Res judicata, invalidity and prima facie validity: a curious Belgian concoction

"Invalidated SPC retains prima facie validity in preliminary injunction proceedings" is the grand title of a note by Kathleen Mercelis and Philippe de Jong (Altius) which was recently published on International Law Office.  The note deals with a Belgian Supreme Court ruling on the end-game in a battle between generics manufacturer Eurogenerics and Lundbeck, whose SPC for escitalopram had been invalidated.  The facts are a little unusual, as appears from the text:

Background 

Pharmaceutical company Lundbeck held a European patent for escitalopram, the active substance of an antidepressant commercialised in Belgium under the trademark SIPRALEXA. The patent expired in 2009, but Lundbeck obtained a supplementary protection certificate (SPC) extending protection for escitalopram until June 1 2014. However, the SPC was invalidated by the Brussels Commercial Court following a nullity suit brought by several generic manufacturers. Lundbeck appealed that decision. 

Pending the outcome of the appeal, another generic company, Eurogenerics, brought its generic version of escitalopram to market. Lundbeck started preliminary injunction proceedings against Eurogenerics based on the invalidated SPC. At first instance, Lundbeck's claim was rejected, but its appeal was successful and the Brussels Court of Appeal issued an injunction against Eurogenerics. According to this court, the Supreme Court decision of January 5 2012(1) – which held that the revocation of a patent by the European Patent Office's opposition division, against which an appeal had been lodged pursuant to Article 106(1) of the European Patent Convention, did not affect the prima facie validity of the Belgian counterpart of the revoked patent – was equally applicable to the present circumstances. The court held that the appeal of a nullity decision of a Belgian court has suspensive effect as well. Lundbeck's SPC was therefore found to retain its prima facie validity pending the outcome of the appeal against the first instance invalidation decision (in which the SPC was eventually upheld).(2) 

Supreme Court decision 

Eurogenerics appealed to the Supreme Court, claiming that the annulment of the SPC by the first instance court had the authority of res judicata (ie, the fact that a case has already been decided) and should therefore have been respected by the court that issued the preliminary injunction. 

The Supreme Court rejected Eurogenerics's reasoning and upheld the decision of the Brussels Court of Appeal on the following grounds: 

• There is a difference between the authority of res judicata, which is attributed to every final court decision that has not been overruled, and the force of res judicata (ie, an unappealable decision). As long as the decision has no force of res judicata, the authority of res judicata is only conditional.

• According to the Belgian Patent Act, a decision by which a patent is invalidated normally has the authority of res judicata. However, such decisions are not recorded in the patent register before obtaining the force of res judicata.

• The Patent Act also states that an appeal to the Supreme Court has suspensive effect with respect to an invalidated patent.

• Finally, the Belgian Judicial Code states that an appeal normally suspends the enforceability of a decision. 

The Supreme Court consequently held that a patent that was invalidated by a first instance decision can still be the basis for a subsequent preliminary injunction action. 

Comment 

In its January 5 2012 decision the Supreme Court held that the fact that a patent was revoked by the opposition division of the European Patent Office did not affect the prima facie validity of the revoked patent, as long as no final decision has been taken in the opposition proceedings, because according to Article 106(1) of the European Patent Office, an appeal against decisions of the opposition division has suspensive effect. 

In the present case, the Supreme Court took this reasoning one step further and found that the prima facie validity of a patent (or SPC) is also not affected by an invalidity decision of a national court, notwithstanding the fact that this decision has the authority of res judicata. Consequently, a patent holder requesting a preliminary injunction against an alleged infringer can rely on the prima facie validity of its patent or SPC until the decision by which the patent was invalidated has obtained the force of res judicata – that is, once an appeal to the Supreme Court has been rejected or the limitation period for bringing the appeal has expired.

Endnotes

(1) For further details please see "Prima facie validity of granted European patents in summary proceedings".

(2) Brussels Court of Appeal, September 17 2012, IRDI 2013, p 40.

Resolution not barred from seeking to revoke escitalopram SPC

In Resolution Chemicals Ltd v H. Lundbeck A/S [2013] EWHC 739 (Pat), a trial of preliminary issues ahead of a full trial scheduled for November 2013, Mr Justice Arnold (Patents Court, England and Wales) was asked to rule in an action in which Resolution sought revocation of Lundbeck's SPC/GB02/049 for escitalopram, alleging invalidity of the basic patent (European Patent (UK) No. 0 347 066).

