The Turkish Competition Authority’s Preliminary Report on the Pharmaceutical Sector (the Report), published in August 2026, and the Workshop on Competition in the Pharmaceutical Sector (the Workshop), held on September 21 2026, have prompted renewed discussion on the interaction between patent and competition law.
The Report is a significant study that assesses the mechanisms of patent protection, market authorisation, reimbursement, and distribution throughout the process from the development of a medicinal product in the laboratory to its provision to patients. As the Competition Authority is due to prepare its final report, the following issues are particularly important for that process:
Patent exclusivity and competition law – while the Report recognises the role of patents in encouraging innovation, it also treats patent exclusivity as a starting point for competition concerns in certain areas. Yet preventing unauthorised exploitation of an invention is the very function of the time-limited exclusivity granted in exchange for disclosure. Competition law should therefore distinguish ordinary patent protection from specific manipulative conduct and its exclusionary effects, rather than treating exclusivity itself as problematic. This distinction is consistent with TRIPS articles 7, 8(2), and 27(1), which recognise innovation incentives, measures against abuse, and uniform patentability standards.
The value of “secondary patents” – the concept of secondary patents features prominently in the Report, and categorical statements concerning their patentability were made during the Workshop. However, as also clarified in the European Commission’s 2009 Pharmaceutical Sector Inquiry, “primary” and “secondary” patents are not legally defined categories, nor does this terminology imply any difference in quality or validity. All kinds of patents must be assessed individually under the applicable patentability criteria, without presumptions of illegitimacy or anti-competitive intent.
“Therapeutic benefit” as an assessment criterion – the Report distinguishes “innovations that provide a genuine therapeutic benefit” from minor modifications intended to prolong a product’s market presence. This distinction should not become an additional patentability requirement. Under the Turkish Industrial Property Code, novelty, inventive step, and industrial applicability govern patentability. A more stable formulation or improved manufacturing process may constitute a patentable invention without producing a new therapeutic effect. The Competition Authority should not become an additional patent-quality assessor.
The cumulative nature of pharmaceutical innovation – discovering an active ingredient does not complete pharmaceutical R&D. Further work may address stability, bioavailability, administration, formulations, or new indications. As noted in the OECD’s Health at a Glance 2025, product–indication combinations in active development worldwide more than doubled between 2013 and 2023, reaching 41,370. Establishing a hierarchy between initial and subsequent inventions would overlook this cumulative process. Each invention requires its own technical and legal assessment.
Patent “extension” and divisional applications – a subsequent patent covering a different invention relating to the same medicinal product does not extend the earlier patent’s statutory term. Under the Turkish Industrial Property Code, patent duration and the scope of protection are governed by the filing date and claims, respectively. Once an active-ingredient patent expires, its exclusivity ends; a separate, still-effective formulation or use patent may nevertheless remain relevant to a specific generic product. This is not an extension of the earlier patent, and labels such as “evergreening” cannot replace claim-specific analysis.
In relation to divisional applications, the Report identifies the number, frequency, and overlap in the content of applications as potential screening factors. A degree of overlap between the disclosure of a divisional application and that of its parent application is inherent in the divisional mechanism, particularly given that the divisional may not extend beyond the content of the earlier application as filed. Overlap alone therefore cannot establish anti-competitive intent.
Patent litigation and preliminary injunctions – litigation, requests for information, cease-and-desist letters, and applications for preliminary injunctions are ordinary means of enforcing patent rights. Their potential deterrent effect on generic entry does not make them anti-competitive. The relevant distinction is whether additional manipulative conduct exists, such as withholding material information from a court or deliberately misleading patent or administrative authorities. Vigorous enforcement should not be equated with misuse of judicial procedures.
The risk of over-deterrence – failure to calibrate competition-law intervention clearly risks unnecessarily deterring legitimate patent enforcement and investment. A predictable framework should prevent competition law from becoming a tool for counter-threats while still allowing scrutiny of genuine abuse.
The final report should clarify when the exercise of patent rights warrants competition-law intervention, distinguishing stakeholder allegations from the authority’s findings. Terms such as “secondary patent”, “divisional patents”, and “threat of litigation” should not themselves create presumptions of invalidity or anti-competitiveness. Clear criteria focused on concrete conduct and its effects would better support both effective competition and pharmaceutical innovation.
Finally, future consultations would also benefit from greater interdisciplinary participation, reflecting the interplay between technical patent law, clinical development, pharmaceutical regulation, and competition policy.
