China's drug patent link to come, generic drug enterprises how to deal with?

Guide: This paper analyzes the establishment and implementation progress of China's drug patent compensation system and drug link system by comparing the relevant drug patent systems in various countries.
drug research and development has the characteristics of long cycle, high investment and high risk, so the results of drug research and development need to be fully protected by the design of the relevant system.
, the establishment of drug patent compensation system and drug patent link system is one of them.
drug patent compensation system: extended protection period for valuable patent patents for innovative drugs, which encourages the development of innovative drugs.
drug patent linking system: provides balanced protection for innovative and generic drugs to encourage innovation, challenge, and competition.
Since 2017, the CPC Central Committee, the State Council and the Drug Administration have issued documents that clearly state that the establishment of a drug patent link system and a drug patent compensation system has been explored.
July 3, 2020, the National People's Congress (NPC) to the People's Republic of China Patent Law Amendment (Draft Of the Second Review) to the public for comments, involving drug patents for the 12th and 27th provisions, meaning that China's drug patent compensation system and drug link system is about to land.
this paper analyzes the establishment and implementation progress of China's drug patent compensation system and drug link system by comparing the relevant drug patent systems in various countries.
. The extension of the validity of the patent is beneficial to innovative pharmaceutical enterprises 1. The extension of the patent validity period of the patent compensation system profile dispensed with the introduction of the patent in order to make up for the loss of the effective patent period caused by the introduction of the patent for the listing of the drug, europe, the United States, Japan and other countries have implemented the system for many years.
Although there are slight differences in system design from different countries, they have expressed a consistent attitude towards the encouragement of innovative drug research and development.
(1) the United States first put forward the concept of "drug patent period compensation".
the Hatch-Waxman Act of 1984 provides for a maximum of five years of expiration of U.S. drug patents, but the cumulative duration of patent compensation and the remaining patent period after listing cannot exceed 14 years;
(2) Extended patent protection period (SPC) for pharmaceuticals in the form of supplementary patent certificates in Europe.
Article 63 of the European Patent Convention (EPC), states that a Contracting State may provide for an extension of the period or corresponding protection when the object of the patent is the method of manufacture or use of the product.
(3) Japan's patent extension system mainly borrows from the United States, but Japan's patent compensation system is more relaxed. article 67 of the
Japan Patent Law provides that multiple patents for pharmaceuticals are allowed to be extended multiple times, without a ceiling on the effective patent period after the drug is marketed.
2. China's Patent Compensation System Profile October 2017 "Opinions on Deepening review and approval system reform to encourage innovation in pharmaceutical devices" for the first time explicitly proposes to give appropriate patent term compensation to drug patents that are delayed to market due to clinical trials and approval.
the Amendmentto (Draft) of the Patent Law, published in January 2019, proposes that the State Council may grant an extension of the patent period for the simultaneous application for listing of innovative pharmaceutical inventions within and outside China. The Amendment to the Patent Law (The Second Review Draft) published in July 2020 by the
amends it to provide appropriate patent term compensation for new drug invention patents approved for listing in China.
it provides for two types of cases in which patent compensation may be obtained: "If the patent right for an invention is granted four years after the expiration of the date of the patent application for an invention and three years after the date of the substantive examination request, the patentee may request compensation for the validity of the patent in the course of infringement of the invention patent";
the progress of the relevant policies of China's drug patent compensation system: 2017.10.08 Opinions on Deepening the Reform of review and approval system to encourage innovation of pharmaceutical medical devices clearly stated for the first time: For the delay in listing due to clinical trials and approval, appropriate patent term compensation should be given.
2018.04.12 Premier Li Keqiang presided over the executive meeting of the State Council: the new drugs that are simultaneously applied for listing in China and China will be compensated for the patent protection period of up to five years.
