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    Home > Active Ingredient News > Drugs Articles > Drug Patent Link System: How much more way to achieve the balance of imitation. Regulatory observation.

    Drug Patent Link System: How much more way to achieve the balance of imitation. Regulatory observation.

    • Last Update: 2020-09-29
    • Source: Internet
    • Author: User
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    ✔ the relevant provisions of the Patent Link for Pharmaceuticals appeared for the first time in the draft of the Patent Law Amendment.
    ✔ the amendment to the patent law is considered to have made a major breakthrough, helping to further improve the rule of law environment for pharmaceutical innovation, although there are also voices that the introduction of a patent link system is not a good choice at present.
    ✔, Yasheng Pharmaceuticals, Baiji Shenzhou, Xinda Bio, Green Leaf Pharmaceuticals and other enterprises have begun to start intellectual property matters.
    Innovative pharmaceutical enterprises in recent years under the support of good policies to grow rapidly, and innovation is closely linked to the patent level, the discussion on the drug patent link system has long been at the legislative level, but due to many practical factors, the system has not really been established.
    July 3, 2020, the website of the National People's Congress published the full text of the Amendment to the Patent Law (Draft II) for public consultation.
    , the relevant provisions of the drug patent link appear for the first time in the draft of the Patent Law Amendment.
    This is in fact the fourth revision of the Patent Law to fully implement the October 8, 2017, the General Office of the CPC Central Committee, the General Office of the State Council issued "on deepening the reform of the review and approval system to encourage drug medical device innovation" (the "two-office Opinion"), a program document to encourage innovation in the pharmaceutical industry.
    industry has also begun to pay attention to the system rules refinement and effective implementation of the stage.
    1984, the Hatch-Waxman Act, introduced in the United States, was an important part of the patent link system.
    the passage of the bill, the presidents of AAM (Universal Pharmaceutical Association, former generics association) and PhRMA (American Association of Pharmaceutical Research and Manufacturers) issued separate statements calling it their respective victories.
    practice has proved that the U.S. patent link system promotes the balanced development of original and generic drugs in the United States, making the United States the world's largest market for original research drugs and generic drugs.
    to expand the reading drug patent link: innovation and imitation of the beautiful balance of drug patent link: into or out of China's new drug intellectual property protection status quo? How do we assess the timing of the implementation of the patent link system at this stage? What other details of Draft II need to be discussed? In the new policy environment, how should the ip's intellectual property strategy be adjusted?The need for a patent link system From the policies introduced since 2015 to the new provisions of this year's draft revision of the Patent Law, China's determination to protect the achievements of pharmaceutical innovation can be seen.
    feedback from innovative companies, many policies do not appear to have had the desired effect.
    Cheng Yongshun, director of the Beijing Center for Pragmatic Intellectual Property Development, said: "According to feedback from many innovative pharmaceutical companies at home and abroad, the biggest problem facing innovative drugs is that the research and development of new drugs is becoming more and more difficult, investing more and more time, financial resources and energy, but in patent applications, there are still many difficulties, long and difficult to obtain authorization;
    the same time, due to the lack of institutional interface mechanism, generic drugs were approved for market under-consideration of patent issues, last year to the first half of this year even appeared 'January 1 imitation' situation.
    "Expanding reading process Yongshun: introducing system design to provide institutional basis for drug patent links" generic drugs before the expiration of the relevant patent protection period to obtain a listing license, access to the medical insurance bidding and quantitative procurement system, will crowd out the market for innovative drugs, to combat the enthusiasm of innovative pharmaceutical companies;
    generics are withdrawn, patients may no longer have access to cheap generics and will have to switch again to high-priced, innovative drugs.
    no innovation, there is no imitation, no innovative drugs, imitation will become a sourceless water, no wood.
    long-term, harming the innovative pharmaceutical industry, and ultimately harming the development of the generic drug industry, is the effect of double loss.
    ," Cheng added.
    Beginning in the second half of the last century, many countries, in order to balance the interests of innovative pharmaceutical enterprises and generic pharmaceutical enterprises, promote access to drugs, ensure the stability of national drug use, began to explore the establishment of a feasible drug intellectual property management system, including patent protection period extension system, test data protection system, trial exemption system, compulsory licensing system and a series of systems.
    the United States, Canada, South Korea has also introduced a patent link system.
