An assessment on the Competition Authority’s Preliminary Report on the Pharmaceutical Sector Review and the Workshop on Competition in the Pharmaceutical Sector
The Competition Authority’s Preliminary Report on the Pharmaceutical Sector (“Preliminary Report” or “Report”), published in August 2026, and the Workshop on Competition in the Pharmaceutical Sector (“Workshop”), held on 21 September 2026, have facilitated a comprehensive discussion on the dynamics of competition in the pharmaceutical sector for the first time in a long while. The Preliminary Report is a significant study in that it assesses the mechanisms of patent protection, market authorisation, reimbursement and distribution throughout the entire process which includes the development of a medicinal product in the laboratory to its provision to patients.
The Preliminary Report acknowledges that intellectual property and competition law serve a common purpose in promoting innovation and ensuring dynamic efficiency. The Report states that innovation in the pharmaceutical sector requires significant effort, capital and time; and that patent protection serves to reward innovation, encourage new research and prevent piggybacking.
Our expectation of the Final Report is that this approach will also be taken in the assessment of patent strategies. There is no doubt that it is necessary to examine specific cases where the patent and judicial systems have been instrumentalised to hinder competition. However, the mere existence of a patent right or its ordinary use should not be treated in the same way as the misuse of these mechanisms.
“The view that there are numerous patents held by reference drug manufacturers covering the same active ingredient, and that this is done for the purpose of continuously extending the term of patent protection (evergreening), is frequently expressed both in the literature and in court rulings. In this regard, the role that competition law may play should be to determine whether manipulative conduct has taken place in the acquisition and use of patent rights … that goes beyond the function of innovation.” (Preliminary Report, p. 92, para. 258)
We therefore believe that the criterion of “manipulative conduct” adopted in the Preliminary Report should be explained in terms of specific acts and their exclusionary effects, rather than the type or number of patents.
The Preliminary Report’s Approach to Concepts Specific to Patent Law
Whilst the Preliminary Report acknowledges the fundamental role of patent protection in encouraging innovation, it regards the exclusivity conferred by patent rights as the starting point for competition concerns in certain areas. In this regard, it is important to distinguish between the exclusivity granted to the patent owner and the conduct that may arise during the exercise of that right, which must be assessed separately under competition law.
A patent grants the patent owner the right to prevent third parties from exploiting the invention without authorisation for a specified duration. The ability to restrict certain conduct of competitors is not an incidental consequence of this system, but rather the legal function of the time-limited exclusivity granted in return for the disclosure of the invention. Therefore, interpreting patent protection merely as a factor that delays the entry of existing competitors into the market would lead to an oversight of the patent system’s role in competition driven by innovation.
The Concept of a Secondary Patent
The TRIPS Agreement, to which Türkiye is a party, clearly reflects this dual structure. Whilst Article 7 provides that the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and the dissemination of the technology, Article 8(2) allows for appropriate measures to be taken against the abuse of rights or practices that inappropriately restrict trade. As regards to patentability, Article 27(1) provides that inventions in all fields of technology must meet the criteria of novelty, inventive step and industrial applicability, without making any distinction between “primary” and “secondary”. [1]
Our view is that, this system adopted in the TRIPS Agreement is significant. This is because the exclusivity afforded to an invention by patent law is a distinct matter from the abuse of that exclusivity in a specific case in a manner contrary to competition law. Intervention by competition law should not stem from the fact that a patent right affords exclusive protection.
The discussion of the concept of “secondary patents” is prominent in the Preliminary Report’s assessments of patent strategies. It was also observed during the workshop that categorical assessments regarding patentability were made in regard to this concept. For this reason, it is important to clarify the legal nature of the term “secondary patent”.
Whilst similar terminology is also used in the European Commission’s 2009 Pharmaceutical Sector Inquiry, the Commission has specifically emphasised that the concepts of “primary” and “secondary” patents are not legally defined categories under patent law, and that this classification does not imply that “secondary” patents are of lesser importance, quality or validity. The Commission states that the term “secondary patent” should not be understood to mean that the patent is of lower quality or value, but should merely refer to patents that follow the primary patent in terms of timing. [2]
Indeed, the term “secondary patent” is not a category in patent law that determines the conditions for patentability, the scope of the protection granted, or the scientific value of the invention. In practice, it encompasses a wide range of inventions that are technically considerably distinct from one another, such as formulations, pharmaceutical combinations, manufacturing processes, salts, polymorphs, crystal forms, dosing regimens and second or subsequent medical use.
