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Publications
Research
2001
Patenting Life Forms: An International Comparison
Prepared For
The Canadian Biotechnology Advisory Committee Project Steering
Committee on Intellectual Property and the Patenting of Higher Life
Forms
By Dr. Richard Gold
February 2001
Table of Contents
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Executive Summary
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Methodology
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The Subject Matter of Patent Rights
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Patent Carve Out
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Establishing Patent Requirements
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Scope of Patent Holder’s Exclusive
Rights
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Approaches to HLF Patenting
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Conclusion
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TRIPs Section 5: Patents
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Article 27
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Article 28
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Article 29
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Article 30
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Article 31
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Executive Summary
In formulating Canadian policies on the patenting of higher life
forms (HLFs), it is important to understand the options
available in light of international treaty obligations and the
options selected by our trading partners. In this document, I
describe these options and the choices selected by some other
biotechnology exporting and importing nations.
The first decision that any country must make is which HLFs and
related processes to include within its patent scheme. The issue
of whether Canada provides patent protection on plants and
animals (unlike the United States, Japan, and European Union
members), is still uncertain as we await the Supreme Court of
Canada to rule on the issue. Once Canada has decided which
categories of HLFs and related processes are eligible to be
patented, it must decide whether to exclude particular HLF
inventions from patent protection to further ethical or social
policy. TRIPs (the World Trade Organisation Agreement
on Trade Related Aspects of Intellectual Property) lays
down careful rules for countries that want to exclude otherwise
patentable inventions. The majority opinion among developed
countries is that inventions whose exploitation would injure
public order and morality ought not to be patentable. Canada,
along with the United States, follows the minority view that
patent law and morality ought to be kept separate. These
countries hold that moral concerns have no place within patent
law itself but ought to be addressed specifically, for example,
through regulation or in the criminal law.
After Canada decides upon the list of HLFs and related processes
over which it is willing to grant patents, it must establish the
test that an inventor must meet to receive a patent. Because
TRIPs sets out the criteria that all WTO members must
use, Canada cannot impose additional requirements for HLF
patents. Although there is wide agreement between the countries
on the nature of inventions that are patentable, there is less
consistency in the type of disclosure required to support the
patent application and in the time it takes patent offices to
rule on applications. According to available data, Canada is
slower than most other Quad countries in reviewing biotechnology
patent applications. While the speed of processing patent
applications is due to many factors (including to delays caused
by patent applicants) and is subject to different measuring
techniques, Canadian patents may be viewed as less valuable to
the inventor than U.S. patents because of the extra processing
delay. This is less true with respect to pharmaceuticals since
these materials face regulatory approval for human use in any
event.
Patents provide inventors with limited rights over patented
inventions. Most countries allow individuals to use patented
inventions for research and experimentation without infringing
on the patent. The scope of the experimental use exception could
have a fundamental impact on basic research using HLFs and
related processes. Canada’s position on the experimental
use exception is unclear as it applies to HLFs. In formulating a
clear research exception, TRIPs would likely require
Canada to construct substantially the same exception for HLFs as
it does for all other types of invention. Some countries also
require patent holders, in limited circumstances, to provide the
right to use the patented invention even when the patent holder
would prefer not to do so. This is done through compulsory
licensing. Canada and the United States have the most
restrictive policies of the Quad members with respect to
compulsory licensing. The European Union is implementing a third
exception to patent rights: farmer’s privilege. This
privilege would permit farmers to plant seeds collected from
genetically-modified plants and to cause genetically-modified
animals to reproduce.
There is a divergence of opinion among Quad members and others
over the manner in which patent laws apply to HLFs and related
processes. Except for Canada, which does not recognise any
patents in whole plants, seeds, or animals, the differences
between countries are fairly limited. Most developed countries
are concerned with potential abuses of patent protection,
whether for ethical reasons or for anti-competitive activity.
Should Canada decide to extend patent protection over most or
all HLFs and related processes, it must then make decisions
about how to implement that decision in light of the
requirements and limitations contained in TRIPs.
When Canada formulates policies regarding the patenting of
higher life forms, it is important to understand the options
available in light of international treaty obligations and the
policy choices made by other countries. In this document, I will
describe these options and the policies adopted by other
biotechnology exporting nations (the so-called “Quad
members”) and by representative biotechnology importing
nations. I will also sketch out the philosophies that underlie
the different approaches.
Patents are rights that a country grants to an inventor to
prevent all other people in that country from using, selling, or
copying a thing or a process (a way to make something or a way
to provide a service). In order to get a patent, an inventor
must demonstrate that the subject matter of the patent—the
thing or process—is new, not obvious, and useful. By new,
we mean that the thing or process did not exist before in the
particular condition in which it is being patented and that it
was never described in public, subject to a grace period in some
countries (such as Canada and the United States), whether in
journals, press releases, or conferences. By not obvious, we
mean that the inventor had to exercise at least a minimal
(sometimes quite minimal) amount of creativity. By useful, we
mean that the thing or process has to have a concrete commercial
use.
The term higher life form (HLF) does not have any technical
meaning within the law. Generally, we take HLFs to include
animals and plants (except for microorganisms) and any process
using animals or plants (again, except micro-organisms).
Depending on one’s definition, we may also include parts
of animals or plants (e.g. animal organs), cells or genetic
information from animals or plants, or processes that use parts,
cells, or genetic information.
There are clearly ethical, social, and economic considerations
to take into account when a country considers whether and to
what extent it will provide patent protection over HLFs. While
it is beyond the scope of this document to enumerate these
considerations, it is worthwhile to discuss the levels at which
Canadian policy makers can address them. First, Canada can
decide to patent some or all HLFs and related processes.1 Second, Canada can carve out
particular HLFs and processes from patentability on the basis of
general policy, for example, health or moral considerations.2 Third, Canada can set criteria
for determining whether a particular HLF or process is
patentable.3 Fourth, Canada
can define the particular rights that a patent holder over HLFs
and related processes has to exclude others from the use, sale,
or copying of those HLFs and processes.4
In this document, I will discuss each of these levels in turn
and investigate the choices made at each level by other
countries. This necessitates an examination of international
rules, primarily trade rules, that constrain the policy choices
available to countries such as Canada. Therefore, before
discussing each of the four levels listed above, it is important
to describe the general international regulatory framework
within which Canada and other countries must formulate their
policies.
