In 2017, it was honored as the first year of major changes in the intellectual property of pharmaceuticals. Patent linking system, orange book, patent term compensation, data protection system, these ever-familiar words are familiar to Chinese medicine people from this year. Both the generic medicine and the new medicine industry have seen innovation and development in this year. In 2018, the executive meeting of the State Council of the People’s Republic of China made clear the pharmaceutical data protection system and the patent term compensation system on April 12, followed by the release of the draft for the implementation of data protection measures on April 26.
After decades of development, China’s pharmaceutical industry has achieved notable achievements, but it also faces the lack of innovation driving force and the difficulty of improving the quality of generic drugs. The reform of the intellectual property system with the patent link system as the core is trying to change the current situation from a deep level. The patent link system consists of two main lines: patent challenge and infringement litigation. It encourages generic pharmaceutical factories to initiate patent challenges through reward policies, and also wins benefits for the original research party by approving the waiting period system. This seems to be a system that will make both sides happy, but in fact, no matter which side, only powerful players can laugh. Therefore, the patent link system will promote the survival of the fittest, the strong and the strong, and ultimately improve the overall competitiveness of the pharmaceutical industry.
The patent link system is still being explored and established. The actual implementation of the patent link will take time, and this system is not isolated. It requires a lot of supporting reform measures to cooperate. In recent years, China has implemented a series of measures to deepen reforms (hereinafter referred to as the “supporting system”) in many aspects such as the medical and health system, the review and approval system, and the production and circulation of pharmaceuticals. It is actively creating conditions for the smooth landing of the patent link system.
In this article, the author will introduce the supporting system and its role in the patent link system to show readers the panoramic view of the patent linked to the game. For patent links, the role of these supporting systems can be divided into three categories: promoting imitation, encouraging innovation, and resolving disputes. Such classification is only for the convenience of the reader and is not strictly limited.
First, promote imitation
The first supporting systems: experimental exemption system
The experimental exemption system, also known as the “Bolar Exceptions” system, was named after the famous US patent of Bolar v. Roche in the 1980s. The system was written in 2008 in Article 69(5) of the Chinese Patent Law, which stipulates that prior to the expiration of the original research patent, the copyists of the drug and medical device will only ignore the conduct of the trial to meet the registration approval requirements. Infringement of patent rights. The reason for such a requirement is to consider that the development and testing of drugs is a very time-consuming process, even for generic drugs. If it is stipulated that the generic pharmaceutical factory can only start testing after the original research patent expires, it will mean that there will be no generic drugs for a certain period of time after the original research patent expires, which is equivalent to extending the protection period of the original research patent in disguised form. Therefore, the trial exemption system has given the generic pharmaceutical factory time to allow it to complete preparations for listing prior to the validity of the original research patent, so that generic drugs can be marketed as early as possible.
In U.S. law, the test exemption system, as a system that favors generic drugs, coexists with other systems that regulate the relationship between original interests (such as patent term compensation), and has reached a very delicate balance between the original imitations. However, the current Chinese patent law only writes test exemption systems, but it does not provide other systems to balance accordingly, making the original imitation of the two sides in the legal level has not formed a balance of power, which is obviously not conducive to the healthy development of the pharmaceutical industry. In particular, one of the premise of the patent link system is that the behavior of a generic pharmaceutical factory submitting a listing application is regulated as a tort, which contradicts the “exemption” in the current patent law. Therefore, I believe that China’s patent law needs to be revised in this regard.
The second supporting system: simplifying the listing application system for generic drugs
The simplified listing application system for generic drugs is similar to the ANDA system in the United States. The generic pharmaceuticals no longer require comprehensive clinical data when they submit a listing application. Instead, they mainly prove the composition and nature of generic drugs and original research drugs (ie, reference preparations). It is the same and has bioequivalence, that is, so-called “conformance evaluation test”. This will not only reduce the burden on generic plants, but also help improve the efficiency of review and approval, and accelerate the process of listing generic drugs; and, consistency assessment in fact puts higher requirements on the quality of generic drugs, and in the long run Will promote the generic pharmaceutical industry to improve the level of imitation and accelerate the survival of the fittest in the industry. For the patent link system, the use of the original research drug as a reference agent in a simplified listing application was used to conduct a conformity assessment test, naturally linking the original imitation to each other and constituting the “chain” of the patent link system.
Second, encourage innovation
Third supporting system: Patent Term Compensation
The patent term compensation system compensates for the patent period spent on clinical trials and audits. The period for the protection of Chinese invention patents is 20 years, starting from the date of filing of the patent. According to the current patent law, this period is the same for all fields, and the medical field is no exception. However, the peculiarity of the invention of the medicine lies in the long process of research and development, trial and review, evaluation and approval of the new medicine before it is put on the market, leaving little time for patent protection after the listing. Therefore, if we do not give a reasonable compensation for the term of the patent, it will undoubtedly greatly impair the enthusiasm of the entire pharmaceutical industry for the development of new drugs, which is not conducive to industrial development.
