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Jane Lambert
Utility
Last updated 5 March
2005
One
of the conditions for the grant of a patent monopoly is that the
patented product should be useful. In some legislative texts
such as
art 27 of TRIPs and
art 57 of the EPC that requirement is spelt out as "capable of
industrial application" while in others, such as
§ 101 of the US Patents Act merely requires as invention to be
useful. The notes to art 27 of TRIPs provide helpfully that the term
“capable of industrial application” may be deemed by a member of the
WTO to be synonymous with the adjective “useful”.
Meaning of "Industrial Application"
Art
57 of the EPC provides that an invention shall be considered as "susceptible
of industrial application" if it can be used in any kind of
industry, including
agriculture.
Para 4.02 of the Manual of Patent Practice observers that
"industry" should be understood in its broad sense as including any
useful and practical, as distinct from intellectual or aesthetic,
activity. "It does not necessarily imply the use of a machine or
the manufacture of a product, and covers such things as a process for
dispersing fog or a process for converting energy from one form to
another."
Methods of Treatment and Diagnosis
Art 57 (1) EPC is amplified by by
art
52 (4) which excludes "methods for
treatment of the human or animal body by surgery or therapy and
diagnostic methods practised on the human or animal body." That
qualification is itself qualified by the last sentence of the paragraph:
"This provision shall not apply to products, in particular
substances or compositions, for use in any of those methods. The reason
for excluding methods of medical and veterinary treatment and diagnosis,
as explained by Aldous LJ in
Bristol-Myers
Squibb Co. v Baker Norton Pharmaceuticals Inc [2001] RPC 1,
BAILII at paragraph 62 was not to exclude
pharmaceutical preparations from being patentable but for "the
limited purpose of ensuring that the actual use, by practitioners,
of methods of medical treatment when treating patients should not be
subject to restraint or restriction by patent monopolies." The
practical difficult provided by this section arises in "Swiss"
or "second medical use" type
claims which are considered in more detail elsewhere on this website.
S. 4 of the Patents Act 1977 encapsulates articles 57, 52 (4) and 54 (5) of
the EPC with regard to UK patents.
Effect of Amendment to the EPC Although article 57 will not be
affected by the
Act
revising the EPC, arts 52, 53 and 54 relating to second medical use
will be amended. So too will the Patents Act 1977.
S.1 of the Patents Act 2004 will insert a new s.4A whcih will
provide:
"4A Methods of treatment or diagnosis
(1) A patent shall not be granted for the invention of-
(a) a method of treatment of the human or animal body by surgery or
therapy, or
(b) a method of diagnosis practised on the human or animal body.
(2) Subsection (1) above does not apply to an invention consisting of
a substance or composition for use in any such method.
(3) In the case of an invention consisting of a substance or
composition for use in any such method, the fact that the substance or
composition forms part of the state of the art shall not prevent the
invention from being taken to be new if the use of the substance or
composition in any such method does not form part of the state of the
art.
(4) In the case of an invention consisting of a substance or
composition for a specific use in any such method, the fact that the
substance or composition forms part of the state of the art shall not
prevent the invention from being taken to be new if that specific use
does not form part of the state of the art."
This
new section will come into force when the amendments agreed in Munich
in 2000 come into effect. That is likely to be towards the end of 2006
or the beginning of 2007. |
