing the application1. He or she also receives the right to assign a partial or whole interest in the patented invention to another person, institution or corporation. That said, a patent is not an automatic guarantee of economic success for the patent holder. The mere fact that an invention is patented does not enhance its chances at receiving additional regulatory or market approval. Similarly, distribution rights are not included in a patent; they must be independently arranged for by the inventor or the inventor’s legal representative.

      According to the Patent Act, there are two main requirements for patentability. Firstly, the innovation claimed in a patent application must qualify as an ‘invention’ within the definition of section 2 of the current Patent Act. Section 2 states that an ‘invention’ is:
      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.

      Secondly, the innovation must be absolutely novel, useful and non-obvious. Practical interpretations of these three terms have developed over time in keeping with the meaning and the purpose of the Act. Today, an innovation will not satisfy the absolute novelty requirement if thereis any record of the same product or process being previously patented. As well, an innovation will fail to meet the absolute novelty test if its subject matter was disclosed in any forum (including the media, a conference, a presentation, etc.) prior to its patent application filing date. The only exception is if the claimed innovation was disclosed by the patent applicant or by a person who obtained knowledge of the innovation directly or indirectly from the applicant. In this case, the disclosed innovation will still be able to meet the absolute novelty test if its patent application is filed within one year of the disclosure2.

      In order to fulfill the utility criterion an innovation must have industrial value within the traditional sense of the word. Products or processes which only have aesthetic appeal or intellectual meaning, but no practical application in industry, trade or commerce settings are not considered useful under the Act3.

      In order to meet the non-obvious criterion, an innovation must not be apparent to a person skilled in the art or science to which it relates. Satisfying the non-obvious requirement is often difficult because it involves a number of steps. To begin with, the applicant must clearly identify the precise innovation claimed in the patent application. As well, he or she must determine what information relating to the innovation was public knowledge and what information a person skilled in the relevant art or science likely knew at the time of filing. After all this information is compiled, the Commissioner must evaluate whether the difference between what was already common knowledge (i.e. prior art) and the claimed innovation is sufficient enough to render the innovation non-obvious.

      It is important to note that the decision whether an innovation qualifies as an invention and meets the novelty, utility and non-obvious requirements rests with the Commissioner. The latter has the authority to grant or reject a patent application as long as that authority is exercised in keeping with the Patent Act and previous court decisions. However, a patent applicant has the right to seek recourse from the courts if the Commissioner rejects his or her application. The patent applicant may appeal the Commissioner’s decision as of right to the Federal Court of Canada and, with permission, to the Supreme Court of Canada (“SCC”).

      The Canadian patent system benefits not only the individual patent holders, but society as a whole as well. The prospect of reaping economic rewards from patented innovations spurs people and companies to invest their time and money into novel areas of scientific research. Consequently, new and better products and technologies become available to the public at a faster pace. In addition, society’s collective knowledge is enriched by the public disclosure of all data contained in patent applications and any related documents. The Patent Act states that all patents, patent applications and any documents filed in connection with them shall be laid open for public inspection at the Patent Office eighteen months from their filing date4. Since patent applications need to include sufficient information about the nature, construction and anticipated use of new innovations so as to enable any person skilled in the art or science to which it pertains to make, construct, compound or use them, the mandatory disclosure of all this data ensures that knowledge about new and useful products and processes is widely shared5. Another advantage of the patent system for Canadian society is that persons other than the patent holder can benefit financially from patented inventions. The Patent Act expressly states that a non-patentee has the right to be granted a license in a patented invention if it is in the public interest to do so and the terms of the license are reasonable. Accordingly, a non-patentee could receive a license to sell a patented product in Canada (e.g. a medical drug) and assume all the profits except the royalty fee paid to the original patent holder.

    2. What is included/excluded from patentability in Canada in terms of biotechnological innovations?

      By definition, a biotechnological innovation is a product or process that produces or manipulates biological material. The advent of genetics-based biotechnology allows scientists to manipulate living organisms in ways that were not previously possible. While these manipulations sometimes result in valuable health and other benefits for humans, animals and plants, they also introduce new social, legal, and policy considerations.