    Drug patent link is in the drug registration and approval process, the generic drug market application approval and the corresponding drug patent rights and infringement procedures linked, before the generic drug market for innovative pharmaceutical enterprises to provide a clear patent relief path, while for generic drug companies to clarify the risk of infringement, and strive to resolve disputes before the drug market system.
    in fact, as soon as Draft II was launched, there was speculation that the content of the new patent link system was the result of pressure from the first phase of the Sino-US economic and trade agreement.
    , Song Ruixuan, president of the China Association for the Promotion of Pharmaceutical Innovation, said: "In 2017, the two companies clearly wrote to explore China's drug patent link system, trial patent period compensation system."
    , the gradual increase in intellectual property protection is not so much external pressure as the internal demand for China's economic development.
    this revision of the patent law is not a matter of effort, nor should it simply be attributed to any provisions, but we have long recognized that strengthening patent protection is an important basis for China to promote an innovative society.
    " and Baiji Shenzhou patent lawyer Xu Yang believes that the current establishment of patent link system proposed in the amendment of patent law in China, is not a good choice.
    " patent link system is based on the Legal Policy environment of the United States more than 30 years ago, China's patent system and the United States are very different.
    articles 18 and 19 of the original Measures for the Administration of Drug Registration, the patent link established in the light of China's national conditions has achieved good results in practice.
    but in the last ten years of practice, we have not perfected it, but abandoned it, which is a pity.
    we should restore and improve the system that worked, rather than introduce complex and difficult-to-operate patent link systems.
    Issues worth exploring in Draft II The addition of a compensation system for the duration of drug patent protection and a drug patent link system in Draft II is regarded as a major breakthrough in adjusting the drug patent-related system. Article
    Article 75 adds three provisions related to drug patent links: 1, "If the patente or interested party believes that the relevant technical plan for applying for listed drugs falls within the scope of protection of the relevant patent rights published on the patent information registration platform for listed drugs in China, it may file a lawsuit with the people's court within 30 days from the date when the drug regulatory department under the State Council announces the application for a drug listing license or applys for an administrative ruling with the patent administrative department under the State Council."
    If the patente or interested party fails to file a lawsuit or request an administrative ruling, the applicant for a drug listing license may request the people's court or the patent administrative department under the State Council to confirm that the relevant technical plan for applying for listed drugs does not fall into the scope of protection of the relevant patent rights posted on the patent information registration platform for listed drugs in China.
    2. If the people's court or the patent administrative department under the State Council makes an effective decision or administrative ruling within nine months from the date of acceptance of the patent right or interested party's request for acceptance, the drug regulatory department under the State Council may, in accordance with the judgment of the people's court or the administrative decision of the patent administrative department under the State Council, make a decision on whether to approve the listing of the drug.
    party is not convinced of the administrative decision of the patent administrative department under the State Council, he may bring a suit in a people's court within 15 days from the date of receipt of the administrative ruling.
    3, "The drug regulatory department under the State Council, together with the patent administrative department under the State Council, shall formulate a specific interface between the approval of drug listing licenses and the resolution of patent disputes during the application phase of drug listing permits, which shall be implemented after the approval of the State Council."
    " Song Ruixuan believes that the amendment of the patent law will help us to further improve the legal environment of pharmaceutical innovation, among which there are several bright spots worthy of attention: First, on the basis of the original Chinese patent law, the establishment of a proposed infringement system, that is, before there is no substantive infringement, it will be identified as imminent infringement, in order to resolve patent disputes at an early stage; The court and the patent authority confirmed that there is no infringement, can prevent the patentee within 30 days did not file an infringement lawsuit, and then pursue the suit later;
    addition, what other aspects of the new drug patent link in Draft II are worth exploring? Cheng Yongshun believes that although the current provisions have been compared with the original significant breakthrough, but there are still many issues to continue to be discussed.
