Preliminary Injunction Granted to Prevent Indirect Use of Invention

One of the most striking developments of 2020 is a preliminary injunction decision given due to implementing the provision “Prevention of the Indirect Use of Invention” regulated in Article 86 of the IP Code.

Although the expression “Indirect Use of Invention” is often confused with the “Indirect Infringement of Patents” concept, indirect patent infringement is not explicitly regulated in our law. Because as is known, the Turkish IP Code numbered 6769 (“IP Code”) lists the acts that constitute patent infringement in Article 141, according to the numerous clauses principle. The actions constituting “indirect” infringement of a patent or acts of inducement, help, contribute to infringement are not mentioned among the actions listed in Article 141. However, IP Code has a provision in Article 86, which is similar to the “indirect infringement” provision in Article 60(2) of the UK Patents Act (1977) and 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 IP Code as follows:

The patent owner shall be entitled to prevent third persons from giving the elements and instruments related to a part of an invention which enables the implementation of the invention which is subject to the patent and constitutes the essence of the invention, to persons who are not authorised in the use of the invention subject to the patent. The referred third persons must 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”.

As far as is known, Article 86 has been firstly implemented in a court action where the patentee demanded determination and prevention of indirect use of their patent, disclosing a combination of active ingredients (X) and (Y), and protection scope of the patent did not require the presence of these combination partners in the same pharmaceutical form, or it did not introduce any other similar limitation at all. Considering ongoing use and increasing damages, the patentee asked for a Precautionary Injunction (“PI”) decision.

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 the API (X) will be prescribed, used, and traded together with the API (Y) in practice. Therefore, the defendant aims at the combination market, which constitutes %95 of the whole market. That is to say that the defendant knows that the API (X) is not being used solely for the relevant patient population, and even 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 to accuse the patentee of abusing the patent rights as it comes up with 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 required to be collected by the patentee as there was no other way to reach the necessary evidence. In this respect, the Court sent writs to Social Security Institute and the three biggest hospitals in Turkey asking them to inform the Court if the defendant’s drug, having API (X), is only being used, prescribed and/or reimbursed together with the API (Y).

All responses from SSI and hospitals confirmed the fact that the drug of the defendant is used/prescribed/reimbursed in combination with API (Y). Specifically, the SSI emphasised that among 234 patients, only 43 were prescribed with API (X) only, and 113 were prescribed with API (Y).

Depending on the responses from SSI and hospitals, the patentee argued that all requirements of Article 86 were fulfilled since the defendant as a third person within the meaning of the provision sells/trades/provides the generic product containing the API (X) to the unauthorised parties, which constitutes the essential element of the combination patent and enables implementation of the patent by unauthorised persons like pharmacists, pharmaceutical warehouses. Consequently, the patentee demanded the Court grant a PI to prevent the defendant’s drug reimbursement by SSI when prescribed with API (Y). The patentee explicitly stated that it requires no measures preventing reimbursement (or any use, market or else) of the defendant’s drug, when 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 unauthorised 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 the interpretation of when/which elements should be deemed to be always available on the market. However, the patentee depended on the German and UK case laws. In German Law, it is accepted that the meaning of “product, readily available in the market” constitute all kinds of basic material for daily use, which are generally kept in stocks. Also, per German Law, collective, daily and multitude of products, whether personal or commercial, which are a part of permanent personal needs and may be used in many other ways, in other words, are not described for any special purpose, constitute these products.

Along with this, in British Law, it is stated that the meaning “product, readily available in the market,” was “products, which may be needed daily and which may generally be provided” and in addition, “they must be products, supplied for various commercial uses.” In this context, British courts consider “readily available products” as “basic commercial products,” including raw materials. Therefore, it is impossible to consider a pharmaceutical compound as a basic commercial product as per British law doctrines and 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 on prescription and used when treating specific conditions, may not be deemed as readily available products, referring to these case laws.

The Court granted PI depending on its legal evaluation on the file without referring the case to a expert examination and without ordering for a guarantee bond. The PI decision mainly suspended the defendant’s drug reimbursement when prescribed with API (Y).

The action on merits is still ongoing, and when concluded, it will have a significant contribution to shed light on Article 86 of the Turkish IP Code.

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