Introduction: Pharmaceutical R&D Contracts Now Have a Multinational, Multi-Partner, and Multi-Legal Structure

By 2025, the pharmaceutical industry will be built on multi-layered R&D collaborations between universities, biotech startups, global pharmaceutical giants, CROs, and technology companies.
The key legal risks in these collaborations are:

• Patent ownership,

• Protection of know-how and trade secrets,

• Choice of authority and law,

• Sharing common discoveries,

• Data ownership,

• Technology transfer,

• Use of R&D funds

It focuses on that.

The Private International Law Act is critically important for resolving cross-legal conflicts , particularly in international R&D contracts

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1. The Issue of Patent Ownership in R&D Contracts: How is Applicable Law Determined?

Patentable elements of a drug, such as its molecule, formulation, manufacturing process, or new uses:

• Agreement

• R&D activity

• joint meeting

• employer-employee relationship

There are various legal relationships such as these.

According to Article 24 of the Private International Law Act:

➤ “The parties may determine the applicable law in the contract.”

However:

Patent rights are subject to the laws of the country in which they are registered (lex loci protectionis).

What does this mean?

• Registration in the USA → US law applies

• Registration in the EU → EU directives and national laws apply

• Registration in Türkiye → Turkish Industrial Property Law applies

Therefore, even if the R&D contract is subject to English law, Turkish law applies to patent applications filed in Turkey.

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2. Ownership Disputes in Joint Inventions

The biggest problem in inventions that arise from the contribution of multiple parties is:

➡️ "Who owns the invention and how is the share determined?"

In Türkiye:

• Joint invention → creates a partnership according to the parties' contribution ratios

• Share transfer → subject to written form

• Patent application → must be made with the permission of all partners

Provisions such as "joint ownership shall not require mutual consent," which are frequently seen in foreign contracts:

➤ It is invalid to the extent that it conflicts with Turkish patent law.

This situation the mandatory provisions (lois de police) approach of the Private International Law Act.

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3. Know-How (Trade Secret) Protection: The Most Sensitive Area from the Perspective of Private International Law

Know-how protection is at the heart of R&D contracts.
The problem is:

❗ Know-how is not subject to international registration.

❗ It is protected by treaty, but there are limits to public order.

Trade secret protection in Türkiye:

• Turkish Commercial Code

• Law of Obligations

• SMK (unfair competition provisions)

• KVKK (Know-how carrying personal data)

It is organized by.

Therefore:

➤ Even if the R&D contract is governed by Swiss law, a lawsuit regarding the unauthorized use of know-how in Turkey according to Turkish law .

This occurs through the activation of tort provisions within the scope of Article 35 of the Private International Law Act.

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4. Data Ownership and Rights Over Clinical Data

One of the most valuable elements in R&D processes:

➡️ The data include clinical data, toxicity results, formulation data, and stability reports.

Who owns this data?

In Türkiye:

• Data ownership can be determined by contract

• However, since clinical data is health data, it falls under the scope of the Personal Data Protection Law (KVKK).

• Data transfer is subject to permission and explicit consent

• In regulatory applications (TİTCK, EMA, FDA), the sponsor is considered the owner

Therefore, all provisions relating to data:

✔ Contract +

✔ GDPR +

✔ Mandatory health regulations

It is evaluated according to the three criteria.

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5. Do Jurisdiction Clauses in R&D Contracts Exclude Turkish Courts?

No, it doesn't exclude it in every case.

In the contract:

• London arbitration

• ICC arbitration

• Swiss courts

Even if otherwise determined, Turkish courts shall consider themselves competent:

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A. If the patent is to be registered in Türkiye

Patent application and SMK-related disputes → Turkey's exclusive jurisdiction

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B. If know-how was used unfairly in Türkiye

Tort → Turkish courts have jurisdiction according to Article 35 of the Private International Law Act.

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C. If clinical data were obtained from Turkish volunteers

Personal Data Protection Law and health law → mandatory

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D. If there is a violation of Turkish public order

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6. Most Common Disputes in R&D Collaborations

The most common disputes seen by 2025:

1. Unilateral registration of a joint invention

2. Leaking know-how to a rival company

3. Infringement of employee invention rights

4. Failure to pay royalty payments

5. The technology transfer process was incomplete

6. Incorrect distinction between "Background IP" and "Foreground IP"

7. Disputes over access to clinical data

8. Misuse of R&D funds

Each of these disputes often involves multiple legal systems

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7. Enforcement of Foreign Patent and R&D Decisions in Türkiye

A foreign court may have issued a decision regarding an R&D contract.
For the enforcement of this decision in Turkey:

• The decision must be final

• There should be no violation of public order

• The decision cannot be enforced if the patent is registered in Turkey (exclusive jurisdiction).

• The decision regarding the use of know-how in Turkey may constitute a tort.

• Royalty calculations should not conflict with Turkish public order

• Decisions regarding employee inventions must comply with the Industrial Property Law

Therefore, enforcement of R&D decisions is among the highest-risk types of cases.

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8. Measures to Reduce Risks in R&D Contracts

✔ The applicable law must be clearly defined

✔ Clauses should be added to comply with mandatory Turkish regulations

✔ Patent strategy should be planned on a country-by-country basis

✔ Know-how protection protocols should be prepared

✔ GDPR compliance must be ensured

✔ Data ownership needs to be clarified

✔ The arbitration clause must be clear, comprehensive, and enforceable

✔ Separate protocols should be prepared for employee inventions

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9. Conclusion: R&D Contracts are Now the Most Challenging Area Where Private International Law + Intellectual Property + Data Protection Law Intersect

According to the 2025 plan:

• Patent rights are subject to the laws of the country where they are registered

• Turkish courts have jurisdiction in cases of unauthorized use of know-how

• Clinical data is protected by the GDPR and health law

• The choice of applicable law cannot override mandatory provisions

• Enforcement of foreign decisions regarding R&D contracts carries significant risks

Therefore, compliance with the Private International Law Act has become as critical an element as commercial success for pharmaceutical R&D projects.