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- 2026-03-19 12:07:18
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- Novatis Korea, 5 Copyright arrangements including Exelon
- by An, Kyung-Jin Nov 16, 2019 06:28am
- Exelon Capsules Novartis Korea is working copyright control of some central nervous system (CNS) medicines such as Excelon. According to the industry on 14th Novartis Korea is considering selling the copyrights of some of the CNS products sold by the Rx medicine business division. The intention is to clean up less profitable items and focus sales marketing activities on the company's flagship products. The abolition of division in charge of CNS products such as dementia, epilepsy and Parkinson's disease drugs has already been phased out, leaving only official announcements. Novartis' original copyrighted products are sold to domestic pharmaceutical companies, and it is likely to return the original copyrighted products from other industry to the original developer. Novartis will continue to supply products while maintaining product licensing rights, but the overall sales activities, including product promotions and sales manpower, will be handed over to domestic pharmaceutical companies. The contract partner is not yet confirmed. The products sold by the CNS department are five drugs, including anti-intermittent drugs named 'Trileptal' and 'Tegretol', Parkinson's drugs named 'Stalevo' and 'Comtan' and Alzheimer's dementia drugs named 'Exelon'. Parkinson's drugs named Stalevo and Comtan, are two products that Novartis does not own the original copyright and are likely to return to the original developer without re-signing. Drugs under the copyright sale has been a record a sharp decrease in sales after the rebate suspension According to UBIST Data Bank, outpatient prescriptions sales for ‘Excelon’ in 2018 were ₩1.8 billion, 86.7% less than in 2016, before the suspension of reimbursement was imposed. The total sales of five products in the CNS department, including Exelon, dropped 57.3% from ₩51.5 billion in 2013 to ₩21.6 billion in 2018. In this regard, Novartis Korea was found to provide medical workers with illegal rebates and was suspended from the MOHW for six months (Aug 24 2017 ~ Feb 23 2018) for nine items in 2017. At the time, the sales loss was big due to the inclusion of four different doses of Execlon capsules and three different doses of Execlon patches. The company’s stance is that it is just to optimize the CNS portfolio, not related to the rebate case. A Novartis official said, “In the process of optimizing our product portfolio strategy, we are reducing the activity of some older products and increasing the concentration of new drugs. Reducing the domestic sales marketing of some items does not mean we withdraw our business division. "
- Company
- XOSPATA , AML Medicine landing soon in Korea
- by Eo, Yun-Ho Nov 15, 2019 06:28am
- It is anticipated that new AML (acute myeloid leukemia) drugs which are lack of the treatment will be approved . According to the related industry on the 15th, Astellas Pharmaceuticals is in the process of approving from MFDS for 'Acute myeloid leukemia (AML) drug named Xospata (Gilteritinib). The drug is already approved in 2018 in the US and Japan and received European EMA approval last month. The efficacy of Xospata has been demonstrated in phase 3 clinical ADMIRAL studies. XOSPATA delivered superior survival with a median OS(Overall Survival) of 9.3 months vs 5.6 months with salvage chemotherapy during the ADMIRAL trial. XOSPATA more than doubled the 1-year survival rate compared with salvage chemotherapy. The one-year survival rate was 17% with salvage chemotherapy and 37% with XOSPATA. Adverse reactions occurred in more than 10% of patients receiving XOSPATA for 30days were anemia, increased ALT and AST, febrile neutropenia, thrombocytopenia, constipation, fever, and fatigue. AML is the most common form of leukemia, accounting for about 65% of adult acute leukemia. As you get older, the incidence increases. AML is first treated with a combination of two or three drugs such as Anthracycline. The problem is that even after the first chemotherapy, the leukemia cells fall to less than 5% and the degree of complete perception reaches 50-70%, but up to 50% of these relapse. As a result, many big Pharmacuticals are eager to develop new drugs. An official of the Korean Society of Hematology said, "AML is important to reduce cancer cell numbers in the beginning. We look forward to the appearance of options for prescribing older patients and patients who are unable to apply induction therapy." Meanwhile, Janssen's Decitabine named Dacogen has been prescribed as a primary treatment for older AML patients.
