Valsartan: France back in line with the rest of Europe

From our good friend Laëtitia Bénard (Partner, Allen & Overy LLP, Paris) comes some more fascinating and instructive material for our readers. Laëtitia (whose firm acted as counsel to Novartis in the Valsartan case, and to MSD and Du Pont in the Losartan case) writes:

Novartis v Actavis on the Valsartan SPC: the French Supreme Court has quashed the decision of the Paris Court of Appeals and has put France back in line with the CJEU and national courts in Europe by ruling that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient

Further to a preliminary injunction rendered against Actavis on 28 January 2011, which ruled that Actavis' generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan, the Paris Court of Appeals rendered a decision on 16 September 2011 inconsistent with the almost unanimous interpretation of the SPC Regulation across Europe on the subject matter and effects of an SPC, including France, reversing the preliminary injunction measures ordered in first instance.

On 15 January 2013, ruling on Novartis' appeal, the French Supreme Court quashed the decision of the Paris Court of Appeals, aligning at the highest level the French case law with the interpretation of the SPC Regulation by the CJEU in its Reasoned Orders of 9 February 2012 (C-442/11 and C-574/11), as previously did the Paris First Instance Court ruling on the merits on 8 June 2012 in the Losartan case (decision now final -- you can read the French decision of 8 June 2012 here and the English translation here).

The French Supreme Court ruled that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient.

The main findings of the French Supreme Court are as follows:

"Whereas by order of 9 February 2012 (C-442/11), the Court of Justice of the European Union ruled and held to be law that Articles 4 and 5 of Regulation No. 469/2009 must be interpreted as meaning that, where a product consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that product in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, an SPC granted for that product enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the product, as a medicinal product, which was authorised before that certificate expired;  

Whereas the decision considers, in order to dismiss Novartis' claims, that the litigious generic medicinal product, comprising Valsartan associated with HCTZ, does not constitute the same product as Valsartan, solely covered by SPC No. 97C0050, and consequently that it does not appear likely that any marketing of a medicinal product containing Valsartan as an active ingredient constitutes an infringement and violates the rights owned by Novartis over this active ingredient; 

Whereas, by deciding so, without considering whether the rights owned by Novartis on patent No. EP 0 443 983 would have allowed them to oppose the use of Valsartan, as a medicinal product, in the litigious generic medicinal products associating it with HCTZ, and whether, consequently, these generic products would infringe SPC No. 97C0050, covering, as the basic patent, Valsartan, and conferring to Novartis the same rights as the patent, the Court of Appeals rendered a decision without legal basis;".

This decision of the French Supreme Court is final.

You can read the French decision of the French Supreme Court here and the English translation here. 

Court of Rome applies Medeva, suspends provisional relief

From Evelina Marchesoni (Bird & Bird) comes an update to The SPC Blog's recent post on the Italian proceedings on valsartan and hydrochlorotiazide.She writes:

"On 11 November 2011 the Court of Rome granted a preliminary injunction requested by Novartis enforcing its SPC no. C-UB1999P000648, expiring on September 25, 2012 and covering the medicinal product “Cotareg” (valsartan + HCTZ).

In his decision the dudge ordered Mylan to stop manufacturing, commercializing, advertising, distributing, importing, exporting, storing and/or offering in any form (including the request of insertion in the so called “transparency list”) the generic products of Cotareg. 

Mylan appealed against this interim order and, after the issue of the decision of the Court of Justice in Case C-322/10 Medeva and Case C-422/10 Georgetown, sought an application to stay the preliminary injunction pending appeal. 

Mylan pointed out that, also in light of the Court of Justice's ruling, Novartis’s certificate claiming the combination of valsartan and HCTZ was invalid according to Article 3(a) of the Regulation, as it referred to a basic patent, EP 0 443 983, which did not provide such a combination.

By his decision, issued on 25 November 2011, the President of the IP Division of the Court of Rome, considering that on 24 November 2011 the decisions from the ECJ were published and they affirmed that Art.3(a) of the Regulation should be interpreted “as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”, ordered the provisional suspension of the preliminary injunction decision. 

This short decision of the Court of Rome, which you can access in full here (in Italian) probably constituted the first application in Europe of the interpretation of the Court of Justice decisions in the Medeva and Georgetown cases.

