新着情報

Lee & Ko is representing a Taiwanese medical device supplier in appellate proceedings arising from an international civil dispute against a Korean diagnostic kit manufacturer in connection with a medical device supply agreement.

The dispute concerns the supply of COVID-19 antigen rapid diagnostic test kits to the Taiwanese market during the COVID-19 pandemic. The key issues include performance of contractual obligations, alleged deficiencies in product performance, and the corresponding scope of payment obligations under the agreement. In the first instance, the court ruled against the supplier, finding that no defect in the rapid diagnostic kits had been established. Following its appointment at the appellate stage, Lee & Ko has undertaken a comprehensive review of the trial court’s reasoning and overall analytical framework.

In the appellate proceedings, Lee & Ko is addressing not only issues of contractual interpretation relating to claims for payment, but also a range of complex legal and technical questions. These include applicable medical device performance standards, the adequacy of quality management systems, and the extent to which actions taken by overseas regulatory authorities may influence the assessment of civil liability.

Drawing on its understanding of Taiwan’s regulatory framework and academic environment, the firm has worked in close coordination with local regulatory and academic experts to obtain authoritative expert opinions. These materials have been carefully integrated into the appellate strategy to ensure that the court is presented with a scientifically grounded and legally coherent analysis.

This case represents a multifaceted cross-border dispute involving international distribution arrangements, product performance issues, and foreign regulatory considerations. In the appellate proceedings, Lee & Ko is systematically organizing both the factual record and the governing legal principles, and advancing persuasive arguments from legal and technical perspectives to support a reasoned and balanced determination.
 

The IP & Technology Practice Group of Lee & Ko is representing the patentee of a core patent relating to no-glue artificial eyelashes in preliminary injunction proceedings against multiple companies in Korea that manufacture and sell competing products.

In response, the accused companies have initiated multiple actions before the Korean Intellectual Property Office (“KIPO”), including invalidation trials and trials for confirmation of the scope of patent rights. As a result, civil and administrative proceedings are progressing in parallel. Lee & Ko is leading the overall litigation and trial strategy on behalf of the patentee, encompassing preliminary injunction applications, merits litigation, and patent trial proceedings.

The dispute presents intertwined technical and legal issues concerning a new category of cosmetic products—no-glue artificial eyelashes. A central question is whether specific technical features, such as the extent and method of adhesive application and the mechanism by which the product attaches to a user’s natural eyelashes, fall within the scope of the asserted patent claims.

At the preliminary injunction stage, the patentee must establish a prima facie case of infringement and demonstrate the likelihood of irreparable harm through detailed technical analysis. In the parallel patent trial proceedings, the strategic focus is on defending the patent’s validity, particularly the inventive step of the claimed invention over prior art, and articulating a consistent and legally sound interpretation of claim scope.

As Korean cosmetic brands continue to expand globally amid the prominence of “K-beauty,” the industry is characterized by short product life cycles and the rapid emergence of competing and imitative products. In this environment, early-stage patent registration and proactive enforcement are critical to maintaining competitive advantage. This dispute highlights the importance of promptly enforcing registered patent rights while simultaneously clarifying and reinforcing claim scope through coordinated litigation and administrative proceedings. It provides meaningful guidance for companies in the cosmetics sector in developing effective patent strategies and managing IP disputes.
 

Lee & Ko is representing R Bio Co., Ltd. (“R Bio”) in an administrative lawsuit seeking to revoke the decision of the Ministry of Food and Drug Safety (“MFDS”) rejecting R Bio’s application for marketing authorization (“MA”) for its stem cell therapy, JointStem. R Bio has developed JointStem over a period of approximately sixteen years since 2005.

This case squarely challenges the legality of the MFDS’s refusal to grant MA for a stem cell therapy whose clinical efficacy has been objectively demonstrated. The dispute raises fundamental questions concerning the rationality, transparency, and predictability of regulatory standards applicable to regenerative medicine products. It also carries significant implications for the broader regulatory environment governing Korea’s biotechnology and pharmaceutical industries.

In this matter, Lee & Ko is drawing upon its expertise in clinical biostatistics and pharmaceutical regulatory standards to develop a litigation strategy grounded in scientific rigor. The firm’s analysis addresses complex scientific and statistical issues, including: the appropriateness of the clinical trial design (Study Design), development and implementation of the Statistical Analysis Plan (SAP), hypothesis testing for primary and secondary endpoints, interpretation of efficacy and safety indicators, and the distinction between statistical significance and clinical relevance. In particular, with respect to the MFDS’s assessment of clinical efficacy, Lee & Ko’s arguments extend beyond a narrow inquiry into whether certain numerical endpoints achieved statistical significance. The firm is comprehensively examining the validity of the overall study design, the appropriateness of the patient population, the methodological soundness of the statistical testing framework, and the interpretability of long-term follow-up data. Through this approach, the case fundamentally contests whether the regulatory determination is consistent with accepted scientific and statistical principles.

More than a conventional administrative challenge to a marketing authorization rejection, this matter represents a pivotal examination of Korea’s regulatory standards for stem cell therapies and regenerative medicine products, including their alignment with international practice. The outcome is expected to provide an important reference point for future approval and regulatory processes concerning innovative drugs and advanced biopharmaceuticals.

