Highlights of Saskatoon Roundtable IP/PHL

CBAC Roundtable Consultation on Biotechnological Intellectual Property and Patenting of Higher Life Forms

Saskatoon Session
May 4, 2001

Prepared by:
The Canadian Biotechnology Advisory Committee (CBAC)

Consultation Participants

Technical Resources
Dominique Hussey
Richard Gold
Sanjay Venugopal – Industry Canada
Gary Hewston – Agricultural and Agri-food Canada

Canadian Biotechnology Advisory Committee
Lorne Babiuk
Mary Alton Mackey
Peter Phillips

Canadian Biotechnology Secretariat
Norma Burlington
Kelly-Anne Smith

Media Relations
Carl Martin

Facilitation Team
Christina Burns
Peter Homenuck
Jim Micak
Anna Olsson
Francis Rolleston
Raymond Vles
Christel von Engelbrechten

Roundtable Consultation Purpose and Objectives

The Canadian Biotechnology Advisory Committee (CBAC), as part of its national consultation process, held a roundtable in Saskatoon, Saskatchewan, May 4, 2001, to address matters concerning Biotechnological Intellectual Property and Patenting of Higher Life Forms.

Roundtable Purpose

To engage stakeholders in a dialogue to provide advice to CBAC on possible policy initiatives regarding Biotechnological Intellectual Property and the Patenting of Higher Life Forms (IP and HLF).

Roundtable Objectives

• To obtain the views, opinions and advice of stakeholders on the key questions facing the Government of Canada in delivering a policy on biotechnological IP and patenting of HLFs.
• To initiate discussion among stakeholders to allow for a better understanding of the different perspectives regarding biotechnological IP and patenting of HLFs.

Issues/Topics of Discussion

The roundtable addressed three matters: identifying issues and guiding principles; the types of higher life forms, if any, that should be patentable and subject to patent protection; and determining Canada’s international roles.

Topic 1: Identifying Issues and Guiding Principles

Question A: What are the key issues that need to be understood and assessed in determining Canada’s approach to developing a policy on IP and PHL?

Participants identified a broad range of issues including the overall policy objectives of patenting, the benefits and disadvantages of patenting, and as aboriginal and ethical issues.

Policy Objectives

Patenting is a specific mechanism used to achieve broader objectives. Participants discussed what overall public policy objective the patenting system should serve. As one participant put it: “What is the common good of society?”. Once this is made clear, it will be much easier to determine what ought to be patented and how the patent system should operate. Participants expressed two different views on the nature of this overall objective.

One view was that the broad objective should be that Canada becomes a world leader in biotechnological research and innovation. The general improvement of the common good includes economic benefits. To this end, economic incentives should not always be considered to be bad.

Another view was that the public good includes access to technology, protection of human rights, ethics, etc. It is necessary to deal with these issues now or else we may face serious problems in the future. Participants espousing this view were concerned that patenting would be driven by considerations of competitiveness and pressure to do things in the same way as the United States. Some asked: must an invention be patented simply because it can be made?

Benefits of Patenting

Some participants outlined the benefits of patents:

• Patents provide incentives for innovation, serving the public good.
• Patent Law is a vehicle to ensure economic development and wealth generation through the genuine pursuit of knowledge.
• The alternative to a patent is to keep the innovation secret. This creates a monopoly on information that will slow down the diffusion of information and therefore research.
• Patents are essential for the development of small start-up companies. It allows them to get their product into the market. It is not the only success factor, however for example; sometimes companies obtain patents, but are not able to use the patented invention.

Some participants observed that innovation is driven by curiosity, not money. Therefore, patents might not get in the way of innovation and research.

Many patentees say that their primary focus is not the Canadian patent system but the US patent system, and that the US patent system is more accessible and less expensive. In addition, Canada is a small market and the primary goal is access to the US market.

Some participants noted the need to make the patenting process less expensive for smaller companies. If the cost is prohibitive, industry will dominate. As patenting becomes more expensive, there is an increase in market consolidation, limiting access and competitiveness. The Patent Act can be improved to make it more responsive to the needs of small companies. One specific idea was to add a tax to the processing fee, which could then be used to assist small companies in paying for the costs of patenting.

