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- 2026-03-18 15:06:10
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- Dispute over Eliquis patent will be closed in six years
- by Kim, Jin-Gu Apr 05, 2021 05:51am
- Eliquis The six-year-old Eliquis (Apixaban) substance patent lawsuit will be closed next week in the Supreme Court. If the Supreme Court overturns the judgment of the first and second trials and takes the side of the original company, BMS, an all-round lawsuit for damages against related generic companies is expected and attracts attention. The ruling is expected to affect Eliquis prices. It has not yet been lowered even after the generic launch, because BMS has filed a court request to suspend the drug price reduction until the final conclusion of substance patent lawsuit for Eliquis is concluded. According to the pharmaceutical industry on the 2nd, the Supreme Court announced on the 8th the date of the appeal decision on the patent registration invalidation lawsuit filed by BMS against Navipharm, Huons, Intro Bio Pharma, and Alvogen Korea. On March 20, 2015, the dispute over substance patents will be closed after more than six years after Navipharm et al. requested an invalidation trial against a substance patent of BMS. In the preceding 1st and 2nd trials, a generic company has won. In February 2018, the Patent Tribunal ruled that Eliquis' substance patent was invalid. Based on this trial decision, patent challengers tried to release generics for Eliquis early. Prior to this, the patent was also successfully overcome, so it was possible to release it early. However, when BMS applied for a temporary injunction to prohibit patent infringement at the Seoul Central District Court, the release of the generic was put on hold. The Seoul Central District Court accepted the application, and the generics companies had to postpone the release date of September of that year. In March 2019, the Patent Court ruled that substance patents were invalid, similar to the Intellectual Property Trial and Appeal Board. Generics for Eliquis were released one after another. After June 2019 ▲Chong Kun Dang's Liquisia ▲Yuhan's Yuhan Apixaban ▲Samjin's Elxaban ▲Hanmi's Apixban ▲Ajou's Apixaban ▲Yooyoung 's Yupix have been released. It is analyzed that the release of generics has had some effect on the decline in prescription performance of Eliquis. The outpatient prescriptions for the past five years have steadily increased from ₩19.5 billion in 2016 to ₩49 billion in 2019, but fell 3% to ₩47.7 billion last year. The total prescription amount of generics for Eliquis surged from ₩1.2 billion in 2019 to ₩8.3 billion last year. As of last year, Liquisia was ₩2.6 billion, Elxaban was ₩1.7 billion, and Yuhan Apixaban was ₩1.1 billion. Considering the rise in monthly prescription performance, it is expected to exceed ₩10 billion this year. If the Supreme Court approves Eliquis' substance patent, BMS' lawsuit against patent infringement and claims for damages are expected based on this ruling. The generic company is in a situation where it has to return the sales revenue it has earned so far in the event of a discontinuation of generic sales. The ruling is also expected to affect the lawsuit over Eliquis price cut. Earlier, the government announced that it would cut the upper limit by 30% in July 2019 based on the launch of generics. However, BMS applied for suspension of execution to the administrative court because the final result of the substance patent lawsuit did not come out. As a result, Eliquis price remains the same as before. If the Supreme Court takes side with BMS, Eliquis price is likely to remain as they are. If BMS loses, it will be cut from next month. An official in the pharmaceutical industry said, "Like the first and second trials, there is a high possibility of denying the progressiveness of the optional invention." “However, since the Seoul Central District Court has accepted the BMS' provisional injunction application, there is a possibility that a judgment different from the first and second trials may come out.”
