TURKISH PATENT LEGISLATION IN THE PERSPECTIVE OF THE

PHARMACEUTICAL INDUSTRY

After Turkey has started to admit the patent applications pertaining to the pharmaceuticals and veterinary products in 1995 in accordance with the TRIPS agreement, fierce competition has been ignited in the pharmaceutical industry, and this competition medium has been accelerated as the patent protection was brought into effect on January 01, 1999 with provisional Article 4 of the Decree Law No: 551.

Besides that the Decree Law No: 551 (hereinafter simply referred as DL) constitutes basis for a modern patent legislation as it allows patents of pharmaceutical products and methods, it substantially follows up the major limitations of the European Patent Convention (EPC). For instance, all the “unpatentable” items referred in Art. 6 DL are coinciding with the EPC (Art. 52-53), which items excluded from the scope of patentable inventions, include also methods of diagnosis, therapy and surgery applied to human or animal body. Some special provisions of the DL No: 551, that may be of particular relevance for the pharmaceutical industry, are briefly scrutinized hereinafter.

A. Employee Inventions

The DL No: 551 currently in force contains broad explanations and provisions special to the employee inventions and define the inventor employee as follows (DL-Art. 16): “a person who is in the service of another person and is responsible to carry out the work specified by the employer, with personal liability against the employer, in accordance with the provisions of a private legal contract or a legal relationship of similar nature”. The inventions of the persons falling into this definition are called “employee inventions” and are subcategorized as “service inventions” and “free inventions”. In the context of Art. 17 of the current DL, by mentioning that the inventions are emanated by way of utilizing the physical facilities of the enterprise and are also under obligation of the tasks assigned to the inventor, duty of the employee to report his/her invention to the employer is ensured (DL-Art. 18) and the employer is given the precedence to claim rights on the invention. Such precedence is particularly observable in DL Art. 20. Accordingly, “in case the employer claims ownership in whole for a service invention all rights are automatically assigned to the employer”. The cited situation is very similar in other countries in Europe. One of the major criteria that applies to the above case is that field of activity of the employer is the same with the technical field of the invention. In other words, the employer may not claim rights on the inventions that are independent from the enterprise in which the employee works.

The situation in which an employer does not claim ownership on the invention causes said invention legally to be regarded as a free invention (DL-Art. 21), in which case the employee may freely dispose of his property.

B. Unexamined Patent System

As in many European countries, unexamined patent system is available in the Turkish legislation; however the system is known to be a system open to abusive use because its credibility remains interrogable. This is because, despite the fact that Turkish Patent Institute (hereinafter referred as TPI for the sake of simplicity) governs an opposition mechanism similar to third party observations, it still has the obligation to grant unexamined patents without taking into account the search report and third party oppositions according to DL-Art. 60. Thus, the applicants or patent proprietors would have the right to enforce their patents (DL-Art. 73) against third parties for a period of 7 years starting from the filing date regardless of whether the patent actually involves the patentability criteria. In this case, by way of preliminary injunction, seizure of the products from pharmaceutical warehouses, manufacturer stocks and drugstores, as well as extermination of the production equipment and tools would become possible.

In the pharmaceutical market where even one day of activity is of great importance, the tangible damages and loss of reputation for the pharmaceutical firms may be extremely destructive. In such cases, the “golden rule” for the firms accused of patent infringement would be to carry out an effective defense before the competent courts and also to file request for examination of the unexamined patent at the TPI. This is because the DL-Art. 60 allows third parties to file the request for examination by themselves. Thus, the granted patent shall return to the status of a patent application, time will be gained for defense, and at the same time rejection of the patent can be possible after examination by way of the opposition documents attached to the request for examination.

C. Exhaustion of the Patent Rights

The exhaustion of patent rights applies for the patented products that have been put to sale by the patent proprietor or by third parties with the consent of the proprietor. In other words, patent rights may not be claimed after the product is sold out. Exhaustion of rights defined in DL No: 551 – Art. 76 actually takes the “national exhaustion” as the basis. In accordance with the provisions of the law import of the products that are sold out by the patent owner in abroad (parallel import) is not allowed. According to this national exhaustion principle a particular drug, for instance sold out by the patent owner in Bulgaria with a lower price, may not be imported into Turkey by the third parties. Though the situation outlined above is valid in the trademark (Decree Law No: 556) and Design law (Decree Law No: 554) Competition Authority and Supreme Court have different standpoints (Cahit Suluk – Ali Orhan; Intellectual Property Law, Volume III – Designs, 2008). According to the established rulings, it is free to buy the item in a different country and to import the same to Turkey if the right holder had once put the item to sale in Turkey. It is very likely that this ruling and legislation would be applicable to the patents. Eventually one may consider that principle of “international exhaustion” is applicable in Turkey as long as the patented product is put to sale in the Turkish territories.

