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- InterView
- "Lilly's values in caring and discovery: social contrib."
- by Son, Hyung Min Jan 19, 2026 09:02am
- "Lilly's core values have always been 'Caring' and 'Discovery'. GDOS demonstrates that these values are not merely slogans, but a platform where employees can personally practice them within the community and reaffirm the company's reason for existence."On September 25 last year, Eli Lilly Korea held a volunteer activity attended by all employees to celebrate the 'Global Day of Service (GDOS).' GDOS is a global volunteer program launched by Lilly in 2008, which has accumulated over 1.2 million volunteer hours across 65 countries to date. Eli Lilly Korea has participated since 2010, contributing more than 20,000 hours of service.The Global Day of Service is a day when organizations and individuals worldwide volunteer for local communities and global issues. Lilly operates this day annually as its own GDOS, effectively establishing it as "the volunteering day for Lilly employees worldwide."The theme for the 2025 Eli Lilly Korea GDOS was "A Better World Made Together," centered on two pillars: environmental improvement and support for underprivileged children. Approximately 250 employees were divided into groups to conduct plogging in Jung-gu and Seodaemun, and to create donation kits for child support. The donations were delivered through Save the Children, in cooperation with the Community Chest of Korea. They provided necessary items to children at the Manan District Social Welfare Center in Anyang.2025 Eli Lilly Korea GDOS TF Team. From left: Hyung-min Kim (Regulatory Affairs), Minju Kang (Medical), Yu Seok Kang (ENC), Joohee Lee (Medical)Notably, they introduced 'GDOS Night; for the first time last year, featuring a charity performance by the in-house band and a donation program. A new attempt was made to expand the post-volunteer interaction into another act of sharing by accumulating the entire proceeds from food and beverages purchased by employees as donation funds.GDOS aligns with Lilly's global sustainability strategy, which includes: ▲ expanding access to medicines ▲ improving environments with limited medical infrastructure ▲ strengthening community resilience ▲ minimizing environmental footprints ▲ fostering innovation grounded in inclusion and diversity.We met with Minju Kang, Medical Director of Eli Lilly Korea, who managed last year's GDOS, and the TF team (Joohee Lee, Yu Seok Kang , and Hyung-min Kim) to discuss preparations, operations, achievements, and future directions.Q. Please describe your roles in last year's GDOS.Minju Kang (Medical): I am Minju Kang, head of the Medical Department and the sponsor for GDOS. Each year, a different department takes turns sponsoring GDOS, and since the Medical Department was in charge last year, I took on the role of sponsor.Hyung-min Kim (Regulatory Affairs): I am Hyung-min Kim from the Regulatory Affairs team. For this GDOS, I established the overall program plan, selected volunteer activities, and managed group assignments.Joohee Lee (Medical): I am Joohee Lee from the Medical Department. This program was led by three 'Champion Leaders' centered around Vice President Minju Kang. My role involved planning the program, encouraging employee participation, and setting the direction for which values we should focus on.Yu Seok Kang (ENC): I am Yu Seok Kang from the ENC team. Since GDOS is a long-standing event, my primary role was to ensure that the company's regulations and procedures were strictly followed throughout the support process.Q. What kind of event is GDOS?Minju Kang (Medical)Minju Kang: GDOS is a global corporate social responsibility program in which all Lilly branches worldwide, including the U.S. headquarters and Korea, participate. It has continued for nearly 20 years since its 2008 launch, and Eli Lilly Korea has participated consistently since 2010.It is highly significant because it goes beyond a simple annual event; it is a time for us, as members of a pharmaceutical company, to reconnect with our fundamental purpose asking 'Why do we do this work?'GDOS is operated as a volunteer-based activity involving all employees, and each year the TF Champions plan the program. The format changes annually. In some years, we conduct plogging to improve community environmental health, and other years we assemble donation kits for the underprivileged.Last year, we conducted plogging and kit production simultaneously. Furthermore, we introduced GDOS Night, aiming to extend the lasting impact of volunteer work into a time for sharing and interaction.Q. Compared to other CSR activities, what makes Lilly's program special?Hyung-min Kim (Regulatory Affairs)Hyung-min Kim (Regulatory Affairs): Generally, many volunteer programs rely on external vendors to handle the event's composition and operation. However, at Lilly, employees form their own TF to take the lead in the entire process—from planning and execution to reporting results.Members experience creating the program as protagonists rather than mere participants, gaining a sense of belonging and achievement. I believe this is the fundamental differentiator of Lilly's CSR activities.Joohee Lee: Having worked at other pharmaceutical companies, I found it particularly impressive that Lilly employees worldwide participate in volunteer work on the same day.It is rare to find CSR activities in which employees from every country, including the U.S. headquarters, work toward a common goal with a consistent identity as 'Team Lilly.'Additionally, not only the domestic TF but also TF Champions from each country meet in advance to discuss the planning direction and implementation methods