What are the characteristics of patent link systems in various countries?

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug Medical Device Innovation (hereinafter referred to as the Opinions), which proposed to "explore the establishment of a drug patent link system".
, the State Drug Administration and the State Intellectual Property Office publicly solicited opinions on the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments), and the patent link system for balancing generic and innovative drugs began to enter the landing stage.
New Amendment to the Patent Law was adopted by the 22nd Session of the Standing Committee of the 13th National People's Congress, further incorporating the establishment of a drug patent link system and the resolution of patent disputes into the important agenda.
the essence of patent disputes is the interest game, which is more prominent in the field of drugs.
Because of the high investment in drug research and development, long cycle, risk, innovation difficulties, patent protection policy makes the original drug for a long time exclusive market, generic drug market difficult, the original research drug companies and generic drug companies between the interests of the dispute in the patent field is particularly obvious.
In order to encourage research and development innovation, reduce drug prices and improve drug access, the policy balance in drug market access in various countries and regions has given birth to different patent dispute resolution mechanisms, of which the patent link system is the most representative.
system originated in the United States and refers to the link between the approval of generic drug listings and the effective review of patents for related new drugs to avoid possible patent infringement.
The United States, through the Drug Price Competition and Patent Compensation Act (Hatch-Waxman Act, 1984), the Generic Drug Enforcement Act (1992), the Health Insurance Modernization Act (2003), and the Biological Agent Price Competition and Innovation Act (2010), constitutes a system of drug patent link systems.
The core of the U.S. patent link system is the following seven: First, the information disclosure system, that is, the orange book system, the original pharmaceutical enterprises in the application for a new drug market license, the need to submit patent information related to the drug, and through the orange book to the public, not included in the orange book patents may not claim rights in the link program.
Second, the patent declaration system, generic applicants should file with the FDA with the application for a declaration of the status of the patent, including no relevant patents registered in the Orange Book, the Orange Book registered patents have expired, the applicant will not manufacture, sell generic drugs until the expiration of the patent listed in the Orange Book, and the orange book listed patent invalid or the applicant does not infringe the patent rights registered in the Orange Peel (the declaration is also known as the "patent challenge").
third is to simplify the application system, generic drug market declaration does not need to repeat the new drug application has been proved safety and effective research, only biological equivalent research.
fourth is the infringement exemption system, generic drug applicants for registration purposes in the original drug patent period for research and development is not considered infringement, that is, Bolar exception.
5 is the proposed infringement system, for the filing of a "patent challenge" declaration of the application, should submit supporting materials, and notify the patente, if the patent right to the court within 45 days of notification, the FDA will stop the approval for 30 months.
6 is the containment and protection period system, different types of generic drugs to give different data protection and market exclusive period protection, the first generic drug enterprises, namely, the first successful challenge to the original drug patents and obtained a market license of generic drug companies will enjoy 180 days of market exclusive period, during which no other generic drug market applications will be approved.
is the patent extension system, the maximum can be extended for 5 years, from the date of drug approval, the patent extension period plus the remaining period of the patent after listing can not exceed 14 years.
link system has played an important role in promoting the development of generic drugs, safeguarding the legitimate rights and interests of drug patent holders, and reducing the risk of litigation after drug market.
, Japan, South Korea, Australia and other countries, through the Free Trade Agreement with the United States has introduced a drug patent link system, but the practices and policies of different countries are completely different.
Canada was the first canada to introduce a drug patent link system, the introduction of patent drug registration, additional protection certificate system, registered drugs can be granted up to 20 years of patent protection beyond the additional protection period of up to two years.
Unlike the United States, additional registration of patents is not permitted after the drug is on the market, generics do not have a first-in-the-world period, and the proposed infringement is changed to a prohibition order requiring the original pharmaceutical company to apply to the Federal Court for the initiation of the insulation proceedings after receiving notice of the generic drug's application for listing.
Japan's patent dispute resolution system differs from that of the United States in that generic drugs are not approved for listing when the patent period for active ingredients of new drugs has not yet expires, and after the approval of generic drugs for listing, a pre-dispute consultation system led by the Ministry of Health, Labour and Industry is implemented, and patent patentes may bring infringement proceedings in court, and new drugs are given an extended protection period of up to 10 years of trial data protection and up to 5 years.
Korea and South Korea set the containment period of the patent link system for 9 months, the first generic exclusive period of 9 months for generic drug applicants, the original pharmaceutical enterprises received the application for the listing of generic drug companies, may take the court to sue, to the Intellectual Property Trial and Appeal Board to confirm the scope of rights, and so on, to safeguard their patent rights.
Through combing, it can be found that the drug patent link system in the above-mentioned countries is broadly divided into two categories: one is the strong protection mode in which disputes arise and the listing is suspended, and the other is the weak protection mode that fulfills the obligation to inform, but the infringement does not affect the listing approval.
The EU does not introduce a drug patent link system, but rather a market access system that separates the listing license holder from the production license holder, and the approval department is only responsible for the safety and effectiveness of the drug and does not examine the applicant's patent infringement.
for drug patent disputes, the patente may obtain relief by applying for a temporary injunction from the court.
For patents on listed drugs, a system of trial database protection and extended patent protection periods is in place - up to an 11-year trial data protection period for new drugs and a supplementary protection period of not less than 5 years after the expiry of the patent.
India, a major generic drug manufacturer, has a negative attitude towards the drug patent link system and implements a compulsory licensing system for pharmaceutical patents in order to protect and promote the development of the generic industry.
these systems provide reference for the establishment of drug patent dispute resolution mechanism in China.
However, due to the differences in the basic national conditions, social systems, governing ideas and industrial policies of various countries and regions, especially the level of economic and social development, the innovation ability of scientific and technological research and development, there is a certain gap, China in the establishment of drug patent link system can not carry out copying, transplanting grafting of the Nariism, Nor can we pursue blind international integration, but on the basis of learning from the beneficial practices and successful experiences of foreign patent link system, based on the actual national conditions, focus on the practical needs of drug regulatory system and modernization of regulatory capacity, and speed up the construction of drug patent dispute resolution mechanism with Chinese characteristics.
source: China Medical Daily