Even more about HPV vaccines and SPCs

Just in case you're not immune to issues around SPCs for HPV vaccines, here's the latest juicy case (BL O/335/10) that was decided before the UK Intellectual Property Office (IPO):

The University of Queensland and CSL Limited filed 8 SPC applications at the IPO: 6 different applications to single Human Papilloma Virus (HPV) L1 protein virus-like particles (VLPs) (2 applications for HPV 16, 2 applications for HPV 18, 1 application for HPV11 and 1 application for HPV6), 1 application for a product comprising HPV16 and HPV18 L1 protein LPV, and 1 application for a product comprising HPV6, HPV11, HPV16 and HPV18 L1 protein LPVs. The applications were based on basic patents EP 0595935, EP 1298211 and EP 1359156. The marketing authorisations for Cervarix and Gardasil/Silgard were used to support the applications.

The issues raised here are similar to those in the Medeva and Georgetown et al. cases and concern the interpretation of Articles 3(a) and 3(b) of the Regulation. The IPO therefore proposed to defer further consideration of the applications until the outcome of the references to the Court of Justice of the European Union (CJEU) in relation to the Medeva and Georgetown cases. The applicant however requested a decision to be issued based on the papers on file so that, if the IPO were to refuse the applications, the decision could be appealed and a further referral to the CJEU could be made and considered at the same time as the other HPV-related cases.

The hearing officer, Dr. L. Cullen, found that the 6 SPC applications directed to single HPV L1 protein VLPs did not meet the requirement of Article 3(b) of the Regulation because neither of the MAs cited was a valid authorisation to place any of the single HPV L1 protein VLP products on the market as a medicinal product. Each MA related to a combination of active ingredients rather than a single active ingredient.

Moreover, the HPV combination applications did not meet the requirement of Article 3(a) of the Regulation because the basic patents did not protect combination HPV L1 protein VLP products, but only related a method for preparing single HPV L1 protein VLPs, HPV L1 protein VLPs made by this method and vaccines prepared from HPV L1 protein VLPs made by this method. Nothing in the patents suggested that the single HPV products could be used in combination with each other.

The applications were rejected in accordance with Article 10(4) after the application was provided with an opportunity to correct the irregularities of the application.

The complete decision is available here.

Medeva CJ Reference Questions

The sealed order of the Court of Appeal for the Medeva case, kindly provided by Tim Mitcheson, can be read here.

In short, the questions referred to the Court of Justice are as follows:

On article 3(a)

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. In a case like the present one involving a multi-disease vaccine, 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?

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”?For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if all antigens directed against one disease are “protected by the basic patent in force”?

On Article 3(b)

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

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

(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 200 1/83/EC or 200 1/82/EC which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market?

Medeva Appeal Judgment Handed Down

The Court of Appeal of England and Wales (Lord Justice Etherton and Lord Justice Elias) has handed down the judgment on the appeal in Medeva's SPC Application (our previous postings on the matter can be read here).

In sum, the Court decided to make a reference to the Court of Justice for a preliminary ruling on each of the questions below:

(1) What is the test by which to determine whether “the product is protected by a basic patent in force” for the purposes of Article 3(a)?
(2) Should a different test be applied in cases where the product is a multi-disease vaccine?
(3) Is it sufficient for the purposes of Article 3(a), in the context of a multi-disease vaccine, that the basic patent in force protects one aspect of the product?
(4) For the purposes of Article 3(b) may the product be limited to that part of a multi-disease vaccine as is protected by the basic patent in force?

At the time of posting, the judgement was not available on Bailii, but you can read it here.

More questions to the Court of Justice

A few months ago, we reported on Medeva's appeal against the UK IPO's decision to refuse an SPC application here

The SPC blog has found out that the Court of Appeal for England and Wales will be referring questions to the ECJ on the meaning of Article 3a and 3b of the SPC regulation, in the context of combination products. We haven't seen the questions, yet, but when we do you'll be the first to know.

Breaking news: Medeva appeal dismissed

Earlier this morning the decision of Mr Justice Kitchin in Medeva BV v The Comptroller General of Patents [2010] EWHC 68 (Pat) was released. This is an appeal against the refusal of Lawrence Cullen (see The SPC Blog here) to grant five SPCs for pertussis vaccines.

As of the time of this blogpost (12.56pm), the judgment has not yet been uploaded on to BAILII, but you can read it here. The SPC Blog will discuss it in due course.

Addendum: as of 14.14pm the judgment has been available on BAILII, here.