As the judge explained by way of background, Escitalopram is the S or (+) enantiomer of citalopram. Citalopram is an anti-depressant drug of the selective serotonin re-uptake inhibitor (SSRI) type which was first synthesised by Lundbeck in 1972 and launched in 1989. Some time after it developed citalopram, Lundbeck devised the method for synthesising escitalopram described and claimed in the Patent and discovered that escitalopram was the active enantiomer of the racemate. This led to it launching escitalopram in 2002. Escitalopram has been hugely successful. Lundbeck was also the proprietor of a number of patents for citalopram and methods of making it which have since expired.

On 3 January 2013, in response to Resolution's application for revocation, Lundbeck issued an application seeking:

i) summary judgment on the ground that Resolution was precluded from bringing its claim and/or relying on allegations in its claim by reason of cause of action estoppel or issue estoppel or abuse of process;

ii) alternatively, summary judgment on the ground that Resolution's claim had no real prospect of success; and

iii) in the further alternative, a conditional order that Resolution provide security for Lundbeck's costs of these proceedings.

In short, after three days of hearings and a judgment of 164 paragraphs, laid out with that judge's usual clarity and attention to detail, Arnold J ruled as follows:

i) Resolution was not precluded from challenging the validity of the Patent, and hence the SPC, on the ground that it was a privy of either Arrow Generics or Teva UK/Teva PI and therefore bound by the decisions adverse to those parties in the earlier escitalopram litigation.

ii) Resolution had a real prospect of successfully contending that all the claims of the Patent were obvious over 884 and that claims 1-5 were obvious over Bigler. Accordingly, Lundbeck's application for summary judgment was dismissed and Resolution's application for permission to amend its Grounds of Invalidity was allowed.

iii) Resolution would not be ordered to provide security for Lundbeck's costs.

The judgment is a long one which raises numerous issues. This blogpost seeks to alert readers to the existence and substance of the ruling, but does not attempt at this very early stage to analyse and evaluate it.

Lundbeck's Belgian appeal success over escitalopram: now in English

From Annette Hirschfeld (Hoyng Monegier, Amsterdam) comes news of a case that has attracted considerable interest and attention in the world of SPCs, Lundbeck v Tiefenbacher, Ratiopharm, Teva and Eurogenerics (escitalopram).  In this Belgian litigation, the Brussels Court of Appeal reversed the decision of the Brussels Commercial Court (noted by Steven Cattoor for the EPLAW Patent Blog here) to revoke Lundbeck’s Belgian escitalopram SPC and confirmed the validity of both the SPC and its underlying basic patent: it found that both the patent's product claims and the process claim were novel and non-obvious, and that the SPC fulfilled the requirements of Articles 3(c) and 3(d) of the  SPC Regulation. Declaring that any generic product containing escitalopram as active ingredient would infringe, the Court of Appeal granted injunctive relief.

Of particular note in the Court of Appeal's judgment, which makes substantial reference to European Patent Law (EPO)  case law and Guidelines, are the following:

• As to the novelty of the product claims, in the light of the EPO decisions in T297/87 (Hoechst) and T1048/92 (Pfizer), the generic manufacturers had failed to show that the prior art (including the earlier patent on the racemate) unambiguously disclosed the specific configuration of the claimed S-enantiomer in the form of a technical teaching. Since no document cited would let the skilled person obtain the enantiomers of citalopram in an individualised form, the product claims on the S-enantiomer (i.e. the product escitalopram) were novel.

• As for inventive step, after restating the general principles of the EPO's problem-solution approach, the Court referred, inter alia, to the teaching in  T595/90 (Kawasaki Steel) that an otherwise obvious entity may become non-obvious (and thus claimable as such) if there is no known way in the art to make this entity and the patent is the first to achieve this in an inventive manner. The Court then examined whether the process set out in the patent was indeed the first and an inventive method to prepare escitalopram.

The full text of the judgment, all 128 pages of it, has now been rendered into English and can be read here.

This blogpost is based on a note by Steven Cattoor that was first posted on the EPLAW Patent Blog here.

Escitalopram again, this time in Belgium

Escitalopram is in the news again. The Belgian District Court has very recently given judgment in Ratiopharm, Tiefenbacher v Lundbeck, an action which is of great interest in Benelux circles on account of the parallel proceedings in which a decision is currently keenly awaited.

On 3 October the Belgian District Court invalidated the contested SPC, since the marketing authorization for escitalopram referred to in Lundbeck’s SPC application was not the first marketing authorization for the product under Article 3(d) of the SPC Regulation. According to the court, the SPC should have designated the marketing authorization for citalopram, not the marketing authorization for escitalopram. The court additionally found that a previous SPC had been granted for the same product (Article 3(c) of the same Regulation).