for the GDOS program, and share the results after the event. This systematic approach, in which we learn from and spread the activities of different countries, sets GDOS apart as a sophisticated global volunteer program rather than a simple local activity.Q. We heard the 2025 theme was 'A Better World Made Together.' What were the central messages you focused on?Yu Seok Kang : The first pillar was 'Environmental Improvement.' To this end, we collaborated with the 1365 Volunteer Center to conduct plogging activities that could directly improve the local community's environment. The second pillar was 'Child Support.' In the past, we focused on visiting orphanages to improve their facilities. Last year, during discussions with the Community Chest of Korea, we explored ways to provide more practical help to children.As a result, we agreed that an approach of personally creating and delivering items that children need and would enjoy was more meaningful. By structuring the program around these two core pillars (environment and children), we prepared for the theme of "A Better World Made Together" to be portrayed through the activities.Q. Could you explain what "GDOS Night" was?Joohee Lee (Medical)Joohee Lee: In the past, after the volunteer work was completed, employees typically went their separate ways.Last year, we introduced GDOS Night to strengthen GDOS's communal values further.Many employees voluntarily attended the event even after the official activities ended, continuing the interaction and sharing. I believe this experience catalyzed GDOS to naturally expand its purpose.Minju Kang: GDOS Night was an event planned around the 'Lilly Band,' an in-house club.Employees who participate in the band as a hobby held a charity concert. We expanded the traditional 'one-day cafe' format by renting an external club space, selling food and drinks, and raising funds.It was meaningful because it provided a direct platform for employees to participate and spread a culture of donation beyond just a concert.Q. What is the meaning behind Lilly's core value, 'To unite caring with discovery to make life better for people'?Yu Seok Kang : We thought deeply about how to integrate caring and discovery into our activities harmoniously. In particular, introducing the unprecedented GDOS Night was meaningful because it expanded the event from a mere gathering of Lilly members into a festival where we could share and personally experience the values the company pursues.Furthermore, we interpreted the purpose of GDOS differently by introducing a structure that converted the program's proceeds into donations. I believe this series of processes was an attempt to meld the corporate purpose of caring and innovation into overall activities, and a case of seeking new ways through new methods.Minju Kang: Lilly holds 'Respect for People' as one of its core values, which is based on fundamental respect for human dignity and life. Caring, stemming from this value, has a practical meaning for a pharmaceutical company: providing patients with treatment opportunities and improving their quality of life. At the same time, for such caring to be realized in reality, innovative discovery and continuous R&D investment are essential.Therefore, Lilly simultaneously pursues a people-centered perspective and the discovery that realizes it. The discovery mentioned here refers to the development of new medicines, which directly links to our corporate purpose, as only innovative treatments can provide substantial benefits to patients. From this perspective, GDOS is not an event separate from the company's daily operations, but an extension of the process where caring and discovery for a better life are connected through activities.Q. Is there a message you would like to send to the TF preparing for this year's GDOS?Yu Seok Kang (ENC)Yu Seok Kang: Last year, we made various attempts based on collaborations with several volunteer organizations. However, since most volunteer groups operate with small numbers, there were constraints on schedules and operational methods during the coordination process for GDOS, which requires large-scale participation.In the future, we can enhance efficiency and meaning further if collaboration schedules are coordinated and prepared at an even earlier stage. Although there was some trial and error, the process itself, including discussing with TF members and brainstorming ways to maximize employee participation, was very valuable, and I am satisfied with the overall results.Joohee Lee: The feedback left by CEO after last year's GDOS was also memorable. The suggestion was to consider activities that can deliver hope to patients, caregivers, and the community, aligned with a pharmaceutical company's identity and role. From this perspective, I believe programs that create direct touchpoints with patients, such as the Lilly Band holding a concert for patients, are directions worth considering for the future.Kim Hyung-min: GDOS is not an activity directly linked to performance metrics, but it is an event we must participate in with a sense of mission, personally practicing the company's values as Lilly employees. Since it required preparation outside of working hours, personal motivation was necessary, and being able to provide momentum to each other while working as a team was a great help. I believe a TF involving members who can voluntarily offer opinions is a crucial element for the future success of GDOS.Minju Kang : The charity concert (GDOS Night), which was attempted for the first time last year, received a very positive response. If we consider how to further evolve this format for the charity concert next year, we can expand the meaning of GDOS even further.
