The UK Patents Court recently issued a judgement which referred four questions to the CJEU in the case Actavis Group v Boehringer Ingelheim that aim to clarify how the SPC Regulation ought to be interpreted in respect of products having combinations of active ingredients.

This referral follows three earlier referrals to the CJEU concerning the interpretation of the SPC Regulation in the cases of Actavis v Sanofi, Lilly v Human Genome Sciences and Georgetown University.  These referrals were heard by the CJEU on 12 September 2013 and we are awaiting the CJEU's guidance to be issued.  It is suspected that the guidance on the three earlier referrals will provide a good indication as to how the CJEU will deal with the present referral.

Background and facts

Boehringer's European patent, EP (UK) 0502314, has a claim to a compound called telmisartan.  This compound is used in the treatment of hypertension and is marketed under the brand name Micardis.  The corresponding SPC is due to expire on 10 December 2013.

Boehringer also sells MicardisPlus, a product comprising telmisartan and hydrochlorothiazide.  In 2003 Boehringer applied to the UK IPO for an SPC to the combination of telmisartan and hydrocholothiazide.  EP (UK) 0502314 as granted did not have a claim specifically directed to this combination.  Boehringer therefore applied to amend the patent to insert a claim specifically directed to the combination.  Whilst the application to amend was pending the UKIPO agreed to suspend the SPC application for four months.  The amendment was granted and Claim 12, directed to the combination of telmisartan and hydrocholothiazide, was included in the amended patent.  The SPC for the combination was granted and is due to expire on 30 January 2017.

Actavis Group sought to invalidate the combination SPC in order to clear a path to launch its own product comprising telmisartan and hydrocholothiaziode.  In considering the invalidation action the UK Patents Court referred the four questions to the CJEU in order to seek clarification on the interpretation of the SPC Regulation in respect of combination products.

Questions referred

1.    (a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim could this patent, whether or not such an amendment is made, be relied upon as a "basic patent in force" for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2006/EC ("the Regulation")?

(b)  Can a patent that has been amended after the grant of the patent and either (i) before and / or (ii) after grant of the SPC be relied upon as the "basic patent in force" for the purposes of fulfilling the condition set out in Article 3(a) of the Regulation?

(c)  Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where,

(i)  after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) (the "Patent") is amended so as to include a claim which explicitly identifies A and B;

and

(ii)  the amendment is deemed, as a matter of national law, always to have had effect from the grant of the Patent;

is the applicant for the SPC entitled to rely upon the Patent in its amended form for the purposes of fulfilling the Art 3(a) condition?

The SPC regulation requires the basic patent which protects the active ingredient covered by the SPC to be in force.  In the present case, the patent as granted did not have a claim specifically to the combination of telmisartan and hydrocholothiazide when the SPC application for the combination was filed. Instead, a claim to the combination was added to the patent after the SPC application was filed.  The questions therefore arises as to whether the patent qualifies as "a basic patent in force" as per the requirement specified in the SPC regulation.

The UK judge's preliminary view was that given that amendments to UK patents have retrospective effect to the date of patent grant, if the amendment is allowable then when the amendment occurred ought to not affect the validity of the SPC.

2.    For the purposes of determining whether the conditions in Article 3 are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B, where (i) the basic patent in force includes a claim to a product comprising active ingredient A and a further claim to a product comprising the combination of active ingredients A and B and (ii) there is already an SPC for a product comprising active ingredient A ("Product X") is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone ?

This question essentially asks whether, in order for an SPC to be granted to a combination of active ingredients, is it necessary to consider whether the combination has to be an "inventive advance" over either one of the active ingredients alone.

The issue of whether a combination of active ingredients amounts to an "inventive advance" over either one of the active ingredients is the subject of the referral by the UK Court to the CJEU in the case of Actavis v Sanofi.  The UK judge in the present case did not give his opinion as to what he thought the answer to this question ought to be, but preferred to wait for the CJEU's guidance in Actavis v Sanofi which is expected in the coming months.  However, the UK judge indicated that if the "inventive advance" question is of relevance in the case of telmisartan and hydrocholothiazide, then a further trial on this point will need to be held at a later date.

3.    Where the basic patent in force "protects" pursuant to Article 3(a):

(a) A product comprising active ingredient A ("Product X"); and

(b) A product comprising a combination of active ingredient A and active ingredient B ("Product Y").

And where:

(c) An authorisation to place Product X on the market as a medicinal product has been granted;

(d) An SPC has been granted in respect of Product X; and

(e) A separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted.

Does the Regulation, in particular Articles 3(c), 3(d) and/or 13(1) of the Regulation preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y?

This question essentially asks whether the prior existence of the telmisartan SPC precludes the possibility of obtaining an SPC for the combination of telmisartan and hydrocholothiazide.  If the answer to this question is "no," then the question goes on to ask whether the term of the combination SPC ought to be limited to the term of the telmisartan SPC.

The UK judge indicated that he thought the telmisartan SPC should have no bearing on the grant of the combination SPC and that he would be surprised if the telmisartan SPC affected the term of the combination SPC.

4.    If the answer to question 1(a) is in the negative and the answer to question 1(b)(i) is positive and the answer to question 1(b)(ii) is negative, then in circumstances where:

i) in accordance with Art 7(1) Regulation, an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC;

ii)  following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of the Regulation;

iii)  following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted;

iv)  upon amendment of the basic patent in force, said amended patent complies with Article 3(a);

does the SPC Regulation prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of said application at a later date once the amendment has been granted, the said date of recommencement being

•    after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted but

•    within six months of the date on which the application to amend the basic patent in force was granted?

Question 4 is related to question 1 and asks whether the procedure adopted by the UKIPO to suspend the application for the combination SPC, whilst the application to amend the patent was heard, was the correct approach.  In his preliminary view, the UK judge could see no good reason why this approach could be challenged.

We await the CJEU's guidance on the referrals in the Actavis v Sanofi, Lilly v Human Genome Sciences and Georgetown University cases which is expected in the next few months.  This ought to give an indication of how it will deal with the four questions that have been referred in the present case.