Discussion of the appeal is scheduled for 16 December 2011".

Thank you, Evelina, for this information, which is much appreciated.

Düsseldorf Novartis/Actavis order now in English too

In "Düsseldorf valsartan/HTC proceedings referred for preliminary ruling" (here) The SPC Blog received an update from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf, acting for the Actavis defendanta) on the proceedings in Novartis/Actavis before the Düsseldorf District Court. The update contained the order of that court in the original German, here.

The SPC Blog has since received two English translations of the order of the Düsseldorf District Court.

The first translation to arrive came from Cordula Tellman and Frank-Erich Hufnagel (Freshfields Bruckhaus Deringer LLP), which you can read as a pdf file here. As Cordula and Fran-Erich kindly explain, the Court reconfirms the position which it expressed in its ruling in the previous preliminary injunction proceedings: that is, a protection certificate granted for a single active ingredient (e.g. valsartan) would be infringed by a medicinal product containing this single active ingredient, even if combined with another active ingredient (e.g. valsartan + hydrochlorothiazide).  The Court discusses in detail the arguments brought forward by the parties and gives extensive reasoning for its opinion that the SPC is infringed (see in particular paragraphs 17, 20, 22, 24, 28 and 30 of the order).

The second translation, which arrived in a welter of emails following the resumption of this blogger's internet connectivity, came from Thomas and Henrik. You can read it as a pdf file here.

The SPC Blog is grateful to the lawyers of both firms for their efforts to make the ruling and the reasoning of the Düsseldorf court both available and accessible to the SPC community and for their enthusiasm for the subject.

Düsseldorf valsartan/HTC proceedings referred for preliminary ruling

Düsseldorf District Court

The SPC Blog has received from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf) an important update on the proceedings between Novartis on the one hand and Actavis Deutschland GmbH and Actavis Malta Ltd on the other before the Düsseldorf District Court (Thomas and Henrik are representing the two Actavis companies in the action on the merits pending before the Düsseldorf District Court).  This is what they have told us:

"The SPC Blog entries of 21 and 24 March 2011 (here and here, respectively) provided the following information:

1. On 8 March 2011, the Düsseldorf District Court held in preliminary injunction proceedings (case nos. 4b O 280/10 and 4b O 287/10) that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCT) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036). 

2. The Düsseldorf District Court ordered Novartis to file actions on the merits.

On 8 April 2011, Novartis filed such action on the merits (jointly) against Actavis Germany and Actavis Malta (case no. 4b O 66/11).

The latest news is that that on 8 November 2011 the Düsseldorf District Court decided to stay the infringement proceedings.

The question of whether the scope of protection of an SPC which has an active ingredient as its subject matter also extends to a combination of this active ingredient with a further active ingredient was regarded as decisive for the outcome of the infringement proceedings. Obviously, this question is precisely what the dispute between the parties is about. The court did not want to decide the question. It was considered necessary that the interpretation of Articles 5, 4 SPC Regulation be clarified by the Court of Justice of the European Union (CJEU). The Düsseldorf District Court referred the following question for a preliminary ruling to the CJEU:

"Must Articles 5, 4 of EC Regulation No. 469/2009 be interpreted to mean that the protection conferred by a certificate granted for a single active ingredient (in this case valsartan) extends to an embodiment that contains this single active ingredient in combination with another active ingredient (in this case valsartan + hydrochlorothiazide)?"

The Düsseldorf District Court also summarised the parties' pleadings, which differ to a certain extent from those in the parallel UK proceedings (where the High Court made a referral which is already pending before the CJEU as Case C-442/11)".

Thomas and Henrik have kindly sent us the order of the Düsseldorf District Court that the proceedings are stayed and referred to the CJEU, which readers can access here.

Valsartan: now it's Austria's turn

From Dr Ernst Tremmel (Partner, Wiltschek Rechtsanwälte, Vienna) comes new that, in the recent past, an Austrian first instance court has delivered its judgment in the main proceedings, holding that a Valsartan/HCTZ product infringes the mono SPC for Valsartan. He tells us that, though the judgment is not yet final, he thought it might be of interest both for us at The SPC Blog and for our readers, so he has kindly furnished us with (i) a short English-language summary of the decision and (ii) the anonymised German-language version of the judgment. It is is hope that, within the next few days, he will be able to send us also an unofficial English translation.

