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- 2026-04-29 06:35:06
- Opinion
- [Reporter’s View] How to increase the new drug approval fee
- by Whang, byung-woo Sep 26, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) decided to significantly raise its new drug approval fee to expand its capability for the prompt review of newly developed drugs. The fee for new drug approval, which was previously KRW 8.83 million, was increased 48 times to KRW 410 million based on the benefit principle. Despite the dramatic increase, there has been little backlash as Korea’s drug approval fee has been relatively low compared to overseas. The MFDS aims to raise the new drug approval fee from next year after a 60-day administrative notice period. As the pharmaceutical industry has been actively supporting the realization of the fee, there have been more expectations than concerns. Rather, the industry's concern is whether the fee hike will have an immediate effect. The MFDS plans to use the increased fees to recruit specialized review personnel and expand the proportion of high-competency reviewers, such as doctors, pharmacists, and those with at least 3 years of postdoctoral experience, from the current 31% to 70%. However, whether the government can secure the required specialized personnel remains in question. While the MFDS emphasizes the importance of securing human resources by allocating half of the fee hike to labor costs, it is unclear at what point it will be able to recruit the desired amount of human resources. This is also a concern for pharmaceutical companies. While there is no doubt that the fee hike will speed up approvals, there is also concern that pharma companies will not immediately see the benefits of their inputs. As a result, some pharmaceutical companies are considering accelerating their submission plans and applying for approval before the fee hike. For example, there are concerns about whether the review process for new drug approvals will change dramatically before and after the fee increase, or whether the new system will take time to settle in. In the end, the pharmaceutical industry needs the MFDS to preemptively establish a system so that the increased fees can be utilized as intended. Apart from the consensus on the KRW 400 million increase in review fees, the system should not have a backward-looking investment structure that raises fees and then uses them to increase the number of reviewers. With the expected improvement in the system is expected, attention is likely to be focused on the first case of their application. In the bigger picture, the MFDS is hoping that the fee hike will also prevent the poke-and-see applications without sufficiently demonstrating safety and efficacy, in addition to shortening the review period. In other words, it could act as a hurdle to prevent companies from using Korea’s regulatory authorities as sort of a consulting window. However, the pharmaceutical industry is also hoping that the MFDS’s review will also include consultation at the approval stage, as the authorities are requesting new drug fees at the level of FDA and EMA. The increase in drug approval fees is expected to bring about many changes in the domestic regulatory environment. As the saying goes, 'the beginning is half the battle', so we expect thorough preparation and changes to be made to meet the purpose of the MFDS’s new drug approval innovation plan.
- Opinion
- [Reporter’s View] The new drug approval fee hike
- by Lee, Hye-Kyung Sep 19, 2024 05:48am
- The Ministry of Food and Drug Safety has announced an amendment to the “Fee Regulations for the Approval of Drugs, etc.” that will significantly increase the fee for new drug approvals from KRW 8.83 million to KRW 410 million. This is the first time in 4 years that the government has decided to increase the new drug approval fee, which is in line with the previous four-year cycle fee hike. In 2016, the fee was raised from KRW 6.82 million to KRW 8.83 million in 2020, and this time in 2024, another 4 years later, the fee is being raised to KRW 410 million. The MFDS’s fee hike announcement was received with surprise in the industry. The MFDS had been conducting a study to increase the fee for new drug approvals, so there had been a widespread assumption that the fee would be increased within the year. However, few thought that the increase, which had been 30% four years ago, would soar to 4500% and exceed KRW 400 million. No one expected the MFDS to raise the drug approval fee to a level similar to Europe and Japan at once. Most had expected the government to raise the fee in phases as before. When considering the fees charged by advanced regulatory agencies abroad, Korea's current KRW 8.83 million is unreasonable, to say the least. Even the industry acknowledged this. In Japan alone, which has a similar GDP per capita level, the PMDA KRW 430 million, the European EMA KRW 490 million, and the Canadian HC KRW 550 million. The US FDA charges KRW 5.3 billion, therefore, the MFDS’s administrative notice of raising the fee to 410 million is appropriate to align the fee to a realistic price at the global level. In particular, it has been pointed out the MFDS’s new drug approval fee is much lower than that of advanced regulatory agencies overseas, leading global pharmaceutical companies to apply for approval in a ‘testing the water’ type of manner. Before applying for approval to the FDA or EMA, the companies first apply to the MFDS, and then add the supplementary data requested by the MFDS before applying to regulatory agencies abroad. There has also been a feeling that MFDS is being regarded as a ‘consultant’ for overseas regulators. The damage caused by the understaffed reviewers reviewing the data of false applications was the delay in review, which was ultimately borne by domestic pharmaceutical companies that needed new drug approvals. The increase in the new drug approval fee