No pre-emptive CJEU reference -- but Neutrokine α might still get to CJEU

Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) is a decision of Mr Justice Warren, Patents Court for England and Wales, of 3 August 2012 which touches on some interesting tactical issues relating to patent litigation in Europe as well as to SPCs in the wake of Medeva.

Eli Lilly

In short, Eli Lilly wanted to obtain a declaration that any SPC for which HGS might apply in respect of European Patent (UK) No 0 939 804 (Neutrokine alpha)--- which was expected to expire in 2016 -- would be invalid. Unusually, it applied for the Patents Court to make an immediate reference to the Court of Justice of the European  Union for a preliminary ruling regarding this claim for a declaration. This patent is one with which the British judiciary have become increasingly familiar: it has already been litigated all the way up to the Supreme Court on the question of industrial applicability (see posts here and here); the Supreme Court remitted the case to the Court of Appeal in November 2011 and the further decision of that court is keenly awaited.

Eli Lilly's application for a reference to the Court of Justice was made on two bases: (i) that it was impermissible for any party to apply for an SPC which was based upon an MA obtained by another party (such as, in this instance, Eli Lilly) when the two parties had no connection with each other (this was referred to  as the "third party SPC issue"); (ii) since HGS's patent did not specify or identify Eli Lilly's antibody in its claims, no valid SPC could be obtained even where the patent itself had been upheld as valid (this was referred to as the "specification issue"). HGS both opposed the application for an immediate reference for a preliminary ruling and sought to strike out the action on the basis that it was premature and incapable of resolution, given the current factual uncertainties.

Warren J ruled that Eli Lilly's application for declaratory relief should not to be struck out but should be allowed to proceed. However, the application would be stayed, pending the decision of the Court of Appeal. As to the application for an immediate reference to the Court of Justice for a preliminary ruling, his response was along the lines of "not yet, but maybe later". In the judge's view:

* The holder of a basic patent could apply for an SPC in reliance on an MA granted to a third party which had no connection of any sort with that holder; this issue was sufficiently devoid of doubt that there was no point in referring it for a preliminary reference;

* The 'specification issue' concerned the express words that a patent must contain in order to enable the grant of an SPC which related to an active ingredient within the scope of the patent. On this, the judge said at para.64:

" ... the law remains unclear in many aspects. Whilst sharing Arnold J's puzzlement with the reasoning in Case C-322/10 Medeva BV v Comptroller General of Patents, Designs and Trade Marks 24 November 2011, [2011] ECR I-0000 ("Medeva") and Case C-630/10 University of Queensland v Comptroller General of Patents, Designs and Trade Marks [2011] ECR I-0000 ("Queensland") (see at [37] and [49] of his judgment), it is not possible to disagree with what he says at [53] to the effect that the test laid down in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases or with his statement in [62] that it is inevitable that there will have to be further references to the ECJ.

Since this was a matter of European law to which the answer was unclear in the light of the guidance so far given by the Court of Justice, a further reference would be needed before the Patents Court was able to give an answer to the specification issue;

* The Patents Court had the power under the Civil Procedure Rules, CPR r.40.20, to make binding declarations regardless of whether any other remedy was claimed -- and where there was a commercial imperative that a clearly defined dispute should be adjudicated on, there was no reason why the Patents Court should not have jurisdiction to resolve that dispute by granting declaratory relief;

* The action for a declaration should not be struck out since there were powerful commercial reasons why Eli Lilly should be allowed to proceed, not least because the company was unable to invoke the procedures for challenging the grant of an SPC because no MA had yet been obtained and no application for an SPC could yet be made.

* While it was right for the court to assist in providing the certainty which Eli Lilly reasonably required, the action should not be allowed to proceed until the Court of Appeal had given its decision on the validity issue and any subsequent application for permission to appeal had finally been dealt with. If it turned out that the patent was invalid and no appeal to the Supreme Court was made, that would be an end of the matter and there would be no need for the declaration. If however the patent was held valid, the claim for a declaration should be allowed to proceed.

* There was no point in making any reference to the Court of Justice for a preliminary ruling for as long as the stay was in place. In this instance, no reference should be made unless the facts relevant to each of the third party SPC issue and the specification issue were established.

Neurim rapid response seminar this Thursday

The Olympic Sheep 5K run. Can you tell which sheep is on the melatonin? 

Wasting no time at all, the UK branch of the AIPPI (that's the Association Internationale pour la Protection de la Propriété Intellectuelle, the International Association for the Protection of Intellectual Property or Internationale Vereinigung für den Schutz des Geistigen Eigentums, depending on your preference) is holding a Neurim-themed rapid response seminar this coming Thursday, 2 August.