- Company
- Samsung Bioepis CEO notes 3 reasons why CAR-T struggles
- by Kim, Jin-Gu Nov 14, 2019 09:07am
- Ko Hang-Seung, CEO of Samsung Bioepis Co., picked three reasons CAR-T cell therapy (“CAR-T”) is struggling – price, patient size and productivity. On Nov. 12, CEO Ko shared his opinions about CAR-T and other next generation treatment options during his keynote speech at BIOplus 2019 in COEX, Seoul. “Data was fairly good when CAR-T first came about. The U.S. Food and Drug Administration (FDA) approved the treatment only with a handful of data. But never did we think that it would be so unprofitable. Apparently, Novartis is making about one-third of initially projected sales,” said CEO Ko. As the first reason, Ko pointed out the existing alternative option. Among others, rituximab (brand name Mabthera) is the most famous case. He explained CAR-T is vulnerable in price competition with rituximab out in the market. “When first rituximab was release, many commented how extremely expensive it was. But the price got notably lower after CAR-T was launched. CAR-T is inevitably expensive due to its production process. The manufacturer has to extract a patient’s blood sample and reprogram extracted T-cell first to finally infuse it back to the patient.” The second reason is limited patient size. The approved indication of CAR-T at the moment is limited to patients with hematologic malignancies. But as patient size of the cancer is significantly smaller than that of solid cancer, CAR-T sales figures are also low. Small patient size also negatively affects clinical trials. This also includes price issues. The CEO commented, “Clinical trial for CAR-T is full of obstacles as it has small patient size and its production cost is off the chart. This adds to the issue of generating statistically meaningful evidence for another indication and having it approved”. The third reason is productivity. Ko claimed “Some think pharmaceutical manufacturing is the easy part of the drug development. But mass manufacturing of a product in consistently satisfying quality is easier said than done”. “Production is one of the reasons Novartis is struggling with CAR-T. As the treatment is based on individually customized production, mass manufacturing is impossible and consistent quality control is difficult”, said the CEO. Lastly, he noted “Circumstances are quite similar with cell therapy and gene therapy sector that many of startups are jumping into these days. If they don’t tackle the quality control aspect in manufacturing stage fast, the market would unlikely to grow further”.
- Company
- Merck Korea vs GM employee feud sees no end
- by An, Kyung-Jin Nov 14, 2019 09:07am
- KDPU Merck Korea chapter picketing during morning rush hour After licensing out antihypertensive and anti-diabetic treatments, Merck Korea is finally, and completely, shutting down its General Medicine (GM) division. However, an intense conflict with labor union has deepened as more than a half of the employees have not reached an agreement with the company’s management. The company offering early retirement program (ERP) became highly controversial as it technically asked a certain group of employees to leave the company “voluntarily”. According an industry insider on Nov. 13, imminent shutdown of Merck Biopharma Korea’s GM division is causing increasingly heated labor-management strife with the GM division employees. Merck Korea has officially announced the closing of the GM division by the end of this month as it has sold off local sales rights of two prescription drugs to Korean pharmaceutical companies within a month. On Oct. 11, the company closed a deal with GC Pharma to sell the sales right in Korea for an anti-diabetic drug, Glucophage. And shortly after on Nov. 5, the company and Daewoong Pharmaceutical signed a deal over a sales right of an antihypertensive drug Concor. The signed deals provide Merck Biopharma Korea to maintain the item permit, while GC Pharma and Daewoong Pharmaceutical would initiate marketing and sales activities of the products from the beginning of next year. The decision was made based on the Merck headquarters’ intention to focus on accelerating growth of specialty care sector. “Merck now has a new aim to strengthen specialty care pipelines on oncology, infertility and neurology sectors to become a global specialty innovator. By supplying Merck’s drug products to GC Pharma and Daewoong Pharmaceutical, we would continue to contribute in improving lives of Korean patients,” said Merck Biopharma Korea General Manager Javed Alam. The GM division has about two weeks left to complete the closing, but more than a half of employees and Merck Korea have not settled on a middle ground for their employment condition. Representative of Merck Korea chapter of Korea Democratic Pharmaceutical Union (KDPU) informed that the management has offered ERP compensation to pay out eight month’s wage, in addition to two month’s wage times by a number of years of service. Including a manager-level employee, nine out of 35 employees from GM division have applied for ERP, and other 26 are demanding the management to provide more options of employment security, such as reassignment of position. According to the division shutdown schedule, offices in Gwangju, Daejeon, Daegu, Busan and other regions are also preparing to shut down and reassigning employees to Seoul office from next month, regardless of their unimaginable intercity commute. Merck Korea plans to offer the employees an ERP package, and also to provide opportunities to transfer position within or out of the company. Moreover, the management is offering financial support of maximum 40 million won for up to two-year MBA or master’s degree graduate school programs, and it informed there would be another call for ERP applicant. However, the union claims the management asking one specific department to apply for early retirement is not so far off from them picking on a particular group of employees. The union explains the ERP should be offered to everyone in the company and employees who wish to stay should get a chance to be reassigned to another department. Beginning from Sept. 30, Merck Korea’s labor union has been protesting against the management’s decision to downsize in front of their office building. And to this date, the union members are picketing during the busy commuting time every morning. Head of Merck Korea chapter of KDPU, Cho Young-seok reproached, “The union has attempted to convince the management to postpone the sales right deal and to seek mutually sustainable means for the both parties, but our proposition has been denied. Besides the sales license, the company should at least give employment opportunities to those who want to stay. Relocating employees from closed regional offices to Seoul office is technically pushing them over to the edge to leave the company”. About the issues addressed, Merck Biopharma Korea official stated, “As GM division’s regional offices are closing down soon, their employees have been reassigned to Seoul office. The headquarters’ intention is to discuss various options including ERP. Although the feasible number of employees cannot be specified at this moment, we plan to offer opportunities for them apply for transition to Korean pharmaceutical companies with the sold drug sales rights, or even to other divisions in the company”.
