International Agreements
TRIPS
European Patent Convention
Consolidated amendments
UK Legislation
Patents Act 1977 (Unofficial
consolidation)
Patents Act 2004
Cases
American Home Products Corp. and another v Novartis Pharmaceuticals UK
Ltd and another
[2000] EWCA Civ 231 BAILII
Bristol-Myers Squibb Co. v Baker Norton Pharmaceuticals Inc.
[2000]
EWCA Civ 169 BAILII
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."
Difference between Obviousness and Novelty
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 art 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
which 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.
Case Notes
Second Medical Use
Jane Lambert American Home Products Corporation v Novartis Pharmaceuticals UK Ltd.

Important