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Global food, beverage, and alcohol companies have steadily expanded into the Korean market. With Korean consumers’ tastes evolving quickly and a keen sensitivity to trends, many international F&B brands are eager to launch new products locally.

In addition to the Food Sanitation Act, Korea’s Ministry of Food and Drug Safety (“MFDS”) enacted the Special Act on Imported Food Safety Control in 2016, which imposes stringent regulations specifically on imported products. As a result, newly launched products must undergo a rigorous process—including customs clearance and inspection by local MFDS branches—before they can be approved for importation. For global F&B and alcohol companies with strong compliance cultures, this regulatory landscape requires thorough legal and regulatory review to ensure full compliance prior to product launch.

In anticipation of this growing demand, in 2023, Lee & Ko brought on board Mr. Kangbong Lee as a senior advisor. Mr. Lee has over 30 years of experience at MFDS, where he held key roles, including Director of Imported Food Policy Division. Leveraging his extensive expertise, Lee & Ko has provided highly effective regulatory advice on a wide range of issues related to imported food compliance and safety management, which often can be complex to navigate.

As a result of close collaboration with Lee & Ko’s Healthcare Practice Group, several leading F&B and alcohol companies could successfully launch their new products in the first half of 2025. These achievements reflect Lee & Ko’s deep regulatory expertise and seasoned experience in the F&B sector.
 

Following the amendment to the Pharmaceutical Affairs Act (“PAA”), which took effect as of February 21, 2025, a pharmaceutical data protection system has been introduced in Korea. The amendment restructured the previous re-examination system and now allows for exclusive protection of clinical trial data for new drugs and orphan drugs for a certain period. As a result, pharmaceutical companies are afforded clearer protection for their intellectual property rights and trade secrets under PAA, independently of patent rights.

Lee & Ko has advised various clients on the impact of this new system’s introduction, with a particular fucus on how scenarios involving generic drug approval applications for new drugs may change in comparison with the previous re-examination system. Especially, it was closely examined whether orphan drugs may enjoy a longer protection period under the new system than was granted under the former regime. Based on these analyses, Lee & Ko provided concrete timelines regarding expected generic entry under various approval scenarios, thereby enabling the clients to develop forward-looking portfolio strategies.

Lee & Ko’s healthcare experts possess in-depth expertise not only in the regulatory realm of PAA but also in patent and intellectual property disputes. With this cross-sectional expertise in regulatory affairs and intellectual property law, Lee & Ko has been recognized for delivering timely, customized, and effective legal solutions to its clients.
 

Lee & Ko is acting for LG Chem, Korea’s leading cathode materials manufacturer that succeeded in mass-producing NCM (nickel-cobalt-manganese) cathode materials for the first time in the world, in a lawsuit filed against Ronbay, another representative cathode material manufacturer in China, and Jae Se Energy, Ronbay’s Korean subsidiary.

NCM cathode materials containing nickel, cobalt and manganese as main components, especially the so-called “high-nickel” cathode materials with high nickel content, exhibit a high energy density and thus can be applied to electric vehicles requiring high capacity and high power. On the other hand, such high-nickel cathode materials require state-of-the-art technology for mass production and commercialization due to their low structural and thermal stability.

As far as NCM cathode materials are concerned, Ronbay enjoys the first place in China, and it was pursuing the export of cathode materials to the United States and Europe while gradually increasing the production of high-nickel cathode materials by using the Chungju plant of Jae Sae Energy as one of its main production bases. However, based on conducting comparative analysis of LG Chem’s diverse patent portfolio regarding cathode materials after obtaining samples of high-nickel cathode materials produced by Ronbay and Jae Sea Energy, it was confirmed that their products infringe at least five of LG Chem’s cathode material-related patents 

In response, Lee & Ko sought an injunction on patent infringement with the Seoul Central District Court on behalf of LG Chem. Simultaneously, Lee & Ko filed an application for preservation of evidence to secure evidence that could reveal patent infringement at an early stage. In the process, Lee & Ko successfully carried out procedures to secure evidence of patent infringement entirely under Ronbay’s control, including persuasively explaining the need to preserve evidence and obtaining the court’s evidence preservation order.
 
In addition, Lee & Ko filed an application with the Korea Trade Commission to investigate unfair trade practices in the import and supply of patent-infringing products by Ronbay and Jae Sae Energy, and the Korea Trade Commission has decided to launch an investigation into the matter, and the investigation is currently underway. Lee & Ko is conducting all-out patent infringement disputes representing LG Chem against Ronbay and Jae Sae Energy by actively defending claims of patent invalidity in response to the patent invalidation action filed by Ronbay.