seems to mean that MFDS will no longer act as a ‘consultant’ and fulfill its purpose as a proper regulator. Moreover, it seems like the government decided to foster the development of new drugs by domestic pharmaceutical companies rather than global pharmaceutical companies as the new amendment specifies the benefits provided to such by the MFDS, such as a 50% reduction in fees for domestic pharmaceutical companies and a 90% reduction in fees for modifications made to existing drugs. Although the new drug approval fee seems to have suddenly risen to KRW 410 million, this was an inevitable raise that had to be made to meet the global level sooner or later. The MFDS announced that the new drug approval period will be shortened from 420 days to 295 days with this increase. If it goes as planned, new drugs developed by domestic pharmaceutical companies will be able to enter the market a little faster. However, it would be necessary to expand the number of expert staff to accommodate this. The MFDS has set aside half of the increased fees for labor costs. The amount may seem like a lot, but it will be used as a basis for expanding the number of reviewers. If the increase in the number of expert staff can actually shorten the time it takes to approve a new drug, the fee increase would have been necessary sooner or later.
- Opinion
- [Reporter’s View] Benefits of the U.S. Biosecure Act
- by Son, Hyung Min Sep 13, 2024 05:50am
- The US House of Representatives recently passed the Biosecure Act, which includes the US’s biological sanctions against China. The bill will now head to the US Senate for voting and go through a presidential review process for legislation. The Biosecure Act restricts transactions with major Chinese biotech companies that the U.S. Congress deems to pose a threat to national security. The US Congress has categorized the biotechs into 3 groups, A, B, and C. Group A includes 5 companies: BGI, MGI, and Complete Genomics, which are genomic equipment manufacturers and analytical services, and Wuxi AppTec and Wuxi Biologics, which are contract development and manufacturing organizations (CDMOs). Group B includes companies that are under the control of a foreign hostile government, provide equipment or services to companies on the list of biotechnology companies of concern, or pose a risk to U.S. national security, and Group C includes subsidiaries and parent companies associated with companies in Groups A and B that are under the control of a foreign hostile government. The Biosecure Act will be implemented after a grace period until January 2032, but already expectations are rising on how Korean companies can benefit from the Act. In particular, the inclusion of Wuxi Biologics, China's largest CDMO, in the sanctions has raised attention to the opportunity it brings to other domestic CDMOs such as Samsung Biologics, Celltrion, and ST Pharm. Wuxi Biologics is present in China, the US, Ireland, Germany, and Singapore, and employs more than 12,000 people. The company occupied 10% of the global CDMO market last year. In fact, ST Pharm is believed to have benefited from the proposal of the Biosecure Act, signing contracts previously made with China. Last month, the company was also selected to supply a small molecule blockbuster drug that generates trillions of wons in annual sales. However, we cannot have blind faith that domestic companies will reap all the benefits. The market is dominated by leading global CDMOs such as Switzerland's Lonza, the US's Catalent, and Japan's Fujifilm, all of which have their eyes on Wuxi Biologics' pie. Their competitive advantage is quality. Based on their years of experience in signing contracts with global pharmaceutical companies, the companies have been expanding their market. Global CDMOs have strong technical capabilities in early research, manufacturing, and commercial finishing processes. Indian companies that own price competitiveness are also emerging as viable competitors. Currently, India has more than 15,000 drug manufacturing facilities owned by around 3,000 pharmaceutical companies. Of these, it is estimated that at least 100 of which are specialized CDMOs. India has 40% lower drug manufacturing costs than the US and Europe, and has the highest number of US Food and Drug Administration (FDA)-approved pharmaceutical plants outside the US. In other words, to survive, domestic companies need to secure production capacity, quality, and technology, not settle for just a slice of Wuxi Biologics' pie. Global CDMOs have invested in cell gene therapy (CGT) and antibody-drug conjugates (ADCs) to win orders. Currently, domestic CDMOs are still in the investment stage for ADCs and CGTs. In addition, there is also a possibility that the U.S. will extend the protection of its industry and sanction more companies. In 2022, the U.S. administration has implied restricting overseas companies by proposing an executive order to increase domestic production of biopharmaceuticals. Policies aimed at increasing domestic production and protecting its own biotech sector are bound to be a blow to companies looking to enter the US. In this sense, it is not impossible that the knife pointed at China could be extended to other countries. This is where the government’s support comes into play. While the current government has signaled that it sees the bio-industry as a future growth engine and is committed to implementing relevant policies, there is a consensus that the industry has not felt the impact so far. Experts believe that the government needs to continue to support the industry by increasing the scale of government support and providing tax incentives. In the current state, The US Biosecure Act is clearly an opportunity for domestic companies. If the companies continue to seek growth based on their investment and technological capabilities and are supported by the government, they will be able to enter the global market.