Canada and the other Quad members (the United States, Japan, and
the European Union members) are party to the World Trade
Organisation (WTO) and the agreement on the Trade Related
Aspects of Intellectual Property Rights (TRIPs) made under
the WTO. TRIPs establishes general rules that each WTO
member must follow with respect to the following issues:
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the subject matter of patent rights (i.e., the things and
processes over which a country must provide patent protection
and things and processes, such as plant and animals, over
which a country has the option of providing patents);
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the criteria for patentability (novelty, nonobviousness, and
utility);
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disclosure required of the patent applicant;
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the scope of rights that a patent holder must be given
(exclusive rights to use, sell, and copy);
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exclusions from patentability for moral, health, and
environmental reasons; and
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availability of compulsory licensing.
The TRIPs Agreement is a complicated document that was
the subject of much negotiation. Given that it has been subject
to only one main dispute concerning its principal patent
provisions, it is too early to form any conclusive view of its
ultimate detailed meaning. Nevertheless, this one decision and
decisions dealing with other aspects of the WTO Agreements
provide us with a good indication of how TRIPs is
likely to be interpreted. These interpretations cannot, however,
be viewed as definitive. It is also important to remember the
purpose of TRIPs: to establish consistency among
countries on the protection of intellectual property rights
including patents. It is therefore not surprising that it
constrains the choices that countries can make with respect to
patent protection.
Canada, as well as all Quad members except for the United
States, is also party to the Convention on Biological
Diversity (the Convention). This
Convention sets out countries’ rights to protect
and exploit their biological inheritance and rights to protect
traditional agricultural and health practices and knowledge.
Recently, members of the Convention negotiated the
Cartagena Protocol on Biosafety (the
Protocol). The Convention and the Protocol in
general may affect the manner in which the TRIPs
exclusion of patents for environmental reasons is interpreted.
Public Consultations
In establishing their positions with respect to patenting HLFs,
various countries, including Canada, have adopted different
methods of public consultations. Some of these methods give only
a snapshot of public opinion, such as opinion surveys, whereas
others help develop a consensus, such as through targeted
meetings or juries of citizens on issues related to HLFs. In
addition to these methods, countries have established both
parliamentary committees and advisory committees to help advise
their governments on the best modes of dealing with HLFs. The
Organisation for Economic Cooperation and Development conducted
a study in 1999 of these methods. The summary provided below is
derived from that study.
In Canada, for example, the government has organised a survey, a
focus group, a parliamentary committee, an advisory committee,
and stakeholder consultations on biotechnology. The United
States has conducted many surveys, especially on consumer
attitudes toward biotechnology and has held a House of
Representatives committee on genetic testing. The United Kingdom
has probably done the most in the way of public consultations,
having set up numerous surveys, citizen juries, consensus
meetings, polls, and parliamentary committees on a variety of
biotechnology-related issues, particularly in respect of
genetically-modified foods and human genetic testing. Denmark,
the Netherlands, and Norway have conducted consensus meetings on
food and health related biotechnology. France has held citizen
juries on genetically-modified foods and biotechnology as well
as establishing an advisory committee on genetic screening tests
and transplantation from animals. Germany has used various
methods, from consensus meetings, to interviews and surveys, to
examine public opinion on genetically-modified foods and
biotechnology. Japan has conducted surveys on biotechnology and
has held consensus meetings on gene therapy. Australia has
conducted surveys and consensus meetings on genetically-modified
food as well as establishing an advisory committee on genetic
testing.
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Methodology
In the following sections, I examine how Canada’s choices
with respect to patenting HLFs compare to those of other Quad
countries and selected biotechnology importing countries. To do
this I draw on two principal sources of information. First, the
Working Party of the Trade Committee under the Organisation for
Economic Co-operation and Development (OECD) sent questionnaires
to its members on their patent practices with respect to
biotechnological innovations. Countries responded to detailed
questions covering issues ranging from the sort of biological
material and processes over which they grant patents, to patent
office practices with respect to biotechnological patents. The
results of this study were released in February 1999. Second, in
preparation for negotiations under the WTO Agreements, the
Council for Trade Related Aspects of Intellectual Property
Rights sent out similar questionnaires to WTO members. Developed
countries were required to respond while developing and least
developed countries had the option of responding. Most of the
latter countries did not respond. The Council received responses
throughout 1999.
The material collected through the two studies is not completely
accurate. This is largely due to seemingly different
interpretations of the many questions asked. For example, on the
face of the country responses, there are clear contradictions
that can only be resolved by assuming that the responding
countries had different interpretations of the questions posed.
While I have attempted to take these different interpretations
into account and have compared answers to other primary sources,
some inaccuracies remain. However, the data collected from these
studies paints a useful overall view of the approaches taken by
various Quad members and other countries to the issue of
patenting HLFs and related processes.
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The Subject Matter of Patent Rights
As described earlier, HLFs may include a wide variety of
substances ranging from genetic sequences, to cells, to organs,
to entire animals or plants. The first decision that any country
must make in respect of patent rights in HLFs is which
substances and which processes related to those substances (ways
of using those substances to make something else or to provide a
service) the country will include within its patent scheme.
Of the numerous international treaties that apply to patents,
TRIPs has the largest impact on Canada’s choice
of whether to patent HLFs. TRIPs makes it mandatory for
WTO members to grant patents over certain biological material,
such as micro-organisms and micro-biological processes
(processes such as fermentation that rely on the action of
micro-organisms). It also requires that countries either grant
patents over plants or provide an alternative system to give
protection to those who create new plant breeds (e.g., a
particular variety of a flower rather than flowers within the
same species). Last, TRIPs provides WTO members with
the option of excluding patents on animals and on certain
processes related to medical diagnostics and treatment of humans
or animals, such as CAT scans, surgery, or dialysis.
As the box entitled “Patentable Subject Matter”
(below) conveys, Canada provides patent protection on fewer
types of HLFs than other Quad members, but includes a greater
set of processes within its patent schemes than European
countries. By a Federal Court of Appeal ruling in the summer of
2000, whole plants and animals are eligible for patent
protection in Canada.5 The
Commissioner of Patents filed leave to appeal against this
decision with the Supreme Court of Canada on October 1, 2000.
The question of the patentability of higher life forms in Canada
remains, therefore, open.
All Quad countries provide protection to those who develop new
reproducing plant breeds through legislation. These plant
breeders rights permit those individuals the exclusive right to
control the commercial sale of these plants. The level of
protection under this legislation is significantly narrower than
that granted by a patent. For example, a farmer would normally
be entitled to save the seeds from a plant that he or she
purchased even if the plant was protected under plant breeders
rights legislation. The same would not be true under a patent in
the absence of a clear exemption (discussed below).
