Turkey: Hurdles To Effective Pharmaceutical Patent Protection In Turkey

Last Updated: 12 February 2013
Article by Ozge Atilgan Karakulak and Selin Sinem Erciyas

The fact that the Patent Law and the Patent disputes' history are quite young in Turkey, brings the difficulties in practice.

Although the Decree Law pertaining to the Protection of the Patent Rights, which is in force today, was prepared in the light of the international commitments and European Union legislation, turning a deaf ear to the developments in the international patent practice cause insufficient protection of patent rights in Turkey.

We believe that the main problematic issues in the protection and enforcement of the patent rights are the insufficient expertise and the rules of liability of the court expert panels, to which a patent case is referred, access to the counterparty's evidence in ongoing patent actions and finally the discrepancies between the Turkish Patent Decree Law and the European Patent Convention (EPC).

Ill Functioning Court Experts System

Since the Turkish IP Courts consist of a sole Judge, who has no technical background, the referral of the dispute to the expertise of a court appointed expert panel is inevitable. In the light of the case law of the Courts of Appeal ruling that the Judge should refer the technical case to a court expert panel and if the Judge intends to decide in contrary to the determinations made in the expert report, he/she should be in a position technically grounding the reason of the decision, it becomes clear that the outcome of a patent dispute somehow depends on the outcome of the report of the court expert panel.

However Turkey lacks of a ruled and controlled court expert system. Anyone who is lecturing in a university or drafted some articles related with the matter can be chosen as a court expert.

As a result in complex patent cases, courts are guided by insufficient expert opinions, without properly addressing parties' submissions. An invention granted after thorough examination and deliberation by several expert examiners may be invalidated by adverse opinion of court experts who are not familiar with patent law.

Being aware that the situation is not different in many other countries, the one single truth remains valid for all that the attendance of the expert panel and referral of the case to the expert panel should be ruled and controlled through an institution.

It is our experience that an expert panel from the Faculty of Pharmacy may not have the sufficient expertise to analyze an infringement of a pharmaceutical patent. The lack of patent law knowledge and patent analyze skills of the expert panel, drives seriously wrong understanding and evaluation of the matter. Including a patent law professional (mostly a patent attorney) does also not help to survive because the technical expert must have his/her own patent law knowledge to internalize the point of view of the both parties and to understand what the patent holder is trying to tell and combine this teaching with his/her own technical expertise.

However mostly experts produce very poor reports and carry the risk of being arbitrary. They do not address all questions in order to resolve the dispute and their answers are often unsatisfactory. With lack of proper patent law knowledge, experts usually come up with hindsight knowledge against patents. Parties are entitled to comment on experts' opinion and seek supplementary or alternative opinions, but, such efforts are fruitless and frustrating.

We believe that it is crucial to constitute an institution to educate the experts who will be appointed by the IP Courts, in terms of reading a patent document, understanding an invention and analyzing the patent in the light of national and international patent law standards.

As mentioned above the faith of the patent action lies in the outcome of the court experts, who assumed to be "expert" in their field. However many unfortunate experience showed that the expert panel can make excessive scientific mistakes. The current Civil Procedural Law is insufficient in preventing the court experts to be held liable for their scientifically incorrect report or any other act, which damaged the rights of the parties of the action. The Civil Procedural Law rules that the court experts can not be held liable for their reports unless the report is taken as the ground of the final decision of the court. Besides the court experts cannot be held liable directly in any case. That is to say the action for the liability of the expert panel should be addressed to the state; i.e not the expert panel it self, and the state may claim against the expert panel.

Obviously there is a need for an act ruling the frame of the liabilities of the court experts and the direct consequences of irresponsible acts or scientifically incorrect reports of the experts.

Access to the Evidence

Most of the pharmaceutical patent disputes are arising from the abridged license applications of the generic companies, referring to the original license dossiers of the originator company.

