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Friday, 17 September 2010

More on that Medeva CJEU Reference

The IPKat, and his esoteric companion the SPC Blog, have written previously (here, here and here) about the reference made earlier this year to the EU Court of Justice regarding Articles 3(a) and 3(b) of the SPC Regulation.  The story has now been further complicated by another case at the High Court of England and Wales (Georgetown University et al v The Comptroller-General of the Patent Office) involving an appeal from a decision of the Comptroller last December (BL O/401/09) regarding 8 SPC applications, all of which were refused.

The High Court Order for Reference to the Court of Justice, a copy of which has been uploaded to the IPKat's Google Groups server here, refers to the decision of the English Court of Appeal in Medeva's SPC Application [2010] EWCA Civ 700, in which various questions were referred to the CJEU.  One of these questions related to whether an SPC could be granted for a single active ingredient or a combination of active ingredients where a basic patent in force protected the ingredient(s) within the meaning of Article 3(a) and a product containing the ingredient(s) was the subject of a valid first marketing authorisation.

In brief, the UK-IPO's position is that, if the owner of a patent for an active ingredient A is entitled to rely for its SPC not on the marketing authorisation for A but for A+B, then this will extend the monopoly under the patent for reasons which do not reflect the purpose of the Regulation.  The parties, of course, argue otherwise, contending that it would be anomalous for the SPC regime to discriminate against vaccines, which are often first authorised only as combinations and not singly, with the result that new vaccines would not be able to obtain adequate protection.

To try to resolve this issue, the High Court has agreed to refer the following question to the CJ regarding Article 3(b) in the Georgetown case, and suggested that this case could be consolidated with Medeva given that the question is the same as the Article 3(b) question in Medeva.

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 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 authorisation that places the single active ingredient or combination of active ingredients on the market?
The IPKat, who is getting a little confused by all this, looks forward to seeing what the CJEU have to say on the subject and hopes that some clarity will come out of it, one way or the other.


Anonymous said...

N.B. The question is IDENTICAL to Question 5 in the Medeva reference, though of course the facts are different.

David said...

You mean question 6, of course.

Bart Jansen said...

Most medicines contain generic excipients in addition to the protected active species. For those medicines, SPCs have been granted in the past.
As a patent covering 'A' provides protection for 'A+B' I see no reason why it matters if B is a generic excipient or another active ingredient.
Does anyone have a different view here?

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