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- 2025-12-25 17:28:52
- Policy
- MOHW “COVID-19 vaccine-treatment approval early next year”
- by Lee, Jeong-Hwan Nov 09, 2020 06:18am
- Minister Park Neung-hoo of Health and Welfare stated the South Korean government is anticipating a temporary use approval of COVID-19 vaccine in March next year and treatment early year. However, the minister said the vaccine would most likely to be an imported product by a multinational pharmaceutical company, and Korean-made treatment would receive approval for an urgent use, instead of a complete approval, on products that completed Phase 2 clinical trial. On Nov. 4, Minister Park answered with the said detail to Democratic Party Lawmaker Heo Jongsik at the National Assembly Health and Welfare Committee’s general meeting to review 2021 budget plan for Ministry of Health and Welfare (MOHW) Lawmaker Heo questioned the minister of the estimated timeline of COVID-19 vaccine and treatment approval. Minster Park predicted the vaccine developed by a multinational company would be approved by March next year at latest. The minister also anticipates the government to grant an urgent use approval on COVID-19 treatment developed by a South Korean company with a condition to conduct Phase 3 trial. Minister Park elaborated, “The government would likely to get an access to the vaccine by a global company first. The vaccine is expected to be approved and accessible in South Korea by March next year. Two of Korean-made treatments are to conduct Phase 2 study until the end of this year. The two drugs would have outstanding Phase 3 trial to conduct, which could take a significantly long time.” The Health and Welfare Minister elaborated, “The developers of the two treatments could request for the temporary use approval, if they can properly prove the efficacy in a Phase 2 trial. While the Phase 3 trial is in process, the treatments with completed Phase 2 trial result could be temporarily approved. However, the biggest challenge is insufficient number of clinical patients. Most of the Korean-made treatments are targeting mild case of the infectious disease. In early next year, we expect a drug approved for urgent use with completed Phase 2 trial would be accessible.”
- Policy
- Antiviral Zovirax license transferred from GSK to Ilsung
- by Lee, Tak-Sun Nov 06, 2020 06:26am
- GSK’s Zovirax Tablet sold in the global market. Ilsung Pharmaceuticals is to take over the brand sales rights in South Korean market. Used for decades in South Korea as an antiviral drug against herpes simplex virus (HSV) and varicella zoster virus (VZV), Zovirax (acyclovir) has completed the local sales rights transfer from GlaxoSmithKline (GSK) to Ilsung Pharmaceuticals An acyclovir original, Zovirax, lost ‘GSK’ from its name as recently GSK voluntarily dropped the license on importing the finished pharmaceutical product in the cream and other forms. Instead, Ilsung Pharmaceuticals gained the sales rights in South Korea and renamed the product as ‘Ilsung Zovirax.’ On Nov. 5, GSK intentionally revoked the licenses over two finished products—‘Zovirax Intravenous Injection’ and ‘Zovirax Cream.’ The license on ‘Zovirax Ophthalmic Ointments’ was automatically canceled from last Oct. 1, when the license expired. Now, the multinational company has no license over any of Zovirax lineups in South Korea. However, ‘Zovirax Tablet’ is to maintain its well-known brand name with Ilsung Pharmaceuticals. The South Korean company has requested for license change to rename the product as ‘Ilsung Zovirax Tablet’ and completed the transfer procedure on last Oct. 7. Zovirax is a bestselling antiviral drug sold in South Korea since 1985 by Dong-A ST (formerly known as Dong-A Pharmaceutical). The drug is widely used for treating various viral infections, including first-time and recurrent genital herpes, HSV on skin and mucous membrane and even on shingles. Also the drug has treatment efficacy and benefit on a child over two years of age with chickenpox. However, the drug sales performance plummeted from 2018, when Dong-A ST stopped supplying the product due to contract expiration with GSK. According to IQVIA, the antiviral drug has generated 5.7 billion won in 2016, but the figure dropped to 40 million won last year. Ever since the contract termination with Dong-A ST, Zovirax could not find the right partner. Nevertheless, Ilsung Pharmaceuticals inked the license transfer deal with GSK and followed through with the process. In South Korean market only, there are 172 acyclovir items available. But the market is currently valued only at around 10 billion won, due to pricing reduction and intense competition between products. The industry experts assume Dong-A ST halted the sales after the contract expiration, because of the underwhelming performance. But as the brand has been maintaining its high reputation and credibility for a long time, the experts also predict the product may have another chance in the market again. Now, the market would have to wait and see how Ilsung Pharmaceuticals would resuscitate the Zovirax brand.
