The Early Settlement Mechanism Of Drug Patent Disputes Benefits The Development Of Innovative Drugs And Generic Drugs

Recently, the State Drug Administration and the State Intellectual Property Office issued the measures for the implementation of the early settlement mechanism for drug patent disputes (for Trial Implementation) (hereinafter referred to as the measures). In order to promote the implementation of drug patent linkage system and achieve effective results, the Supreme People's Court issued a judicial interpretation, including 14 articles specifying the jurisdiction court, specific cause of action, mode of exercise of litigation right, connection of administrative and judicial procedures, defense matters, protection of trade secrets in litigation, etc; The State Intellectual Property Office also issued two announcements to clarify the administrative adjudication procedures related to the drug patent link system.

At the same time, the Supreme People's Court further explained that the early settlement mechanism of drug patent disputes is also known as the drug patent link system. Drug patent link refers to the connection between drug approval and patent, so as to solve patent disputes and infringement risks before drugs are put on the market.

This is also a new legal system, which had no practical basis in China before.

On July 6, Zhang Ying, a lawyer from Beijing Gaowen law firm, which focuses on the study of intellectual property protection law, pointed out to the reporter of 21st century economic news that the two announcements issued by the State Intellectual Property Office and the relevant judicial interpretations of the Supreme People's court specify the materials to be provided by the parties, the way of exercising their rights, and the reasons for their defense, It is of positive significance for the parties concerned to safeguard their legal rights.

"On the one hand, from the perspective of encouraging drug innovation, China's drug patent linking system extends the protection period of innovative drug patents to fully protect them; At the same time, from the perspective of improving the accessibility of drugs, we should encourage generic drugs to make use of the rules, through patent challenges and patent evasion, to legally advance the listing as soon as possible. The aim is to balance the development of innovative drugs and generic drugs, so as to encourage the innovative development of the pharmaceutical industry. " Zhang Ying pointed out.

The early settlement mechanism of drug patent disputes will give a monopoly period to the first chemical generic drug that successfully challenges the patent and is approved for listing. Visual China

Introduction of drug patent link system

"In October 2020, Article 76 was added to the fourth revised Patent Law of the people's Republic of China, and an early settlement mechanism for drug patent disputes was set up, which is commonly known as the drug patent link system. On July 4 and 5, 2021, the State Food and drug administration, the State Intellectual Property Office and the Supreme People's Court issued normative legal documents one after another, marking the formation of China's drug patent linking system. " Zhang Ying told reporters of the 21st century economic report.

According to the policy interpretation provided by the two departments, the early settlement mechanism of drug patent disputes refers to the system that connects the relevant drug listing approval procedures with the relevant drug patent dispute resolution procedures, aiming to provide a mechanism for the parties concerned to resolve relevant patent disputes in the relevant drug listing review and approval process, and protect the legitimate rights and interests of drug patentees, Reduce the risk of patent infringement of generic drugs after marketing.

The main contents of the measures include: platform construction and information disclosure system, patent right registration system, generic drug patent declaration system, judicial link and administrative link system, approval waiting period system, drug review and approval classification processing system, first generic drug market monopoly period system, etc.

The related drug patents covered by the early settlement mechanism of drug patent disputes include: patents on active ingredients of chemical drugs (excluding API), patents on pharmaceutical compositions containing active ingredients, and patents on pharmaceutical applications; Patent of traditional Chinese medicine composition, Chinese medicine extract and medicine use; Patent for sequence structure of active ingredients of biological products and patent for pharmaceutical use. Related patents do not include patents on intermediates, metabolites, crystal forms, preparation methods, detection methods, etc.

If the patentee or interested party disagrees with the four kinds of patent declaration in the application for the registration of generic chemical drugs, he / she may, within 45 days from the date when the national drug evaluation and evaluation institution publishes the application for listing of drugs for listing, file a lawsuit with the people's Court on whether the relevant technical scheme of the drug applied for listing falls into the scope of the protection of the relevant patent right, or request an administrative ruling from the administrative department for patent under the State Council. The drug regulatory department under the State Council has set a 9-month waiting period for the registration of generic chemical drugs.

Zhang Li, a lawyer of Zhejiang Jingheng (Ningbo) law firm, pointed out to the reporter of 21st century economic report that the supreme law and the State Intellectual Property Office issued the above legal documents mainly to solve the legal disputes between the "drug marketing licensors" and "patentees or interested parties" caused by the amendment of the drug administration law. Because the drug administration law enters the system of drug market licensors, it may lead to legal disputes about the ownership of intellectual property rights and the distribution of interests between "drug marketing licensors" and "patentees or interested parties", which is rarely seen before.

"The promulgation of the above-mentioned legal documents can more clearly, concretely and effectively solve the patent ownership, interests and other related disputes between the" drug marketing license applicant "and the" patentee or interested party ". In particular, Articles 8 to 12 of the supreme law stipulate that on the premise of safeguarding the legitimate rights and interests of the relevant obligees, it is necessary to guide integrity litigation and oppose the abuse of litigation rights, At the same time, before the dispute is settled, the normal drug application and listing procedure of "applicants for drug marketing license" is to prevent possible abuse of litigation rights to prevent the listing process, resulting in low efficiency of drug listing process. Articles 9 to 10 of the supreme law interpretation and documents of the State Intellectual Property Office have specific provisions on this Zhang Li pointed out.

