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 Experimental Use Exception
Dr.
Jennifer Arnold
As discussed in our December newsletter,
Academics Still
Believe Patent Laws Stifle Innovation,
it is our belief that
weakening IP rights is not going to encourage future drug
discovery and nor will it result in cheaper drug costs.
Patents and the strong protection of IP rights will remain the
critical factor in driving the drug discovery process. This
reality, however, can peacefully coexist with the needs of the
academic community. The Canadian academic community is able to
pursue fundamental research, including subject matter
contained within the scope of claims of patents and patent
applications, provided there is no intent to commercialize or
seek financial gain. This experimental use exception is
addressed under Canadian law by Section 55.2(1) of the
Patent Act:
It is not an infringement of a patent for any person to make,
construct, use or
sell the patented invention solely for uses
reasonably related to the development and submission of
information required under any law of Canada, a province or a
country other than Canada that regulates the manufacture,
construction, use or
sale of any product.
Typically this section would apply most often
to pharmaceutical patents and the research done, often by
generic drug manufacturers, in order to comply with Health
Canada and its regulatory approval requirements. An additional
section of the Patent Act further defines the
experimental use exception, Section 55.2(6):
For greater certainty, subsection (1) does not affect any
exception to the exclusive property or privilege granted by a
patent that exists at law in respect of acts done privately
and on a non-commercial scale or for a non-commercial purpose
or in respect of any use, manufacture, construction or sale of
the patented invention solely for the purpose of experiments
that relate to the subject matter of the patent.
Europe
Each member state, as of October 30, 2005, was obliged to have
introduced a national law to the experimental use exemption
provided for in Directive 2004/27/EC (article 10.6).
Experimental work and clinical trials on a patented product
are permitted prior to the expiry of the patent provided that
the experimental work and clinical trials are made with the
aim of obtaining regulatory approval. It is not clear at this
time how uniform the interpretation of article 10.6 will be as
each individual jurisdiction interprets the legislation.
United States
The experimental use exception (“safe harbour provision”) is
addressed under U.S. law by Section 35 USC 271(e)(1) of the
Patent Act:
It shall not be an act of infringement to make, use, offer to
sell, or sell within the United States or import into the
United States a patented invention (other than a new animal
drug or veterinary biological product (as those terms are used
in the Federal Food, Drug, and Cosmetic Act and the Act of
March 4, 1913) which is primarily manufactured using
recombinant DNA, recombinant RNA, hybridoma technology, or
other processes involving site specific genetic manipulation
techniques) solely for uses reasonably related to the
development and submission of information under a Federal law
which regulates the manufacture, use, or sale of drugs or
veterinary biological products.
The Supreme Court vacated the Federal Court
ruling in Integra and expanded the “safe harbour” to include
pre-clinical experiments to produce information that is
relevant to an IND or NDA submission to the FDA1.
The interpretation provided to Section 35 USC
271(e)(1) brings it more into line with the current status of
the experimental use exception of Europe but it is still far
more restrictive than the experimental use exception in
Canada. Neither the United States or Europe make the
distinction between research which is done for profit or for
commercialization, which would be a direct threat to the
rights of the patentee, and research done with no intent to
seek profit or commercialize, which helps to expand the R&D
base and can only benefit the patentee.
A review of the relevant literature suggests
that there are two common arguments against an expansion of
the experimental use exception to the degree currently
legislated in Canada:
1. Violation of Article 30 of the TRIPS
Agreement
This agreement prohibits countries from implementing
exceptions to a patent owner’s exclusive rights, unless the
exception does not “unreasonably conflict with the normal
exploitation of the patent” and does not “unreasonably
prejudice legitimate interests of the patent owner, taking
account of the legitimate interests of third parties”. In a
dispute between the EU and Canada (over the protection of
pharmaceutical products) the resolution procedures under the
WTO did not find that Canada’s experimental use exception was
acting outside Article 30 of the TRIPS Agreement2.
2. Decreases the Financial Gain of the Patentee
In Canada, any use of the patent that falls within the
experimental use exception, by its very definition cannot
involve any attempt to seek commercialization or financial
gain. If research conducted, with no attempt to commercialize
or make a profit, with the patented invention results in new
uses or improvements that are openly published, the end result
will likely be increased interest in the scientific
community, increased use of the invention, and subsequently
reduced financial risk for future investment in the area. As
such, there would only be additional incentives for the
patentee to continue inventing and patenting in the same area.
Clearly defined experimental use exceptions,
such as those in Canada, create an environment which makes
it more likely for the patented invention to become known in
the scientific community and to commercialize. There is an
open working relationship between the academic and pharma
communities where the boundries between what is and is not
infringing activity are clearly defined. It would be in the
best interests of companies conducting R&D and patenting to
do the work where they would get the best return on their
investment – a country, like Canada, which has strong
enforcement of Patent Laws and has a strong and clearly
delineated experimental use exception.
1. Merck KGaA v. Integra Lifesciences I, Ltd., 545
U.S.__(2005), 125 S. Ct. 2372, No. 03-1237 (June 13, 2005).
2. World Trade Organisation Panel Report Canada – Patent
Protection of Pharmaceutical Products (http://www.wto.org/english/tratop_e/dispu_e/7428d.pdf)
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