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Friday 22 March 2013

"Dysfunctional" SPC system needs revision, says judge

Glaxosmithkline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks [2013] EWHC 619 (Pat)a Patents Court for England and Wales ruling of Mr Justice Arnold, has become the latest SPC case to be the subject of a reference to the Court of Justice of the European Union for a preliminary ruling. 

In short, GSK applied for a supplementary protection certificate for "an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", an adjuvant known as AS03 protected by European Patent (UK) No 0 868 918. Later, GSK applied for a supplementary protection certificate for "an adjuvanted influenza vaccine comprising an influenza virus component which is an influenza virus antigen from an influenza virus strain that is associated with a pandemic outbreak or has the potential to be associated with a pandemic outbreak, wherein the adjuvant is an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", a vaccine comprising an antigen and AS03 protected by European Patent (UK) No 1 618 889.  In both cases GSK relied upon marketing authorisation EU/1/08/453/001 for a pre-pandemic influenza vaccine against the H5N1 subtype of influenza A virus marketed by GSK under the trade mark Prepandrix. In decision BL O/506/12 the UK IPO decided that neither application was allowable: AS03 was not an "active ingredient" of Prepandrix. GSK appealed to the Patents Court and Arnold J decided to refer the following questions to the Court of Justice:
"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?

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?"
Andrew Waugh QC (3 New Square) and Emma Fulton (Hogan Lovells International LLP) both emailed to draw the attention of this blogger to the text which we have reproduced in bold type.
84. In case it assists, I shall state my own view on these questions. While I acknowledge the force of counsel for GSK's argument that the primary purpose of the SPC Regulation is to reward innovative research of the kind that led to the development of AS03 and Prepandrix, I find the arguments presented by counsel for the Comptroller more convincing. In particular, I consider that the SPC Regulation was intended to provide a simple and predictable system that could be operated by the competent authorities of the Member States, and in particular the national patent offices, in a uniform manner. To achieve those objectives, it is necessary to have bright-line rules. Article 1(b) is such a rule. In my view the Court of Justice was correct to hold in Pharmacia, MIT and Yissum that it should be strictly interpreted. The result of a strict interpretation is to deny extended protection for what may well be meritorious inventions, but the price of not adopting a strict interpretation is a level of uncertainty and inconsistency which in my opinion is unacceptable. Accordingly, I would answer both questions no.

85. It is worth adding that, as counsel for the Comptroller pointed out, GSK may be able to obtain an SPC for the antigen contained in Prepandrix based on the 889 patent and the marketing authorisation for Prepandrix. Thus refusal of the appeal would not necessarily leave GSK bereft of protection.

86. Finally, I would observe that this is the third time in six months that I have had to refer questions of interpretation of the SPC Regulation to the CJEU. I do so with considerable regret. That this should be necessary demonstrates the dysfunctional state of the SPC system at present. This is primarily due to the poor drafting of the SPC Regulation and to the failure of the European Commission, Council and Parliament to revise it to address the problems which have emerged. Matters have not been assisted, however, by the fact that the Court of Justice's recent case law interpreting the SPC Regulation has not provided the level of clarity and consistency that is required.
This blogger is fully in agreement with the judge's comments.


Anonymous said...

Go get 'em, Mr Justice Arnold.

Anonymous said...

Judge Arnold seems to stay stuck on MIT, Farmacia Italia and Yissum restrictive interpretation, whereas it s pretty obvious that the Court overruled this case law in Neurim. Arnold deliberately omits that the origin of the change of case law is coming from UK Court of Appeal - appeal against Arnold s judgement if I remember correctly -. The CA defended the opposite position than Arnold0s one in Neurim request for prelinary ruling, requesting a change of position of ECJ on the matter and, indeed, ECJ followed the Court of Appeal, the Commission and the AG-s positions in the final judgement, against J. Arnold stances. Seems that everybody is wrong if they dont share judge Arnold s view...If he was so convinced of the correct interpretation in GSK about the notion of product, why did not he simply rule the case himself according to his interpretation and allows an appeal before the Court of Appeal. The fear was maybe that the Court of Appeal would have again asked for the case-law to be overruled on this question.

Anonymous said...

Well said, anonymous.

I've never understood the difficulty reconciling Neurim with decisions like MIT and Yissum. Although there are factual similarities between all three, the CJEU was not asked the same open-ended question "is an SPC allowable with this kind of fact pattern" in each case. It was asked much narrower questions like (in MIT) "can a non-active ingredient still be considered an active ingredient in certain combinations" or (in Yissum) "can an active ingredient be defined by its use". The CJEU (perhaps understandably) said no to both questions, but it didn't (and I think couldn’t) say that SPCs would always be unavailable in cases with similar fact patterns. Even in MIT and Yissum, the applicants were presumably free to go back to their national courts and argue alternative points to see if they could find a different way through the Regulation. Like the route that turned out to be successful in Neurim.

As I see it, the CJEU can only answer the specific questions it is asked. It would be dangerous for it to rule more generally on all cases with similar fact patterns because a) it is not a fact-finding tribunal and b) it might not hear the strongest arguments for those fact patterns in any given referral (like MIT/Yissum versus Neurim).