The patent term compensation system, which can be formally incorporated into patent law, is a matter of snowfall for innovative pharmacists. It will increase the confidence of capital markets in the investment of new medicines in research and development and will create a virtuous circle in the future for the chinese pharmaceutical industry in transition
They were encouraged by the introduction of the patent term compensation system, which brought innovation to spring. However, they are somewhat disturbed by the current requirements of the consultation draft for the possible application of the new drugs listed since april 2018
Given the predominance of generic drugs in our country, there is nothing wrong with the system's design, but this does not mean ignoring the legitimate claims of innovative medicines
Will the dividends of the patent term compensation system benefit new medicines already on the market? This issue has been extensively discussed in the industry since the publication by the national intellectual property agency of the recommendations for the revision of the implementing rules of the patent law (the consultation draft) (hereinafter referred to as the consultation draft)。
The most recent revision of the law of the people's republic of china on patents, to be implemented on 1 june of this year, established a “compensation system for the duration of patents on medicines” to make innovative medicines a joy. However, when compensation begins to apply to new medicines listed, depending on the specific provisions of the implementing regulations subsequently amended by the patent law。
The draft statement of opinion stipulates that a patentee requesting compensation for the duration of a patent for a drug shall submit a request for compensation for the duration of a patent for a drug to the patent administration of the department of state within three months of the date of approval of the application for a licence to list the drug. This means that the consultation draft has only a red line “within three months”, and if the article is finally adopted, the new drugs that were on the market before 1 march 2021 (also considered to be before 1 june 2021) will not be entitled to patent term compensation。
This has led to the loss of many innovative medicines, and daily journalists of the rule of law have learned that they have now submitted proposals for amendments to the national intellectual property authority to introduce a “transitional period” that will be applied retroactively to new medicines to be listed after april 2018. The main reason for this is that, in april 2018, the standing committee of the state council decided “to award compensation for the duration of patent protection for up to five years for the application of innovative medicines to be listed simultaneously in china and abroad”. Since then, up to 31 new types of drugs have been developed for listing by local pharmaceutical companies。
Intellectual property experts also expressed concern. “the above-mentioned provisions of the exposure draft will make it possible to respond early to policy demands, to complete research and development of innovative medicines earlier, to apply more actively for listing approval and to reach the patients earlier, and may instead lose between one third and one half of the patent protection period simply because they were approved for listing one or two years or months earlier, which would be unreasonable for innovative enterprises and would probably discourage their innovation。
The patent system keeps the escort safe
It's the best time for innovation
When i was released in 2018, the issue of patenting and pricing medicines was the subject of social debate. The price of the original swiss pharmacological pharmacophagus, which treats chronic leukaemia, is much higher than that of a generic drug, the latter being only 17 per cent of the former。
Why is that? The timing and pre-investment of research and development are enormous, and enterprises can often only offset the upfront research and development costs if they receive high economic returns within 10 or several years of the drug being marketed. After entering china, with only 12 years of patent protection left, and high prices were difficult to avoid。
In the long run, the right to life and health of nationals cannot be protected in the long run without the development of innovative medicines by enterprises. In addition to the increased level of research and development in the country and the increasing number of original medicines, the establishment of a system of compensation for the patent duration of medicines is ripe for our country. Earlier, in an interview with the media, zhang hongchun, a member of the national political consultative council and director of the health department of the china-japan friendship hospital, revealed that, as of january 2018, there were more than 4,100 new drug research and development enterprises worldwide, and that china had the third largest number of new drug research and development enterprises in parallel with canada, accounting for 5 per cent of the world。
It is clear that innovative drug companies are the most active in this regard. As early as 2015, the representative of the national people's congress and chairman of the board of directors of beida pharmaceutical industries ltd., ding, outlined the creation of a new patent extension system at the 12th national people's congress to encourage autonomous innovation in pharmaceutical enterprises. This was the focus of his attention at both national meetings for many years。
“international experience has shown that the pharmaceutical patent term compensation system has been set up at some stage by the pharmaceutical powers and has become an important policy for the further upgrading of the pharmaceutical innovation capacity.” d。