Lee & Ko has prevailed before the court of first instance, representing Naver in a database rights infringement dispute concerning unauthorized crawling of property listing information from ‘Naver Real Estate,’ Korea's leading real estate information service.

Naver and Naver Financial have built the ‘Naver Real Estate’ database through systematic maintenance, management and verification of property listing information, backed by significant human and material investments over an extended period. The two have been providing a high-quality online real estate service to customers by utilizing this database. The counterparty had been engaging in unauthorized crawling of ‘Naver Real Estate’ property listings by way of posting the same on its website ‘Darwin Property’ and proactively exploited it for the purpose of promoting its business. In response, Naver filed a lawsuit in May 2022, invoking database rights infringement under the Copyright Act and unfair competition, specifically misappropriation of achievements.

During the litigation, which lasted over three years, the counterparty claimed that it merely retrieved the property listing information temporarily from ‘Naver Real Estate’ through simple linking rather than copying or transmitting such information and contended that its use amounted to temporary reproduction and was therefore not illegal. Therefore, proving the counterparty’s database rights infringement became the key issue. Lee & Ko, based on its advanced technical understanding of databases, internet linking, crawling and network communication methods, focused on the technical evidence generated on the counterparty’s website during the period it, without authorization, crawled, accessed and copied ‘Naver Real Estate’ property information. Working closely with Naver’s engineers, Lee & Ko secured and submitted evidence of approximately 260,000 instances of unauthorized crawling-related copying and transmission to the court. Most importantly, Lee & Ko convinced the court by establishing through technical evidence that errors indicated in ‘Naver Real Estate’ were identically showed up on ‘Darwin Property,’ and that when certain information was deleted from ‘Naver Real Estate,’ such information was subsequently deleted from ‘Darwin Property’ as well after a certain period. This remarkable outcome illustrates the expertise and know-how accumulated by Lee & Ko’s Intellectual Property Group, which comprises numerous science and technology experts who have handled many similar cases.

In particular, Lee & Ko successfully fended off the typical “power abuse framing” strategy attempted by copycat latecomers in unauthorized crawling cases - namely, the claim that the market leader is “preventing market entry by latecomers.” Lee & Ko proved the infringement through objective evidence while convincingly explaining the illegality of the infringing acts from a legal perspective, ultimately succeeding in protecting the rights of Naver as the database creator.

In 2021, Versum Materials Korea (“Versum”) filed a patent invalidation action against Tri Chemical Laboratories (“Tri Chemical”) regarding a thin film formation material patent. Lee & Ko, representing Tri Chemical, the patentee, successfully defended the patent’s validity at the Intellectual Property Trial and Appeal Board (“IPTAB”) in July 2023. Although Versum subsequently filed an appeal with the IP High Court to revoke this decision, the IP High Court also upheld the patent’s validity on August 22, 2024 (prevailing on all claims), and this ruling was rendered final and conclusive on September 14, 2024.

The patent at issue directs to Cp hafnium compounds used as thin film formation materials, which are representative high-dielectric materials used to form insulating films at the ends of semiconductor DRAM capacitors or metal gates. This patent is considered so significant in the industry that it is valued at over KRW 1 trillion.

Versum argued that the patent lacked inventiveness as the patented compound was structurally similar to compounds disclosed in prior art references and could be easily derived. In response, Lee & Ko not only successfully articulated the legal principle that in the chemical field, even if compounds show structural similarities, the patent’s inventiveness cannot be readily denied if there are unpredictable and significant differences in effects. Lee & Ko also clearly demonstrated these differences by conducting and presenting comprehensive comparative experiments between the patented compound and prior art compounds.

As a result, both the IPTAB and the Patent Court determined that the patent could not be invalidated due to its unpredictable and significant effects compared to prior art compounds, successfully defending the patentee’s rights. The ruling serves as an important precedent regarding the finding of inventiveness in compound-related inventions.

This case attests to Lee & Ko’s Intellectual Property Group’s superb capabilities and expertise, as it successfully protected an enormously crucial patent from invalidation attempts through more than three years of persuasive arguments in hearings, grounded in  thorough technical review and legal analysis.
 

Lee & Ko Law secured a landslide victory (prevailing on all claims) on August 21, 2024 in a trade secret and copyright infringement lawsuit filed on June 29, 2020 on behalf of Ajinextek, a KOSDAQ-listed company that manufactures motion control chips and equipment for factory automation. The lawsuit was filed against former officers and employees who had misappropriated motion control technology-related source code files and were manufacturing and selling motion controllers using these files. The ruling was rendered final and conclusive on September 6, 2024.

In the related criminal case, (due to investigative authorities notifying the suspects before conducting the search and seizure), only seven source code files were seized from the former officers and employees, making it impossible to directly compare the source codes between the two companies. In response, Lee & Ko sought to prove trade secret and copyright infringement by analyzing the similarities between pseudocodes obtained through decompiling the core executable files of both companies’ motion control equipment software.

