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Total legal services for global blockbuster Entresto®
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.
2023.12.29
Lee & Ko wins all 10 cases for domestic blockbuster drug Dukarb®
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.
2023.11.30
Lee&Ko successfully defended a traditional Korean medicine principles based food manufacturer against claims for damages for violation of the Product Liability Act
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.
2023.07.20
Successfully defended trade secret misappropriation and copyright infringement claims brought against former employees in a lawsuit involving bone density and body composition analysis technology
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.
2023.05.16
Successfully resolved a copyright infringement and unfair competition dispute related to a television show format
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.
2023.03.21
Obtained a victory in a patent invalidation action related to the Soliris® use patent
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.
2023.02.10
Supreme Court of Korea Found Copyright Infringement in Selection, Arrangement or Combination of Elements in Games for the First Time

The First Supreme Court Decision for Copyright Infringement in Games is Issued in June, 2019. 

On June 27, 2019, the Supreme Court of Korea issued a decision in a case for copyright infringement in substantially similar selection, arrangement and combination of the elements in games. This ruling is the first Supreme Court decision recognizing copyright infringement in copied games including mobile games. Lee & Ko represented the plaintiff, King.com, throughout the proceedings before the lower courts as well as the Supreme Court, and played important role in achieving the ground breaking decision of the Supreme Court.


Facts of the Case and Questions Presented

King.com, a prominent game company and creator of “Farm Heroes Saga,” brought a copyright infringement suit against the defendant who distributed another game, “Forest Mania” which was substantially similar to Farm Heroes Saga. Both games expressed the game rules through similar movement and order of introduction but had different game characters. Seoul Central District Court found no copyright infringement but held that the defendant violated the Unfair Competition Prevention and Trade Secret Protection Act (the “UCPA”) and on appeal, Seoul High Court held in favor of defendant, finding no copyright infringement and no violation of the UCPA. King.com appealed the decision of Seoul High Court.

 

On the appeal case heard before the Supreme Court, Lee & Ko presented how the “creative characteristics” of Farm Heroes Saga were actualized through selection, arrangement and combination of game rules. Given the nature of the case where many contentious issues were based on visual expressions, the Supreme Court allowed both sides rare opportunities of presenting the arguments before the court using visual materials and Lee & Ko successfully presented convincing evidence of substantial similarities between Farm Heroes Saga and Forest Mania. Finding copyright infringement based on Forest Mania’s copying of the creative characteristics of Farm Heroes Saga, the Supreme Court held in favor of King.com, thereby reversing Seoul High Court’s decision and remanded the case back to Seoul High Court.

 

In King.com case, defendant’s game had design elements such as characters which were different from such elements in plaintiff’s game but selection, arrangement and combination of game rules were substantially similar in both games. In the decision, the Supreme Court explained that a game can be protected under copyright if its elements are selected, arranged and combined in accordance with certain intention so that the resulting game has creative characteristics distinguishing itself from other games. This case is the first Supreme Court case where the court recognized copyright infringement in substantially similar games.


Implications in Game Industry

A game is a complex work which combines narratives, music, visual design, video and computer programs. Until King.com decision, there has been no clear precedent on to what extent the copyright protection is available for games, especially on whether a copyright infringement can be found for a game which imitates original games but changes the design of characters. With King.com decision, the court provided a guideline for determining copyright infringement for games by recognizing creative characteristics in selection, arrangement and combination of game elements.
 

2019.06.27
Lee & Ko successfully represents Big Hit Entertainment against unauthorized use of BTS’ photos

Lee & Ko, on behalf of Big Hit Entertainment (“Big Hit”), obtained the first-ever decision in Korea to recognize the entertainment companies’ right to independently request for injunction against those who free-ride on the customer attractiveness that is based off of popularity and fame of the artists managed by the companies. This landmark decision is expected to serve as an important pedestal in protecting the legitimate interest of entertainment companies (domestic as well as international) that manage famous artists and entertainers and remain vulnerable to unfair competition of free-riders.

 

Big Hit is the mastermind behind the global sensation BTS, also known as the Bangtan Boys (방탄소년단), one of the most popular boy bands in the music industry today. Ever since BTS’ conception, Big Hit has been the engine and fuel behind all aspect of BTS’ activities. As BTS rose to global fame, however, rampant exploitation of their fame grew in high demand and merchandises using BTS’ name, portrait and photo without Big Hit’s permission started to flood the market. Fans who purchased these merchandises (specifically photobooks with collection of BTS’ portraits and photos) by believing them as official goods were disappointed to learn the truth, and poured complaints to Big Hit.

 

Lee & Ko was engaged as Big Hit’s legal representative to take legal measures against these unauthorized merchandises. At the time Lee & Ko sought to take action, however, the Korean court’s then-current position was that the entertainment companies are not entitled to seek legal protection for their artists’ right to publicity when there is no explicit legislation governing such right. This called for an immediate introduction of new legal basis that can protect the entertainment companies from the free-riders of their artists’ fame.