- Opinion
- [Reporter's View] ‘Tyranny of Drug Committees persist'
- by Eo, Yun-Ho Sep 11, 2024 05:54am
- Even after a drug is approved by the Ministry of Food and Drug Safety and listed for reimbursement, the drug cannot be prescribed immediately by medical staff at general hospitals. A drug can only be prescribed at each hospital after a prescription code is generated upon review by their respective drug committees (DCs). The process, in itself, is quite systematic. Rather than allowing prescriptions of all drugs that are commercialized, an expert meeting is held internally to discuss the need to introduce the drug to each medical institution. DCs have long been regarded as powerful sales targets within the pharmaceutical industry. When it's time for each hospital's DC, a war ignites between pharma companies to land their products. Like all wars, there are winners and losers. The problem is that the winner is not necessarily the company that deserves to win, and the loser is not necessarily the company that deserves to lose. Landing a drug in some hospitals still often depends on the deals made, rather than good clinical results that prove the drug's efficacy and effect. Such cases are especially prominent when the patent of the original drug expires and generics are launched. The DC of a hospital is mostly composed of professors (doctors) in each medical department, except for the head of the pharmaceutical department (pharmacist). Naturally, they are the first targets in line if a company wishes to generate prescription codes for their newly launched drugs. Add to that the medical institution’s foundation’s influence and unexpected code-ins and code-outs do occur. A hospital with a strong DC still calls up the pharmaceutical companies of original drugs when the drug’s patent expires and requests so-called ‘code maintenance fees.’ In fact, over the past 2-3 years, the hospital has gone without some of the most popular original drugs for hypertension, hyperlipidemia, and antithrombotic medications that anyone in the industry would know. This is because the companies that own them refused to pay the code maintenance fees requested by the foundation. DC lobbying also occurs between original drugs when new drugs of the same generation, or same-class drugs, are introduced one after another. This means that pharmaceutical companies are at the mercy of foundations and professors alike to get a drug ‘coded in’ in these hospitals. However, with the recent trend of new drugs being released for cancer and rare diseases, the proportion of drugs that hold a unique position rather than having competitors is increasing, reducing the DC's power. However, industry representatives say ‘it still exists.’ The end consumer of the drugs is the patient, not the doctor or the foundation. It is now time to examine whether the introduction of drugs is being done properly. Isn't it time that drugs are prescribed in hospitals based on fair value assessments?
