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    Home > Medical News > Medical World News > "Market exclusive period" one-year patent link waiting period reduced to 9 months to innovation or imitation

    "Market exclusive period" one-year patent link waiting period reduced to 9 months to innovation or imitation

    • Last Update: 2020-11-03
    • Source: Internet
    • Author: User
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    What investments will you focus on in the future? "I think there is a long-term competitiveness of generic drug companies, the main medical and health needs of the future of the country still rely on generic drugs to meet, for the overall level of economic development and national finance and other aspects, the basic words must rely on generic drugs, " an industry investor replied.
    a pharmacy in Wuhan, Mr. Li, a citizen, needed to buy a cephalosporine injection because of a respiratory infection.
    salesman recommended a Roche finn made by Roche in Switzerland for 65 yuan.
    Mr. Li is ready to turn away, the salesman called him, took out another domestic brand of the same specifications of the drug, the price is only 10 yuan, " after media reports.
    industrial structure, the domestic generic drug market accounts for more than 60% of the overall drug market size, accounting for 95% of the size of the chemical market.
    ... Whether from the price or industrial structure, generic drugs in China is obviously more adapted to the market and patient needs.
    when the original drug is about to expire, the first generic drug after the successful patent challenge will stand out as the first choice for "high pay and high return".
    , the State Drug Administration issued a draft for comments on the Implementation Measures (Trial) of the Early Resolution Mechanism for Drug Patent Disputes.
    The draft opinion, which proposes a "waiting period" for first-generic companies to apply for patent challenges when approved by the Drug Administration, and a "market exclusive period" for first-generic drugs, is considered to be the domestic version of the Hatch-Waxman Act (the U.S. Drug Price Competition and Patent Term Amendment), and these two provisions are also considered to be clearly good for first-generic companies.
    since 2015, domestic innovative drugs not only have a clear definition, since then a number of policies to encourage priority review and approval, innovative drugs on the market ushered in a major outbreak.
    And the first generic drug has also been introduced by the Drug Review Center in 2016 in the "first imitation" varieties in the "first imitation" varieties of the basic principles of priority review and evaluation of the first time in the drug registration application review process, but has always been hidden under the leadership of innovative drugs.
    the introduction of this draft for comments for the domestic first generic field, especially in the field of chemical drugs what does it mean? What will be the impact of these changes? Does this mean that the battle for the first generic drug in China will also be as hot as the launch of innovative drugs?01 The first point of review speeding up the industry's attention is that "super-long" shortens the waiting period for patent links. Article 8 of the Article
    states, "From the date when the people's court or the patent administrative department under the State Council files a case or accepts it, the drug regulatory department under the State Council shall set a nine-month waiting period for the application for registration of chemical generic drugs, during which the State Drug Review Agency shall not stop the technical review."
    " In fact, as early as 2017, the industry's attention to the "Announcement No. 55" "On encouraging drug medical device innovation to protect the rights and interests of innovators related policies (draft for comments)" has proposed for generic drug companies to apply to the court for patent challenges, drug review institutions set a waiting period, waiting period after the end of the judicial authorities did not make an infringement judgment, drug review institutions can approve the drug market.
    the original text of the announcement was: "The establishment of a drug patent link system ... If the patent right of the drug in question considers that it infringes its patent rights, it shall file a patent infringement lawsuit with the judicial organ within 20 days after receiving the notice of the applicant and inform the drug review institution.
    the drug review institution may set a maximum approval waiting period of not more than 24 months after receiving the relevant supporting documents for the filing of a patent infringement case by the judicial organ;
    " During the approval waiting period, if the two parties reach a settlement or the judicial organ makes an effective judgment on infringement or non-infringement, the drug reviewing institution shall not approve or approve the drug market in accordance with the settlement between the two parties or the relevant effective judgment of the judicial institution;
    a drug application accepted by the court, the applicant has not declared that the relevant patent is involved, and the patent right has filed an infringement lawsuit, the drug reviewing institution shall include the application in the approval waiting period in accordance with the acceptance situation of the judicial organ.
    intellectual property litigation a resulting from the listing and sale of drugs, the judgment of the judicial organ shall prevail.
    ", it can be seen that in the course of the applicant's lawsuit, the drug review agency "does not stop the technical review of the drugs received" in 2017, when the waiting period was 24 months.
    this draft will shorten 24 months to nine months, a reduction of more than a year, the time span is large.
    note that as early as Announcement No. 55 of 2017, the industry was at best talking about "whether 24 months is enough."