- Company
- OB-GYNs fume over the price hike of HPV vaccines
- by Moon, sung-ho Apr 05, 2021 05:51am
- The medical community is in turmoil over the news that MSD Korea will raise the price of ‘Gardasil 9,’ its 9-valent HPV vaccine. Relevant doctors’ associations are determined to discuss countermeasures for the unilateral price increase carried out by the pharmaceutical company. The Korean company in charge of domestic sales of the vaccine also brace for the burden that it would need to bear due to the price hike. On the 30th, industry sources said that MSD Korea has recently sent a notice that it will increase the supply price of its human papillomavirus vaccine by 15% to front-line clinics and hospitals. MSD Korea's position was that the price hike was inevitable due to the inherent complexity of production, long production periods, and quality control processes required for the vaccine. Some clinics and hospitals have been using the news of the price increase in April as a marketing tool to encourage customers to vaccinate sooner than later. Gardasil 9 is indicated for the prevention of cervical cancer, vulvar cancer, vaginal cancer, anal cancer, and genital warts caused by 9 types of the HPV virus (HPV Types 6, 11, 16, 18, 31, 33, 45, 52, 58). However, as Gardasil 9 is not provided as part of the Korean National Immunization Program (NIP), it is currently administered without reimbursement in front-line clinics and hospitals. The average non-reimbursed price of Gardasil 9 in clinics and hospitals range from 107,928 won to 202,524 won. As Gardasil 9 is administered through a 3-dose schedule, at most, roughly 600,000 won will be required to complete the vaccination. Based on the non-reimbursed price disclosed by the Health insurance Review and Assessment Service (HIRA), a price hike of 15% from April will increase the price of a single dose of Gardasil 9 to range around 120,000 won to 240,000 won. “Clinics and hospitals cannot individually protest against the pharmaceutical company’s unilateral decision to increase the price,” said one gynecologist who owns a clinic in Seoul. “My pharmaceutical sales representative had told me about the rumors of the price increase earlier on this year, so I actually ordered more in advance.” Furthermore, the medical community is voicing complaints as they will not be able to directly charge the 15% price increase applied from April to their patients. “Some hospitals and clinics are encouraging people to vaccinate in advance; however, it is unlikely that the people will be able to receive all three doses of the vaccine in the limited time period," another ob-gyn explained, “We can’t charge or explain the price hike to the patients awaiting their last vaccination if they have already received the first and second dose before March.” Faced with such strong opposition, HK inno.N, the company that signed a joint sales agreement for 7 vaccines including Gardasil 9 with MSD Korea, is also positioned in a fix. HK inno.N had prepared a marketing team dedicated to the sale and marketing of the 7 vaccines this year and was moving to expand its sales capacity. However, HK inno.N’s position is that they have no say regarding vaccine prices. Despite the burden they will have to bear selling the more expensive vaccines to hospitals and clinics, the company has to follow MSD Korea’s decision regarding the price increase. As a result, the Korean Association of Obstetricians and Gynecologists (KAOG) decided to hold a meeting to gather opinions on the matter. The association plans to hold an internal meeting first and discuss countermeasures. ”It may already be late, but we plan to discuss the issue and garner opinions at the association’s level.” said Lee Gi-Chul, vice president of insurance at KAOG. “The problem was in the unilateral notice. We will have to discuss the price hike with the pharmaceutical company and then notify our members.” “Up until now, pharmaceutical companies used to consult relevant expert associations before carrying out measures like price increases for vaccines, etc. However, the system seems to have changed now." Lee continued, "We will discuss ways and create a system so that relevant medical groups and pharmaceutical companies can discuss their options in advance when similar issues arise.”
