[Contribution] Summary of major precedents and revised laws in the biopharmaceutical field in 2025

Attorney Daeryun Lee Il-hyung, “It is time to respond quickly in the face of rapidly changing regulatory environment.”
 

The major precedents and changes in laws that shook the pharmaceutical and bio industry in 2025 are summarized in detail through four key tables of contents.

1. System change – implementation of the Digital Medical Products Act

The ‘Digital Medical Products Act’, which came into effect in 2025, has great legislative significance in that it is the world’s first independent bill that reflects the unique characteristics of digital technology, breaking away from the existing hardware-centered medical device law system.

In practice, despite the emergence of innovative products such as digital therapeutics (DTx) such as Aimmed's 'Somzz' and Lunit's diagnostic assistance software, there have been many confusions due to being bound by outdated medical device law regulations. This legislation is evaluated as a result of resolving these difficulties in the field and preemptively reflecting the trend of the times called digital transformation.

This law clarifies the classification system into digital medical devices, digital convergence medicines, and digital medical health support devices, and rationalizes regulations according to the characteristics of digital products.

What is particularly noteworthy is the flexibility of the licensing and follow-up management system. Component performance evaluation regulations were established, regulations were relaxed to allow products to be provided to medical personnel for performance evaluation in actual clinical settings, and the GMP review process was also adjusted to suit the digital environment. This provides companies with the opportunity to create new data-based business models beyond simple regulatory compliance, and will become a key foundation in determining the global competitiveness of countries and companies in the digital healthcare field.

2. Patent field – 13-valent pneumococcal vaccine ruling

An important precedent in the field of pharmaceutical bio patents in 2025 is the Supreme Court ruling on the 'export of 13-valent pneumococcal vaccine (Prevenar 13) crude solution' between Pfizer and SK Bioscience.

According to the ‘principle of completeness of components’ of the Patent Act, in principle, if only parts are exported, there is no infringement on the finished product patent. However, through the so-called ‘Suture Ruling’ in 2019, the Supreme Court said that ‘direct infringement’ of the finished product patent can be recognized if only the parts are exported, if it can be viewed as virtually the same as producing and exporting the finished product. Afterwards, the trial court in the Pfizer-SK Bioscience case acknowledged the plaintiff (Pfizer)’s claim of direct infringement by invoking the above legal principles.

However, the second trial overturned the first trial ruling and sided with the defendant. This Supreme Court ruling is significant in that it reaffirms the validity of the second trial's conclusion and presents clear guidelines on whether it can be considered an infringement of domestic patent rights when parts or raw materials of a patented invention produced domestically are exported overseas and turned into finished products.

Specifically, in the target ruling, the Supreme Court denied both direct and indirect infringement regarding SK Bioscience's act of supplying raw vaccine solution to a Russian pharmaceutical company for research purposes.

On the basis that the mixing process to produce a finished vaccine product is a complex process that must meet strict conditions such as input amount, pH, and temperature, the court ruled that the supply of raw solution (parts) alone cannot be considered 'production' that realizes the technical effect of the patented invention. In particular, it was made clear that “under the principle of territoriality, the production of a patented product means completion within the country, so the export of semi-finished products scheduled for assembly overseas is not subject to the patent right.”

By acknowledging that the export is an exception that limits the effectiveness of patent rights because it is 'conduct for research or testing' for clinical trials and analysis, it has resolved much of the legal risks that domestic bio companies may have in the process of global research cooperation and technology export.

3. Human Resources and Labor - Case of irregular dispatch relationship of night cleaning workers at bio factory

A meaningful ruling that reflects the special characteristics of the biopharmaceutical production site also attracted the attention of the industry in 2025.

In a lawsuit to confirm the worker dispatch relationship brought by workers from a partner company who performed night cleaning work in the clean room of a global bio CMO company, the court ruled against the plaintiff. The core of the trial was whether the standard operating instructions (SOP) provided by the main contractor for GMP compliance constituted actual work instructions and orders.

Considering the special nature of the biopharmaceutical industry, the court ruled that SOPs for maintaining the cleanliness of bioprocesses are only essential guidelines for safety and quality and cannot be viewed as specific instructions on how to carry out work.

In addition, it denied illegal dispatch, acknowledging that cleaning work is an independent professional area separate from the main body production process. This case provided legal justification for designing a contract structure based on business expertise and the specificity of facility management for bio companies that need to manage the risk of outsourcing production lines.

4. Compliance sector – Establishment of CSO reporting system and strengthening of rebate punishment

The Sales Promotion Operator (CSO) reporting system will be fully established in the market by 2025, improving the transparency of the pharmaceutical distribution order. In particular, as expenditure reports providing economic benefits prepared by CSOs begin to be made public, health authorities are expected to regularly conduct data-based investigations using them in the future.

Now, pharmaceutical companies have gone beyond simply outsourcing sales and are now responsible for monitoring and training in real time whether the CSO, which is an outsourcer, complies with the law.

The regulatory network to block illegal rebate structures at the source is becoming tighter than ever. Accordingly, in the future, compliance in the biopharmaceutical field is expected to go beyond the scope of the legal team and become a key element of management directly related to the survival of the company.

5. Sintering

I think that 2025 will be remembered as a more changeable year than ever before. In the face of a rapidly changing regulatory environment, the pharmaceutical and bio industry also needs to respond quickly.

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[Contribution] Summary of major precedents and revised laws in the biopharmaceutical field in 2025