Regional Court of Appeals: The Decision of the TMMDA 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 Authorization, which regulates “Abridged Application”, 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, only referencing to the authorization information of the original pharmaceutical that is pre-licenced is sufficient.

However, due to the obligation of the product, which is subject to the reference application must be essentially similar to the original product, which is protected by patents, a significant risk of infringement emerges against the patent rights. Even though the authorization procedures are exempted from the patent right, to analyze 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 emerge from the law are used effectively by the patent owners, the patent right holder should be informed on reference applications in question. Within this context, the attorneys of the pharmaceutical companies that own the original product that is protected by patent, according to Article 2 of the Attorneyship Act, request information from the Ministry of Health Turkish Medicines and Medical Devices Agency (“Agency”) whether new product application and/or abridged authorization application or import permit application, referring to the authorization dossiers of their pharmaceuticals, under protection with patent rights or other rights, had been filled, if yes, the number of these applications and related applicants, document registry information, including dates thereof, whether such applications were pending or not, whether such applications were withdrawn, dismissed or returned for any purpose, the stage of pending applications, and the information of whether authorization was granted or not.

In fact, in 2007, the two cases that we brought before the State Council on behalf of our clients and 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 10^th Civil Chamber decision dated 06/03/2007 and numbered 2004/10375 E (Merits), 2007/891 K (Decision). This decision of the State Council was regarded, and the information request applications were duly answered with content by the Agency, which is ministerial to the Ministry of Health until June 2019

However, although there is no amendment in the circumstances or the jurisprudence of the State Council, a second administrative action became inevitable due to the Agent’s sudden renunciation from its legal practice and leaving the right holders in the dark on the way to protect their rights by giving the response of “The requested information is included in the Authorized Pharmaceuticals List and Active Substance List published on the official website of the Agency“ to the information request applications of patent holder pharmaceutical companies.

As a matter of fact, in the Authorized Pharmaceuticals List or Active Ingredient List which the Agent has referred to, 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. These lists, which do not include more than the number of applications as in numbers, have led to a serious adjourn in the protection of the patent rights of the patent holder.

In this second action which was 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 has dismissed the decision of the Court of First Instance and, once again, similar to the previous decision of the State Council;

• As per article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) and article 28 of the Regulation on Authorization, 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 control whether the data submitted to the original pharmaceutical authorization file by the inventors are effectively protected against unfair competition by the administration only by having 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 as trade secrets would mean restricting the efficient use of the right to legal remedies.

The court held on 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 law has created an element of surprise in 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 institution was prevented from being an obstacle before the protection and oversight of the patent rights of the original authorization holders.