Boehringer Ingelheim, a long-standing client of Dehns, has recently become involved in a dispute with Actavis regarding the marketing of a combination of the compounds telmisartan and hydrochlorothiazide (HCT) and a Supplementary Protection Certificate (SPC). Mr. Justice Birss considers that some agreed questions should be referred without delay to the Court of Justice of the EU (CJEU). He has also settled some of the terms in a cross-undertaking to be given by Boehringer whilst the matter is pending (see Actavis Group and others v Boehringer Ingelheim Pharma  EWHC 2927 (Pat)).
The CJEU currently has before it a number of issues relating to SPCs, some of which may have a profound and lasting effect upon their value. Not the least of these is a determination of the extent to which any individual patent might be allowed to serve as a basis for a plurality of SPCs. SPCs are granted in relation to specific marketed products whereas the chemical patents upon which they are based almost always describe and claim a wide range of possible ‘products’ based on individual compounds and possible combinations. It has frequently been the case to date that single patents have given rise to numerous ultimately valuable commercial products on which specific SPCs have been able to be granted.
Putting aside that aspect of this particular dispute, though at the time of writing it remains at issue and provides at least one reason for not delaying the judge’s reference, some interest arises out of the manner in which the SPC itself was obtained.
The compound telmisartan is sold commercially as an anti-hypertensive and is covered by Boehringer’s European (UK) patent No. 0502314. This expired in January 2012. An SPC based on this and covering “telmisartan, optionally in the form of a pharmaceutically acceptable salt” was granted in August 1999. This SPC expires in December 2013.
Marketing approval was subsequently obtained in 2002 for a combination of telmisartan and a further active ingredient, the diuretic HCT. In September 2002, within the allowed six-month period, Boehringer applied to the UK Intellectual Property Office (UKIPO) for another SPC under the same patent for this combination. Such a combination had not been explicitly claimed in the patent as granted, though it clearly fell within the scope of its broader claims and was described within the patent specification. However, the UKIPO pointed out the absence of an explicit claim during its examination (foreshadowing a ruling to be handed down by the CJEU in the later Medeva case) but suggested that an application to amend the patent could be made to include one.
Provided that any requested post-grant amendment in the U.K. does not i) disclose subject-matter that extends beyond what was disclosed before amendment, and ii) extend the protection conferred by the patent, and there is plenty of practice and case law in this regard, such an amendment is perfectly legitimate and not uncommon. Such amendments also have retrospective effect, i.e. it is as if they have always been present. Boehringer applied to amend their patent to add a claim to the specific combination. This was considered and allowed by the UKIPO and was advertised for any opposition in the usual way. No opposition was raised.
The SPC application procedure had been suspended during these amendment proceedings but was then recommenced and an SPC for the combination was granted. It will expire in early 2017. Actavis recognise that they will infringe this if, as they wish to do, they market their proposed combination.
The questions agreed for the CJEU can very briefly be summarised as:
- If a granted patent does not contain a specific claim to an entity but could be amended 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’ under the SPC Regulation 469/2006/EC for a product comprising that entity? As a rider to that, if a patent is amended before and/or after grant to include a claim to the entity, can that be relied on as what the SPC Regulation deems ‘the basic patent in force’? Can an applicant for an SPC for a product rely on an amended ‘basic patent in force’ when the amendment of the patent to include a specific claim to the product took place after grant but before grant of the SPC?
- Does an earlier SPC for a single material have any effect upon a later one for a combination of the material with another agent? Whilst the issue of whether or not any single patent can be used as the basis for more than one SPC remains to be settled with clarity, if two SPCs are supported by different claims in the same patent, does each such claim have to be for a distinct and separate invention?
- Does the procedure adopted by the UKIPO in relation to the amendment affect the situation? In particular, can a procedural authority (such as the UKIPO) allow suspension of an SPC application in order to allow amendment of the patent to include a claim to a product, and then recommence consideration of the SPC application once amended, even though this recommencement might take place (as was the case in this instance) more than six months after the marketing authorisation for the product (the original application having been timely made)?
Mr. Justice Birss did, as he is permitted (or even encouraged) to do, give his views on most of these issues, stating that he could see no problem with the existing status quo in relation to the grant and co-existence of the two different SPCs and their respective durations, nor with the procedure adopted by the UKIPO in relation to the amendment and grant. The only issue on which he declined to comment was that in relation to whether or not any additional claim in a patent to a combination on which a second or subsequent SPC might be based required any separate inventive advance over a claim in the same patent to the single ingredient. This is already under consideration in another case that is before the CJEU (see Actavis v Sanofi  EWHC 2545).
In relation to the issues raised relating to the cross-undertaking, it was held that it was fair and reasonable for the cross-undertaking to cover other Actavis Group companies that might become involved with the commercialisation of the combination product in the future, but not to cover unspecified customers or potential customers as this was too vague and the nature of any possible loss was unclear. The judge commented that if a person thought they might experience losses on account of the parties’ undertaking not to sell the products, they could apply to the Court to become part of the cross-undertaking.