Supplementary Protection Certificates

31 Dec 2019 updated 11 Jan 2021

A supplementary protection certificate ("SPC") is an intellectual property right ("IPR") that protects the active ingredients in pharmaceutical or plant protection products.  The right comes into force upon the expiry of a patent for such a product.  The rationale for SPCs is that new pharmaceutical and plant protection products cannot be marketed unless and until they are found to be safe by the relevant national or European authorities. Evaluating the safety of a new drug or plant protection product can take time.  As the maximum term of a patent is 20 years the time waiting for such evaluation reduces the effective term of the monopoly. The purpose of an SPC, as Lord Justice Floyd explained in  Teva UK Ltd and others v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 Dec 2019), is, therefore, to compensate the patentee for such lost time by protecting the active ingredient of the pharmaceutical or plant protection patent for up to 5 years (or in the case of a product used for treating children a further 6 months) after the expiry of the patent. 

Legislation

The legislation that provided for SPCs in the UK before 23:00 on the 31 Dec 2020 was as follows:
Reg 2 of The Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007 SI 2007 No. 3293 inserted a new s.128B and a new Schedule 4A into the Patents Act 1977.  Rule 118 of the Patents Rules 2007 governs applications for and renewals of SPCs in the UK.

Art 50 (3) of the Treaty of European Union provided that EU law would cease to apply to the UK from the entry into force of an agreement setting out the terms of British withdrawal from the EU. Under The Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community ("the withdrawal agreement"), the UK left the EU on 31 Jan 2020. However, art 126 of the withdrawal agreement provided for an implementation agreement during which time EU law would continue to apply to the UK until 31 Dec 2020.  Art 60 (1) of the withdrawal agreement provided for Regulations  (EC) No 1610/961 and No 469/2009 to continue to apply to applications for SPCs lodged before 23:00 on 31 Dec 2020.  Art 60 (2) provided for certificates granted pursuant to art 60 (1) to enjoy the same degree of protection as would have been enjoyed before 31 Dec 2020.

Although EU law ceased to apply to the UK from 23:00 on 31 Dec 2020, s.3 (1)  of the European Union (Withdrawal) Act 2018 incorporated all direct EU legislation including Regulations (EC) No 1610/961 and into the laws of England, Wales, Scotland and Northern Ireland immediately afterwards.  Part 6 of The Patents (Amendment) (EU Exit) Regulations 2019 amend Regulations (EC) No 1610/961 with regard to SPCs for plant protection products in the UK and Part 8 of those Regulations amend Regulation No 469/2009 with regard to SPC for medicinal products.  Further amendments are made to the incorporated Regulations by Part 8 of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020.

Essentially, those Parts substitute references to British procedures and authorities for references to EU procedures and institutions so that the incorporated legislation can function more or less as it did before the UK's withdrawal from the EU.
 
Eligibility

Art 2 of Regulation 469/2009 as amended provides that A product may, under the terms and conditions provided for in this Regulation, be the subject of a certificate if it is protected by a patent; and the subject of a UK authorisation prior to being placed on the market as a medicinal product. 

Conditions for the Grant of an SPC
Art 3 of Regulation 469/2009 as modified provides:

"Where an application is submitted under Article 7, a certificate shall be granted if, at the date of submission of that application—
(a) the product is protected by a basic patent in force;
(b) there is a valid UK authorisation to place the product on the market;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first UK authorisation to place the product on the market as a medicinal product.”.

Art 3 of Regulation 1610/96 imposes similar conditions for the grant of an SPC for a plant protection product.

In the UK marketing authorization must be a national product licence issued by The Medicines and Healthcare Products Regulatory Authority, The Veterinary Medicines Directorate or a valid UK plant protection product authorization (see Agricultural Industries Confederation Approval, authorisation and marketing of plant protection products).

Applications for SPCs

SPCs may be granted to the proprietors of basic patents or their successors in title (art 6 of Regulation 469/2009 and art 6 of Regulation 1610/96).   An application for an SPC must be made to the Intellectual Property Office on Form SP1 in accordance with rule 116 (1) (a) of the Patent Rules. The application must be lodged within 6 months of the date on which marketing authorization referred was granted unless market authorization is granted before the grant of the patent in which case the application must be lodged within 6 months of the grant of the patent (see art 7 (1) and (2) of Regulation 469/2009 and art 7 of Regulation 1610/96). 

Protected Intellectual Asset

It is important to note that an SPC is not an extension of the term of a patent.   Art 4 of Reg 469/2009 makes clear in the case of a medicinal product that the protection conferred by an SPC shall extend only to the product covered by the market authorization and for any use of the product as a medicinal product that has been authorized before the expiry of the SPC. Similarly, art 4 of Regulation 1610/96 provides:

"Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorizations to place the corresponding plant protection product on the market and for any use of the product as a plant protection product that has been authorized before the expiry of the certificate."

Effect of the SPC

Subject to the above provisions, an SPC confers the same rights as were conferred by the basic patent and are subject to the same limitations and obligations.

Northern Ireland

Readers should be aware that different arrangements apply to Northern Ireland as it will remain in the EU single market and customs union for certain purposes/

Further Information

The IPO has provided some further guidance in Supplementary protection certificates from 1 January 2021 dated 15 Dec 2020 including marked-up versions of the EU Regulations as amended by the 2019 and 2020 statutory instruments.

 Call Jane Lambert on +44 (0)20 7404 55252 or send her a message through her contact form.

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