SPCs and combination products: basic patent on a sole ingredient cannot double as basic patent for combination SPC

24 March 2015


Background

On 20 May 1998, Boehringer was granted European Patent (UK) No. EP0502314 ("Boehringer's basic patent"). Boehringer's basic patent contained a claim to the compound telmisartan. Telmisartan is the sole active ingredient in 'Micardis', a medical product sold by Boehringer for the treatment of high blood pressure.

On 9 August 1999, on the basis of Boehringer's basic patent and the marketing authorisation it had obtained for Micardis, Boehringer obtained an SPC for telmisartan ("the telmisartan SPC").

Later, on 19 April 2002, Boehringer obtained marketing authorisation for a combination of telmisartan and hydrochlorothiazide, for 'MicardisPlus'.

On 6 September 2002, Boehringer filed an application for an SPC for the combination of telmisartan and hydrochlorothiazide (‘the combination SPC’).

The UK IPO indicated to Boehringer that, in order to be eligible for an SPC, the combination must be clearly claimed in Boehringer's basic patent. Boehringer’s basic patent only claimed telmisartan, so Boehringer sought and obtained an amendment so that it also claimed the telmisartan and hydrochlorothiazide combination.

Following the amendment to the patent, the combination SPC was granted on 13 January 2005. The combination SPC is due to expire on 30 January 2017.

Actavis' claim

In 2013, Actavis brought a claim in the English High Court, arguing that the combination SPC was invalid on the basis that, when the application for the combination SPC was made (on 6 September 2002), Boehringer's basic patent did not claim the telmisartan and hydrochlorothiazide combination.

Both the parties and the court agreed that this claim could not be answered without further guidance from the CJEU on the interpretation of the SPC Regulation 469/2009, and so the court referred several questions to the CJEU for further ruling.

Article 3 of the SPC Regulation

Article 3 of the SPC Regulation 469/2009, entitled "Conditions for obtaining a certificate", is worded as follows:

"A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that 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 product has been granted in accordance with Directive 2001/83/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)] …;

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

(d)   the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product."

Ruling of the CJEU

The CJEU's judgment is available here. The CJEU noted that there were diverging views on the approach it should take but ultimately its judgment was short and succinct.

The CJEU first reminded us:

"that it is possible, in principle, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’ ".

However, ultimately it agreed with Actavis that Boehringer should not be entitled to the combination SPC. As the CJEU explained, granting the combination SPC would go against the objectives behind the granting of SPCs i.e. recognising the investment necessary for research and ensuring that such investment is protected. The CJEU stated:

"…it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, an active ingredient, protected as such by the holder’s basic patent and constituting the subject-matter of the invention covered by that patent, and, on the other, another substance which does not constitute the subject-matter of the invention covered by the basic patent".

With that in mind, it followed that for an active ingredient to be protected by a basic patent "as such", "that active ingredient must constitute the subject-matter of the invention covered by that patent".

It was common ground between the parties that the inventive subject matter of Boehringer's basic patent was telmisartan. Hydrochlorothiazide is a well-known diuretic and has been known in the art since 1958.

In light of this, the CJEU ruled that where a basic patent claims an active ingredient that constitutes the sole subject matter of the invention, and an SPC has been obtained based on that sole ingredient, a further SPC for a combination product containing that active ingredient will not be available.

This was in accordance with its ruling given in the similar case of Actavis v Sanofi (Case C-443/12) that a holder of a SPC for an innovative active ingredient cannot obtain a second SPC to a combination of active ingredients on the basis of the same basic patent.

However, as has become somewhat of a theme in referrals concerning SPCs, the CJEU also ducked several of the UK court's questions. In particular, it did not address whether a patent amended after grant can be relied on as a "basic patent in force". This seems an issue that is likely to find itself back before the CJEU in the future and it is disappointing, although understandable, to see it glossed over here.

Nevertheless, it is pleasing to see continued consistency here from the CJEU; you cannot double up on SPCs under the same basic patent using a combination product unless the combination constitutes the inventive subject matter of the basic patent. 


NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as, legal advice. You should not rely on, or take or fail to take any action based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Gowling WLG professionals will be pleased to discuss resolutions to specific legal concerns you may have.