UK: Recent Court decisions relating to Articles 3(a) and 3(b) of the SPC Regulation and the application of Case C-322/10 Medeva

01 January 0001

Trevor Cook

In the May edition of the Life Sciences Update we reported on an Italian decision which sought to apply the principle established in Case C-322/10 Medeva which precluded the grant of a supplementary protection certificate “relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.” Since then there have been several further decisions in various EU Member States seeking also to apply Case C-322/10 Medeva and the various other decisions of the Court of Justice of the EU (CJEU) given at around the same time as to Articles 3(a) and 3(b) of the SPC Regulation.  

Thus earlier in 2012 there were two decisions in the English Courts in which the active ingredient was held not to be specified in the wording of the claim in the sense required by the Regulation, namely Novartis v Medimunne (10 February 2012) - a monoclonal antibody case - and Medeva v Comptroller General of Patents (3 May 2012) - a vaccine case.  In Medeva v Comptroller General of Patents, a vaccine case, where the claim was directed to an active ingredient providing immunity against pertussis, the Court of Appeal, which had originally referred Case C-322/10 Medeva to the CJEU, rejected the application for an a SPC occasioned by the grant of a Marketing Authorisation for a combination vaccine of which this was a component, observing that:
    
[33] … the issue for the national court is to determine which active ingredients are specified in the wording of the claims. The ambit of "specified" may range from express naming, through description, necessary implication to reasonable interpretation. Where on that scale the dividing line is to be drawn will necessitate further references in due course in the light of the facts of the cases in which the issue arises. The problem for Medeva in this case is that wherever the dividing line is to be drawn the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio are excluded.

However, on 20 September 2012, the English Patents Court encountered a case in which the question was less clear-cut and decided to make what is believed to be the first new reference to the CJEU seeking clarification as to what in this context “specified” (or in some of other decisions “identified” in the English versions) actually means.   The English Court also decided that another issue raised in the decision in Case C-322/10 Medeva, relating to Article 3(c) of the Regulation, and which has, separately, been referred to the CJEU by the Dutch courts, was one that it should also refer to the CJEU.

These references to the CJEU arose in Actavis v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat).  Here Sanofi had secured an SPC with EP (UK) No 0 454 511 as the basic patent for the single product irbesartan, which SPC expired on 14 August 2012,It had also secured a second SPC with the same basic patent, with an expiry date of 14 October 2013, but for a combination of irbesartan and hydrochlorothiazide, the validity of which SPC Actavis challenged.  The combination product which had led to the application for the second SPC was indicated for the treatment of hypertension. There were claims in the basic patent not only to irbesartan (and other related compounds) but also to pharmaceutical compositions containing irbesartan (or other related compounds), in association with various actives described generically by reference to function, one of which was to a diuretic. Hydrochlorothiazide is a commonly used diuretic and so the issue was whether or not such claim could be said to specify or identify such combination; if it did not the SPC was invalid as the requirement under Article 3(a) that "the product is protected by a basic patent in force" would not be fulfilled.   The English court thus referred to the CJEU the question:

"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the Regulation?"

Courts in other countries, considering parallel national designations of the same patent, had come to differing views on the issue. Thus the Paris Court of First Instance (10 August 2012 – Case RG 12/55806) had refused to grant an interim injunction because it questioned the validity of the SPC whereas the Dusseldorf District Court (15 August 2012 – Case 4a O 109/12) and the Hague District Court (14 September 2012 – Case 425814 / KG ZA 12-905)) had taken the view that it was liley that the SPC was valid and had granted such interim injunctions.  But beyond referring the question to the CJEU the English court also made its own proposal as to how it should be answered, having observed that it was evident from the decision in Case C-322/10 Medeva that it was a necessary, but not a sufficient, condition, that the combination infringe the patent claim.  It suggested that the further requirement was that:  

[76] … the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent. Thus in a case such as the present, where the inventive advance of the Patent consists generally of the compounds of formula I, including specifically irbesartan, a medicinal product whose active ingredient is irbesartan is protected by the Patent within the meaning of Article 3(a) because it embodies the inventive advance of the Patent. A medicinal product whose active ingredients are irbesartan and a diuretic such as [hydrochlorothiazide] in combination is not protected by the Patent within the meaning of Article 3(a) because the combination, as distinct from irbesartan, does not embody the inventive advance of the Patent. …

