[Contribution] Evergreening patent strategy, various shapes and shades
The basic spirit of the patent law is to promote industrial development by encouraging invention and disclosing technology., Developers are granted exclusive rights for a certain period of time as compensation.. In particular, because the value of technology is important in the pharmaceutical and bio industries, 'patent'The importance of can be said to be very great.. However, the current patent period is based on the application date. 20years and years, For medicines, the maximum 5Extension is possible for less than a year(There are also issues related to this due to the recent revision of the patent law.).IMS Institute for Healthcare InformaticsA report published by(Price Declines after Branded Medicines Lose Exclusivity in the U.S)According to, All drugs are proprietary(patent)After losing this 1Drug prices within a year 51% fell. 10When years have elapsed, the maximum 88%plummeted to. Strengthening the item approval process, Due to competition with new technologies, the difficulty of developing new drugs increases and development costs increase accordingly., The moment the patent expires, the price of the drug plummets, so the expiration of the term is more fatal to the original pharmaceutical companies than anything else.. Therefore, original pharmaceutical companies have no choice but to always try to compensate as much as possible for losses resulting from patent expiration..As a result, many original pharmaceutical companies adopt a strategy of continuously filing for follow-up patents before the existing patent expires, effectively achieving the same effect as extending the patent period.. generic drugs, The purpose is to block so-called generic drugs from entering the market and extend the period of maintaining market occupancy., This is usually 'Ever Greening(Evergreening) patent strategy'It is said that.◇Various Types of Evergreening Patents The original purpose of patents is to protect innovation and R&D(Research and development)To promote, If the evergreening strategy is abused, it may work differently from its original purpose.. Companies are using various methods to extend the protection period of existing patents within the legally permitted range., The main types are:.①Formulation(Formulation) change: Contains the same active ingredients but sustained-release formulation, Apply for a patent for a new dosage form such as oral or injectable form②use(Indication) change: New indications in addition to the original therapeutic purpose(medicinal uses)Applied for a patent on③furtherance(Composition) change: Improved effectiveness by changing composition ratio and applied for new patent on this④production process(Process) improvement: Applied for a patent optimizing the production method of existing drugs⑤combination drug(Combination Therapy): A representative example of applying for a patent for a new composition with improved efficacy and effectiveness by combining existing single-ingredient drugs with other active ingredients is Viagra.(Viagra)and Lipitor(Lipitor)You can choose. Developed by the American pharmaceutical company Pfizer, Viagra was originally a cardiovascular treatment.. However, during clinical trials, a new effect for treating erectile dysfunction was discovered, and Pfizer applied for a new patent due to change of use.. Accordingly, the original patent expiration date was 2012year 3in month 2019year 10Approximately per month 7Exclusive rights extended for one year. Through this, the erectile dysfunction treatment market 92%was able to generate enormous profits, including. Pfizer's hyperlipidemia treatment Lipitor 2007year 5Month original patent expired. However, in order to defend profits, starting with the first material patent, preclinical 3Continuously applied for follow-up patents throughout the entire phase.. Optical isomer patent, Combination drug patent, Various efforts were made to defend profits even after the expiration of patent rights, such as filing for amorphous patents..◇The positive and negative aspects of Evergreen's patent strategy from the perspective of health care authorities., Evergreen's patent strategy has both positive and negative aspects.. In some countries, there are attempts to regulate it through fair trade laws or patent abuse by focusing only on the negative aspects., It is difficult to deny that Evergreen's patent strategy also has positive aspects..①positive side: From the original pharmaceutical company's perspective, it is possible to secure stable profits through new patents, and based on this, an environment is created in which investments in new research and development can be made.. In fact, because the development of new drugs requires enormous costs and time, some argue that a certain level of market monopoly is necessary for continuous research and development.. Another patient(consumer)Real benefits can be provided to. A typical example is when the convenience of taking is increased or side effects are reduced through improved drug formulation.. If the goal is to actually improve quality and improve the quality of life of patients rather than simply extending the monopoly, this can be a positive factor..②negative side: Contrary to the above, patients may suffer losses due to restrictions on competition.. Subsequent patents make it difficult for generics to enter the market., As a result, drug prices rise.. Patients do not have the opportunity to use cheaper alternatives, which leads to increased medical costs.. If it goes further, it will lead to loss of insurance finances on a national level.. In some cases, there may be a possibility of becoming embroiled in legal disputes.. Recently, regulatory agencies have tended to strictly judge the inventive step of composition patents, etc., so there is a possibility of invalidation.. In addition, if it is judged to be an abuse of patent rights, regulatory agencies may take action under the Fair Trade Act, etc.. Generic companies may become embroiled in another dispute by filing patent invalidation trials, rights scope confirmation trials, or using other strategies to avoid patents altogether..Evergreening patent strategy is an important tool for maximizing the profitability of pharmaceutical and bio companies.. However, if abused, it not only undermines fair competition., It can also cause harm to consumers.. Therefore, in order for the pharmaceutical industry to achieve sustainable development in the future, a certain degree of balance with legal regulations is necessary.. At the same time, companies will be required to develop innovative new drugs and develop ethical and fair patent strategies rather than simply extending monopolies.. Small and Medium Business Team [View full article]
[Contribution] Evergreening’s patent strategy, various shapes and shades (link)