There does not seem to be any inherent conflict between
protecting a plant under plant breeders legislation and under
patent law. That is, those countries that provide patent
protection for plants also provide plant breeders rights
protection for plants. The opposite is not necessarily true.
Some countries oppose plant patents, preferring the plant
breeders rights scheme over patent law. This is particularly
true among developing nations.
Patentable Subject Matter
Human and Animal Material that is Subject to Patent Rights
Country
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Proteins
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Genes
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Cells
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Animal Organs
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Animals
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Animal Varieties
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Human Organs
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Canada
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United States
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Japan
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Europe
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Australia
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Hungary
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Korea
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Although the European Patent Office has issued patents over
human genes and cells that are applicable in France, the French
Minister of Justice stated, in June 2000, that these patents may
be invalid if challenged in France.
Plant Material that is Subject to Patent and Other Rights
Country
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Proteins
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Genes
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Cells
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Plants
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Plant Varieties
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Plant Breeders Rights
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Canada
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United States
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Japan
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Europe
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Australia
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Hungary
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Korea
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Asexually reproduced plants only
The term higher life form comprises a wide variety of materials,
but their common link is that they derive from living organisms,
whether plants or animals. As the term higher implies, HLFs do
not include micro-organisms. They also do not include human
beings since humans are not subject to ownership. In between
these extremes there lies, however, a vast amount of materials
ranging from strands of DNA, to cells, to organs, to entire
plants and animals. In addition to the raw material falling
within the definition of HLF, there are also processes that use
HLFs to manufacture something or to provide some service. Some
of these processes involve nothing more than allowing nature to
do its work; others involve substantial human intervention.
There are different approaches to patenting HLFs and related
processes around the world. The following charts compare
different approaches taken by Canada, other Quad members, and a
few selected countries. The charts set out the responses given
by the national governments or, in the case of Europe, by the
European Patent Office.
Processes Using Higher Life Forms
Country
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Processes Without Substantial Human Intervention
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Animal Diagnostics
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Animal Therapies
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Gene Therapy for Animals
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Human Diagnostics
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Human Therapies
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Gene Therapy for Humans
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Canada
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United States
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Japan
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Europe
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Australia
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Hungary
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Korea
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Please note that the boxes “Animal Diagnostics” and
“Human Diagnostics” apply only to diagnostic
procedures used on animals or humans directly (that is, not
diagnostic methods performed outside the body). Similarly,
“Gene Therapy for Animals” and “Gene Therapy
for Humans” apply only to gene therapy procedures
performed on animal or human bodies and includes neither the
materials used in gene therapy nor processes that occur outside
the body.
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Patent Carve Out
Once Canada has decided which categories of HLFs and related
processes are eligible to be patented, it must decide whether to
exclude particular HLF inventions from the scope of patent
protection in order to further ethical or social policies.
Canada’s ability to take ethical and public policy
considerations into account in deciding what to patent is
limited by TRIPs. This is so because TRIPs
sets out a standard of equality across all inventions. According
to TRIPs, countries must grant patents over all
categories of inventions despite the possibly different natures
of the inventions. The result of this principle of equality is
that, once a country decides to grant patents over a class of
HLFs, it can only single out particular inventions within that
class for exclusion in limited circumstances. 6
Despite the general rule of equality between inventions,
TRIPs does allow, in limited circumstances, for a
country to exclude certain inventions from patentability because
of the particular dangers they pose. Nevertheless,
TRIPs lays down strict rules for countries wanting to
exclude otherwise patentable inventions on this basis. In
particular, TRIPs states that a WTO member may only
exclude a particular invention from patent protection where the
commercialisation of that invention must necessarily be
prohibited in order to protect public order 7 or morality of that country, to
prevent harm to human, animal, or plant health, or to prevent
serious prejudice to the environment.
We are to interpret all WTO Agreements, including
TRIPs, in accordance with their ordinary meanings. We
are to read exclusions from obligations carefully since they
take away from the basic undertaking of the parties to these
Agreements. 8 We may look to
decisions of dispute resolution panels and the appellate body
for further assistance in understanding these Agreements. 9 Using these general rules of
interpretation, a country wishing to rely on the exclusions
listed above in order to withhold patent protection from a
particular invention involving an HLF or related process will
likely have to demonstrate something along the lines of the
following:
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that there is a definite threat to public order or morality
from the sale of the invention or that the sale of the
invention will lead to significant health or environmental
problems;
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that no other measure will prevent the threat10 (for example, making the sale
of the invention illegal); and
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that withholding the patent will help to prevent the threat.
It is important to notice that the danger must emanate from the
sale of the invention and not from the mere existence of the
invention.
A threat to public order (“ordre public”) is
generally taken to mean a threat to the operation of the state
and its institutions.11 Thus,
the sale of nuclear technology may be considered a threat to
public order. A threat to morality means a threat to generally
accepted norms within society. Several states have incorporated
this exclusion for a considerable time and have applied it to
prevent such things as the patenting of contraceptive devices.
In the field of biotechnology, Europe has gone further than
other countries in defining the meaning of the morality
exception. The European Union has, in its Directive on the
legal protection of biotechnological inventions (the
Directive), proscribed various activities as morally
unacceptable, including processes to clone human beings,
modifying germ line identity, using human embryos for commercial
purposes, and modifying the genetic makeup of animals so as to
cause them suffering without substantial medical benefit. The
common element in all of these examples is that the activity
itself, rather than the mere fact that the activity is patented,
is considered immoral. To the extent that this is illustrative
of the scope of the morality exception, it means that a country
can only withhold a patent over an invention where the invention
itself or its distribution to a large number of people is
morally objectionable.
The question of what constitutes a threat to human, animal, or
plant health or to the environment is not clearly addressed in
TRIPs. Decisions reached under other WTO provisions12 indicate that the threat must
be based on sufficient scientific evidence rather than pure
speculation.13 These
provisions deal with situations in which the very activity that
the country is attempting to limit through reliance on the
exception may cause direct harm to human, animal, or plant life.
In such circumstances, there is greater reason to provide
countries with room to maneuver. The situation is quite
different with TRIPs in which a country uses the
exception to prevent patentability of an invention, not the use
of the invention itself. The reason for this is that once an
invention is found to be unpatentable, it is forever outside the
scope of patent protection even if circumstances change and the
invention no longer presents an ethical problem. Given this
difference, previous WTO-related decisions, and the general
interpretative rule that the exception should not be read
broadly so as not to undermine the intent of the Agreement, one
would expect that a country relying on this exception would have
to do so on the basis of good scientific evidence. That is, a
country would likely only be able to withhold a patent on an
invention if scientific evidence supported the conclusion that
the commercialisation of the invention would, in fact, harm
health or the environment. A claim of harm in the absence of
good scientific support would not likely be sufficient.
