A Whistlestop Guide to SPCs

14/02/2020

Supplementary Protection Certificates (SPCs) are European sui generis rights which provide a form of patent term extension available in Europe for medicinal products or plant protection products.

The period of effective patent protection for medicinal products and plant protection products can be significantly less than in other sectors because of the need to obtain a marketing authorisation (MA). Obtaining an MA can take a significant amount of time (typically around 12 years), which can be a large portion of the lifetime of a patent (20 years from its filing date).

SPCs are national rights available in individual EU countries (and European Economic Area (EEA) countries: Switzerland and Norway) which are governed by EU regulations. They will also continue to be available in the UK following its exit from the EU.

The SPC sphere is a fascinating and extremely active area of intellectual property law. There is a steady stream of decisions from the Court of Justice of the European Union (CJEU) attempting to clarify the SPC Regulations, and there are a number of issues outstanding. This brief guide attempts to give a sense of the current state of play.

What is the duration of an SPC?

• The term of an SPC is equal to the period of time between the filing date of the basic patent and the date of the first relevant marketing authorisation in the EEA, minus five years, but the maximum duration is 5 years.
• A Paediatric Extension can extend the duration of an SPC by 6 months.

What protection does an SPC provide?

• An SPC confers substantially the same rights as the basic patent and is subject to the same limitations and obligations, but the scope of protection of an SPC extends only to the product authorised to be placed on the market, rather than extending the protection of the whole claim scope of the basic patent.
• For SPCs applied for after 1 July 2019, European generics and biosimilar manufacturers can manufacture products which are protected by an SPC, for export to markets outside the EEA where protection does not exist or has expired. In addition, European generics and biosimilar manufacturers can manufacture and stockpile medicines that are protected by an SPC in the Member States during the six months before expiry of the SPC, thus allowing them to launch the product in the EEA on the day after expiry of the SPC. See Robin Ellis’ blog.

Who can apply for an SPC?

• An applicant for an SPC must own the basic patent. However, the applicant does not have to hold the relevant MA. So, an SPC can be obtained on the basis of a third party MA (C-181/95 (Biogen v SKB)).
• It has become common practice that SPCs are granted to owners of the basic patent who rely on an MA held by a third party, including even a competitor, without the consent of that third party. Unlike similar types of patent extensions in Japan and the US, there is no legal provision expressly calling for any specific relationship or agreement between the SPC applicant, and the holder of the MA.

When should you apply for an SPC?

Within 6 months of either:

a) the date on which the marketing authorisation to place the product on the market was granted in the member state in which the application was filed; or

b) the date on which the basic patent was filed.

Where can you get an SPC?

• In an EU country (and/or European Economic Area (EEA) country: Switzerland, Norway) in which a basic patent is in force covering the product and where there is a marketing authorisation in place to put that product on the market in that country.
• The basic patent can either be a national patent or a European patent which has been validated in a contracting state.
• The marketing authorisation can be a national marketing authorisation issued by that particular country, or a centralised (Community) marketing authorisation issued by the European Medicines Agency (EMA).
• There is no centralised SPC. One must apply for an SPC in each individual country in which one is desired.

What is eligible for protection in an SPC?

• Medicinal products defined as “any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals”.
• “Product” is defined as the “active ingredient” or combination of active ingredients
  • A substance that does not have any therapeutic effect of its own and is used to obtain a certain pharmaceutical form of a medicinal product is not covered by the concept of ‘active ingredient’ (C-210/13 (GSK)).
• Plant Protection Products – defined as “active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:

(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;

(b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);

(c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;

(d) destroy undesirable plants; or

(e) destroy parts of plants, check or prevent undesirable growth of plants”.

• “Active substance” is defined as substances or microorganisms including viruses, having general or specific action against harmful organisms; or on plants, parts of plants or plant products.
  • “Active substance” may cover a substance intended to be used as a safener, where that substance has a “toxic, phytotoxic or plant protection action of its own”.

What are the conditions for getting an SPC?

One may obtain an SPC if, in the member state in which the application is submitted and at the date of application:

a) the product is protected by a basic patent in force;

b) a valid authorisation to place the product on the market as a medicinal or plant product has been granted

c) the product has not already been the subject of a certificate; and

d) the authorisation of b) is the first authorisation to place the product on the market as a medicinal/plant product

a) When is a product protected by a basic patent in force?

