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Friday 14 January 2011

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 6th 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 21st 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.


Anonymous said...

Some questions for either of the parties, their lawyers, anyone else involved, or the wider "SPC Community":

(1) From the terms of the settlement as posted, this appears to be a Denmark-only resolution. Is this assumption correct?

(2) In the earlier SPC Blog post of Monday 6 December 2010, referring to the Novartis attempt in the UK (ultimately unsuccessful) to piggy back on the ECJ references on the other combination SPC cases, there was reference to other European litigation. ("Teva was suing Novartis in Italy, Belgium and the Netherlands, alleging that Novartis's SPC for a combination of Valsartan and hydrochlorothiazide was invalid since the product in question was not protected by the basic patent -- thus also raising a question under Article 3(a). There were also proceedings in Belgium in which it was argued that a generic combination product could not infringe the SPC for Valsartan alone"). Have such cases also settled, as part and parcel of the Danish settlement, or are they ongoing?

(3) Why did the Danish Agency have a volte face as regards its re-imbursement of the Valsartan + HCTZ product? A unilateral decision by the Danish Agency on, or was this prompted by someone?

Manos Markakis said...

On the 2nd question of Anonymous:

(2) “and in so far (…) as this SPC is valid”. The insertion of the said term in Teva’s cease and desist undertaking leaves open the possibility for Teva to challenge the validity of the Valsartan SPC and/or its basic patent in Denmark or elsewhere.

In particular, the said condition serves as a ‘reservation of rights’ in so far as validity issues are concerned, including the crucial question under Article 3(a) pending in Italy, Belgium and the Netherlands (pursuant to the earlier SPC Blog post of Monday 6 December 2010).

Accordingly, it would be interesting to know whether the Danish settlement was actually extended to all other cases pending across Europe or not.