"On 19th July 2012, the Court of Justice of the European Union delivered its eagerly anticipated Neurim Pharmaceuticals judgment [see earlier posts on this weblog here and here]. Following the Advocate General's guidance, the Court has made it clear that Neurim should be granted its SPC for melatonin despite the existence of earlier authorisations relating to that active ingredient. However, the judgment is expressed in terms which are considerably broader than the facts at issue in the Neurim case.

Continuing AIPPI UK's quick response events on SPCs, Hugh Goodfellow returns to give his insightful views having acted for Neurim along with Ed Oates. Jürgen Dressel from Novartis will be speaking to give his views. They will together examine the extent to which the Neurim judgment has changed the SPC system".

This event kicks off at 5.30pm for 6pm and its official title is "The world of SPCs post-Neurim. So what has changed?"  Even though almost every corner of London is filled with Olympians contending for gold in sports as obscure as tiddlywinks, shove-ha'penny and hunt the slipper, the AIPPI UK has found an appropriate place to hold the seminar: Carpmaels & Ransford, One Southampton Row, London WC1B 5HA. Tickets are considerably cheaper for this event than for most Olympic ones: admission will set you back just £20 (AIPPI non-members) or indeed nothing at all if you belong to AIPPI.  Drinks are apparently free, whether you belong to AIPPI or not. Further details by email here or online here.

A more “fit for purpose” SPC Regulation?

Apart from the various comments posted at the foot of yesterday's blog item on Case C-130/11 Neurim Pharmaceuticals,  The SPC Blog has also received the following observations from Andrew Hutchinson (Associate Solicitor, Simmons & Simmons LLP)

A more “fit for purpose” SPC Regulation?

The CJEU’s judgment has allowed Neurim to obtain an SPC and so in that sense has followed the Court of Appeal (England and Wales) and the Opinion of Advocate General (AG) Trstenjak of 3 May 2012. However, while the CJEU has allowed Neurim’s application to proceed, as is now a common theme in SPC decisions, it seems to have struggled to formulate a legal test that can be applied generally and simply to all cases.

The CJEU has not applied the same test or gone into the detailed reasoning of the AG’s Opinion, which suggested that an earlier authorisation should be ignored if it did not fall within the scope of the protection of the later basic patent. This test required the assessment of the scope of protection of the basic patent in question and a determination of whether any earlier authorisations fell within it. The clear water between Neurim’s patent and the earlier authorisation was not in dispute. However, the CJEU may have been reluctant to apply this test given that finer distinctions may arise and an assessment of the scope of protection of a basic patent could overburden the SPC-granting authorities. The CJEU may have also been concerned about causing conflicts with its own earlier decisions, in particular Pharmacia (case C-31/03) and Yissum (case C-202/05), which the High Court for England and Wales had already assessed and considered, acte clair, to preclude Neurim’s SPC.

While the CJEU has held that the mere existence of an earlier authorisation can no longer be said to be automatically relevant to (and perhaps preclude) a later SPC application for the same product, the CJEU has provided hardly any test at all. As a result, it is not completely clear how similar to Neurim a subsequent case will need to be to benefit from this decision. In this sense, the decision provides for a specific exception to the stricter, literal interpretation of Articles 3(d) and 13(1), as opposed to applying a wider, more general teleological interpretation.

The requirements for benefiting from Neurim are split into two parts, which are closely connected: (1) is your SPC application for an old product with a “different application" and (2) do you have a “new patent” for that different application as your basic patent (paras 25-27). The central question is therefore: what is covered by "a different application"? A second medical use appears to qualify. There is no mention of the need for there to be a different species (as was the case in Neurim) but, as this is not addressed, it may be argued that this is a further limitation. This also leaves open the issues of any non-active components, new formulations, inventive excipients, etc.

Overall, some will seek to limit the scope of this decision while others will seek to extend it, so the circumstances of the case in question will be paramount. Another common theme in SPC decision continues: more referrals are likely.  It remains to be seen whether, as Jacob LJ commented when referring Neurim to the CJEU, cannot yet be ascertained whether allowing Neurim’s SPC will create a more “fit for purpose” SPC Regulation. It may only be a small step in that direction.

Neurim judgment liberalises SPC system

Today marked the publication of the eagerly-awaited decision of the Court of Justice of the European Union (CJEU) in Case C-130/11 Neurim Phamaceuticals, which the Court of Appeal for England and Wales sent for a preliminary ruling on the basis that it was up to the CJEU to determine whether the SPC Regulation was "fit for purpose" or not.