Thanks, so much Ernst, both for this information and for your offer to deal with any questions arising out of these attachments.

Valsartan: now it's the turn of the Cour d'appel de Paris

From our French friends Tougane Loumeau and Grégoire Triet (Gide Loyrette Nouel A.A.R.P.I.) comes news of more developments concerning the much-litigated Valsartan. These relate to an order of the Cour d'appel de Paris dated 16 September 2011, kindly translated into English here for the benefit of this weblog's non-French-reading followers. The facts are these:

Novartis owns a patent on medicinal substance A which expired on 12 February 2011 and an SPC on product A which will expire in November. Novartis currently markets a blockbuster drug composed of A + B (another active ingredient). Actavis took steps to put on the market a generic version of product A + B after the expiration of the patent but before expiration of the SPC. Novartis sued Actavis to obtain an interim banning injunction based on its SPC on A.

On three occasions, French courts had ruled that an SPC confers exactly the same protection scope as a patent so that a product A+ B was considered as infringing an SPC on A.

Now for the first time, the Cour d'appel has had a chance to consider the issue. This is how it ruled:

A product, as defined by the EU Regulation, is not restricted to an active ingredient. An SPC, within the meaning of Article 4 of the Regulation, protects a product and not an active ingredient. In this case, the SPC only protects Valsartan as a product. 

It follows that, although the medicinal product Valsartan + HCTZ contains the active ingredient Valsartan, it is not the "product" Valsartan within the meaning of the Regulation but another "product" comprising a combination of active ingredients. 

Any other interpretation would be contrary to the rule of non-aggregation of sources of protection laid down in Article 3 of the Regulation according to which an SPC cannot protect another product and there can by only one SPC per product per patent holder. The active ingredient HCTZ cannot be considered a mere additional ingredient in the same way as we might view a vitamin. 

Accordingly, it does not appear likely that any marketing and sale of a medicinal product containing Valsartan as an active ingredient will constitute an infringement and thus violate the rights owned by Novartis in this active ingredient until 13 November 2011. 

Actavis' interpretation of the EU Regulation and its objections to the injunctive and other relief requested by Novartis are genuine and have merit and, contrary to what the lower court summary hearings judge held, remove all obviousness from the allegation of infringement.

Thanks so much, Tougane and Grégoire, we do appreciate your kindness.

Novartis v Actavis and Valsartan in Düsseldorf: an update

On Monday 21 March, The SPC Blog posted this item on two decisions of the Düsseldorf District Court, issued on 8 March 2011, in preliminary proceedings which had been initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta. Our information was kindly supplied by Frank-Erich Hufnagel and Cordula Tellmann (Freshfields, Bruckhaus Deringer LLP, Düsseldorf) who acted for Novartis.

We have now heard from Henrik Holzapfel and Thomas Bopp(Gleiss Lutz), who acted for the two Actavis defendants. They comment as follows:

"We fully agree with Frank-Erich's and Cordula's report on the proceedings, but we thought it would be worth mentioning two additional matters which may or may not be interesting for your readers.

1. In the joint oral hearing for both proceedings, the court acknowledged that difficult questions of interpretation of the SPC Regulation were at stake. The issue was to be finally decided by the ECJ. In this context, it is particularly noteworthy that the court has made any enforcement of the preliminary injunctions dependent on Novartis providing securities (of EUR 12 million against Actavis Germany and EUR 3.6 million against Actavis Malta).

2. The court has ordered Novartis to file actions on the merits against Actavis Germany and Actavis Malta by 8 April 2011. In actions on the merits, a referral to the ECJ will be possible, other than in preliminary injunction proceedings".

Henrik and Thomas have also sent the blog this order of 17 March 2011, in which the Düsseldorf District Court ordered Novartis to file an action on the merits against Actavis Germany. In the parallel preliminary injunction proceedings against Actavis Malta there is an equivalent decision.

Coincidentally, The SPC Blog received -- in the same batch of emails and just a few seconds after that of Henrik and Thomas -- another email from Cordula accompanied by this English language translation of the decision of 8 March which was the subject of the earlier post.

The SPC Blog thanks all the attorneys involved for their willingness to share this information with our readers. For those of us with little experience of the manner in which litigation is conducted in Germany, it has been very helpful and instructive.