2018.12.23 Statement by Shen Changyu, Director of the State Intellectual Property Office, on the draft amendment to the Patent Law: The State Council may resolve the extension of the patent rights period for the simultaneous application of patent applications for listing of innovative pharmaceutical inventions within and outside China.
2019.01.04 The term of the patent rights of Chapter 5 of the Patent Law (Draft) is 20 years, the term of the patent right for a utility model is ten years, and the term of the design patent right is fifteen years, all calculated from the date of application.
in order to compensate for the time of review and approval of the listing of innovative drugs, the State Council may decide to extend the patent rights period for innovative drug inventions that are simultaneously applied for listing within china and abroad, for a period of not more than five years, and for a total patent right for innovative drugs after listing, not more than fourteen years.
2019.12.02 Opinions on Strengthening the Protection of Intellectual Property Rights (IV) improve the protection system in new areas.
to strengthen the protection of patents, trademark copyrights, new plant varieties and integrated circuit drawing design in view of the current development of new industries.
explore the establishment of drug patent link system, drug patent duration compensation system.
study and strengthen the guide to the protection of intellectual property rights in sports events, formulate operating guidelines on contract models and rights protection processes, encourage enterprises to strengthen the construction of risk prevention mechanisms, and continuously optimize the innovation and protection of the environment by mass entrepreneurship.
study and formulate protection measures in the fields of traditional culture and traditional knowledge, and strengthen the protection of intellectual property rights in Chinese medicine.
2020.01.15 China-U.S. Trade Agreement 2020.07.03 Amendments to the Patent Law of the People's Republic of China (Draft Second Review) 3. Comparison note simply for patent compensation systems around the world: Note 2: Drugs in products are defined as active ingredients, including substance monomers, salts or esters, Excluding metabolites, individual or combinations of other active ingredients Note 3: The scope of protection of drug use patents in the United States is limited to FDA-approved indications, and the scope of protection for preparation method patents is limited to the preparation steps of approved drugs, i.e. the extended scope of protection claims is limited to the active ingredients of FDA-licensed drugs, technical options related to preparation methods and uses, and not the overall scope of protection required by the authorization rights.
comparative analysis of the patent compensation system of various countries know: (1) FDA-approved drug patent validity period extension of the scope of protection is less than the scope of the original patent requirements protection, as shown in the following figure: (2) FDA for the patent extension of the drug patent in the active ingredients have a special qualification, as follows: (3) Japan drug patent compensation difference sand son of Europe and the United States, the same drug can be multiple patent validity compensation.
(4) The duration of drug patent compensation in China (draft II) is basically in line with that of the United States, but it is not clear how the compensation period will be calculated and the type of patent available for compensation.
the type of patent compensation is specified in the Sino-US trade agreement: product patents, method patents, and use patents.
2. Effective mechanism for early settlement of patent disputes, the establishment of drug patent link link of the drug patent link system refers to the "link" between the approval of generic drug listing and the expiration of the patent of innovative drugs, that is, the registration application for generic drugs should consider the patent status of the drug listed first, so as to avoid possible patent infringement.
drug link system originated in the United States, in 1984, the United States through the Hatch-Waxman Act, which provides for drug patent link system, drug patent protection period compensation, data protection and other content.
at present, Canada, Australia, South Korea and other countries through the signing of free trade agreements with the United States, has introduced a patent link system, the European Union, Japan, India has not yet established the system.
after 2017, China began to gradually explore the establishment of drug patent link system, "Patent Law Amendment (Draft Second Review Draft)" clearly stipulates the patentee's prosecution period, 9 months litigation period and other content, the basic framework of its establishment is consistent with the United States, but many places still need to be further refined.
