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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.
 

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.

In a trade secret misappropriation lawsuit brought by Company A, a manufacturer of analytical devices for bone density and body composition, against its former employees and Company B founded by the former employees, Lee & Ko’s IP Practice Group successfully defended Company B and the former employees and obtained a court decision in favor of the defendants on all claims. 

Before this civil lawsuit, Company A had filed a criminal complaint against Company B and the former employees for trade secret misappropriation. During the criminal investigation, Company B’s product source code was found to contain portions that are similar to Company A’s product source code, which led to an indictment of Company B and the former employees. Company A then filed a preliminary injunction action against the defendants, seeking prohibition of trade secret misappropriation. As the defendant’s legal counsel, Lee & Ko conducted a thorough analysis of the two companies’ products, and showed that there were overall differences between the two products, from basic working principles to specific algorithms, and that the similar portions of the two products’ source codes were already disclosed in the public domain. Lee & Ko also showed that Company A failed to protect its source codes as a trade secret. As a result, Lee & Ko obtained an acquittal for Company B and the former employees in the criminal action and a court decision dismissing the preliminary injunction request in the civil lawsuit.

After this double loss, Company A additionally claimed copyright infringement of its computer software in the civil lawsuit. In response, Lee & Ko persuasively explained to the court that the source codes at issue were in fact taken from the public domain (such as dissertations) and that Company B did not use Company A’s technology in its product. The court agreed, and found in favor of the defendants on all claims, dismissing every claim raised by Company A in the complaint.

While this case started in unfavorable circumstances, with similarity found between the two companies’ source codes and the defendants having been criminally indicted, Lee & Ko’s IP Practice Group was able to reverse the tides and obtain a triple win, in the criminal case, the preliminary injunction case and finally the copyright infringement case, which nicely illustrates the prowess and expertise of Lee & Ko’s IP Practice Group.

Lee & Ko’s IP Practice Group successfully resolved the legal dispute on behalf of Broadcasting Company M, in a lawsuit brought by a competitor, Broadcasting Company J, that claimed copyright infringement and violation of the Unfair Competition Prevention Act ( “UCPA”). The issue in this case was whether the client copied the television show format of the competitor.

The two broadcasting companies had television audition programs for trot, a genre of Korean pop music, which enjoyed sensational popularity in Korea. Around January 2021, Company J filed a lawsuit against Company M seeking damages compensation as well as an injunction on the airing of Company M’s television show on the ground that Company M copied the format of Company J’s television show. Company J argued that such alleged copying constituted copyright infringement and unauthorized use of another’s achievements prohibited under the UCPA.

The central issue in the lawsuit became whether copyright infringement and unfair competition can be recognized with respect to a television show format. As Company M’s legal counsel, Lee & Ko carefully analyzed the legal principles on the format rights as recognized under the Copyright Act, and building on this analysis, persuasively showed that the elements underlying Company J’s claims  should not be seen as creative on their own and therefore were not eligible for copyright protection. Through its analysis of extensive materials regarding audition programs in South Korea and around the world,  Lee & Ko presented compelling evidence and ultimately established that the claimed elements had, in fact, been universally used in audition programs in the past, and that the two audition programs were not similar in terms of the overall construction and specific expressions, thus forcefully proving that Company M did not commit copyright infringement or an act of unfair competition. 

Subsequently, following fierce exchanges of legal arguments at oral hearings, Company J withdrew the case about 2 years after filing the lawsuit, which led to a successful resolution of the dispute. As this was a case specifically addressing intellectual property issues in the context of television show format rights, it is expected to carry a high precedential value. Lee & Ko’s meticulous analysis of the elements of the two television shows at issue, coupled with its extensive efforts to gather relevant evidence on both domestic and foreign copyright and unfair competition laws, resulted in this successful outcome.