It may be possible that, under the recent Cartagena Protocol
on Biosafety, under the Convention on Biological
Diversity, countries may be permitted to act on less than
convincing scientific evidence to withhold patents over
inventions claimed to harm the environment. Under the
Protocol, countries have the right to prevent the
import of living genetically modified organisms unless
scientific evidence demonstrates that these organisms are safe.
That is, under the Protocol, a country may act in the
absence of proof of harm. While, in theory, this same reasoning
could be applied to disputes under TRIPs it is unlikely
for two reasons. First, TRIPs, being part of the WTO
Agreements, is independent of the Convention on Biological
Diversity and the Cartagena Protocol. In fact, the
Protocol clearly states that it was not intended to
override the provisions of the WTO Agreements. Second, given
that TRIPs already balances the rights of patent
holders against safety through fairly restrictive language,14 it is unlikely that a dispute
panel will override that balance in favour of incorporating the
Protocol into TRIPs.15
The majority opinion among developed countries is that
inventions whose exploitation would injure public order and
morality should not be patentable. Canada, along with the United
States and Australia, follows the minority view that patent law
and morality are completely separate. This does not mean that
issues of morality or harm to health or the environment are not
important; it simply means that these countries prefer to deal
with these issues outside of patent law.
Among those countries that recognise exceptions to the general
rule of patentability, most restrict those exceptions to public
order and morality concerns.
Patent Exemptions
Once a country has decided to grant patents over a category of
inventions, such as animals, plants, or human material, it may
wish to exempt particular inventions from its patent scheme for
moral or public policy reasons. Generally, it is up to the
patent authorities in a country having these exemptions to
determine whether a particular invention fits within the
exception.
World opinion is split on the wisdom of these exemptions. Their
existence was an important element in the first international
patent conventions. Many countries were unwilling to guarantee
broad patent protection without the ability to withhold patents
on inventions they believed were contrary to the social good.
Other countries, the United States being the primary example,
believe that morality and broad social policy (as opposed to the
social policy inherent in patent law encouraging innovation and
commercialisation of that innovation) should be kept separate
from patent law. That is, to the extent that a particular
technology gives rise to moral or social policy concerns, we
should enact specific laws or regulations to deal with those
concerns rather than withhold a patent.
The accompanying chart sets out the different approaches taken
by the Quad members and other selected countries with respect to
the power to withhold a patent over an invention that is deemed
to breach ethical or social policy.
Patent Carve-Outs
Country
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Ordre Public
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Morality
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Human Health
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Canada
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United States
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Japan
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Europe
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Australia
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Hungary
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Korea
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Establishing Patent Requirements
After Canada decides upon the list of HLFs and related processes
over which it is willing to grant patents, it must establish the
test that an inventor must meet in order to receive a patent.
This has two components. First, Canada must establish the formal
criteria that it will require inventors to meet before it issues
a patent. Second, Canada must determine how it will apply these
criteria to particular patent applications involving HLFs and
related processes.
There are two types of criteria that apply to the review of a
patent application. The first are the criteria applying to the
invention itself. These criteria essentially define when an
innovation is worthy of patent protection. For example, just
because you have created a new mousetrap does not mean that you
will receive a patent over it. You will only receive a patent if
the mousetrap meets the conditions set for patentability in the
country. In Canada, the mousetrap would have to be new, not
obvious, and useful. If the mousetrap failed to meet any of
these requirements, no patent would issue. The second type of
criteria are those used to evaluate the patent application
itself as opposed to the invention. Simply because you have
invented a new, not obvious, and useful mousetrap does not mean
that you will receive a patent. You must first file a patent
application that contains information about the patent in a
particular form before you receive the patent.
The difference between these two types of criteria is important.
Where the invention fails to meet the requirements of
patentability, no patent can ever issue. On the other hand,
assuming that the invention is patentable, if the patent
application does not meet the requirements set out, the inventor
can remedy this problem by filing an application in proper
format. In other words, the first set of criteria are
substantive whereas the second set are procedural.
As in other areas, TRIPs imposes limitations on
Canada’s ability to define the substantive criteria it
uses to assess whether an invention is patentable.
TRIPs requires that all WTO members use the substantive
criteria of novelty, non-obviousness, and utility, and only
those criteria, in assessing whether a particular innovation is
patentable. This means that no WTO member may impose additional
or alternative criteria in assessing whether a particular
invention is patentable within that country.
In addition to circumscribing a WTO member’s ability to
establish substantive criteria for patentability, TRIPs
only allows countries to apply three procedural requirements for
patentability. TRIPs requires that all countries oblige
a patent applicant to fully disclose the invention that is
sought to be patented. In addition, it permits countries to
require patent applicants to disclose the best way of using the
invention and to disclose other jurisdictions in which a patent
application was filed over the invention.
In formulating its policy with respect to patenting HLFs and
related processes, Canada likely cannot impose additional
substantive or procedural requirements on patent applicants.16 The European experience with
patenting material from human sources provides an excellent
example of this point. During its debates over the adoption of
what came to be the Directive on the legal protection of
biotechnological inventions, the European Parliament
concluded that no person should be granted a patent over
human-derived DNA, cell-lines, and tissue unless he or she
demonstrated that he or she had received full and informed
consent from the human source of that material prior to its
removal from the body. The European Commission resisted this
proposal, however. It felt that adding the requirement that an
inventor prove that he or she had received informed consent from
the source of the biological material prior to its removal was
going beyond the requirements permitted under TRIPs.17 Given this, the requirement
could not be added. Instead, the European Commission suggested
that the Directive state, in a preamble, that inventors
have a moral obligation to get informed consent, but that this
moral obligation not be translated into a legal requirement.18 In the end, the European
Parliament accepted this compromise. Thus, the European Union
was not able to incorporate its concern over informed consent
into its patent laws.
There is consensus not only on the formal substantive
requirements of patentability but, for the most part, on the
application of those requirements. I say for the most part
because although countries more or less agree on the tests for
novelty and non-obviousness (although they may disagree in
particular cases), they disagree to a greater (although still
limited) extent on the utility requirement. The utility
requirement is important given that many biotechnology
inventions are nothing more than the isolation of naturally
occurring materials.19 This
is particularly true of, for example, DNA strands and whole
genes. The Human Genome Project has led and continues to lead
researchers to identify new genes, but often without much idea
of what function those genes play. A low standard of utility
would nevertheless result in patents being granted since these
genes could be made or put to some industrial use, even without
knowledge of its function. A higher standard would result in a
patent where the inventor could, for example, point, at some
level, to the function that the DNA plays within the cell.