The District Court took the view, with reference to the Court of Justice ruling in Case C-431/04 MIT, that in the racemic mixture citalopram, only the S-enantiomer (es-citalopram) had "a therapeutic effect of its own". Accordingly the active substance (or "product") in citalopram and es-citalopram is the same, namely: es-citalopram. The court refers, inter alia, to the decision of the CBG (the Dutch MEB), which had decided that there were no cliniacally relevant differences between citalopram and es-citalopram and that es-citalopram was to be considered a line extension of citalopram. The court also explicitly deviated from the earlier decision of the German Federal Supreme Court (which had held the SPC valid) because, in its view, the German decision was not in line with the SPC case law of the Court of Justice -- in particular, its understanding of the word “product”.

An English translation of the Belgian District Court has been kindly provided by an anonymous benefactor. you can read it here.

German Escitalopram ruling in English: now we know why there's no ECJ reference

The deckchair is empty:
we're all at work!

Last Wednesday The SPC Blog posted here a note on the recent Escitalopram SPC decision from Germany. The text of this decision was kindly supplied by Chris Hayes (Lundbeck), who offered us sight of an English translation once it became available. This afternoon, some ten minutes ago in fact, this member of the blogging team found the English translation sitting in his in-box. He has lost no time in uploading it here for the benefit of anyone who finds the original German text too difficult. As mentioned in last week's post, the German Patent Court declined to make a further reference to the Court of Justice for a preliminary ruling. Said the Court:

"The present legal dispute does not raise any questions not yet clarified as to the interpretation of Regulation (EC) 469/2009, and this is why the Board has not followed the suggestion of Plaintiff to stay the proceedings in accordance with Art. 267 Treaty on the Functioning of the European Union (TFEU) and to refer the questions Plaintiff has formulated to the European Court of Justice as part of proceedings for a request for preliminary ruling. Such a referral is only possible if questions need to be decided regarding Community law, which cannot be answered either on the basis of legal sources nor have been sufficiently clarified in the case law of the European Court of Justice. Plaintiff was not able to formulate such a question of the law nor is such a question otherwise apparent. In the present nullity proceedings, the question is, on the contrary, decisively the subsumtion of the specific facts under the legal rules pertinent in this regard. The question that is of major significance in this case is whether escitalopram has its own medicinal effect and thus must be considered to be a different active ingredient than is citalopram. However, the Board cannot present the European Court of Justice with this factual question. The viewpoint in connection with this of whether the authorization for a medicinal product that contains as active ingredient a chemical compound as racemate that bars the grant of an SPC for a medicinal product that contains as active ingredient an enantiomer of the racemic compound and is the subject matter of a later marketing authorization as well as its own substance patent, also does not raise any legal questions requiring clarification. The purpose of Art. 3 (d) Regulation (EC) 469/2009 as a regulation lies in the objective to not prolong the overall term of protection granted by an SPC for a product in that several subsequent certificates can be granted for one and the same product (cf. German Federal Court of Justice decision “Escitalopram” in GRUR 1010, at 123, no. 76). Since, however, it must be assumed – as presented – for lack of any convincing, contradictory reference points that escitalopram is, within the terms of Art. 1(b) Regulation (EC) 469/2009, a different product than is citalopram, this viewpoint does not bar the grant of the SPC. That no other conclusion could be derived from the decision of the German Federal Court of Justice of 14 October 2008 (“Doxorubici-Sulfat”, X ZB 4/08, in GRUR 2009, at 41) was already specifically clarified by the Federal Court of Justice in its “Escitalopram” decision (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 77).

None of the other disputed questions decisive for the present nullity proceedings reveals an abstract, not-clarified legal question which would require an interpretation by the European Court of Justice. For these reasons, the Board did not order a stay of the proceedings pursuant to Art. 267 TFEU nor did it refer the case, in accordance with the suggestion made by Plaintiff as an auxiliary motion, to the European Court of Justice. The Board believes that its opinion is confirmed by the evaluation voiced by the Federal Court of Justice in its “Escitalopram” decision which insofar was also based on an “acte claire” (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 78)".

Escitalopram decision from Germany -- but no ECJ reference this time

From Chris Hayes (Lundbeck) comes news of another Escitalopram SPC decision, this time from the German Patent Court (you can download it here). An English translation has been promised in due course. Chris explains:

"The case was heard earlier this year, but we have only just received the full reasons for judgment. This was an attack on the SPC only, and the Patent Court's decision is in alignment with the earlier decision of the German Supreme Court on the validity of the basic patent and the SPC.