- Company
- 16 Korean pharma win first appeal against 'Rinvoq' crystal-form patent
- by Kim, Jin-Gu Jan 19, 2026 09:02am
- Product photo of 'Rinvoq (upadacitinib)'Generic companies won the first trial against the crystal-form patent for 'Rinvoq (upadacitinib),' AbbVie's oral autoimmune disease treatment.According to the pharmaceutical industry on the 16th, the Intellectual Property Trial and Appeal Board (IPTAB) recently issued a favorable ruling in a passive scope-of-confirmation trial filed by 16 companies, including Chong Kun Dang, against AbbVie's crystal-form patent for Rinvoq (10-2753815).Chong Kun Dang initially filed for the trial against the Rinvoq crystal-form patent in August last year. Following Chong Kun Dang, 15 other companies, including Daewoong Pharmaceutical, Alico Pharm, Genuone Sciences, Genupharma, GC Biopharma, Samjin Pharm, Sama Pharm, Kolon Pharma, Whan In Pharm, Ildong Pharmaceutical, Pharmbio Korea, LitePharmTech, Hanlim Pharm, Dong-A ST, and Huons, joined the dispute by filing identical trials.With this ruling, the patent-challenging companies have moved a step closer to securing exclusivity for the first Rinvoq generic entrant. To qualify for the exclusivity, three conditions must be met: ▲first to file for trial ▲first to win the trial or subsequent litigation ▲first to apply for marketing authorization. Among these, the companies have now satisfied the requirements of being the first to file and winning the trial.The patent-challenging companies plan to launch generics prematurely following the expiration of the substance patent in May 2032. Currently, two Rinvoq patents are registered: a substance patent expiring in May 2032 and a crystal-form patent expiring in October 2036. The generic companies have successfully circumvented the latter.Rinvoq is a JAK inhibitor used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. Its mechanism of action involves inhibiting inflammatory cytokines to block inflammation, pain, and cell activation.According to UBIST, a pharmaceutical market research firm, Rinvoq's outpatient prescription sales reached KRW 36.2 billion last year. This represents a 39% increase over the past year, up from KRW 26.1 billion in 2024. After claiming the top rank in the JAK inhibitor market in the fourth quarter of 2023, Rinvoq has steadily expanded its market share.