      In Canada, the list of what is patentable or not in terms of biotechnology is far from settled. Over the years, however, the Commissioner and the courts have interpreted the Patent Act to include and exclude certain categories of biological innovations.

      1. Products
        1. Genetic Material

          The fundamental building blocks of the human body- DNA, RNA, proteins and genes- can be patented in Canada if they meet the statutory criteria of novelty, utility and non-obviousness. As such, a claim for a gene sequence in a patent application could be granted as long as the sequence had been isolated or purified from its natural state, had no previously known existence and had an established function. However, a claim that did not disclose a function for a gene sequence would be refused.

          The Commissioner’s rationale for allowing the patenting of genes and gene sequences is that they are basically chemical compounds, much like complex sugar or protein molecules, when removed from their natural state. Consequently, they too are patentable subject matter under the current Patent Act.

        2. Unicellular Organisms

          Unicellular organisms (e.g. bacteria, algae, cell lines and hybridomas) were the first type of life forms to be patentable in Canada6. In 1982, the Commissioner held that unicellular organisms should be patentable because they are very much akin to the products of inanimate chemical reactions. Much like reactants, reagents and catalysts, these organisms could be reproduced en masse such that they all possess uniform properties and characteristics7. The Commissioner also stated that Canada should no longer refuse patents on living matter per se in light of the new trend towards granting patents on microorganisms in the United States, United Kingdom, Australia and Japan.8 As a result of this decision, the Canadian Intellectual Property Office (“Canadian Patent Office”), the federal body that administers the Patent Act, modified its practice guide to permit claims to microbial life forms on the basis that they were very similar to the products of chemical reactions.

        3. Non-Human Multicellular Organisms

          Until very recently, multicellular organisms (e.g. genetically-modified plants and animals) were not patentable in Canada. However on August 3rd, 2000, a decision of the Federal Court of Appeal (“FCA”) altered the status quo as far as genetically-modified animals were concerned. In a case entitled President and Fellows of Harvard College v. Commissioner of Patents and Canadian Environmental Law Association (Intervenor), the majority of the FCA held that the Patent Act’s current definition of ‘invention’ should be construed broadly because “inventions are, necessarily, unanticipated and unforeseeable.”9 This reasoning led the majority to overturn the decisions of both the Commissioner and the Federal Court Trial Division (FTD) and conclude that the Harvard oncomouse, a genetically-modified mouse, was a new, useful and non-obvious ‘composition of matter’ that qualified as a patentable ‘invention’ in Canada.

          In arriving at this conclusion, the FCA’s majority relied heavily upon the decision of the United States Supreme Court (“USSC”) in Diamond, Commissioner of Patents v. Chakrabarty. In this landmark American case, the majority of USSC reasoned that since the language in the U.S. Patent Act was broad and general, Congress must have intended the Act’s definition of “invention” to be given wide scope10. The majority of FCA noted this point and stated that since the language in the Canada’s Patent Act is very similar to that of the U.S., Parliament must also have intended its statutory definition of “invention” to be interpreted broadly.

          As a result of the FCA’s decision, genetically-modified animals are now patentable subject matter in Canada. Nonetheless, it should be noted that the Commissioner has sought permission to appeal the FCA’s judgment to the SCC and as such, the matter is not settled. It is unlikely that the Canadian Patent Office will issue a patent on the Harvard oncomouse or any other genetically-modified animal before the SCC renders its decision on the case.

          The non-patentability of other multicellular organisms in Canada (i.e. plants, plant seeds and plant parts) was not dealt with in the recent Harvard oncomouse judgment11. On this matter, another decision of the FCA still stands. In Pioneer Hi-Bred Ltd. v. Commissioner of Patents, the FCA considered the patentability of a new soybean variety as well as certain selection techniques that included seeds of the new variety12. It concluded that the current definition of ‘invention’ in the Patent Act. In particular, the court stated that:
          the common ordinary meaning of the words “manufacture” and “composition of matter” [within section 2 of the Act] would be distorted if a unique but simple variety of soybean were to be included within their scope…such a plant cannot really be said, other than on the most metaphorical level, to have been produced from raw materials or to be a combination of two or more substances united by chemical or mechanical means13.