One year market monopoly period of "first generic drug"

Judging from the contents of the above documents, it is indeed good for innovative drugs and generic drugs.

According to Conway, the chief executive officer of rdpac, the pharmaceutical patent protection system of patent link system will vigorously promote the pharmaceutical innovation in China.

China's indigenous drug innovation potential is huge. Domestic innovative drugs catch up with the global R & D progress. From the "follow-up" of the third echelon in the past to the "parallel running" of the second echelon in the past, the introduction and transfer of the drug licensing have been greatly broken out. The establishment and implementation of the early settlement mechanism of drug patent disputes marks the beginning of the era of drug patent protection with patent linkage system in China.

In fact, the patent war has been going on in various fields, including medicine. According to the statistics of media in the industry, from 2017 to 2019, 38 original research drugs of multinational pharmaceutical enterprises were filed with patent invalidation claims in China. Among the review decisions made, 33 (55%) were invalid, 20 (33%) were partially invalid, and 7 (12%) remained valid; In 2020, about 18 patents related to original research drugs of multinational pharmaceutical enterprises were challenged by Chinese pharmaceutical enterprises or individuals, involving 26 decision numbers made by the State Intellectual Property Office, accounting for 54% of all invalid decisions.

On July 2, the official website of the State Intellectual Property Office announced that xinlitai, Shiyao Ouyi and Nanjing Zhengda Tianqing launched a patent challenge to the core patent "drug combination product of angiotensin receptor antagonists and NEP inhibitors" of Novartis Novartis (sacubatravalsartan sodium). Finally, the State Intellectual Property Office made the decision that "the patent is partially invalid".

"After the promulgation of the above-mentioned measures, the process of drug application and listing can be carried out more efficiently, and the interests of legitimate rights holders can be effectively prevented from being damaged due to abuse of litigation rights. At the same time, it is also an effective and specific protection of intellectual property rights and intellectual property owners in the pharmaceutical industry. " Zhang Li pointed out to the 21st century economic reporter that the early settlement mechanism of drug patent disputes established a link between China's drug approval department and patent department, and solved unnecessary disputes in the later stage.

Wang Ying further analyzed that compared with other industries, drug patent litigation takes a long time and the situation is more complex. The drug patent link system provides an early solution mechanism and reduces the litigation burden of the parties. The effective judgment of drug patent linkage litigation, especially the determination of whether it falls into the scope of patent protection, has res judicata for the subsequent patent infringement litigation or confirmation of non infringement litigation against the same patent right and the drugs applied for registration, which not only benefits the original pharmaceutical research enterprises, but also contributes to the benign development of original research drugs and generic drugs.

It is worth noting that in terms of the market monopoly period system, the early settlement mechanism of drug patent disputes will give the market exclusive period to the first chemical generic drug which successfully challenged the patent and was approved for listing. The drug regulatory department under the State Council shall not approve the listing of generic drugs of the same variety within 12 months from the date of approval of the drug, except for those who jointly challenge the patent successfully.

The so-called patent challenge success refers to the four kinds of patent declaration submitted by the chemical generic drug applicant for the registration application of chemical generic drug, and according to the request for declaring the patent right invalid, the relevant patent right is declared invalid, and the generic drug can be approved for listing.

From the previous documents and related policies, China has been encouraging the development of generic drugs, especially high-quality generic drugs, and there is a certain inclination in payment and other links for the first generic drugs.

"Generic drugs require consistency evaluation, and the enterprise investment is also very large. For the 12-month exclusive period specified in this document, it is actually an encouragement for enterprises to actively invest. At present, it is often tens of millions to do a drug consistency evaluation, and the enterprise cost is not small." A person in charge of a listed pharmaceutical company pointed out to the reporter of 21st century economic report that this is good for Chinese local pharmaceutical enterprises with multiple first generic drugs.

In fact, the rapid follow-up of local generic drugs will also accelerate the encroachment on the original drug market.

For example, the imported target drug gefitinib, originally developed by AstraZeneca, was approved by FDA on May 5, 2003 and approved by CFDA in December 2004 with the trade name of "Iressa". According to the PDB database of China Pharmaceutical Industry Information Center, in 2012, the sales volume of gefitinib sample hospitals was 320 million yuan, and the domestic market scale was 800 million yuan. In December 2016, Qilu pharmaceutical's gefitinib was approved to be listed on the market. In 2017, that is the first year of listing, "irek" sales are expected to exceed 100 million yuan. At present, "IRICO" has passed the generic drug consistency evaluation.

In this regard, Wang Ying stressed that both original research drug patentees and generic drug applicants should deeply study the relevant provisions of China's drug patent linkage system, so as to formulate appropriate patent layout strategy and drug registration and application strategy in China.