the following table for the comparison of drug link systems in each country: Drug link system in major countries comparison Note 1: U.S. biosimilars follow the U.S. "PatentDance" system Note 2: The original research enterprises in the drug to obtain a license to market within 30 days after the registration application, the drug after the listing of the patent, within 30 days after the patent authorization to apply. Patents granted after the
drugs are approved are limited to patents before the drug is granted before the listing date, and for patents that do not file applications after the drug has been approved for listing, it cannot be included in the list note 3: The flow chart of the U.S. drug link system: Analysis from the table above, we can see that China's drug link system has the following characteristics: (1) The Patent Law Amendment (Draft Second Review) in article 27, paragraph 2, provides for the review of technology The drug regulatory department under the State Council may, in accordance with the decision of the people's court or the patent administrative department under the State Council, decide whether to approve the listing of drugs", which makes it clear that the types of drugs to be applied in China's drug link system are "chemical drugs" and do not include biological agents, Chinese medicine, etc., which is consistent with the scope of application of the U.S. drug link system; If the patentee or interested party considers that the relevant technical scheme for applying for a listed drug falls within the scope of the relevant patent protection published on the patent information registration platform for a listed drug in China, he may file a lawsuit with the people's court within 30 days from the date of publicizing the application for a drug listing license by the drug regulatory department under the State Council or apply to the patent administrative department under the State Council for an administrative award."
, after inquiry, there is no "China listed drug patent information registration platform."
has the information of drug patents for the "China listed drug catalog set" platform.
U.S. patent information is registered in the FDA Orange Book.
(3) Article 27, paragraph 1, of the Amendment to the Patent Law (The Second Review Draft) stipulates that "if the patentee or interested party considers that the relevant technical plan for applying for a listed drug falls within the scope of patent protection published on the China Listed Drug Patent Information Registration Platform, he may file a lawsuit with the people's court within 30 days from the date of publicizing the application for a drug listing license by the drug regulatory department under the State Council or apply to the patent administrative department under the State Council for an administrative decision."
it can be seen that the patentee or NDA holder's prosecution period is 30 days, but unlike the United States, the draft does not provide for the obligation of generic drug applicants to voluntarily notify the patentee or NDA holder, the starting point of the prosecution period is within 30 days from the date of the State Council Drug Supervision and Administration to announce the application for drug listing license, it can be seen that the patentee or NDA holder of the information publicly available to the FDA needs timely attention to find potential infringers in order to find out the potential infringer (4) Article 27, paragraph 3, of the Amendment to the Patent Law (Second Review Draft) stipulates that "where the people's court or the patent administrative department under the State Council has made an effective ruling or administrative ruling within nine months from the date of the patentee or interested party's request to accept the application, the drug regulatory department under the State Council may, in accordance with the ruling of the people's court or the administrative ruling of the patent administrative department under the State Council, make a decision on whether or not to approve the listing of a drug.
the Drug Link System in the United States, the patentee or interested party has received notice from the applicant for the generic drug, if an infringement lawsuit is filed, the generic drug application will automatically stop approval for 30 months, but will not stop the approval.
if the patentee wins the case within 30 months, the ANDA application of the generic drug applicant will not be approved;
it is clear that the draft provides for a nine-month litigation period compared to the U.S. link system, but does not specify whether the nine-month lawsuit does not address whether or not to approve the drug's listing.
, 9 months is far less than the FDA's 30 months, which also means that patentees not only need to pay timely attention to the FDA's public drug listing application information timely find infringers, but also need to timely file a lawsuit or request an administrative ruling, if 9 months without results, it is likely to face the FDA for generic drug applications issued a listing license.
provisions of this provision, but also foreshadows the future of domestic patent challenges more and more cases, innovative pharmaceutical enterprises and generic drug companies need a strong level of patent analysis.
, China's drug patent compensation system and link system mostly learn from foreign experience, I believe that with the "Patent Law Amendment (Draft Second Review Draft)" open, China's drug patent compensation system and link system will be gradually implemented, supporting judicial regulations and related systems will gradually improve, will eventually establish an effective "convergence and link" mechanism with Chinese characteristics, and then effectively promote China from the pharmaceutical power to the pharmaceutical power.
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