Experts on the implementation of China's patent linkage system suggest that original research drug companies tighten fences to prevent jackals

Expert advice on the implementation of China's patent linkage system

　　The original research drug company "tighten the fence to prevent jackals", the generic drug company "takes up the shotgun and goes to the battlefield"

　　Core reading

　　Both the original research drug company and the generic drug company must make good use of the rules of the game.

The provisions of the patent linkage system are very clear. Generic drug companies can evaluate the feasibility of the fourth type of declaration before applying for the market, or they may choose the third type of declaration next to them, or conduct licensing consultations to choose the second type of declaration.

The original research drug company must be aware of its core patents, self-check the stability early and prepare emergency plans in case of invalidity.

　　□ Our reporter Zhang Wei

　　Recently, relevant regulations on drug patents have been intensively promulgated.

　　In two consecutive days, the State Intellectual Property Office successively issued the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" (jointly issued with the State Drug Administration, hereinafter referred to as the "Measures") and the "Early Resolution Mechanism for Drug Patent Disputes" The Administrative Adjudication Measures (hereinafter referred to as the "Adjudication Measures") shall come into force on the date of promulgation.

The State Intellectual Property Office also issued an announcement on the acceptance of administrative rulings on the early resolution mechanism for drug patent disputes.

　　The Supreme People's Court also issued the "Regulations on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration", and the judicial interpretation will be implemented on the same day.

　　"So far, the relevant regulations on drug links have a closed-loop connection, which perfectly interprets the five parties in the pharmaceutical patent link system, namely the original research drug companies, the generic drug companies, the State Food and Drug Administration, the State Intellectual Property Office, and the courts. The interaction and convergence of judicial and administrative procedures provide a legal basis and operational guidelines for resolving possible patent infringements with the patentee of the original research drug before the listing of generic drugs." Li Ying, Director of the Department of Biomedicine, Han Kun Law Firm The doctor said in an interview with a reporter from the Rule of Law Daily.

　　The lack of system disputes continue

　　From June 1st, the newly revised Patent Law came into effect, and new regulations on drug patents followed.

Among them, the most noticeable is the implementation of the early settlement mechanism for drug patent disputes.

　　According to the relevant person in charge of the State Intellectual Property Office, the early resolution mechanism for drug patent disputes refers to a system that links the approval procedures for the marketing of related drugs with the resolution procedures for related drug patent disputes.

This mechanism is actually the so-called drug patent linkage system.

　　This move is of great significance.

"After nearly five years of ups and downs from 2017 to 2021, China's own patent linkage system has finally settled down." said Wu Lili, a partner at Han Kun Law Firm.

　　Why is the patent linkage system called for so many times?

As early as October 2017, the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council proposed to explore the establishment of a drug patent linkage system.

　　In November 2019, the General Office of the CPC Central Committee and the General Office of the State Council reiterated the above requirements in the "Opinions on Strengthening the Protection of Intellectual Property Rights".

　　In October 2020, the newly revised Patent Law introduced relevant provisions on early resolution of drug patent disputes, clarifying that the drug regulatory department of the State Council, in conjunction with the patent administration department of the State Council, will formulate specific methods for the connection between the approval of drug marketing authorization and the resolution of patent disputes at the drug marketing authorization application stage. .

　　It is understood that China's pharmaceutical industry is dominated by generic drugs. Due to drug patent issues, domestic generic drug companies often get into patent disputes with foreign pharmaceutical companies.

　　Hengrui Medicine has been sued by Sanofi's oncology drug docetaxel for its strong imitation of Sanofi's oncology drug docetaxel; AstraZeneca has sued AstraZeneca in China and Chongqing Winbond Pharmaceuticals, respectively, involving AstraZeneca's original hypoglycemic drug Sag Liettin (Arize) and anastrozole (Rainide) for breast cancer treatment.

　　In recent years, domestic pharmaceutical companies have also taken the initiative to challenge the patents of foreign-funded original research drugs, and there are many winners.