A study published under the WIPO CDIP programme states that the term “secondary” patent is essentially a term used to distinguish between different types of claims; it notes that inventions such as types of dosages, formulations, manufacturing methods and new therapeutic applications may emerge during subsequent stages of development. [3]
Yusufoğlu Bilgin states that it is not necessary to deviate from the fundamental principles of patent law with regard to second medical use inventions, and that the conditions for patentability should be assessed in accordance with EPC and European practice. [4]
The General Assembly of the Court of Cassation, in its decision dated 21.10.2021 and numbered 2017/145 E. 2021/1278 K., also recognised that inventions relating to second and subsequent medical uses may be eligible for patent protection under the EPC system; and established that such claims cannot be excluded from patent protection merely because they relate to a second medical use. Thus, while clarifying that inventions relating to second and subsequent medical uses are not excluded from patent protection under Turkish law; it also accepted that such inventions must be assessed within the framework of the general conditions for patentability, particularly novelty and inventive step.
The fact that one of the academic speakers at the Workshop made a categorical statement to the effect that “secondary patents are not protected in Türkiye” also demonstrates a lack of sufficient legal knowledge on this subject and highlights the importance of clarifying the legal consequences of the terminology used. The fact that an invention was developed chronologically after an active ingredient invention does not negate its patentability; nor should the use of the expression “secondary” in itself create any presumption regarding quality, validity, or competition law and the abuse of a dominant position.
The Concept of Therapeutic Contribution
This terminological issue concerning the concept of a “secondary patent” also arises in the section of the Preliminary Report dealing with the assessment of which type of innovation are worthy of being granted patent protection.
The Preliminary Report describes the distinction between “innovations that provide a genuine therapeutic benefit” and practices aimed at keeping an existing product on the market for longer through minor modifications as one of the criteria defining the scope of both patent and competition law.
We are of the opinion that this statement requires careful consideration, particularly from the perspective of patent law. Pursuant to Article 82(1) of the Industrial Property Code No. 6769 (“IP Code”), a patent is granted for inventions in any field of technology, provided that they are novel, involve an inventive step and are susceptible of industrial application. Article 52(1) of the European Patent Convention also stipulates the same fundamental conditions for patentability.
In this context, attempting to introduce “assessment” criteria whose scope and limits are unclear and which are not outlined in the IP Code —such as providing “a genuine therapeutic contribution”— to ensure that a patent right does not give rise to competition concerns are particularly problematic, especially in the case of pharmaceutical patents. This is because, in the case of medicinal products, it is, of course, the case that a new manufacturing process, a more stable pharmaceutical formulation, a development that facilitates storage or administration, or another invention that resolves a technical manufacturing problem, may satisfy the conditions for patentability even without producing a new therapeutic effect.[5]
Therefore, it would not be correct to make the concept of “therapeutic contribution” into a general criterion for patentability or “entitlement to protection”. Indeed, in its 2009 Pharmaceutical Sector Inquiry, the European Commission stated that inventions in the pharmaceutical sector may relate, not only to new active ingredients, but also to new formulations or new manufacturing methods for existing active ingredients; and that all of these are, in principle, patentable. The Commission also explicitly states that the fact that a new medicinal product is therapeutically more effective than an existing one is not a condition for patentability.[6]
In summary, the fundamental assessment of whether an invention is worthy of protection under the patent system must be carried out within the framework of patent law’s own criteria for patentability. In our view, the Competition Authority’s role should not be to carry out this technical assessment as an additional patent quality control mechanism.
The Ongoing Nature of Pharmaceutical Innovation
One of the points which we believe was not given sufficient attention in the Preliminary Report is the fact that pharmaceutical innovation is not, in most cases, a linear process completed by a single invention, but rather a process of research and development that continues even after the discovery of the active ingredient.