D. Process Patents

The provisions pertaining to process or method patents regulated under DL-Art. 84 require that any product or substance having same properties with the product of the patented process shall be deemed to have been obtained by using the patented process. The aforementioned “method” may directly be provided by method or process claims (e.g. a method for producing Y) or by use claims (e.g. Use of X in the production of Y). On the other hand burden of proof lies with the parties claiming contrary. In this regard, the process patents are treated like product patents and even in a more advantageous way in certain conditions. In practice, this causes some problems especially for the pharmaceutical industry. This is because, in case of a conflict, the party accused of the patent infringement is enforced to declare his production process and to bring out extensive amount of know how into the open because of the aforementioned burden of proof. DL-Art. 84 includes provisions ass to the necessity to keep the manufacturing and business/trade secrets in secrecy, during the court proceedings, and IP courts generally pay attention to treat the marketing authorization documents as secret evidences (not open to public). However, it may sometimes be a serious hurdle to treat in secrecy the evidences other than marketing authorization documents. Court appointed experts who generally have authorization to access the secret documents need to pay special attention for not to disclose the information in secrecy in their expert reports which eventually becomes public. 


E. Obligation to work/use of the patent

In accordance with DL-Art. 96, the inventions to which a patent is granted in Turkey are required to be practically used. The main purpose of this provision is not to dispauper the public from the products of the invention.

The patent proprietor is required to prove his use by an official certificate issued by an official authority such as chambers of commerce (DL-Art. 97). In accordance with the law legal consequence of not fulfilling this requirement is establishing compulsory licenses (DL-Art.99-a). To explain in a more concrete manner, third parties may request a compulsory license before the competent courts in case that the invention, starting from the grant of the patent, is not used within 3 years or such use is interrupted for a period of 3 years. However, if the patent proprietor has justifiable/legitimate technical, economical and legal reasons, the request of the third party for compulsory license may be rejected (DL-Art. 100). From the point of view of the pharmaceutical firms, application for a marketing authorization before the Ministry of Health would be an example of a valid reason as the procedure is rather lengthy.

Some patent proprietors try to overcome this obligation by way of filing an “offer for licensing” before the TPI (DL-Art.94). However, once the patent holder offers his patent for licensing and should any third party requests for having the license there is no way of recourse. In case the parties fail to reach an agreement on the license fee, conflicts are resolved at the competent courts and eventually the requesting party most likely obtains the license. Therefore, offering for license apparently causes a similar result with the compulsory licenses. In view this fact, offering for license before the TPI has no practical benefit at all. 


F. Patents of Addition

A patent of addition is a kind of patent application which is bound to a main patent application and which provides protection for the subject matter intended to be added to the main invention that has not been disclosed in the main application. The patentability criteria for the patents of addition are not the same with normal patent applications.

The first condition to be met is unity as required by DL-Art. 45. Accordingly subject matter of the patent of addition shall have to be meet unity with the subject matter of the main patent application (DL-Art. 121). A further criterion is “novelty” as defined in DL-Art. 7. However, interestingly “inventive step” as defined in DL-Art. 9 is not required (DL-Art. 121). Therefore, it is to be noted that patents of addition are exposed to the same criteria with the utility model applications according to the present law.

According to the current legislation, despite the fact that methods, products by processes and chemical substances are not entitled to protection by utility models (DL-Art. 155), the applicants have the right to protect their inventions by way of patents of addition having similar criteria with those of the utility models. The only condition for having such a right lies on a previously filed normal patent application where this system becomes very similar to the system of CIP (continuation-in-part) used in the USA. As an example, an inventor disclosing the active ingredient of “sunitinib” for the first time may later on file a patent of addition in order to protect a number of sunitinib salts such as  D-tartaric acid, L-tartaric acid, citric acid etc. wherein novelty would be sufficient to obtain a grant. Inventive step, as regards a technical or surprising effect is not considered and sought.