 

To do so, Lee & Ko developed a new legal basis for protection based on the Unfair Competition Prevention and Trade Secret Protection Act (“UCPA”). The UCPA prohibits actions that infringe another person’s economic interest by using such person’s achievements, which are the result of substantial efforts and investments for many years, without permission for unjust profit. Using the UCPA, Lee & Ko asserted that the economic value of BTS (e.g., BTS’ name, logo, portrait, photo, etc.) correspond to Big Hit’s enormous achievement resulting from many years of tremendous efforts and investments, by emphasizing the fact that Big Hit has planned and managed BTS’ entire career from debut to their present tremendous success. Lee & Ko argued that the very act of selling the unauthorized merchandises of BTS constitutes an act of unfair competition prohibited by the UCPA.

 

Convinced by Lee & Ko’s argument, the Seoul Southern District Court entered an injunction order on November 30, 2018 prohibiting all unauthorized production, distribution, sale and export of BTS photobooks, and also imposed a strict penalty by ordering a payment of 20 million KRW (approximately 20 thousand USD) won per day in the event of continued violation.

 

Despite the Court’s order, once the publishing companies were not allowed to make photobooks using unauthorized photos, they found ways to circumvent the court’s scrutiny by creating and selling photobooks fronted as entertainment magazines (that still included large number of BTS photos) and claiming freedom of press.

 

Publishing companies started to print magazine-like photobooks as shown below


 

Use of unauthorized BTS’ photos within the magazine 


 
 

In response, Lee & Ko filed an injunction to stop the publishing company from selling such “magazines” in name only. The Seoul Central District Court, however, denied the claim by holding that since the magazines still cover stories of other artists as well, they constitute legitimate media coverage and are protected under the freedom of press. Lee & Ko appealed the decision by showing the court that the magazines were serving as actual photobooks to the fans (which was verified through fan surveys, general perception of the public, comparison with other legitimate entertainment magazines, etc.), and that the publishing companies were using such guise to free-ride on the fame and popularity of BTS. After reviewing the exhaustive evidences submitted by Lee & Ko, the Seoul High Court on May 30, 2019 expressly acknowledged that the magazines in effect constitutes a “photobook” or “photobook-like magazine” similar to the official photobooks produced and sold by Big Hit and further held that the publishing company’s act of publishing and selling such magazines exceed the scope of ordinary media coverage and therefore cannot be protected under the freedom of press. The Seoul High Court granted an injunction relief and ordered the publishing company to pay Big Hit 10 million KRW (approximately 10 thousand USD) per day in the event of continued violation.


The two recent Korean Court’s decisions are significant in that they serve as first-ever decisions to recognize that entertainment companies are also independently entitled to legal protection for their artists’ name, logo, portrait, photo under the UCPA, therefore extending the scope of legal protection from artists to the entertainment companies that built the artists’ customer attractiveness through substantial investments and efforts.

2019.06.14
Plaintiff prevails in Copyright Infringement Lawsuit against Manufacturer regarding Imitation Dolls of “Jibang-ii”, an Obesity Clinic Character

365mc, an obesity clinic, filed suit for copyright infringement against Dodam Korea, a manufacturer and distributor of the imitation dolls of Jibang-ii, a famous mascot representing the clinic. Finding such infringement, the Seoul Central District Court (presiding judge Sang-Gu Park) on January 11 granted judgment in favor of 365mc and awarded KRW 30 million in damages and a permanent injunction on the manufacture and sale of the imitation dolls.

 

Jibang-ii is a character with a round and cute appearance that garnered huge popularity after being featured in various advertisements continuously throughout Korea (advertisement costs totaling about KRW 29 Billion). Jibang-ii’s popularity was so extensive that the Jibang-ii dolls gifted by 365mc to their clients were traded and resold in the second-hand markets at a lucrative value. As Jibang-ii’s popularity grew, however, there was also a sharp increase in the demand for imitation dolls of Jibang-ii, and Dodam Korea started making imitations of the Jibang-ii dolls since the end of 2015. These imitation dolls were distributed at a low price under the same name Jibang-ii or other similar names. In response, 365mc filed a suit in early 2018, claiming that Dodam Korea's manufacture and sale of the imitation dolls constituted copyright infringement and unfair competition.

 

Lee & Ko’s IP Practice Group, led by Attorney Young-mo Kwon, Choong Jin Oh, Vera Eunwoo Lee and Joo Hyun Choi, represented 365mc and was able to obtain a successful result for the client, which is a clear victory for the medical industry preparing for the 4th industrial revolution by creating and utilizing their own brand.

2019.01.23