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This section summarizes and comments on recent interesting judgments. It is not intended to be exhaustive, nor are the papers intended to constitute legal advice. For further information contact:

Michael Burdon

Partner and Head of Intellectual Property Group

Olswang

90 High Holborn

London WC1V 6XX

UK

Tel: +44 (0)20 7067 3279

Fax: +44 (0)20 7067 3999

Email: Michael.Burdon@olswang.com

www.olswang.com

Overview

The specialist Patents Court of the English High Court has recently issued a decision in which it confirmed that it has jurisdiction to hear a declaration for non-infringement with respect to the French, German, Italian, Spanish and UK parts of a European patent. In the UK, and elsewhere in Europe, it is possible to seek a declaration of non-infringement as a matter of right, without any threat of infringement by the patent-holder. It is increasingly common for generic pharmaceutical companies to ‘clear the way’ by seeking a declaration of non-infringement and/ or revoking the patent in advance of generic product launch, mainly to minimize the risk of a preliminary injunction. Actavis did not challenge the validity of the patent in these proceedings. It is unusual for the English court to exercise cross-border jurisdiction in a patent dispute.

Background

Eli Lilly and Company (‘Lilly’) had been marketing its Pemetrexed cancer treatment under the brand name Alimta since 2004. It was protected by a basic patent which had been extended by a Supplementary Protection Certificate which expired in December 2005. Lilly also owned European Patent No. 1 313 508 (the Patent) which does not expire until June 2021, for the use of pemetrexed disodium in combination with vitamin B12 or a pharmaceutical derivative thereof. Actavis contended that dealings in pemetrexed dipotassium will not infringe the Patent. Lilly disagreed. Actavis sought to have the issue resolved so they could enter the market on expiry of the SPC without risk of infringement proceedings and a preliminary injunction.

Actavis sought to have the infringement issue determined with respect to the French, German, Italian, Spanish and UK designations of the Patent, which cover the major pharmaceutical markets in Europe, in a single trial.

Actavis commenced proceedings seeking declarations of non-infringement of all these country designations of the Patent. Lilly applied for a declaration that the UK court does not have, or should not exercise, jurisdiction in respect of the French, German, Italian and Spanish designations of the patent. Lilly did not contest the court's jurisdiction with regard to the UK designation.

The headquarters of the Actavis Group were in Switzerland having moved there from Iceland in 2009. Actavis is in the process of being acquired by Watson Pharmaceuticals. The ultimate holding company The Actavis Group is a company incorporated in Luxembourg. Actavis has a number of subsidiaries incorporated in different countries which are responsible for marketing and selling the group's products in those countries.

Lilly is incorporated in the state of Indiana in the USA. Lilly has a number of subsidiaries including one which is incorporated in England. Lilly's European patent operations department is part of the English company and based in England.

Judgement

Importantly, Actavis did not challenge the validity of the Patent and undertook not to challenge validity, or to contend that the patent is invalid, in the proceedings either by way of claim or by way of defence to any counterclaim for infringement. Lilly was forced to accept that the English court was not required to decline jurisdiction by virtue of Article 22(4) of the Brussels I Regulation, which confers exclusive jurisdiction over challenges to the validity of registered intellectual property rights on the courts of the state where they are registered (see Case C-4/03 GAT v LuK [2006] ECR I–6523).

Lilly also did not dispute that the UK court had subject matter jurisdiction with regard to the non-UK designations of the patents in the light of a recent UK Supreme Court decision (Lucasfilm v Ainsworth [2011] UKSC 39). The Lucasfilm case held that the UK courts could consider copyright disputes on an international basis.

The English court was not required to deal with the issue considered by the CJEU in Solvay v Honeywell (C-616/10), which enabled the local court to have jurisdiction to grant an interim or interlocutory cross-border injunction notwithstanding that an invalidity defence had been raised in relation to the patent. The CJEU in Solvay held that the local court had provisional jurisdiction to grant a cross-border preliminary injunction based on Article 31 of the Brussels Regulation and this jurisdiction to grant provisional relief was not affected by the challenge to validity.

Lilly had commenced an infringement suit against Actavis in one of the German courts, in Düsseldorf. However, the German court was not seized of the infringement case until 4 days after the English court had been seized of the non-infringement case. As the UK court had held that it had jurisdiction regarding the German non-infringement claim, the German court would be forced to suspend its proceedings under Article 27 of the Brussels Regulations until the decision of the English court had become final.

The major dispute which the court had to decide, was therefore, not the question of whether the English court had jurisdiction to hear the case about the non-UK patents, but rather, the issues of (1) whether Lilly had consented to service and jurisdiction in relation to the non-UK patent and, (2) whether the UK court should decline to hear the cases under the principle of forum non conveniens.