However, an important issue one should carefully consider is that patents of addition cannot benefit of the priority date (effective date) of the main patent. Effective date of a patent of addition is regarded as its original filing date and has the same protection term with the main patent (DL-Art.122).

G. Divisional Applications

As generally known a patent application may provide protection for one invention concept only, and plurality of inventions cannot be protected by a single patent. Application should be divided in case that unity cannot be assured within the description and claims as filed. The divided applications contain a number claims disclosing different inventions, however each of them is treated as to having the same filing date and, if available, same priority date with the originally filed application (DL-Regulations-Rule 16). Each divided application is searched and examined just like the main application and is treated individually. The only connection with the first application is the effective date (filing or priority date) as mentioned above.

The right of the applicant to divide the patent application may have some inconvenient effects in certain conditions. For instance, the applicant may have the opportunity to divide a patent application before the rejection is issued after an unfavorable search and/or examination report, thereby the procedural steps restart and the same application may remain on the agenda for many years. As may be appreciated, the aforementioned situation constitutes uncertainty for the third parties.

In order to eliminate these problems, the European Patent Office has put some regulations into force as of April 01, 2010 (Decision of the Administrative Council - CA/D 2/09). Accordingly, the right to file divisional is limited to the period of 24 months following the first office action in the examination phase (Rule 36(1)(1) EPC; GL A.IV, 1.1.1.2). Currently, the similar provisions have also been added to new draft law which is now waiting for approval of the Turkish Parliement.  

H. Data Protection in the Applications for Marketing Authorization

Apart from the shortened marketing authorization applications, the Ministry of Health applies data protection (data exclusivity) for the pharmacological test results and other data included in the marketing authorization applications for active ingredients, formulations, solutions and other similar pharmaceutical products. The secrecy of such data is also subject to the provisions under DL-Art 83 wherein explicit ruling for protection of the experimental data is available. However, the article brings the precondition that “drugs for which a patent application has been filed” may benefit of the data exclusivity in which case the drugs having no patent application are simply excluded. Furthermore, it is an unclear issue in the broad definition of the article whether the patent application referred to would mean a Turkish patent application or another national/regional patent application. Nevertheless, regardless of whether a patent application has been filed or not, it is a known practice of the Ministry of Health that experimental data included in the authorization applications are to be kept secret.

Data exclusivity or data previlage is applied for a 6-years term starting from the date of first marketing authorization either in Turkey or in a state of European Customs Union which ever is first. This term however is limited by the patent term of the concerned product. 


I. Activities Excluded from Infringement in View of the Pharmaceutical Patents

Although it has been remained as an unclear point of law for many years, experimental activities especially for purposes of marketing authorizations have been clarified with DL-Art. 75 as amended by the Law No: 5194. According to the relevant provisions, the following acts are excluded from the scope of rights conferred by patents, and are explicitly referred to as noninfringing activities:

(i) Acts devoid of any industrial or commercial purpose and limited to private ends/aims;
(ii) Acts involving, for experimental purposes, the invention, subject matter of a patent;
(iii) Extemporaneous preparations of medicines in pharmacies involving no mass production and carried out solely in making up a prescription and acts related to the medicines thus prepared;
(iv) Experimental acts involving an invention subject to a marketing authorization including tests and experiments necessary for obtaining marketing authorization of pharmaceuticals.

CONCLUSION

Although the Decree Law No: 551 which stands as the main source of the Turkish patent legislation is mostly compatible with the European legislation some issues having relevance also with the pharmaceuticals have not been updated. Biotechnological inventions pertaining to biologic and genetic materials and microbiological products, for instance, are not available in the current legislation. However, the regulations as regards biotechnology inventions have already been accepted with the Directive (98/44/EC) of the European Union upon which the corresponding provisions have been adapted in the EPC in 1999 (OJ EPO 1999, 101). Therefore, there is no legal basis in the current legislation as to biotechnological inventions subject to patent applications at Turkish PTO. Inventions of this type have no hindrance when they are filed as an extension of a European patent. This is because the international agreements (i.e. EPC) have precedence over the national law (DL-Art. 4). Nevertheless, the provisions of biotechnology inventions as referred above are included into the newly drafted law which is now waiting for the approval of the Turkish Parliement (New Articles 91-104).

 

Aydin Mutlu

Turkish & European Patent Attorney