Interim injunctions against pharma patent infringement
The patent system gives innovators a monopoly right - a right which in the life science and pharmaceutical sector can be extremely valuable. For a blockbuster drug, annual revenue of $10 billion is not unusual and it is perhaps unsurprising that a manufacturer will go to some lengths to enforce their patent rights protecting it. One immensely powerful tool for this purpose is the injunction, which if deployed correctly, can stop a potential infringer in their tracks.
Although the Enforcement Directive (2004/48/EC) makes interim and final injunctions available across Europe, the question of whether one is granted remains discretionary and a question of national law. In the sections below, our European offices summarise some of the key issues and developments as to how applications for interim injunctions are handled by their national courts.
In Austria, the grant of interim injunctions are decided on the merits and such injunctions are relatively common, possibly due to prima facie evidence being sufficient and the courts being prepared to deal with interlocutory issues on the basis of the senates' (the lay-judges') own expertise. As Rainer Schultes of the Vienna office notes,"due to the Courts’ technical expertise, not even questions of equivalence and obviousness are per se excluded from preliminary proceedings".
Furthermore, some of the factors which go against the grant of an interim injunction in other jurisdictions have less influence in Austria. For example, "the balance of convenience" is not an established criterion as the payment of damages is never considered an adequate remedy for IP infringements.
Outside of the life-science sector, the UK courts are reluctant to grant interim injunctions as they are considered to be a draconian remedy. As a result, the threshold to pass before an interim injunction is granted is relatively high, and one will only be granted if all the factors set out in the American Cyanamid case (the legal test that is usually applied) are met, that is (i) there is a serious question in issue, (ii) damages are not an adequate remedy for the patentee and (iii) taking all the circumstance into account, the balance of convenience lies in favour of granting an interim injunction.
This reluctance to grant interim injunctions is arguably reversed in life-science patent cases and pharmaceutical patent cases in particular. This is because since SmithKlineBeecham -v- Apotex in 2002, there has been very clear judicial guidance that an alleged infringer in the pharmaceutical sector should "clear the way" of any blocking patents prior to entering the market. The traditional view is that an unauthorised entrant onto the market can cause significant and irreparable damage to the innovator's market where products are typically marketed on an exclusive basis and at a significant price premium.
Although this view may have softened in recent years, as particularly exemplified by the Modafinil case (Cephalon & Ors v Orchid & Anor  EWHC 2945 (Pat)) in which failure to clear the way and arguments of irreparable damage to market were not effective, the view is still that the UK courts are ready and willing to grant injunctions in this sector to protect the patentee.
Recently, in Merck Sharp Dohme Corp v Teva Pharma BV  EWHC 627 (Pat), the Patents Court even ordered a quia timet injunction against the sale of generic efavirenz (i.e., before the efavirenz had even entered the market). This was, however, granted in narrow circumstances where the court drew inferences about Teva's intentions from the fact that they obtained a marketing authorisation for efavirenz a little over two years before SPC expiry, and where the defendant refused to disclose its marketing intentions in correspondence. The fact that Teva had launched atorvastatin at risk on an earlier occasion also weighed in favour of the conclusion that pre-patent expiry launch was intended.
If a patent is valid and infringed and the defendant cannot rely upon a legal defence such as a license agreement, German courts always grant a permanent injunction as a standard remedy. To make matters worse for defendants, infringement and validity are dealt with in separate proceedings (bifurcated system). Because infringement proceedings are about one year faster than proceedings on validity, injunctions can be granted long before the defendant has a chance to present invalidity arguments and get the injunction lifted. Infringement courts have a discretion to wait for the outcome of proceedings on validity, but are very reluctant to do so.
The German courts' approach to interim injunctions in general focuses more on the merits of the case itself than on its economic impact. German courts are also willing to grant interim injunctions if they are convinced that a patent is valid and infringed, and the patentee acts without undue delay. Interim injunctions proceedings are dealt with in a mini trial that takes 6-8 weeks and is entirely independent of the proceedings on the merits.
In interim proceedings, validity and infringement will be reviewed by the same court and the burden of proof for validity is with the patentee. Usually, only patents that have survived contradictory proceedings (oppositions or nullity actions) are a suitable basis for an interim injunction. However, in cases dealing with a generic launch in Germany the Düsseldorf court has recently applied a different, more generous standard. Even if the validity of the patent is unclear, interim injunctions are possible (even ex-parte), if the balance of convenience is in favour of the patentee, which is – according to the recent case law of the Düsseldorf Court - usually assumed in cases of a generic launch. Further, in cases of patent infringement at trade fairs or early entry of generic drugs in the German market, German courts may even grant interim injunctions ex parte, i.e. without oral hearing.
In this patent-friendly environment, the launch of new products in Germany should be prepared by patent searches. The recent case law also suggests that generic launches in Germany should be prepared by clearing the way actions against critical patents to be filed about 24 months prior to the intended launch.
In France, interim injunctions may be granted if it can be shown that there is a likelihood of patent infringement or that such infringement is imminent (Article L. 615-3 of Intellectual Property Code). In general, the courts require evidence of infringement (or intent to infringe) before granting an interim injunction although it has been held that life-science companies merely doing acts to prepare for launch post-patent expiry (for example, obtaining regulatory approval before patent expiry) is not sufficient to show an intent to infringe during the patent term.
As to the substantive examination of the patent in question, the French courts will conduct a preliminary assessment of the patent's validity and also consider whether there are any serious arguments raised by the parties on this issue.
If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.
Saufung is an associate in the Intellectual Property department based in London.
Nigel is a partner in the Intellectual Property department based in London.
Dietrich is a partner in the Intellectual Property department based in Munich.
Christoph is a partner and Head of Patents (Germany) based in our Munich office.
Evelyne is a partner and Head of Antitrust and Business Law (France) based in our Paris office.
"After some 40 years of efforts, we now appear to be close to having a Unitary Patent and Unified Patent Court (UPC) in Europe. The Unitary Patent will have unitary effect in all EU member states (except Spain and Italy) and the UPC will have exclusive jurisdiction over issues of infringement and validity of Unitary Patents and those European Patents that have not been opted out of the UPC system."
"Although the Enforcement Directive (2004/48/EC) makes interim and final injunctions available across Europe, the question of whether one is granted remains discretionary and a question of national law."