- Policy
- The HIRA is conducting RWE research on cancer & rare dz
- by Lee, Hye-Kyung Nov 04, 2020 06:09am
- The HIRA will be conducting prospective clinical research to secure real world evidence (RWE) for cancer and rare disease treatments in earnest starting next month. From last year to recently, the RWE guidelines were created through retrospective studies, and from this year to 2023,'prospective clinical research to prepare a platform for actual clinical basis for drug payment management' will be conducted. The HIRA will complete the selection of the final researchers by this month and collect data on whether or not treatments for rare diseases, anticancer drugs, and expensive new drugs are showing effects in the actual clinical environment after listing. Jin-Yong Lee, director of the Health Insurance Review and Assessment Research Institute, said in a briefing by the Journalists Association on the 3rd, "RWE research is the next-generation resource in domestic pharmaceutical policy, and it is a must." He said, "In pharmaceutical companies, Korea is a single market with a population of 50 million, and it has to go through for the registration of drugs in East Asia, but once listed, the drug price remains unchanged." He said that after marketing, RWE should be compared to see if the efficacy is the same as in clinical trials. "After 2-3 years of drug price registration, if the effect is lower than the clinical result in the RWE study, the drug price should be reduced, and if the effect is high, the drug price should be increased." He also said that it will take at least five years for the results of the RWE study to be linked to drug price adjustment. Regarding the opposition of pharmaceutical companies over the introduction of RWE in Korea, he said, "100 people participated in the clinical trial of a drug worth ₩100 million per dose, and the effect was 90%. If the effect is reduced to 50% in the results of the medication, shouldn't the drug price be readjusted?" He explained, "It's actually happening in the US, and that's why the RWE issue came out in Korea." He said, "The HIRA will evaluate it directly, and if it does not work, we will lower the drug price, and if it works, we will approach it from the perspective of expanding the scope of indications and benefits, and adjusting drug prices." He added, "If clinical professors participate in prospective clinical research from December, they will select drugs and conduct RWE research together for 3 years." Prior to the start of prospective clinical research, the HIRA Forum was held to disclose the results of the retrospective RWE research conducted from May last year to July of this year based on request data and medical records for all gastric cancer and breast cancer patients in Korea. It will be released. He took office as the 7th Director of the Health Insurance Review and Assessment Research Institute on August 18th. He is a person who worked as the head of the Department of Public Medicine at SNU Boramae Medical Center and worked on public quarantine in the field as the head of the Epidemiological Investigation Technical Support Team in response to COVID-19 in Seoul. He said that he applied for the public recruitment of the director of the review and evaluation researcher after much thought. He said that the institute, which has more than 200 members, is one of the largest national research institutes in Korea, and that the review and evaluation institute will be able to serve as a think tank for establishing health insurance policies. To this end, it was planned to promote the registration of academic journals, establish a website dedicated to the HIRA policy trends, and form a specialized academic journal in the field of health insurance policy. He said, "As the organization of the research center grows, we are determining what to do with the increase in manpower and work management." "Like the RAND Corporation of the United States, I will try to make this institute a think tank proactively proposing policies," he stressed.