- Company
- Novartis' Xolair self-administration prescribed at GHs
- by Eo, Yun-Ho Apr 02, 2021 06:06am
- The self-administration formulation of the asthma treatment ‘Xolair’ can now be prescribed at general hospitals. According to industry sources, Novartis Korea’s Xolair (omalizumab) prefilled syringe 75mg solution has passed the review of drug committees (DCs) in 8 general hospitals nationwide, including the Seoul National University Hospital, Seoul Asan Medical Center, and Cheonnam National University Hospital. On December 20th, 2018, Novartis had abruptly withdrawn Xolair's application amid negotiations with the National Health Insurance Service (NHIS) after receiving the nod on its reimbursement feasibility. The reason for the sudden withdrawal was the company's concern over its impact on the Chinese market, as the drug price set in Korea may negatively affect the drug price in China as well. The incident made an exemplary case of the ‘Korea Passing’ phenomenon. After launching Xolair in China in 2019, Novartis reconducted the pharmacoeconomic evaluation procedure to apply for reimbursement listing in Korea. As a result, the Xolair injection was first listed in July last year. The maximum reimbursed price for the Xolair injection and the Xolair prefilled syringe injection in 150mg is 271,700 won, and 143,000 won for the Xolair prefilled syringe injection in 75mg. However, due to Novartis’s internal supply issues, the Xolair prefilled syringe 75mg solution started reimbursement in January of this year. The prefilled syringe 150mg solution will be reimbursed from October. Novartis's plan is to quickly proceed with the landing process in general hospitals as soon as the supply of pre-field syringe solutions begins. Various trials on Xolair including the ASTERIA, GLACIAL, OPTIMA, XTEND-CIU, and X-ACT have demonstrated that Xolair ▲rapidly improves symptoms and quality of life of chronic idiopathic urticaria patients; ▲alleviates symptoms of patients who do not respond to antihistamine treatment or leukotriene receptor antagonists; ▲is safe and continuously effective for long-term use; ▲can manage symptoms when used for retreatment after discontinuation. The clinical effect of Xolair in treating allergic asthma has been confirmed through the INNOVATE study conducted on 419 patients from 108 centers in 14 countries. The rate of clinically significant asthma exacerbations, the primary efficacy endpoint in the INNOVATE trial, was 0.68 for the Xolair group and 0.91 for the placebo group, demonstrating a significant difference between the two groups. Response of patients evaluated using the Global Evaluation of Treatment Effectiveness (GETE) showed that 64.3% of the patients responded favorably to Xolair, as reflected by a GETE rating of “excellent” or “good."
- Company
- Aldactone, which was frequently sold out, is resupplied
- by Apr 02, 2021 06:05am
- Pfizer Korea's diuretic drug Aldactone, which was often sold out, is scheduled to resume supply. According to the distribution industry on the 27th, the supply of Aldactone (Spironolactone) 25mg is expected to resume from the 29th. It was earlier than the April 8th, the resupply date originally expected by the company. Aldactone is often sold out due to continued supply disruption. Last year, there were five reports of production, import, and supply interruptions and shortages to the MFDS. In December of last year, Pfizer expected to resume supply around February, but it was postponed for another two months. This is because it has not been able to resolve the supply and demand of drug substance. Aldactone was available from April. Pfizer Korea said, "We apologize for the inconvenience caused by the sold-out of Aldactone, and we will do our best to stabilize supply." Sanofi Aventis' amyotrophic lateral sclerosis drug Rilutek, which has been out of stock for nearly two years, is also scheduled to be supplied at the end of April. Sanofi Aventis explained, "We expect Rilutek to resume supply from the fourth week of April. Based on the shipping date to the wholesaler, there may be 1-2 days difference by region. There are no product codes, insurance, and benefit related changes," Sanofi explained. Rilutek has not resumed supply since it temporarily sold out in October 2019. This is due to a shortage of main ingredient raw materials in overseas manufacturers. It was expected to resume in February 2020, but the company delayed the schedule until January this year. Finally, supply started at the end of April. Sanofi Aventis said, "We apologize once again for any inconvenience caused by supply instability. We will do our best to supply the product smoothly with patient health as our top priority."