In order to maintain the benefits of patenting, some participants felt that it was important to keep our patenting process in conformity with our international obligations. Canada can choose to be out of the step with our trading partners but would do so at the cost of not being internationally competitive. Doing things differently from our trading partners could harm the biotechnology industry in Canada.

Disadvantages of Patenting

Some participants voiced concerns about patenting:

• In the area of health, there is a need to ensure that patents do not have an impact on accessibility and cost.
• What happens in animal – human transplants if an economic organization controls the production of transplant ‘animals’.
• Patent holders may unfairly control innovation.
• Onerous conditions on use can stifle further innovation. These conditions may also block research or the examination of safety.
• Royalty payments may restrict access to inventions for use.
• Patents support industry. Patents are not required if there is no desire to develop a particular industry. Does Canada want a biotechnology industry? There is a need to balance the negative effects of development of a biotechnology industry with the betterment of mankind.
• Is there another process that can serve as an alternative to patents?

The Impact of US Patenting Practices

The patenting process in the United States has an important impact on Canada. The US is willing to patent everything. What is the effect on Canada if we are out of step with the US? Canadian firms often go to the US for patenting because it is an easier system and the market is larger. The US sees patenting as a strategic business advantage; Canada may see it more as an adjudicative process.

Some participants felt that Canada’s small market size was a disadvantage in that we continue to use old technology that may have negative effects (e.g. more use of herbicides and pesticides). In general, participants felt it is important to craft a Canadian position in line with the US patent system because of the effect of the US economy on ours. Nevertheless, Canada can do some things a little differently if necessary to reflect Canadian values.

Ethical Issues

Ethical issues and how to deal with them were the subject of much discussion. Does the public good override individual rights, and, if so, to what extent? Should human DNA sequences be patentable? Should Canada redefine patent law to address ethical matters? What are the tests for determining whether an invention is ethical? Is it safety?

Some participants felt that ethical issues should be dealt with outside the patenting process. There should be regulations that set the standards for the use of biotechnological products. If these regulations are strong and sufficient they will reflect ethics. It was noted that the Patent Act does not supersede the Canadian Charter of Rights and Freedoms.

If ethics must be dealt with within the patenting process, the Canadian Intellectual Property Office (CIPO) should not be responsible for this aspect, this will bog down the patenting process.

Other participants felt that patenting higher life forms necessarily involves ethical issues; “live organisms are different than widgets”. The issue is the sanctity of life. Ethical concerns must be addressed prior to patenting. Ethics should be “a gate”, although it is not clear whom the gatekeepers should be. One suggestion was to create an opportunity for a non-judicial opposition process.

Participants pointed out that wherever ethical issues are involved, procedural and normative concerns cannot be separated. There is a need to discuss ethical concerns in a public forum and to involve the public in policy formulation. Information is required to ensure that those participating in the dialogue are well informed.

It was suggested that Canada might be able to lead in linking patenting and ethics. Some participants disagreed, suggesting that this was unrealistic due to pressures exerted by the United States.

A concern was voiced that if the patenting process becomes too complicated, small companies might stay away from it.

There was some discussion as to whether ethics should be enshrined in legislation. Those in favour of this position noted that ethics present a common set of values that deserve the status that law provides. The House of Commons should put our values into a public policy context. One should not look for a procedural solution to an ethical issue.

Other participants felt that the mechanisms or institutions in place need not be rooted in legislation since this may be too rigid. Since ethics change over time, there is a need for a device that is more flexible than legislation.

It was noted that there is a need to balance economic drivers with ethical considerations. There is a “creative tension” between the two with which we must deal.

Benefits to Indigenous People and the Economies of the South

Some participants raised concerns about the unequal distribution of the benefits of patents. Patents were described as protecting northern developed economies, but may disadvantage other cultures in the South (less industrially developed countries).

Indigenous cultures, whose traditional knowledge is being used as part of an invention over which patent protection is being sought, do not obtain the benefits of the patent or the invention. Some countries (e.g., Kenya) are establishing procedures to protect indigenous knowledge. Some research centres have a requirement that use of a patent is to be given without charge to developing countries (the Danforth Center, St. Louis).

