Litigation Portal: What can the producer of an innovative medicine do if it finds out that a competitor is marketing a generic drug that infringes its patent?
Joanna Krakowiak: Innovative firms typically monitor the market and discover fairly early that generic manufacturers are working on a copycat drug. Obviously, it is permissible to market generic drugs, but only so long as they do not violate the Polish Pharmaceutical Law or a patent held by an innovative firm.
When I mention the Pharmaceutical Law, I have in mind data exclusivity, which may be defended before the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Starting 1 May 2011, the previous six-year period for data exclusivity was adjusted to meet the requirements of EU law, and now the formula for years of data exclusivity and market exclusivity is 8+2+1. After the end of the administrative protection period, any disputes between innovative firms and generic firms will typically move to the arena of patent law.
If the innovative firm has well-founded suspicions that a generic manufacturer is marketing, during the patent protection period, a drug that infringes the patent, it may, for example, file a civil claim seeking an order to cease and desist. The problem is that proceedings in patent disputes tend to last for years, and for the whole time the infringing product may remain on the market, while the losses of the innovative firm quickly mount. In such a case, ultimately prevailing in court may prove to be a pyrrhic victory. The innovative firm may obviously seek damages, but the amount is hard to calculate. Thus it is important to consider seeking interim relief at the beginning of the litigation in order to secure the claim.
What does security for a claim involve?
Securing a claim temporarily governs the relations between the parties, and thus on the market, for the duration of the proceeding. The motion for interim relief may be filed with the civil court prior to filing the statement of claim, together with the statement of claim, or when the main proceeding is already underway. The court will grant relief if it finds that the claimant has substantiated its claim and its legal interest in obtaining security for the claim. The relief may consist, for example, of prohibiting the generic firm from manufacturing, offering, or marketing a generic drug that most likely infringes the patent, for the duration of the proceeding. This is intended to secure the claims for patent infringement, e.g. for a permanent injunction against marketing the drug.
Is it easy to obtain interim relief?
It is not a simple matter, but our experience demonstrates that it is possible even in complex patent disputes within the pharmaceutical sector. Success in obtaining interim relief depends primarily on a well-drafted motion, presenting appropriate evidence to demonstrate the likelihood of patent infringement and to show that the lack of interim relief will prevent or seriously hinder enforcement of the ultimate ruling in the case. The attitude of the court is also important, obviously.
So how should a motion for interim relief best be presented?
There is no magic formula that would guarantee success, of course, but based on our practice it is extremely important that the legal as well as technical arguments be presented with the utmost simplicity and clarity. Even the most complex technical arguments and expert opinions should be presented in such a way that the judge, who typically has no knowledge or experience in pharmaceutical issues, can understand what the alleged patent infringement consists of.
What happens if the court receives two conflicting opinions concerning patent infringement?
In a number of rulings, courts have held that in that situation they are not in a position to assess the probability of the claim. In my view this practice is not proper, because the court is always required to assess the evidence presented to it. It is true that in a proceeding for interim relief there is no option to name a court-appointed expert, because this is not provided for in the Civil Procedure Code, but nonetheless, even in the main proceeding it is not the court-appointed expert who resolves the dispute, but the judge who assesses the opinion of the expert and issues a judgment accordingly.
The good news is that new rulings have now been issued holding that even when there are two conflicting opinions from private experts, the court may maintain a temporary injunction in force.
Is a private expert opinion sufficient to substantiate that a patent is being infringed?
That depends on the specific factual situation as well as the reliability of the opinion and the manner in which it was prepared. If an opinion obtained by a party was prepared by a recognised expert in the field and it appears from the opinion that the expert made an objective analysis of the patent claims and compared them to the characteristics of the product, it cannot be assumed that such an opinion would be of any less value for explaining the case than an opinion prepared by a court-appointed expert.
There is another issue related to assessing the reliability of opinions submitted to the court. According to the justification for some rulings, in a proceeding for interim relief the courts require a very high degree of probability for the claims, approaching a requirement of undisputed proof of infringement, as in the main proceeding. However, the characteristic feature of a proceeding for interim relief is that it is less formalised, which also means that the required level of proof relied on by a party is lower than in the main proceeding. This has been confirmed in recent rulings, according to which it is sufficient when seeking interim relief to demonstrate the probability that the patent is being infringed by sale of the specific drug, and the proof may take the form of an opinion from a private expert.
Once interim relief has been granted, will it remain in force for the duration of the proceeding, which may go on for several years?
It may, but not necessarily. Generic manufacturers have a right to defend themselves against measures entered against them, such as an injunction against selling a given drug. They may play an active role in the proceeding at the stage when interim relief is being sought, and often file interlocutory appeals against orders granting interim relief. This is why relief may remain in place for a fairly short time, until the higher court has a chance to rule on an interlocutory appeal, which might be 3 or 4 months. If the interlocutory appeal is unsuccessful, however, the interim relief may remain in force for the entire duration of the main proceeding.
This is obviously a desirable position for the innovative firm to be in, and quite burdensome for the generic firm, but we should bear in mind that the defendant has a right to file a motion during the course of the proceeding to set aside or modify the interim relief, if it demonstrates that the relief imposed by the court, such as an injunction against marketing a drug, is overly burdensome, or the grounds for issuing it no longer exist. The generic firm may also seek damages if, for example, it is demonstrated in the main proceeding that the security was unwarranted.
And in a cross-border situation, would obtaining interim relief in Germany, for example, increase the probability of obtaining similar relief in Poland as well?
If the same drugs are being sold in both countries, infringing the corresponding patents in Germany and Poland, obtaining interim relief in Germany would be expected to increase the chances for obtaining the same relief in Poland. This is not always the case, however, because the grounds for granting interim relief and the judicial practice in this respect vary across different EU member states.
This issue, which often leads to discrepancies in judicial rulings, has drawn the attention of AIPPI (the International Association for the Protection of Intellectual Property). The issue is addressed in a report on Poland that I co-authored this year for AIPPI [available at the AIPPI website]. Significantly, national groups from various countries around the world prepared analogous reports, which will be discussed in October at the AIPPI Forum in Hyderabad, India. This should lead to adoption of a joint position by AIPPI, which may then be presented at international forums during work on unifying intellectual property law.
Interview conducted by Justyna Zandberg-Malec