Patenting of Higher Life Forms and Related Issues: Summary of Comments, Responses to CBAC Interim Report

Summary of Contents

Responses to CBAC Interim Report on Biotechnological Intellectual Property and Patenting of Higher Life Forms

This document sets out the range of views provided to the Canadian Biotechnology Advisory Committee (CBAC) in response to the draft recommendations contained in our Interim Report on the Patenting of Higher Life Forms. The majority of those who responded to our invitation to provide feedback had a stake in biotechnology -- they were members of the biotechnology industry, users of these technologies, industry or university researchers, or funders of research in the biotechnology field. The reader should bear in mind that this group of commentators is not a random sample of the Canadian public. The strength of support for any particular view described in this document does not, therefore, necessarily represent that of the Canadian population.

Despite this limitation, the responses we received have assisted us in developing the recommendations in our report by providing us with a better understanding of the range of views concerning the issues addressed in the interim report. We believe these views provide an important double-check on our research and on our previous consultations. It also reflects our commitment to transparency and consultation. As noted in the report itself, the responses have helped us hone our recommendations and to introduce more subtlety into the discussion of those recommendations.

Thus, while we caution the reader not to read this document as revealing a snapshot of current Canadian public opinion on the issues addressed in the Report, we believe that this document provides a useful summary of the concerns arising in relation to the patenting of biological inventions.

Approaches to Addressing Social and Ethical Considerations

These three approaches to addressing social and ethical concerns raised by or related to patenting of higher life forms were described in detail in the interim report. We asked readers whether this characterization was a useful way of discussing the issue and we also asked them to tell us which of the three approaches seemed most likely to address the issues of greatest concern to them.

There was general agreement that these general approaches set out the policy alternatives available to Canada. Apart from this general agreement, however, respondents differed significantly on their preferred approach. Most selected either the status quo approach or the open-ended approach. Even most of those who ostensibly supported the alignment approach in actuality favoured the creation of a more open-ended mechanism.

While cautioning the reader not to interpret the responses received as expressing the opinion of Canadians as a whole or even of a segment of the Canadian population, the industry responses that we received in respect of this question strongly favoured the status quo approach. Those who supported this position argued that the Patent Act was not the appropriate vehicle through which to deal with social and ethical values. Parliament has, these respondents argued, better instruments such as regulation and other laws to deal with the potential negative social and ethical effects of biotechnology patenting. Some respondents felt that higher life form patents raised no social issues, although they agreed that the use of the technology so patented might on occasion raise concern.

On the other hand, most university, government, non-governmental organizations and individual respondents favoured the open-ended approach. They argued that patenting higher life forms has direct and important social and ethical repercussions that can only be addressed through the introduction of an ethically oriented mechanism into the Patent Act. Respondents tended to favour an ethical review process parallel to the patent examination process, with an independent group of experts sitting as a tribunal separate from the patent office to rule on the social and ethical implications of an invention. These respondents argued that their position was in line with the patent legislation of Canada’s major trading partners and thus should provide no disincentive for research and development in Canada.

Responses to Draft Recommendations

1. CBAC recommends that the Patent Act include a statement that human beings, at all stages of development, are not patentable.

This recommendation met with the overwhelming support of those who responded to our Interim Report. Only one respondent opposed the recommendation, not on principle, but because of the difficulty of defining the meaning of such terms as "human beings" and "all stages of development."

If the recommendation met with strong support by the respondents, it was also heavily criticized for lacking clarity. Respondents from all walks of life pointed to the importance of clarifying the scope of the exception. Most pointed to the open-ended nature of terms such as "human beings" and "all stages of development." One respondent noted that the term "human being" included metaphysical aspects of being human and thus was much too broad a term.

There was little agreement on how to clarify the phrases cited. Some, for example, wished the exclusion to apply only to whole human bodies; others called for the exclusion of human genes and other human materials from the scope of patent law. Industry respondents were most opposed to extending the exclusion beyond whole human beings while universities, non-governmental organizations, and individuals were most inclined to include a wider range of human materials in the exclusion.