Valsartan: now it's the turn of Düsseldorf

The SPC Blog thanks Frank-Erich Hufnagel and Cordula Tellmann (Freshfields, Bruckhaus Deringer LLP, Düsseldorf) for drawing our attention to two decisions by the Düsseldorf District Court.  Both were issued on 8 March 2011 in preliminary proceedings which had been initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta. Frank-Erich and Cordula (who acted for Novartis in these proceedings) explain as follows:

"On 8 March 2011, in preliminary proceedings initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta, the Düsseldorf District Court held that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCTZ) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036).  However, in view of the pre-trial correspondence between the parties, there was no imminent threat as to an infringement of the underlying basic patent EP 0 443 983 B1. These decisions may be appealed.

The key legal question before the court was whether a combination product containing two active ingredients (in this case valsartan and HCTZ) would fall under the scope of a SPC for just one of those active ingredients, valsartan. The Court explained: 

"In view of the not very precisely phrased and thus not easy to understand wording of article 4 of the SPC Regulation, the legislative purpose of the limitation of the protection only to "the product covered by the marketing authorisation" is of key importance for the interpretation of this article."  

The Court then refers to Recitals 3, 6 and 7, 8 and 9 of the SPC Regulation and summarized them thus:

"The cited Recitals show that the Regulation aims at a de facto extension of the patent protection in order to achieve a compensation of the loss of effective patent protection ...

In view of this ratio of the SPC Regulation, the content of Articles 4 and 5 SPC Regulation and its relationship between each other must be understood as follows: Article 5 SPC Regulation concerns -- as is confirmed by its official title -- the effects of a certificate and stipulates that they are identical to the effects of the underlying basic patent. On the other hand the purpose of Article 4 SPC Regulation is to determine the object of these effects - i.e. the subject-matter. In this context, Article 4 uses three criteria: 

- First - and actually merely declaratory - it is clarified that the absolute limit is set by the scope of protection of the basic patent. 

- Then the product is identified in order to delimit it from other compounds which potentially are also encompassed by the basic patent. Here, Article 4 SPC Regulation does not - contrary to the view of the Defendant - aim for a limitation to the specific authorised medicinal product, as results from various passages of the SPC-Regulation which speak about the product identified by the marketing authorisation: Articles 8(1)(b) and (c), 9(3)(d), Article 11(1)(d), SPC Regulation. 

- Finally, Article 4 SPC Regulation stipulates a purpose-bound compound protection by limiting the subject-matter to the authorised uses (see Kraßer, § 26 A II, p. 586). This third criterion confirms that with regards to the understanding presented here Article 4 SPC Regulation is not redundant and cannot simply be replaced by a mere term extension for the basic patent. 

The limitation of the subject-matter of a certificate in Article 4 SPC Regulation as a whole has to be understood in a sense that it has the sole purpose to exclude an "over-extensive" protection: In case the basic patent protects further products or active ingredients which are not subject-matter of the certificate, it stipulates an exception from the principle of Article 5 SPC Regulation that the protection of basic patent and certificate are identical. When determining the subject-matter of the certificate the patent claims which possibly also protect further compounds fictitiously have to be regarded as if they only contained the active ingredient indicated in the certificate; Article 4 SPC Regulation thus leads to a hypothetical patent claim which is product and purpose related (see Benkard/Grabinski, PatG, 10th edition, § 16a, note 38). The compensation is not limited to an authorisation procedure for a specific medicinal product, but for the term since the filing of the basic patent during which a product according to the invention cannot be marketed (considering also a maximum term of 5 years since the certificate entered into effect, Article 13 SPC Regulation)." 

The Court also rejected Actavis' position that the purpose of an SPC was a reward for obtaining a marketing authorisation, pointing out that this approach would mean that "the compensation for loss of effective patent protection could be circumvented all too easily which would contradict the purpose of the SPC Regulation (see ECJ, GRUR Int. 2000, 69, 70 et seq. - Farmitalia)".

A copy of the German original of the decision against Actavis Deutschland GmbH can be accessed here. Frank-Erich and Cordula inform the blog that, possibly early this week, they might be able to provide us with a full English translation of the judgment.

