Novartis v. Teva: Patent rivalries meet again, this time on a non-negligible injunction.

On June 7, 2018, the Paris Court of First Instance (Judge Marie Courboulay) issued a preliminary injunction against Teva's generic version of Novartis' anti-hypertensive drug Exforge (valsartan/amlodipine) on the basis of Novartis’ European Patent EP 2 322 174. The dispute was subject to parallel proceedings in several EU countries. In fact, an injunction was issued by the Oberlandesgericht Düsseldorf on 14 December 2017, but an injunction was refused by the courts in Spain and Switzerland. Teva decided after these earlier rulings not to proceed with the planned commercialization of the generic version in Austria and Finland.

The patented pharmaceutical. EXFORGE holds a considerable market share with a world turnover in 2016 of $926 million dollars,  of which the amount of $53, 806, 874 was attributable to revenues in France. The patent expires on  July 9, 2019. Already on October 16, 2017, Novartis discovered that Teva was commercializing generic versions of the said pharmaceutical in France. Some months later, in February 2018, Teva held as much as 42% of the market.

Novartis sued for the infringement of claims 1 and 2 of the EP 2 322 174, while Teva counterclaimed alleging the invalidity of the patent based on double patenting, insufficiency, extension and obviousness. In its 42-page ruling, the Court reviewed and one by one rejected all of Teva’s invalidity arguments(the same arguments had been made but were rejected in the EPO opposition proceedings).

One central issue on the invalidity issue related to the sufficiency of disclosure. Teva claimed lack of sufficiency of disclosure based on the fact that the dosages applied in the clinical trials on rats were not sufficiently specified as well as because the exact dosages to be administered to humans were equally unclear. The Court clarified that the patent in question does not protect a second medical indication of a known substance, but rather the combination of two known substances with known medical indication. The inventive character of the specific patent lies with the clinical superiority of the combination itself. The Court concluded further that clinical trials on rats were sufficiently documented and reported; further, it is a well-known fact to the man skilled in the art that the dosages administered to humans are not the same as those administered to rats.

In its ruling,  the Court ordered Teva to pay Novartis more than €13,000,000 as an advance on damages (€5,846,628 to Novartis Pharma AG, the Swiss company which owns the patent, and €7,308,285 to Novartis Pharma SAS, the French licensee). The ruling provides a prohibition on further production of the generic medicines and imposes on Teva the obligation to provide Novartis with information concerning the names and addresses of those involved in the production of the generics, information on the quantities produced, as well as to submit all relevant documentation related to the acts of infringement.

This is probably the highest amount ever awarded by a French court as an advance payment on damages in a patent infringement case. Query whether an award of such size on connection with the grant of a preliminary injunction May lead generic companies to think twice about their product strategy.

By Frantzeska Papadopoulou

Novartis v. Teva: Patent rivalries meet again, this time on a non-negligible injunction. Novartis v. Teva: Patent rivalries meet again, this time on a non-negligible injunction. Reviewed by Frantzeska Papadopoulou on Friday, June 29, 2018 Rating: 5

1 comment:

Where is inventive step? said...

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 in the decision 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 further comment: should a physician prescribe separately Valsartan and Amlodipine he would not be an 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. It seems a bit far away from common sense not to check whether the combination pill has an effect an effect on blood pressure, and merely be satisfied by just checking whether they interfere together.

The OD maintained the patent, but this decision has been appealed and it is far to early to have an idea of the outcome as the proprietor has not replied to the appeals and the BA not scheduled an OP.

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

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