- Policy
- New reimbursement standards on Rinvoq and Remicade
- by Kim, Jung-Ju Nov 04, 2020 06:09am
- Starting this month, the drug reimbursement would be granted on AbbVie Korea's rheumatoid arthritis treatment Rinvoq Sustained-release Tablet (upadacitinib) 15mg. As a result, the reimbursement standards have been changed for drugs with other various substances available for a treatment switch, and the combination therapy with the drug would be included in the reimbursement standards. Janssen Korea's Remicade (infliximab) injection, an immunosuppressant drug used in adult patients with Crohn's disease, has been newly indicated to treat intestinal Behçet's disease and received expanded coverage. South Korea's Ministry of Health and Welfare's (MOHW) partially revised standards of the healthcare reimbursement (pharmaceuticals) has come in effect from Nov. 1. ◆New and revised standards on pharmaceuticals: As Rinvoq is newly listed from this month, a new reimbursement standard for upadacitinibs, including Rinvoq, was added. An additional six months of reimbursed use would be permitted, if DAS28 score is decreases by 1.2 or more after six months of the use. From then on, the score would be evaluated every six months and the continuous administration would be approved if the evaluation results from the first six months are maintained. Due to the new reimbursement standard on the injection, the standards for other substance drugs eligible for switching have been added and changed. Following are the drugs, including upadacitinib, to be applied with modified standards; Janssen Korea's rheumatoid arthritis treatment Simponi (golimumab) Prefilled Syringe Injection 50 mg, JW Pharmaceutical's Actemra (tocilizumab) Injection and Actemra Subcutaneous Injection 162 mg, Korea BMS' Orencia (abatacept) 250 mg and Orencia SubQ-Prefilled Syringe 125 mg, AbbVie Korea's Humira (adalimumab) Injection, Pfizer Pharmaceuticals Korea's Enbrel (etanercept) Injection, and Roche Korea's lymphoma treatment Mabthera (rituximab). ◆Newly listed Pencivir Cream: A new reimbursement standard was established to list a herpes simplex virus infection treatment Pencivir (penciclovir) Cream by Kolmar Korea. According to the detailed criteria of the reimbursement, the healthcare benefit would be limited to the use within the approved indication of the drug (herpes simplex virus infection (herpes labialis)). ◆Additional changes on Remicade Injection: Among all infliximab drugs, immunosuppressant Remicade Injection by Janssen Korea was able to expand indication to treat intestinal Behcet's disease. The coverage would be limited to the drugs with the indication. As orally taken upadacitinib is newly listed, the reimbursement standard for the drug would add the name of the ingredient for a prescription switch. The healthcare benefit on treating intestinal Behçet's disease is granted on patients older than 19 years of age, diagnosed with Behçet's disease, confirmed an intestinal ulcer via endoscopy, and not responsive to standard of care (SOC) (two or more drugs) or discontinued treatment due to adverse reaction. Further sustained administration would be approved when the Behcet Disease Activity Score for Intestinal Behcet's Disease (DAIBD) is decreased by over 20 points within 14 weeks after the initial administration (administered three times).
- Policy
- Hanmi’s generic for Nexavar has been approved
- by Lee, Tak-Sun Nov 04, 2020 06:08am
- Hanmi's generic for Nexavar (Sorafenib, Bayer) was first approved in the liver cancer treatment market. In addition, it acquired exclusive rights in the generic market for nine months after its launch. On the 29th, the MFDS approved Hanmi's Soranib 200mg. Soranib is generic for Nexavar. It is used for hepatocellular carcinoma, advanced renal cell carcinoma, refractory to radioactive iodine, locally recurrent or metastatic advanced differentiated thyroid cancer, which has failed previous cytokine therapy, or for which this treatment regimen is not appropriate. Nexavar is the only oral drug for the first-line treatment of liver cancer since it obtained a domestic product license in 2008. Last year, when Eisai's Lenvima (Lenvatinib) was approved as the first-line treatment for liver cancer. Last year's IQVIA sales of Nexavar was about ₩25 billion. Hanmi will participate as the only generic competitor in this market. Hanmi won Nexavar's lawsuit for invalidation of patents for formulation and use. If it was lost, it could only be released after February 22, 2026, when the patent expires. Hanmi also obtained a generic for exclusivity license, which grants exclusive rights to the generics market. Accordingly, the ban on the sale of same active ingredient drugs is for 9 months from today (October 30) to July 29 next year. Considering the time it takes to acquire drug prices, the generic for exclusivity can be extended within the range of two months, so Hanmi is expected to enjoy exclusive rights without entering other generics for nine months after the release of benefits. Currently, other generic companies such as Kwang Dong are preparing to commercialize generic for Nexavar. The success or failure of the market depends on how much Hanmi's share of the original Nexavar during the generic for exclusivity period. Although it is the only generic drug, it is expected that it will be a difficult challenge as most of the liver cancer treatments are used in large hospitals and original product (Nexavar) are mainly prescribed.