- Opinion
- [Reporter’s View] Reform of reimb reevaluations
- by Jung, Heung-Jun Jan 19, 2026 09:02am
- While it is difficult to predict whether the revision of reimbursement reevaluation standards lead to an expansion or contraction of the list of targeted products, a transparent selection process appears necessary to prevent unnecessary controversy.Without proper discussion on the designation of active ingredients subject to re-evaluation, there is concern that wasteful debates will follow.Even before today's (15th) discussion on revising the reevaluation criteria at the Drug Reimbursement Evaluation Committee, the Pharmaceutical Society for a Healthy Society (PSHS) has voiced opposition, stating, “The direction is tilting solely toward the convenience of the pharmaceutical industry.”The group claims that the revised criteria lack clarity, particularly in cases where medicines are recommended by academic societies or experts, or where conflicting clinical data and efficacy evidence exist.Compared to the previous system, under which old drugs were filtered annually based on overseas reimbursement status and reimbursement claims, the new standards are seen as more ambiguous. As a result, critics fear that the reform may be aimed at shrinking the scope of products subject to re-evaluation.Conversely, however, this also means that any drug deemed necessary can be reevaluated, regardless of factors like listing countries or claim amounts.For instance, even drugs with claims under 0.1% (approximately KRW 20 billion) or listed in at least one foreign country (A8) would no longer be completely excluded from reevaluations.Last year, HIRA announced plans to revise the criteria, discussing expanding the scope to include items with claims under KRW 10 billion and fewer than three overseas countries listed.If that original direction is maintained, the revision of reimbursement reevaluation criteria could actually lead to an expansion of reevaluation targets, contrary to the concerns raised by the Pharmaceutical Society for a Healthy Society.Of course, industry backlash is expected even in this case. It will be difficult to accept the inclusion of ingredients that were not previously subject to reevaluation under the old criteria.Ultimately, regardless of where the impact of the standard revision lands, mechanisms are needed to minimize unnecessary controversy.At present, the revised criteria have not yet passed the Health Insurance Policy Deliberation Committee, nor has a concrete implementation plan been announced, making it too early to reach any firm conclusions. However, if a clear and broadly acceptable selection process is established, the reform could achieve meaningful progress in post-listing management of reimbursed drugs in Korea.
- Company
- Entresto patent dispute comes to an end after 5yrs
- by Kim, Jin-Gu Jan 19, 2026 09:02am
- The long-running patent dispute over Novartis’ heart failure drug Entresto (sacubitril/valsartan) has effectively come to an end, with Korean generic manufacturers securing decisive victories at the Supreme Court.The Supreme Court ruled in favor of the generic companies in all three appeals related to Entresto: ▲ the polymorph patent ▲ the salt/hydrate patent ▲ and the use-of-product patent lawsuits.The assessment is that the domestic generic companies' consecutive victories in this dispute stemmed from a strategic approach that went beyond simple ‘patent invalidation or avoidance’ arguments, instead precisely identifying and countering the structural vulnerabilities of each individual patent.Entresto patent dispute concludes with generic companies' victory after over 5 yearsAccording to industry sources on the 16th, the Supreme Court on the 15th dismissed Novartis’ appeal in its scope confirmation lawsuit against 10 companies, including Elyson Pharmaceutical, concerning Entresto’s polymorph patent.On the same day, the Court also ruled in favor of generic companies in Novartis’ appeal against Hanmi Pharmaceutical regarding the Entresto salt and hydrate patent. The dispute over the validity of the salt and hydrate patents between Novartis and Daewoong Pharmaceutical/ Elyson Pharm is awaiting a ruling at the Patent Court (second instance).Earlier, in April 2024, the Supreme Court had already dismissed Novartis’ appeal in its use-patent lawsuit against 11 companies, thereby affirming the generics’ victory.This effectively concludes the nearly 5-year-long Entresto patent dispute, according to analysis. Although an appeal remains pending in the salt/hydrate patent dispute between Novartis and Daewoong Pharmaceutical/ Elyson Pharm, the prevailing view is that a similar ruling will be issued, given the Supreme Court's precedent on identical patent issues.The Entresto patent dispute intensified after 2021. Generic companies filed comprehensive patent invalidation petitions targeting Entresto's crystal form patent, salt/hydrate patents, two use patents, and two formulation patents. The generics won all cases at the first instance. After losing the first instance, Novartis selected three patents for appeal: ▲the polymorph (crystal form) patent, ▲the salt/hydrate patents, and ▲the use patent. Ultimately, these three appeals became the focal point of the litigation. For each issue, the patent challengers presented different arguments.Polymorph patent dispute: scope of rights for ‘broad claims’ without experimentationThe starting point and most critical battle in this dispute was the validity of the Entresto polymorph patent. The patent covered a specific crystalline form of the supramolecular complex formed by sacubitril and valsartan.The core issue was whether the patent