Thanks to the efforts given before the Council of State, since 2007 the Ministry of Health has been ordered to respond to the freedom of information applications filed by the originator company. By this way the originator company can learn if any generic application referring to the originator's licensee dossier has been filed and what the status of the generic application is. However the content of the generic license dossier is not open to the originator. The only option for the originator company to find out whether the information in generic license dossier infringes its patent is to file an infringement action before an IP Court. However generic companies' argument of the "confidentiality of the generic license dossier" prevented the access to the abridged applications dossiers by the plaintiff patent holder. Considering that the generic dossier is the only and the main evidence of the case, needless to say that without access to these dossiers the action cannot be continued.

Through the efforts of years it has been managed to convince the IP Courts that the evidence of an action can not be hidden from a party of the action. For a couple of years the IP Courts agreed on deciding for expert examinations on the generic licensee dossiers at the premises of the Ministry of Health, with also the presence of the plaintiff attorney and the private expert of the plaintiff company. However there are still problems such as the narrow approach of the Ministry of Health as well as the Courts limiting the examination to the limited parts of the dossier which may leave out the patent related information, surprising loss of some of the generic license dossiers at the date of the examination, questioning of taking notes from the generic dossier by the party experts, etc.

Discrepancies between Turkish Patent Law and the European Patent Convention

Finally, one of the important hurdles before the effective patent protection in Turkey is the inconsistencies between the Turkish patent system and the EPC.

Although Turkey is a member of the EPC, the patent owners in Turkey are in a disadvantageous position to survive their patents, due to several discrepancies between the Turkish Patent Decree Law and the EPC.

The main difference is that EPC provides for a post-grant opposition proceeding whereas the Turkish patent system adopts a pre-grant opposition system. Besides, the Turkish Patent Decree Law does not allow for amendment of claims after grant, also during the nullity proceedings before the courts.

Almost immediately upon national validation of granted European patents, the Turkish Patent Institute ("TPI") grants Turkish patents. However because the validated EP has not gone through a pre-grant opposition before the TPI, and there is no post-grant opposition available in the Turkish law, the validated EPs are directly exposed to nullity actions before Turkish IP courts, without giving regard to the fact that EPO granted patents can be amended after grant during or after oppositions and the amendments on the EP will directly reflect to the Turkish validation without further examination or evaluation. Turkish companies and lawyers often commence nullity actions based on oppositions publicly available at EPO's website.

Consequently while the EPO continues dealing with the European Patent application and the patentability question, Turkish IP Courts simultaneously deal with the patentability question of the same patent.

On the other hand, in fact the final scope of protection conferred by the European Patent application will not have been finally determined yet and the scope of protection that will be determined after the aforementioned proceedings will have a retroactive effect, which means that the patent subject to the action before Turkish IP Courts may be deemed as not existed at all at the end of the proceedings before the EPO.

Moreover in the invalidation actions filed before the national court, the European Patent, which is at the opposition, limitation or revocation proceedings phase before the EPO will either be maintained as it was filed or invalidated, since the IP Court has no right to permit the applicant to amend its application and maintain the patent as amended.

However the EPO Opposition Division, that evaluates the same opposition grounds for the same patent, gives the applicant the right to amend the application and maintain the patent as amended. It goes without saying that the mentioned patent maintained with amendments in the proceedings before the EPO will also be registered and protected in Turkey as a member of the EPC.

It is clear that the patentability assessment of the Turkish Patent Court, conducted upon the first registration decision of the EPO Examining Division, without waiting for the outcome of the opposition, limitation or revocation proceedings will be useless as once the patent is maintained as amended it will be registered in the Turkish Patent Bulletin or if the patent is revoked then it will also be deleted from the Turkish Bulletin.

Although the first draft of the draft patent law which was prepared in order to dispel some of the problematic issues mentioned above gave us hope, it is rumored that some governmental institutions raised objections to new rules some of which are the translation of the EPC provisions. We believe that the first draft of the draft patent law was a promising step and the new law should carefully consider the legal environment provided to European and national patents in Turkey and it should carry the Turkish patent practice to the international standards.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Authors
Ozge Atilgan Karakulak
Selin Sinem Erciyas
 
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