The Regional Administrative Court’s Decision on Trade Secrets And The Administration’s Responsibility Against Unfair Competition

Protecting patent rights in a timely manner is crucial for original pharmaceutical product manufacturers, particularly in being informed of potential infringements before an infringing product enters the market.

However, information requests submitted by legal representatives of original drug marketing authorisation (MA) holders regarding the authorisation files of generic companies—who seek approval through an abridged application referencing the original pharmaceuticals—are consistently denied by the Turkish Medicines and Medical Devices Agency (“Agency”) on the grounds that such applications may contain trade secrets.

In 2007, a landmark decision of the Council of State ruled that attorneys representing original authorisation holders must be granted access to information regarding generic applications referencing original authorisations. The court specifically referenced the Attorneyship Law, emphasising that legal representatives require access to critical data—including the applicant’s identity, product name, application date, and status of the generic applications— to provide adequate legal services to their clients.

In accordance with this decision, the Agency responded to information requests from attorneys regarding generic applications until 2019. However, from that year onward, the Agency ceased responding, citing publicly available lists of active substances and authorised products as sufficient sources for obtaining the requested information.

As the 2007 Council of State ruling accurately emphasised, in order for a lawyer to effectively represent their client, they must have access to critical information regarding a generic license application, even at the application stage. This includes details such as the identity of the applicant, the product name, the application date, and the current status of the application. However, the active substance list and licensed product list referenced by the Agency do not provide the essential information needed by the lawyer to deliver comprehensive legal services to their client.

Consequently, the matter was once again brought before the judiciary in 2019, resulting in an action before the 23rd Administrative Court of Ankara seeking annulment of the Agency’s refusal to provide information. During the proceedings, the court ruled that while the term “trade secret” is not explicitly defined in existing regulations, the 11th Civil Chamber of the Court of Cassation has determined that the primary characteristic of a trade secret is its confidentiality from both the public and competitors within the relevant industry. The court further argued that providing information to legal representatives of original pharmaceutical product MA holders could allow competitors to gain insight into the commercial strategies of generic drug applicants, thereby classifying the requested data as trade secrets.

Additionally, the court dismissed claims that disclosure of abridged MA applications was necessary to prevent unfair competition. It reasoned that proving unfair competition requires evidence of unlawful interference, and since the products in question had not yet entered the market, there was no basis for claiming unfair competition at that stage.

This decision was subsequently appealed to the Regional Administrative Court.

The Regional Administrative Court overturned the lower court’s ruling, mandating that the Agency resume providing responses to attorneys’ information requests, including details such as the generic authorisation applicant, product name, application date, and application status. The court also made critical determinations regarding the contested definition of “trade secrets” and reinforced the obligation of the Agency to protect the proprietary data submitted by original product MA holders from unfair competitive practices.

In its ruling, the Regional Administrative Court defined trade secrets as information encompassing scientific data, financial and economic conditions, and marketing strategies held by commercial enterprises. The court further clarified that, under Article 39 of the TRIPS Agreement and Article 28 of the Licensing Regulation, confidentiality protections apply strictly to preventing unauthorised access to proprietary documents and safeguarding commercially valuable information. The court explicitly stated that “categorising information requests submitted by patent owners for informational purposes as trade secrets would effectively restrict the right to legal recourse.”

This high court ruling provided clarity on two long-debated issues:

1. The information sought by attorneys on behalf of original product MA holders— specifically, whether an abridged MA application referencing the original drug file has been submitted, the number of such applications, the identities of the applicants, the application dates, and the current status of the applications— does not qualify as a trade secret.
2. Under Article 39(3) of the TRIPS Agreement, since the Agency mandates the submission of undisclosed test data or other proprietary information as a prerequisite for authorising pharmaceutical or agricultural chemical products containing new chemical substances, it is legally obligated to protect such data from unfair commercial Consequently, ensuring regulatory transparency and safeguarding against unfair competition necessitates that information requests concerning abridged MA applications referencing original authorisations be granted.

This ruling reaffirms the need for transparency in regulatory processes while maintaining a balanced approach to trade secret protections, ensuring that legal recourse is not unduly obstructed.

First published by IAM Weekly in Apr 23, 2025.