While, apart from the utility standard, there is wide agreement
between countries on both the formal substantive requirements
for patentability and the application of those requirements,
there is less consistency on the procedural criterion of
disclosure. As stated earlier, the basic premise of patent law
is that, in return for a time-limited monopoly, the inventor
must fully disclose his or her invention so that others may
learn from it. While all countries agree that disclosure is
required, they do not agree on how to apply that criterion.
As the box entitled “Enablement Requirement” (below)
illustrates, the majority of countries do not require that the
patent application identify all particular instances of the
invention that fall within the category covered by the patent
description. It is enough if there is a close link between what
was disclosed and the invention claimed. Overall, Canada takes a
middle approach but requires a closer link than some countries
between the claimed invention and the disclosure given.
One last issue in the application of the substantive and
procedural criteria for patentability is the amount of time it
takes the patent office in each country to rule on a patent
application after that application is filed. This usually takes
place in two steps. The patent office initially reviews a patent
application and indicates any problems with the application to
the inventor. It is very rare that a patent office will accept
the patent application as initially filed.
An inventor will decide whether to pursue a patent in a
particular country based on a number of factors, including size
of market, cost of business, and delay in obtaining the patent.
It is therefore important to know how long it takes, on average,
for the patent office to respond to the initial patent
application and how long it takes the patent office to finally
dispose, one way or the other, of the patent application. This
information, to the extent it is available, is provided in the
following chart.
The United States is implementing new procedures and guidelines
to speed up the process of reviewing patent applications. Its
goal is to finally dispose of an application within 12 months of
filing. As the chart indicates, Canada takes significantly
longer than most of the other Quad countries in reviewing
biotechnology patent applications. While it must be acknowledged
that the speed of processing patent applications is due to many
factors and is subject to different measuring techniques, a
Canadian patent may nevertheless be viewed as less valuable to
the inventor than a U.S. patent simply on the basis of this
increased delay.
Application of Utility Criterion
There are two principal traditions with respect to utility.
Canada and the United States interpret utility to mean that the
patent applicant has claimed that the invention has a credible
commercial use. The United States Supreme Court stated in one
case, for example, that it is not enough that the invention be
useful for other researchers: the invention has to be of
commercial value. The other tradition, which is prominent in
Europe, is that an invention must have an industrial
application. As long as someone can use the invention, it is
thought to meet the industrial application standard. This may be
an easier test to meet with respect to HLFs since they can
generally be put to some use even if that use is for research
purposes only.
In the debates preceding the adoption of the Directive on
the legal protection of biotechnological inventions, the
European Parliament questioned the wisdom of permitting patents
over DNA sequences with unknown function. The Directive
addressed this issue somewhat ambiguously by stating that a
patent application must disclose the industrial application of
the DNA sequence of human origin: something that was already
required by European patent law. It is unclear whether this
statement was designed to increase the difficulty of the
industrial application standard in Europe, although European
Commission officials indicated that it may. Certainly some of
the recitals to the Directive indicate that the
inventor must either disclose the protein produced from the
human DNA sequence or at least the function performed by that
protein in order to demonstrate industrial application. It is
too early to know whether the Directive will result in a more
strenuous utility requirement in Europe since it only became
obligatory in July 2000.
Enablement Requirement
TRIPs requires that inventors disclose their inventions
with sufficient clarity to enable others to make the invention.
Beyond this general requirement, countries are free to establish
the nature and form of disclosure required. In fact, as the
following chart indicates, different countries take different
approaches to the enablement requirement. The greater the level
of disclosure required to support the patent grant, the more
strict the enablement requirement.
In the following chart, I look at two areas in which countries
apply different standards to the level of disclosure required to
meet the enablement requirement. Specifically, I examine how
general the description can be to support a patent grant. In the
first column, I indicate whether a person can receive a patent
over several different DNA sequences by describing only one
related sequence. In the second column, I show whether a
description of the function--what the DNA sequence does--is
sufficient disclosure to support a patent grant or whether the
DNA sequence itself must be described. The information used in
this chart derives from the governments of the countries listed.
Disclosure Sufficient to Support Multiple DNA Sequences
Country
|
Working Examples that are Similar to Claimed DNA
Sequences are Sufficient
|
Functional Descriptions of DNA Sequences are Sufficient
|
Canada
|
|
|
United States
|
|
|
Japan
|
|
|
Europe
|
|
|
Australia
|
|
|
Hungary
|
|
|
Korea
|
|
|
Average Months Elapsed Between Filing and Final Ruling on
Patent Application
Country
|
Months to Initial Action
|
Months to Issue or Abandonment
|
Canada
|
24.6
|
44.7
|
United States
|
|
27
|
Japan
|
22
|
|
United Kingdom
|
|
32
|
Germany
|
|
24
|
Hungary
|
|
56
|
-
Scope of Patent Holder’s Exclusive
Rights
Once granted, a patent provides an inventor with certain rights
over the patented invention. The most notable of these are the
rights to exclude all others from selling or reproducing the
invention in any form. These rights are not, however, without
limits. All countries recognise that people can make some uses
of the invention without infringing on the patent holder’s
rights. For example, most countries recognise that individuals
can use the patented invention for research and experimentation
without infringing on the patent. These exceptions are, however,
fairly narrow, especially in the United States. Some countries
also provide that, under certain circumstances, a person can
require the patent holder to provide him or her with the right
to use the patented invention even when the patent holder would
prefer not to do so. This is done through a regime of compulsory
licensing. Rules surrounding compulsory licensing are extremely
limited by the provisions of TRIPs. One important
example of legitimate compulsory licensing under TRIPs
is its availability with respect to an invention needed to use
another invention that represents a significant advance on that
first invention. Third, some countries have indicated that they
are prepared to provide farmers with the right to use seeds
harvested from a genetically-modified crop or breed
genetically-modified animals on their own farms without
violating the patent on the crop or animal.
Even though the Community Patent Convention in Europe
has not come into force for lack of adhesion, most European
countries follow its rules with respect to the scope of
researchers’ rights to use a patented invention for
experimental purposes. A researcher may use a patented invention
under two exemptions. The first states that individuals may use
the invention for purely private and non-commercial purposes.