- Opinion
- [Reporter’s View] Vaccine sovereignty only during epidemics
- by Son, Hyung-Min Sep 05, 2024 05:51am
- The Korea Disease Control and Prevention Agency recently announced that it will support messenger ribonucleic acid (mRNA) vaccines in preparation for the next pandemic. The government will support research and development from preclinical to Phase III trials, focusing on companies with the potential to localize mRNA vaccine platforms. Candidate companies include GC Biopharma, Samyang Holdings, and ST Pharm, which have a history of developing COVID-19 vaccines. The rapid increase in COVID-19 cases in a short period of time has raised the need for domestic vaccine development. Securing vaccine sovereignty is being discussed again following the peak of the COVID-19 pandemic from 2020 to 2022. The government has consistently claimed that it will localize COVID-19 vaccines. However, the government gradually reduced the scale of support with the easing down of the pandemic. In fact, there were vaccine candidates from the domestic pharmaceutical and biotech industry that entered Phase I, Phase II, and Phase III clinical trials, but some abandoned the development of new drugs due to high costs incurred during late-stage clinical trials. Genexine, which started COVID-19 vaccine development, abruptly discontinued its R&D in 2022 after conducting Phase II/III clinical trials. The company cited oversaturation of the market and failure to receive foreign approvals, but also cited a lack of government support. Genexine reportedly had close to KRW 10 billion in government funding. In June, Eubiologics also canceled plans for domestic clinical trials of its COVID-19 vaccine. Various domestic pharma and biotech companies, including Eyegene, ST Pharm, GenOne Life Science, Auratis, Telcon RF Pharm, and Quratis, have been working on COVID-19 vaccines, but their movement has been slow since COVID-19 turned into an endemic. 4 years have passed since the outbreak of the COVID-19 pandemic, but minimal progress has been made in the domestic vaccine development scene has been minimal. SK Bioscience's vaccine SKYCovione and Celltrion's treatment Regkirona have been developed for COVID-19, but they lack utility. SKYCovione and Regkirona are not able to respond to new COVID-19 mutations. Many infectious disease experts emphasize the need for government support for domestic companies to develop local vaccines. This is because the pharmaceutical industry has to invest a lot of money in research and development (R&D), while the expected return is small. According to the Ministry of Science and ICT, the R&D budget for infectious diseases reached KRW 438.5 billion in 2021 and KRW 508.1 billion in 2022, when COVID-19 was at its peak. However, the budget dropped to KRW 413 billion in 2023, the year the pandemic began, and did not even reach KRW 300 billion in 2024. While the budget for infectious disease R&D has declined, the cost of purchasing overseas vaccines has snowballed. The government reportedly spent more than KRW 7 trillion on overseas COVID-19 vaccine purchases from 2020 to last year. As for COVID-19 treatments, the budget for purchases this year is KRW 179.8 billion, but the rising number of patients has led to the need for additional funding. The COVID-19 drugs being procured are all new drugs produced by foreign companies. It is said that it has become difficult for the pharmaceutical industry to develop vaccines as the scale of the government’s project has shrunk and support reduced. This is in contrast to the trend overseas. The U.S. has invested KRW 41 trillion in mRNA platforms to help Pfizer and Moderna commercialize their vaccines. In China, CSPC Innovation Pharma developed an mRNA vaccine, SYS6006, in March last year and received approval from its country's health authorities. In Japan, Daiichi Sankyo also secured vaccine sovereignty in September last year with the development of its mRNA vaccine, Daiichirona. Daiichi Sankyo is continuing its research on targeting the dominant variant through its mRNA platform. The Korean government decided to support the specific field of mRNA upon the rise of confirmed COVID-19 cases. The timing is indeed a bit late, as it seems like Korea is following the steps of neighboring East Asian countries that already succeeded in developing mRNA vaccines. Couldn’t they have prepared for the next pandemic by increasing the budget in the post-pandemic stable state? Vaccine sovereignty cannot be secured by mending the barn after the horse is stolen.
- Opinion
- [Reporter's View] pros and cons of concurrent reimb listing
- by Eo, Yun-Ho Aug 30, 2024 05:49am
- When there are no changes to demand, increased supply reduces prices. This model of price determination can be applied to the pharmaceutical market. For pharmaceuticals, inducing competition between pharmaceutical companies can decrease financial expenses. However, it often results in increased time for reimbursement listing. Drug prices must be adjusted through negotiation with the government, and companies cannot adjust them arbitrarily. As we face a high-priced drug era, the government's stance is that "good things come to those who wait.' When reimbursement applications for new drugs fall into the same class, the government often discusses reimbursement listing two or even three new drugs at once when a follow-up drug approval is expected. Because drugs are high-priced, the government can use the market to its advantage by having pharmaceutical companies compete with each other. Under the National Health Insurance system, financial saving creates another opportunity. The more it saves, the more coverage the government can expand. However, the issue is the time sensitivity. In theory, it would be good to have drugs of the same class receive approval around the same time and pass reimbursement listing, but this is different in practice. The application dates of drugs that apply for reimbursement listing differ by six months to up to one year. There could be other delaying factors than the different 'application' dates. For example, among drugs with the same mechanism of action, the first-in-class drug received regular listing, whereas follow-up drugs were listed for reimbursement under the Risk Sharing Agreement (RSA). Strikingly, those drugs had been approved domestically 5-10 years ago. It is fortunate that these drugs were listed, and patients benefited. However, the process took too long. Additionally, there are differences in what pharmaceutical companies want. Companies that applied first wish to be evaluated alone. Entering the market first has the advantage in addition to drug price. Clinical data also plays a role in this issue. Even if new drugs have the same mechanism of action, their indication and clinical results may carry different weight. Indication influence reimbursement criteria, while data values affect drug prices. There is no concrete answer to this issue. We have to consider different factors. In addition to considering losses and benefits, the nature of each drug and patient circumstances must be considered. All parties must work together in order to reach an agreement embracing the Korean National Health Insurance system and pharmaceutical companies' stances.
