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Publications
Advice
2003
Higher Life Forms and The Patent Act
February 24, 2003
Canadian Biotechnology Advisory Committee
Advisory Memorandum
Background
In early 2000, the Canadian Biotechnology Advisory Committee (CBAC)
initiated a research and consultation project on the patenting of
higher life forms and related issues.
In August 2000, the Federal Court of Appeal found in favour of
Harvard, which had appealed the decision of Canada's Commissioner
of Patents to refuse to grant a patent on its onco-mouse, a
genetically modified strain used in medical research. Shortly
thereafter, CBAC issued an Advisory Memorandum addressing the issues
raised by the appeal court's ruling.
In October 2000, government lawyers representing the Commissioner of
Patents filed an application seeking leave to appeal the decision to
the Supreme Court of Canada (SCC). Leave was granted, and in May of
2002, the Supreme Court heard the case.
In the meantime, CBAC proceeded with its project on the patenting of
higher life forms and related issues. It commissioned background
research, held workshops with scientists, industry members, and
non-governmental organizations, developed a consultation document to
guide national consultations, held roundtable meetings in five
regional centres, invited comments from the public by email, telephone
and letter, and issued an interim report in November 2001. After
taking account of all the earlier input and the responses to the
interim report, CBAC issued its recommendations in its report of June
2002.
On December 5, 2002, the Supreme Court of Canada issued its decision
in the case of Harvard v. The Commissioner of Patents,
concerning the patentability of the Onco-mouse.
The CBAC Report
CBAC's report, Patenting of Higher Life Forms, addressed
and made recommendations on three categories of issues:
-
matters pertaining to the patenting of higher life forms,
-
other matters of principle related to biotechnological intellectual
property, and
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operational issues in the current patent system.
The majority of CBAC members recommended that non-human higher life
forms (defined as seeds, plants and animals) be patentable,
subject to the incorporation of certain provisions in the
patent regime. Annex A contains an overview of the final report and
the complete List of Recommendations.
The Supreme Court Decision
The only question before the Supreme Court of Canada was whether
Harvard's onco-mouse was a "composition of matter" and
therefore fit within the definition of "invention" in
section 2 of the Patent Act. In a 5-4 decision, the Court
ruled that the mouse was not a composition of matter and, therefore,
was not an invention.
The majority pointed out that it was not up to the courts to decide
whether higher life forms should be patentable. Justice
Bastarache wrote that, due to the controversial nature of patenting of
higher life forms and the complex issues raised, higher life forms
should only be considered to be patentable under the clear and
unequivocal direction of Parliament.
The Court also noted that the Patent Act is currently
ill-equipped to deal with the complex issues that arise in relation to
higher life forms; the Court considered this an indication that it was
not Parliament's original intent to patent higher life forms. The
fact that genetically modified higher life forms are living and
self-replicating raises concerns and issues that other types of
inventions do not.
Some of the matters mentioned by the majority in their decision
related to recommendations in CBAC's final report on the patenting
of higher life forms, namely:
-
farmers' privilege
-
innocent bystander protection
-
a research and experimental use exception from claims of
infringement
-
non-patentability of humans at all stages of development
The minority of the Court concluded that Harvard's onco-mouse was
a composition of matter and therefore patentable. Despite this
conclusion, the justices were not prepared to rule that the patents
should be granted; rather, they would have sent the patent application
back to the Commissioner to re-examine the patent claims related to
the entire mouse.
The majority decision quotes fairly extensively from the CBAC report
and the minority refers to it, noting that its recommendations were
properly directed to Parliament. Both use the report in support of
their arguments.
Congruence between the SCC decision and CBAC's Conclusions and
Recommendations
Both the majority and the minority opinions made a number of
references to CBAC's report. Without endorsing specific
recommendations, the Court cited the CBAC report a number of times as
providing useful information for discussions about patenting of higher
life forms.
The Supreme Court of Canada was in agreement with the issues CBAC
identified as being within the purview of the Patent Act.
...several of the issues raised by the intervenes and the literature
are more directly related to the patentability and to the scheme of
the Patent Act itself. These issues which pertain to the
scope and content of the monopoly right accorded to the inventor by a
patent, have been explored in depth by CBAC, ...the report recommends
that higher life forms should be patentable. Nonetheless, it
concludes, at p.7, that given the importance of issues raised by the
patenting of higher life forms and the significant "values"
content of the issues raised, Parliament and not the courts should
determine whether and to what degree patent rights ought to extend to
plants and animals.