A reference to the ECJ was refused, as the Court decided that this was a purely factual dispute. The Court decided that foreign regulatory proceedings had no bearing on the validity of the SPC;, nor did decisions of the German pricing authorities".

Thanks so much, Chris, for this judgment.

Escitalopram in France

On Friday Chris Hayes (Lundbeck) furnished The SPC Blog with an English-language translation of the Austrian Supreme Court’s ruling concerning an SPC for Escitalopram (17 Ob 5/11a).  Today we have further reason to thank Chris: he has also let us have this translation of another decision involving Escitalopram -- this time from the Tribunal de Grande Instance (first instance court) de Paris, dated 30 September 2010.

The decision relates both to the patent and the SPC and, Chris explains, the SPC part of the judgment raises some interesting points about the interplay of the SPC Regulations and other pharma regs.

Injunction lifted as Spanish escitalopram dispute edges towards full trial

Readers may have missed a recent note on the 8 March 2011 decision the Barcelona Court of Appeal to lift the preliminary ex parte injunctions sought by Lundbeck against various companies selling generic escitalopram medicaments for which they had obtained marketing approval.  This decision upheld the decision of Barcelona Commercial Court No 4 in April of last year.  At stake were Lundbeck's patent EP347.066 - ES2.986.891 and SPC 200200019, which claimed a certain manufacturing process for the active ingredient escitalopram.

The main trial in the first instance main proceedings is due to take place in July 2011.

Details of this dispute so far can be found in the source referred to below.

Source: "Appeal court lifts preliminary injunction against sale of escitalopram generics", by Sara Pelaz (Grau & Angulo), International Law Office, 3 May 2011

Escilatopram - English translation of German decision available

Yesterday, we posted a piece on the German Federal Supreme Court decision on Escilatopram.

Non-German speakers will be delighted to know that the English translation of the decision can be obtained here. It was kindly provided to the Blog by Klemens Stratmann (Hoffmann-Eitle, Munich)

Escilatopram in Germany - the BGH decides

The German Federal Supreme Court (FSC) recently reversed the German Patent and Trademark Court decision on the validity of Escilatopram patent EP 0347 066 and its related SPC (SPC No. 103 99 030 to Escitalopram and non-toxic acid addition salts thereof) - Read the decision in original - here (unfortunately, no English language version available). The IPKat (Thanks!) provides a short summary of the facts of the case here.

On SPCs, the FSC held that a marketing authorisation for a racemic product does not prevent the grant of a supplementary protection certificate to an enantiomer form of the product based on a later marketing authorisation to the enantiomer of the product and a patent on that enantiomer.

You might recall that this case has also been heard and decided in the Netherlands (here in Dutch, and here for an English translation) and the UK (here).

Israel refuses escitalopram SPC

In April the SPC Blog published news of the invalidity of Lundbeck's escitalopram patent and SPC in the Netherlands (see also IPKat post here). Now, via Jeffrey Boone (Covidien), comes information of the fate of escitalopram in Israel, thanks to a newsletter article by the Reinhold Cohn Group. According to that firm,

"... The Israeli Patent office recently refused H. Lundbeck's application to extend the term of its Israeli patent, covering its blockbuster drug Cipralex® whose active pharmaceutical ingredient is the single (S)-enantiomer (escitalopram) of the racemate Citalopram. The refusal was based on the Israeli Registrar's conclusion that the first registration of a drug containing escitalopram by the Israeli Ministry of Health was the previous registration of the racemate (Citalopram, marketed as Cipramil®)".

The newsletter article then goes on to analyse the Patent Office decision which, it concludes, was erroneous.

Escitalopram patent/SPC held invalid in the Hague

The Dutch first instance decision in ratiopharm et al v Lundbeck, concerning the validity of Lundbeck’s escitalopram patent (EP 066) has now been handed down by the Hague District Court. The court held that all the claims of Lundbeck’s escitalopram patent (and Lundbeck’s Dutch Supplementary Protection Certificate which was based upon it) were invalid for lack of inventive step.

Interestingly, the court's decision contains many references in the decision to the 4 May 2007 decision of Mr Justice Kitchin, with which decision the Dutch Court on relevant points “respectfully disagrees” (as the court said, in English, at § 6.39), on the basis of different/further evidence to that put before Kitchin J. You can read the court's decision in full here -- in Dutch.

[Information supplied by Richard Ebbink and Mark van Gardingen, Brinkhof].