Some respondents, particularly those from the agricultural sector, felt that it was beyond the scope of their mandate to comment on this recommendation.

2. CBAC recommends that higher life forms (i.e., plants, seeds and non-human animals) which meet the criteria of novelty, non-obviousness and utility be recognised as patentable, subject to the limits on patent holders’ rights contained in draft recommendations 3, 4 and 5.

There was a clear division in the nature of the responses we received between the biotechnology industry and the agricultural and non-governmental communities. While industry and universities were in favour of extending patent protection to plants and animals, those who used plants and animals for agricultural purposes, as well as those concerned about the effects of plant and animal patents on the environment and on the developing world, were strongly opposed to this proposal.

The industry respondents put forward the view that, without patents, they would not be able to invest in the research and development necessary to bring a broader diversity of plants and animals to market. Patents, according to these respondents, will have a positive effect on both the animal genetics industry as well as on the environment. In order to maintain Canada’s competitive position with respect to its major trading partners, these respondents argued that Canada needs to extend patent protection to plants and animals while concurrently permitting creators of plant varieties to seek protection under the Plant Breeders’ Rights Act.

Those opposed to patenting plants and animals had a variety of reasons for their opinions. Some felt, for example, that patenting plants and animals is morally wrong, especially given the exclusion of humans from patent protection. Others argued that the current patent system is unable to adequately deal with the nature of biotechnological inventions. Given this, they submitted that plants and animals ought not to be patented.

The strongest opposition to higher life form patenting was provided by those engaged in the animal genetics industry and the livestock industry. They argued that patents over animals were particularly inappropriate since most of the value of an animal will not lie in the particular gene introduced by the patent holder, but by the overall genetic make-up of that animal determined by years of breeding. When, as these respondents urge, one recognizes that patents extend to progeny that will only possess a fraction of the original animal’s genes, patents seem to represent a substantial windfall to the biotechnology industry at the expense of the livestock and genetics industries. These respondents finally argue that patents will cause serious harm to Canada’s livestock industry, which, they point out, is larger than Canada’s biotechnology industry.

3. CBAC recommends that a farmer’s privilege provision be included in the Patent Act that specifies farmers are permitted to save and sow seeds from patented plants, or to reproduce patented animals as long as these offspring are not sold as commercial propagating material, in the case of plants, or commercial breeding stock, in the case of animals.

Most of those who supported extending patent protection to plants and animals were opposed to the inclusion of a farmer’s privilege. They argued that such a provision would undermine the incentive that patent protection would bring. Essentially, their position was that animal and plant patent holders ought to receive the same protection as patent holders in other industries. The inclusion of a farmer’s privilege would create, in their view, a special class of individuals entitled to infringe upon the plant or animal patent holder’s rights. Some industry respondents noted that the effect of such a provision would be to limit their protection to one generation of plant or animal. This, they argued, would increase the price of seeds to farmers and would diminish the quality of seeds grown in Canada. Industry respondents further argued that the existence of a farmer’s privilege exemption in the Patent Act would have a different effect from that in the Plant Breeders’ Rights Act.

Most of those who opposed the patenting plants and animals, including the non-governmental organizations that responded to the Interim Report, did not address the issues of farmer’s privilege since the privilege would not be needed in the absence of patents on plants and animals. Nevertheless, some of these respondents did support the provision. They argued that such a clause was needed to prevent an overextension of patent rights to future generations of the patented plant or animal. They also pointed out that the agricultural sector was larger than the biotechnology sector, and warned against awarding so large a set of rights to the biotechnology sector as to undermine the agricultural sector.

Both government and university respondents supported the inclusion of a farmer’s privilege within Canadian patent law.

