Supplementary Protection Certificates

31 Dec 2019

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 provides for SPCs for pharmaceutical products is Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products OJ L 152, 16.6.2009, p. 1–10.  It has been amended by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products OJ L 153, 11.6.2019, p. 1–10 which is discussed in Jane Lambert Supplementary Protection Certificates - The Waiver Regulation 27 Nov 2019 NIPC Law.  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 OJ L 198, 8.8.1996, p. 30–35 provides for SPCs for plant protection products.  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.

Eligibility

Art 2 of Regulation 469/2009 provides that any product protected by a patent in the territory of an EU member state and subject, prior to being placed on the market as a medicinal product, to an administrative authorization procedure may, under the terms and conditions provided for in that regulation, be the subject of an SPC.  Art 2 of Regulation 1610/96 makes similar provision for plant protection products.

Conditions for the Grant of an SPC
Art 3 of Regulation 469/2009 requires an SPC to be granted if at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorization to place the product on the market as a medicinal product has been granted;
(c) the product has not already been the subject of an SPC;
(d) the authorization referred to above is the first authorization 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 the marketing authorization may be either:
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).   In the UK, 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.

Further Information

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

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