- Opinion
- [Reporter’s View]Support domestic COVID-19 drugs
- by Lee, Hye-Kyung Aug 28, 2024 05:52am
- The recurrence of COVID-19 has sparked interest in COVID-19 drugs. After the pandemic turned into an endemic, the government set a budget of KRW 179.8 billion for COVID-19 drugs this year, which was a 53.2% cut from last year, and the number of COVID-19 drugs introduced in Q1 and Q2 of this year was 179,000, half of the 341,000 that the government procured during the same period last year. The government claimed that the budget cut was due to preparations for the reimbursement of COVID-19 treatments, but the government ultimately set aside KRW 326.8 billion in emergency reserves to purchase an additional 262,000 doses of treatment after failing to predict the resurgence of COVID-19. The amount of the reserve is nearly equivalent to the KRW 384.3 billion budget the government had set for the purchase of COVID-19 drugs last year. Due to the lack of a Korean treatment option, Korea has to rely on global pharmaceutical companies for all supplies of treatments in the event of a COVID-19 outbreak. This is because there are currently only 3 COVID-19 drugs available in Korea - Pfizer's Paxlovid Tab, MSD's Lagevrio Cap, and Gilead's Beklury Inj. If there were locally developed COVID-19 treatments, not just global pharmaceutical companies' products, the government could have addressed the outbreak faster. To stabilize the supply and demand of cold medicines, the government asks domestic pharmaceutical companies to increase production through a public-private consultative body to balance the supply and demand when medical organizations report unstable supply. The recent shortage of COVID-19 drugs is likely to have been affected by Korea’s reliance on imported products. Curing the COVID-19 pandemic, there has been a movement toward self-sufficiency of drugs. Celltrion developed Regkirona Inj and received marketing authorization in September 2021. However, in 2022, the company suspended new supplies due to its low effectiveness against omicron mutations. Following this, Ildong Pharmaceutical's Xocova, which was developed in collaboration with Japan's Shionogi Pharmaceutical, and Hyundai Bioscience's Xafty tried to cross Korea’s threshold through the emergency use authorization pathway but failed. The MFDS pointed to the small number of clinical trial subjects and requested Phase III clinical data for the domestic approval of each drug. COVID-19 treatments need to accumulate clinical data on COVID-19 patients, and this is why domestic pharmaceutical companies have been struggling to recruit patients in the endemic. The need for homegrown drugs and vaccines has been emphasized during the outbreak. The government has also provided various support such as emergency use authorization and expedited review. However, since COVID-19 was declared endemic, many people lost interest in domestic COVID-19 treatments. But the resurgence of COVID-19 this time has made everyone realize that a second or third wave could come at any time. The endemic is not the end of COVID-19. We need to expand our support for domestic drugs to ensure self-sufficiency of COVID-19 treatments in Korea.