Norwegian valsartan ruling: now in English too

Earlier this month The SPC Blog posted this information concerning the ruling of the Oslo District Court on 10 February that Actavis’ valsartan/HCTZ product infringed Novartis’ Norwegian process patent NO 304 023 for a route of synthesis for valsartan as well as SPC/NO 1998 024. The judgment, which is now under appeal, was handed down on 10 February 2011; it deals inter alia with the question of the scope of Novartis’ Norwegian SPC in relation to valsartan (SPC/NO 1998 024).

Gunnar Sørlie (Partner, Bugge, Arentz-Hansen & Rasmussen) has now kindly sent this weblog a transcript of the original decision (in Norwegian) together with an unofficial translation into English. The SPC Blog thanks him very much for his kindness.

Norwegian valsartan case goes on appeal

The SPC Blog has just learned this morning from Kaja Veel Midtbø (Wikborg Rein, Oslo) that the litigation in Norway in Novartis v Actavis concerning valsartan (noted here by The SPC Blog on 8 March) is to go on appeal.  The original judgment, from the Oslo District Court (10 February 2011) will be appealed by Actavis to the Borgarting Court of Appeal. There are two grounds of appeal -- the patent infringement issue in general and the issue specifically concerning the scope of the SPC.

Wikborg Rein (Ingvild Hanssen-Bauer) represents Actavis in this litigation.

Novartis v Actavis in Norway

"Novartis v Actavis: ruling on the merits confirms scope of SPC" is the title of this blog's first note from Norway -- and also one of the first full hearings on the merits of any litigation relating to Novartis’ compound valsartan. In this ruling the Oslo District Court held that Actavis’ valsartan/HCTZ product infringes Novartis’ Norwegian process patent NO 304 023 which protects a route of synthesis for valsartan. The judgment, handed down on 10 February 2011, deals inter alia with the question of the scope of Novartis’ Norwegian SPC in relation to valsartan (SPC/NO 1998 024).

The SPC Blog is grateful to Gunnar Sørlie (Partner, Bugge, Arentz-Hansen & Rasmussen, Oslo) for kindly providing this information. As Gunnar explains:

"On the question of whether the scope of the valsartan SPC covers Actavis’ valsartan-plus-HCTZ combination products, the court found as follows:

“The wording of SPC/NO 1998 024 is not restricted to mono products. The target molecule is drawn under the product designation “Valsartan”. This is an argument in favour of concluding that SPC/NO 1998 024 protects against infringement through the marketing of any form of valsartan.

The Court is of the view that valsartan is a “product” for the purposes of Article 1(b). Reference is also made to Stenvik (2006), p. 359, where it is assumed that a certificate will also protect against use of the active ingredient in combination products.

The Court therefore concludes that SPC/NO 1998 024 also protects against valsartan in combination products.”

The effect of the decision is that following the expiry of patent NO 304 023 on 18 February 2011, SPC/NO 1998 024 will continue to provide protection until 13 May 2011 for any valsartan-containing medicine in Norway if the route of valsartan synthesis infringes Novartis’ synthetic process claims. As a result of the decision, Actavis had to withdraw both its monotherapy and combination therapy valsartan-containing medicines from the Norwegian market with immediate effect".

Novartis v Actavis: preliminary injunction for Valsartan confirmed

The SPC Blog is grateful to David Por (Allen & Overy, Paris) for submitting the following note:

"Novartis v Actavis: French Court renders a preliminary injunction confirming the scope and effects of an SPC (Valsartan)

After the preliminary injunction rendered on 12 February 2010 enjoining Mylan and Qualimed from marketing a generic drug comprising Losartan and HCTZ on the basis of Du Pont's SPC granted for Losartan, the President of the Paris First Instance Court confirmed on 28 January 2011 that an SPC covering a compound (Valsartan in the present case) obviously prohibits the marketing of pharmaceutical products containing Valsartan alone or in combination with another active ingredient.

The French Judge carried out a combined reading of Article 4 (subject-matter) and Article 5 (effects) in light of the definitions given in Article 1 of the SPC Regulation: 

“Within the limits of the protection conferred by the basic patent (EP No. 0 443 983), the protection conferred by an SPC (SPC No. 97C0050) shall extend only to the active ingredient that is to say valsartan covered by the corresponding MA, for any use of the product as a medicinal product that has been authorised before the expiry of the certificate”,

and added that

"while Article 4 of the Regulation provides some limits to the effects of an SPC, once these are defined, the SPC grants the same rights as those conferred by the basic patent".