It was noted that many countries do not have a patent system, so people in these countries can use a patented product or process without the risk of being sued.

The issue of the protection of aboriginal collective rights within the patent system was raised. Certain populations have unique genetic profiles that have value for research. There is a need for partnership and for sharing of these research benefits. There is also a moral obligation to share profits resulting from the use of traditional knowledge.

There should be a First Nations representative on CBAC to deal with these issues.

Principles

Participants felt that the principles listed on page 3 of the CBAC consultation document provide a good framework. The challenge will be applying them to particular cases. It is anticipated that no one will object to the principles, but there will be divergence of opinion on their application.

Some participants suggested that the wording of the principles be clarified. What does “respect for persons” mean? What is meant by beneficence? How does one achieve a fair distribution of benefits and burdens? Is justice for one the same as justice for another?

It was suggested that a principle of non-malfeasance (do no harm) should be included. This would deal with the potential for misuse of biotechnology.

The principle should include a reference to the quality of life. Biotechnology should not aim simply at commercial development but also at the enhancement of the quality of life.

Topic 2: What should be patentable?

Participants were asked to address the questions of whether plants and animals should be patentable and if so with what conditions and safeguards. As might be expected the views of the participants were quite diverse on both topics. In general, the patenting of plants was seen as being more acceptable than patenting of animals.

The key points of concern were where to start and stop (draw the line); whether humans have the moral right to control other living things; and the implications for Canada if we are out of step with our major trading partners?

Many participants seemed to agree that before there can be clarity of what Canada’s position should be, there needs to be a good public process to determine the values and opinions of Canadians on these matters.

The following sections provide more detail on the discussions.

Plants

Many participants were favourably disposed towards the patenting of plants. The believed that this would foster innovation, make information on inventions available, and would encourage beneficial developments such as crops that require fewer pesticides or give higher yields. Patenting is preferable to trade secrets from a governmental perspective. It was pointed out that a patent is only a licence to sue people, and it has no real value unless the process or product has a use.

It was also noted that if there were no profit to be made, the private sector would not fund innovation. Who would fund research? Government? If we do not keep up with the strongest economies we only hurt ourselves.

There were a number of concerns expressed about patenting plants that some participants felt would justify some exclusions from patentability:

• It is important to have an effective regulatory system.
• Genetically modified plants can spread their seeds and possibly come to dominate natural plants (unmodified).
• Instead of patenting plants or genes, only the use or the process should be patented
• We should focus on the use/implementation of the patent on a case by case basis and not on making broad provisions or prohibitions within the actual Patent Act.
• The principle of informed consent must be respected especially when dealing with indigenous peoples.
• Canada should focus on the implementation of the innovations rather than their patenting. Also, a patent on a plant should not prevent others from doing research to seek improvements to that innovation, although if new intellectual property is developed and patent sought, reference must be made to the previous patent.
• Canada’s competitive position in the world economy will be affected by our decisions on patenting. There are arguments for Canada keeping up with the strongest patent system. On the other hand, perhaps Canada should be seeking an alternative to the patent system for plants?
• Attention is needed to developing a mechanism for revoking patents as a form of safeguard against wrongful use of the patent. An effective regulatory system on the use of patented innovations is needed and may be in place in only a few sectors.

Some participants proposed that one way to deal with these problems would be to revoke the patent if a need to do so is identified. Others felt that dealing with these problems was the role of regulatory agencies and not the Patent Office. Others argued that there may be no need to revoke the patent as the market may decide what is useful or undesirable impacts (i.e., consumers simply will not purchase those patents of limited usefulness and with undesirable effects.

Animals

Participants were divided on the question of patenting animals. Some were strongly in favour, others strongly opposed, and still others were open to the idea but had reservations.

Allow Patenting

In addition to the benefits of patenting that have already been mentioned, these participants did not see why patenting should not be allowed:

• Humans have been tinkering with genes for centuries though breeding. It is not clear, therefore, that patenting will, in itself, encourage undesirable conduct.
• We already accept animals as commodities. The issue is not ownership but stewardship
• There should be a consistent approach to what is patentable
• If simple life forms are patentable, and no one has a problem with this, the genie is already out of the bottle. Creating something new from the natural state should be patentable. Animals are just another life form, in the continuum from microorganisms. The difference between higher and lower life forms it is only a matter of complexity, not principle.
• Patenting of animals does not open the door to patenting of humans since this would be against other principles and laws, such as the Charter.
• Should we make a distinction between domesticated animals and all animals?

