Frequent Domestic Signals When does the “Pharmaceutical Patent Compensation System” land?

As a commodity, medicines have intellectual property rights. However, due to the complicated clinical laboratory research and listing administrative approval procedures, it is difficult for their core patents to achieve true 20-year protection. Coupled with high R&D cost pressures, Greatly affect the development of innovative drugs. Based on this, the patent compensation system has been used abroad, but China has not yet implemented it. Recently, Shen Changyu, director of the State Administration Bureau, once again mentioned in the speech of the 10th China Intellectual Property Annual Meeting "establishing a system of compensation for infringement punitive damages and a patent protection period for drugs"; for the frequent occurrence of this signal in the country, I believe this policy The landing will not last long.
01. Why do you need compensation for the development of innovative drugs?
As mentioned above, the so-called drug patent protection period compensation system, that is, after the expiration of the patent protection period, the pharmaceutical patent product is given appropriate compensation to the patentee in order to make up for the effective patent period delayed by the drug clinical trial and the listing review and approval. A system for reasonable compensation for its patent protection period.
According to the TRIPS Agreement, patents can enjoy a protection period of not less than 20 years from the date of filing the application. At the beginning of the TRIPS Agreement, countries have different views on the length of the protection period, and finally determined in 20 years, mainly considering the needs of inventions in certain industrial fields. But in fact, the actual validity period available to pharmaceutical patent holders is far less than 20 years.
The implementation of the principle of prior application has led to the fact that the highly competitive pharmaceutical industry will apply for patents as early as possible to obtain priority, but the disadvantage is that “the time left for the enterprise is not much”. Pilot determination, candidate determination, preclinical development, clinical development, queuing for registration approval, etc... Even if the links are seamlessly linked, the time cost that must be paid is already used in the patent term, which is Naturally, it will harm the interests of the patentee; and those who know the development know that if you want to achieve the seamless connection of the above links, it will not only pay the time cost. If a question (first in class) is successful, 10 years of "burning money" to complete the above content, the speed is already amazing, but the real benefit time has been greatly reduced, which will undoubtedly hit the enthusiasm of developers, so the drug patent Compensation is imperative.
02. Discussion on the patent compensation period in China in the past 3 years
On December 8, 2017, the "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices" issued by the General Office of the Central Committee of the Communist Party of China/The General Office of the State Council clearly pointed out that the approval of drug listing review should be accelerated, and some new drugs should be selected in China. The trial of the patent patent period compensation system shall provide appropriate patent term compensation for the time when the clinical trial and administrative examination and approval take up the valid patent period.
On January 4, 2019, Article 42 of the "Patent Law Amendment (Draft) of the People's Republic of China" increased the provisions on the validity period of compensatory drug patents, and compensated for the time for review and approval of the listing of innovative drugs; Innovating pharmaceutical invention patents, the State Council may decide to extend the patent period, the extension period shall not exceed 5 years, and the total effective patent period after the listing of innovative drugs shall not exceed 14 years.
03. Where does the extension period of 5 years & 14 years originate?
The implementation of China's pharmaceutical administration is mainly borrowed from the United States, Japan, and Europe. The patent compensation system is no exception; "the extension period is no more than five years, and the total effective patent period after the listing of innovative drugs does not exceed 14 years." policy. Introduce one by one below.
The United States - the first country to establish a compensation period
In 1984, the extension of the patent period for pharmaceuticals was clearly stipulated by the Law on Drug Price Competition and Patent Period Recovery. The procedure is set as follows: The applicant submits an application for extension to the USPTO within 60 days from the date of receipt of the FDA's approval letter, and then submits the application to the FDA within 60 days; the FDA calculates the mandatory review period and announces the mandatory The results of the review, hearings, and appeals; the USPTO examines the patent extension application and determines the extension period.
The specific calculation method for the extension of the patent protection period of the drug is: 1) half of the clinical research time plus the time required for the entire FDA new drug to go through the approval process, the sum of the time is ≤ 5 years; 2) the drug is approved after the listing The longest patent protection period is ≤14 years, and the patent protection period plus the compensation period of more than 14 years is calculated according to 14 years; 3) The patentee must apply within 60 days after the approval of the new drug listing.
Japan ~ followed
In 1987, the Japanese Patent Law first proposed a system for extending the patent protection period. The specific calculation method for the extension is: the date on the date of patent registration and the date of clinical research minus the date on which the drug is approved for marketing, up to ≤5 years. Japan's extension system for pharmaceutical patents, except for preparations, active ingredients, and uses, is the same as the United States. In addition, each patent can be extended for multiple patent periods, and each approved drug can also receive multiple patent terms. Extension.
EU ~ Provide a certificate for compensation
In 1992, the Supplementary Protection Certificate (SPC) promulgated by the European Parliament provided for the extension of the patent protection period for pharmaceuticals. The application conditions include: drugs that have not been applied before and the application for the patent protection period has not expired; the application for the patent period compensation must be the first sale of the drug.
The calculation method is as follows: the time interval between the patent application and the first approval for listing is reduced by 5 years; the validity period of the extension is not more than 5 years, and the sum of the basic patent protection period and the compensation period remaining after the drug is approved for listing does not exceed 15 years. .
04. Is the drug patent period compensation really needed?
The answer is undoubtedly affirmative. Looking at the compound patents of Class 1 new drugs that have been listed in China in the early years, it is not difficult to find that most of the texts have less than 10 pages. In addition to the lack of early patent writing ability, most patent holders are not very stable on patents. Care, awareness only stays on whether to get authorization. PS: Many patentees do not think that domestic companies will copy their own varieties...
Nowadays, the application texts of compound patents are mostly more than 50 pages, and some even exceed 200-300 pages. This is enough to illustrate the importance that domestic new drug development companies attach to compound patents, and also to the confidence level of their products. Possibly, most people understand that domestic innovative drugs are still in the me-too stage. Of course, this is still the mainstream, but more potential me-betters are forming, and Chinese innovative drugs have begun to gain favor from the media. Therefore, the supporting drug administration needs to be settled, and the patent compensation system is definitely one of the important supports.