In its summary of the applicable law, the Federal Circuit emphasized "public accessibility" as the "touchstone in determining whether a reference constitutes a 'printed publication. A reference is considered publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it. The court noted further: If accessibility is proved, there is no requirement to show that particular members of the public actually received the information.
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.
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 Patent protection for pharmaceuticals in turkey expert.
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.
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.
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.
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 the Ministry of Health has been ordered to respond to the freedom of information applications filed by the originator company. 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.
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.
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.
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.Patent provisions of Turkey’s new IP Law a compensation fee is introduced in the IP Law allowing the revival of an application or a patent, the protection period of which is deemed to be ended due to the lack of an annuity fee (Article (4)).
She represents a number of multinational pharmaceutical companies before the Ministry of. PATENT EXPIRY DATES 1/3. The global generic pharmaceuticals market is likely to witness strong growth in the next few years owing to the patent expiration of key blockbuster drugs and the judicious cost containment efforts of governments and healthcare service providers worldwide.
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Jan 19, · Patent protection effectively grants the pharmaceutical industry a monopoly, regardless of the human consequences. For a patient with a particular disease and a single solution available in the. Feb 12, · 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.
Accordingly, pharmaceutical companies had better to obtain European Patents instead of national patents especially for the inventions relating to secondary indications and biotechnological inventions as this would be safest route to protect such inventions.