Participants in favour of patenting were concerned about the consequences of taking a “time-out” rather than going ahead.

Do not Allow Patenting

Participants opposed to patenting animals cited a number of reasons for their position:

• Aboriginal peoples respect animals; they see them as equals. Owning an animal is a western concept with which they cannot agree.
• Humans should not play God. Where will we draw the line between those animals that are patentable and those that are not?
• There could be problems if a genetically modified animal escapes into the environment and mates, resulting in unknown life forms. A specific example was that of modified fish escaping from a fish farm and getting into the environment.
• How can we be sure that animals used in the production of products (e.g., the spider milk goat) are “comfortable”, that their metabolism is not affected, and that they are not suffering? Who gives the consent for animals?
• Humans should not be mixing species; “mother nature knows best”. If we mix species, do we know what the results will be? What control do we have over the end result?
• We should not patent for spiritual and cultural reasons and out of respect for animals.
• There may be alternative technology to simulate animals for research and testing protocols.
• Patenting a process is fine, but patenting of life raises serious questions.

In the view of these participants, it is necessary to take a pause in biotechnological development so as to think of the impact on future generations. This will require moral courage, but we do not have to be in a hurry, regardless of where we are going. Good leadership is needed.

Some of these participants said they would accept patenting of animals only if it leads to human benefit.

Perhaps Allow Patenting...

A number of participants had difficulty coming to a firm opinion on whether animals should be patentable or not. They raised a number of issues of concern:

• What is the definition of animal – does it include humans? (In law, the answer appears to be no, e.g. as shown by the guarantees enshrined in the Charter of Rights, for humans).
• How does the concept of sentience come into this at all? For example, elephants are members of a very complex species. Do we have the right to use elephants in biotechnology?
• Where then do you draw the line? Should we have ownership of every other life form on the planet?
• We are venturing into an area over which we have no control, and we do not know the output. We are opening a Pandora’s Box. We need to know where we are going, and why.

Exclusions

For the purposes of discussion, participants were asked to assume that patenting of animals was allowed. On this assumption, what should be excluded from patenting?

• Processes or uses in which animals suffer. This is something that needs to be assessed. Consistent animal welfare rules for all, public and private research and uses.
• No pain and suffering for “lifestyle” benefits, but perhaps pain and suffering of animals would be more acceptable for health and medical benefits.
• Human organs should be excluded from patenting (the organ itself, not the process to make or use the organ).

A Morality Clause

Some participants felt that Canada should have an ordre public and morality clause in the Patent Act. This would deal with animal welfare and risk to humans.

Other participants felt that these issues should be addressed in a separate framework outside of patent process.

Farmer’s Privilege

Participants felt that there was potential value in having a farmer’s privilege for animals. Farmers play an important role in improving stock. This is something society should not restrict.

The Experimental Use Exemption

The discussion focused on the differences between the American experimental use exemption from infringement and that of the European Union. After some discussion, participants suggested that Canada should consider allowing research on subject matter as is done in the EU, as opposed to the more limited exemption in the USA.

A Formalized Opposition Procedure

A number of participants were interested in the potential of an opposition procedure to deal with ethical issues. The problem that was identified was that it was not easy to identify patent applications that raised ethical issues. Furthermore, these issues may only arise once the patented product is used.

It was proposed that mechanisms be developed to identify relevant ethical or other issues during the patenting process. A way of monitoring issues that may come up some time after a patent has granted is also needed. There is a need for a mechanism for a second opposition to deal with moral and ethical concerns, possibly linked to the morality clause.

Some participants noted that if government revokes a patent some years after it has been granted, a corporation might sue for damages and lost income.

Who Should Address Ethical And Moral Concerns?