Having held that SPC No. 97C0050 has for its subject-matter the sole active ingredient valsartan, the Judge ruled as follows:

"[O]nce this SPC No. 97C0050 is defined, the rights conferred to Novartis are the same as the rights conferred by the basic patent, such that Novartis can oppose to any use of this active ingredient for the treatment of hypertension, alone or in combination with another active ingredient.


Any marketing of a medicinal product containing valsartan as an active ingredient therefore obviously constitutes an infringement, since it infringes the rights that the claimants hold on this active ingredient until 13 November 2011.


The obviousness of the infringement that would result from the arrival of the pharmaceutical products “valsartan hydrochlorothiazide Actavis 80mg/12.5mg” and “valsartan hydrochlorothiazide Actavis 160mg/25mg” before 13 November 2011 is therefore demonstrated".

This decision can be appealed".

You can read the French decision here and the English translation here.

Novartis/Teva settlement in Denmark: the terms

The SPC Blog thanks Mette Clausen Hygum (Plesner, Copenhagen) for letting us have the following note, the contents of which are self-explanatory:

The parties in the Danish case Novartis AG and Novartis Healthcare A/S v Teva Denmark A/S concerning the scope of protection of Novartis's SPC for Valsartan, have agreed to end the case on the terms proposed by the Danish Maritime and Commercial Court.

Following a preliminary injunction case against Teva concerning Novartis's patent covering (amongst others) the active ingredient Valsartan, Novartis filed a declaratory action against Teva claiming that Teva should acknowledge that Novartis' SPC for the active ingredient Valsartan not only protected products containing Valsartan as the only active ingredient but also products containing a combination of Valsartan and one or more other active ingredients.

Teva refused to give such acknowledgement and claimed that Novartis' SPC only protected products containing Valsartan and thus not Valsartan in combination with other ingredients.

Only a few weeks before the oral hearing in September 2010 Teva announced that for commercial reasons Teva would not market any products containing Valsartan before expiry of the SPC. The reason for the decision was, according to Teva, that the Danish Medicines Agency, following a re-evaluation of the reimbursement for the antihypertensive products acting on the renin system [1], had decided to remove the general reimbursement for various products, including products containing Valsartan and Hydrochlorothiazide.

Based hereon Teva claimed that the case should be dismissed as there was no actual commercial dispute between the parties.

The oral hearing was held on the 15 September 2010 and the case was afterwards ended in accordance with the proposal from the court, which reads as follows:

"In continuation of the hearing held on 15 September 2010, the Danish Maritime and Commercial Court held a deliberation on the merits of the case and, on that basis, requested the Parties to enter into the following Agreement, it being understood that the Danish Maritime and Commercial Court will close its file on receiving information that the Agreement be concluded between the Parties:

(1)           Teva Denmark A/S and all companies in the Teva-Group commit themselves to Novartis AG and to all companies in the Novartis-Group, not to produce, import or export, market, bring into circulation or in any way, whatsoever, use medicals containing Valsartan, alone or in combination with one or more other active ingredients, until the time where the Plaintiff’s SPC has expired, and in so far and for such time as this SPC is valid, including any period for which its validity may be extended on the basis of the Plaintiff’s application of 13 September 2010 or any other application  for extension that the Plaintiff might make at any later stage.

(2)           Teva must no later than on 6^th October 2010 pay to Novartis the costs of the case with 450,000 DKK. In the case of delayed payment, interest must be paid in accordance with Article 8 of the Danish Act on interests on delayed payments.

(3)           This Agreement enters into force immediately and is enforceable in accordance with the provisions of Article 478, Section 1, Number 2, of the Danish of Administration of Justice Act, so that it is immediately enforceable.

Done in Copenhagen this 21^st September 2010 as a part of the official records of the Danish Maritime and Commercial Court

For Novartis AG and all Novartis Companies                             

For Teva Denmark A/S and all Teva Companies"

---

[1]       The reason was that losartan was out of patent protection which is why several companies have launched generics at a price compared to that of the generic ACE-inhibitors.