- Company
- Only hope for pancreatic cancer Onivyde seeking for coverage
- by Eo, Yun-Ho Apr 01, 2021 06:08am
- The pancreatic cancer with highly unmet medical needs may welcome a newly listed drug. The pharmaceutical industry sources reported Servier Korea’s Onivyde (Irinotecan Hydrochloride) would be deliberated by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). Requested for the National Health Insurance (NHI) reimbursement last July, the drug is finally starting the practical discussion on the listing after about six months. Onivyde has requested for reimbursement on an indication to treat patients, who have failed a first-line gemcitabine-based treatment, as second-line 5-FU/LV combination therapy. But Onivyde faces an unexpected challenge. The South Korean government has recently decided to significantly reform the anticancer treatment reimbursement standard used for pancreatic cancer. As a result, HIRA is to enforce the revised notification of drugs prescribed and administered to cancer patients reflecting the details from Apr. 1. According to the change, the division between the first and second tier anticancer treatments has been removed, and the first tier anticancer therapies (10 items including cisplatin monotherapy) were delisted, while gemcitabine plus paclitaxel combination, previously categorized as a second tier anticancer treatment for first-line palliative therapy with reimbursement, can be now also prescribed for second-line therapy. As patients with pancreatic cancer had extremely limited option for a first-line therapy so far, the patients would greatly appreciate the government’s new reimbursement expansion decision. But the latest change can be burdening for Onivyde. As many of anticancer treatments initially not listed for reimbursement as second-line or later therapy are now listed, the government’s standard on reviewing the reimbursement feasibility, such as ICER, could get tougher. Medical experts complain the government should have included Onivyde, when discussing about the reimbursement listing reform. Professor Yoo Chang-hoon of Oncology Department at Asan Medical Center noted, “To this date, we talk about the second and third-line treatment with a lot of pancreatic patients. Because they do not get coverage, we also check on their private medical expense insurance. It is regrettable that Onivyde has not gotten reimbursement, yet, even it has global Phase III trial and Asian subset analysis data and Korean RWE.” The global multicenter Phase III trial NAPOLI-1 study has confirmed Onivyde, in combination with a standard second-line treatment option '5-FU/LV,' significantly improved the treatment outcome on patients, who did not respond to first-line gemcitabine-based treatment. The drug raised awareness of the importance of sequential combination strategy in treating metastatic pancreatic cancer. It is the only treatment recommended as a Category 1 by NCCN guideline when second-line gemcitabine-based anticancer therapy is used to treat patients with metastatic pancreatic cancer.
- Company
- Equfina can be prescribed at general hospitals
- by Eo, Yun-Ho Mar 31, 2021 06:08am
- Equfina, a treatment for Parkinson's disease from Esai, can be prescribed in general hospitals. According to related industries, Equfina (Safinamide) has passed the drug committee (DC) of Seoul National University Hospital and Asan Medical Center among Big 5 medical institutions, and is undergoing landing procedures at major medical institutions. According to the MOHW notice, it was applied health benefits as 'adjuvant therapy of Levodopa-containing drugs in patients with idiopathic Parkinson's disease with movement agitation symptoms'. Equfina was approved by the MFDS on June 24, 2020 as a once-a-day Levodopa supplemental therapy for Parkinson's disease patients. Equfina is a third-generation monoamine oxidase-B (MAO-B) inhibitor that doubles as dopaminergic and non-dopaminergic signaling. It showed significant improvement in motor and non-motor symptoms in Parkinson's disease patients with motor agitation in a phase 3 clinical trial. Levodopa is mainly used as a standard treatment for Parkinson's disease, but it is reported that about 75% of levodopa can cause complications when taking Levodopa for a long time for more than 5 years. Equfina is an adjunct therapy for Levodopa, can be reduced by long-term use of levodopa. Results of a Phase 3 clinical trial (SETTLE study) to evaluate the efficacy and safety of Equfina in Parkinson's disease patients with motor agitation symptoms, the ON time of drug efficacy without dyskinesia compared to placebo in patients who took Equfina for 24 weeks. A significant improvement effect of was observed. Equfina significantly reduced the OFF time of Levodopa as an adjunct therapy for Levodopa compared to placebo, and showed a significant decrease in the time to disappear regardless of the type of concomitant drug or the degree of exercise agitation. In the SETTLE study, as a result of the PDQ-39 score, which assesses the quality of life of Parkinson's disease patients, the change from the baseline PDQ-39 score of the 50-100mg/day group of Equfina was -3.17, which was improved compared to -0.68 in the placebo group. In another phase 3 clinical study, Study 016, the Equfina 100mg group showed a statistically significant improvement in the PDQ-39 score compared to the placebo group. In particular, in terms of emotional well-being, the change at 24 weeks from baseline in the Equfina 100mg group was -5.14, which was improved compared to the placebo group. Sung Young-hee, professor of neurology at Gachon University's Gil Hospital, said, "If Levodopa is administered for 5 years or longer to Parkinson's disease patients, motor fluctuations and complications may occur. Therefore, not only symptom control but also the possibility of complications that may occur in the future is considered.” She added, "By administering Equfina as an adjunct therapy to Levodopa, the dose of Levodopa can be reduced, so it will increase the duration of dyskinesia-free medication and help manage complications."