- Company
- Rolontis®to get ₩11.6 billion upon FDA's approval
- by An, Kyung-Jin Nov 14, 2019 03:25am
- The royalty scale of Rolontis® was first revealed. Hanmi Pharmaceuticals will receive rayalty of nearly ₩ 12 billion upon final FDA approval. After the release, Hanmi Pharmaceuticals will also likely receive a certain percentage of revenue annually, depending on sales. Spectrum Pharmaceuticals, Hanmi Pharmaceutical’s partner, recently filed quarterly report SEC. Spectrum Pharmaceuticals noted in its report that it has completed reauthorization application process on Oct 24. The company rescinded its initial BLA for the reason of the FDA’s request for more CMC data in March. The company resubmitted the biologics license applications (BLA) for Rolontis® to the FDA after 7 months. Spectrum pharmaceuticals said with confidence ,“Rolontis® demonstrated safety and efficacy in 643 early breast cancer patients with neutropenia following myelosuppressive chemotherapy. The two phase III clinical trials showed non-inferiority in terms of the duration of neutropenia compared with Pegfilgrastim during the four cycles of chemotherapy.”It expects to enter the Pegfilgrastim market generating $ 4 billion in revenue annually, if approved. According to the report, Spectrum pharmaceuticals agreed to pay $ 10 million milestones to Hanmi Pharmaceuticals upon FDA’s approval. After launch, Spectrum pharmaceuticals will pay a certain percentage of royalties annually based on the net sales. Rolontis® is a biological new drug with long-acting that utilizes Hanmi’s Labscovery platform technoloy. In 2012, Hanmi Pharmaceuticals signed a licensing agreement with Spectrum Pharmaceuticals, giving the global rights for Rolontis® except for Korea, China and Japan. Hanmi Pharmaceuticals and Spectrum Pharmaceuticals did not disclose the total contract size, including the upfront fee and the technology at the time of contract. According to Spectrum Pharmaceuticals, a certain deposit was paid to Hanmi Pharmaceuticals when they signed the contract initially. In September 2014, after confirming the positive phase II clinical results and deciding to proceed with phase III clinical trials, they said the terms of the contract, such as milestones and sales royalties were modified. Spectrum Pharmaceuticals first paid Hanmi Pharmaceuticals $1.9 million milestones when it started the ADVANCE study in the first quarter of 2016. Spectrum pharmaceuticals issued 318,750 common shares for Hanmi pharmaceuticals in April of the same year. Considering the stock price at that time, it was worth $ 2.3 million in cash. , Currently, Hanmi pharmaceuticals owns 0.29 percent of Spectrum pharmaceuticals shares. Joseph W. Turgeon, CEO of Spectrum, who attended the conference call on July 7, said, “Spectrum pharmaceuticals submitted theRolontis®BLA to the FDA last month with a strategic decision considering management priorities.” We plan to introduce the Rolontis® Phase III clinical integration data which was released at the 2019 ASCO conference, at the San Antonio Breast Cancer Symposium (SABCS) in Texas, USA next month“.
