EPLAW Patent Blog

UK - Resolution v Lundbeck

Resolution Chemicals Limited v H. Lundbeck A/S, High Court of Justice, Patents Court, London, UK.  Case No. [2013] EWHC 739 (Pat)

Resolution sought revocation of Lundbeck’s SPC for escitalopram on the basis of the alleged invalidity of the basic European Patent (UK) No. 0 347 066 (“the Patent”).  Escitalopram is the (+) enantiomer of citalopram, a selective serotonin re-uptake inhibitor used to treat depression.

On 3 January 2013 Lundbeck issued an application seeking, amongst other things:
1. Summary judgment on the ground that Resolution was precluded from bringing its claim
The validity of the Patent was previously challenged unsuccessfully by Arrow, Teva UK and Teva Pharmaceutical Industries Ltd (“Teva PI”), and it was common ground that Arrow, Teva UK and Teva PI would be precluded by issue estoppel and the doctrine of abuse of process from challenging the validity of the SPC on the ground that the Patent was invalid. Lundbeck argued that Resolution was also precluded from doing so by virtue of privity of interest with Arrow, or alternatively with Teva UK or Teva PI.

Mr Justice Arnold reviewed the law on privity, confirming that what is required is “a sufficient degree of identification between the relevant persons to make it just to hold that the decision to which one is party should be binding in the proceedings to which the other is party” and that this may or may not be the case for group companies.  He applied the law to the facts as follows.

BE - Lundbeck v. Tiefenbacher, Ratiopharm, Teva and Eurogenerics (escitalopram)

Lundbeck H. A/S v. GmbH Tiefenbacher, Ratiopharm GmbH, Ratiopharm Belgium N.V., Teva Pharma Belgium N.V., Eurogenerics NV, Court of Appeal, Brussels, Belgium, 17 september 2012, Case No. 2011/AR/2821, with thanks to Steven Cattoor, Hoyng Monegier, for sending in the case and an extended summary in English

** Now including a translation in English **

"Less than a year after the first instance judgment of the Brussels Commercial Court (see here), the Brussels Court of Appeal has rendered its final decision in the escitalopram case. The first instance decision of 3 October 2011, under which Lundbeck’s Belgian escitalopram SPC had been revoked, is completely overturned, and the Court of Appeal confirms the validity of the SPC and the underlying basic patent.

"In particular, the Court finds that both the product claims as well as the process claim of the patent are new and inventive, and that the requirements of Articles 3(c) and 3(d) SPC Regulation are met. Consequently, any generic product containing escitalopram as active ingredient is held to be infringing and the requested injunction is granted.

"The (128 page) judgment is well-motivated and analyzes in detail the nullity arguments raised by the generics, dismissing them one by one.

"When dealing with the issues of patent validity, the Court repeatedly refers to the EPO case law and Guidelines:

Read the entire summary in English here.

Read the decision (in Dutch) here.
Read the decision (in English) here.

NL - Lundbeck v. Sandoz / escitalopram

H. Lundbeck S/A v. Sandoz B.V., District Court The Hague, The Netherlands, 14 August 2012, Case No. 424154 / KG ZA 12-787, with thanks to Willem Hoyng, Jeroen den Hartog and Geert Theuws, Hoyng Monegier, for sending in the judgment and a translation in English

*** Now with translation in English ***

The Judge in Interlocutory Proceedings of the District Court in The Hague ordered a preliminary injunction against Sandoz based on Lundbeck’s  escitalopram patent.

The Judge followed Lundbeck’s reasoning that an earlier decision of the Dutch Court of Appeal (which may be read here), stating (in brief) that a substance may only be patented if the substance itself is inventive, is likely to be erroneous. The Judge awarded the injunction based on a process claim in the patent. Sandoz, according to the Judge, did not successfully argue that it did not implement the patented process.

Interestingly, the Judge awarded a provisional injunction already at the oral hearing, for the duration of the preliminary injunction proceedings.

Read the decision (in Dutch) here.
Read the decision (in English) here.