The Korea Copyright Commission conducted an appraisal, which showed that the quantitative similarity of pseudocodes for each executable file was relatively low at around 10%. However, Lee & Ko successfully argued and proved through detailed technical analysis that when pseudocodes were similar, their corresponding source codes were nearly identical, and that there were multiple qualitative similarities that could not exist in the first place, unless the source code had been misappropriated. As a result, the court recognized the trade secret and copyright infringement by the former officers and employees, ordering a complete ban on the use, disclosure, production and sale of source codes and executable files as well as their destruction and fully awarded the claimed damages of KRW 100 million (as part of the total claim).

This case stands as a rare example where trade secret and copyright infringement of software programs was fully recognized without direct source code comparison, achieved through more than four years of strong advocacy in hearings, based on thorough technical review and legal analysis. It exemplifies the outstanding capabilities and expertise of Lee & Ko’s Intellectual Property Group, gained from their extensive experience in handling numerous software-related trade secret and copyright infringement cases.

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.
 

Representing the patentee Regen Biotech, Lee & Ko’s IP Practice Group secured a judgment from the Intellectual Property Trial and Appeal Board (the “IPTAB”) finding for patent validity in a patent invalidation action against Regen Biotech’s patent on the method for manufacturing biodegradable polymeric microparticles.  This was a patent dispute between manufacturers of biodegradable polymeric filler for use in skin care products, and the dispute was expected to have a significant impact in the beauty industry, depending on the outcome.

The counterparty argued that the novelty and inventive step of the patent-in-suit should be denied by picking and choosing certain disclosures scattered across different prior art references.  After analyzing the technical features of the patent-in-suit and the prior art in great depth, Lee & Ko’s IP Practice Group emphasized the differences between the two.  In particular, Lee & Ko’s IP Practice Group highlighted that the patent-in-suit was directed to a manufacturing method, and the desired effect could be achieved only by the chronological and organic combinations of each claim element according to the manufacturing method, forcefully noting that such features of the claimed manufacturing method must be fully considered when comparing with the prior art. 

In the end, the IPTAB sided with Lee & Ko’s arguments and found that the patent was not denied novelty or inventive step.  As to the inventive step, the IPTAB’s judgment, rather than dissecting the invention and focusing on the technical difficulty of deriving each claim element separately, carefully analyzed the difficulty of deriving the constitution of the invention as a whole.  This analysis is expected to serve as a precedent for judging inventiveness of manufacturing method inventions.
 

Lee & Ko represented Samyang Chemical and Donghee Industrial in a patent dispute initiated by a Korean domestic chemical company that manufactures and sells rust removers applied to the metal surface of automobile bodies and prevailed on all claims.

Immediately after obtaining a patent registration for rust removers, Chemical Company S, the patentee, filed a request for preliminary injunction, a request for permanent injunction, a scope confirmation action as well as a criminal complaint against Samyang Chemical, which manufactures and sells rust removers, and Donghee Industrial, which receives supplies of rust removers from Samyang Chemical and applies them to metal surfaces of automobile bodies.  The dispute over this single patent lasted for more than a decade.  Initially, the Intellectual Property Trial and Appeal Board (the “IPTAB”) found the patent valid and this decision was rendered final and conclusive.  The IPTAB also held that Samyang Chemical’s product fell within the scope of rights claimed by the patent.  Lee & Ko was retained after these unfavorable decisions to represent both Samyang Chemical and Donghee Industrial. 

Lee & Ko discovered new prior art references and filed a petition for invalidation action.  In this invalidation action, Lee & Ko argued that the appraisal results from the previous lawsuit could not serve as evidence of infringement, as significantly lacking reasonableness.  Lee & Ko also carefully orchestrated the progress of each case to ensure that the representatives of Samyang Chemical and Donghee Industrial were not investigated until the Supreme Court ruled on the issue of patent invalidity.  As a result, the IPTAB, the IP High Court and the Supreme Court all ruled that the patent at issue was invalid, and based on this ruling, Lee & Ko secured winning judgments in all related actions, including the preliminary injunction, the main infringement action and the scope confirmation action.  The criminal case also was concluded with the prosecutor finding that there was no suspicion.

Before Lee & Ko’s representation, the situation was particularly unfavorable to the clients, given the IPTAB decision in favor of the patent validity and the appraisal results from a related case indicating patent infringement.  Based on expertise gained from handling various types of patent disputes, however, Lee & Ko reversed the tides and was successful in invalidating the patent.  This case is illustrative of Lee & Ko IP Practice Group’s deep expertise and formidable performance in patent litigation.