Section 128B: Supplementary Protection Certificates
Section (128B.0 - 128B.12) last updated: July 2017.
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. In combination with Schedule 4A to the Act, it sets out how certain provisions of the Act apply to supplementary protection certificates, and applications for such certificates. These certificates exist under the two supplementary protection certificates Regulations – namely Regulation (EC) No 469/2009 of 6 May 2009 (which superseded Council Regulation (EEC) No 1768/92 of 18 June 1992) concerning the supplementary protection certificate for medicinal products, and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products. These two Regulations are referred to in the Act as “the Medicinal Products Regulation” and “the Plant Protection Products Regulation”. Section 128B and Schedule 4A do not implement those provisions of the Regulations that are directly applicable.
The Medicinal Products and Plant Protection Products Regulations provide for the availability of a supplementary protection certificate in order to compensate a patentee for the loss of effective protection arising out of the time taken to obtain regulatory approval for a medicinal or plant protection product which is protected by a patent. The Medicinal Products Regulation also provides for the possibility of a six month extension to a certificate if the product in question has undergone an approved investigation plan for use on children.
The 1992 Medicinal Products Regulation and Plant Protection Products Regulation were originally implemented in the UK by the Patents (Supplementary Protection Certificate for Medicinal Products) Regulations 1992 (SI 1992 No 3091) and the Patents (Supplementary Protection Certificate for Plant Protection Products) Regulations 1996 (SI 1996 No 3120). On the introduction of section 128B and Schedule 4A, these original implementing Regulations were revoked. The general application of the Act to supplementary protection certificates that they set out was replaced, in Schedule 4A, with a more specific list of provisions in the Act which apply (with the necessary glosses) to supplementary protection certificates in the UK. Legislation equivalent to the 1992 and 1996 implementing Regulations continued to apply in the Isle of Man until the Patents (Isle of Man) Order 2013 (SI 2013/2602), which modified the Patents Act as it applies to the Isle of Man to introduce section 128B and Schedule 4A (see paragraph SP0.05).
PR rr.73-88 is also relevant
The Medicinal Products and Plant Protection Products Regulations set out a number of proceedings which may take place before the comptroller in relation to supplementary protection certificates. These include proceedings to apply for a declaration of invalidity of a certificate, or to apply for revocation of a “paediatric” extension to a certificate. All proceedings before the comptroller in relation to certificates fall within the scope of Part 7 of the Patents Rules 2007, which also 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 are launched under Part 7 of the Rules, and how such proceedings would then progress.
Detailed commentary on the Medicinal Products and Plant Protection Products Regulations, and on UK implementation and practice, is provided in the separate part of this Manual which is dedicated to supplementary protection certificates.
|Schedule 4A contains provision about the application of this Act in relation to supplementary protection certificates and other provision about such certificates.|
Paragraph 1(1) of Schedule 4A makes clear that certain references in the Act which relate to patents should, in relation to supplementary protection certificates, be construed differently. Thus, for example, references to a patent proprietor are construed as references to the holder of a certificate, and references to a patented product or invention are construed as references to a product for which a certificate has effect. Paragraph 1(2) of the Schedule identifies the sections of the Act to which these various glosses set out in paragraph 1(1) apply. Thus, for example, section 19(1) applies to an application for a certificate, but the references in section 19(1) to the ability of a patent applicant to amend his application before grant are construed as references to the ability of an applicant for a certificate to amend his application for a certificate before that certificate is granted.
Paragraph 2 of the Schedule makes clear that certain provisions of the Act which refer to a patent application are only construed as referring to an application for a certificate in the circumstances where the patent has expired while the application for the certificate is still pending. This ensures that certain rights associated with a patent application (notably, the provisional protection provided by section 69) only become rights associated with an application for a certificate in the circumstances where there are no patent rights still in force.
Paragraph 3 of the Schedule makes clear that certain references in the Act to the Act itself include within their meaning the Medicinal Products and Plant Protection Products Regulations, and similarly that certain references in the Act to a section of the Act include within their meaning the equivalent provision of those Regulations. For example, the references in section 124A to “requirements of the Act” are taken to include requirements set out within the provisions of the Medicinal Products or Plant Protection Products Regulations.
Paragraph 4 of the Schedule deals with two specific glosses which require more detailed explanation than those set out in the list in paragraph 1(1) of the Schedule. In accordance with paragraph 4, the reference in section 21(1) to the question of whether the invention is a patentable one is to be construed, for the purposes of supplementary protection certificates, as a question of whether the product is one for which a certificate may have effect. Also, the condition in section 69(2)(b) is to be construed as being that the act in question would, if the certificate had been granted on the date of publication of the application, have infringed not only the certificate as granted but also the certificate for which the application was made.
Paragraph 5 of the Schedule states that a certificate does not take effect unless the prescribed fee is paid before the end of the prescribed period, or the prescribed fee and any prescribed additional fee are paid before the end of the period of six months beginning immediately after the prescribed period. See paragraphs SPM12.01 to 12.14 for a detailed discussion of fees in relation to certificates.
Paragraph 6 of the Schedule states that expressions used in the Act that are defined in the Medicinal Products or Plant Protection Products Regulations have the same meaning as in those Regulations. Furthermore, paragraph 6(2) ensures that, if those Regulations are amended in the future, the references to them in the Act will continue to apply without further amendment being needed. Paragraph 7 of the Schedule defines the terms “Medicinal Products Regulation” and “Plant Protection Products Regulation”. This paragraph was amended by the Patents (Supplementary Protection Certificate) Regulations 2014 (SI 2014 No. 2411) in order to update the definition of the Medicinal Product Regulation to refer to the 2009 EC Regulation. Paragraph 8 of the Schedule sets out transitional provisions which ensure that a reference in the Act to the 2009 EC Regulation is read as being, or including, a reference to the superseded 1992 EEC Regulation for all relevant purposes.
|In this Act a “supplementary protection certificate” means a certificate issued under—
(a) Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products, or
(b) Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products.
Subsection (2) defines the term “supplementary protection certificate” for the purposes of the Act (and rules made under it). It was amended by the Patents (Supplementary Protection Certificate) Regulations 2014 (SI 2014 No. 2411) in order to update the reference to the Medicinal Product Regulation.