- Company
- “EMA authorizes Rekirona, sales projected at KRW 1.2 tln”
- by Kim, Jin-Gu Mar 31, 2021 06:06am
- The financial experts project Celltrion's COVID-19 monoclonal antibody treatment Rekirona injection’s (regdanvimab) sales in Europe would hit 1.2 trillion won as the European Medicines Agency (EMA) has granted conditional approval on the treatment. Leveraged by the Rekirona sales in Europe, the experts also projected Celltrion’s annual sales revenue this year would surpass 3 trillion won. Researcher Sun Min-jeong at Hana Financial Investment published a report with the said details. Previously, Celltrion announced EMA has issued advice on the use of Rekirona, prior to the formal marketing authorization. Based on the advice issued, European countries are authorized to use the South Korean drug to treatment patients with COVID-19. Researcher Sun Min-jeong explained, “Following the monoclonal antibody treatments by Regeneron Pharmaceuticals and Eli Lilly, Rekirona is now the third antibody treatment that received the conditional approval in Europe. However, unlike the U.S., European countries have not yet procured sufficient volume of the antibody treatments.” The researcher elaborated, “Due to the slow nature of monoclonal antibody treatment production, the drug makers would not be able to supply sufficient volume of the drugs promptly.” The COVID-19 treatments by Regeneron Pharmaceuticals and Eli Lilly would be unlikely to get supplied to the European market in time, which leaves a good window for Celltrion’s Rekirona to tackle the market. Celltrion expects to manufacture 3.2 million doses of Rekirona injection at maximum. The researcher stressed, “Besides the 100,000 doses secured from last year, the first and second plants and the overseas contract manufacturer would be able to produce 1.3 million doses, 1.3 million doses and 600,000 doses, respectively.” Regarding the pricing, the report estimated it would “differ depending on the contract signed with each country, but considering the U.S. government has settled with Eli Lilly to supply bamlanivimab for USD 1,250, Rekirona would be priced around the same level.” The reported explained, “Generally, the drug pricing in Europe is about 70 percent of the U.S. price. Rekirona is expected to be priced at 875 dollars (approximately 1 million won) per dose.” The researcher predicted, “Celltrion’s Rekirona sales revenue would reach 1.2 trillion won, based on the said pricing estimation. Accordingly, Celltrion’s overall sales revenue for the year would skyrocket by 77 percent compared against last year, and generate 3.3 trillion won.” In last year, the South Korean company has made 1.85 trillion won from sales only.
