FR – Novartis v. Teva – Valsartan / Amlodipine – € 13,000,000 advance on damages

Posted: June 11th, 2018

Preliminary injunction issued by a French court against Teva’s generic of Novartis’ Exforge anti-hypertensive drug (valsartan/amlodipine) plus €13,000,000 awarded as an advance on damages

On 7 June 2018, the tribunal de grande instance of Paris (Judge Marie Courboulay) issued a preliminary injunction against Teva’s generic of Novartis’ anti-hypertensive drug Exforge (valsartan/amlodipine) on the basis of Novartis’ EP 2 322 174.

The court order mentions that the oppositions against this patent were rejected by the opposition division of the EPO in December 2017; it also mentions that in parallel proceedings, an injunction was issued by the Oberlandesgericht Düsseldorf on 14 December 2017, but was refused in Spain and Switzerland.

The 42-page judgment reviews in detail and rejects all the invalidity arguments raised by Teva (double patenting, insufficiency, extension, obviousness).

As Teva’s generic has been put on the market in October 2017, the court orders Teva to pay Novartis more than €13,000,000 as an advance on damages (€5,846,628 to Novartis Pharma AG, the Swiss company who owns the patent, and €7,308,285 to Novartis Pharma SAS, the French licensee).

This is probably the highest amount ever granted by a French court as an advance payment on damages in a patent infringement case.

A copy of the decision (in French) can be read here.

Pierre Véron, Honorary President EPLAW

4 Responses

  1. Attentive observer says:

    To be correct the title should not be” Novartis v. Teva / Valsartan” but “Novartis v. Teva / Valsartan + Amlodipine” as Valsartan exists already as generic and is distributed under the generic name “Valsartan” 80 or 160 mg by various manufacturers.

    I am not a specialist of French legislation, but giving in a primary injunction 13.000.000 € of damages for a patent which will fall in the public domain in July 2019 seems a priori a bit high, even if the alleged infringing products are what can be called a block-buster.

    That a fee of 40% has been chosen to the benefice of Novartis in order to compensate for the commercial and the moral prejudice is surprising, if on the other hand the judge considers that the profit margin for TEVA was determined to be 50%. Those figures might be correct, but are nevertheless surprising.

    Another reason is that the decision is not a decision on the substance, but purely provisional taken by a single judge.

    A last question/comment: if a physician prescribes separately Valsartan and Amlodipine would he also be infringer? It seems from the decision that those products are already known for themselves and could be combined, albeit not in a single pill, see page 31 of the decision. To merely state that the only purpose was to determine if the association is absent of side effects and that no effect on hypertension was sought for seems a bit short for a convincing argument.

    The Paris TGI has often delivered surprising decisions, which led to some eyebrows raising, this is clearly another one of this kind.

    • Sandeep says:

      When a doctor prescribes the two drugs separately, there won’t be a patent hurdle. Please note – the claims (at least English language claims) require that the 2 drugs be in a single, fixed dose composition.

      • Attentive observer says:

        Dear Sandeep,

        I fully agree with your reply. This shows to me that some reasonable doubts can be raised in respect of inventive step when the two components are merely brought into one single pill.

        If the combination therapy with two separate components is absent of side effects, can it really be inventive to bring them in the same pill?

        I am not a pharma specialist, but I would need really convincing arguments to change my reservations.

        • Sandeep says:

          Dear Attentive observer:

          I am not well versed with French language or French patent law principles. Additionally, due to my professional background, I would be deemed as a ‘biased observer’.

          Having said that, from what I read of the above case here and on the IPKAT blog, there are a couple of things that stand out – a) The EPO also had a similar decision upholding the patent and b) These high damages at this stage (in advance) seem to be surprising to even FR practitioners.

          For your direct query of convincing arguments, it may make sense to read the EPO decision.

Leave a Reply