4. CBAC recommends that the Patent Act include provisions that protect innocent bystanders from claims of patent infringement with respect to natural/accidental spreading of patented seed, patented genetic material, or the insemination of an animal by a patented animal.

Respondent opinion was quite varied with respect to this recommendation. There was even a substantial division within the group of biotechnology industry respondents. Some of these respondents felt that it would be better to deal with the accidental spreading of plants or animals through environmental law or the common law of negligence or the civil law of obligations. These industry respondents argued that the inclusion of the recommended provision would make it difficult to enforce patents over plants and animals. Other biotechnology industry respondents were willing to accept such a provision provided that clear language was used to describe the exclusion (by, for example, substituting the word "adventitious" for "natural/accidental") and that the person using this provision would need to provide scientific evidence in support of his or her claim.

Crop growers stated that the recommended provision was a logical necessity, given the nature of agricultural production and the difficulty of preventing volunteer patented crops from growing.

5. CBAC recommends that Canada actively participate in international negotiations to address issues of liability negotiations (such as those currently in progress under the Biosafety Protocol) for undesired natural/accidental spreading of patented seed, patented genetic material, or the insemination of an animal by a patented animal.

All respondents agreed that Canada ought to participate in international negotiations concerning liability issues with regard to genetically modified organisms. A number of respondents pointed out that, from the point of view of the one who has suffered damage, whether the particular plant, seed, animal or genetic material is patented is not relevant.

Some respondents argued that Canada ought to take the lead in these negotiations and ought to develop internal policies to address issues of accidental spreading first.

6. CBAC recommends that the Patent Act be amended to include a research and experimental use exception which states that it is not an infringement of a patent to use a patented process or product for either (a) private or non-commercial study, or (b) to conduct research on the subject-matter of the patented invention to investigate its properties, improve upon it, or to create a new product or process. In developing the specific provision, care should be taken to ensure that differential impacts among technologies or economic sectors are avoided.

While all but one respondent was in favour of an experimental use exemption, some of the biotechnology industry respondents preferred that the courts and not Parliament elucidate it. These latter respondents pointed out that section 55.2(6) of the Patent Act states that the judge-made experimental use exemption continues to exist in Canada. They argued that there was no need to further clarify the exemption in Canada. Some of these respondents stated that most patent holders would not, in any event, enforce patents against non-commercial entities conducting research. The plant and seed sector respondents felt that, since there is a research and experimental use exception in the Plant Breeders Right’s Act (PBRA), a similar provision is required in the Patent Act if plants become patentable.

Other biotechnology industry respondents as well as government, non-governmental, university, and professional respondents all agreed with the recommendation. One industry respondent argued that the exception should not be read to apply to patented components included in a final product. A university respondent called for the exception to apply to the use of an invention for instructional purposes.

One respondent noted that we had not completely followed the formulation of the exception as it exists in Europe. This respondent suggested that the "or" in subparagraph (a) be changed to an "and" to follow the language in Europe. In addition, this respondent wished to make it clear that subparagraph (b) would not permit the use of a research tool without a licence.

7. CBAC recommends that the federal research granting councils, the National Committee on Ethics in Human Research and other relevant bodies explore options for sharing the benefits of research (including its commercial exploitation) with the communities or populations involved in the research.

The respondents were generally in favour of this recommendation, although they found it vague. Some suggested making the recommendation stronger by having CBAC insist that the research granting agencies and other bodies do more than explore and actually develop policies with respect to benefit sharing. They also suggested that CBAC better define the concept of traditional knowledge. Other respondents stated that particular attention must be given to the Convention on Biological Diversity and its provisions dealing with obtaining informed consent of traditional knowledge holders.

Only one biotechnology industry respondent association was opposed to the recommendation; in this view, any direct sharing of benefits would undermine the value of patents. This respondent argued that communities and populations already benefit from research by having access to research and the products created by that research. Another respondent took the contrary view that there should be an obligation to invest part of the profits earned from the commercial exploitation of such innovations in supporting research for the health of the participating communities.