Whilst the identification of the active ingredient is one of the most important scientific stages of the medicinal product development process, it does not imply that all technical issues have been resolved—issues necessary to ensure the provision of a safe and effective product to patients, which is a prerequisite for marketing authorisation and market entry, as well as the provision of stable and feasible alternatives that improve patient adherence to the medicine. Ensuring that the active ingredient is administered at the appropriate dosage and by the appropriate method, guaranteeing its stability and bioavailability, determining its compatibility with excipients, or demonstrating the efficacy of a known ingredient in a new patient group or for a new indication may require significant additional research and development activities.
According to the OECD’s Health at a Glance 2025 report, the number of product-indication combinations in active development worldwide more than doubled between 2013 and 2023, reaching 41,370; the OECD notes that this increase is partly due to the development of the same products for multiple indications.[7] In our view, this data demonstrates that pharmaceutical R&D does not end with the discovery of new active ingredients, and that the development of new applications for existing products constitutes a significant part of research activities.
We, therefore, believe that establishing a hierarchy of scientific or legal value between the “initial invention” and subsequent developments would be incompatible with the nature of the medicinal product development process. Whether each specific invention involves an element of novelty and an inventive step must be the subject of a separate technical and legal assessment.
An Assessment of Patent Strategies from the Perspective of Competition Law
It was noted that the discussion in the Preliminary Report concerning patent strategies touched upon the issue of “extending” patent protection. However, the succession of different patents relating to the same product over time is not, in legal terms, the same as extending the term of a single patent right.
According to Article 101(1) of the IP Code, patent protection lasts for twenty years from the date of filing and this period cannot be extended; whilst, pursuant to Article 89(1) of the IP Code, the scope of protection afforded by a patent application or a patent is determined by its claims.[8]
Therefore, the grant of a subsequent patent relating to the same product does not legally extend the term of protection of the earlier patent; the subsequent patent will provide protection only in respect of the separate invention defined in its own claims and within its own term of protection. Therefore, the grant of a patent for a formulation, process or new medical use that meets the conditions for patentability following a patent for an active ingredient will not alter or extend the expiry date of the active ingredient patent.
In our opinion, this distinction is also significant in terms of the entry of a generic product into the market, as third parties are no longer bound by the exclusivity arising from the active ingredient patent once it has expired. Conversely, if a product intended for market launch falls within the scope of a separate formulation, process or use patent that is still in force, the subsequent patent will also be taken into account. The reason for this is not that the first patent has been “extended”, but that an independent right exists for a different patentable invention. It is, therefore, important that general characterisations such as “evergreening” do not replace legal analysis.
The same conceptual rigour is also required with regard to patent clusters and divisional patents. The Preliminary Report highlights that these tools may increase uncertainty regarding the generic entry under certain conditions, and recommends, particularly in the case of divisional applications, that indicators such as number, frequency and overlap in content be assessed. However, it is important that these indicators are further clarified so that such assessments are meaningful to practitioners and legal professionals.
Firstly, it is clear that there is no principle of patent law stipulating that a pharmaceutical product must be protected by a single patent. The active ingredient, the pharmaceutical composition, the manufacturing process, the method of administration or specific medical uses may each constitute distinct technical inventions and, to the extent that each meets the conditions for patentability, may be protected by a separate patent right.
Divisional patent applications are also a standard application mechanism provided for under Turkish patent law and the EPC system. The Preliminary Report itself classifies divisional applications as “routine procedures” under patent regulations. Nevertheless, the inference that divisional applications filed at the applicant’s own request are more likely to have been made with the aim of hindering market entry requires a stronger factual basis.
A voluntarily filed divisional patent application is one of the options provided for by the system and has legal basis. Indeed, Article 91(3) of the IP Code stipulates that the subject-matter of a divisional application must not exceed the scope of the original application; whilst under Article 76(1) of the EPC, it is stipulated that the subject-matter of a divisional application must not go beyond the content of the original application as first filed. In practice, the specifications of divisional patent applications are generally identical, whereas claims are, in any case, rejected if they do not contain features distinct from those of the original application. Therefore, the overlap in technical content and specification between the parent application and the divisional application is a natural consequence of the legal structure of the instrument. In this context, it would be misleading to regard the overlap in content between applications as, in itself, an indication that the applicant is pursuing an anti-competitive strategy.