- Opinion
- [Reporter’s View]Gov’t disappointing response to COVID-19
- by Son, Hyung-Min Aug 23, 2024 06:18am
- COVID-19 is spreading rapidly in Korea. Currently, the variant leading the COVID-19 pandemic is KP.3 of the Omicron family. The spread of COVID-19 has been in full swing since the end of June, and the number of hospitalized patients in the 2nd week of this month reached 1,366, recording the highest this year. In the last four weeks, the number of hospitalized COVID-19 cases in 220 hospital-level surveillance centers nationwide was 226 in the 3rd week of July, 474 in the 4th week, 880 in the 1st week of August, and 1,366 in the 3rd week. The Korea Disease Control and Prevention Agency (KDCA) has stated that the KP.3 variant is highly contagious but has a low severity and fatality rate, making it manageable at current levels. Despite the government's opinion that it is manageable, there is much confusion at the point of care. Pharmacies are reportedly experiencing stockouts of cold medicines and diagnostic kits, and are having difficulty securing COVID-19 drugs. Relevant government agencies have been scrambling to come up with countermeasures. The Ministry of Health and Welfare has announced that it will start reimbursing COVID-19 treatments in October to ease the shortage. The Ministry of Food and Drug Safety has begun reviewing the approval of new COVID-19 drugs. After COVID-19 had turned into an endemic, the government has been lukewarm about approving and reimbursing COVID-19 drugs. Last year, public opinion had been formed on the need to introduce the major COVID-19 treatments that demonstrated clinical effectiveness and public opinion. Still, the KDCA delayed approving new COVID-19 drugs, citing the sufficient quantity of existing COVID-19 drugs. The reimbursement for the COVID-19 drug Paxlovid is also making little progress. Pfizer applied for reimbursement coverage of Paxlovid in October last year, but the application is yet to be reviewed by the Drug Reimbursement Committee. This is not unlike the situation at the height of the COVID-19 pandemic. Back then, the government struggled to secure COVID-19 vaccines and treatments. There were also shortages of acetaminophen-based antipyretic analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), which can reduce the symptoms of COVID-19. Under the banner of securing vaccine sovereignty and treatment sovereignty, various government policies were launched, including the K-Bio Vaccine Fund and the establishment of a control tower for the pharmaceutical and biotech industry. However, since then, no domestic pharmaceutical or bio company has succeeded in receiving approval for new COVID-19 vaccines or treatments. Various domestic companies have taken up the challenge, but as the number of COVID-19 cases decreased, interest in vaccines and treatments faded. Some companies have applied for marketing authorization and reimbursement, but have not been approved. Like the rise of the KP.3 variant, there is a high probability that COVID-19 will resurface. While the KP.3 variant, like the Omicron variant, has lower rates of severity and fatality, no one can predict how or when it will spread. The COVID-19 pandemic and endemic have made the procurement of various treatments imperative. Rather than relying on the fact that there are enough existing treatments to keep the field on track, we need to proactively identify and acquire new treatments to ensure their availability when needed. There are still many areas that need to be addressed, including treatments, vaccines, healthcare infrastructure, staffing, facilities, and equipment. We should not forget the lessons we learned during the COVID-19 pandemic, including quarantines, the waiting lines for masks, the vaccine reservation rush, and cold medicine shortages.
- Opinion
- [Reporter's View] Delays in medication switching for eczema
- by Eo, Yun-Ho Aug 13, 2024 05:48am
- When patients switch from their current medication to a different medication, the switched products are not covered by insurance reimbursement. This non-reimbursed status of medication switching has been a long-standing issue in South Korea. The field most impacted is atopic dermatitis. Treatment options had been limited for atopic dermatitis, but various new drugs became available over the past years. New medications, such as interleukin (IL)-inhibitors and JAK inhibitors, have relieved patient burdens, and fortunately, these drugs are listed for reimbursement. However, an issue related to medication switching recently surfaced. When a patient switches prescriptions to a different medication after initially using biologic mediation, such as interleukin (IL)-inhibitors, or oral medication, such as JAK inhibitors, reimbursement is no longer provided. As a result, patients cannot easily switch to a different drug when they experience adverse reactions during treatments or do not benefit from the drugs. Individuals respond differently to all drugs. This could be due to genetic differences or various factors such as age, gender, and race. Having many treatment options means that patients can choose from a pool and anticipate other possibilities when they do not respond to a particular drug. The current Korean policy may be limited to offering this type of 'expectancy.' Additionally, this policy leads to prescription bias. Conventional biologics are more expensive than chemically manufactured medicines. If two medications have equivalent therapeutic status but vary significantly in price, and medication switching is not covered, most patients may be biased towards biologics. In the first half of the year, the Korean Atopic Dermatitis Association stepped forward. The Association submitted an opinion report to the Ministry of Health and Welfare (MOHW) demanding medication switching in treating atopic dermatitis. Furthermore, the Association clarified that there are no differences in therapeutic status between biologic agents and oral medication through the guideline revision made in 9 years. The government initiated a review. Presumably because it has decided that demands and needs are precise. Previously, the government had hesitated to provide reimbursement approval for medication switching due to the "shortage of scientific evidence regarding medication switching." Of course, medication switching is not backed up by clinical studies. However, South Korea is the only country not approving medication switching. Indeed, a study cannot be conducted every time new drugs are introduced and cannot wait for real-world data or other literature review. Ultimately, the speed matters. We have records of wasting close to 10 years in approving reimbursement for medication switching of TNF-alpha inhibitors to treat rheumatoid arthritis. Medication switching of JAK inhibitors in other autoimmune diseases, including ankylosing spondylitis, is already allowed. If the government hesitates, it will take a long time. Furthermore, companies must put efforts into increasing volume of use and finance.