EU - Commission starts citalopram 'pay for delay' case against Lundbeck, Merck, Ranbaxy and others

Antitrust: Commission sends Statement of Objections to Lundbeck and others for preventing market entry of generic antidepressant medicine

The European Commission has informed the Danish pharmaceutical company Lundbeck of its objections regarding agreements concluded with four generic competitors concerning citalopram, a blockbuster antidepressant. The Commission is of the preliminary view that the agreements aimed at preventing the market entry of cheaper generic medicines, in violation of EU antitrust rules. The Statement of Objections is also addressed to Merck KGaA, Generics UK, Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma, A.L. Industrier and Ranbaxy, which belonged to the generic groups that concluded the agreements. The sending of a Statement of Objections does not prejudge the final outcome of the investigation.

In its Statement of Objections, the Commission takes the preliminary view that Lundbeck concluded agreements with generic companies to prevent the market entry of competing generic versions of its best-selling medicine citalopram. Generic entry became in principle possible when certain of Lundbeck's citalopram patents had expired. But the companies entered into agreements that foresaw substantial value transfers from Lundbeck to its four generic competitors, who subsequently abstained from entering the market with generic citalopram. The value transfers included direct payments from Lundbeck to the generic competitors and also occurred in other forms, such as the purchase of generic citalopram stock for destruction or guaranteed profits in a distribution agreement.

BE - Escitalopram / PI based on EP annulled at first instance

Brussels court of appeal, 27 June 2012, Lundbeck / Eurogenerics, case number 2012/KR/129 and 2012/KR/137 (PI proceedings)

In an earlier decision from the Belgian supreme court (reported here on the EPLAW Patent Blog), the Belgian tier of a European patent was declared prima facie valid despite having been revoked by the EPO Opposition Division.  It was held that, in view of the suspensive effect of the appeal that was lodged before the EPO Board of Appeal against that decision (Article 106(1) EPC), the revocation could not prevent a PI being granted on the basis of that patent.

The Brussels court of appeal has now declared this reasoning applicable to invalidity decisions issued by Belgian first instance courts. Lundbeck’s SPC for escitalopram was declared invalid by the Brussels commercial court in October 2011 in proceedings against the generic manufacturers Teva and Tiefenbacher.  Lundbeck has in the meantime appealed this decision and has already obtained a partial reversal of the first instance decision.  It now sought to enforce the same SPC against another generic manufacturer of escitalopram, Eurogenerics.  Eurogenerics argued that the patent was not prima facie valid because it had been annulled at first instance. The Brussels court of appeal did not accept this defence and stated that, by analogy to the supreme court decision on Article 106(1) EPC, the SPC should be considered prima facie valid for the purpose of PI proceedings, given the pending appeal against the first instance nullity decision.

Read the decision (in French) here.

Head note: Philippe de Jong

 

BE - Lundbeck v. Ratiopharm (Teva) and Tiefenbacher (escitalopram)

H. Lundbeck A/S v. Alfred e. & CO. Tiefenbacher GmbH, Ratiopharm GmbH, Ratiopharm Belgium N.V and Teva Pharma Belgium N.V., Court of Appeal Brussels, Belgium, 14 February 2012, Case No. 2011/AR/2821, with thanks to Steven Cattoor, Hoyng Monegier, for providing the case and a head note.

As reported earlier (see here), on 3 October 2011 the Brussels Commercial Court revoked Lundbeck’s Belgian escitalopram SPC and declared its decision immediately enforceable, notwithstanding appeal.

Lundbeck appealed this first instance decision and, by way of preliminary issue, requested that the ordered immediate enforceability be declared illegal. By judgment of 14 February, the Brussels Court of Appeal upheld Lundbeck’s appeal on this point and found that a first instance decision revoking a patent or SPC cannot legally be declared provisionally enforceable. According to the Court of Appeal, such immediate enforceability is contrary to Article 51§2 of the Belgian Patent Act (BPA), which, in view of Articles 18 and 19 SPC Regulation and in absence of any specific provision relating to SPC’s, is held to be applicable to SPC’s.