The full text of the judgment of the CJEU can be read here. Meanwhile, the following note has been kindly provided for The SPC Blog by Edward Oates (Carpmaels & Ransford). Edward writes:

Earlier this morning the CJEU, Europe’s highest court, issued its ruling in case C-130/11 Neurim Pharmaceuticals. The CJEU’s judgment has a liberalising effect on supplementary protection certificate (“SPC”) law and presents new opportunities for extending patents through SPC filings.

Prior to today, and based on a line of CJEU jurisprudence (C-31/03 Pharmacia, C-431/04 MIT, C-202/05 Yissum, C-195/09 Synthon and C-427/09 Generics), it was generally thought that an SPC was precluded (or its duration was truncated) if the active ingredient in question had been authorised in any earlier marketing authorisation within the EU, even if the earlier authorisation related to a different use in a different species. Today’s ruling clarifies that that is not the case and thereby provides an incentive for companies to engage in the research of new uses of previously authorised actives. The precise terms of the Court’s ruling are as follows.

1. Articles 3 and 4 of Regulation ... 469/2009 ... concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

2. Article 13(1) of Regulation ... 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

In referring to “a case such as that in the main proceedings” and “an earlier marketing authorisation obtained for a veterinary medicinal product”, the above ruling at first sight avoids explicitly addressing the question of whether the CJEU would have reached the same conclusion had the earlier marketing authorisation related to human use. However, the CJEU’s reasoning makes it clear that the CJEU would indeed have reached the same conclusion had the earlier marketing authorisation related to human use (emphasis added):

“25 Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product.

26 In such a situation, only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first MA of ‘that product’ as a medicinal product exploiting that new use within the meaning of Article 3(d) of the SPC Regulation…

30 … Therefore, the MA referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.”

As such, today’s judgment widens the possibility of obtaining SPC protection and will be enthusiastically received by holders of pharmaceutical and agrochemical patents.

Post-Medeva CJEU references on the horizon, this time from the Netherlands

From The SPC Blog's friend Margot Kokke (De Brauw Blackstone Westbroek N.V., Amsterdam) comes news that a Dutch District Court is proposing to refer some questions to the Court of Justice of the European Union in Dutch Georgetown and Queensland cases regarding the continuing saga of "one SPC per patent" (it seems that not all national intellectual property offices are continuing the practice of granting "one SPC per product per patent" as they used to do in the days before before Medeva.

The Dutch court in question here is the District Court of The Hague, which wants to obtain preliminary rulings that clarify the "one SPC per patent" rule mentioned in paragraphs 41 of Medeva (C-322/10) and 34 of Georgetown (C-422/10) in two parallel decisions: (Dutch) Georgetown and (Dutch) Queensland.

Initially the Dutch IPO refused the requested SPCs, basing its decision on Article 3(b) of the SPC Regulation but, once it was clarified in Medeva that an SPC for a single product can be granted based on a marketing authorisation containing that product together with other active ingredients, this was no longer an issue. The IPO subsequently refused to grant the SPCs based on Article 3(c) of the Regulation: in both cases another SPC (Queensland) or SPCs (Georgetown) was/were granted based on the same patent. The Court doubts whether the fact that Queensland renounced its right to the other SPC makes a difference as it is not sure whether the renunciation of an SPC has retroactive effect. The most important questions are:

* Does Article 3(c), in the situation where (the claims of) a basic patent claims several products, preclude the grant to the owner of the patent of an SPC for every product that is claimed?

* If the answer to this questions if affirmative, where an SPC is granted for one product but was renounced, does this preclude the grant of an SPC for another product claimed by the same basic patent?

* If it should be relevant that the renunciation has retroactive effect, is this governed by Article 14 of the SPC Regulation or by national law? In the latter case, does renunciation of an SPC have retroactive effect?

The parties have six weeks to give their opinion on the proposed questions, before the Court will formulate its final referral.

Atorvastatin PIP dispute not for Luxembourg, says court

Given the number of references for a preliminary ruling that have been made by UK courts to the Court of Justice of the European Union (CJEU) on patent term extension matters, it is almost a relief to be able to write about a dispute in which a reference for a preliminary ruling was not made.  That case is Dr Reddy's Laboratories (UK) Ltd and another company v Warner-Lambert Company LLC [2012] EWHC 1719 (Ch), a Patents Court, England and Wales, decision of Mr Justice Roth on 28 June, which raises some fascinating questions regarding the desirability of referring questions to the CJEU -- and also regarding the context in which such references are made. 

