One of the most striking developments of 2020 is a preliminary injunction decision given as a result of the implementation of the provision, “Prevention of the Indirect Use of Invention,” regulated in Article 86 of the IPL.
Although the expression “Indirect Use of Invention” is often confused with the concept of “Indirect Infringement of Patents,” in fact, indirect patent infringement is not clearly regulated in our law. Turkish IP Code numbered 6769 (“IP Code”) lists the acts that constitute patent infringements in Article 141, according to the numerus clauses principle. The actions constituting “indirect” infringement of a patent, or acts of inducement, help or contribute to infringement, are not mentioned among the actions listed in Article 141. However, the IP Code has a provision in Article 86 that is similar to the “indirect infringement” provision in Article 60(2) of the UK Patents Act (1977), and to the provision regarding “Prevention of the Indirect Use of Patent” regulated under Part 10 of the German Patent Law.
This issue, which can be defined as “contributory infringement” or “indirect infringement” in different laws, is regulated in Article 86 titled, “Prevention of the Indirect Use of the Invention,” in the IPL, as follows:
“The patent owner shall be entitled to prevent third persons from giving the elements and instruments related to a part of the invention that enables the implementation of the invention, which is subject to the patent, and constitutes the essence of the invention, to persons who are not authorized in the use of the invention that is subject to the patent. It is necessary for the referred third persons to know that these elements or instruments are sufficient to implement the invention, and that they will be used for these purposes, or this condition should be sufficiently clear for this provision to be applicable.”
Article 86 was first implemented in a court action where the patentee demanded determination and prevention of indirect use of its patent, disclosing a combination of active ingredients (X) and (Y), and the protection scope of the patent did not require presence of these combination partners in the same pharmaceutical form, nor it did introduce any other similar limitation, whatsoever. Considering the ongoing use and increasing damages, the patentee asked for a Precautionary Injunction (“PI”) decision, as well.
The challenge of the case lay with the fact that the defendant was manufacturing and marketing a drug including API (X), only, as it certainly knew and counted on that API (X) will be prescribed, used, and traded together with API (Y), in practice. Therefore, the defendant is focused on the combination market that constitutes 95% of the whole market. That is to say that the defendant knew that API (X) is not being used solely for the relevant patient population and even if it is, the patient population using API (X) only is around 5%, which does not commercially justify manufacturing and marketing a drug with API (X) only. However, this fact needed to be proven, and until then, it did not stop the defendant from arguing that it does not indirectly use the patent, as it manufactures and markets a drug with API (X) only, and accused the patentee of abusing the patent rights as it filed this lawsuit after expiration of the compound patent protecting API (X).
The Court successfully determined that the expired compound patent is not the subject of the case, but the combination patent, and it agreed to collect the evidence that is required to be collected by the patentee as there were no other means through which to obtain the necessary evidence. In this respect, the Court sent writs to the Social Security Institute and the three largest hospitals in Turkey asking them to inform the Court if the defendant’s drug, API (X) is being used, prescribed and/or reimbursed, alone, or together with API (Y).
All responses from the SSI and the hospitals confirmed the fact that the drug of the defendant is used/prescribed/reimbursed in combination with API (Y). Specifically, the SSI emphasized that among 234 patients, only 43 of them were prescribed with API (X), alone, and 113 of them were prescribed it, together with API (Y).
Depending on the responses from the SSI and the hospitals, the patentee argued that all requirements of Article 86 had been fulfilled since the defendant, as a third person within the meaning of the provision as one who sells/trades/provides the generic product containing the API (X) to unauthorized parties, which constitutes the essential element of the combination patent, enabled implementation of the patent by unauthorized persons, such as pharmacists and pharmaceutical warehouses. Consequently, the patentee demanded the Court to grant a PI to prevent reimbursement of the defendant’s drug by the SSI when it is prescribed together with API (Y). The patentee explicitly stated that it requires no measures preventing reimbursement (or any kind of use, market, etc.) of the defendant’s drug, when it is prescribed, used or marketed, not together with API (Y).
The defendant tried to defend itself by referring to paragraph 2 of Article 86, which says that if the elements or instruments stipulated in clause one are always available on the market, the provision of clause one shall not apply unless third persons provoke/induce unauthorized persons to perform the referred acts. Accordingly, the defendant argued that API (X) is such an element of the invention that can always be found on the market, and the defendant does not provoke/induce anyone to implement the invention by using API (X).
Unfortunately, there is no case law in Turkey about interpretation of when/which elements should be deemed to be always available in the market. However, the patentee depended on German case law and UK case law. In German Law, it is accepted that the meaning of “product, readily available in the market,” constitutes all kinds of basic materials, for daily use, which are generally kept in storage. Also, in accordance with German Law, collective, daily and a multitude of products, whether personal or commercial, which are a part of permanent personal needs, and which may be used in many other ways, in other words, which are not described for any special purpose, constitute these products.
As well, under British Law, it is stated that the meaning “product, readily available in the market,” was “products, which may be needed on a daily basis and which may generally be provided” and, in addition, “they must be products, supplied for various commercial uses.” In this context, the British courts consider “readily available products,” as “basic commercial products,” including raw materials. Therefore, in British law doctrine and in case-law, it is impossible to consider a pharmaceutical compound to be a basic commercial product.
Referring to these case laws, the patentee claimed that it is impossible to hear the claim that the products, comprising API (X), which may only be provided from pharmacies through prescription, and used for the treatment of specific conditions, may not be deemed as readily available products.
The Court granted PI depending on its legal evaluation on the file without referring the case to a court expert examination, and without ordering a guarantee bond. The PI decision mainly suspended re-imbursement of the defendant’s drug when it is prescribed with API (Y).
The action as to the merits is ongoing and when concluded, it will have a significant contribution to shed light on Article 86 of the Turkish IP Code.