8. CBAC recommends that Canada support the efforts being undertaken in the World Intellectual Property Organization (WIPO) working group on Genetic Resources, Traditional Knowledge and Folklore to determine whether and how a form of intellectual property can be created for traditional knowledge.

Although few comments were addressed to this recommendation, some respondents called for an examination of the interaction of patent rights and Article 8(j) of the Convention on Biological Diversity, which calls on member countries to preserve and promote traditional knowledge. One respondent noted that there are currently discussions under this Convention dealing with the issue of traditional knowledge through the Ad Hoc Open-ended Working Group on the Implementation of Article 8(j) and Related Provisions and the Ad Hoc Open-ended Working Group on Access and Benefit Sharing. Some industry respondents felt that the issue of patentability of traditional knowledge was moot, as the criteria for patentability set out in the Patent Act (novelty, utility, and non-obviousness) would not be met by traditional knowledge, which, they argued, is, by its very nature, not new.

9. CBAC recommends that the Canadian Intellectual Property Office clarify that the description of the existing state of knowledge ("prior art") in patent applications must include, so far as is practicable, traditional knowledge that has been made public through oral, as well as written or published, transmission.

Views were mixed with respect to this recommendation. Certain biotechnology industry respondents found no justification for departing from existing practice with respect to traditional knowledge. These respondents argued that the specific inclusion of an obligation to disclose traditional knowledge in a patent application is unworkable and unfair. Applicants currently have no obligation to list all prior art. Given the often intangible nature of traditional knowledge, these respondents argue that it would be difficult for an applicant to find, let alone describe, the nature of traditional knowledge with any accuracy. The burden thus imposed would unfairly prejudice biotechnology patent applicants.

Not all biotechnology industry respondents agreed with this viewpoint. One found this recommendation worthwhile.

On the other hand, not all holders of traditional knowledge agreed with the recommendation. One such respondent stated that, until control and ownership of traditional knowledge are determined, traditional knowledge should not be available to the public for fear that it will be taken and used without the permission of or benefit to the community that created it.

10. CBAC recommends that a systematic program of research be undertaken on the impact of biotechnology patents on health services that would address, among other things:
    • the incentive or disincentive effects of patents on biotechnological inventions on the conduct of basic and applied research on preventive, diagnostic, therapeutic, epidemiological and service delivery aspects of health care
    • the effect of patents on the incentives and ability of patent-holders or companies to commercialise their inventions, thus making them available to the health care system
    • the effect of patenting of biological inventions on the net cost of health care, including comparative risk-benefit analyses of biotechnological and alternative methods
    • the effect of patenting of biological inventions on factors, other than cost, affecting accessibility to important preventive, diagnostic and therapeutic innovations
    • methods to address concerns about the impact of the cost of new inventions for the health care system (for example, licences, mandatory access, large buyer groups, assessments of medical/health value to support provincial formularies or analogous systems used for other kinds of medical technology)
    • the effect of Canada’s international obligations on the various options for addressing the impact of biotechnological patents on the health care system
    • whether there are features of biotechnological or biological patents that suggest they should be treated differently than other patented inventions used in health care

The comments from respondents touched on a number of health care, policy and process issues.

Only one respondent, from the biotechnology industry, was opposed to this recommendation. Most respondents, whether from the biotechnology industry, user communities, non-governmental organizations, universities, or government, thought this research is important. Some respondents argued, however, that the research needs to be objective, science-based and done in co-ordination with stakeholders. One respondent asked CBAC to address the issue of which government or body ought to pay for this research.

Some respondents suggested further research questions for study. These included whether Canada has paid enough attention to research on the social determinants of health and on the effect of patents on the agricultural sector (in terms of access and cost). Some respondents proposed that the research be conducted on a pan-Canadian basis. They pointed to the Ontario government’s important contribution to this debate in its report proposing a coordinated approach to studying the impact of genetics, testing and gene patenting on the future of health care.

