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.

Popular posts from this blog

Copyright in Photographs: Temple Island Collections and Creation Records

Image
In our very first NIPC newsletter which we published in June 1997 I wrote a case note on Mr. Justice Lloyd's decision in  Creation Records Ltd. and Others v News Group Newspapers Ltd   [1997] EMLR 444, [1997] EWHC Ch 370, (1997) 16 Tr LR 544. In that case Mr. Noel Gallagher of Oasis and others applied for an interlocutory injunction to restrain The Sun from offering for sale and selling a poster of Oasis that featured a photo of an elaborate set that included a white Rolls Royce in a country club swimming pool. The Sun's photograph was very similar to the photograph that appeared on an Oasis album cover. The similarity arose because The Sun's photographer shot the same scene at roughly the same time and from the same angle as Mr. Gallagher's photographer but he did not reproduce any part of Oasis's print or negative. The learned judge held that the plaintiffs had no arguable case for infringement of copyright though he accepted that they had an arguable case for br...
Read more

"What is meant by "Due Cause" in s.10 (3) of the Trade Marks Act? The Red Bull Case

Image
Amsterdam   Source Wikipedia According to Wikipedia  Red Bull is the most popular energy drink in the world, with 5.2 billion cans sold in 2012. Its manufacturer, Red Bull GmbH , has registered the RED BULL mark has registered those words and their accompanying logo as word and device marks in trade mark registries around the world including the Benelux Office for Intellectual Property ( "BOIP" ) . The company registered that sign with BOIP for non-alcoholic drinks in class 32 with effect from 11 July 1983. After decades of massive sales and extensive advertising nobody could argue that that mark has a reputation within the meaning of art 5 (2) of the Trade Marks Directive (Directive 2008/95/EC of the European Parliament and the Council of 22 October 2008   to approximate the laws of the Member States relating to trade marks OJ 8.11.2008 p 299/25).  S.10 (3) of our Trade Marks Act 1994   implements that provision. There is in the Net...
Read more

Copyright: Creation Records Ltd. v News Group

It is trite law that if two photographers take identical pictures of the same scene at the same time from the same position each of their photographs is an original work and neither infringes the copyright in the other. However, much of the skill of a photographer lies in his choice of subject and the arrangement of the scene. The question whether copyright subsists independently in such an arrangement arose in Creation Records Ltd. v News Group Newspapers Ltd . (1997) The Times 27 April.   The Facts A swimming pool at a country club was drained and various props including a white Rolls Royce motor car assembled for a photograph of a well-known group of musicians for reproduction on their album cover. Although the public was not admitted to the session certain fans of the group who happened to be there were allowed to photograph the scene before official pictures were taken. A freelance photographer who was booked into the club photographed the scene during the session. One of his pict...
Read more