Deviating from the general rule under Belgian procedural law in this respect, Article 51§2 BPA stipulates that an application before the Supreme Court against a patent revocation decision rendered by an appellate court, has a suspensive effect. Allowing the immediate enforceability of a nullity decision in first instance is irreconcilable with the necessary suspensive effect of a cassation request under Article 51§2 BPA and would render the latter devoid of any meaning. A revoked patent/SPC cannot be declared valid again. The Court added that, given the erga omnes (and ex tunc) effect of a revocation decision, the legal guarantee under the Belgian Code of Civil Procedure providing that the party enforcing a judicial ruling does so at its own risk, cannot offer sufficient protection for the patentee.

This is the first time a Belgian court has ruled on the question of the (il)legality of the provisional enforceability of a nullity decision. The merits of the case will be heard shortly.

Read the decision (in Dutch) here.

NL - Lundbeck v. Tiefenbacher / Escitalopram Appeal

Joined cases of H. Lundbeck A/S v. Alfred E. Tiefenbacher GmbH and H. Lundbeck A/S v. Centrafarm Services B.V. and H. Lundbeck A/S v. Ratiopharm GmbH, Court of Appeal The Hague, The Netherlands, 24 January 2012, Case Nos 312468 / HA ZA 08-1827, 314574/HA ZA 08-2142 and 314783/HA ZA 08-2172, with thanks to Marleen van den Horst en Jaap Bremer, BarentsKrans, for sending in the judgment and a summary in English

The Court of Appeal in the Hague has decided that Lundbeck’s patent for escitalopram, which patent had been invalidated in its entirety by the District Court in first instance, is partially invalid. The product claims for the active substance escitalopram were nullified for lack of inventive step, whilst the method claim describing a specific procedure for the synthesis of escitalopram and the claim relating to an intermediate product were considered valid. The SPC-specific nullity arguments were dismissed.

Read the entire summary in English here.

Read the judgment (in Dutch) here.  

BE - Ratiopharm (Teva) and Tiefenbacher v. Lundbeck (escitalopram)

Brussels Commercial Court, 3 October 2011, Ratiopharm (Teva) and Tiefenbacher v. Lundbeck, joined cases A.R. 7.271/08 and A.R. 8.245/08

Brussels court holds escitalopram to be the same product as citalopram under Articles 3(c)-(d) of the SPC-Regulation.

Lundbeck commercialises two antidepressants called Cipramil® and Sipralexa®.  Both drugs inhibit the re-uptake of serotonine by the brain. The first MA for Cipramil® in Belgium dates back to May 1990, whereas the first MA for Sipralexa® was issued in July 2002. The active ingredient of Cipramil® is citalopram, whereas that of Sipralexa® is escitalopram. Escitalopram is the S-enantiomer of the racemate citalopram. Lundbeck is the proprietor of an SPC for citalopram, granted in September 1994, and one for escitalopram, applied for in December 2002 and granted in June 2003. The basic patents (one Belgian and one European) from which these SPCs ensued, have expired. Ratiopharm (later on Teva) and Tiefenbacher wished to launch a generic escitalopram product on the Belgian market and sought the invalidation of both the patent and SPC for escitalopram, which extended the protection until 1 June 2014.

 

AT - Lundbeck v. Ratiopharm / Escitalopram SPC

H.Lundbeck A/S, Lundbeck Austria GmbH v. Ratiopharm Arzneimittel Vertriebs GmbH, Escitalopram, SPC, Supreme Court, Austria, 7 March 2011, Case No. 17 Ob 5/11a

Another Escitalopram decision re the SPC for Escitalopram.

The Austrian Supreme Court considers the SPC valid. This is in line with other European courts such as the Bundespatentgericht in a decision of 30 March 2011 (the reasons have not yet been published).

Read the Austrian Supreme Court decision (in English) here.
Read the Austrian Supreme Court decision (in German) here.

Read the German Bundespatentgericht decision (in German) here.

EU - Commission opens antitrust investigation into pharmaceutical company Lundbeck

"The European Commission has opened a formal antitrust investigation into the international pharmaceutical undertaking Lundbeck to examine potential breaches of EU rules on restrictive business practices and on the abuse of a dominant market position under Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU). The Commission in particular intends to investigate unilateral behaviour and agreements by Lundbeck which may hinder the entry of generic citalopram into markets in the European Economic Area. Citalopram, originally developed by Lundbeck, is an anti-depressant drug known as a selective serotonin reuptake inhibitor (SSRI)."

Read the complete press release here.