- Company
- Kisqali joins reimbursement race as Faslodex combination
- by Eo, Yun-Ho Nov 13, 2019 01:11am
- A third CDK4/6 inhibitor in the Korean market, Kisqali now stands next to the first two drugs, Ibrance and Verzenio, as it applies for National Health Insurance (NHI) reimbursement listing. Novartis Korea recently submitted a reimbursement listing application of Kisqali (ribociclib) after its approval by Ministry of Food and Drug Safety (MFDS) on last Oct. 30. Accordingly, Ibrance and Verzenio are to face another competitor, while they are already fighting over insurance benefit under an indication as a combination therapy with Faslodex (fulvestrant),. Currently both Pfizer’s Ibrance (palbociclib) and Lilly’s Verzenio (abemaciclib) are waiting for deliberation by Drug Reimbursement Evaluation Committee (DREC), after Health Insurance Review and Assessment Service’ (HIRA) Severe and Cancer Disease Deliberation Committee has passed them as a combination therapy with Faslodex. And now with Kisqali joining the race, the three pharmaceutical companies are to compete intensely against each other for the first-in class indication as ‘second-line combination therapy with Faslodex’. All three of them are in the same class of cyclin-dependent kinase (CDK) 4 and 6. But reportedly, their reimbursement listing applications vary in strategy. In November 2017, Ibrance has already been listed as a first-line therapy in combination with Letrozole via refund type risk sharing agreement (RSA). And now it is in process of expanding the indication. Verzenio, on the other hand, is applying for reimbursement listing for the first time. The treatment has simultaneously applied for reimbursement not only as a second-line therapy, but also as a first-line therapy in combination with aromatase inhibitor. But under its current circumstances, Verzenio’s only option is RSA. However, a follow-on drug is not yet eligible for RSA. And because its indication as a combination therapy with faslodex targets wider range of patients with prior experience of treatment regardless of menopause, the drug maker Lilly is highly likely to apply as a second-line treatment before any other product applies for it. But, Kisqali is also likely to apply for the second-line treatment indication as well. Kisqali was approved by the regulator based on a meaningful improvement of prolonging progression free survival (PFS) demonstrated in its clinical trial. Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as first-line treatment for pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer, and proved the drug’s effect of significantly extending patient’s overall survival (OS). Compared to the existing endocrine-based single therapy, Kisqali’s result in the Phase 3 MONALEESA-3 extended OS longer and improved treatment efficacy when used as initial endocrine-based therapy in combination with fulvestrant for postmenopausal women with locally advanced or metastatic breast cancer.
- Company
- Takeda provides free supply of MM treatment Ninlaro
- by Eo, Yun-Ho Nov 13, 2019 01:09am
- Takeda Pharmaceutical started providing free supply of oral multiple myeloma treatment, Ninlaro. According to industry insider, Takeda Pharmaceutical has decided to provide free supply the only oral option for multiple myeloma treatment, Ninlaro (ixazomib), last month and recently entered general hospital’s list of drug codes. Currently, the Big Five general hospitals including, Seoul National University Hospital, Severance Hospital, and Samsung Seoul Medical Center, have coded in the treatment for prescription. The decision was made as a temporary arrangement due to the delayed insurance reimbursement listing procedure. The treatment was designated as an orphan drug in May of 2017, and was approved in July same year. But its reimbursement application is pending in the hands of Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) to this date. Ninlaro also expanded its indication as a combination therapy with lenalidomide and dexamethasone for multiple myeloma patients who have not responded to at least one standard therapy. The proteasome inhibitor drug demonstrated its efficacy and safety from Phase III TOURMALINE-MM1 clinical trial in patients with relapsed or refractory multiple myeloma. The study found triplet regimen of ixazomib, lenalidomide, and dexamethasone had significantly improved the length of progression free survival (PFS) to average 20.6 months, longer than 14.7 months of PFS recorded by a combination of placebo, lenalidomide and dexamethasone. Meanwhile, a triple combination therapy with Revlimid is the most recommended multiple myeloma treatment option according to the U.S. National Comprehensive Cancer Network (NCC) guideline and the European Society for Medical Oncology (ESMO). And Revlimid (lenalidomide) is the backbone for all triple combination therapies. Following are some of major triple combination therapy options for second line and later treatments; Amgen’s Kyprolis (carfilzomib) KRd combination (Kyprolis, Revlimid, dexamethasone); BMS’ Empliciti (elotuzumab) ERd combination (Empliciti, Revlimid, dexamethasone); Takeda’s Ninlaro (ixazomib) IRd combination (ixazomib, Revlimid, dexamethasone); and Janssen’s Darzalex (daratumumab) DRd combination (Darzalex, Revlimid, dexamethasone).
