REGIONAL COURT OF APPEALS: The Decision of the Turkish Medicines and Medical Devices Agency of Refusal of the Applications of the Original Medicine Owners to Obtain Information on Reference Product is Unlawful

As per Article 9 of the Regulation on Licensing of Human Medicinal Products (“Licensing Regulation”), which regulates “Abridged Application[s]”, if a pharmaceutical has been authorized before, it is not necessary to repeat the tests and research, and the data of these tests doesn’t have to be submitted for authorizing again. Referencing the authorization information of the original pre-licensed pharmaceutical is sufficient.

However, because the subject product must be essentially similar to the original patented product, a significant risk of infringement emerges against the patent rights. Even though the authorization procedures are exempted from the patent right, the patent holder should be informed of such applications to enable them to analyse whether the activities to be undertaken after granting authorization to the reference product would create a risk of patent infringement and to ensure that the patent rights can be used effectively. Within this context, the attorneys of the pharmaceutical companies that own the patented product, according to Article 2 of the Attorneyship Act, may request information from the Ministry of Health Turkish Medicines and Medical Devices Agency (“Agency”) on whether the new product application and/or abridged authorization application or import permit application has been filed. If so, they may request the number of these applications and applicants, document registry information, dates thereof, whether the applications are pending, withdrawn, dismissed, or returned for any purpose. They are also entitled to request information concerning whether authorisation has been granted.

In fact, in 2007, we brought two cases before the State Council on behalf of our clients and on our behalf as a proxy after the attorneys of the patent owner pharmaceutical companies requested this information and the Ministry of Health rejected these requests of information. The Council of State decided to cancel the individual decision and actions of the Ministry of Health on refusing to provide information, and it held that the information of “whether an abridged authorization application has been made by referring to the authorization of the plaintiffs, and if so, the number of them and by whom” should be provided (State Council 10th Civil Chamber decision dated 06/03/2007 and numbered 2004/10375 E (Merits), 2007/891 K (Decision). This decision of the State Council was followed and the requests fulfilled by the Agency.

Despite no change to the circumstances, a second administrative action became necessary due to the Agent’s sudden renunciation of its legal personhood which left the right holders in the dark on how to protect their rights. Its response to new information request applications was “The requested information is included in the Authorized Pharmaceuticals List and Active Substance List published on the official website of the Agency“.

As a matter of fact, critical information such as whether the abridged authorization application has been made, who the applicant is, the application date and the status of the application are not included in the Authorized Pharmaceuticals List or Active Ingredient List the Agent referred to. These lists include nothing but the number of applications and have led to a serious decrease in the protection offered by patent rights.

In the second action filed, the legal ground of the case was determined wrongfully, and a majority vote dismissed the case. However, in the dissenting opinion annotated in the decision, it is stated that the documents and information requested are not trade secrets, so rejecting the request for information instead of accepting it is against the law.

As a result of the appeal brought against this decision, the District Court dismissed the decision of the court of first instance and echoed the State Council’s aforementioned judgment;

  • As per Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) and Article 28 of the Licensing Regulation, the rule of confidentiality of information regarding applications made for obtaining a license for a product is limited to preventing the information and documents in the file from being viewed by others and protecting information that has an economic value from being shared.
  • It is possible to check whether the data submitted to the original pharmaceutical authorization file by the inventors are effectively protected against unfair competition by the administration only through access to information on the abridged authorization applications made regarding the pharmaceutical authorizations they have,
  • Within this context, concluding that the applications made for receiving information by the manufacturer invention owners are trade secrets would mean restricting the efficient use of the right to legal remedies.

The court ordered the cancellation of the response given by the defendant, the Agency.

The unlawfulness of the Agency’s non-responsiveness to requests for information was already determined by the State Council decisions years ago, and as a matter of fact, responding to the information request applications that are duly filed according to the decision of the State Council has turned into a settled administrative practice. However, the fact that the Agent suddenly stopped providing the requested information in return for the applications for information contrary to the decision of the State Council, its practices, and the law has surprised the sector. Receiving a decision in the same direction about this practice, the illegality of which was previously determined by the decisions of the State Council strengthened the institution regarding the request for information of the original authorization holder company on reference authorization applications. With this second decision, arbitrary changes in the administration’s attitude ended, and an administrative entity was prevented from becoming an obstacle to the protection and oversight of patent rights.

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