In october 2017, good news came from the central office of the communist republic of china and the office of the state council, which issued an opinion on the reform of the system of in-depth review and approval to encourage innovation in pharmaceutical medical devices, proposing “a pilot project for a system of compensation for the duration of the patent period of medicines”。
In april 2018, the standing committee of the state council decided “to grant a maximum of five years of patent protection compensation for the application of innovative medicines for listing in china and abroad”, the first time at the policy level that the state has explicitly granted patent compensation protection for innovative medicines。
Since then, local pharmacies have reached a new peak in their research and development: according to statistics, 31 new types of medicines have been developed for listing by local pharmaceutical companies, with the largest numbers being developed in front enterprises such as heung shwe, hausen, baiji dynamite and yellow palae。
By the last year, the recently revised patent law had formally established a system of compensation for the duration of patents on medicines. Article 42 of the new patent law specifies that, in order to compensate for the time taken for the approval of new drug listing reviews, for patents related to new drugs licensed in china, the state patent administration, at the request of the patentee, is to grant compensation for the duration of the patent for a period not exceeding five years, and for the duration of the total valid patent upon approval of the new drug for a period not exceeding fourteen years。
“the ability of patent term compensation systems to be formally incorporated into patent laws can be said to exceed our expectations and to be a matter for innovative pharmacies. This will increase the confidence of capital markets in the investment of new medicines in research and development and will lead to a virtuous cycle in the chinese pharmaceutical industry in transition. Zhang lianshan, senior deputy general manager of hen swe medicine and managing director of global research and development。
Lanhon, vice-president of the beida pharmaceutical industry and head of the beijing research and development centre, was very pleased to see china's policies to promote the development of innovative medicines, such as the new medicines patent term compensation system and the drug patent link system, being gradually and internationally harmonized: “we have a large number of people who have returned home with experience and capital, and can say that we are meeting the best times in china to make innovative medicines.”
In his view, domestic innovation drugs are at a time of thinness, which, if the patent system can remain a guardian of innovation, will greatly enhance the innovation confidence of the industry as a whole. “the chinese advantage of thinness will gradually emerge in the coming years.”。
China's new drug application is a well spray
Concerns about the application of the new rules
They were encouraged by the introduction of the patent term compensation system, which brought innovation to spring. However, they were somewhat disturbed by the current requirements of the consultation draft for the possibility of applying to new medicines listed since april 2018。
And the impact is not small. Since 2018, china's new drug application has begun to blow up with drastic pharmaceutical policy reforms and patent policies. According to chen kai, a member of the chinese academy of sciences, 10 new types of drugs were added to the market in 2018, 12 in 2019 and 15 in 2020. Of these, 31 are new types of drugs that have been developed and listed by local pharmaceutical companies。
“the number of new drugs is not only increasing, but also the level of innovation is quite high.” chen kai took the example of the rosaster capsule, which was developed by beijing's zambojin company and was the first “global new drug” developed on the basis of the “cell perception and adaptation to oxygen supply” mechanism that won the 2019 nobel prize for medicine. In december 2018, rosashi capsules were first approved for listing in china, making my country, for the first time, the first country to introduce drugs. “this marks some of china's drug research and development in the international arena.” chen kai said first。
For the developers of rosashi's capsules, access to the protection of the patent term compensation system is their greatest concern at this time. “we have invested more than a decade of time, manpower and enormous financial resources for this. This new drug of groundbreaking innovation, if compensated for during the patent period, would fully motivate business innovation and benefit more people with anaemia.”
It is understood that rosashi capsules are currently on the market in china and japan and will be listed in the united states and europe, where patent term compensation systems are in place.” he was the first to be approved for listing in china, and hopes that he will also be the first to obtain the support of the state for the extension of the patent, highlighting the state's support for innovation。
“in fact, the contribution of new drugs currently on the domestic market to the state is extraordinary and addresses a significant part of the issue of accessibility and livelihood. If these innovative medicines, which were actively called for in the early years and which have already contributed to the country's livelihood, are not compensated on a patent basis, then the entrepreneurial motivation for innovation will be undermined.” zhang changshan says。
According to zhang lianshan, seven new medicines have been developed for listing. Most of the core patents have been on the market for more than 10 years from application to approval. “it is not much time left for businesses to be listed”. If it is less than eight years since the second autonomous new drug, appartini, was on the market, “what incentives do enterprises have to continue to innovate if they cannot generate sufficient commercial returns during the remaining patent period?”
