Manual of Patent Practice

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Section 128A: EU Compulsory licences

Sections (128A.01 - 128A.08) last updated: April 2009.

128A.01

This section was introduced by regulation 2 of the Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007 (SI 2007 No. 3293), on 17 December 2007. It sets out how certain provisions of the Act apply to EU compulsory licences, and applications for such licences, under the Compulsory Licensing Regulation (namely, Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems). The Compulsory Licensing Regulation provides for the availability of a compulsory licence for anyone who wishes to make a specific patented pharmaceutical product solely in order to export it to a developing country with a particular public health problem. Section 128A does not implement those provisions of the Regulation that are directly applicable in relation to UK patents.

128A.02

PR rr.73-88 is also relevant

The Compulsory Licensing Regulation sets out a number of proceedings which may take place before the comptroller in relation to these EU compulsory licences. These include proceedings to apply for, modify or revoke such a licence. All proceedings in relation to such licences fall within the scope of Part 7 of the Patents Rules 2007, which governs procedures in relation to all proceedings before the comptroller in relation to patents. Reference should be made to paragraphs 123.05 to 123.05.13, which set out in general terms how proceedings (such as an application for an EU compulsory licence) are launched under Part 7 of the Rules, and how such proceedings would then progress.

128A.03

Section 128A and related provisions in the Rules to EU compulsory licences do not apply in the Isle of Man.

 
Section 128A(1)
In this Act an “EU compulsory licence” means a compulsory licence granted under Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (referred to in this Act as “the Compulsory Licensing Regulation”).

128A.04

Subsection (1) defines the terms “EU compulsory licence” and “the Compulsory Licensing Regulation”.

 
Section 128A(2)
In the application to EU compulsory licences of the provisions of this Act listed in subsection (3)
(a) references to a licence under a patent,
(b) references to a right under a patent, and
(c) references to a proprietary interest under a patent, include an EU compulsory licence.
 
Section 128A(3)
The provisions referred to in subsection (2) are –
sections 32 and 33 registration of patents etc);
section 37 (determination of right to patent after grant);
section 38 (effect of transfer etc of patent under section 37), apart from subsection (2) and subsections (3) to (5) so far as relating to subsection (2);
section 41 (amount of compensation);
section 46 (2) (notice of application for entry that licences are available as of right);
section 57(1) and (2) (rights of third parties in respect of Crown use).

128A.05

Subsections (2) and (3) together make clear that certain references in the Act to a licence or a right or a proprietary interest under a patent include within their meaning an EU compulsory licence granted under the Compulsory Licensing Regulation. In particular, subsection (3) identifies the sections of the Act to which the gloss set out in subsection (2) applies. Thus, for example, references in section 38(1) to the continuation in force of licences (in certain circumstances following an entitlement dispute) include not only licences granted under the Act but also EU compulsory licences granted under the Compulsory Licensing Regulation. It should be noted that references to licences in section 38(2) do not include EU compulsory licences. This is because section 38(2) sets out that in certain circumstances a licence under a patent may lapse when a person becomes the new proprietor of the patent following entitlement proceedings – but the Compulsory Licensing Regulation does not envisage that an EU compulsory licence could lapse in such circumstances.

 
Section 128A(4)
In the following provisions references to this Act include the Compulsory Licensing Regulation –
sections 97 to 99B, 101 to 103, 105 and 107 (legal proceedings);
section 119 (service by post);
section 120 (hours of business and excluded days);
section 121 (comptroller’s annual report);
section 123 (rules);
section 124A (use of electronic communications);
section 130(8) (disapplication of Part 1 of Arbitration Act 1996).

128A.06

Subsection (4) makes clear that certain references in the Act to the Act itself include within their meaning the Compulsory Licensing Regulation. For example, the reference in section 120 to the Office’s opening hours and business done “under this Act” includes business done by the Office under the provisions of the Compulsory Licensing Regulation.

 
Section 128A(5)
In section 108 (licences granted by order of comptroller) the reference to a licence under section 11, 38, 48 or 49 includes an EU compulsory licence.

128A.07

Subsection (5) makes clear that the reference to “a licence under section 11, 38, 48 or 49” includes within its meaning a licence under the Compulsory Licensing Regulation. Thus any order for the grant of an EU compulsory licence shall, without prejudice to any other method of enforcement, have effect as if it were a deed (executed by the patent proprietor and all other necessary parties) granting a licence in accordance with the order. This ensures that such an order under the Compulsory Licensing Regulation will be effective even if the parties affected take no action in response to it.

 
Section 128A(6)
References in this Act to the Compulsory Licensing Regulation are to that Regulation as amended from time to time.

128A.08

Subsection (6) ensures that, if the Compulsory Licensing Regulation is amended in the future, the references to it in the Act will continue to apply without further amendment being needed.