satisfied the written description and enablement requirements. Under established precedent, polymorph inventions in chemistry are considered highly unpredictable and therefore require detailed experimental disclosure and reproducibility.While Novartis’ specification disclosed experimental data for a specific 2.5-hydrate supramolecular complex, it failed to provide manufacturing methods, reproducibility principles, or experimental support for other solid forms of the supramolecular complex included in the claims. The patent challengers focused on this aspect.The Supreme Court ultimately held that a patent asserting a broad claim scope without experimental support constitutes insufficient disclosure. The rulings of the Intellectual Property Trial and Appeal Board and the Patent Court were therefore upheld.Salt/Hydrate patent dispute: doctrine of equivalents infringementIn the salt/hydrate patent case, the key issue was whether the scope of rights was infringed, particularly whether the generics’ products infringed Novartis’ patent under the doctrine of equivalents.Novartis's patent was based on Entresto's 2.5-hydrate supramolecular complex. In contrast, the domestic pharmaceutical company's product possesses a trihydrate structure with a different number of water molecules. Novartis argued that since the two hydrates represent substantially equivalent technology, they constitute equivalent infringement.The generics countered that the difference was not a mere numerical change, but reflected a fundamentally different problem-solving principle for achieving supramolecular complex stability.The Supreme Court accepted this argument. It ruled that the technical core of Novartis’ invention lay in achieving a specific stoichiometric structure. A hydrate with a different number of water molecules could not be regarded as using the same technical solution.Use patent dispute: judgment of novelty in the heart failure treatment effectIn the Entresto use patent case, the issue was whether the patent possessed novelty. The key question was whether the heart failure treatment effect from the combination of sacubitril and valsartan could be evaluated as a new medical effect compared to prior art.The Patent Court ruled that, in light of existing pharmacological mechanisms and prior technologies, the claimed therapeutic effect could not be regarded as an unpredictable or novel medical outcome. The Supreme Court upheld this reasoning, dismissing Novartis’ appeal without a full hearing.Attorney Dong-joo Kwon of Yoon & Yang, who represented the client in this case, commented, “This Supreme Court ruling is significant not merely as a victory in an individual dispute, but because it provides clear guidance on the boundaries of written description requirements and on how far the doctrine of equivalents can be stretched, which is central to determining the scope of rights.”Kwon added, “Even a global pharmaceutical company’s robust patent portfolio cannot survive if it attempts to claim excessive scope without experimental backing or relies on overly broad doctrine of equivalents arguments that deviate from the technical essence.”“This case demonstrates that rational patent challenges by domestic pharmaceutical companies can strike a balance between market competition and patient access. This ruling will serve as an important precedent for future similar patent disputes.”
- Policy
- Pharma-MOHW disagree on drug pricing policy
- by Lee, Jeong-Hwan Jan 16, 2026 08:52am
- The Korean pharmaceutical industry has announced its stance that the government's drug price reform plan, which centers on generic price cuts and preferential pricing for "Innovative Pharmaceutical Companies," is too vague and requires both a delay in implementation and significant revisions.The industry requested a sufficient grace period, arguing that the plan excludes long-term impact assessments on the pharmaceutical-bio industry and public health, which could lead to industrial contraction.In contrast, the government stated it has no intention of delaying its plan to submit and finalize the reform at next month's (February) Health Insurance Policy Deliberation Committee for full implementation in July. This has left the gap between the two sides unbridged.As the pharmaceutical industry and the government have not bridged the divide in opinion, the conflict over drug pricing reform is expected to continue.On the 14th, the "National Assembly Forum on Drug Price Policies for Becoming a New Drug Powerhouse," hosted by Democratic Party Representatives Lee Un-ju, Seo Young-seok, and Kim Yoon, brought together the MOHW and industry representatives to exchange views.Pharmaceutical Industry, "Concerns over job losses, supply instability, and slowed growth"Hong Jeong-Ki, Managing Director of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), pointed out that repeated drug price cuts, executed 10 times since 1999, have gradually shrunkne the industry's overall profitability and investment capacity.Hong also expressed concerns that large-scale cuts to generic prices, as foreshadowed by the MOHW, would inevitably deepen reliance on low-cost imported raw materials and finished imported drugs.While price cuts might yield short-term fiscal savings, Hong warned that, based on implementation of policies in the past, they could lead to long-term employment shrinkage, instability in the supply of essential medicines, and a slowdown in industrial growth.Hong argued that the implementation of price cuts should be reconsidered after a comprehensive assessment of the impact on the industry and public health. Hong argues the need for a sufficient grace period for a