- Company
- Controversy over 7-day packaging Rx drugs
- by Nho, Byung Chul Mar 29, 2021 05:58am
- Packed with 56 Omethyl Cutielet Soft Caps. In the case of a prescription for 60 days (two months), a photo of 4 pieces is attached to one box. Although it is the product of the same company, the packaging units of Lipitor (28 tablets) and Norvasc (30 tablets) are different., and packaged every 7 days (clockwise at the top left)Due to the packaging unit different from the domestic prescription style, drug prescription and storage difficulties for pharmacists and patients in countries are increasing and improvement is required. According to the pharmacy, it is difficult to dispensing some high-frequency, long-term prescription drugs because the packaging unit is set for 7 days (28 days) rather than 10 days (or 30 days). Representative drugs related to this include Korea United Pharm's Omethyl Cutielet Soft Caps 2g and Pfizer Korea's hyperlipidemia treatment Lipitor 10mg. The packaging units of Omethyl Cutielet and Lipitor are 56 packets and 28 tablets, respectively. A pharmacist at Pharmacy A in Gangnam-gu, Seoul said, "Most of the drugs for hyperlipidemia are long-term prescriptions for 1 to 2 months. These drugs are packaged in 56 or 28 tablets, so another same product is opened and attached." . This is because the pattern of prescription days is different between Korea and foreign countries. In Korea, the unit is mainly used for 10 days (30 days, 30 tablets), but in Europe, it is based on 7 days (28 days, 28 tablets). However, in order to solve this problem, most pharmaceutical companies' production sites have replaced the 'packaging unit change device' to prevent the occurrence of the problem. The cost may vary depending on the facility line, but it seems that it usually costs about 10 million won. If the change part is modified, both 10 and 7 units can be packaged in both directions. An official from Korea United Pharm said, "It has been confirmed that there have been cases of phone calls from front-line pharmacists to related departments such as customer services at the head office. However, there is no plan to modify the packaging unit." Pfizer Korea said, "Lipitor 10·20mg is also available in 90T bottle type. Changing the packaging unit may be difficult to apply in a short period of time because various factors in the production process must be considered. However, in order to improve the discomfort of domestic pharmacists and patients, We will figure out what is possible, and we will work hard and take action.”
- Company
- Boehringer is interested in open innovation with Yuhan
- by Mar 29, 2021 05:58am
- Boehringer Ingelheim emphasized the importance of open innovation and announced that it has a long-term partnership with Yuhan. It also mentioned the possibility of further open innovation for R&D materials in Korea. In addition, they expressed their will to do their best in the development of COVID-19 treatment and anticancer drugs targeting KRAS. Boehringer Ingelheim held an online global annual press conference on the morning of the 24th (local time in Germany) and announced last year's results and forecasts for this year. In spite of COVID-19 crisis, Boehringer Ingelheim showed good performance last year with its flagship items, Jardiance and Ofev. Total sales amounted to €19,570 million, an increase of 3% from the previous year. During the same period, operating profit rose 22.2% to €4,620 million. SGLT-2 inhibitor Jardiance posted the highest sales in the human medicine division at €2.48 billion, and Jardiance is expected to expand the range of treatment to heart failure and kidney disease. Ofev showed remarkable growth last year. It recorded €2,060 million, an increase of 41% year-on-year, ranking second in revenue contribution for the first time. Carinne Brouillon, director of the human medicine business unit, said "It's not because of COVID-19, because Ofev isn't related to COVID-19 comorbidity, This is because there is more room for finding and treating target patients with the development of diagnostic technology than in the past." Boehringer Ingelheim plans to focus on developing COVID-19 treatments, and it started development from the beginning of last year. BI767551, which is being developed as an inhalant, entered a phase 1/2a clinical trial in December last year in collaboration with the University of Cologne Hospital in Germany, the University of Marburg, and Deutsches Zentrum für Infektionsforschung. It is also developing COVID-19 neutralizing antibody that can be used in combination with BI767551, a low molecular weight substance that inhibits the replication of COVID-19, and a therapeutic agent for preventing microcoagulation. It also invests in the development of new drugs for diseases with high unmet medical demand.Boehringer Ingelheim showed high interest in KRAS anticancer drugs. It is developing therapeutics that target a wide range of KRAS mutations. The company said, "There is a lot of interest in KRAS mutant cancer. It is an important mutant gene that causes pancreatic cancer, colon cancer, and lung cancer, but there is no licensed agent yet." Boehringer Ingelheim said that it has a broad portfolio that can be used in combination with other substances as well as candidates that can target all important KRAS mutations as candidates that block SOS1 protein, so it could be the core of KRAS mutations. It also emphasized collaboration with partnerships for IMD development. Boehringer Ingelheim is building partnerships with pharmaceutical companies around the world, and a new drug for non-alcoholic steatohepatitis (NASH) is being developed with Yuhan in Korea. Yuhan technically exported the NASH candidate material to Boehringer Ingelheim in 2019. Director Carinne Brouillon said, "We have a long-term strategic partnership with Yuhan, Korea's leading pharmaceutical company, and we are working closely with R&D in the NASH sector." the director added, " As there are many interesting R&D activities in Korea, we are interested in additional open innovation if there is a good opportunity that matches the area we focus on or explore."
