A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday 4 May 2012

Medeva: the final chapter in the UK

First, thanks to all those kind readers who sent copies of the final judgment of Medeva to us yesterday; we now have the link, too: it's here and the citation is Medeva BV v Comptroller General of Patents [2012] EWCA Civ 523. In this ruling the Court of Appeal for England and Wales (the Chancellor -- Sir Andrew Morritt, Lords Justices Etherton and Elias) applied the now-familiar preliminary ruling of the Court of Justice of the European Union (CJEU) in Case C-322/10 Medeva and dismissed the appeal.

To recap for new readers of The SPC Blog, Medeva had filed five SPC applications. Three related to vaccines against five diseases (diphtheria, tetanus, meningitis, polio and whooping cough), while the other two omitted the vaccine against meningitis (Hib). The UK IPO's hearing officer rejected all five applications. In the case of four of them, the active ingredients included some which were not protected by Medeva's patent (ie the vaccines against diseases other than whooping cough); as to the fifth, while the active ingredients were limited to those protected by Medeva's patent, the market authorisation covered a combination vaccine which included vaccines against the other four diseases. Thus in all five there was a mismatch between the active ingredients protected by the patent and the active ingredients in the vaccine or medicinal product for which the relevant market authorisations had been given.

Medeva appealed unsuccessfully to the Patents Court and then again to the Court of Appeal, which stayed the proceedings and referred a number of questions concerning art.3(a) of the SPC Regulation to the CJEU for a preliminary ruling. In its ruling, the CJEU held that art.3(a) had to be interpreted as precluding the competent industrial property office of a Member State from granting an SPC relating to active ingredients which were not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

Medeva put quite a positive spin on this ruling.  The way they saw it, the CJEU's explanation of the law still entitled them to the grant of SPCs on the first four of their applications --  or, if this was not so, that the EU's senior court had insufficiently answered the questions referred , so that another reference was needed.

The Court of Appeal dismissed Medeva's further arguments and, with it, the appeal. It held that, since both the Advocate General and the CJEU had rejected any test based on infringement or on the protective effect of the basic patent, all that was left for the national court to do was to determine which active ingredients were specified in the wording of the patent's claims. In this context, "specified" is an interesting word: it could mean anything between expressly naming, actually describing, effectively implying something, or this could be the result of a reasonable construction of the claims. Medeva's problem was that, wherever the dividing line was to be drawn, the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio were excluded, while the CJEU's ruling required that the other elements or active ingredients be specified in the wording of the claims. Here was no such wording to indicate that the active ingredients of the vaccines against diphtheria, tetanus, meningitis and polio were included.

6 comments:

Anonymous said...

Fair enough, it was always going to be tough for Medeva following the CJEU's decision in November 2011. But what sticks in one's craw is the way in which the Court of Appeal did so. The nub of it is para 33: "The ambit of "specified" may range from express naming, through description, necessary implication to reasonable interpretation. Where on that scale the dividing line is to be drawn will necessitate further references in due course in the light of the facts of the cases in which the issue arises". Yet another muddying of the waters I am afraid. So cue more references to the CJEU, resulting no doubt in yet more opaque judgments from the CJEU, with some woolly opinions from the Advocate General along the way....

Anonymous said...

What was the Court supposed to do? It's the CJEU's call and if they'd taken the opportunity to properly clarify things in Medeva, Georgetown, or Daiichi no further references would be needed.

The waters are no more muddied by this decision (or indeed Arnold J's similar comments in Novartis v MedImmune) than they were before.

Anonymous said...

So what happened to Medeva's SPC application for the sub-combination that WAS actually specified in the claims? Paragraph 5 suggests it was withdrawn after the CJEU's decision. Odd that it took a question to the CJEU on this Article 3(b) point and got a favourable answer but then did not rely on it back in the UK. Maybe it was asking for too much...

Anonymous said...

To Anonymous 4 May 2012 18:09. The withdrawn application would have failed under Article 3(d) because of an earlier authorisation for a vaccine containing pertactin and FHA. Are we sure this is the end of the story or could Medeva appeal to the Supreme Court?

Anonymous said...

Thanks Anonymous 14 May 2012 11:44. That was my understanding too, but if the sub-combination application was doomed from the start because of Article 3(d), why take it to the CJEU with the question under Article 3(b)? The CJEU was unlikely to be generous on both issues: they should have concentrated on the one they needed to win (Article 3(a)).

Did the CA give leave to appeal, I wonder?

Anonymous said...

Does anyone know if this case is dead yet?