Hague Court's Georgetown questions

The SPC Blog posted this piece towards the end of October on the five questions which the District Court in The Hague was referring to the Court of Justice of the European Union for a preliminary ruling in a case which has now been designated by Curia as Case C-484/12 Georgetown University. The official English version of the questions, as cut-and-pasted from the UK IPO and mildly edited, appears below:

"1. Does Article 3(c) of the Regulation preclude, in a situation where there is a basic patent in force which protects several products, the holder of the basic patent from being granted a certificate for each of the protected products?

2. If so, how should Article 3(C) be interpreted in the situation where there is one basic patent in force which protects several products, and where, at the date of the application for a certificate in respect of one of the products (A) protected by the basic patent, no certificates had in fact yet been granted in respect of other products (B, C) protected by the same basic patent, but where certificates were nevertheless granted in respect of those applications in respect of the products (B, C) before a decision was made with regard to the application for a certificate in respect of the first-mentioned product (A)?

3. Is it significant for the answer to the second question whether the application in respect of one of the products (A) protected by the basic patent was submitted on the same date as the applications in respect of other products (B, C) protected by the same basic patent?

4. If the answer to question one is in the affirmative, may a certificate be granted for a product protected by a basic patent which is in force if a certificate had already been granted earlier for another product protected by the same basic patent, but where the applicant surrenders the latter certificate with a view to obtaining a new certificate on the basis of the same basic patent?

5. If the issue of whether the surrender has retroactive effect is relevant for the purpose of answering question four, is the question of whether surrender has retroactive effect governed by Article 14(b) of the Regulation or by national law? If it is governed by Article 14(b), should that provision be interpreted to mean that surrender does have retroactive effect?".

If you would like to comment on this case and advise the UK government whether it should make any representations, please email policy@ipo.gsi.gov.uk by the agreeably generous deadline of 10 January 2013 -- a welcome change from the three or four days within which one usually needs to respond.

Lipitor paediatric extension surprise: judge doesn't refer questions to CJEU

Dr Reddy's Laboratories (UK) Ltd & Another v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat) is a Patents Court for England and Wales ruling of Mr Justice Roth -- who is not one of the usual Patents Court judges [though it seems that he is now officially a Patents Court judge: see the Comment posted below this article]. This action however required the judge to exercise purely legal skills rather than to possess technical knowledge of the field in which the patent had been granted.

In brief, Pfizer applied for and was granted a paediatric extension for Atorvastatin (Lipitor). Dr Reddy's challenged the grant of the paediatric extension on three grounds:

(1) The European Medicines Agency (EMA) acted ultra vires it powers under the Paediatric Regulation by approving a paediatric investigation plan (PIP) that let Pfizer to defer completion of the third of its three required studies. The circumstances in which studies in a PIP may be started but not finished are expressly defined by the Regulation and must be covered by a deferral under Article 20. No such deferral was applied for by Pfizer or granted in this case. Accordingly, the PIP was not lawfully approved under the Paediatric Regulation and Pfizer was therefore not entitled to the extension.  

(2) Under Article 45(3), a paediatric extension should be granted only when significant studies contained in the PIP have been completed. Here, none of the relevant bodies made an assessment as to whether either of the two studies which had been completed was significant; and, on the facts, they were clearly not significant.  

(3) Even if, contrary to ground (1), it was legitimate for the EMA to approve a PIP that required the initiation but not the completion of the third study, under Article 36 Pfizer was not entitled to a paediatric extension unless it included, within its application for a marketing authorisation, the results of the completed third study.

The learned judge dismissed all three challenges, describing the third as "misconceived", and declined to follow what seems almost standard practice these days when he decided that there was no need to make a reference to the Court of Justice of the European Union relating to the second ground.

The decision is quite long -- some 76 paragraphs -- and would have benefited from being just a little bit longer, if Roth J had added a short paragraph at the end which summarised what he actually decided.

Case C-493/12: referring decision now available

Following yesterday's post, The SPC Blog can confirm that the mystery judgment leading to the reference to the Court of Justice of the European Union in Case C-493/12 is that of Mr Justice Warren of 10 October 2012 in Eli Lilly v HGS. The ever-helpful Micaela Modiano has even rooted out a copy for readers' consideration here (thanks, Micaela -- and thanks to our readers for their comments posted on the earlier item).

