South Korea’s Ministry of Food and Drug Safety (MFDS) has announced that it will accept applications until June 7, 2026, from participating companies and consulting firms for its “2026 Strategic Consulting Support Program for Pharmaceutical Patent Response.” The program is designed to support small and mid-sized pharmaceutical companies seeking to challenge patents on existing drugs. This year, the MFDS plans to select up to nine companies and provide support such as domestic and overseas patent searches, patent analysis, and guidance on R&D direction, with up to KRW 30 million in assistance per company. Eligible applicants are small and mid-sized pharmaceutical companies with average annual sales of KRW 180 billion or less over the past two years. At the time of application, companies may either designate their preferred consulting agency or receive a list of registered agencies.
From Defensive IP to Offensive IP
What stands out in this news is that the focus of the support is not on ordinary patent filing or securing rights, but on “strategies for responding to existing patents.” Supporting patent searches, analysis, and strategic planning with an eye toward invalidation trials and non-infringement arguments means that this is not merely a system for protecting intellectual property. Rather, it is a system designed to help companies break through IP barriers and enter the market. In fact, as early as 2016, the MFDS had already introduced consulting support for small and mid-sized pharmaceutical companies seeking to advance drug development by challenging patents. In its official 2023 guidance, the agency also included strategies for securing first generic exclusivity, in addition to patent analysis and strategic planning, within the scope of support.
The Real Aim of the Program
Under South Korea’s drug approval–patent linkage system, a generic drug applicant may be eligible for first generic exclusivity if it is recognized as not infringing a patent or prevails in a patent trial or litigation. According to the government’s official explanation, in such cases a nine-month period of exclusive marketing may be granted. In other words, the quality of a company’s patent response strategy affects more than just its ability to avoid disputes. It can directly determine the timing of market entry and the ability to secure first-mover advantages. This support measure should therefore be seen as an effort to strengthen companies’ capabilities at the very entry point: designing a challenge they can win.
The Real Barrier for Small and Mid-Sized Pharmaceutical Companies
For small and mid-sized pharmaceutical companies, the true burden is not simply the existence of patents themselves. The heavier burden lies in the initial cost of determining which patents are genuine obstacles, which claims can be designed around, where grounds for invalidation may exist, and whether such a challenge makes commercial sense. Patent searches and freedom-to-operate analyses are needed at a very early stage of R&D, yet they are also areas where costs tend to be incurred well before any revenue is generated. That is why filling this gap through public support has a significance that goes beyond an ordinary subsidy. Rather than merely covering part of R&D expenses, it amounts to the government partially underwriting the “intellectual infrastructure for market-entry decisions.”
Why the Impact Can Be Large Even on a Small Scale
This year’s support is limited to up to nine companies, with a maximum of KRW 30 million per company, so in quantitative terms it may not appear to be a large-scale industrial policy measure. However, this kind of support is likely to be more effective when targeted at companies with concrete development candidates and clearly identified patent issues, rather than being spread thinly across a broad range of recipients. Moreover, the MFDS has continued similar support since 2016 and states that it has supported 104 projects involving 61 companies to date. The agency has also explained that, among participating companies, there have been cases in which firms secured first generic exclusivity and similar outcomes through patent challenges. As a policy measure, it may not be flashy, but from a practical standpoint it is highly well-conceived support.
A Changing Role for the Regulatory Authority
This news also shows that the role of the regulator is no longer limited to being an administrative body that reviews safety and efficacy. Of course, the MFDS’s core mission is to ensure the safety of pharmaceuticals. In practice, however, it is increasingly incorporating into its support programs the very IP strategies needed to bring competitive products to market. This means that pharmaceutical policy does not end with regulatory approval review alone. No matter how promising a generic drug candidate may be, it cannot reach the market if it cannot overcome patent barriers. Conversely, strengthening the ability to deal with patents can itself function both as industrial policy and as access policy.
Implications from a Japanese Perspective
In Japan as well, stable supply of generic drugs and broader adoption of biosimilars have become important policy issues. Yet the discussion tends to focus on manufacturing systems, quality control, drug pricing, and measures to address supply instability. Those issues are certainly important, but Korea’s latest move is notable because it directs policy resources toward building capabilities at the starting point of competition: how to read patents and how to challenge them. That is an important implication. The competitive environment for generic drugs is shaped not only by approval systems and pricing systems, but also by practical capabilities in dealing with intellectual property.
Conclusion
At first glance, this new MFDS support measure may look like just another public call for small and mid-sized pharmaceutical companies, but in fact it carries broader significance. What lies behind it is a policy judgment that enhancing the competitiveness of generic and improved drugs requires not only R&D funding, but also support for the intellectual strategies needed to overcome patent barriers. In the pharmaceutical industry, patents are rights to be protected, but they are also market-entry barriers to be overcome. Korea appears to be acknowledging that reality head-on and seeking to equip smaller companies with the capacity to challenge it.