For the half-year to 30 June 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Alberto Bellan, Darren Meale and Nadia Zegze.

Two of our regular Kats are currently on blogging sabbaticals. They are David Brophy and Catherine Lee.

Friday, 19 April 2013

Three cheers for the UK IPO -- at last! -- as commenting on CJEU references just got easier

The IPKat bloggers allow themselves a smile ...
The IPKat and Merpel are collectively and indivisually delighted to have received the following notice from their friends at the UK Intellectual Property Office whom, they now know, not only read this weblog but take it seriously [Kat comments in red]:
High Court case GlaxoSmithKline v Comptroller General of Patents [2013] EWHC 619 (Pat) [you can read the full judgment of Mr Justice Arnold here; SPC Blog note here]

We have received notification of a High Court reference to the ECJ [Er, shouldn't we be talking about the CJEU now, since it's the Court of Justice of the European Union?]  In GlaxoSmithKline v Comptroller General of Patents [2013] EWHC 619 (Pat) the following questions were referred:
1.            Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an 'active ingredient' within the meaning of Article 1(b) of Regulation 469/2009/EC? 
2.            If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a 'combination of active ingredients' within the meaning of Article 1(b) of Regulation 469/2009/EC?" [This is helpful: there was a time when the IPO's notice didn't give you the questions -- you had to click through to its website and then ferret around for them]
Case summary:

The appellant applied for an SPC relating to the product "an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", an adjuvant known as AS03. An additional application was filed for a pandemic influenza vaccine containing the adjuvant AS03.

Question 1 concerns whether or not an adjuvant, such as that common to these applications, can be considered an active ingredient within the meaning of Article 1(b) of the Regulation. Question 2 seeks to determine if the combination of an antigen, such as the influenza vaccine component of the latter application, and the adjuvant may be considered an active ingredient if the adjuvant alone may not.[This is also a huge improvement.  If you don't know the background to the questions, you may not appreciate the imperative importance of considering a response to the IPO notice]

This case and the questions referred to the court can be viewed on our website at:


If you would like to comment on this case please e-mail policy@ipo.gov.uk.  At this point there is no deadline for comments as we have not received notification of this case from the Court of Justice. [This is the best bit! In the past, recipients of these notices have had just a few days, often inclusive of weekends and/or public holidays, in which to consult with lawyers, trade and professional organisations etc and then draft a response that was cogent enough to persuade the government to make representations to the Court of Justice. The IPKat has criticised that practice again and again -- see eg here, here and here.  The IPO has taken the intelligent and incisive step of inviting comments when its own antennae tell it that there's a new CJEU case in the offing, not when the Treasury Solicitors Office gets off its comfy cushions and tells it].  
Congratulations to the IPO for taking this step!  In the great scheme of things, these improvements relate to what are, in reality, only little, trivial matters -- but in the IPKat's grand molecular theory of intellectual property, every big thing is made up of little things, so let's put right the things we can, and worry about the bigger things when the opportunity is ripe.

Merpel agrees, but adds: why not go one step further and add to its circular, as well as on its website, a hyperlink to the judgment of the court that has referred the questions for a preliminary ruling, where such a link is available?   Then people who want to know more about the questions can more swiftly and easily see the reasoning of the judge who's asking them.

Both Kats are concerned that, so far as they can tell, most other countries don't provide facilities for commenting on Court of Justice references for preliminary rulings.  Time to catch up?

1 comment:

Anonymous said...

On Court terminology, CJEU does not automatically replace ECJ post Lisbon. The Court of Justice of the European Union (CJEU) comprises (or in the words of the TEU 'includes' - allowing for new tribunals perhaps) the Court of Justice (CJ), the General Court (GC)and specialised tribunals (Article 19 TEU - though the distinction is less clear when you get to TFEU provisions on the court). We can argue about whether we should use CJEU or CJ for preliminary ruling references: CJEU is not wrong as CJEU includes CJ, but is obviously is less specific. Also the treaties allow for the possibility of references going to GC but that has not yet been activated. At that point you would probably have to use CJEU to talk about all references, but not until then.

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