European Court of Justice Issues Further Guidance on Supplementary Protection Certificates

In three judgements released on 12 December 2013 (C-493/12 Eli Lilly v HGS, C- 443/12 Actavis v Sanofi, C-484/12 Georgetown v Octrooicentrum), the Court of Justice of the European Union (CJ-EU) gave further guidance on the interpretation of Regulation (EC) No 469/2009 (the SPC Regulation). Their guidance concerns:

  1. when a medicinal product is "protected" by a basic patent, such that an SPC is available; 
  2. whether or not it is possible to have multiple SPCs based on a single basic patent;
  3. the availability of SPCs for combination products; and
  4. the allowability of SPCs where the Applicant was not responsible for the clinical trials behind the marketing authorisation. 

These matters are discussed further below.

1  Article 3(a) - when is a product "protected" by a basic patent?

Article 3(a) of the SPC Regulation requires that the product subject to an SPC be "protected by a basic patent". There has, however, been considerable debate as to the level of specificity required in a patent claim to meet this requirement. The CJ- EU's earlier decision C-322/10 (Medeva) held that Article 3(a) precluded grant of a patent for an active ingredient which was not "specified" in the wording of the claims. There has, though, been further debate as to how that test should be applied.

Decision C-493/12 (Eli Lilly v HGS) considered the situation where an SPC for a specific medicinal product (here, an antibody) could be granted on the basis of a patent claim defining that compound in functional terms only (here, as an antibody that binds to neutrokine-alpha).  The CJ-EU ruled as follows:

"Article 3(a) of 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 must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court."

We welcome the clarification from the CJ-EU that a generic disclosure such as a functional definition which embraces a marketed product can in principle support the grant of an SPC. However, it is regrettable that the CJ-EU has failed to set out clear criteria for establishing when a patent claim defines a marketed product with enough specificity to satisfy Article 3(a) of the SPC Regulation. Thus, it is far from clear how to determine whether a claim "implicitly but necessarily and specifically" relates to an active ingredient.

The CJ-EU's judgement does, however, underline the importance of defining medicinal products as specifically as possible in patent claims if it appears likely that an SPC application will be filed for that medicinal product. The introduction of narrow dependent claims may therefore be required during prosecution of relevant patent applications, particularly as it becomes more apparent which lead compounds may be pursued through clinical trials, and in what forms/combinations etc. This judgement also highlights the importance of filing where possible follow-on patent applications specifically claiming products which were covered more generally in earlier filings. 

2  Article 3(c) - is it possible to have multiple SPCs based on a single basic patent? 

Article 3(c) of the SPC Regulation provides that an SPC shall be granted only where the product has not already been the subject of a certificate. Following earlier decisions from the CJ-EU (C-181/95 Biogen & C-322/10 Medeva) uncertainty had arisen as to whether or not this provision should preclude the grant of multiple SPCs based on a single basic patent, under circumstances where a number of different medicinal products are authorised, each of which is protected by the basic patent. 

The CJ-EU has provided some welcome clarity on this issue in C-484/12 (Georgetown v Octrooicentrum). In that judgement the CJ-EU explained that it is, in principle, possible to have multiple SPCs granted for multiple different products on the basis of the same basic patent, provided that each product is protected by the basic patent (reason 30 of the decision).

3  Article 3(c) - is it possible to have an SPC for a combination of active ingredients following grant of an SPC for one ingredient of the combination?

The issue considered by the CJ-EU here arose in C-443/12 (Actavis v Sanofi). Sanofi had been granted an SPC for irbesartan, and subsequently sought an SPC for the combination of irbesartan and hydrochlorothiazide based on the same basic patent.

The CJ-EU held that under such circumstances the second SPC should not be allowed. The Court thought that it was significant that the first SPC for the monotherapy allowed the innovator company to prevent competitors from launching combination products containing that drug. Under these circumstances, the Court felt that upon expiry of the SPC for the monotherapy, competitors should be free to launch combination products. Thus, further SPCs for combination therapies based on the same basic patent should not be allowed. The specific ruling made by the court is set out below.

"In circumstances such as those in the main proceedings, where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) of 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 must be interpreted as precluding that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients."

It is perhaps significant that the ruling is restricted to the situation where the subsequent SPC application for the combination is made on the basis of the same patent as the previous SPC for the monotherapy. It may be possible to secure an SPC for the combination therapy simply by dividing out into a separate patent application claims to the combination therapy. It may therefore be appropriate to consider carefully whether a divisional application should be filed from any pending patent application which protects a product which might be used in a combination therapy.

In this regard, from 1 April 2014, the previous time limit for filing divisional applications at the European Patent Office (2 years from the first Official Action) is being relaxed. Thus, from 1 April 2014 any pending European patent application can be divided.  It may in some cases be advantageous to delay prosecution of pending applications, so that they remain pending on 1 April 2014 and can be divided on that date. 

4  Availability of SPCs based on an unrelated third party marketing authorisation

Before the UK High Court Eli Lilly argued that an SPC application made by a Patentee (here HGS) on the basis of an unconnected third party (here Eli Lilly) marketing authorisation should not be permitted. The point as such was not referred to the Court of Justice and is not addressed in the ruling. However in its discussion the CJ- EU in C-493/12 (Eli Lilly v HGS) expressed the view that refusal of an SPC application for an active ingredient not specifically referred to in the patent may be justified where the patent holder had not made any investment in identifying his invention specifically.

The Court commented that to grant an SPC on that basis would undermine the objective of the SPC Regulation as referred to in recital 4 which is to encourage research and, to that end, to ensure that the investments put into research are covered. This seems, however, to overlook the investment that HGS in this case made in the research which identified the protein to which both HGS (belimumab) and Lilly (tabalumab) subsequently developed antibodies for therapeutic use.

If you have any questions about these three judgements, or SPCs in general, please do not hesitate to get in touch with Andrew Webb, Ravi Srinivasan or your usual J A Kemp contact.

12 December 2013

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