It went on to justify this suggested approach by explaining that:

[76] …. This is not a question of the wording of the claims of the basic patent, which as discussed above can be manipulated by the patent attorney who drafts it, but of its substance. ….  if a later inventor were to obtain a patent for an invention consisting of a combination of irbesartan and substance X which surprisingly had a synergistic effect in treating hypertension, then a medicinal product whose active ingredients were irbesartan and X would be protected by that patent since it would embody the inventive advance of that patent.  ... this interpretation of Article 3(a) would accord with the object of the Regulation, which is to encourage invention in the field of medicinal products by compensating inventors for the delay in exploiting their inventions due to the need to obtain regulatory approval, and not to confer unjustified monopolies.

As to the second question, relating to Article 3(c) of the Regulation, the English court observed that the Dutch Patent Office had adopted the opposite interpretation of the CJEU's ruling in Case C-322 Medeva to that adopted by the UK Intellectual Property Office in holding that Article 3(c) precluded the grant of more than one SPC per basic patent. In Case AWB 10/4769 Georgetown University v Octrooicentrum Nederlandthe Hague District Court (11 July 2012) had held that the correct interpretation of Article 3(c) was unclear and decided to refer a question to the CJEU provisionally worded as follows:

"Does [the Regulation], more specifically Article 3(c), in the situation in which multiple products are protected by (the claims) of a basic patent, preclude the proprietor of the basic patent being issued a certificate for each of the products protected?".

As the same issue arose in the Actavis case before it, the English court decided to refer this question as well, provisionally worded in the same terms as the Dutch court had done.  The English court observed however that the issue did not arise if Article 3(a) were interpreted in the way it had proposed.  Thus if "the product is protected by a basic patent" within Article 3(a) because the active ingredient (or combination of active ingredients) embodies the inventive advance of the patent, then one SPC may be granted in respect of that product and that patent. If, however, the patent protects two products, because it discloses and claims two inventively distinct active ingredients (or combinations of active ingredients), then one SPC may be granted in respect of each product, and hence two SPCs in respect of that patent.

As we head towards this further iteration in the CJEU as to the meaning of Article 3(a) of the Regulation we have, in the meantime, yet to see how national patent offices and courts seek to apply the potentially even more momentous decision of the CJEU in Case C-120/11 Neurim of 19 July 2012 in which the CJEU held:

1. Articles 3 and 4 of [the SPC Regulation] must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

3. The answers to the above questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive marketing authorisations, the second marketing authorisation required a full application in accordance with Article 8(3) of Directive 2001/83/EC … on the Community code relating to medicinal products for human use, or if the product covered by the first marketing authorisation of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant.

This decision involved a somewhat extreme fact pattern, in that the CJEU thereby told the national court that the UK Intellectual Property Office had been wrong to have held that Article 3(d) of the Regulation, (precluding the grant of an SPC in those cases in which the Marketing Authorisation referred to under Article 3(b) was not the first one to place the product on the national market as a medicinal product), meant that an earlier Marketing Authorisation for melatonin as a veterinary medicinal product precluded the grant of an SPC in respect of a basic patent which would not have been infringed by the veterinary product, following the grant of a Marketing Authorisation for this as a human medicinal product.  Use of the “in a case such as that in the main proceedings” wording could give the CJEU scope to limit its decision to similar extreme situations, but the reasoning as set out in the decision, and the wording of its conclusions on their face, suggests that the principle as formulated by the CJEU in Case C-120/11 Neurim is of general application.  If so, this then opens up the prospect of being able to secure a separate SPC in respect of a newly authorised indication for a previously authorised product, always assuming that the basic patent for the new SPC would not have been infringed by the previously authorised product.   This is a question that can ultimately only be answered by the CJEU itself, but until this happens we can expect to see patent offices and courts in different Member States exploring it over the coming several months, in much the same way as they have, for the past several months, been exploring the fall-out from the CJEU's decision in Case C-322 Medeva in a way which has culminated in the recent reference to the CJEU in Actavis.