- Company
- Bonviva generics dodge a bullet from patent dispute
- by Kim, Jin-Gu Mar 26, 2021 05:38am
- The generic makers won the patent dispute over an antiarthritis Bonviva (ibandronate) and now they are finally free from the risk of sales ban and damage compensation. According to the pharmaceutical industry source on Mar. 23, the Intellectual Property Trial and Appeal Board issued a trial decision that the dosage regimen patent for Bonviva was invalid. South Korean companies launched Bonviva generics in 2012. Sales continued for several years without special patent disputes. Roche owned the dosage regimen patent for the original Bonviva, but did not file a patent lawsuit at the time of the generic launch. At the time, the Patent Court and the Supreme Court did not recognize the dosage regimen patent. As for the original maker, a patent dispute meant nothing when the company was bound to lose it. However, in 2015, the table has turned. The Supreme Court abolished the precedent of the Baraclude (entecavir) patent dispute, and fully recognized the dosage regimen patent. Bonviva’s dosage regimen patent, initially affected by the precedent, gained its validity. Regardless, Roche did not file a patent dispute immediately. The company did not intend to overturn the decision that it concluded that there were no problems at the time of release. But a problem arose when Bonviva's patent rights were transferred from Roche to a British pharmaceutical company Atnas Pharma in 2018. More assertive Atnas Pharma took a sharp turn on the matter and filed patent infringement suit against Bonviva generic makers in South Korea. At the same time, they claimed for a colossus compensation for the damage. The companies then were struck with the crisis. Although they have been selling Bonviva generics for years without any problems, they were faced with sales ban and also cough up the revenue earned so far. Accordingly, 10 generic companies such as Theragen Etex, Korea Arlico Pharm, Wooridul Pharmaceutical, ChoA Pharmaceutical, Korea Kolmar, Huvist, and Dongkwang Pharmaceutical, which sold Bonviva generics, decided to respond together. A trial was filed to nullify the Bonviva dosage regimen patent. Considering the gravity of issue, the Intellectual Property Trial and Appeal Board allocated the case to the Special Joint Trial Board. Generally, a patent trial is handled by three judges, but the Special Joint Trial is conducted by five judges. Ultimately, the Intellectual Property Trial and Appeal Board decided to invalidate the case. South Korean companies are now relieved. As of now, there is a high possibility that Atnas Pharma, holding the patent right, would request for an appeal. Patent Attorney Park Jong-hyuk of Park Jong-hyuk Patent Law Firm said, “After the Supreme Court recognized the dosage regimen patent in 2015, the method of judging non-obviousness in dosage regimen patent was somewhat formed through the tadalafil case. He emphasized, “The Intellectual Property Trial and Appeal Board conducted an elaborate trial for a long term through a Special Joint Trial Board, and determined requirement of a dosage regimen patent, necessity of test data, improper description and non-obviousness. The latest decision would be used as a standard to other similar cases related dosage regimen patent.” A pharmaceutical market research firm UBIST reported Bonviva's outpatient prescription last year was 2.9 billion won. In South Korea, Handok is in charge of sales. Adding the prescription volume of Bonviva Plus (5.4 billion won), which combined with cholecalciferol, Bonviva makes about 8.3 billion won per year. Currently, 93 Bonviva generics have been approved for marketing in South Korea. These drugs combined generate about 10.3 billion won.