Participants had a number of ideas regarding the institutional arrangements needed to address ethical and moral issues:

• Some suggested establishing an ethical review panel that undertakes a review of patent applications. An opposition process would trigger it. The structure could be made consistent with international trade agreements.
• Ethical and moral issues should be dealt with within other regulatory processes. The Patent Act should not deal with it.
• A public forum.
• Government should appoint a social and ethical review body that would operate at arms length from government.
• Environment Canada as long as it is completely separate from government, and follows guidelines, not political whims.
• A transparent and open body, representative of Canada, including expert and lay persons. The make-up of the group may vary depending on what the issue is. Flexibility is needed.

Topic 3: Determining Canada’s International Role

The third breakout discussion topic addressed Canada’s international objectives and role concerning biotechnological intellectual property and the patenting of higher life forms. The discussions focussed on two themes:

• Is it necessary for Canada to fulfill its current obligation, if so, what actions should be considered?
• What future role should Canada play in developing international agreements?

Respecting current obligations, many participants felt that they could not provide specific advice since they were uncertain as to the details of the various commitments made by Canada in treaties and agreements. From a broader perspective the following was suggested:

• Canada is a sovereign nation and has not surrendered any right to determine policies that are in the best interest of Canada. It was suggested that in fulfilling the requirement of treaties like NAFTA, the government must assess the implications of compliance. The proposed guiding principle should be used in the assessment.
• Many of the international treaties and agreements provide Canada with flexibility regarding IP and PHL. It was suggested that Canada should develop and implement an ordre public and morality clause.
• With respect to whether plants and animals should be patentable, Canada should chart is own course even though there are clear economic benefits associated with the U.S. approach to patenting of higher life forms. Canada must fully understand the potential environmental and health risks of adopting an approach similar to that of the US. Some suggested that it would be in Canada’s interest to harmonize its approach with respect to biotechnological intellectual property and the patenting of higher life forms with the European Union and through a growing critical mass, influence change in the US approach.

Regarding Canada’s future role for the biotechnological intellectual property and patenting of higher life forms, roundtable participants felt that Canada should consider assuming a leadership role in future negotiations and international agreements. This leadership role in the international arena could include the following:

• The full consideration of social and ethical considerations for any future western hemisphere free trade agreements.
• Becoming more pro-active and promoting “GELS” as a model to influence treaties and agreements pertaining to biotechnology.
• Developing a partnership framework for benefit sharing ensuring that any population that contributes to biotechnology research fairly shares in the distribution of the benefits. As part of the partnership framework, Canada should promote the establishment of clear guidelines ensuring informed consent by all participating in biotechnology research.
• Supporting the Cartegna Biosafety Protocol and the Convention on Biological Diversity. In particular, Canada should develop and fund bilateral capacity development of biotechnological intellectual property and the patenting of higher life forms for emerging countries.
• All of Canada’s actions should be geared towards anticipating a possible global patenting system. Canada should ensure that this system fully reflect social and ethical considerations.
• Develop an international agreement with a dispute resolution processes.

Some participants felt that before Canada can assume a leadership role on the international stage, it must first “get its act together” at home. It was suggested that if Canada wants a vibrant and healthy biotechnological industry as part of the Canadian economy, a change in approach is necessary.

The following suggestions were provided:

• Develop policies and procedures to reduce the time required to issue a patent in Canada. The goal should be a timeline comparable to the U.S. patent system.
• The Government should ensure that CIPO is properly funded with sufficient resources to effectively manage patent applications.
• Adopt a peer review process for biotechnology patent application. Peer reviews will not only ensure a more critical assessment of patents but could also accelerate application-processing timelines.
• Canada should become more aggressive in protecting patent holder rights from imported products. An approach similar to the U.S. was proposed.

Finally, many participants felt that it was important for CBAC and the Government of Canada to continue to consult with stakeholders and the public on emerging biotechnology issues. In particular consultation should occur prior to Canada entering into any treaty negotiations.

Please note that similar reports from each of the 5 CBAC roundtable consultations on Biotechnology Intellectual Property and the Patenting of Higher Life Forms, conducted across Canada from April 23 to May 4, 2001, are being posted on the CBAC website. As well, results from all 5 roundtables will be integrated into a single roll-up report that will also be available on the CBAC website by the end of May 2001.

Please visit the CBAC website at www.cbac-cccb.ca or call the CBAC toll-free number at 1-866-748-2222 for additional information or document related to this or other CBAC projects.