- Opinion
- [Column] On patent strategies post Amgen v. Sanofi dispute
- by Kim, Jin-Gu Aug 12, 2024 05:55am
- One of the most significant events that occurred in the bio-pharmaceutical sector in recent years was the ruling made on the Amgen vs. Sanofi patent dispute in the United States. In May last year, the U.S. Supreme Court issued its final ruling on the patent dispute between the two biotech giants. The case received special attention, as the dispute over the validity or invalidity of patents lasted for nearly a decade in the KRW 1 trillion drug market and the first in a long time the U.S. Supreme Court ruled on the 'enablement requirement' of a patent. In 2011, Amgen and Sanofi each patented an antibody for the treatment of hyperlipidemia that binds to the PCSK9 protein, and developed Repatha and Praluent, respectively. Three years later, in 2014, Amgen registered two additional patents for antibodies that bind to the PCSK9 protein and immediately filed a patent infringement lawsuit against Sanofi. In response, Sanofi sought to invalidate both of Amgen's patents, and the dispute came to a head. Amgen was able to file its patent infringement lawsuit in 2014 instead of 2011 for a reason. Amgen's 2011 patent limited antibodies to an amino acid sequence, whereas the 2014 patent claimed antibodies more broadly. Amgen’s patent consists of an antibody that ▲binds to a specific amino acid or epitope of PCSK9; and ▲ prevents PCSK9 from binding to the LDL receptor. Claiming an entire group of antibodies that exhibit this specific function is called a “genus type” claim, which can include millions of individual species antibodies. As a result, genus-type claims have a very broad scope. Despite making such a broad claim, Amgen’s patent specification only disclosed: i) 26 amino acid sequences for antibodies that would block or inhibit PCSK9, and ii) two alternative methods (the roadmap, conservative substitution) for arriving at the remainder of the genus. The court found that the 26 exemplified antibodies were not sufficient to readily produce the entire genus of antibodies and that Amgen's 2 methods constituted separate research projects. The experts ruled Amgen's patents invalid and that they did not meet the enablement requirement because it would require extensive experimentation and trial and error to reproduce the invention. The Supreme Court’s ruling does not overturn the existing view of the enablement requirement, but it does set a clear precedent for the strict application of the requirement, which will have a significant impact on the industry going forward. The Amgen case has several implications. First, it highlights the need for new patent portfolio management. The U.S. Supreme Court's decision has a significant impact on the global patent industry in general. In the biotech sector, especially for antibodies, it will become more difficult to patent an entire genus of antibodies by function. The number of patent applications will naturally increase, and divisional patent application is expected to increase. Furthermore, the treatment of a double patent varies by country, requiring closer attention. A company that discovers a new target should attempt various different types of patent claims. In the bio field, discovering a new target is like finding a gold mine. Therefore, the company should protect the mine by pursuing the broadest claims possible. "Functional claims," like in Amgen’s case, have the advantage of capturing the best features of the target, but they are more likely to be rejected or invalidated. Therefore, rather than pursuing purely functional claims, claims should be drafted in a way that blends functional and structural elements. It's also a good idea to experiment with multi-step claim construction, such as going from broad to narrow. Deciding when to file is a key point in the bio patent application strategy. Historically, patent strategies had been focused on patent maps during the R&D phase, freedom to operate (FTO), or litigation strategies before the product launch, but companies should now pay more attention to the patent application strategy. In the bio sector, it takes a long time to generate experimental data, so it is especially important to decide when to file the patent, after securing how much data. More data can lead to a broader scope of rights but at the cost of a later patent application date. The patent application date should take into account whether the patent is for a platform technology or a follow-on technology, whether it is in the early research or clinical stage, how large the market is for the product, and how much data can be produced. It is recommended that universities, research institutes, and companies plan their patent application strategies according to their data production capacity. The stricter the patent system interprets the enablement requirement, the more favorable it is for global companies. For example, if a global company and a university discover a disease target "at the same time," the global company will have a better chance of obtaining a broad patent because it can produce a lot of data in a relatively short period of time. If a university, research institute, or startup makes an important early stage discovery, one way to reduce the risk is to find a collaborative research partner or license out the technology to increase data production capacity.