- Policy
- Daewoong's DWP16001 targets synergistic effect with Zemiglo
- by Lee, Tak-Sun Nov 03, 2020 05:58am
- Daewoong Daewoong's new SGLT-2 inhibitory diabetes drug candidate is aiming for synergy with another domestic drug. The drug, first designated for expedited review, has been approved for three phase III clinical trials. The MFDS approved a phase III clinical trial protocol for Daewoong Pharmaceutical's new diabetes drug candidate 'DWP16001 (Enavogliflozin)' on the 30th of last month. This clinical trial is a Phase III therapeutic confirmation clinical trial conducted to evaluate the efficacy and safety of DWP16001 in patients with type 2 diabetes who have insufficient blood sugar control with Metformin and Gemigliptin. The clinical trial hospital is Bucheon ST. Mary’s Hospital. It is already the third phase III approval. In September, it received approval for Phase III clinical trials for both monotherapy and combination therapy with Metformin. In addition, validation of the combination therapy with Metformin-Gemigliptin is in progress. Gemigliptin is the active ingredient for Zemiglo, a new DPP-4 inhibitory diabetes drug developed by LG Chem. Daewoong has been selling Zemiglo since 2016. It also recently agreed to extend the joint sales until 2030. As Daewoong started selling the single drug Zemiglo and the combination drug Zemimet, last year, it achieved sales of ₩100 billion for the first among Korean new drugs. It is very interesting that Daewoong's SGLT-2 drug combination therapy selected a new domestic drug among DPP-4 drugs. In the case of the SGLT-2 series drugs mentioned above, most of the combined DPP-4 drugs are imported new drugs. Januvia (sitagliptin) and Onglyza (Saxagliptin) for Forxiga, Januvia (sitagliptin) for Suglat, Trajenta (linagliptin) for Jardiance and Januvia (sitagliptin) for Steglatro was validated through combination therapy. In addition, if Daewoong sells Zemiglo for the next 10 years and a new drug SGLT-2 is released in the middle, the combination therapy is expected to produce synergies in terms of profitability. The medical community argues that even if the SGLT-2 drug is administered in combination therapy clinical trials with one DPP-4 drug, the benefit should be made even if it is used in combination with another DPP-4 drug. Daewoong's Enavogliflozin is expected to be used in combination with other DPP-4 drugs even if it is used in combination clinical trials with Gemigliptin. Enavogliflozin is a drug that was selected for the first rapid review by the MFDS. It has been operating an expedited screening system based on corporate application since September. For drugs designated for expedited review, the approval review period is shortened by about 30 days (120 days → 90 days), and advance consultation is possible, so the supplementation rate is also lower. The MFDS said that Daewoong was designated as an innovative pharmaceutical company and that Enavogliflozin was designated as a subject for rapid review because it was a Korean drug.
- Policy
- Merck green lit to test novel COVID-19 antiviral in Korea
- by Lee, Tak-Sun Nov 03, 2020 05:58am
- A novel COVID-19 antiviral candidate, currently in development by a U.S.-based pharmaceutical company Merck, is to conduct a clinical trial in South Korea. Previously, Bloomberg covered the novel candidate as a ‘potential game-changer in the COVID-19 therapeutic scene. On Oct. 29, the Ministry of Food and Drug Safety (MFDS) has approved of a Phase 2/3 trial on Merck’s novel COVID-19 treatment candidate 'MK-4482.' The trial would test efficacy, safety and pharmacokinetics of MK-4482 in 60 adult patients in South Korea confirmed positive with COVID-19. The multinational company is enrolling total 1,300 patients around the world to test the novel antiviral candidate. The primary outcome measures are the time-to-sustained recovery, adverse event and adverse event to halt the test. The secondary outcome measures are all-cause mortality, pulmonary score on a scale, the U.K. National Early Warning Score on a scale and the World Health Organization (WHO) 11-point outcome score on a scale. MK-4482 is an antiviral candidate developed to treat patients with influenza. First discovered by the researchers at Emory University in the U.S., the candidate medicine is under development with a partner company Ridgeback Biotherapeutics. The treatment in tablet form, taken orally unlike remdesivir, has been under the public’s spotlight with an anticipation to significantly improve administration convenience, when its efficacy is confirmed.