The English court decided, on the facts of this case, that the lawyers for Lilly had consented to accept service, and in doing so, had also consented to jurisdiction, in relation to the claim for a declaration of non-infringement, not just in relation to the UK, but in relation to the other countries as well. As Lilly had consented to jurisdiction as well as service, they could not dispute jurisdiction on grounds of forum non conveniens.

The Court also considered whether service had been valid on two further procedural bases. They held that service on the patent attorney registered for service at the UK Patent Office was not good service in relation to the non-UK patents. The Court held that Lilly, despite being incorporated in the USA, had a place of business in the UK through its direct involvement in the European Patent Operations Center and had been validly served in relation to all patents.

The court then went on to consider Lilly's arguments that the English court should decline jurisdiction on grounds of forum non conveniens. It considered the factors in favor of hearing the case in relation to all patents in one set of proceedings against the problems or potential difficulties of doing so, for all concerned. The court decided that on the benefit side it was clearly more efficient to hear all the cases together and that, importantly, it removed the risk of different courts reaching different decisions over what was effectively the same patent and the same infringement issue. The substantive law on infringement was the same throughout Europe, even if the application of, and procedures used to apply, that law were different from time to time. The UK court said that it was increasingly familiar with hearing evidence of foreign law where that differed from UK law and that to do so would not introduce significant inefficiency or difficulty into the UK trial. The UK court decided that there was no good reason, based on forum non conveniens ground for it to decline to hear the case.

Comment

Some IP lawyers were surprised that the English courts were prepared to hear a cross-border patent case. However, that is because most patent cases involve both infringement and validity. It is clear that the English court will not consider cases involving non-UK patents where it would be required to reach a view on validity and in doing so would follow the GAT v LuK decision of the CJEU. However, where validity is not disputed the English court will hear infringement issues on a cross-border basis. The claim must be properly served and the receiving lawyers must be careful in the letters they write not to accept service and jurisdiction on a cross-border basis.

Overview

In September 2012, Mr Justice Arnold issued his decision regarding a dispute between Actavis and Sanofi concerning the drug irbesartan. This case is yet another SPC decision, reflecting the continuing uncertainty in the case law relating to SPC applications.

The issues raised have led to yet another referral to the CJEU regarding questions concerning the necessary requirements for a valid SPC application. In addition, the case is interesting because of the strong language used by Mr Justice Arnold in his reference to the CJEU.

Background

In brief, Sanofi was proprietor of European patent number EP 0 454 511. Claim 7 of the patent specifically covered irbesartan. Claim 20 of the patent covered a pharmaceutical composition containing a compound according to any of claims 1–7 in association with a diuretic.

Sanofi had obtained a first SPC based on EP 0 454 511 to cover irbesartan. This dispute contained a later SPC application, based upon the same patent, this time relating to the combination of irbesartan with hydrochlorothiazide (HCT), a known diuretic. Actavis argued, inter alia, that the patent did not claim the combination product in a sufficient level of detail to fulfil the requirements of the SPC regulation. As will be well known to those following SPC case law, the CJEU decision in Medeva had decided that it was necessary for the claims of the basic patent to specify the active ingredient. In the related Daiichi and Queensland decisions the CJEU used the term ‘identified’ rather than ‘specified’. There has been an ongoing debate about what is needed to fulfil this legal requirement.

The CJEU referral – Article 3(a)

The issue and the uncertainty over the Medeva language was not new to Mr Justice Arnold or the UK courts. In his earlier decision of Novartis v. Medimmune, the same Judge had stated: ‘the court did not actually answer question 1 [of the reference in Medeva]. … I am disappointed by this’. Following on from that, the Court of Appeal in Medeva BV v. Comptroller General of Patents (2012, EWCA Civ 523), and Warren in Eli Lilly & Co v. Human Genome Sciences Inc. (2012, EWCA 2290) also indicated that the test laid down by the Court of Justice in Medeva was unclear. Courts in France, Germany and the Netherlands had given divergent rulings on the same point of law.

The specific point in question here was whether irbesartan with hydrochlorothiazide (HCT) was sufficiently well identified or specified by a claim directed to irbesartan in combination with ‘a diuretic’ as more generically claimed in claim 20 of the patent. The answer was not clear to the judge, who referred the following question to the CJEU:

A second question – Article 3(c)

A second question was also referred to the CJEU, relating to whether it is possible to obtain two SPCs from the same patent. The Medeva decision had called this into question. The second referred question is:

Comment

The legal uncertainty surrounding SPCs has caused frustration for all companies impacted by SPC protection. It is to be hoped that the CJEU will provide some more definitive guidance for practitioners in the near future.

