Section 128A: Compulsory pharmaceutical licences

Sections (128A.01 - 128A.08) last updated: January 2024.

128A.01

This section was introduced by regulation 2 of the Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007 (SI 2007/3293), on 17 December 2007. It sets out how certain provisions of the Act apply to compulsory pharmaceuticals licences (originally, “EU compulsory licences”), and applications for such licences, under the Compulsory Licensing Regulation (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 for the purpose of exporting it to a developing country with a particular public health problem. Section 128A does not implement those provisions of the Regulation that were directly applicable in relation to UK patents under the provisions of section 2(1) of the European Communities Act 1972 and are now incorporated into domestic law by the European Union (Withdrawal) Act 2018.

128A.01.1

Under the provisions of the European Union (Withdrawal) Act 2018, EU-derived domestic legislation and direct EU legislation in force in the UK at 11pm on 31 December 2020 was saved or incorporated into domestic law. This included the Compulsory Licensing Regulation as well as its implementation through the 2007 Regulations. These remain in effect as assimilated law. The Compulsory Licensing Regulation was amended by the Patents (Amendment) (EU Exit) Regulations 2019 (SI 2019/801), which established that the comptroller is the competent authority for the grant and maintenance of compulsory pharmaceutical licences.

128A.01.2

This section was also amended by the Patents (Amendment) (EU Exit) Regulations 2019 (as modified by the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (SI 2020/1050)), to replace references to “EU compulsory licences” with “compulsory pharmaceutical licences”, including in the title.

128A.01.3

Under the provisions of the Protocol on Ireland/Northern Ireland in the Agreement on the Withdrawal of the United Kingdom from the European Union, the EU version of the Compulsory Licensing Regulation continues to apply in Northern Ireland for as long as the Protocol has effect. In terms of the grant and maintenance of compulsory pharmaceutical licences, there is no substantive difference in how the two versions operate in relation to Office practice.

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 compulsory pharmaceutical 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 a compulsory pharmaceutical licence) are launched under Part 7 of the Rules, and how such proceedings would then progress.

128A.03

[Deleted]

 
Section 128A(1)
In this Act a “compulsory pharmaceutical 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 “compulsory pharmaceutical licence” and “the Compulsory Licensing Regulation”. As per paragraphs 1 and 1A of schedule 8 to the European Union (Withdrawal) Act 2018, the reference to Regulation (EC) No 816/2006 is to be interpreted as a reference to the version as incorporated into UK domestic law, or as the EU version which has effect under the Protocol, depending on context.

 
Section 128A(2)
In the application to compulsory pharmaceutical 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 compulsory pharmaceutical 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 a compulsory pharmaceutical 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 compulsory pharmaceutical licences granted under the Compulsory Licensing Regulation. It should be noted that references to licences in section 38(2) do not include compulsory pharmaceutical 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 a compulsory pharmaceutical 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 a compulsory pharmaceutical 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 a compulsory pharmaceutical 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) is an “ambulatory reference”. It ensures that, if the Compulsory Licensing Regulation is amended in the future by UK domestic legislation, the references to it in the Act will continue to apply without further amendment being needed. This is supported by paragraph 1 of schedule 8 to the European Union (Withdrawal) Act 2018. Similarly, paragraph 1A of the same schedule will mean that any changes affecting the EU version that has effect in Northern Ireland will be recognised without further amendment.