          This decision was appealed to the SCC14. However, the highest court chose not to address the issue of the patentability of a new plant variety in its final judgment. Instead, the Supreme Court dismissed Pioneer Hi- Bred Ltd.’s appeal on the grounds that the appellant had not sufficiently disclosed the nature of the invention claimed in its patent application.

        4. Human Body Parts

          In Canada, human body parts, such as limbs, organs and tissues, cannot be patented in their natural form (i.e. as they exist within the human body) because they are not new inventions. In addition, modified human body parts (i.e. limbs, organs or tissues that have been isolated from the body and genetically altered) cannot be patented because they are multicellular organisms15. In comparision, modified human organs and tissues can receive patent protection in the United States, Japan and Australia.

          The use of human body parts that have been isolated and modified from their natural state is patentable in Canada.

        5. Human Body

          The human body is also not patentable in Canada. However, there is no clause in the Patent Act or in the regulations stating as much, nor have the courts conclusively decided the issue16.

          The rationale for denying a patent claim to a human being in Canada would be two-pronged17. Firstly, an innovation pertaining to the whole human body would not be patentable subject matter in Canada because it is neither a “manufacture”, nor a “composition of matter”. Thus, it cannot be considered an ‘invention’ within the current meaning of the Patent Act. Secondly, it could be argued that a patent on a human body is not permissable because it would violate the inalienable right to life, liberty and security of the person guaranteed to all people under section 7 of the Canadian Charter of Rights and Freedoms. This argument was cited, in obiter, by Judge Rothstein of the FCA in the Harvard Oncomouse decision as justification for his conclusion that humans are not patentable in Canada.

      2. Processes

        1. Non-Biological and Essentially Biological Processes

          As a result of the statutory definition of ‘invention’ in the Patent Act, most microbiological processes are patentable in Canada. However, there are certain exceptions. Essentially biological processes that utilize or produce biological material are excluded from patent protection in Canada. The reasoning is that essentially biological processes do not require significant human intervention to occur; they would occur in nature regardless of human involvement. Thus, they do not satisfy the Patent Office’s requirement for inventive ingenuity. As a result of this exception, traditional animal and plant breeding methods (e.g. crossbreeding) cannot be patented in Canada even where human intervention is involved in selecting mating partners and the breeding is done under human-controlled conditions.

        2. Gene Therapies

          Gene therapies are patentable in Canada unless they are methods of medical treatment. There are two types of gene therapy- somatic cell gene therapy and germ line gene therapy18. The former affects only individuals upon whom it is performed since it remedies genetic defects in non-reproductive cells. The latter, in comparison, has the potential to affect the future offspring of the persons upon whom it is performed because it remedies genetic defects in reproductive cells.

        3. Cloning

          Cloning is the process of transferring DNA from the nucleus of an adult multicellular organism’s cell into an unfertilized egg of the same species. The result is an entity that is genetically identical to the organism from which the DNA was originally taken. Transgenic cloning takes this same procedure one step further. After removing the DNA from the nucleus of the adult organism, transgenic cloning adds a new gene to the DNA and then inserts the genetically-modified DNA into an unfertilized egg of the same species. Although both cloning and transgenic cloning for the purposes of human reproduction are unpatentable in Canada, the creation of animals by cloning is patentable subject matter.

      3. Methods of Medical Treatment

        A method of medical treatment (i.e. a process of treating a disease in humans or animals by surgery or therapy) is not patentable in Canada. According to the Supreme Court’s decision in Tennessee Eastman Co. v. Commissioner of Patents, a surgical or therapeutic process that is performed on humans or animals cannot be patented because it does not satisfy the utility requirement for an invention19. Traditionally, the utility criterion in the Act is satisfied if an innovation has industrial applicability. The nature of curative treatments for humans or animals is such that they will rarely meet this requirement.

        Since the Tennessee Eastman decision, there have been numerous judicial pronouncements that have limited the scope of what qualifies as a ‘method of medical treatment’. For instance, the courts have held that diagnostic methods and any processes that do not involve actual treatment of the human body or an animal are not ‘methods of medical treatment’ in the strictest sense, and therefore can be patented20. As well, patent claims have been allowed for new therapeutic uses of existing compounds even though these new uses can be seen as essentially new ‘methods of medical treatment’21. It should also be noted that articles or apparatus designed for use in the treatment of humans or animals may be patentable if they meet the statutory requirements.