Para. 169
Furthermore,
...CBAC has recommended that higher life forms (i.e., plants, seeds
and non-human animals) that meet the criteria of novelty,
non-obviousness and utility be recognized as patentable. The concerns
above therefore are not raised to justify a position that higher life
forms should not be patentable, but rather serve to illustrate that
the Patent Act in its current form is not well suited to address the
unique characteristics possessed by higher life forms. The lack of
direction currently in the Patent Act to deal with issues that might
reasonably arise signals a legislative intention that higher life
forms are currently not patentable. In addition, the discussion of the
issues raised by the CBAC and other groups illustrates the complexity
of the concerns. In my view, this Court does not possess the
institutional competence to deal with issues of this complexity, which
presumably will require Parliament to engage in public debate, a
balancing of competing societal interests and intricate legislative
drafting."
Para. 183
In both opinions, the justices made it clear that human beings are not
patentable, although they differed on whether it would be necessary to
spell this out in the Patent Act.
The majority also acknowledge that the judicially created research
exemption may no longer provide suitable guidance because the
legislation being considered in the court case which established it
has since been changed. The Court identified many of the same points
raised by CBAC about the need to clarify what researchers may and may
not do without requiring a licence from the patent-holder. Such a
clarification would benefit both researchers and patent-holders.
The Supreme Court also concurred with CBAC's approach to dealing
with many of the wide range of peripheral issues that various groups
sought to use as justification for changes to the Patent Act.
The SCC argued, for example, as had CBAC, that:
These issues are only tenuously linked to the patentability of higher
life forms and more related to the development and use of the
technology itself... It is preferable to address this issue through
existing or new regimes for protecting animal welfare. Similarly, if
it is determined that additional measures are needed to protect the
environment from the products of biotechnology, this may be effected
through the Canadian Environmental Protection Act, R.S.C.
1985,c. 16 (4th Supp.), or other comparable regulatory
mechanisms.
Para. 168
Implications of the SCC decision
Several inventors and developers expressed disappointment in the
Supreme Court decision. BIOTECanada, in a news release issued the day
of the decision, went so far as to say that it "stops our pursuit
of knowledge and innovation dead in our tracks. It is a great loss to
Canada at both the social and economic level." Yet, at a certain
level, nothing has changed. Canada's Patent Office still does not
grant patents on higher life forms while those of most other OECD
countries do. Inventors and developers are still free to apply for
these patents outside Canada. Even within Canada, they can still apply
for patents on modified DNA sequences in higher life forms or the
processes used to create them. The full impact of the Supreme
Court's decision requires further in-depth analysis and will be on
CBAC's agenda in the coming months. Nonetheless, there is
immediate concern that inventors and developers who were anticipating
that the Federal Court of Appeal ruling would be upheld may view the
Supreme Court of Canada ruling as an indication that Canada is not
sufficiently supportive of biotechnology.
If the availability of patents on higher life forms is seen by the
biotechnology industry in Canada as crucial to their ability to
continue growing, one implication of the Supreme Court's decision
will be pressure on the government to bring Canada's patent regime
into line with those of its main trading partners. CBAC saw this as an
important argument in favour of higher life forms being patentable.
However, as noted in our report, higher life forms are different from
other types of inventions. Simply amending the Patent Act to declare
them patentable, without addressing their special characteristics, was
not seen by CBAC as an appropriate way to achieve that end.
The patent regime is not the only way in which governments in Canada,
both federal and provincial, support biotechnology. It should be
remembered that, although other countries have allowed patents on
higher life forms for many years, the biotechnology industry / sector
has flourished in Canada, to where this country is now second in the
world in the number of biotechnology companies. Other mechanisms may
be available for encouraging research and development in Canada, such
as the legislated research exception proposed in our report.
Sorting out the implications of the special characteristics of higher
life forms for the patent regime will not be accomplished overnight.
Taking the time to do so carefully and thoroughly, however, is, in
CBAC's view, a worthwhile endeavour. Working through the questions
raised by CBAC and mentioned in the Supreme Court decision does not
mean that researchers, inventors, and industry are unprotected in the
meantime. Most patent applications contain many claims. For example,
although Monsanto was not granted a patent on Round-Up Ready canola,
its patent on the particular modified gene sequence which conferred
the "readiness" enables it to exercise its patent rights
over the plants in which that modified gene sequence appears.
