yellow-pills-batching
1 May 2010EuropeStéphane Agasse

New rules for French patents

Changes to the IP law

Article L.615-3 CPI

Before the entry into force of Directive 2004/48/ EC, Article L.615-3 CPI of French IP law said: “Where proceedings are brought before the Court for infringement of a patent, the President of the Court, acting and ruling in summary proceedings, may provisionally enjoin, under penalty of a daily fine, the carrying out of the allegedly infringing acts (…) if the substantive proceedings appear well founded and are instituted within a short time of the day on which the patentee became aware of the facts on which the proceedings are based.”

Under this law, a preliminary injunction proceeding was only available to the patentee after the introduction of an action on the merits. Consequently, the preliminary injunction proceeding was ‘derived’ from the action on the merits, so that both legal actions were to some extent ‘connected’.

In addition, the same judge was in charge of granting injunctions and dealing with the substance of the case, and one of the main requisites for granting an injunction was that the main action appeared to be well funded. Accordingly, if an injunction was requested, the judge started by examining the potential validity (or invalidity) of the patent and the seriousness of the action.

Current Article L.615-3 CPI

Following the implementation of Directive 2004/48/EC, Article L.615-3 CPI was amended and now stipulates:

“Any person having the right to sue for infringement may bring summary proceedings before the competent civil court in order to have ordered, if need be under penalty of a daily fine, any measure intended to prevent an imminent infringement of the rights conferred by the property right or to stop the continued carrying out of allegedly infringing acts, against the alleged infringer or intermediary agents whose services the latter uses.

Upon request, the competent civil court may also order any urgent measure, when circumstances command that such measures should not be taken in the presence of both parties, in particular when any delay might cause irreparable damage to the plaintiff. Ruling in summary proceedings or upon request, the court may only order the requested measures if evidence, reasonably accessible to the plaintiff, credibly establish that his rights are being infringed or that such infringement is imminent.

The new Article L.615-3 CPI therefore makes new ‘weapons’ available to patentees (e.g. originator companies) to prevent the launch or to stop the commercialisation of a product (e.g. a generic medicine). In particular:

  • A preliminary injunction can be requested before the introduction of a legal action on the merits
     
  • A preliminary injunction can also be obtained against an ‘imminent threat’ to the patent protection (until now, the grant of a market authorisation or the fixing of a medicine's price were considered to be insufficient per se to demonstrate an imminent threat)
     
  • Under exceptional circumstances, an ex parte preliminary injunction can be requested: according to our opinion, it is unlikely that this could be successfully used in the pharmaceutical domain
     
  • The notion of ‘well founded substantive proceedings’ has disappeared.

We are of the opinion that a strict application of new Article L.615-3 CPI without any control of the validity of the patent would not be in line with the purpose of the directive. Indeed, this directive aims to defeat counterfeiting and piracy. And some measures provided by the directive, such as ex parte interim injunctions, provide IP owners with new means of effectively enforcing their exclusive rights.

“We remain convinced that the new law will change the approach adopted by judges to grant a preliminary injunction and that unless very clear evidence of possible patent invalidity is submitted, discussion will now focus more strictly on the alleged infringement”

This is of particular relevance in sectors such as luxury goods. However, it is not transposable to all sectors: for example, in the pharmaceutical area, there is very rarely counterfeiting, piracy or forgery; instead, more ‘conventional’ infringement occurs, resulting in the ‘normal’ or usual controversies about the scope or validity of a patent of interest.

Consequences

As in most of Europe, the French public has favourably greeted the enactment and transposition of European Directive 2004/48/EC into its national laws.

For the past 20 years, it has been unusual to grant preliminary injunctions in French patent litigation (on average, there has been one each year). Since the implementation of Directive 2004/48/EC, the number of granted injunctions has drastically increased.

The first French decisions showed that certain courts were more inclined to strictly apply new Article L.615-3 CPI and to abandon any preliminary analysis of the patent validity. Only the question of likelihood of infringement was discussed. Before the implementation of the new law, the situation was different, since validity of the patent had to appear ‘reasonable/serious’ to the judge before an injunction was granted.

The first significant decision in the pharmaceutical area was rendered by the Court of Lyon on July 21, 2008 (Mundipharma Laboratories GmbH v. Mylan SAS). In this decision, the judge adopted a strong position, considering that the validity of the patent prevailed and that only the likelihood of infringement had to be examined.

Based on this interpretation of new Article L.615-3 CPI, the judge pronounced a preliminary injunction based on an imminent threat in order to prevent the launch of a potentially infringing generic compound.

A second decision was rendered by the Court of Strasbourg on March 10, 2009 (SAS Laboratoire Negma v. SAS Biogaran) in which the judge took an even stronger position. In this case, a nullity action had been initiated by the generic company before the Court of Paris prior to the launch of its product.

Following the introduction of the product to the market, the patentee requested a preliminary injunction against the generic company before the Strasbourg Court. That court decided to ignore the pending action before the Paris Court and considered that the validity of patent prevailed, acknowledged the likelihood of infringement and ruled that the generic company should withdraw its product from the market.

However, these two decisions may prove to be rare examples. The Paris Court has decided to adopt a more pragmatic approach in its recent decisions by conducting a preliminary analysis of the validity of the patent before pronouncing a preliminary injunction.

Conclusion

As no judgments have been rendered by the Supreme Court on the interpretation of new Article L.615-3 CPI, it is impossible to predict how the courts will finally apply it.

In addition, it is likely that the European Court of Justice (ECJ) will have to take a decision on the matter to standardise the application and understanding of Directive 2004/48/EC by national jurisdictions within Europe.

Despite this new situation, it is nevertheless already clear that the number of requests for preliminary injunctions lodged (and obtained) by originator companies will continue to increase in the near future and that the generic companies will need to adapt their strategies for preparing product launches.

We remain convinced that the new law will change the approach adopted by judges to grant a preliminary injunction and that unless very clear evidence of possible patent invalidity is submitted, discussions will now focus more strictly on the alleged infringement. We also think that the French judges will relax and stick to the recent decisions of the Paris Court.

The fact that all patent litigations have now been allocated to the Paris Court should lead to less disparity in the criteria applied for granting or refusing a preliminary injunction and avoid any ‘forum shopping’ in the choice of jurisdiction.

Stéphane Agasse is a French and European patent attorney at Germain & Maureau. He can be contacted at: stephane.agasse@germainmaureau.com