2 Description of the draft Order
9. As noted above, the 1977 Act sets out the
legal rights and requirements for UK patents and patent applications.
Currently, there is a research exemption contained in section
60(5)(b) of the 1977 Act. Section 60(5)(i) of the 1977 Act also
exempts from infringement certain activities performed for the
regulatory approval of generic drugs (commonly called the Bolar
exception).[9] The draft
Order would amend section 60 of the 1977 Act to provide an exemption
from infringement in relation to acts done for experimental purposes
relating to the subject matter of the invention.
10. The draft Order would insert new paragraphs
6D to 6G into section 60 of the 1977 Act. The proposed new subsections
would make the following changes:
- New subsection 6D provides that anything done
in or for the purposes of a medicinal product assessment is to
be regarded as done for experimental purposes relating to the
subject matter of the invention;
- New subsection 6E provides a definition of what
is meant by a "medicinal product assessment". The draft
Order is intended to cover clinical trials for human medicines,
field trials for veterinary medicines and activities which fall
within the term "health technology assessment." It includes
acts done in the UK or the Isle of Man[10]
in testing or in a course of testing or other activity undertaken
with a view for providing data for a specified purpose. The purposes
that are specified are:
(a) obtaining or varying an authorisation for a medical
product to sell or supply, or offer to sell or supply a medicinal
product (whether in the UK or elsewhere); or
(b) complying with any regulatory requirement imposed
(whether in the UK or elsewhere) in relation to such authorisation;
or
(c) enabling a government or public authority or
a person (whether in the UK or elsewhere) with the functions of
providing healthcare on behalf of such a government or public
authority; or providing advice to or on behalf of, such a government
or public authority about the provision of healthcare to carry
out an assessment of suitability of a medicinal product for human
use for the purpose of determining whether to use it, or recommend
its use, in the provision of healthcare.[11]
- New subsection 6F defines the meaning of "medicinal
product" by reference to European Directives 2001/82/EC and
2001/83/EC defined currently in section 60(7).
- New subsection 6G provides that nothing in the
preceding subsections is to be read as affecting the application
of subsection 5(b) of the 1977 Act in relation to any act of a
kind not falling within new subsection 6D.
11. The Explanatory document issued by the Intellectual
Property Office also notes (at paragraph 1.21) that where the
proposed changes go beyond the scope of the current Bolar exception,
generic manufacturers would be able to rely on the new provision.
9 Explanatory Document, paragraph 1.5 Back
10
See Annex, Q 6 Back
11
Explanatory Document, paragraph 1.16-1.17 Back
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