- Company
- Doctors choose PPI to replace ranitidine alternative
- by Nho, Byung Chul Nov 12, 2019 06:26am
- Apparently, healthcare providers are in favor of proton pump inhibitor (PPI), as an alternative to ranitidine after confirmed contamination of carcinogen N-nitrosodimenthylamine (NDMA) in some of ranitidine products. Doctor Ville, an online community exclusive to healthcare providers, recently conducted a survey on 1,664 doctors about alternatives to ranitidine. The survey studied which medicine would healthcare providers prescribe in place of ranitidine, due to the sales suspension on ranitidine products. 1,664 doctor members of the online community, who prescribes ranitidine, participated in the latest survey. 33.4 percent, 20.7 percent, 4.4 percent, 3.6 percent, and 3.6 percent of survey participants were from internal medicine, family medicine, neurology, surgical, and dermatology departments, respectively. Apparently, the overall 796 doctors are prescribing ranitidine for about ten patients a day. The study found the most number of doctors (48.7 percent) are considering on prescribing PPI instead of ranitidine, and other options like H2RA (35 percent) and mucosal protective agent (15.1 percent) followed. On a questionnaire confirming doctor’s preference order of single agent treatment alternative to ranitidine, 82.9 percent of survey participants ‘agreed’ with the order of ‘PPI, H2RA and mucosal protective agent’ as preferred options in the order. Among the group of doctors who chose PPI for an alternative option, 70.6 percent of them particularly picked esomeprazole as their primary option in mind. Lansoprazole (11.6 percent), rabeprazole (9.8 percent) and pantoprazole (8 percent) followed the list of preferred options of PPI. 43.2 percent of the group of doctors who chose H2RA answered they are contemplating on famotidine, and others chose lafutidine (29 percent), cimetidine (14.9 percent) and nizatidine (12.9 percent), in the order of preference. The survey also reported doctors’ preference order of mucosal protective drug was rebamipide (64.5 percent), artemisia asiatica medicine (27.1 percent), sucralfate (4.4 percent) and bismuth (4.0 percent). As for ranitidine combination therapy, 40.6 percent of doctors answered ‘combination of esomeprazole and Mosapride’, and other combinations of ‘esoeprazole and rebamipide (27.2 percent)’, ‘famotidine and rebamipide (18.5 percent)’ and ‘famotidine and Mosapride (13.6 percent)’ followed the list. 86.4 percent of the survey participants said they ‘agree’ on top three preferred prescription option of alternative ranitidine combination therapy to be ‘PPI and mucosal protective agent,’ ‘PPI and PKT’ and ‘H2RA and mucosal protective agent’, in the respective order. On the other hand, 58.2 percent of doctors said the most crucial factors affecting ranitidine-alternative option are ‘acid blocking and mucosal protective effects,’ and other 18.2 percent of doctors said ‘safety’.
- Company
- Mavyret’s 8-week indication approved in Korea
- by Eo, Yun-Ho Nov 11, 2019 10:40pm
- A hepatitis C treatment Mavyret is to soon be available as an eight-week treatment in Korea, after its approval in the U.S. After receiving an approval from the U.S. Food and Drug Administration (FDA) first, AbbVie received an approval from Korean Ministry of Food and Drug Safety (MFDS) last month for another indication as an eight-week once-daily treatment for chronic hepatitis C virus (HCV) patients across all genotypes (GT 1 to 6) with compensated cirrhotic, who has never been treated before. However, the drug is planning to follow a separate approval procedure for genotype 3 HCV. Moreover, Mavyret now can be prescribed to treat pediatric patients over age of 12 with HCV. The drug has been approved in the U.S. as an eight-week pan-genotypic treatment for treatment-naïve patients without cirrhosis in August, 2017. The indication expansion got a nod from the regulators based on evidence resulted in the Phase 3b EXPEDITION-8 study, a single-arm, open-label clinical trial evaluating the safety and efficacy of Mavyret in treatment-naïve adult patients with all six genotypes of chronic HCV and compensated cirrhosis. In the study, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatments (SVR12). The EXPEDITION-8 study had one reported case, out of 336 patients treated, for relapse, and found none of them discontinued treatment due to adverse reaction. The indication expansion on adolescent patient from age 12 to 18 was based on results from Part 1 of DORA study, a single-arm, open-label clinical trial assessing the safety and efficacy of Mavyret in pediatric patients treated for eight or 16 weeks. The study demonstrated 100 percent SVR12 in the adolescent patient group, proving the efficacy of the treatment successfully. Professor Kim Ji Hoon of Korea University Guro Hospital stated, “With the launch of Mavyret last year, eight-week treatment for HCV of all genotypes is now a prevalent option for the disease. But now with the new approval shortening the treatment duration from 12 weeks to eight weeks, patients with all genotypes of HCV, except for genotype 3, who has no experience of treatment can have a shorter treatment of eight weeks, regardless of cirrhosis.” Meanwhile, drug committees of all five major general hospitals in Korea, including Seoul National University Hospital, Severance Hospital, Samsung Seoul Hospital, Asan Seoul Medical Center and Seoul St. Mary’s Hospital, passed Mavyret for prescription. Similar to hepatitis B and alcohol, hepatitis C virus is a main cause of liver cancer. About 70 to 80 percent of HCV cases progress to chronic hepatitis, and 30 to 40 percent of such case get worsen to cirrhosis and liver cancer. Up to three or four years ago, only option for HCV treatment was combination therapy of injection and oral antiviral. For the long treatment duration of six to 12 months, patients had to endure many adverse events, and even so, the treatment success rate was just around 50 percent. The treatment success rate reached 90 percent and treatment duration was shortened to 12-to-24 weeks after orally taken direct-acting antiviral (DAA) was launched in the market.