  3. Plant Breeders’ Rights Act

    1. What is the purpose and the application of the Plant Breeders’ Rights Act?

      The rights accorded to plant breeders under the Plant Breeders’ Rights Act (“PBRA”) are separate and distinct from any other form of intellectual property protection. The intent of the legislation is to stimulate plant breeding in Canada, facilitate the access to protected foreign varieties and facilitate the protection of new Canadian varieties in other countries. The PBRA permits a plant breeder who has developed a new plant variety to obtain the exclusive rights in Canada for a period of eighteen years for a new variety of any plant species excluding algae, bacteria or fungi22. The rights granted under the PBRA include the right to sell and produce a new plant variety for the specific purpose of selling its propagating material (e.g. seeds, cuttings, etc.) in Canada as well as the right to authorize others to do the same2324. A plant breeder who has received PBRA protection for a new plant variety has a legal remedy against anyone else who attempts to sell the new variety’s propogating material without authorization. However, he or she has no remedy if the new plant variety is sold as an end product (e.g. as grain), except where that end product is cut flowers or an ornamental plant variety. The Act also states that repeated use of a plant variety’s propagating material to produce another variety (e.g. an in-bred line constantly used in a cross to produce a hybrid) infringes the rights accorded by the PBRA25.

      To receive PBRA protection, a new plant variety must satisfy four statutory requirements26. To begin with, it must be a variety that has not been sold in Canada or outside of Canada for longer than four years. Second, it must be a distinct variety in that it is clearly distinguishable from all other varieties commonly known at the time of the PBRA application. Third, it must be a stable variety capable of repeated reproduction so that each subsequent plant generation resembles the parent plants. Finally fourth, it must be a uniform variety such that all of the plants look approximately the same.

      There are two critical differences between the PBRA and the Patent Act. The first relates to the fact that the rights granted under the PBRA are more limited in scope than those under the Patent Act. Under the latter Act, a patent holder gains protection over every commercial utilization of his or her patented invention. He or she also has the authority to decide whether anyone else can make, sell or use the patented invention for commercial purposes. However under the former Act, a PBRA holder only gets protection over the commercial production and sale of the protected variety’s reproductive material. Furthermore, there are no provisions to prevent other people from using the seeds of the protected plant variety as propagating material for their personal use or to produce another variety.

      The second important difference relates to the subject of farmer’s privilege. Although there is no specific provision in the PBRA, it is implied therein that Canadian farmers are allowed to save and reuse the seeds obtained from their cultivation of protected plant varieties without making any further payment to the original plant breeder or infringing the breeder’s rights. In comparison, there is no similar implication in the current Patent Act. This is primarily because plants and seeds are not patentable subject matter in Canada at the moment. However, should the Act’s definition of ‘invention’ be broadened to include plants and seeds in the future, the need for including a clause to protect farmers’ rights to save and use patented seeds or propagating material would have to be addressed. In particular, the issue of whether saving or reusing the seeds of a protected plant variety that contained a patented gene without authorization from the gene patent holder constitutes patent infringement would need to be determined.

  4. Conclusion

    As is evidenced by the aforementioned paragraphs, the current Patent Act and Plant Breeders’ Rights Act impose limits on the intellectual property protection afforded to biotechnological products and processes in Canada. Presently, it is only possible to receive patent protection for biotechnological innovations involving simple or complex chemical compounds, unicellular organisms and most microbiological processes. To date, patents have not been allowed on innovations involving higher life forms because it is the Canadian Patent Office’s position that multicellular organisms do not satisfy the definition of “invention” within the current Patent Act. Likewise, the protection afforded under the Plant Breeders’ Rights Act is limited to the propagating material of any new protected plant variety, and does not extend to its plant parts, DNA, RNA or genes. However, the dawn of a new technological revolution may mean that these legal limits need to be revised. Canada’s success in the new knowledge-based economy depends critically on the growth of sectors like biotechnology that foster innovation and entrepreneurship. To this end, it may be necessary for Canada to review its practices and policies on the intellectual property protection of biotechnological innovations to ensure that Canada is capable of being competitive in the global marketplace and that Canadians are able to safely avail themselves of the economic, social and health benefits of biotechnology.

