Polish your IP

Catch me if you can – preliminary injunction practice in Polish life science sector

The article was published in Managing Intellectual Property IP Focus, Life Sciences, in October 2011

 Polish life-science-related patent litigation has been on the increase for some years. In this time the courts have tackled a number of substantive legal issues such as equivalents, contributory infringement, validity problems, damages for wrongful preliminary injunctions, etc. The outcome of proceedings is now much more predictable than 10 years ago. The enforcement system is longer inexperienced and would better be termed in transmission, with some aspects quite advanced and others lacking. The area in which significant progress is still required is length of proceedings. Whereas trade mark or unfair competition cases tend to proceed more smoothly than a decade ago, patent enforcement with its reliance on court-appointed experts and complex factual-technical patterns still takes a while. The outcome of a large market and lengthy main action proceedings is the increased importance of preliminary measures.

 Contrary to the main action, preliminary measures are imposed quite swiftly. There is, however, a great specificity to the way they are handled making the factors relevant quite different from main EU jurisdictions. To play the patent litigation landscape it is important to understand these factors in order to use them to your advantage or minimize the negative impact they can have on you.

 This article is not intended to fully analyze particular provisions on preliminary injunctions under the Polish law. The purpose of this article is rather to indicate some general directions which can be expected on the part of Polish judicial bodies, when requesting injunction for the duration of the patent infringement proceedings.

 General issues

 The statutory criteria for obtaining a PI order are: (a) likelihood of claims being secured and (b) legal interest in obtaining a preliminary injunction. The level of proof in PI proceedings is much lower than in case of the main proceedings. The party seeking infringement is only obliged to make the facts supporting a PI action probable.

 A PI motion can be filed and achieved during the pending trial or prior to filing the main action. A motion should be decided promptly, not later than within 7 days of its submission. The above terms are not binding on a court, however, they are usually abided by judges and decisions are issued in a matter of days, sometimes weeks.

 Generally, preliminary injunction motions in Poland are decided ex parte. In some cases, it can happen that a judge handling the matter will organize a hearing instead of deciding the motion at an in camera session (e.g. it can happen when a judge has serious doubts with respect to facts supporting the injunction request). These are, however, relatively rare situations.

Once a decision on preliminary injunction is issued, parties to the proceedings are entitled to appeal the court’s decision to the court of higher instance. The deadline for filing the appeal is 7 days from official receipt of the injunction order. In the appeal the defendant party can also apply for a stay of enforcement of the court decision.

 Where the preliminary injunction order is granted but the claims are subsequently dismissed or the entitled party decides to withdraw the court action before the verdict, the alleged infringer is entitled to demand compensation for the damages arising from the preliminary injunction granted.

 Expert opinion

 One of the main evidence sources to be used in PI proceedings is an expert opinion (usually even more than one) making probable the patent infringement. Judges in Poland have no technical background so that they are unable to assess the likelihood of patent infringement on their own. For that reason, in the vast majority of cases they defer to private expert opinion filed with the motion, only assessing whether the opinion appears reliable.

 As it was mentioned above, the preliminary injunction proceedings are usually ex-parte. However, sometimes it happens that the defendant becomes aware of the PI motion filed (usually by systematic monitoring of court dockets) and manages to take part in the proceedings. In such a situation, the defendant can present the court a contrary expert opinion confirming lack of patent infringement. The fact that a decision is usually taken at an in camera session does not mean that the party against which the motion is directed cannot intervene in the proceedings. This only means that a judge will not communicate the defendant party that such a motion has been filed. However, if the obliged party manages to find out that the proceedings are pending, it can produce its own submission and evidence to refute the motion and the judge will be obliged to consider them.

 Tackling-the-“two contradictory opinions” problem

 The above tactics usually decreases the chances of obtaining a PI order. In the situation where a court has “two contrary opinions” which it cannot reconcile, it usually comes to the conclusion that this raises sufficient doubts and the claims are not made sufficiently justified to use such a far-reaching remedy like a preliminary injunction. An analogous approach is often taken by courts of higher instance, at the stage of appeal from the PI, which also do not analyze the technical aspect of infringement case in details. When faced with two contradictory opinions (eg. on the issue of equivalency) the patentee has to be extremely diligent in choosing the arguments and the strategic approach to still prevail. Filing further opinions usually doesn’t work, resulting in similar response and a subsequent inflation of the opinions, which the courts have been known to indicate as adding to their dubts. It is better for the patentee to try and keep things simple attempting to disqualify the adverse opinion on formal or legal (wrong question asked) grounds.

 The alleged infringer

 Another difficulty to be taken into account is the necessity to determine who a PI motion should be directed against. This can be easily illustrated by the example of pharmaceutical patent disputes.

 It is common that pharmaceutical concerns have complex organizational structures which divide regulatory, marketing and sales competences among different, legally separated, entities. This structural organization is usually difficult to assess by third parties. An effort needs to be made to identify the defendant as a PI, even if granted may prove useless.  

 Threat of infringement – MA holder as defendant?

 Usually, there is no difficulty to evidence who is the marketing authorization holder of an infringing medicinal. Indeed, most legal actions are taken against that entity. However, it is worth remembering that marketing authorization holder is not always the entity which sells the products and first of all, that the Bolar (very broad in Polish law) exception allows pharmaceutical companies to file and obtain a drug registration before the expiration of the existing patent term. PI action can theoretically be based on threat of infringement, but the practicalities of showing such threat are daunting. Therefore, PI actions are rather not recomended (at least) some declaration of intent to produce, distribute or import patented pharmaceutical products is made. This requires careful market monitoring and creative work with whatever tiny hints of evidence one is capable of obtaining.

 Contributory infringement

 Under certain circumstances , the claim should better be based on the of contributory infringement concept. Admittedly, the Polish Patent Law only regulates direct patent infringement. However, there are arguments to derive the liability of a contributory infringer from the general civil rules dealing with tort liability of an accessory.

 Urgency

 Under the Polish law urgency is not considered a statutory condition for granting preliminary injunction as it is, for example, in German jurisdiction. Nevertheless, it is still important to undertake legal steps in the most urgent manner possible as this criterion might be assessed by Court together with the condition of legal interest in the injunction being granted. At the very least urgency have some bearing on the judge’s approach to the case and eg. likelihood that he will decide against deciding ex parte and serve the request onto defendant.

 Patent validity

 Patent validity issues are examined under separate proceedings before the Polish Patent Office or the European Patent Office and the general rule is that a patent is enforceable as long as a final decision on invalidation of the rights will be issued. The validity defense is thus not available in court. Indeed this division is so strong that even in preliminary injunction proceedings the courts usually refuse to consider invalidity defense. This greatly strengthens the patentee’s position but requires extreme efforts on behalf of the defendant in particular when making a squeeze-type argument.

 Forum shopping

 All of the above factors vary substantially between courts in various locations. Eg. the courts in the west of Poland have been found to take a particularly stringent position on the validity and infringement separation, this is further complicated by still different approaches to stay proceedings pending invalidity. The possibilities of forum-shopping also have a specific character as the courts in general try to avoid jurisdiction rather than embrace cases. Coupled with strict requirements to show cause for action (see threat of infringement above) establishing jurisdiction may require careful consideration.

Aurhors: Agnieszka Galazka, Marek Lazewski

For any questions on this article, contact: Agnieszka Galazka, Marek Lazewski

Author: admin