dailypharmkorea

Opinion
[Reporter's View] Patent expired original
by Lee, Tak-Sun May 03, 2023 05:38am
For original drug patents that have expired, the upper limit is adjusted under the authority of the Ministry of Health and Welfare when a generic drug with the same product appears. Original drugs will be reduced to 70% of the previous price for one year, and from the second year onwards, the price will drop to the same 53.55% level as generic drugs. If the price drops by half, sales are likely to drop in proportion to him. That's what we call performance cut in half. Therefore, from the company's point of view, it is necessary to devise a strategy to prevent generics from being produced. First, it is to delay the expiration of the patent. In order to further guarantee the validity of a 20-year substance patent, the patent period can be extended by requesting an extension of the duration. In Korea, there is no limit on the extension of the duration. Therefore, pharmaceutical companies have been delaying the expiration of patents by extending the duration in consideration of the drug registration period. Another is to register subsequent patents. Commonly referred to as an evergreening strategy, it is to delay the release of generics by additionally registering salt patents, formulation patents, composition patents, and use patents. Domestic pharmaceutical companies sometimes make salt-modified drugs to avoid extending the duration or subsequent patents. However, as the Supreme Court disallowed it as a means of avoiding extending the duration, it is now widely used to neutralize subsequent patents. However, the salt-modified drug is not the same drug as the original drug because the salt is different. Therefore, even if a salt-altering drug comes out, the upper limit of the original drug does not fall. Maybe the original drug's evergreening strategy worked. Last year, generics were also released for diabetes treatment Tenelia, but the price ceiling did not fall because they were all salt-modifying drugs. Despite this patent strategy, generics are bound to come out. Last month, generics of Forxiga, a diabetes treatment, were poured out in heaps. Therefore, the original drug price was scheduled to be adjusted ex officio this month. The drug price cut was temporarily postponed because AstraZeneca, a pharmaceutical company, applied for suspension of execution to the court, and this was tentatively quoted. AstraZeneca applied for suspension of execution to the court because Forxiga, unlike generics, has indications other than diabetes. The company claims that it is unreasonable to cut drug prices that affect all other indications for which benefits have been applied, such as heart failure and kidney disease. It is interpreted that AstraZeneca pulled out a suspension card as a last resort when generics came out and drug price cuts became a reality. If the company suffers huge property damage, the possibility of suspension of collection increases. As mentioned earlier, the original drug's original drug price cut is halved, so property loss is inevitable. As a result, the rate of suspension of execution is also high. Once a suspension of execution is cited, price adjustments are not made until the outcome of the trial on the merits, so pharmaceutical companies can buy time for a long time. The longer the drug price adjustment period is, the more it will inevitably lead to financial losses for health insurance. As this problem has emerged, there is a movement to crack down on the door through revision of the law. The amendment to the Health Insurance Act, which provides for the recovery and refund of drug expenses paid or unpaid during the period of suspension of enforcement following the outcome of administrative litigation to cancel drug price cuts by pharmaceutical companies, passed the National Assembly on the 27th of last month. It is expected that if this law goes into effect six months after the government promulgation, the number of indiscriminate applications for suspension of enforcement by dissatisfaction with drug price cuts will decrease. A partial amendment to the Patent Act was proposed to limit the extension of the patent term to 14 years after approval and limit the number of patent rights that can be extended. If this law is passed, it is expected that generics will be more likely to be released earlier than before. I would like to think about introducing a more active reduction strategy, such as applying the ex officio adjustment condition limited to generics of the same product to late-release drugs with the same active ingredient after the expiration of the substance patent. There may be many things to consider, such as resistance from the pharmaceutical industry, laws and principles, and equity, but if the mechanism for adjusting authority is narrowly designed as it is now, strategies or tricks that abuse it will inevitably continue.