Also of concern is the medicine industry in bedda. It was listed in november 2020 as the company's second self-researched, heavy 1-pound new drug, nshadini, the first self-developed national alk inhibitor, which was listed after 13 years of research and development and approval. The patent for its compounds will expire in 2031 and the remaining active patent period after listing will be nearly 11 years. The exclusive market period would be extended for more than three years if the drug could be included in the scope of compensation for the exclusive term. “it would be unfair for innovative pharmacies to lose more than three years of patent protection simply because they were approved for listing a few months earlier.”
Retroactivity of the recommended compensation system
Encouraging pharmaceutical companies to strengthen research and development innovation
Is the fear of innovative medicine justified in the eyes of experts
Cheng yong-soon said that in 2015 china had begun to emphasize the encouragement of innovation in the pharmaceutical industry and had taken a number of initiatives. Innovative drug companies respond to national policy requirements, undertake drug innovation and eventually achieve drug listing in china through reviews by the pharmaceutical sector, and their innovative behaviour should be encouraged. The terms of the consultation draft are not fair to the early response to policy demands, to the earlier completion of the development of innovative medicines, to the more active application for listing and to the earlier benefit of the patients concerned。
Cheng yong chong recommended that, in the light of international practice and past domestic practice, the system of compensation for the duration of patent protection be retroactive, as in the case of a new paragraph 2 of article 85 septies implementing the law on patents, which provides that a new drug licensed in china prior to the entry into force of the law on patents that meets the conditions for compensation for the duration of patent applications under paragraph 1 of this article may be submitted to the patent administration of the state council within three months of the date of entry into force of the law on patents. A separate transitional provision has been added to the implementing regulation of the patent law, which provides that a new medicine that was licensed in china prior to the entry into force of the patent law may be submitted to the patent administration of the state council within three months of the date of entry into force of the patent law and its implementing regulations, if it meets the conditions for compensation for the duration of the patent, as set out in article 42, paragraph 3, of the patent law and article 85 septies of the implementing regulation of the patent law. The state intellectual property office has announced the extension of patent rights for inventions, but has not updated the patent certificate and the original patent certificate remains valid。
“all of this is conducive to further stimulating the pharmaceutical industry's input into the development of innovative medicines.” it is always logical。
In the view of zhang xiaoyu, minister of intellectual property of the hausen pharmacy industry, in order to demonstrate equity, as well as the state's encouragement and support for innovative leading firms, it is very important to include a transitional clause in the rules for the application of patent law, which will trace the system dividend to the new medicines that have been listed following the state council's decision in april 2018 to grant compensation for patent duration。
Zhang lanshan added that “since in april 2018 the state expressly introduced a patent term compensation and legislation objectively required a process of time, once legislation had been established, new medicines should be introduced in response to the policy to compensate and to honour previous commitments”
It is understood that, in european and american countries, legislation or jurisprudence has made it clear that the application of the regime of compensation for the period of patent protection of medicines is retroactive. The european patent office, for example, has issued a “transitional period” provision along with new eu regulations on additional patent protection certificates, which entitles it to apply for protection as required if it has obtained a listing licence in member states and the patent remains valid。
Would it be possible to delay the listing of generic pharmaceuticals by adding a transitional clause that would extend retroactive power until april 2018? According to lanhon, these new drugs are listed for a maximum of three years and are still under patent protection for a period of 20 years, without prejudice to generic drugs — normally five years after a new drug has been listed, it is only when a generic drug is listed that it is determined by market conditions。
“most of the new drugs in the country are of the same type as me too or me better. Thus, patents on innovative medicines abroad usually expire before patents on new medicines of the same kind in the country, and the best target for domestic generics must be imported drugs with earlier maturity.” in seo-yang's view, the greatest threat and competition for new drugs in the country in the future come from generic drugs of the same kind。
Cheng yong chong added: “the purpose of the new patent law is to stimulate and protect innovation. Given the predominance of generic drugs in our country, the system's design is highly selective, but this does not mean ignoring the legitimate claims of innovative drug companies. It would be unreasonable and unscientific to impose undue restrictions on patent-protected compensation systems for medicines that would otherwise be conducive to innovative medicines to take into account, and even accommodate, the benefits of imitating pharmaceuticals, which are inherently contrary to the design of the system.”
