Overview of Drug Patent Link System and Its Significance

In recent years, strengthening drug patent protection has becomeCountries and regionsThe consensus of regulators and the pharmaceutical industry to establish a drug patent link system (Patent Linkage) is even more concerned.

What is the drug patent link system?

The drug patent link system refers to the phase between the approval of the listing of generic drugs and the expiration of the patent of innovative drugs.“Link”That is, generic drug registration applications should consider the patent status of previously marketed drugs to avoid possible patent infringement.The system was first created in the United States,In 1984, the United States passed the Drug Price Competition and Patent Restoration Act (Hatch-WamanAct), the groundbreaking establishment of the drug patent link system, and has undergone many modifications and adjustments. This is the drug review and approval and drug patent protection mutual“Link”A system design, in balancing the original research drug.(Patent medicine)Enterprise and Generics(Generic drug)The interests between enterprises have a good effect.

The construction of drug patent link system hasWhat?MeaningWhat?

1, for the original research and development enterprises, to protect the original research and development drug patent rights,Improve the enthusiasm of the original research drug enterprises to develop innovative drugs and help the original research drug innovation.. For example throughpatent declaration system andOrange book system, you can find possible violations in a timely manner. For another example, through the system of extending the patent protection period, it provides legal support for the original drug research enterprises to recover the cost by using the patent monopoly position.The original research and development enterprises can sue before the possible infringing generic drugs are licensed to market, which means that the risk of the original research and development drugs being encroached on the market by the infringing products is reduced during the validity period of the patent. At the same time, the litigation cost of the original research and development enterprises will be greatly reduced in the aspects of investigation and evidence collection, litigation cycle and so on. The original drug research enterprises will not be easily challenged for their own drug patents, and the drug patentee will pay more attention to innovation and perfect patent layout in the process of research and development.

2For generic drug companies,.TheThe system givesIt'sThe opportunity for generic drug companies to challenge patents, the success of patent challenges can allow generic drugs to be listed early, and it is also possible to get the first generic drug award,In addition to bringing huge economic benefits to itself, it will also give itself the opportunity to transform itself into a R & D pharmaceutical company,Improve the enthusiasm of generic drug companies to innovate.After all, in the future market, innovation is king. For example, throughWith the exception of Bolar, the time for clinical trials and approval of generic drugs is shortened, and the time for which the original drug still enjoys a substantial monopoly after the patent period expires.

3Standardize the drug access system,Rules of competition between original research drug companies and generic drug companiesbecomemake it clear,Promote orderly competition between the two sides. For example throughThe 45-day litigation period system and30The monthly containment period system will resolve possible patent infringement disputes before the drug is marketed.The budding stage,This will undoubtedlySignificantly reduced judicial resources.

Based onRight.drug patent protectionattention andIn the free trade agreement with the United States, China, South Korea, Canada, Australia and other countries have followed up the practice of the United States, and have made different adjustments or changes in the specific scope of application (such as whether biological agents are included) and rules (such as the way the procedure is started and the length of the relevant period) according to their own actual situation. At the same time, not only because of different national conditions, drug patent linkage system does not exist.“General Mode”Some countries or regions also hold a negative attitude towards the system, such as India, the European Union and Japan. India, as a major generics country,Through court jurisprudence, it is clear that the patent law provides.In the case of Bolar, the drug market approval agency only needs to review the safety and effectiveness of the drug, and does not need to consider the factors of patent disputes. In Europe, if a drug patentee wants to prevent the listing approval process of generic drugs, he first needs to get a temporary injunction from the court, which is obviously much higher than the threshold in the United States. Japan simply stipulates that generic drug applications are prohibited before the patent for the active ingredient of a new drug expires.

How about China's patent linkage system?

There are two main opinions on whether China has established a drug patent link system: one is that China already has a drug patent link regulation. It is based on China2005Year5Month1The Measures for the Administration of Drug Registration and the Amendments to the Measures(2007Year10Month1effective date, hereinafter referred to28Desk Order No.)The provisions on the description of the patent situation of drugs, including Article 8.(Information publicity)Article 18(Pharmaceutical patent status and non-infringement statement)Article 19(Generic Drug Application Restrictions)Article 20(data exclusive)and article 66(Monitoring period protection clause). These are similar to the patent link provisions for drug applications in the United States and the drug patent information published in the Orange Book. Another view is that China has not really established patent links in the drug registration process. It is based on the fact that, although28Desk Order No.(Pharmaceutical patent status and non-infringement statement)and(Time limit for generic drug application)However, because China does not have a list of patent information with legal effect like orange peel, and there is no functional cooperation between drug authorities and patent authorities, generic drug enterprises do not have a clear legal environment in the process of drug registration, which makes the State Food and Drug Administration(SFDA)In dealing with patent challenges as in the United States.ANDAThere is no time to rely on.

Even scholars who support the establishment of a drug patent link system in China admit that drug patent links are still basically in the form in China. In practice, there are problems such as poor credibility of the content of patent non-infringement statements,SFDAInability to examine relevant patent disputes in the process of drug registration examination,SFDAand State Intellectual Property Office(SIPO)There are many problems such as the inability to realize the link of functions, and the examination of drug registration information and drug patent examination have extremely high requirements for professionalism, so it is impossible for one department to solve all the problems independently. It must rely on each department to give full play to their respective advantages and cooperate with each other. Therefore, the most important problem to be solved is how to deal with the drug registration process.

2017Year10Month1On the same day, the State Office of the Central Office issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceutical Medical Devices, proposing to explore the establishment of a drug patent link system. This is an important institutional innovation in the field of intellectual property protection in China. The Economic and Trade Agreement between the Government of the People's Republic of China and the Government of the United States of America, signed earlier this year, proposes to establish"Effective Mechanism for Early Settlement of Patent Disputes"Its core content is the drug patent link system. A scientific grasp of the essence, value, function, key, premise, essence and art of the drug patent linkage system is conducive to judging the hour and sizing up the situation, seeking advantages and avoiding disadvantages, and maximizing the potential and advantages of this system. The drug patent linkage system involves both the litigation system and the administrative management system, and the effective connection between the two is the condition for the operation of the drug patent linkage system.

How about the patent linkage system in Taiwan?

The patent linking system in Taiwan is a modification and adjustment of the patent linking system in the United States. The main difference is that it will only target chemicals in the United States.Expanded to apply to biosims and chemicals;and will take the market exclusivity period of the first generic drug from the U. S.180 days extended to Taiwan12Months;andGenericIn terms of the approved stasis period, the United States is.30 months, while Taiwan is12Months. Under the background that the importance of biopharmaceuticals in the field of medicine is becoming more and more prominent, Taiwan's move to apply the patent linking system to biosimilar drugs can undoubtedly better stimulate local biopharmaceutical companies to carry out technological innovation and ensure the original research drug. The economic interests of manufacturers, while encouraging generic drug manufacturers to compete“First imitation”the dominant position to accelerate subsequent improvement research and development.

Anyway...This system will encourage generic drug companies to challenge patents, and original drug companies will actively consider filing patent lawsuits in order to maintain patent rights and maintain market competitiveness. Whether for original drug companies or for generic drug companies, the drug patent link system.ExecutionAnd change will bring about huge market changes. WithVarious itemsSystemIn many countries and regions are constantlyPerfect, global pharmaceutical companies can refer to the U.S. patent link system, advance layout and preparation, in the future fully competitive market to occupy a place.