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High Court case GlaxoSmithKline v Comptroller General of Patents  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  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?
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.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 firstname.lastname@example.org. 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].
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?