    Cheng Yongshun said: "The current link system just set up a procedural framework, how to follow up to the court, how to apply for an administrative ruling to the Patent Administration Department of the State Council, how long can get the results of the judgment, if within 30 days both sides did not respond, after whether can also sue and so on are not guaranteed by substantive law." The first sentence of
    "emphasizes that to confirm that falling into the scope of protection of the relevant patent right, then falling into the relevant patent right can be regarded as infringement, confirming that falling into or not falling into what to do, these are not clear in the law, which will make it difficult to define in the future whether such disputes should be regarded as infringement or invalid.
    addition, the provisions of the new generic drug companies can actively apply for confirmation not to fall into the scope of protection of the relevant patent rights, if determined not to fall, then the patente can not sue again? If not, is it fair to the patente? If possible, then through the patent link system to achieve the early settlement of patent disputes can not be achieved, such a system design is meaningless.
    " Cheng Yongshun asked a series of questions.
    it is not difficult to find that the Patent Law Amendment "30 days from the date of the public announcement of the drug market license application" litigation period and the United States set the litigation period "within 45 days after receiving the notice of the generic drug application to market" is different.
    the patente needs to find and screen for generic drugs, which increases the patenter's obligation.
    Lily Wang, senior director of intellectual property at Asasheng Pharmaceuticals, expressed concern: "30 days is too short, which requires companies to have strong teams to do searches on a regular basis, where the reality is that the information retrieved is often limited."
    if this is really going to happen in the future, whether the compound structure will be published, and the extent to which the details of the disclosure will be made public is the focus of our concern.
    Of course, we would most like to have an information channel to notify the patente in the first place, and the time limit for requiring the patente to respond should be calculated from the date they receive the notice.
    " As to whether the nine-month period can be understood as a containment period, it is almost impossible to achieve a nine-month effective decision in current judicial practice, while a nine-month administrative decision that does not take effect, followed by a decision on whether to approve the listing of generic drugs on the basis of an administrative decision that does not take effect, and then a judicial review of the administrative decision, may create a range of problems in terms of the design and practical operation of the procedural rules.
    is also noteworthy that the provision gives the patent administrative department of the State Council new powers to deal directly with patent infringement disputes, which is rare in countries in the world that currently have patent systems.
    , it is rare for other state-level administrative organs with authorized powers and administrative adjudication powers to make administrative decisions on torts.
    Cheng Yongshun pointed out: "If this is implemented in the future, the patent office will be responsible for both patent examination authorization, examination and declaration of the validity of patents, handling patent infringement disputes, and sometimes may also be in the licensing, rights and infringement disputes as defendants in litigation."
    whether this is in line with the requirements of the construction of the rule of law is debatable.
    , chairman of Assail Pharmaceuticals, thinks this will pose a challenge to the company: "Under the terms, companies will be confused as to whether they should choose to go to court or apply for an administrative ruling."
    can (need) apply for a final judicial decision after the results of the administrative decision have been issued? This stretches the waiting time for a verdict.
    patent right is a kind of civil right, the exercise of rights mainly lies in the rights of the rights, so enterprises need more clear guidance.
    " enterprises how to deal with the new policy environment domestic understanding of the patent link system, there is a step-by-step process.
    in 2008, some U.S. industry associations and enterprises proposed to add a patent link system to the revision of China's patent law.
    at that time, the domestic recognition is that the system is to protect innovation system, more to be more direct, is to protect the interests of foreign enterprises.
    , the localization of foreign enterprises gradually deepened, and China's local innovation enterprises are on the rise.
    the intellectual property rights problems encountered in the development of Chinese pharmaceutical innovation, the importance of the patent link system is becoming more and more prominent.
    " good imitation also needs a certain degree of innovation ability, so whether it is innovative pharmaceutical companies or generic companies, should strengthen the study and understanding of the patent system, but also should pay attention to legislative developments, actively and actively in the legislative process to give advice, rather than passively waiting.
    " Cheng Yongshun believes that this is the enterprise needs to consider and face the problem at the time.
    some companies are already in action.
    , according to Yang Dajun, as a member of the Drug Promotion Association, Assin has been actively feedback on the demands of innovative enterprise practices.
    's research and development headquarters in Suzhou, usually and the local Intellectual Property Office also have close exchanges.
    policy-making period, the head of jiangsu center of patent examination collaboration of the Patent Office of the State Intellectual Property Office has also visited enterprises many times.
    , through exchanges with several other business managers, researchers have found that the voice of innovative pharmaceutical companies has received more and more attention.
    , they have stressed in interviews that developing and building IP strategies and teams with a global perspective has become a major focus for business development.
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