On 7 June 2018, the Paris Court of First Instance issued a preliminary injunction against T’s generic version of N's blockbuster drug Exforge.
Exforge, which contains a combination of valsartan and amlodipine, is used to treat high blood pressure. N.'s Exforge holds a considerable market share with a worldwide turnover of $1,047bn in 2015 and $92m in 2016. In France, revenues generated by the sale of Exforge amounted to €53,806,874 in 2016 and €65,512,759 in 2017.
N. is the owner of the European patent EP 2 322 174 (EP’174), filed on 09 July 2009, and entitled “Combined use of valsartan and calcium channel blockers for therapeutic purposes”. In particular, EP’174 covers a combination composition which is in one fixed combination combined unit dose form comprising valsartan and amlodipine.
T. obtained a marketing authorisation for a generic version of Exforge on 07 June 2017 under the abridged procedure. T.’s generic version of Exforge was then registered on the French register of generic groups on 18 September 2017. Thereafter, T. obtained a price for its generic speciality and a rate of reimbursement from the Economic Committee for Health Products.
On 16 October 2017 N. was informed of the launch by T. of a generic version of Exforge and sought a preliminary injunction against T.
In its 42 pages order issued on 07 June 2018, the Paris Court of First Instance first carried out an in-depth review of the invalidity arguments raised by T. (double patenting, insufficiency of disclosure, obviousness, extension) and rejected all of them. The court, then, issued a preliminary injunction blocking T. from selling the generic version of Exforge. In addition, the court ordered T. to pay N. more than €13m as an advance on damages for patent infringement.
On the one hand, T. has been ordered to pay more than €5m to the patentee. The court found that the turnover derived from the sale of T.'s generic version in France, between 16 October 2017 and the date of the decision hand down, amounted to €14,616,571. Then, the court applied a royalty rate of 40% to reach the amount of €5,848,628. On the other hand, T. has been ordered to pay €7,308,285 to the licensee, by reference to the loss of profits suffered by the licensee. The court also ordered the seizure of stocks of the generic products in the French premises of T.
To the best of our knowledge, this is the highest amount ever awarded by a French Court as an advance payment on damages in a patent infringement case. This decision is fully in line with the upward trend in the amount of damages awarded by the French Courts to the patent holders. However, such a trend may lead generic companies to think twice about their launch at risks strategy.
This trend towards higher damages awarded in patent infringement cases fits with another current trend: in the past few years the French Courts have tended to increase the amount of attorneys’ fees to be reimbursed by the losing party in patent cases. For instance, on 29 June 2018, the losing party has been ordered to pay €450,000 to the prevailing party as reimbursement of legal fees (which is probably the highest amount ever awarded).
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