  1. 1 Only patents filed on or after October 1st, 1989 receive a 20 year term of patent protection starting from the date on which the patent application was filed. Patents filed before October 1st, 1989 receive a 17 year term of patent protection starting from the date on which the patent was granted.
  2. 2 supra note 2, s.28.1(a)
  3. 3 Manual of Patent Office Practice (last revised September 2000), Chapter 16.02.01, 16.03
  4. 4 supra note 2, s.10(2). Please note that if the applicant approves, information about his or her patent application and any documents that were filed at the same time can be made open to the public before the end of the confidentiality period of eighteen months.
  5. 5 supra note 2, s. 27(3).
  6. 6 See Website on Biotech: Life Sciences Resources and Reference Tools, (http://biotech.icmb.utexas.edu). A cell line is a culture of a particular type of cell that can reproduce indefinitely, thereby making the cell line “immortal”. A hybridoma is an immortalized antibody-secreting cell line that is used to produce certain desirable antibodies.
  7. 7 Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81 at 89. (Pat. App. Bd.)
  8. 8 ibid at 88.
  9. 9 [2000] F.C.J. No. 1213 at 17.
  10. 10 206, U.S.P.Q. 193 (1980) at 200.
  11. 11 Although the FCA’s reasoning that the definition of ‘invention’ must be given wide scope because “inventions are, necessarily, unanticipated and unforeseeable” may have legal implications for the patentability of multicellular organisms other than genetically-modified animals like the Harvard oncomouse, the legal situation is still unclear in light of the Commissioner’s decision to seek leave to appeal the FCA’s decision to the SCC.
  12. 12 Pioneer Hi-Bred Ltd. v. Commissioner of Patents (1987), 14 C.P.R. (3d) 491 (F.C.A.).
  13. 13 ibid at 495-496.
  14. 14 (1989), 25 C.P.R. (3d) 257 (S.C.C.).
  15. 15 See note 12. Should the FCA’s decision in the Harvard Oncomouse case be upheld by the SCC, the legal argument for the patentability of other multicellular organisms like modified human body parts could be strengthened.
  16. 16 However, the majority of the FCA did state, in obiter, in the Harvard Oncomouse case that “the Patent Act cannot be extended to cover human beings. Patenting is a form of ownership of property. Ownership concepts cannot be extended to human beings.” see President and Fellows of Harvard College v. Commissioner of Patents and Canadian Environmental Law Association (Intervenor), [2000] F.C.J. No. 1213 at 56.
  17. 17 As of January 2001, there are no patent applications for a human being on file with the Canadian Patent Office.
  18. 18 See Website on Human Genome Project Information (http://www.doegenomes.org/)A gene therapy is a therapeutic process of treating a genetic disease by replacing a defective gene in a human being or an animal with an effective one.
  19. 19 (1972), 8 C.P.R. (2d) 202 (S.C.C.)
  20. 20 See Re Application for Patent of Goldenberg (Now Patent No. 1,244,344) (1988), 22 C.P.R. (3d) 159 (Pat. App. Bd. and Comm. of Pat.)
  21. 21 See Re Application for Patent of Wayne State University (1988), 22 C.P.R. (3d) 407; Re Application for Patent of Merck & Co. Inc. (now patent No. 1,294,879) (1992), 41 C.P.R. (3d) 52.
  22. 22 The PBRA covers all plant species as of December 23, 1998.
  23. 23 Plant Breeders’ Rights Act, S.C. 1990, c. 20, am. by S.C. 1994, c.38; 1995 c.1, section 5(1)(a), 5(1)(d).
  24. 24 The rights accorded under the PBRA are in line with Canada’s international obligations under the 1978 International Convention for the Protection of New Varieties of Plants (1978 UPOV Convention) to which Canada is a signatory, and not the more recent 1991 UPOV Convention. Canada has yet to ratify the 1991 Convention. The 1991 Convention indicates that a broader range of plant materials can be protected using plant breeders’ rights seeds, propagated or harvested materials, essentially derived materials and seeds.
  25. 25 supra note 20, s.5(1)(b)
  26. 26 ibid at section 4(2) and 7(1)
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