University of Queensland CSL Ltd & Anor v Comptroller -General of Patents, Designs and Trade Marks

On 10 February 2012 I partly allowed and partly dismissed an appeal by the University of Queensland and CSL Ltd against a decision of Dr Lawrence Cullen acting for Comptroller-General dated 24 September 2010 (O/335/10) to refuse applications SPC/GB/07/014 (“014”), SPC/GB/07/015 (“015”), SPC/GB/07/016 (“016”), SPC/GB/07/017 (“017”), SPC/GB/07/021 (“021”), SPC/GB/07/081 (“081”), SPC/GB/07/082 (“082”) and SPC/GB/07/084 (“084”) for supplementary protection certificates. These are my reasons for so deciding.

The factual background is set out in the hearing officer’s decision at paragraphs 1-6. The University of Queensland is the proprietor of European Patents (UK) Nos 0 595 935 (“935”), 1 298 211 (“211”) and 1 359 156 (“156”). 211 and 156 are divisionals from 935. 935 covers a method for producing papillomavirus virus-like particles (“VLPs”) of human papillomavirus (“HPV”) type 6 or 11 L1 protein (claim 1), VLPs obtainable by that method (claim 16) and vaccines produced from such VLPs (claim 17). 211 covers a method for producing VLPs of HPV type 16 L1 protein, VLPs obtainable by that method and vaccines produced from such VLPs. 156 covers a method for producing VLPs of HPV type 18 L1 protein, VLPs obtainable by that method and vaccines produced from such VLPs. GlaxoSmithKline has a marketing authorisation for Cervarix vaccine which contains a combination of HPV type 16 and type 18 L1 proteins in the form of VLPs. Sanofi Pasteur/Merck Sharp & Dohme have a marketing authorisation for Gardasil/Silgard vaccine which contains a combination of HPV type 6, 11, 16 and 18 LI proteins in the form of VLPs.

The Appellants’ applications fall into two groups. The first group consists of applications 014 and 084, based on the 935 and 156 patents and the marketing authorisations for Gardasil and Cervarix respectively. These applications defined the product in respect of which the SPC was sought as the combination of antigens (i.e. active ingredients) which was the subject of the relevant marketing authorisation. The second group consists of applications 015, 016, 017, 021, 081 and 082, based on 935 and Gardasil (015 and 016), 211 and Gardasil (017), 156 and Gardasil (021), 211 and Cervarix (081) and 156 and Cervarix (082). These applications defined the product in respect of which the SPC was sought as a single antigen (i.e. active ingredient) selected from those which were the subject of the relevant marketing authorisation.

The hearing officer refused the first group of applications for non-compliance with Article 3(a) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (“the Regulation”) and refused the second group of applications for non-compliance with Article 3(b) of the Regulation.

The legal background to the appeal is set out in detail in my judgment in Novartis Pharmaceuticals UK Ltd v MedImmune Ltd [2012] EWHC 181 (Pat) at [4]-[6] and [14]-[49] and I shall not repeat it here. As explained there, in this appeal I referred the following questions to the Court of Justice of the European Union:

“1.

Regulation 469/2009 (the Regulation) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by ‘the product is protected by a basic patent in force’ and what are the criteria for deciding this?

2.

In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?

3.

Is one of these further or different criteria whether the active ingredients are admixed together rather than being delivered in separate formulations but at the same time?

4.

For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens ‘protected by a basic patent’ if one antigen of the vaccine is ‘protected by the basic patent in force’?

5.

In a case like the present one involving a medicinal product comprising more than one active ingredient, is it relevant to the assessment of whether or not ‘the product is protected by a basic patent’ according to Article 3(a) that the basic patent is one of a family of patents based on the same original patent application and comprising a parent patent and two divisional patents which between them protect all the active ingredients in the medicinal product?

6.

In a case like the present one involving a basic patent with claims to ‘a process to obtain a product’ in the sense of Article 1(c), does the ‘product’ of Article 3(a) have to be obtained directly by means of that process?

7.

Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient where:

(a)

a basic patent in force protects the single active ingredient within the meaning of Article 3(a) of the SPC Regulation; and

(b)

a medicinal product containing the single active ingredient together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC which is the first marketing authorization that places the single active ingredient on the market?

8.

Does the answer to Question 7 differ depending on whether the authorisation is for the single active ingredient admixed with the one or more other active ingredients rather than being delivered in separate formulations but at the same time?”

Following its judgment in Case C-322 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 (“Medeva”), the CJEU ruled upon the questions referred in the present appeal by way of reasoned order in Case C-630/10 University of Queensland v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 as follows:

“1.

Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

2.

Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients.

3.

In the case of a basic patent relating to a process by which a product is obtained, Article 3(a) of Regulation No 469/2009 precludes a supplementary protection certificate being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard.”

The Appellants accept that in the light of the Court of Justice’s first and third rulings quoted above, the first group of applications do not comply with Article 3(a) since the combinations of active ingredients specified in the applications include active ingredients which are not identified in the wording of the claims of the basic patents relied on in support of the applications. Accordingly I dismissed the appeal so far as it related to those two applications.

The Comptroller-General accepts that in the light of the Court of Justice’s second ruling quoted above, the hearing officer’s decision to refuse the second group of applications cannot stand. His reasoning was that the marketing authorisations relied on are authorisations to place the combinations of active ingredients on the market, and not authorisations to place the single active ingredients on the market otherwise than in the form of the combinations. In the hearing officer’s view, the “product” for the purposes of Article 3(b) could only be the combination the subject of the relevant marketing authorisation, and not any of the individual active ingredients. It is clear from its second ruling, however, that the Court of Justice has disagreed with this interpretation of Article 3(b). It follows that the hearing officer was wrong to hold that the second group of applications failed to comply with Article 3(b). Accordingly I allowed the appeal in respect of those six applications.

In the case of applications 015, 016, 017 and 021, the Comptroller-General accepts they may now proceed to grant.

In the case of applications 081 and 082, it is common ground that they should be remitted to the Intellectual Property Office for further consideration, so that it can be determined whether they comply with other provisions of the Regulation. In particular, there is an issue as to whether Gardasil was the first marketing authorisation to cover the active ingredients (HPV16 VLP and HPV18 VLP), thus preventing the grant of applications 081 and 082 based on the Cervarix marketing authorisation. The VLPs for Gardasil and Cervarix are derived from different sources and the Appellants contend that this means that SPCs for each can be validly granted.

As indicated above, applications 015 and 016 are based upon the same basic patent, 935. They differ in that they are for different active ingredients, namely HPV11 VLP and HPV6 VLP respectively.

In Medeva the Court of Justice held at [41]:

“ … where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28).”

I am aware that some commentators have interpreted this statement literally as meaning that there can only be one SPC per basic patent, whereas other commentators have interpreted it as meaning that there can only be one SPC per product per patent. Counsel for the Comptroller-General informed me that it is the Comptroller-General’s view that the Court of Justice was not intending to change the law as previously stated in Case C-181/95 Biogen Inc v SmithKline Biologicals SA [1997] ECR I-357 at [28], which was generally understood to mean that there can be one SPC per product per patent.

Accordingly, the Comptroller-General accepts that SPCs can be granted in respect of both applications, even though they are based upon the same patent, since they are for different products. In support of this counsel for the Appellants pointed out that the claims of 935 cited above all refer to “HPV-11 or HPV-6 [emphasis added]”.