Conclusions
If the Government of Canada wishes higher life forms to be patentable,
it must propose amendments to the Patent Act and gain
Parliament's agreement. Patentability can no longer be extended,
as it has been in other countries, and was in Canada with regard to
single-celled organisms, through administrative or judicial action.
This gives Canada the unprecedented opportunity to ensure that the
special characteristics of biological inventions are taken into
account throughout the Patent Act and not only in the
definition of "invention.".
We encourage the Minister of Industry to introduce, as soon as is
practicable, amendments to the Patent Act based on our
Recommendations 1-5 (making non-human higher life forms patentable
with certain safeguards), 10 (guidelines for biotechnological
inventions) and 13 (opposition procedure).
CBAC further encourages the Government of Canada to identify
responsible departments and/or mechanisms for addressing
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the non-Patent Act issues identified in Recommendations
6-9 (liability, access to genetic resources, benefit-sharing, and
handling of traditional and local knowledge) and
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other issues raised by biotechnology, such as the impact of
biotechnological inventions on regulatory systems, the impact of
gene patents on access to health care and sustainability of the
health care system, and the availability of highly qualified
personnel.
Annex A
Following is an overview of CBAC's June 2002 report together with
the complete List of Recommendations.
Patenting of Higher Life Forms is a to the Biotechnology
Ministerial Co-ordinating Committee of the Government of Canada
arising from a project undertaken by the Canadian Biotechnology
Advisory Committee (CBAC). The key issue addressed in the report is
whether Canada should permit the patenting of plants, seeds and
animals. The report identifies a number of factors bearing on that
question. In the course of the project, it became clear that the
patenting of biological material generally (whether DNA sequences,
breast cancer genes, microbes, or Harvard mice) raised a number of
additional issues worthy of consideration
In arriving at our recommendations, we have commissioned research,
consulted with stakeholders and the public, and considered comments
received in response to an Interim Report. The present document
follows the general structure of the Interim Report, except that some
of the descriptive material presented there now appears in annexes to
this document in order to keep the focus on our recommendations.. In
formulating our recommendations (reduced to 13 from 16), we took into
account a Statement of Principles and Values we adopted to guide our
activities.
The report is divided into four major topic areas:
Social and Ethical Concerns Raised by Biotechnology:
In this section of the report, we describe a number of social and
ethical concerns arising from or linked with the development of
biotechnology and summarize three possible approaches to addressing
these considerations.
Patentability of Higher Life Forms: After addressing
the issue of the patentability of human beings, this section of the
report describes the main arguments supporting or opposing the
patenting of plants, seeds and animals. Four of the five
recommendations in this section are linked and should be considered as
a group.
Other Issues Related to Biotechnology and Intellectual
Property: This section deals with other issues that of a
social or ethical nature that are clearly linked to the patent regime.
We make recommendations about liability for damage caused by the
unwanted spread of products of biotechnology, access to genetic
resources, benefit-sharing, and protection of traditional knowledge.
Also in this section, we draw attention to recent developments
concerning the impact of biotechnology patents on the health care
system.
Improving the Administration of the Patent System:
This section contains a series of comments and recommendations
concerning both the operation and the policy orientation of the
Canadian patent system. The advice provided to the Government of
Canada in this section is intended to ensure that Canada's patent
policies and procedures keep pace with developments in the Canadian
biotechnology industry, while ensuring that the appropriate balance
between inventors and citizens is maintained. The focus of this
section is to identify a series of measures to strengthen the patent
system.
List of Recommendations
Human Beings Not Patentable
-
We recommend that the Patent Act be amended to include the
following statement:
No patent shall be granted on human bodies at any stage of
development.
Patentability of Higher Life Forms
-
We recommend that higher life forms (i.e., plants, seeds and
non-human animals) that meet the criteria of novelty,
non-obviousness and utility be recognized as patentable. The scope
of the patent rights in respect of these higher life forms is to be
determined in accordance with Recommendations 3, 4 and 5.