The patent term compensation system is also very important for the patent link system. When the patent period is extended, it not only determines the time for the original research drug to remain monopolized in the market, but also determines the time when the generic drug factory is kept out of the market and further affects the patent challenge strategy of the generic pharmaceutical factory. It can be expected that, on the one hand, the original research pharmaceutical factory will benefit from the system, and on the other hand, the generic pharmaceutical factory will be more motivated to challenge the original research patent in the face of the extended original research patent period.
Forth Supporting System: Data Protection System
The data protection system means that the pharmaceutical supervisory department shall, in principle, cease to accept applications for listing other people’s drugs of the same species within certain data protection periods for drugs that meet certain conditions. As early as in 2002, the “Regulations for the Implementation of the Drug Administration Act,” in order to fulfill its WTO accession obligations, China has prescribed a six-year data protection period for new chemical components, which is the initial prototype for China’s data protection system. Since 2017, the state has issued a series of documents related to the data protection system. Although some specific regulations are not the same, the basic framework of the system has already been formed.
The data protection system can more directly prevent the listing of generic drugs. Therefore, under the circumstances that the original research patent cannot be authorized, declared invalid, or the patent protection period is too short, it can still ensure that the innovative drugs can enjoy substantive market monopoly and protect the patents. The system constitutes an effective supplement. Especially for biological drugs, because of the higher costs associated with testing, the original researcher prefers to prevent others from copying through strong data protection systems.
It needs to be emphasized here that the beneficiaries of the data protection system are not just original research drug manufacturers. According to the consultation draft issued by the State Food and Drug Administration in 2017, those who challenge patent success can enjoy a 1.5-year data protection period. For the generic drug manufacturers, the greatest attraction of the patent link system is that they can give certain challenges to the success of market exclusivity, and China’s market exclusivity is likely to be given in the form of data protection. This further increases the importance of the data protection system for patent linkages.
Third, resolve disputes
Fifth Supporting System: Patent Declaration System
The patent declaration system requires the generic pharmaceutical factory to specify the relevant patents and their ownership status when submitting a listing application; if there is a patentee of the relevant drug, it must also inform the patentee. The significance of the patent statement system lies in that before the listing of generic drugs, the patent disputes between the original and the imitation are put on the table to solve the problem, so as to avoid the rekindling of patent warfare after the listing of generic drugs, which will bring even greater losses to the original imitation. In the patent link system, the patent statement will also directly become a mode of action for the initiation of a patent challenge by a generic pharmaceutical factory and constitute an important part of the patent link system.
The patent declaration system was already stipulated in the “Drug Registration Regulations” as early as in 2007, but it has not been implemented so far. The reason for this is that there are no specific operating rules. Since the patent declaration system directly relates to the issue of how the patent challenge operates, it is necessary to further elaborate the statement. The U.S. patent statement system is very specific. It divides the contents of the patent statement into four categories: i. no patent rights, ii. patent rights have expired, iii. promised to wait until the patent expires before it is listed, iv. / Does not infringe the patent. Will China also make such specific regulations? The industry is waiting to see it.
Sixth supporting system: Orange Book System
At the end of 2017, China released the first edition of the “List of Listed Drugs,” which the industry also called China’s own Orange Book. Many of the information disclosed in the Orange Book include the patent number and expiration date of the relevant patent. What is the significance of disclosure of patent information? The aforementioned patent declaration system requires the generic pharmaceutical factory to explain the relevant patent situation, but in reality, many generic pharmaceutical manufacturers do not know how to obtain relevant patent information. The Orange Book solves this problem. The generic factory can only understand the patent rights of its own product by consulting the Orange Book. In the patent link system, the patent challenge behavior of generic drugs is precisely for the Orange Book. Registered original research patents are initiated, so the Orange Book will also constitute a “link point” for the patent link system.
With the release and implementation of the aforementioned system, the big chess game of the Chinese patent link system has begun to take shape.
In addition to the supporting systems described above, other policies that the country has introduced or plans to introduce have more or less affected the immediate interests of both parties in the recent years. Together with the patent linkage system, they have promoted the innovation and development of the Chinese pharmaceutical industry. Accelerating the review and approval process has successfully solved the backlog problem that has plagued CFDA for many years. While improving the efficiency of review and approval, it also encourages more original research drugs to enter the Chinese market, and further more original research drugs will be incorporated into the patent link system. In the market, the licensing mechanism for marketers to allow drug research subjects to apply for drug listing is no longer subject to the “bundling” of production entities, which will undoubtedly greatly encourage scientific research subjects to invest in R&D, thus providing a source for the development of the pharmaceutical industry in China. The compulsory licensing system, which provides a “green channel” for the listing of generic drugs under special circumstances where public health is a major threat, is an important supplement to the patent linkage system from the perspective of public interest. All these systems will form an organic whole and work together. Ultimately, the majority of patients in our country will be able to enjoy the fruits of modern medical science and technology, and will continue to use more generic and even innovative medicines with more quality and cheaper prices.
Although the implementation of the patent link system still faces some problems, but with the continuous improvement of the aforementioned supporting system, the foundation of the patent link system has become more and more solid, and conditions have also The more mature. With good conditions and ready facilities, the establishment of a patent link system in China will be just around the corner.