INNsight article by Elisabeth Berthet-Maillols, June 2012

On March 21, 2012, the Paris Court of Appeal rendered a decision which seems to change the preliminary injunction landscape in favour of innovative companies.

In this case, Mylan and Qualimed had obtained their generic marketing authorization (MA) and the Registration on the generic list to be substitutable (“Répertoire des génériques”). They had also asked for their price from the French Authority dealing with the prices of health care products (Comité économique des produits de santé - CEPS). Moreover, Mylan and Qualimed had specified to this Authority that they could commercialize their generic without infringing Novartis’s Supplementary Protection Certificate (SPC), before the latter’s expiration.

It was under these circumstances that Mylan and Qualimed were sued by Novartis through a preliminary injunction.

By order dated 21 June 2011, the French Paris Court rejected Novartis’s request on the ground of the dispute regarding the lack of inventive step.

However, the Paris Court of Appeal reversed this Order and pronounced an injunction.

The Court of Appeal firstly noted that the granting of the generic MA and price and the registration of the generic on the refundable medicines list are allowed before the expiration of the patent / SPC and cannot be characterised as imminent infringement.

However, the decision put forward the fact that the generic companies had told the CEPS that they could commercialize their generic before the expiration of Novartis’s rights and concluded on this ground that the infringement was imminent.

This decision is, on this point, in line with the previous Losartan decision (Du Pont de Nemours and al. v/ Mylan et Qualimed, TGI Paris, No. 10/51453, 12 February 2010, available on : http://www.eplawpatentblog.com/2010/April/dupont_merck_c_mylan.pdf confirmed by Paris Court of appeal, 15 March 2011, available on:
http://legimobile.fr/fr/jp/j/ca/75056/2011/3/15/10_03075/).

Regarding the argument put forth by Mylan and Qualimed in defence that the SPC was void (because the patent was void), the Court of Appeal stated that “the judge's assessment in the course of a preliminary injunction must not lead him to determine the seriousness of the main action, i.e., the nullity action” and that the measures of article L. 615-3 IPC are only subordinated “to the likelihood of infringement and not to the likelihood of validity of the patent at issue”. Moreover, the Court of Appeal ruled that “before the judge dealing with a preliminary injunction, only the obvious nullity of the title can make the imminent infringement to these rights unlikely”.

If this position of the Court of Appeal is followed by further decisions, the defence of a generic company in the course of a preliminary injunction is going to become difficult. We can imagine more precisely that only prior arts able to nullify – beyond a reasonable doubt – the patent for lack of novelty could be put forward successfully by the generic company.

It is worth noting that such a position contrasts with previous case law and notably with the above-mentioned Losartan case where the judges had ruled that in order to decide whether they should pronounce the interim injunction they have to “appreciate the seriousness of the contestation” on the validity of the title and on the infringement.

The  Valsartan decision (Novartis c/ Actavis, Paris Court of Appeal, 16 September 2011, available on :
http://www.eplawpatentblog.com/2011/November/2011-09-16_CA_Valsartan_Novartis_Actavis.pdf) had also decided in the same direction and had rejected the preliminary injunction on the ground of the seriousness of Actavis’s contestation.

It is also important to note that, in fields other than pharmacy, in order to refuse the preliminary injunction, case law requires the mere fact that the validity of the patent is challengeable (see notably Paris Court of Appeal, 18 May 2010, which confirmed the previous Order refusing to grant the preliminary injunction since “the protection of the patent at issue is liable to be challenged, since the patent validity could be put into question before the judges on the merits regarding the inventive step” ; see also Paris Court, 19 February 2010, which even went so far as to adopt a tough position towards the patentee stating that the likelihood of the infringement provided by article L. 615-3 CPI implied that the title according to which the claimant bases its claims is not challengeable.

In addition, the Court of Appeal seems to have reproached Mylan and Qualimed for not having “cleared the way” by launching a nullity action against the SPC further in advance so as to obtain a decision on the merits regarding the nullity of the SPC before launching their product.

Finally, it is worth noting that the Court of Appeal has ordered the recall of the generic product from the distribution channel, which is a very harsh measure against the generic companies.

The future will tell if this decision will remain isolated or if the generic companies have to fear a toughening of the Courts towards them.