The dispute arose over a paediatric extension for atorvastatin, where the European Medicines Agency had approved the paediatric investigation plan (PIP) without one of the three studies having been concluded. Seeking a reference for a preliminary ruling, Dr Reddy's applied for revocation. 


Mr Justice Roth refused the application for a preliminary ruling. In his view, while most applications to the CJEU for a preliminary ruling involved the agreement of the parties, in this case the defendants vigorously opposed the reference and even the final draft of the questions to be referred did not appropriately express some of the questions on which the court might want to seek a ruling. Moreover, arguments of the parties had not been sufficiently developed and clarified on both sides to the point that the court could confidently frame clear, precise questions that would pinpoint the issues on which a preliminary ruling was required. It was indeed true that the court might decide to refer questions to the CJEU at the end of the trial, but at this stage it was by no means certain that such a reference would be necessary.  On the financial side, this was not a situation in which the court could avoid substantial costs by making a reference ahead of the trial.

Recent developments: a new article

Published later this week in volume 12, issue 4, of the Bio-science Law Review is this 12-page article by Gertjan Kuipers, Tjibbe Douma and Margot Kokke (De Brauw Blackstone Westbroek, Amsterdam). In addition to the text, this general survey, entitled "Recent European Developments Regarding Patent Extensions (SPCs and Paediatric Extensions)", has some useful tabular representations.

The SPC Blog wishes to thank the BSLR's publisher, Lawtext, for agreeing to let our readers see this ahead of its publication date.

Medeva: it isn't over till it's over ...

The 4 July 2012 issue of the UK Intellectual Property Office's Patents Journal (No.6424) contains the following entry:

"MEDEVA BV

EP1666057

Method of manufacture of an acellular vaccine comprising bordetella pertussis antigens

Notice of Appeal against the decision of the Court of Appeal dated 05 May 2012 [judgment delivered on 3 May, with comment on The SPC Blog on 4 May here] lodged with the Supreme Court on 31 May 2012 (UKSC 2012/0144)

Appeal - Lodged"

It is by no means certain that the Supreme Court will agree to hear the appeal.

Thanks, Daniel Wise (Carpmaels & Ransford), for letting us know.

Antitrust and SPCs in Italy

From Micaela Modiano (Modiano & Partners) comes some useful information concerning developments in Italy, where the national antitrust authority seems to have been taking a closer interest in patent extension than most of its counterparts in EU Member States.  She writes:

"You may have heard that there was a recent decision rendered by the Italian Antitrust Authority regarding divisionals and SPCs. The decisions relates to a European divisional patent and an Italian SPC owned by Pfizer.

I attach both the public version of the decision and an English translation of it.

At point 176. of the decision the Antitrust Authority lists the elements of the alleged exclusion strategy enacted by Pfizer. In particular, the following elements are listed:

"i) the application to the EPO of the divisional patent EP 168 in 2002; 

ii) the validation of same only in Italy, [omissis] for the purpose of requesting in some countries the SPC on Xalatan and thus align the duration of the patent protection to that in force in the rest of Europe; 

iii) the intervention with AIFA for the purpose of preventing the issue of the MAs to the generic pharmaceutical manufacturers and subsequently their inclusion in the transparency list; 

iv) the delivery to the manufacturers of the Xalatan generic drugs of warning letters relating to their marketing prior to the patent expiry of July 2011; 

v) the commencement of civil and criminal litigation in order to discourage or render more burdensome the sale of the generic drugs based on latanoprost (including through massive compensation claims) or to prohibit directly the marketing; 

vi) the application for the subsequent patent extension following the pediatric trial, in other words extending the patent protection of Xalatan until January 2012."

The Antitrust Authority decision is quite striking as it lists a number of things fully contemplated by European (EPC and EU) and Italian law -- such as filing a divisional, validating it in the countries of choice, filing an SPC for it, filing a request for paediatric extension -- among the elements of the alleged exclusion activity.

I think it will make fascinating reading for all those interested in the interaction between IP law (and SPCs in particular) and antitrust regulations. 

Thanks so much, Micaela, for sharing this information with us, as well as your insight on it.

Telmisartan + hctz: combination SPC in Spain -- now in English

Pamplona: city of great
excitement -- even for SPCs

Last month, in "Telmisartan + hctz: combination SPC revoked in Spain" (here), Javier Huarte and his colleague Sara Pelaz (Grau & Angulo, Barcelona) kindly sent us information concerning a judgment of the Commercial Court No. 1 of Pamplona, which upheld a revocation action by Cinfa and Actavis against the Spanish SPC for telmisartan + hctz.


Javier and Sara have now sent us an English translation of this decision, which you can read here.  Thanks so much, Javier and Sara, for your thoughtfulness.