Through its representation in this case, Lee & Ko further demonstrates its capabilities in bio/healthcare IP and regulatory disputes, including data-driven advocacy, sophisticated clinical data analysis, and strategic litigation at the intersection of science, regulation, and administrative law.

 

On behalf of Samsung Bioepis, Lee & Ko’s Intellectual Property Practice Group prevailed in patent invalidation and infringement actions relating to Soliris®, paroxysmal nocturnal hemoglobinuria treatment, thereby enabling Samsung Bioepis to launch its biosimilar on an earlier schedule.

Soliris® is a rare disease treatment developed by Alexion Pharmaceuticals (“Alexion”), a U.S. pharmaceutical company, and is an extremely expensive drug with annual costs borne by each patient reaching KRW 500 million (approx. USD 363,100).  Alexion, the patentee, held two registered patents for Soliris®, of which the composition patent expired in 2015, with only the use patent remaining at the time of the suit.  Last June, Samsung Bioepis preemptively filed an invalidation action against the use patent, and in response, Alexion filed a patent infringement suit against Samsung Bioepis.

Lee & Ko argued that the priority claim of the asserted patent should be denied and that there was a lack of novelty and inventive step.  The Intellectual Property Trial and Appeal Board (the “IPTAB”) agreed and invalidated Alexion’s patent.  Alexion appealed the decision to the IP High Court, which affirmed the IPTAB’s decision, again siding with Lee & Ko’s arguments.  With Alexis deciding not to file an appeal with the Supreme Court, the determination on the patent invalidity became final and conclusive.  Samsung Bioepis also won in the patent infringement suit on the ground that the filing of the suit amounted to an abuse of patent rights based on an invalid patent.

Based on these wins, Samsung Bioepis obtained market approval for Epysqli®, a biosimilar of Soliris®, from the Ministry of Food and Drug Safety in January 2024 and successfully launched the product in Korea in April.
 

Lee&Ko successfully defeated the generics’ challenge against Boryong’s patent covering Dukarb®, which is a domestic blockbuster drug, before the IPTAB and subsequently the IP High Court. On November 30, 2023, the IP High Court ruled in favor of the patentee in all 10 cases, including both scope confirmation actions and invalidation actions, filed by dozens of generic companies, including Arlico pharmaceuticals, against the Dukarb® combination product patent. 

Dukarb tablet, as a combination of Kanarb® (fimasartan) with amlodipine, is a blockbuster drug that has shown excellent antihypertensive effects and generated sales of KRW 40 billion in 2022. In 2021, more than 45 domestic generic companies filed scope confirmation actions and invalidation actions to assert non-infringement and invalidity of the Dukarb® patent, but the patentee prevailed in all cases. The generic companies subsequently filed 10 appeal cases to the IP High Court, but the IP High Court upheld the decisions of the IPTAB on November 30, 2023.

The generic companies alleged invalidity of the patent at issue on various grounds such as novelty, inventiveness, lack of the description requirement, and incomplete invention, while simultaneously claiming non-infringement on the grounds of compound differentiation and salt change. Therefore, it was essential for the patentee to present a consistent and strategic response to the various claims made by different generic companies. Despite unfavorable case precedents on combination drug patents, Lee & Ko successfully argued for inventiveness of the patent at issue by focusing on the synergistic effects of the combination product. Likewise, in the negative scope confirmation action cases, Lee & Ko presented persuasive claim construction and equivalent infringement based not only on the claim language but also on the specification and the common technical knowledge of the pharmaceutical industry. Ultimately, Lee & Ko prevailed in all 10 cases, again demonstrating the team’s expertise in healthcare and IP.

Lee&Ko represented and remarkably defended Pyunkang Botanic Lab Co. Ltd. (“Pyunkang”) in the lawsuit filed by individuals who consumed Pyunkang’s deer antler product (the "Product") and claimed damages for violation of the Product Liability Act.

In the above lawsuit, the plaintiffs asserted that they suffered various problems after consuming the Product manufactured and sold by Pyunkang and that if Pyunkang had labeled the Product with instructions on measures for consumers against abnormal symptoms or adverse reactions, they would have avoided such problems, and thus Pyunkang was liable for damages in tort for defective labeling (defective instructions and warnings) under the Product Liability Act.

In response, Lee&Ko clearly explained to the court that the Product was manufactured and sold in compliance with the relevant food laws, that quality investigations conducted by Pyunkang had met all relevant standards, and that there was no basis to argue that the ingredients in the Product caused the problems which the plaintiffs claimed to have suffered. More importantly, Lee&Ko pointed out in detail, with evidence, that there is no defect in the labeling of the Product under the Product Liability Act because Pyunkang has labeled the Product, especially including the precautions or warnings, in full compliance with the requirements of the Food Labeling and Advertising Act.

Accepting all arguments presented by Lee&Ko, the court granted judgment in favor of Pyunkang, dismissing all of the plaintiffs’ claims.

In this case, Lee&Ko’s Healthcare Team prevailed by persuading the trial court with its strong arguments based on a thorough understanding of food ingredients and proper application of legal principles of the Product Liability Act. 

Lee&Ko’s Healthcare Team has extensive experience and know-how in successfully defending manufacturers against product liability claims in the healthcare sector – some notable examples include cases where a number of consumers alleged that sanitary pad manufacturers failed to disclose the harm caused by substances in sanitary pads, and where a number of consumers sought damages against implant manufacturers for the violation of product liability laws.