A guide to the UPC and the UP - Flipbook - Page 161
Art.27(d) UPCA – Tests and Studies for Marketing Authorisation Applications
for Medicinal Products
10-49 Art.27(d) UPCA incorporates the limitations provided by art.13(6) Directive 2001/82/EC on the
Community code relating to veterinary medicinal products 38 and art.10(6) Directive 2001/83/EC
on the Community code relating to medicinal products for human use. 39
10-50 These Directives require Member States to make provision in their national law such that
conducting the necessary studies and trials (and the consequential practical requirements)
to demonstrate that a medicinal product is a generic of a reference medicinal product, or a
biological medicinal product is similar to a reference biological product 40 is not considered to
infringe patent rights or SPCs for medicinal products. This is often referred to as the “Bolar”
exemption following the name of the similar legislative provision in the US.
10-51 The purpose of these limitations is to allow parties who wish to market generic or biosimilar
versions of patented medicinal products to conduct the necessary tests and studies in order
to obtain regulatory approval so as to be able to put the product on the market as soon as the
relevant patent or SPC expires. The limitation only extends to trials carried out for the purposes
of obtaining marketing authorisation in the EU and does not extend to trials for obtaining
regulatory approval elsewhere.
10-52 Art.27(d) UPCA only provides a defence to infringement in relation to patent rights covering the
reference medicinal product, and not a more general defence covering any patent rights which
could be infringed in the course of a medical trial. The exemption is also specifically limited to
clinical trials for generics and biosimilars. It does not provide a broader exemption (such as
has been implemented in Germany, France and Italy) for trials relating to innovative medicinal
products where the patentee has not already obtained regulatory approval in the EU.
However, particularly in the case of biosimilars, such clinical trials may fall within the
experimental use exemption in art.27(b) UPCA.
Art.27(e) UPCA – Preparation of a Medicine by a Pharmacy
10-53 Art.27(e) UPCA is derived from art.31(b) CPC and provides an exemption from patent
infringement for the preparation of medicaments by pharmacies when dispensing to
individuals in response to a prescription. This is a limited exemption that protects dispensing
pharmacists from infringing a patent when they put together a specific prescription for a
patient, where in combining a set of ingredients they might otherwise infringe a patent. It is
unlikely to be relevant to modern pharmacy practice where the vast majority of products are
provided in pre-packaged form to pharmacists.
Art.27(f) to (h) UPCA – Vessels, Aircraft and Land Vehicles from Outside Contracting Member
States in which the Patent has Effect
10-54 Art.27(f) and (g) UPCA provide exemptions for the use of patented inventions in vessels, aircraft,
land vehicles or other means of transport of countries, other than those Contracting Member
States in which the patent has effect, of the International Union for the Protection of Industrial
Property (Paris Union) or members of the World Trade Organisation, when these temporarily or
accidentally enter the waters or territories of a Contracting Member State in which the patent
does have effect. More specifically, art.27(f) UPCA exempts such use of patented inventions on
board vessels and in the body, machinery, tackle, gear, and other accessories of the vessel,
38
39
40
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
veterinary medicinal products (OJ No. L 311, 28.11.2001, p. 1).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ No. L 311, 28.11.2001, p. 67).
As specified in art.13(1) to (5) of Directive 2001/82/EC and art.10(1) to (6) of Directive 2001/83/EC.
© Bird & Bird LLP | May 2023
A Guide to the UPC and the UP 151