    The "waiting period" in the United States for amendments to the Hatch-Waxman Act was 30 months, so the industry questioned whether patent infringement cases as complex as drugs could be completed within 24 months, which places high demands on the judiciary and the executive branch, particularly the judiciary.
    and this time the waiting period has been significantly reduced to nine months, which is clearly impossible to complete.
    "In fact, patent infringement cases rarely close within nine months due to the complexity of the technical aspects of intellectual property cases and the increasing trend of intellectual property cases in recent years," wrote an intellectual property lawyer.
    " in addition, the reduction of 24 months to 9 months was actually covered as early as July this year in the patent law amendment (draft), which proposed that "for the application for a license for the listing of chemicals approved by the technical review, the drug regulatory department under the State Council may, in accordance with the decision of the people's court or the administrative decision of the patent administrative department of the State Council, make a decision on whether to approve the listing of the drug."
    " counsel cautions that the expression "court decision or administrative decision" in the amendment is significantly different from the previous "effective decision and administrative decision", which means that "the drug regulatory department may make a decision on whether to approve the listing of a drug on the basis of a decision made at first instance or an administrative decision made by the administrative department".
    this may be a clear encouragement to the policy side to the first generic, speeding up the pace of review of the first generic drug from the review time of the drug review body.
    , the head of a research institute of a copy-a-company in China, said, "It feels like the state is encouraging innovation."
    02 first mention of the "market exclusive period", the protection of the first imitation in addition to significantly shorten the review time of drug review agencies, the draft also proposed "market exclusive period", which is a "new" term for the domestic first generic drugs.
    public information, the U.S. Hatch-Waxman Act proposed a market exclusive period of 180 days, while the domestic proposed 12 months. Article
    Article 11 proposes that the "Encouraging Policy" shall give the market exclusive period for the first chemical generic drug that has successfully challenged the patent and the first approved for listing, and the drug regulatory department under the State Council shall no longer approve the listing of generic drugs of the same variety within 12 months from the date of approval of the drug, and the exclusive period of the market shall not exceed the patent term of the challenged drug.
    drug review agencies do not stop technical reviews during the exclusive market period.
    application for registration of chemical generic drugs approved by the technical review shall be transferred to the administrative examination and approval process 20 working days before the expiration of the exclusive market period.
    " clause clearly encourages the first generic drug to be on the market, protects the first year of the market for the first generic drug, and, to some extent, encourages innovation on the policy side.
    We all know that the patent of new drugs is extremely complex, because of the huge cost of research and development, in the process of research and development and market of new drugs, new drug companies will continue to build their own patent protection, from compounds, to crystalline, to preparations, to adaptive disorders, if you do not find obvious "breaks", generic patent challenges are very difficult.
    , in the search for "breaks", the first generic drug companies will undoubtedly cost a lot.
    "This regulation, from the perspective of new drug enterprises, is also promoting new drug enterprises to continuously build their own products intellectual property system, for the current research and development of new drugs, I personally feel that not only is not inhibition, but also a process to promote the development and market system of new drugs."
    At the same time, the industry also believes that this provision is the protection of the first generic drugs, the innovation of domestic pharmaceutical companies have a role in promoting, "to give a certain degree of administrative protection, to accelerate the listing of generic drugs, is also a role in promoting."
    there is a kind of you catch up with me, the new drug in front of the continuous setting of patent barriers, the overall pharmaceutical industry research and development is still a role in promoting."
    03 The voice of doubt exists but there is also some doubt in the industry, that from the first generic drug can not reach the height of innovation, whether it is the newly revised patent law, or this draft, or earlier proposed patent links and new drug data protection system are foreign". To walk, think that there are still a large number of unsolt domestic clinical needs to be innovative to meet, but "our newly revised patent law, based not on protecting innovative patents, but to encourage imitation or even infringers to challenge innovative patents, its legislative thinking itself is distorted."
    is now to the exclusive period to encourage the first imitation to challenge innovative patents, although the short-term price of patented drugs down, but to pay a fundamental damage to innovation in the long-term cost.
    " and the domestic environment is not matched with the Hatch-Waxman Act (adopted in the 1970s), when the United States has relied on breakthrough innovation for decades, but the domestic "low-growing peaches are picked, the difficulty of high innovation flower picking has increased dramatically, costs have increased sharply, risks have risen sharply, regulation has increased sharply, consumers have over-claimed rights, and the payment environment has deteriorated dramatically, and the period of innovation returns has been greatly shortened."
    also argues that "the progress that humans have made so far in the face of health challenges remains extremely limited, with a large number of diseases still at a risk, and the new crown outbreak is only the latest case."
    at a time when the international relations represented by China-U.S. relations are deteriorating, national independent innovation and respect for international innovation in China are particularly important drivers of innovation in our social transformation.
    "
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