The Preliminary Report’s own findings regarding Türkiye also support a measured approach. The report found that, for the period 2023–2025, divisional patent applications in the pharmaceutical sector accounted for a very low proportion of total pharmaceutical patent applications and did not emerge as a widespread practice in Türkiye. In light of this data, the number, frequency or the technical link between applications should not be treated as objective criteria that replace anti-competitive conduct.
Another area addressed by the Preliminary Report in relation to patent strategies is patent litigation and preliminary injunctions. Here, too, the same need arises: the act of preventing a product falling within the scope of a patent’s protection from entering the market on the basis of that patent right, should not, in itself, be categorised as conduct giving rise to concerns under competition law. Preventing such a categorisation becomes all the more important when one considers that the effective exercise of a patent right is directly dependent on judicial protection.
Although the patent owner is granted an exclusive right, if the very act of requesting information, issuing a cease-and-desist notice, bringing legal proceedings or, where the conditions are met, applying for a preliminary injunction in the face of a threat of infringement is regarded as a competitive risk in itself, the practical and economic value of the patent right will undoubtedly be significantly diminished. It falls within the normal scope of the patent right for the patent owner to resort to the remedies provided by law if they believe that a competitor’s activity falls within the scope of their patent.
The Preliminary Report also explicitly acknowledges that bringing legal proceedings is a legal right of innovator manufacturers. However, it draws attention to the fact that the costs and risks associated with such proceedings may have a deterrent effect on market entry, particularly for smaller generic manufacturers. However, the existence of such a deterrent effect should not, in itself, be regarded as problematic from the perspective of competition law. This is because one of the fundamental functions of a valid patent right is to prevent unauthorised use within the scope of the claims; the prevention of a competitor from bringing a specific product to market as a result of the successful exercise of that patent right is a natural consequence of that right.
In our view, situations that may be problematic from the perspective of competition law involve the introduction of additional manipulative conduct independent of the patent dispute. The examples cited in the Preliminary Report, such as the concealment of material information that could influence the court’s decision or the deliberate provision of misleading information to patenting/administrative authorities, clearly illustrate this distinction. The issue that should be regarded as problematic from a competition law perspective is not the vigorous assertion of patent rights, but rather the misleading of the decision-making process or the manipulation of procedure for purposes other than those intended. Naturally, ensuring effective legal and judicial protection to encourage sound and competitive innovation should also be a matter requiring intervention by the Competition Authority.
Wider Implications of the Preliminary Report
It is entirely natural that the concepts used to define conduct in sector inquiries prepared by competition authorities also influence the future conduct of market actors. For this reason, in such studies, consideration must be given to the possibility that blurring the line between patent law and its standard practice on one hand, and conduct contrary to competition law on the other, may lead not only to incorrect legal conclusions but also to the deterrence of legitimate conduct.
In other words, failure to calibrate intervention correctly in competition law entails not only the risk of anti-competitive conduct going unnoticed, but also the risk of unnecessarily deterring competitive conduct.
Indeed, in the Turkish competition law literature, this issue has been addressed under the concepts of “erroneous intervention” and “excessive deterrence”. Sümer Özdemir points out that, when determining the abuse of a dominant position, competition authorities’ overly interventionist perspective may lead enterprises to refrain from conduct that is, in essence, competitive; emphasising the need to carefully distinguish between competitive and anti-competitive exclusionary practices. Similarly, Madan highlights that competition law intervention may be excessively deterrent and notes that it would be beneficial to favour tests with a lower risk of erroneous intervention in terms of optimal deterrence. This approach also highlights the importance of setting out the criteria for intervention as clearly and predictably as possible.[9],[10] With regard to the limits of such intervention, close attention is being paid to how the Competition Board’s Tetra Pak[11] decision will be finalised following judicial review.
