Compulsive Reference Disorder: another SPC case heads for the Duchy -- Part I

The Grand Chamber: a Kat's eye view

Here's a bit of drama, if you like.  Picture the scene, if you will: according to the Curia agenda it's 12 September 2013, a cloudy day in the Grand Duchy of Luxembourg. In the Grand Chamber of the Court of Justice of the European Union (CJEU), exhaustion has set in following nearly five hours of oral argument in the technical, tedious disputes over the inner meaning of the law on supplementary protection certificates (SPCs) in Actavis v Sanofi, Eli Lily and Georgetown [on which see SPC Blog posts here, here and here]. Suddenly there is a breath of fresh air and a ray of optimism slashes through the gloom: Counsel for the European Commission expresses the hope that the CJEU will finally clarify the interpretation of Article 3(a) of the SPC Regulation and its decision in Medeva [noted on the SPC Blog here and here] and thus avoid so many referrals from national courts (especially those of England and Wales).  But alas, two weeks later,on 23 September, while the CJEU was still engaged in its deliberation, another SPC referral struck home, once again from those persistent persons from E & W, in Actavis v Boehringer [2013] EWHC 2927 [inexplicably not posted on BAILII, but you can read this Kat's copy is here].

Brief background

Boehringer is the proprietor of a European patent, EP (GB) 0 502 314, claim 5 of which is for the hypertension blockbuster telmisartan [this might come in handy for stressed CJEU judges, notes Merpel] sold under the brand name Micardis.  Boehringer's SPC, based on the patent and marketing authorisation for Micardis, isn't due to expire in the UK till 10 December 2013.  Claim 12 covers a combination of telmisartan and hydrochlorothiazide (HCT), marketed under the brand name MicardisPlus, for which the SPC runs till 20 January 2017.  

Mr Justice Birss -
getting in on the
SPC reference game

Actavis, no stranger to the British courts of late, obtained a marketing authorisation for Actelsar, this being a generic formulation of telmisartan and HCT.  Actavis, wishing to sell Actelsar but not if it meant being sued for infringing the combination SPC which, it felt, was invalid, commenced proceedings against Boehringer to "clear the path".  If this is all sounding eerily familiar, the Kat suggests you read Actavis v Sanofi -- another treat for hypertension enthusiasts --which Actavis commenced a full year before commencing proceedings against Boehringer and which is also subject to a reference to the CJEU.  The parties agreed that, should the Patents Court for England and Wales feel that a reference was necessary, there were certain questions that should be referred; they were even able to agree a Statement of Facts and Questions to be Referred for this very purpose, along with
(i) Actavis sportingly agreeing to give an interim undertaking not to launch its own product pending the resolution of the action and (ii) Boehringer, equally sportingly, agreeing to provide a corresponding cross-undertaking that it would compensate Actavis in the event that its SPC turned out to be invalid.    

The questions before Mr Justice Birss were as follows: (i) was it appropriate for him to refer questions to the CJEU before trial (discussed immediately below, 'The Questions') and (ii) what form of undertaking/cross-undertaking should the parties undertake (on which see the separate Part II of this blog post, appropriately labelled 'The Cross-Undertaking').  

The Questions  

Birss J considered that the four agreed questions that arose did require a reference for a preliminary ruling before he could decide the case.  In exercising the power to provide a preliminary ruling on the questions under paragraph 24 of the Recommendations of the CJEU (2012/C 338/01), he commented on aspects of three of the four questions in terms that were favourable to Boehringer, but's but declined to comment on the fourth (which was actually the second).

The referred Questions andthe judge's comments run like this:

Question 1:  

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?

This question related to the fact that the claim to the combination was introduced as a result of an amendment to its patent only after Boehringer made its an application for the SPC.  Under Article 3(a) of the SPC Regulation, a product must be protected by a basic patent in force at the time that the SPC application is made.  Whether a product is protected by a basic patent in force is the famous Medeva question.  In that case the court stated that a product is protected by a basic patent in force where it is explicitly identified in the claims of the patent. That simple proposition has so far caused pan-European disagreement: does the CJEU mean that the product can only be protected if it is explicitly identified in the numbered claims, or does Article 69 of the European Patent Convention apply so as to provide a wider penumbra of protection? That question attracted most of the attention at the CJEU hearing in September, with most parties seemingly favouring a wider interpretation.  Be that as it may, patent amendments are retrospective in the UK to the date of grant.  This being so, at the date that Boehringer made its SPC application it did have a basic patent that protected the product which was subject to the SPC application.  

The judge's preliminary view was in favour of Boehringer.  He stated: 

"The system of amending patents is an integral part of the patent system. Part of that system includes the retrospective effect of amendments. Amendments are only permitted if they comply with the law. There is nothing untoward or unusual or "wrong" in a patentee amending a patent. It does not and should not matter where an amendment is made. If the amendment is a lawful amendment, then I can see no good reason why it matters from the point of view of the validity of an SPC when the amendment took place. Indeed in many cases it is necessary to amend a patent in order to cure an invalidity as a result of a trial and that may well happen years after the grant of an SPC."

Question 2:  

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 related to whether the combination product is protected by the amended patent and stems from the idea advanced by Actavis and by Arnold J in Actavis v Sanofi that the combination product may need to embody a separate inventive advance.  The question is therefore whether this is even a relevant factor to consider. This Kat understands that almost all the parties and factions who attended September's CJEU hearing, including the UK Government (the exception being Actavis) rejected the "inventive advance" test.  Mr Justice Birss commented:

"If it is not a relevant factor, then not. I will not add to the already substantial volume of text and learning on these questions by expressing a preliminary view about Question 2."

The judge said that this question in particular needed to be referred before any time or cost is spent on the issue as it is the only one which may lead to a substantial factual trial in this matter and because "it may well be that there will be no need to deal with the substantive issue at all".  

Question 3:

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 relates to the fact that there already exists an SPC for telmisartan. Does that fact have any impact on the combination SPC, which asked whether the duration of the SPC to the combo product should be limited to that of the mono product:

"I would be surprised if there could be said to be any basis in the Regulation for giving an otherwise valid SPC a lesser term than it would otherwise be entitled to for this sort of reason."

Question 4:

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?

The final question relates to how the application for the combo SPC proceeded at the UK Intellectual Property Office (IPO) and the impact of the procedure adopted by the IPO.  To explain: when Boehringer applied for the SPC for the combo product, the IPO suggested that Boehringer amend its patent to include a new claim which explicitly identified the combo product.  Boehringer was granted the amendment (the new Claim 12) and the combo SPC proceeded to grant.  The question therefore was whether the IPO was correct in undertaking this procedure.  The judge stated:

"I can see nothing wrong with what the IPO did in this case and I can see no good reason why
the procedure adopted by the IPO in this case should lead to any difficulty or any problem with the SPC which resulted."

To be continued ...