- Company
- Generic to pay for original’s lowered pricing loss?
- by Kim, Jin-Gu Nov 08, 2019 08:55am
- To this date, a boundary of patent infringement damage against generic was up to ‘sales profit of generic’. But now a lawsuit claims the damages should include ‘loss made from original’s price reduction’ due to generics’ launch. Related court case is currently waiting for the Supreme Court’s final decision. Lilly Korea and two Korean companies, Hanmi Pharmaceutical (“Hanmi”) and Myung In Pharm (“Myung In”), are tangled in a decade-long fierce dispute over patent covering Xyprexa (olazapine). Initially, Xyprexa’s patent was supposed to expire on Apr. 24 of 2011, but Hanmi and Myung In challenged the patent. Both ‘Intellectual Property Trial and Appeal Board’ and Patent Court ruled in favor of the Korean companies stating that the original’s patented invention lacks creativity. Based on the ruling, Hanmi and Myung In launched their generics in early 2011, a few months earlier than the challenged patent’s expiration date. At the same time, Xyprexa’s price was lowered by the government. Patent case gets a twist, litigation for damages immediately followed But, things got complicated as the Supreme Court overruled the previous decision stating the patent is still valid. The patentee, Eli Lilly, filed litigation for damages against the two Korean companies’ patent infringement. As a result, Hanmi and Myung In paid Lilly all sales profit made from the generic as damages. Typically, a patent infringement case concludes there. But Lilly did not stop and filed another case claiming the two companies should also pay for Lilly’s loss caused by the original’s price reduction. Lilly insisted Hanmi and Myung In’s early generic release had the original’s price to drop and hence, the loss from the price reduction should be compensated. Contrasting second trial, Supreme Court to make final decision in December at earliest The court gave a nod to some of Lilly’s claim at the first trial against each of the two Korean companies. But the second trial was ruled quite the opposite. The Seoul High Court dismissed Lilly’s claim on the case against Hanmi. Infringement of patent was recognized, but the court rejected damage claim on loss by drug price reduction. On the other hand, the Patent Court agreed with Lilly’s case against Myung In. The decision ordered Myung In to pay damages even for Lilly Korea’s loss generated by the original’s price drop. The court stated “The generic’s drug price listing application has directly affected government’s decision. And it brought Xyprexa’s price down to 80% of the original price”. The two contrasting decisions have been sent to the Supreme Court. Experts predict the court would make a decision by the end of the year. “The Supreme Court is reviewing legal principle and the issue comprehensively. The court decision would be out before next year,” a legal expert commented. More burden on early generic release if Lilly wins Actually, the damage amount alone for the two Korean companies was not that much. For instance, Myung In was ordered to pay damage of KRW 98.07 million from the first and second trials. The total sales were low to begin with, as the launch was only a few months ahead of the patent expiration. However, pharmaceutical industry’s patent experts view the decision on the litigation would significantly affect the industry. The court ruling in favor of Lilly would heavily influence early release of generics in the future. If patent infringement damages are to consist of generic sales profit and loss by the original’s price reduction, the damage amount could sum up astronomically and detrimentally depending on the generics’ release date. The Supreme Court’s final decision is soon to be made. As a matter of fact, Korean judiciary has never made a precedent ordering a generic manufacturer to pay for the original’s loss by price reduction. Now the public waits to see whether or not an exceptional decision would be made.