• A “basic patent” is a patent which protects a product as such; a process to obtain a product; or an application of that product. This can either be a national patent, or a European patent designating the member state in which the SPC is lodged.
• A product composed of several active ingredients is “protected by a basic patent in force” where “even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

(i)    the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

(ii)    each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.” (C-121/17 (Teva v Gilead))

• What if a single active ingredient is defined in the patent by reference to a Markush structure? Awaiting clarification from CJEU (C-114/18 (Sandoz v Searle)).
• What if a single active ingredient is defined in the patent by a functional claim? In the context of an antibody at least, it is not necessary for an active ingredient to be identified in the claims of the basic patent by a structural formula. However, where the active ingredient is covered by a functional formula in the claims, it must be possible to conclude that on the basis of those claims, interpreted inter alia in the light of the description of the invention as required by Art. 69 EPC and the protocol on its interpretation that the claims relate implicitly, but not necessarily and specifically, to the active ingredient in question (C-493/12 (Eli Lilly v Human Genome Sciences)).
• We are awaiting further guidance from the CJEU on the functional definition of active ingredients and eligibility for SPC protection (C-650/17 (Royalty Pharma)).

b) What is a valid authorisation? 

• The authorisation must be for a product that includes the relevant active ingredient. So, if the MA is for a product that includes A, it can serve as the basis for an SPC for A, even if the MA is for a combination of A + B (C-322/10 (Medeva); C-422/10 (Georgetown University))
• SPCs cannot be obtained on the basis of an “end of procedure notice”, i.e. on the basis of a notice of an agreement to to grant a MA under the decentralized procedure (the procedure for authorising medicines in more than one EU Member State in parallel), but the relevant authority has not yet taken the step to actually grant it. (C‑567/16 (Merck))
• SPCs cannot be obtained on the basis of an authorisation of a drug-device combination product obtained under the Medical Devices Directive (Directive 93/42/EC), i.e. “a CE certificate” (C-527/17 (Boston Scientific Ltd))

c) When has a product not already been the subject of an SPC? 

• The holder of more than one patent for the same product cannot be granted more than one SPC for that product.
• If a product is protected by a number of basic patents which belong to different patent holders, SPCs can be granted to each of those patentees. This may include the situation where: 1) patent holder A has a patent which protects the product per se; 2) patent holder B has a patent for a process for making the product; and patent holder C) has a patent for a therapeutic use of that product.
• Multiple SPCs can be granted on the basis of the same patent, provided that each of the products in respect of which an SPC is sought, is protected as such by the basic patent.
  • If a patent owner already has an SPC for a combination of active ingredients, they may be entitled to a further SPC for one of those active ingredients alone which, individually, is also protected as such by the patent (C-484/12 (Georgetown)).
  • If an SPC has already been granted for a single active ingredient, and a later application is filed for an SPC for a combination containing that active ingredient, the later SPC could be granted in these circumstances particularly if the combination provides a solution of technical problem beyond the monotherapy alone ((C-443/12 (Actavis v Sanofi); C-577/13 (Actavis v Boehringer))
• If an applicant has previously been granted an SPC for a product which is protected by a basic patent in force for the product per se, are they precluded from being granted an SPC concerning a new use of the product in the case where the new use constitutes a new therapeutic indication which is specifically protected by a new basic patent? Awaiting clarification from CJEU (C-354/19 (Novartis)).

d) What constitutes the first authorisation to place the product on the market? 

• An earlier marketing authorisation does not preclude the grant of an SPC for a different application of the same product provided that the application is within the limits of protection conferred by the basic patent (C-130/11 (Neurim)). So, an earlier authorisation which is outside the scope of a basic patent should not be taken into account. In this specific case, the earlier authorisation was for a veterinary use (use in regulating the seasonal breeding activity of sheep) which was outside the scope of the basic patent, the basic patent covering human use in treating insomnia.
• There has been a lack of clarity as to how broadly Neurim should be interpreted, but there has been some recent guidance….
  • SPCs cannot be granted for new formulations of previously approved active ingredients, even if the MA for the new formulation is the first one that falls within the scope of the basic patent relied upon for the SPC filing (C-433/17 (Abraxis))
  • Further guidance is expected shortly from the CJEU C-673/18 (Santen) – see Robin Ellis’s earlier blog .

What happens to SPCs in the UK now the UK has left the EU?

• The Patents (Amendment) (EU Exit) Regulations 2019 come into effect at the end of the transition period on 31 December 2020. These regulations will bring current EU legislation into UK law as far as possible, to maintain current systems and processes.
• Authorisations from the EMA will be converted into equivalent UK authorisations on 1 January 2021.
• An SPC that has already taken effect in the UK will remain in effect after 31 December 2020. SPCs granted but not yet in force will come into force at the end of the associated patent term, as normal. A pending SPC will continue to progress. There is no need to refile.
• Current EU law provides for a 6-month extension to SPCs which protect medicines that have been tested for paediatric use. From 1 January 2021, the availability of this extension will be determined based on equivalent provisions in the UK’s Human Medicines Regulations 2012.
• The SPC Manufacturing Waiver came into force after the Patents (Amendment) (EU Exit) Regulations 2019 were made on 4 April 2019, so it has not yet been fixed into UK law, but the intention is that UK law will be changed to bring the manufacturing waiver into effect.

This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.