C-493/12: Where is the referring decision?

Can you help a reader of The SPC Blog who has written as follows:

I am trying to track down the decision that leads to the reference C-493/12 [on which see The SPC Blog post here] but cannot find it on BAILII or Curia.  I have emailed the UKIPO policy unit but have had no reply.  Are you able to put out a request on the blog for the decision or order for reference?  

I understand from another source that it is a Patents Court decision dated 24 October 2012.  I would have thought that those involved in it are assiduous blog readers and might be happy to share the information (which should be in the public domain, surely). 

One further thought.  Why doesn’t the CJEU put the reference from the national court onto the relevant part of Curia?  All it says in the relevant bit of C-493/12 is:

Source of the question referred for a preliminary ruling High Court of Justice (Chancery Division) - United Kingdom

If you can shed any light on this, please do so!

Rivastigmine patent, SPC confirmed invalid on appeal

Yesterday, in Novartis AG v Generics (UK)Ltd t/a Mylan [2012] EWCA Civ 1623 CA (Civ Div), a three-man Court of Appeal for England and Wales consisting of Lords Justices Munby, Lewison and Kitchin dismissed Novartis's appeal against the decision of Mr Justice Floyd (noted here on The SPC Blog) that Novartis's Rivastigmine patent and SPC were invalid.

The main focus of the appeal was not specifically related to the law or practice with regard to SPCs, but rather to whether the trial judge had taken the correct approach to the question of inventive step. An analysis of the Court of Appeal's reasoning on this point has been written for the IPKat weblog by David Brophy (FR Kelly), here.

Eli Lilly: another batch of SPC questions for CJEU

The UK Intellectual Property Office is soliciting comments from interested parties that might persuade it to become involved in Case C-493/12 Eli Lilly & Co, the latest SPC case to go to the Court of Justice of the European Union for a preliminary ruling. There have been so many cases involving Eli Lilly in recent times that this blogger is uncertain precisely which of them has led to this reference, but he suspects that this reference is of British origin, emanating from the Patents Court ...

 The questions posed of the Luxembourg tribunal have at least some familiarity to them:

" (1) What are the criteria for deciding whether the product is protected by a basic patent in force in Article 3(a) of Regulation 469/2009/EC;

(2) Are the criteria different where the product is not a combination product, and if so, what are the criteria?

(3) In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?".

If you would like to comment on this case, please email policy@ipo.gsi.gov.uk by 17 December 2012. This may interfere with your end-of-year partying urgent work, but not too much!

AstraZeneca fine upheld: legal team comments

AZ: probably feeling
a bit blue today ... 

The Court of Justice of the European Union, as expected, dismissed AstraZeneca's appeal against the aggregate of 54.5 million euros which it was fined for abuse of dominant position. The acts to which objection was taken included the making of deliberate misrepresentations to national patent offices in order to secure and sustain SPC protection for its Losec anti-ulcer product.

The decision, in Case C-457/10 P AstraZeneca v Commission, is neatly summarised in the Curia press release here.

Lawyers for Bristows LLP, who have been keeping a watchful eye on this case on behalf of their clients, have been quick to comment.  Said Marie Manley, head of Bristows’ Pharmaceutical Regulatory team:

“The Commission will be delighted with the endorsement to its approach; innovative pharma less so. The pharmaceutical industry is now subject to a set of onerous but not fully clear obligations. Ensuring compliance will require pharmaceutical companies to build in more checks and balances to their internal procedures. Strategic corporate decisions when a product is close to patent expiry should be particularly carefully scrutinised”

Pat Treacy, head of Bristows’ competition team, added:

"The effects of this judgment resonate beyond the pharmaceutical sector. Companies which may be dominant now have an obligation to conduct themselves transparently when dealing with the public authorities. AstraZeneca has been penalised for making arguments that favoured its position when the issue was legally unclear. The Commission, in a position which has been endorsed by the courts, believes that AstraZeneca should have made the uncertainty about the legal position clear to the patent authority. This has wide implications for the way dominant companies conduct themselves".