Since much biotechnology research, even at a university or
research institution, may result in the development of a
commercial product, it is the second component that is more
important. This second exemption holds that a researcher may use
the patented invention to conduct research relating to that
invention, as opposed to merely using the invention to research
something else. If the German courts are indicative of European
practice, the class of activities considered to be
“related to” an invention is quite broad.20 According to these courts, as long
as there is some logical link between the patented invention and
the research, even if that research has a commercial purpose,
the research falls within the experimental use exception.
The position of the experimental use exception in the United
States is far from clear.21
U.S. patent legislation does not explicitly recognise this
exception. Courts have nevertheless held that research conducted
for merely philosophical curiosity does not infringe upon a
patent.22 This concept is not
only unclear but subject to much debate. The few cases that have
discussed the experimental use exception have interpreted it
narrowly as applying only where the researcher has no commercial
or institutional purpose in mind. Literally, the research must
aim at no other purpose than the pursuit of pure knowledge. Most
recognise that this test does not easily fit with current
biotechnology research, which almost always has some commercial
application. Contemporary American courts have yet to wrestle
with this issue, is unclear how they will interpret the
experimental use exception. If they follow the existing caselaw,
it would be difficult to ever rely on the exception. The United
States also has a narrower experimental use exception relating
to testing patented generic drugs in order to gain regulatory
approval prior to expiry of the patent.23
There are two experimental use exceptions in Canada. One is
quite narrow. This exception, provided in the Patent
Act, is designed to permit generic pharmaceutical
manufacturers to make a patented pharmaceutical in order to
satisfy federal regulators that their generic pharmaceuticals
meet health and safety laws. This exception was recently upheld
by a trade dispute panel under the WTO.24 The second exception, like the
general exception in the United States, was introduced by court
decisions. The scope of this exception is unclear, but seems to
permit researchers to manufacture and use patented inventions in
order to experiment on and improve upon them.25 It is unclear how this
experimental use exception would apply to HLFs.
As the box, “Case Study: Experimental Use”
illustrates, the scope of the experimental use exception could
have a fundamental impact on basic research using HLFs and
related processes. The European approach would allow researchers
to freely use patented research tools–HLFs that are used
to assist further research rather than being ends in themselves,
such as gene sequences and cell-lines–in their research
provided that this research involves improving, developing, or
testing the invention. The American approach would likely
prevent the free use of research tools. The Canadian approach
seems to lie between that of the United States and Europe.
If Canada chooses to clarify the nature of the experimental use
exception, it would have to be mindful to construct the similar
exception for HLFs as it does for all other types of invention,
from mousetraps to chemical processes. This is because
TRIPs requires that Canada treat different technology
equally.
Many countries impose a second limitation on the rights of
patent holders. Under certain circumstances, most countries
provide that an individual can be awarded a licence to use a
patented invention without the approval of the patent holder.
TRIPs establishes detailed rules on the grant of
compulsory licences. For example, it states that a country may
only grant a compulsory licence under one of three
circumstances: where the licensee attempts but fails to
negotiate for the use of the patented invention on reasonable
commercial terms, where there exists a national emergency, or
where the patent holder has been acting in an anti-competitive
manner.
While the United States has the most restrictive policies of the
Quad members with respect to compulsory licensing, Canada is not
far behind. In Canada, compulsory licences are only available to
the government or in cases of anti-competitive activity. Most
other developed countries permit compulsory licensing where a
patent holder does not actively use the patent in the country or
where the existence of the patent blocks the use of another
patent within the country. Nevertheless, despite the existence
of compulsory licences, countries uniformly report that they are
rarely, if ever, granted.
The third limitation imposed on a patent owner’s
exclusivity is the so-called farmer’s privilege. It is
only relevant in those countries in which plants and animals are
patentable (hence, not Canada). To the extent that it is
recognised, this privilege permits farmers who have grown
genetically-modified crops to harvest the seeds from those crops
and plant them. Similarly, under this privilege, farmers would
be able to breed geneticallymodified animals. Without this
exception, neither activity would be permitted. This is because
the person holding the patent in the crop or animal has the
exclusive right to copy or reproduce the patented invention.
That is, without the farmer’s privilege, farmers would not
be permitted, under patent law, to reproduce the plant or
animal.
Countries generally recognise the existence of a farmer’s
privilege with respect to plants protected under plant breeders
legislation. The European Union, through the Directive,
has provided that the same plants currently subject to a
farmer’s privilege under plant breeders legislation26 are subject to the same
privilege under patent law. The European Union has also expanded
on farmer’s privilege by extending it to animal varieties
(a term that has not yet been defined).
Case Study: Experimental Use
To better understand the differences between the European,
American, and Canadian experimental use exceptions, consider the
following example. Company A holds a patent over a human gene
that is correlated with an increased incidence of cancer.
Company A licenses that gene to Company B for use in a genetic
test and in developing a therapy for cancer. Company B has
identified four mutations in the gene that correlate with
cancer. It offers a diagnostic test to individuals at risk of
cancer for a fee. Researcher C is interested in finding
additional mutations in the gene. Researcher C therefore
recruits individuals at risk of cancer and offers them the test
in order to find other mutations. Researcher C provides this
service for free. Researcher C also provides the test for
Researcher D who is similarly looking for other mutations.
Researcher C charges Researcher D a fee equal to Researcher
C’s cost of operations.
Under the European research exemption, Researcher C is not
infringing upon Company A’s patent. In terms of Researcher
C’s provision of tests to his or her own patients,
Researcher C is conducting research on the patented invention,
here the human gene. Researcher C’s provision of tests to
Researcher D is less clear because Researcher C charges a fee
and is not conducting the research him or herself, but would
likely fall within the same exemption since the goal is research
on the gene.
Since Researcher C’s research will likely, at some point,
result in a commercial product–a new diagnostic test or
new pharmaceutical agent–Researcher C could probably not
rely on the experimental use exception in the United States,
even in relation to Researcher C’s own research. Although
this situation has yet to be litigated, there are reports that
U.S. patent owners have threatened researchers in the position
of Researcher C with lawsuits if they do not cease their
research.
Given that Researcher C is trying to improve on the patent by
finding new mutations in the gene, it is likely that a Canadian
court would determine that Researcher C is entitled to rely on
the experimental use exception in respect of his or her own
research. On the other hand, since Researcher C charges
Researcher D a fee for the test, Researcher C would probably not
be able to rely on this exception with respect to the provision
of services to Researcher D.