successful landing and the establishment of a government-industry governance system.Furthermore, he requested fair compensation for companies that contribute to innovation and supply stability.The compensation aims to provide uniform preferential pricing for all Innovative Pharmaceutical Companies and to grant price benefits to non-certified companies that demonstrate excellent R&D performance and facility investment."The current reform plan is structured such that damages from strengthened regulations increase while compensation for innovation and supply stability remains limited," Hong pointed out. "This could act as a barrier to becoming one of the world's top five pharmaceutical powerhouses."He emphasized, "The implementation of drug price cuts must be reconsidered after an assessment of both short- and long-term impacts. We request a sufficient grace period to ensure a soft landing for the system," adding, "It is also necessary to establish a government-industry governance structure for constructive discussions on drug price policy."He further stressed, "By specifying the innovation-based price addition period and ensuring fair value compensation, we must build a virtuous cycle that accelerates innovation, such as through R&D reinvestment, and leads to the creation of global new drugs," and maintained, "Cuts to the prices of existing listed generics should be minimized to secure investment capacity and ensure supply stability.""Preferential pricing plan fails to reflect company contribution and diversity"Kim Sang Jong, Managing Director of Hanmi Pharmaceutical, also criticized the reform, stating it could weaken the foundation for domestic companies to continue investing in new drugs.Kim argued that cutting existing generic prices without accounting for a company's contribution to new drug R&D creates a structure in which larger companies with higher investment volumes incur greater absolute losses. In his view, the policy is becoming an overall price cut premised on the notion that Korean generics are expensive compared to overseas markets, rather than a system that guarantees fair returns on investment.Notably, Kim highlighted that limiting preferential pricing to "Innovative Pharmaceutical Companies" and a few others fails to benefit the many firms that contribute to the industry through Phase 2/3 trial investments, manufacturing facility expansions, quality advancements, and employment of research personnel.Kim added that extending the price increase period for Innovative Pharmaceutical Companies by three years is only effective in the early stages of the patent-expired market. Once generic market share expands in the later stages, prices drop significantly, making the compensation effect felt by companies very limited."The resources needed for new drug R&D, maintaining production facilities for stable supply, and maintaining employment currently come from generic sales," Kim criticized. "It is questionable whether an overall price-cutting policy aligns with reward investment."Kim further criticized, "The financial resources required for new drug R&D, maintaining production facilities for stable supply, and sustaining employment come from the sales of existing listed generics. For now, this is unavoidable," adding, "While the MOHW stated it would focus on outcomes such as innovation, I question whether implementing a blanket price-cutting policy, based on the idea that high generic prices can now be lowered, actually aligns with the policy goal of rewarding investment."He added, "It is questionable whether it is truly necessary to further divide preferential drug pricing among Innovative Pharmaceutical Companies into upper and lower tiers. Once the three-year preferential period ends, generic expenditures drop significantly. We are not sure if this can be considered a reward for Innovative Pharmaceutical Companies," adding, "Pharmaceutical companies also need to analyze the reorganization of the drug price system. Since the announcement on November 28 last year, time has been needed to run simulations to determine how to manage operations in line with the policy goals. A grace period (for the drug price cuts) is necessary."MOHW "Current system has reached its limit... will reform to minimize industry concerns"Despite such requests from Hong and Kim to delay implementation and revise the preferential pricing policy, the MOHW rejected these requests, stating that the current system has reached its limit and cannot be further delayed.Kim Yeon-Sook, Head of the Division of Pharmaceutical Benefits at the MOHW, explained, "This reform is being implemented because the current system has reached its limit. It is a structural policy change designed to improve these limits, strengthen the supply stability of both new and essential drugs, and maintain the sustainability of national health insurance," and explained, "Other countries also periodically adjust generic prices while considering fiscal efficiency.""While our drug price system has previously lacked predictability and fallen short of achieving the goal of generic activation, this reform is different," Kim added. "Unlike past approaches focused solely on reducing drug expenditures, this reform includes mechanism to reward innovation based on investment, even for generics."Kim concluded, "The government views this reform as a golden time for structural improvement and a leap forward for the industry, centered on Innovative Pharmaceutical Companies. We will implement a drug price system that leads to rewards for the industry to minimize the concerns of domestic pharmaceutical firms."
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