As we also noted in the comments we submitted to the Competition Authority following the Workshop, the risk of excessive deterrence has begun to materialise, and examples have started to emerge where even cautious requests for information made by a patent holder – with the purpose of clarifying a potential infringement prior to litigation – are met with the threat of a “complaint to the Competition Authority”, without any discussion of the scope of the patent or the ingredient of the infringement claim. Such a situation poses the risk of hindering the assertion of legitimate patent rights rather than preventing anti-competitive conduct.
We are certain that the Competition Authority does not wish to see competition law become a tool for counter-threats that supersede the legal debate on the merits of patent rights. In our view, the solution lies not in exempting patent rights from competition law scrutiny, but in defining as clearly and concretely as possible which other conduct transforms ordinary patent practice into a competition law issue.
Competition policy choices relating to patent protection should not be assessed in isolation from the current structure of the Türkiye pharmaceutical market. It should not be forgotten that, as far as Türkiye is concerned, the only access issue is not merely the timing of generic entry. Creating a predictable ecosystem for R&D and technology investment—one that encourages the development of new treatments and their timely availability in Türkiye—is also part of the same policy equation.
As was also mentioned at the Workshop;
- According to IQVIA’s 2024 Türkiye Pharmaceutical Sector Report, patent-protected products accounted for approximately 14% of the Türkiye pharmaceutical market in 2023, whilst this figure ranges between 40% to 60% in many EU countries. The same report states that, of the 167 innovative treatments that received marketing authorization from the EMA between 2019- 2022, access to 6 was provided in Türkiye according to the access methodology; of these 6 products, 5 were authorised and included on the public reimbursement list, whilst access to the sixth was provided via the Foreign Drug List.[12]
The report in question was prepared under the sponsorship of AIFD and EFPIA, and it is stated that the research, analysis and conclusions were independently produced by IQVIA. The report also states that strong intellectual property protection is one of the factors influencing trade and investment decisions; however, it notes that the investment climate is influenced by a combination of many factors, such as predictable and stable policies, a skilled workforce, market access conditions, and production and logistics capabilities. For this reason, the data in question is valuable in demonstrating the need for a multi-faceted approach to policy assessment.[13]
- As also noted at the Workshop, the 2026 EFPIA Patients W.A.I.T. Indicator reports that the median access time across Europe for 168 innovative medicines is 532 days, and that significant disparities in access persist between countries. In Türkiye, however, this period is considerably longer. The report, which is an industry source, attributes the delays to a number of factors, including the speed of regulatory processes, evidence requirements, budgetary constraints and pricing/reimbursement processes.[14] Whilst a precise number of days cannot be calculated for Türkiye, according to data from the 2025 IQVIA / AIFD / EFPIA Turkey Pharmaceutical Sector Report, Türkiye’s rate of full access to innovative medicines stands at just 3%.
No doubt these figures demonstrate the importance of not reducing the measure of success of competition policy solely to the rate of generic market entry or short-term price decreases. Patients must have access both to existing treatments at sustainable prices and also to innovative treatments of the future in reasonable time. A robust and predictable patent system is also one of the elements of this broader ecosystem.
Conclusion and Recommendations for the Final Report
We believe that the primary aim of the Final Report should be to clarify under what conditions intervention is necessary under competition law.
This approach must also be reflected in the report’s terminology. The arguments of industry stakeholders and the Authority’s own findings should be distinguished more clearly throughout the report; it is important that terms such as “secondary patent”, “weak patent”, “patent cluster”, “divisional patent” or “threat of litigation” are not used in a way that creates a presumption of invalidity or anti-competitiveness without explaining the additional factors that render them problematic under competition law in a specific case. Whilst the Preliminary Report’s presentation of the views of reference and generic medicine manufacturers under separate headings is a good starting point for establishing this distinction, it would be beneficial for the Final Report to distinguish stakeholders’ viewpoints even more clearly, allowing to distinguish from those of the Authority’s own findings.
The same degree of sensitivity must be maintained in the Workshop and other stakeholder consultations. Pharmaceutical patents lie at the intersection of technical patent law, clinical development, regulation and competition law. Therefore, strengthening interdisciplinary diversity in the selection of speakers and experts in future occasions, and ensuring that the scientific aspects and technical characteristics of patent law and pharmaceutical development practice are adequately reflected in the discussions, will contribute to the scientific and legal quality of the Final Report.