Compulsory Licensing
Country
|
Emergency
|
As Remedy for Anti-Competitive Behaviour
|
Government Use in Accordance with TRIPs
|
Available Where Non-Use by Patent Holder
|
Available in Accordance with TRIPs
|
Available for Other Reasons
|
Canada
|
|
|
|
|
|
|
United States
|
|
|
|
|
|
|
Japan
|
|
|
|
|
|
|
United Kingdom
|
|
|
|
|
|
|
Austria
|
|
|
|
|
|
|
Australia
|
|
|
|
|
|
|
Hungary
|
|
|
|
|
|
|
Korea
|
|
|
|
|
|
|
Canada does not have compulsory licensing per se for this
activity, but the Commissioner of Patents has the power to award
a licence under s. 66(1)(a) of the Patent Act for an
abuse of patent which, under s. 65(2)(c) of the Act,
includes this activity.
-
Approaches to HLF Patenting
As the foregoing discussion illustrates, there is a divergence
of opinion among Quad members and others over the manner in
which patent laws apply to HLFs and related processes. Except
for Canada, which does not recognise any patents in whole plants
or animals, the differences between countries are fairly
limited. Nevertheless, some important differences exist. These
are largely in three areas: the grant of patents over biological
processes, the existence of a morality exception to the grant of
patents, and the uses that an individual may make of a patent
without the authorisation of the patent holder.
Overall, the patent system in the United States is the most open
to inventors. The general philosophy is that anything, except
for human beings themselves, is patentable, without
reservation.27 The only
requirement is that the inventor must fully disclose the
invention so that others can use it without difficulty. Once
given, the patent is almost absolute. Only the experimental use
exception which, under current law, appears to be narrow, limits
the scope of the patent holder’s rights.
The rest of the developed world is less aggressive in providing
patent protection. While patents over HLFs are generally
available, patents over processes using those HLFs are more
difficult to obtain. Most developed countries are concerned with
potential abuses of patent protection, whether for ethical
reasons or for anticompetitive activity. For example, European
countries have a greater ability to withhold patents or to allow
others to use patented inventions without authorisation.
The differences between Europe and the United States may,
however, be more theoretical than practical. In practice, Europe
does not use its ability to withhold patents on moral grounds
and does not grant compulsory licences. Even the fact that
Europe does not grant patents over many processes involving HLFs
is less material than one would otherwise think. This is because
once a person has a patent over an HLF he or she can effectively
prevent the use of that HLF in any process.
-
Conclusion
Canada diverges in several important respects from the patent
practices of most other developed nations with respect to HLFs.
This is due more to the absence of policy in the area than to a
positive decision to diverge from the patent practices of
Canada’s trading partners. In formulating its policies
with respect to HLFs and related processes, Canada ought to
consider not only the policies selected by other countries but
the constraints imposed upon it by international agreements such
as TRIPs.
-
TRIPs Section 5: Patents
-
Article 27
-
Patentable Subject Matter
Subject to the provisions of paragraphs 2 and 3,
patents shall be available for any inventions,
whether products or processes, in all fields of
technology, provided that they are new, involve an
inventive step and are capable of industrial
application. Subject to paragraph 4 of Article 65,
paragraph 8 of Article 70 and paragraph 3 of this
Article, patents shall be available and patent
rights enjoyable without discrimination as to the
place of invention, the field of technology and
whether products are imported or locally produced.
-
Members may exclude from patentability inventions,
the prevention within their territory of the
commercial exploitation of which is necessary to
protect ordre public or morality, including
to protect human, animal or plant life or health or
to avoid serious prejudice to the environment,
provided that such exclusion is not made merely
because the exploitation is prohibited by their law.
-
Members may also exclude from patentability:
-
diagnostic, therapeutic and surgical methods for
the treatment of humans or animals;
-
plants and animals other than microorganisms, and
essentially biological processes for the
production of plants or animals other than
nonbiological and microbiological processes.
However, Members shall provide for the protection
of plant varieties either by patents or by an
effective sui generis system or by any
combination thereof. The provisions of this
subparagraph shall be reviewed four years after
the date of entry into force of the WTO
Agreement.
-
Article 28
Rights Conferred
-
A patent shall confer on its owner the following
exclusive rights:
-
where the subject matter of a patent is a
product, to prevent third parties not having the
owner’s consent from the acts of: making,
using, offering for sale, selling, or importing
for these purposes that product;
-
where the subject matter of a patent is a
process, to prevent third parties not having the
owner’s consent from the act of using the
process, and from the acts of: using, offering
for sale, selling, or importing for these
purposes at least the product obtained directly
by that process.
-
Patent owners shall also have the right to assign, or
transfer by succession, the patent and to conclude
licensing contracts.
-
Article 29
Conditions on Patent Applicants
-
Members shall require that an applicant for a patent
shall disclose the invention in a manner sufficiently
clear and complete for the invention to be carried out
by a person skilled in the art and may require the
applicant to indicate the best mode for carrying out
the invention known to the inventor at the filing date
or, where priority is claimed, at the priority date of
the application.
-
Members may require an applicant for a patent to
provide information concerning the applicant’s
corresponding foreign applications and grants.
-
Article 30
Exceptions to Rights Conferred
Members may provide limited exceptions to the exclusive
rights conferred by a patent, provided that such
exceptions do not unreasonably conflict with a normal
exploitation of the patent and do not unreasonably
prejudice the legitimate interests of the patent owner,
taking account of the legitimate interests of third
parties.
