Judgement of the Warsaw Regional Court of 16th June 2020 (case no. XX GC 1117/16)

The claimant, a Swiss pharmaceutical company, entitled from the patent for the use of the active substance in treatment of gastrointestinal stromal tumors, on 1st April 2014 filed a lawsuit demanding that the defendant cease to infringe its patent, withdraw the medicinal products allegedly infringing the patent from the market and that the judgement of the court is made public. Medicinal product of the defendant contain the same active substance as the product of the plaintiff, but its therapeutic indication is for use in adjuvant therapy for adult patients with significant risk of recurrence of gastrointestinal stromal tumors after surgery to remove the tumor. Marketing authorization was granted for the defendant’s drug and it was placed on the reimbursement list.

According to the plaintiff, the defendant offered a medicinal product for use in the treatment of cancer and this medicine is applicable to the treatment of the same disease as the plaintiff’s drug, so the scope of use of the defendant’s drug is the same as the scope of claimant’s patent.

Adjuvant therapy (from the Latin adiuvare – to help), also known as adjunct therapy or adjuvant care is applied after completion of the main treatment, so after surgical excision of the tumor. Adjuvant therapy may involve use of chemotherapy, radiotherapy or hormone therapy. Its main objective is to eliminate micrometastatic cells and thereby reduce the risk of relapse of the disease and increase survival of patients. Unlike the main treatment, it kills those cells that could not be cut out.

The defendant claimed that its actions did not fall within the scope of the claimant’s patent, because the registered therapeutic indications of its drug relate o adjuvant treatment, which is a treatment that takes place after the surgical removal of the primary tumors. The defendant’s drug, unlike the claimant’s drug, is not intended to treat the disease itself, but to prevent its recurrence (which is precisely the essence of adjuvant therapy). As of the claimant’s patent priority date, there were no studies confirming the effectiveness of the active substance in adjuvant treatment of patients after tumor resection. This type of use was also not indicated in the claimant’s patent claims. It must be noted that a patent protects the invention within the scope defined in the patent claims. The defendant also claimed that its actions did not fall within the scope of any form of patent infringement enlisted by the law. The drug was not manufactured by the defendant, but by its contractor, a company operating in Cyprus, and its inclusion on the reimbursement list did not, according to the defendant, constitute a form of offering the product.

The plaintiff also applied for an interim injunction to secure its claims. The Warsaw Regional Court issued an order prohibiting the use, offering, marketing, manufacturing and importing medicinal products containing the active substance in question for its use in adjuvant treatment of the above-mentioned cancer by the defendant for the duration of litigation, as well as an order for the bailiff to seize the above-mentioned medicinal products in possession of the defendant. The Warsaw Court of Appeal partially upheld the defendant’s complaint and dismissed the application for seizure of the goods.

During the course of the trial, in August 2016, a partial amendment to the text of the defendant’s drug’s Summary of Product Characteristics was approved of. It involved deletion of the indication for the use of the drug in the treatment of adult patients with a significant risk of recurrence after removal of gastrointestinal stromal tumors. Apart from this use, the product also has a number of other therapeutic indications, including the treatment of children and adolescents with newly diagnosed chronic myeloid leukemia and the treatment of adult patients with newly diagnosed acute lymphoblastic leukemia.

The plaintiff’s claim was dismissed in full by the Warsaw Regional Court (judgment of 29th January 2020, case no. XX GC 311/14). In opinion of the Court the claimant did not indicate precisely which forms of patent infringement were to take place. After the plaintiff’s appeal the case was held by Warsaw Court of Appeal. The Court ruled in judgment of May 17, 2020 (case no. IV ACa 640/15)  that the Court of first instance should have, firstly, determined whether at least one of the actions leading to the infringement of the patent had been performed and, secondly, take evidence from an expert opinion as to whether the scope of use of the defendant’s medicinal product is the same as the claimant’s drug and thus may constitute a patent infringement. The case was remitted to the Court of first instance for re-examination, as the issuing of the judgment required conducting the evidentiary proceedings in full.

The Court of Appeal attributed to the defendant the placing of the product on the market, pointing out that it itself admitted this fact, because pursuant to Art. 25 sec. 3 of the Act on the reimbursement of drugs, foodstuffs for particular nutritional uses and medical devices, the defendant was obliged to submit, together with the application for reimbursement of the medicinal product, proof of its availability on the market at the time of submitting the application. The court also established that the defendant’s action of placing the drug on the reimbursement list was a form of offering the product. The District Court, re-examining the case, was, pursuant to Art. 386 § 6 of the Code of Civil Procedure, bound by the above legal assessment of the Court of second instance.

The Court of Appeal ordered the Regional Court to decide whether the defendant’s drug fell within the scope of the claimant’s patent. For this purpose, the Regional Court took evidence from an expert opinion. The experts were to answer the question whether the fact that the active substance can be used to treat existing tumors clearly shows for an oncologist, being a specialist in the case’s matter, that the same substance can also be effectively used in adjuvant therapy.

Both in the first opinion and in the supplementary opinion, the experts concluded that the use of the defendant’s drug was not the same as the use of the claimant’s drug. The effectiveness of the active substance in the treatment of gastrointestinal stromal tumors does not imply the possibility of its use in adjuvant treatment. The efficacy of molecularly targeted drugs must be demonstrated by clinical trials. The experts indicated that there are examples of active substances which, despite the therapeutic indication for cancer treatment, do not show efficacy in adjuvant treatment and are not used in it.

The Court pointed out that content of the same active substance in a medicinal product does not indicate a patent infringement in the presented case, since the scope of patent in this case is not for the substance itself but for its therapeutical use, which is a different category of invention. According to Art. 63 sec. 2 of the Industrial Property Law Act, the scope of a patent is defined by patent claims. Indication of a particular therapeutic use in the patent claims limits the scope of patent protection to that use. Having considered all of the above, the Court dismissed the claim in its entirety. The judgment is not final yet.

Two important issues should be noted. Firstly, putting a drug on the reimbursement list constitutes a form of offering of the medicinal product and therefore it may potentially constitute a patent infringement. Secondly, it should be remembered that the invention covered by the patent may not only be the active substance itself, but it can also be its new medical use, and the scope of patent protection is determined by the patent claims. Very often demarcation, whether the application satisfies the condition of novelty or is within the scope of previous applications can cause controversy and requires delving to the opinion of experts, who have professional knowledge in this field and are able to objectively evaluate the issue. In   patent cases, the appointment of an expert is usually necessary. Indeed, in the presented case, the line between patent infringement and non-infringement seemed difficult to establish.

Another important issue is of a procedural nature, namely the duration of the proceedings and its practical consequences for entrepreneurs. Almost 6 years passed from the filing of the statement of claim to the first judgment in the case, and today, one year later, the case is still pending. Despite the fact that the plaintiff’s claims were not considered justified by the court of first instance, granting the interim injunction and uncertainty as to the outcome of the trial, combined with its long duration, effectively hindered the defendant’s free conduct of business activity.