Overview

This decision is the first from the High Court (UK) which concerns a challenge to the grant of an extension to the Supplementary Protection Certificate (‘SPC’) as applied to a medicinal patent under Regulation (EC) 1901/2006 (‘the Pediatric Regulation’) of the European Union. In it, the Court provides insight into the interpretation of various provisions in the Pediatric Regulation and the provision in Regulation (EC) 726/2004 (‘the SPC Regulation’), which grants the power to revoke pediatric extensions.

Background

Atorvastatin is a medicine used in the treatment of high blood cholesterol. It was developed and marketed under the name of Lipitor by the Defendant company in this action, herein referred to as simply ‘Pfizer’.

At the time when the Pediatric Regulation came into force, Pfizer's atorvastatin patent had already been granted an SPC. On 19 October 2007, Pfizer submitted a proposed pediatric investigation plan (‘PIP’) for a new oral form of atorvastatin, suitable for children and adolescents, to the Pediatric Committee (‘PDCO’) of the European Medicines Agency (‘EMA’). Their PIP, which consisted of three clinical studies, was approved by the EMA on the 20 July 2008.

Each of the clinical studies proposed in Pfizer's PIP had different scopes and timelines. The first was a bioequivalence study which was to be conducted in healthy adult volunteers. The second was an 8-week pharmacokinetic study in children and adolescents (aged between 6 and 18 years) with heterozygous familial hypercholesterolaemia, a genetic condition characterized by high cholesterol levels. The third was a follow-up study of the safety and efficacy of atorvastatin treatment in children and adolescents with the same condition. The PIP specified that each individual child or adolescent taking part in the third clinical study was to be subject to study for a period of 3 years. It specified that the first and second clinical trials were to be completed by 30 September 2009 and 30 December 2009, respectively. The third study was to be initiated by 31 March 2009 but no date of completion was specified.

Upon completion of the first two clinical studies, whilst the third study was still in progress, Pfizer applied to the Committee for Medicinal Products for Human Use (‘CHMP’), the scientific advisory body to the EMA, for an opinion and report in favor of granting a marketing authorization for pediatric use of atorvastatin in its new formulation. The report was issued and approved by the European Commission on 1 July 2010. This decision was later implemented by the UK Medicines and Healthcare products Regulatory Agency (‘MHRA’) through the grant of multiple marketing authorizations. Pfizer was then able to obtain a 6-month extension to the SPC for their atorvastatin patent from the UK Intellectual Property Office (‘the UK IPO’).

Dr. Reddy's Laboratories, a substantial manufacturer of generic medicines in the UK, brought an action against Pfizer in which they challenged the pediatric extension and asked for it to be set aside.

They claimed that none of the relevant bodies involved had made an assessment as to whether the two studies Pfizer had completed before their application for marketing authorization were ‘significant’, as required by Article 45(3) of the Pediatric Regulation. On the facts, they argued that the relevant clinical studies were indeed not significant and thus the pediatric extension had been improperly granted.

Furthermore, they claimed that Pfizer was not entitled to a pediatric extension because it had failed to complete the third clinical study before submitting its application for marketing authorization.

Judgement

The Court considered Article 45(3) of the Pediatric Regulation and concluded that this particular provision had no application to the present case. It stated that the provision was a transitional one meant to be applied to clinical studies that had been conducted before the coming into force of the Pediatric Regulation. As the two clinical studies forming part of Pfizer's PIP were completed after the coming into force of the Pediatric Regulation, there was no need for them to be ‘significant’.

Moreover, the Court noted that the PDCO had in fact indicated in their report that the second study of Pfizer's PIP could be considered significant and that in granting its marketing authorizations, the MHRA had issued an accompanying statement that referred to the relevant PIP clinical studies as significant as well. However, the Court did not consider the matter further and instead relied upon its determination that the relevant provision, Article 45(3), was not applicable.

The Court also found that the argument that Pfizer was not entitled to a pediatric extension because it had not submitted the results of its third clinical study with its application for market authorizations was misconceived. It stated that Pfizer had complied with the terms of the approved PIP as no completion date had been specified for the third study, only a date of initiation.

Finally, the Court also gave an opinion regarding the general power to revoke pediatric extensions granted to national bodies by Article 16 of the SPC Regulation. The court considered the wording of this provision and determined that it granted a discretion to national bodies (in the UK, the Court) to revoke these extensions rather than an obligation to do so. That is, even if Dr. Reddy's Laboratories had been successful in arguing its case, this would not necessarily have resulted in an automatic revocation of Pfizer's pediatric extension and that ultimately, the decision to revoke is left to the discretion of the Court.

Comment

This decision is of particular importance because it effectively encourages pharmaceutical innovators to engage in further research into the applicability of their already patented medicines in the treatment of children and adolescents by providing assurances that the rewards granted for such research, pediatric extensions, will not be arbitrarily withdrawn or revoked on formal grounds.