-
Article 31
Other Use Without Authorization of the Right
Holder
Where the law of a Member allows for other use of the
subject matter of a patent without the authorization of
the right holder, including use by the government or third
parties authorized by the government, the following
provisions shall be respected:
-
authorization of such use shall be considered on its
individual merits;
-
such use may only be permitted if, prior to such use,
the proposed user has made efforts to obtain
authorization from the right holder on reasonable
commercial terms and conditions and that such efforts
have not been successful within a reasonable period of
time. This requirement may be waived by a Member in the
case of a national emergency or other circumstances of
extreme urgency or in cases of public non-commercial
use. In situations of national emergency or other
circumstances of extreme urgency, the right holder
shall, nevertheless, be notified as soon as reasonably
practicable. In the case of public non-commercial use,
where the government or contractor, without making a
patent search, knows or has demonstrable grounds to
know that a valid patent is or will be used by or for
the government, the right holder shall be informed
promptly;
-
the scope and duration of such use shall be limited to
the purpose for which it was authorized, and in the
case of semi-conductor technology shall only be for
public non-commercial use or to remedy a practice
determined after judicial or administrative process to
be anti-competitive;
-
such use shall be non-exclusive;
-
such use shall be non-assignable, except with that part
of the enterprise or goodwill which enjoys such use;
-
any such use shall be authorized predominantly for the
supply of the domestic market of the Member authorizing
such use;
-
authorization for such use shall be liable, subject to
adequate protection of the legitimate interests of the
persons so authorized, to be terminated if and when the
circumstances which led to it cease to exist and are
unlikely to recur. The competent authority shall have
the authority to review, upon motivated request, the
continued existence of these circumstances;
-
the right holder shall be paid adequate remuneration in
the circumstances of each case, taking into account the
economic value of the authorization;
-
the legal validity of any decision relating to the
authorization of such use shall be subject to judicial
review or other independent review by a distinct higher
authority in that Member;
-
any decision relating to the remuneration provided in
respect of such use shall be subject to judicial review
or other independent review by a distinct higher
authority in that Member;
-
members are not obliged to apply the conditions set
forth in subparagraphs (b) and (f) where such use is
permitted to remedy a practice determined after
judicial or administrative process to be
anti-competitive. The need to correct anti-competitive
practices may be taken into account in determining the
amount of remuneration in such cases. Competent
authorities shall have the authority to refuse
termination of authorization if and when the conditions
which led to such authorization are likely to recur;
-
where such use is authorized to permit the exploitation
of a patent (“the second patent”) which
cannot be exploited without infringing another patent
(“the first patent”), the following
additional conditions shall apply:
-
the invention claimed in the second patent shall
involve an important technical advance of
considerable economic significance in relation to
the invention claimed in the first patent;
-
the owner of the first patent shall be entitled
to a cross-licence on reasonable terms to use the
invention claimed in the second patent; and
-
the use authorized in respect of the first patent
shall be non-assignable except with the
assignment of the second patent.
-
1 E.R. Gold, “Biomedical
Patents and Ethics: A Canadian Solution” (2000) 45 McGill
L.J. 413.
-
2 E.R. Gold, “Making Room: Reintegrating Basic
Research, Health Policy, and Ethics into Patent Law” in T.A.
Caulfield & B. Williams-Jones, eds., The Commercialization
of Genetic Research: Ethical, Legal, and Policy Issues (New
York: Kluwer Academic/Plenum Publishers, 1999) at 63 [hereinafter
“Making Room”]; B.M. Knoppers, “Status, sale and
patenting of human genetic material: an international survey”
(1999) 22 Nature Genetics 23.
-
3 Knoppers, supra note 2.
-
4 “Making Room” supra note 2.
-
5 President and Fellows of Harvard College v.
Commissioner of Patents, Federal Court of Appeal, no.
A-334-98, August 3, 2000.
-
6 Canada – Patent Protection of Pharmaceutical
Products, (not yet adopted) circulated 7 March 2000,
WT/DS114/R , para. 7.92.
-
7 The technical term for this concept is “ordre
public” which, in English, translates into public order or
public policy. Although international tribunals have, on occasion,
given a very wide meaning to this phrase--to include anything that
a government believes to be good public policy--international
tribunals have given the phrase a considerably narrower
interpretation with respect to international agreements touching on
patents. See, for example, European Patent Office Boards of Appeal
decision T356/93 (OJ EPO1995, 545). In the context of international
patent conventions, “ordre public” generally means the
protection of public security, the physical integrity of
individuals as part of society, and the protection of the
environment.
-
8 United States – Import Prohibition of
Certain Shrimp and Shrimp Products, Adopted 6 November 1998,
WT/DS58/AB/R, para. 156.
-
9 Japan – Taxes on Alcoholic Beverages,
Adopted 1 November 1996, WT/DS8/AB/R.
-
10 By this, I mean no other measure that is less
restrictive to patent rights. United States – Standards
for Reformulated and Conventional Gasoline, Adopted 20 May
1996, WT/DS2/9
-
11 See supra note 7.
-
12 General Agreement on Tariffs and Trade,
Article XX, and Agreement On The Application Of Sanitary And
Phytosanitary Measures.
-
13 See, for example, EC Measures Concerning Meat And
Meat Products (Hormones), Adopted 13 February 1998,
WT/DS26/AB/R, WT/DS48/AB/R.
-
14 As indicated by the use of “necessary,”
the lack of such words as “likely” or
“probable” to modify the phrase “protect human,
animal or plant life or health,” and the requirement that
there be “serious” prejudice to the environment.
-
15 EC Measures Concerning Meat And Meat Products
(Hormones), Adopted 13 February 1998, WT/DS26/AB/R,
WT/DS48/AB/R.
-
16 Article 27 of TRIPs provides that countries must not
discriminate with respect to the availability and enjoyment of
patents on the basis of place of invention, field of technology, or
on whether the product is imported or locally produced. The dispute
resolution panel in Canada – Patent Protection of
Pharmaceutical Products, WT/DS114/R, released 17 March 2000,
found that discrimination between fields of technology could be
either explicit in the law or as a result of differentially
disadvantageous consequences of a measure. It also held, in para.
7.91, that this principle of non-discrimination applies to all
aspects of the availability and enjoyment of patent rights
including the exceptions to those rights. Putting this together
with the meaning of available (at one’s disposal),
biotechnology patents must be available on the basis of criteria
substantively equal to that in other fields of technology. In para
7.92, the panel did recognise, however, that a country would not be
discriminating in dealing with specific bona fide problems with
particular products. This would presumably permit, for example, the
deposit of biological materials rather than a written description
of them. Adding additional substantive or procedural criteria for
patents would seem to go well beyond this.
-
17 Personal interview with D. Vandergheynst of the
Internal Market Directorate General (25 May 1998) Brussels,
Belgium.
-
18 Ibid.
-
19 See Knoppers, supra note 2.
-
20 Boehringer Ingelheim International GmbH v. Dr.
Rentschler Arzneimittel GmbH and others, a decision of the
German Federal Supreme Court (BGH) on 11 July 1995.
-
21 “Making Room”, supra note 2.
-
22 Popenhusen v. Falke, S.D.N.Y. 1861, 19
F.Cas. 1048.
-
23 Roche Products, Inc. v. Bolar Pharmaceuticals
Co., Fed. Cir 1984, 733 F.2d. 858.
-
24 Canada – Patent Protection of
Pharmaceutical Products, WT/DS114/R, released 17 March 2000.
-
25 Micro Chemicals Ltd v. Smith Kline & French
Laboratories Ltd, [1972] S.C.R. 506.
-
26 Regulation No. 2100/94 on Community plant variety
rights [1994] O.J. L227/1.
-
27 Diamond v. Chakrabarty, 447 U.S. 303 (1980).
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