Muazzez Koruturk

Partner

Assesment of patent infringement- especially in pharma matters

Life Sciences

17 September 2024

10

Patent infringement simply refers to the use of someone else’s patented invention without authorization. This use can be in various forms such as utilizing, making, selling, offering for sale, or importing the patented invention without obtaining permission or a license from the patent holder. Specifically, the IP Code includes the following actions to infringement; 

distribution, sales, importation or the commercialization in any other way of products subject to the patented invention, 

keeping products subject to the patented invention in possession for commercial purposes, 

use of the patented product by means of making the patented invention applicable, 

making proposals to establish an agreement related to a patented product. 

Additionally, the IP Code introduces a separate provision with regard to the acts of infringement against process patents. The following actions of third parties who know or should have known that the process is being used without the consent of the patentee are deemed to be infringing;  

Use of the patented process, 

Sales, distribution, importation or commercialization in any other way of the products produced directly by the patented process, 

Keeping products produced directly by the patented process in possession for commercial purposes, 

Use of the patented process by means of making the patented invention applicable, 

Making proposals to establish an agreement related to a patented process. 

Accordingly, the protection provided by a process claim extends to the products directly obtained by said process. Therefore, selling, using or importing the goods which are directly obtained by the claimed process is considered infringement of the patent. This is an important provision especially for pharmaceutical patents.  

Most of the pharmaceutical companies in Turkey prefer to import the active pharmaceutical ingredients (API) rather than producing themselves. In other words, production processes of the majority of APIs are not carried out in Turkey. Under the influence of this situation, the number of lawsuits in the matter of process patents are less than the number of other matters in dispute, in the pharmaceutical field. Nevertheless, the statement of "directly obtained by said process" in the IP Code makes the imported final product possible to infringe the process patent if the product is obtained by the patented process.  

The same applies to the intermediate product patents in which the chemical intermediate compounds of the process are protected. In the case of a final imported product obtained by using a patented intermediate compound, there will be an infringement of the intermediate patent.   

For the infringement cases of process patents, the burden of proof plays a crucial role. Article 141/2 of the IP Code states that where the patent is obtained for a process for the production/preparation of a product or a substance, the court may request from the defendant to prove that the product, possessing the same properties, has been produced/manufactured without infringing the patented process. 

Where the patent is obtained for a process for the production/preparation of a new product or substance, all products, possessing the same properties, shall be deemed to have been produced/manufactured by the patented process. The burden of proof rests with the defendant claiming that he manufactured/produced the product without infringing the patented process. 

Moreover, the IP Code continues to name the following actions as infringement; 

the usurpation of a Patent;  

expansion or transfer of rights granted by the patentee through a discretional/compulsory license agreement without the consent of the right holder. 

Patent infringement can occur in various ways and the main type of patent infringement can be listed as follows: direct infringement which can be literal or equivalent, indirect infringement such as induced or contributory.  

Direct infringement  

Direct infringement refers to the straightforward act of making, using, selling, offering for sale, or importing an infringing product or process without authorization from the patent holder. Direct infringement can be sorted as literal infringement and equivalent infringement.  

According to the IP Code of Turkey, the scope of protection conferred by a patent application or a patent shall be determined by claims. Literal infringement occurs when an accused product, process, or technology directly comprises all the features specified in the claim of the patent.  

However, in the general practice of Turkish IP Courts, in an infringement court action, not only the literal meaning of the words in a claim, but also the equivalents of them are considered. It means that the court takes into account the doctrine of equivalents and the doctrine of equivalents extends the scope of protection beyond literal infringement. 

The infringement is firstly assessed by comparing the properties of alleged product or process with the literal words of the claims. If the court is of the opinion of that there is no literal infringement, then they usually proceed with the assessment of equivalents.  

The product or process is decided to infringe under the doctrine of equivalents if a feature of the alleged product/process performs substantially the same function, in the same way and leads to the same result as the feature of the claim.  

The doctrine of equivalents aims to prevent infringers from making small and insubstantial changes to a patented invention to avoid literal infringement. However, the law must provide the legal certainty. Therefore, the claims should be interpreted in a way not only to provide the applicant or the patentee with the protection they deserve but also to provide the third parties with the reasonable degree of this legal certainty.  

Accordingly, the IP Code states that when determining the scope of protection, the claims shall not be extended in a way covering the ideas that had been thought of by the inventor but had not been demanded in the claims, and also in a way to cover the features which are expected to arise by interpretation of the description and the drawings by a skilled person in the art.  

Additionally, in the assessment of scope of protection and infringement under the doctrine of equivalents, the applicant’s declarations and statements during the prosecution of patent are also important and are considered.  

Indirect infringement  

As mentioned before, indirect infringement can be realized as contributory and induced infringement. Contributory infringement occurs when someone supplies or sells components of a patented invention to be combined or used in an infringing manner. Induced infringement occurs when someone knowingly induces, encourages, or aids another party to infringe a patent.  

Accordingly, Article 86 of the IP Code, regarding contributory infringement, reads as follows: 

(1) The right holder of a patent is entitled to prevent third parties, from handing over to persons unauthorized to work with the patented invention, elements and means related to an essential part of the invention, subject matter of the patent, and rendering that which renders possible the implementation of the patented invention possible. In order that this provision may apply, the concerned third parties have to know, that such elements and means are sufficient for putting the invention to use and that they know, that they will be used to such effect or that the circumstances render such situation sufficiently evident. 

(2) The provisions under Paragraph one of this present Article shall not apply, when the elements or means referred to in Paragraph one of this present Article are products commonly to be found on the market, unless third parties incite the unauthorized persons concerned to commit such (prohibited) acts. 

First, two conditions are to be met according to Paragraph 1, the offered ‘means and elements’ must be essential features of the invention for infringement to be made out. Second, for liability to be established, third parties that offer these elements and means should be aware that they render possible the implementation of the invention. 

In respect of ‘means and elements’ mentioned in Paragraph 1, which are ‘commonly to be found in the market’, Paragraph 2 introduces a third condition in that third parties have to have incited the unauthorized person to commit infringement. 

Deriş Patent Building Kabataş, İstanbul

+90 212 252 6122

[email protected]

© 2025 Deriş. All rights reserved.

© Madde22. All rights reserved