Farmer's Privilege
-
We recommend that a farmers' privilege provision be included in
the Patent Act. It should specify that farmers are
permitted to save and sow seeds from patented plants or to
reproduce patented animals, as long as these progeny are not sold
as commercial propagating material or in a manner that undermines
the commercial value to its creator of a genetically engineered
animal, repectively. The drafting of this provision must be
sensitive to the differences that exist both in the nature and use
of plants and non-human animals.
Innocent Bystanders
-
We recommend that the Patent Act include provisions that
protect innocent bystanders from claims of patent infringement with
respect to adventitious spreading of patented seed, patented
genetic material, or the insemination of an animal by a patented
animal.
Research and Experimental Use
-
We recommend that the Patent Act be amended to include
a research and experimental use exception that states as
follows:
It is not an infringement of a patent to use a patented process
or product either
-
privately and for non-commercial purposes, or
-
to study the subject-matter of the patented invention to
investigate its properties, improve upon it, or create a new
product or process.
Liability for Damages
-
We recommend that Canada actively participate in international
negotiations to address issues of liability and redress for
adventitious spreading of seed, genetic material, or the
insemination of an animal by a patented animal.
Access to Genetic Resources and Benefit-Sharing
-
We recommend that the federal government, in consultation with
other levels of government and other stakeholders, develop
policies and practices that encourage the sharing of the
benefits of research involving genetic material. In particular,
we recommend that:
-
The benefits of medical and pharmaceutical research based on
human genetic material (including its commercial
exploitation) be shared with the groups or communities who
provided the material. All bodies (public, private, and
corporate) involved in funding research and/or establishing
guidelines or codes of conduct for the ethical conduct of
research should ensure that benefit-sharing is addressed in
both policy and practice. Health Canada should lead an
initiative to engage all stakeholders in developing best
practices in regard to benefit-sharing for research involving
human subjects.
-
-
With respect to research based on plant and animal genetic
material, Canada should:
-
continue to participate in the ongoing processes of the
Convention on Biological Diversity to address
outstanding issues with respect to the voluntary Bonn
Guidelines on Access to Genetic Resources and Benefit
Sharing (such as user country obligations and
consideration by the Working Group on Article 8(j) of
the Guidelines by Indigenous and Local
Communities,
-
encourage and facilitate compliance with the Bonn
guidelines within Canada as well as internationally;
-
sign and ratify, as soon as possible, the International
Treaty on Plant Genetic Resources for Food and
Agriculture; participate in the development of the
standard material transfer agreement, including
provisions requiring benefit sharing; and encourage and
facilitate their use within Canada; and
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in general, encourage and facilitate benefit-sharing
arrangements between the users of genetic resources and
traditional and local communities within Canada.
Traditional Knowledge and Intellectual Property
-
We recommend 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 a form of intellectual property could be
developed to protect traditional knowledge.
-
-
We recommend that the Canadian Intellectual Property Office provide
guidance to patent examiners on assessing as "prior art"
traditional knowledge that has been made public through oral, as
well as written or published, transmission.
Guidelines for Biotechnological Patents and Processes
-
We recommend that the Canadian Intellectual Property Office
develop and publish interpretative guidelines concerning
biological inventions. The guidelines should be updated on a
regular basis and should provide direction to applicants and
examiners, notably 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 inventions,
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the process to be followed by patent applicants and the
benchmark time frames for each step to the extent (if any)
that these may differ from other patent applications.
Service Standards and Performance Reporting
-
We recommend that the Canadian Intellectual Property Office :
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regularly update its service standards, based on best
international practice, for processing patent applications,
and
-
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.
International Harmonization
-
We recommend that Canada pursue further harmonization of patent
policies and procedures at the international level by
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continuing to participate in international initiatives to
harmonize patent law policy, such as reform of the Patent
Cooperation Treaty, the work of the Substantive Patent Law
Committee, and work under the Agenda for Development of the
International Patent System (the Patent Law Agenda), and
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ratifying, as soon as possible, the Patent Law Treaty, which
addresses the formal requirements for filing patent
applications and maintaining patents.
Opposition Procedure
-
We recommend that the government introduce an opposition procedure
into the Patent Act to permit a patent to be opposed on the grounds
that it is invalid or void. As it is essential that this process be
faster, less cumbersome and less expensive than the procedures
currently available, we recommend that the time limit for filing
oppositions be 6 months from the date the patent was granted and
that procedures be established and resources provided to ensure
that proceedings are concluded within 18 months from the date the
patent was granted.
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