- Policy
- 1 out of 4 claims for unltra priced Spinraza were approved
- by Lee, Hye-Kyung Nov 03, 2020 05:58am
- Only one out of four applications for pre-approval for salary medication 'Spinraza (Nusinersen)', a treatment for Spinal Muscular Atropy (SMA), was approved last month. The remaining one can be approved conditionally, and two have to be supplemented with data. A monitoring report must be submitted before administration of maintenance dose every 4 months after approval of benefits, and all 34 cases of administration monitoring were approved. The HIRA (President Kim Sun-min) unveiled cases of review by the Medical Review and Evaluation Committee in September. Spinraza is an ultra-high-priced new drug with upper limit price of ₩92.3 million per 5ml bottle, and medical institutions that want to take it must apply for prior approval. According to the details of the standards and methods for applying medical care benefits, in the case of Spinraza, a patient with 5q spinal muscular dystrophy, who was genetically diagnosed with a 5q SMN-1 gene defect or mutation, developed SMA-related clinical symptoms and signs at the age of 3 years or younger, and should not be using a permanent ventilator in order to receive benefits. Soliris (Eculizumab), which was the subject of pre-approval application prior to Spinraza, was approved in only one out of five applications for pre-approval. Last month, there were no reports of paroxysmal nocturnal hemoglobinuria (PNH), and only one out of five new applications for Soliris benefits for atypical hemolytic uremic syndrome (aHUS) were approved. Medical institutions which have received pre-approval of Spinraza and Soliris must administer it within 60 days from the date of notification of the review result, and reapply if they intend to administer it after 60 days. On the other hand, detailed deliberations deliberated by the Medical Review Evaluation Committee in September can be found on the HIRA’s website.
- Policy
- Hyundai is preparing for domestic approval of Mifegyne
- by Lee, Jeong-Hwan Nov 02, 2020 06:13am
- Hyundai Pharm, which maintains the No. 1 market share in the emergency (post) contraceptives market, is preparing for the domestic market approval of the artificial abortion drug Mifegyne. Mifegyne was ruled by the Constitutional Court for an abortion inconsistency in April last year, and the need to legalize domestic use and interest in domestic pharmaceutical companies also increased significantly. On the 1st, it was confirmed that Hyundai Pharm had inquired in advance with the MFDS about the requirements for submitting data on safety and efficacy in order to apply for Mifgene for artificial saving during pregnancy. So far, no pharmaceutical company has applied for approval or consulted in advance for spontaneous abortion-inducing drugs. Hyundai Pharm’s Mifegyne is the only drug that has inquired in advance on the data submission requirements. The MFDS believes that it is possible to apply for Mifegyne's product permission in the future based on the fact that the revision of the Criminal Law, the Maternal and Child Health Law, and the Pharmaceutical Affairs Law were announced. Under the current law, artificial abortion is possible only by surgery. After the constitutional abortion crime was determined to be inconsistent with the constitution, amendments to the related law are announced, and artificial abortion through medicines is expected to be allowed. Mifegyne is a prescription drug approved in 1998 by the French pharmaceutical company Exelgyn. Mifegyne (Mifepristone) induces abortion by blocking the progesterone receptor. Approved in France in 1998, the prescription drug was developed by Russel Uclaf SA, one of Sanofi's predecessors. Currently, All rights reserved outside the United States by Exelgyn. If Hyundai Pharm acquires the copyright of Mifegyne and succeeds in licensing, it becomes the first pharmaceutical company to market artificial abortion drugs in Korea. In addition, Hyundai Pharm is expected to enjoy the effect of further strengthening its obstetrics and gynecology pipeline. Hyundai Pharm currently holds the No. 1 market share in the domestic emergency contraceptives market with Ellaone and Norebwon. A company official briefly replied that it is difficult to respond to the related details as there is currently no specific knowledge of the plan to introduce Mifegyne in Korea.