The one industry respondent opposing this recommendation did so fear that further study would delay implementation of our other recommendations. This respondent felt that biotechnology patents should not be treated any differently from other patented inventions. They felt that any suppression of research due to the patents could bring about the industry members to seek alternate markets. On the other hand, one non-governmental organization expressed surprise that we were willing to make any recommendations with respect to patenting higher life forms in the absence of this research on the health care implications of patenting plants and animals.

11. CBAC recommends that the Canadian Intellectual Property Office (CIPO) develop and publish interpretative guidelines concerning biological material. The guidelines should be updated on a regular basis and should provide reasonable direction to applicants and examiners, including on:
    • the interpretation of the criteria for issuing a patent (i.e., novelty, non-obviousness, utility, and breadth of claims) as they relate to biological material and/or inventions
    • how traditional knowledge made public through oral transmission is to be described as part of the prior art (see also Recommendation below)
    • the process to be followed by patent applicants and the benchmark time frames for each step

All those who responded to this recommendation supported it. They argued that it would increase the transparency of the patent system and provide clarity and consistency to patent applicants and patent examiners. Several respondents called for a continued updating of any guidelines created which, they argued, ought to include the opportunity for public comment. Some respondents suggested that CIPO could provide the guidelines through the Manual of Patent Office Practice.

12. CBAC recommends that CIPO develop, publish and regularly update service standards, based on best international practice, for processing patent applications.

Those who responded to this recommendation supported it. One respondent pointed out that CIPO must be given the financial resources to meet any performance standards.

13. CBAC recommends that CIPO report regularly on its performance with respect to those standards and the steps being taken (such as increasing capacity and/or expertise) to meet them.

Those who responded to this recommendation supported it. One respondent noted that CIPO already provides some of this information in its Annual Report.

14. CBAC recommends that Canada pursue further harmonisation of patent policies and procedures at the international level.

Respondents agreed with this recommendation. One professional organization noted, however, that harmonization should not be taken to mean that Canada ought to agree to a "one size only" approach. According to this respondent, Canada ought to look out for the special interests of Canadian inventors and the Canadian public in any negotiations. A non-governmental organization argued that Canada ought not to "harmonize" to the standard of the United States; rather, Canada should consider the effects of the Convention on Biological Diversity and of international trade agreements in establishing its position. A biotechnology industry respondent suggested that Canada adopt a patent term extension procedure similar to that in Europe in respect of any regulatory delays.

15. CBAC recommends that Canada ratify the Patent Law Treaty, which addresses the formal requirements for filing patent applications and maintaining patents, as soon as possible.

There was agreement with this recommendation.

16. CBAC recommends that CIPO establish an opposition procedure to permit a patent to be opposed on the grounds that it is invalid or void (i.e., fails to meet the requirements for patentability, is too broad in scope, was obtained through failure to disclose material information, or intentionally provided information intended to mislead). To be effective, it is essential that this process be faster, less cumbersome, and less expensive than the procedures currently available.

Most biotechnology industry, user community, and non-governmental respondents expressed general support for this recommendation. Given the experience with opposition procedures in other countries, several respondents noted the importance of ensuring that the process actually be quick and inexpensive. In particular, the respondents from the professional community stressed the importance of providing a clear and workable procedure. Respondents asked for more precision on how this procedure would work. For example, respondents asked who would have standing to file an opposition, who could make submissions to the tribunal deciding the opposition, and whether there would be a public input period. Some respondents suggested that the opposition procedure apply both pre- and post-patent grant.

Two biotechnology industry respondents were opposed to this recommendation. They felt existing mechanisms in the Patent Act are sufficient to challenge patents.

¹ Although referred to as "open-ended," it is not wide open. Rather, it is bound by the scope of the ordre public or morality provision itself, which in turn, must fit within the parameters set out in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property.