Recent Developments

Lee&Ko has been representing Novartis AG, a global pharma company, in dozens of lawsuits related to its blockbuster heart failure drug Entresto® and advising on various regulatory matters.

Entresto is not only the first standard treatment in 30 years for heart failure, a leading cause of human mortality, but also a blockbuster drug which achieved global sales of $4.64 billion by 2022.

Since the beginning of 2021, dozens of generic companies have filed invalidation actions as well as scope confirmation actions against patents covering Entresto, seeking to bring generic drugs to market sooner. While simultaneous patent litigations are currently pending in the U.S., Europe, India, and other parts of the world, Lee&Ko has been able to successfully defend the patentee in the Korean market for Entresto against infringing generics until now through strategic litigation based on deep expertise which also includes independent discovery of supporting evidence such as data from the Cambridge Structural Database.

As the first case involving a supramolecular compound, the case, requires solving complicated technical issues through evidence interpretation and legal analysis in a completely new technical area.  This will set an important precedent for future cases involving highly technical issues in a completely new technological sector.

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.

Lee & Ko’s IP Practice Group represented Samsung Bioepis in a patent invalidation action involving Soliris®, a treatment for paroxysmal nocturnal hemoglobinuria, and obtained a winning decision for the client. Soliris® is a rare-disease treatment developed by Alexion Pharmaceuticals (“Alexion”) in the United States, and is a ultra-high-price medicine with annual medication costs reaching KRW 0.5 billion. Two patents were registered for Soliris®,a composition patent that expired in 2015 and a use patent. Samsung Bioepis filed an invalidation action on the use patent last June.

In this invalidation action, Lee & Ko argued that the patent’s priority claim should be denied and that its novelty and inventive step are also denied in view of the prior art. The Intellectual Property Trial and Appeal Board (the “IPTAB”) agreed and found that the use patent should be invalidated.

Samsung Bioepis had completed phase III clinical trials on its biosimilar product of Soliris® in October 2021 and applied for marketing approval with the Ministry of Food and Drug Safety in July 2022. The win at the IPTAB now paves the way for Samsung Bioepis to potentially launch its biosimilar this year.

Lee & Ko successfully defended KBS, MBC, SBS, YTN, and Korea DMB (“Clients”) in a legal dispute involving MPEG standard essential patent initiated by a United States Non-Practicing Entity (“NPE”), by obtaining invalidation decision.  

Clients are representative broadcasting companies of Korea, and have maintained ground radio wave DMB broadcasting business since 2005. In October 2020, the U.S. NPE, who is a patentee of two MPEG standard essential patents, filed suit against the Clients with a Korean court while asserting that Clients’ DMB broadcasting services infringe the MPEG standard essential patents.

Lee & Ko represented Clients to defend against the patent infringement claim. In particular, Lee & Ko argued that the asserted patents were markedly different from the known standard for MPEG, thus not amounting to standard essential patent, and also that the embodiment practiced by Clients in their DMB broadcasting business was significantly different from the asserted patents and thus not infringing. At the same time, Lee & Ko also filed invalidation action against the patents before the Intellectual Property Trial and Appeal Board (“IPTAB”) to challenge the validity of the patents. Specifically, Lee & Ko emphasized that the asserted patent should be found invalid for lack of novelty or inventiveness, since the same standard content was publicly disclosed in standard documents.

In November 2021, consistent with Lee & Ko’s invalidation argument, IPTAB determined that one of the asserted patents lacked novelty or inventiveness. Thus, Clients secured an advantageous position in the infringement action as well. In particular, one of the legal issues for the invalidation action was whether a standardization document, which seemed to have originated from foreign country, would qualify as prior art. By presenting wide range of precedents and evidence, Lee & Ko was able to convincingly argue and prove that the standardization document should clearly qualify as prior art and that its disclosed date was before the filing date of the assert patent. The invalidation action against the other patent is currently pending. 

Recently, NPEs who would not engage in any productive business activities but rather profit from its patent rights by via litigation and licensing have become many companies’ nightmare. If Clients could not adequately defend against NPE’s exercise of the patent rights, Clients would not have been able to continue providing stable DMB services, which could have harmed public interest in using DMB service. Further, there were chances that, if NPE were successful in exercising its patent rights, then the dispute could have expanded to include other Korean DMB broadcasting companies, threatening the entire broadcasting industry of Korea. Lee & Ko was able to minimize the legal risk threatening the Clients with the team’s thorough analysis of law and factual background, therefore allowing the Clients to maintain their public services without problem.