- Policy
- Special agreement for re-evaluation of α-GPC is urgent
- by Lee, Jeong-Hwan Nov 02, 2020 06:12am
- Nam In-soon a member of Democratic Party of Korea Nam In-soon, a member of Democratic Party of Korea, stressed that there is a need for a 'special contract to return the reimbursement price' between the NHIS and pharmaceutical companis that applied for the clinical re-evaluation of Choline alfoscerate. In clinical reevaluation, a pharmaceutical company that failed to prove the usefulness of Choline alfoscerate for indications other than dementia should sign a special contract to return the entire reimbursement price paid during the reevaluation period to prevent unfair pharmaceutical companies from applying for reevaluation for the purpose of deleting the indication or avoiding damage. She raised the need for a special contract for returning Choline alfoscerate reimbursement, and furthermore, the Health Insurance Act, which reimburses pharmaceutical companies unfair benefits according to the results of winning or losing administrative litigations such as drug price cuts and positive list system, or compensating for damages to pharmaceutical companies caused by the government's incorrect disposition. The revised bill is also planned. On the 28th, she said that the deadline for submitting the application for clinical reevaluation of Choline alfoscerate is less than two months, so it is urgent to issue an executive order for the special contract to return the reimbursement of the MOHW. The MFDS announced December 23 as the deadline for submission of clinical reevaluation plan for Choline alfoscerate. Accordingly, 134 pharmaceutical companies with Choline alfoscerate are preparing to submit re-evaluation plans for 255 items. She believes that prior to reevaluation, Pharmaceuticals with Choline Alfoscerate and the NHIS should sign a special agreement to return all reimbursement prices paid by the pharmaceutical company within the reevaluation period in case of clinical failure, so that pharmaceutical companies which apply for reevaluation will be able to delay the duration of indication maintenance. In particular, she pointed out that it would be difficult to prevent unnecessary damage of health insurance finances because there is no basis for returning the reimbursement price of Choline alfoscerate sold by pharmaceutical companies during the clinical reevaluation period, which takes more than 3 years if the drug efficacy fails to prove unless a special contract is signed. In addition, for a special agreement between Choline alfoscerate pharmaceutical company and the HIRA, the procedure for issuing an administrative order is required by the MOHW, but it is not enough time because the administrative order procedure must be followed before the deadline for the application for reevaluation. Beyond clinical re-evaluation of Choline alfoscerate, she was also contemplating a revised bill of the Health Insurance Act related to the administrative disposition of pharmaceutical reimbursement such as drug price reduction and positive list system. In this year's National Audit of the Health and Welfare Committee, as pharmaceutical companies' administrative lawsuits for cancellation of notifications and provisional disposition for suspension of execution became issues, the necessity to advance lawsuits related to the drug price of Choline alfoscerate as well as all medicines emerged. As a single example, there is no legal regulation that allows the government to return the amount of prescriptions and benefits for indications other than dementia paid during the period following the first trial, a trial on an appeal case, and a trial at the Supreme Court when the pharmaceutical companies in the Colin Alpo lawsuit finally lose. This is why there are criticisms that it is highly likely that pharmaceutical companies will abuse the lawsuit to neutralize the effect of drug price cuts or delay the effective time to pursue unfair drug prescription profits. Assuming the actions the MOHW can take if Choline alfoscerate pharmaceutical company loses under the current legal system, it is about the disposition of government loss payment notice and reimbursement claim against the unpaid pharmaceutical company. This means that the reimbursement redemption is not legalized, so separate administrative orders and additional lawsuits are carried out. In response, she plans to make an amendment to the Health Insurance Act to compensate for the unfair repayment of pharmaceutical companies' unfair benefits according to the results of a drug price reduction lawsuit between the pharmaceutical company and the government, or to compensate for the damages in sales of drugs that pharmaceutical companies unfairly suffered due to government administrative measures. In a drug price cut lawsuit, it is a two-way bill that establishes a law to recover unfair benefits incurred during the lawsuit if a pharmaceutical company loses, and calculates and compensates the damage caused by the disposition by the government, such as drug price cuts. She plans to collect opinions from the MOHW, the MFDS, the NHIS, and the HIRA, as well as domestic and foreign pharmaceutical companies, civic groups, and related academic societies. Since the impact on the government administration and pharmaceutical industry is great, the goal is to collect opinions from various fields and reflect them in the legislation. She said the immediate urgent thing is that the MOHW issues an executive order to sign reimbursement return contract between the pharmaceutical company and the NHIS before the MFDS conducts clinical reevaluation of Choline alfoscerate. She also explained that the contract could eliminate the cases of pharmaceutical companies applying for unfair re-evaluation and prevent possible financial damage to health insurance during the re-evaluation period. In addition, she said that she plans to promote legislation to supplement and improve problems arising from administrative disposition lawsuits related to drug prices, including lawsuits for canceling Choline alfoscerate’s positive list system and temporary disposition for suspension of execution. In addition, she emphasized that the major framework of the current legislation is to redeem the treasury for unfair benefits when a pharmaceutical company loses and to compensate for unnecessary sales damage suffered by pharmaceutical companies when the government loses.