For example, Hausen Pharmaceuticals, Kelun Pharmaceuticals, Jiangsu Wanbang, Sino-US East China and Chia Tai Tianqing have successfully applied for the patent CN201310414119.9 of Boehringer Ingelheim's SGLT2 inhibitor antidiabetic drug Enpagliflozin compound CN201310414119.9. All claims are invalid. .

　　No matter what kind of dispute, the root cause is related to the lack of a system, that is, the drug patent linkage system, which makes generic drugs unable to eliminate the hidden dangers of patent disputes before they are approved.

　　Clear rules for multi-party interaction

　　According to reports, the "Measures" issued by the State Food and Drug Administration and the State Intellectual Property Office this time aim to provide parties with a mechanism for resolving patent disputes during the review and approval of relevant drug listings, protect the legitimate rights and interests of drug patent holders, and reduce imitations. The risk of patent infringement after the pharmaceutical is marketed

The main content of the "Measures" includes: 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 system, and the first generic drug market Exclusive period system, etc.

　　In Wu Lili's view, the "Measures" mainly regulate the following three aspects of the relationship between the original research drug company and the generic drug company, a pair of "happy friends".

One is that both the original research drug company and the generic drug company must be honest with each other.

In order to let generic drug companies know which listed drugs are still under patent protection, and to let original research drug companies know which generic drug companies have begun to imitate their own drugs and begin to apply for new drug approval, the Chinese Drug Administration has set up two platforms for original research Pharmaceutical companies and generic drug companies realize mutual information exchange.

　　The second is that both the original research drug company and the generic drug company should "fight" instead of "fight".

Wu Lili said that there has been a long history of open and secret battles between generic drug companies and the original research drug companies in the pharmaceutical industry. The "Measures" stipulate that the five parties of drug marketing license holders, generic drug companies, drug supervision and management departments, patent administration departments, and courts may The rules of interaction of the parties involved have been clarified.

The Measures set a 45-day opposition waiting period for all generic drugs. If the patentee or interested parties have objections to the four types of patent declarations, they can, within 45 days from the date of publication of the drug marketing authorization application by the National Drug Evaluation Agency, To file a lawsuit with the people’s court or request an administrative ruling from the patent administration department (hereinafter referred to as the “confirmation lawsuit or ruling”) as to whether the relevant technical solution for the drug applied for marketing falls within the protection scope of the relevant patent rights.

If a party is dissatisfied with the administrative ruling made by the patent administration department, he may, after receiving the administrative ruling, bring a suit in a people's court according to law.

Patent holders or interested parties who file a lawsuit or request an administrative ruling within the prescribed time limit shall submit a copy of the case registration or acceptance notice to the national drug review within 15 working days from the day the people’s court filed the case or the patent administrative department accepted it. Organization and notify the applicant of generic drugs.

　　Third, if the original research drug company and the generic drug company want to "fight with gods", please follow the standard routine.

For example, for generic drug registration applications for Class I and Class II declarations, the State Council’s drug regulatory authority makes a decision on whether to approve the listing based on the conclusions of the technical review; for generic drug registration applications for Class III declarations, if the technical review passes, approval will be given In the listing decision, the relevant drugs may not be marketed until the expiration of the corresponding patent rights and the period of market exclusivity.

That is to say, one to three types of declarations are peaceful declarations and will not trigger a lawsuit for confirmation or judgment.

Only the fourth type of statement is a challenge statement.

If it is a chemical generic drug that has passed the technical review, the drug supervision and management department will make two choices if the result of the confirmation lawsuit or the ruling triggered by the challenge statement during the waiting period and the administrative approval period.

　　Usher in the golden age of medicine

　　Facing the newly implemented patent linkage system, what should original research and generic drug companies do?

　　Wu Lili's advice to the original pharmaceutical company is to "tighten the fence to prevent jackals."

The original research pharmaceutical companies should take the R&D and core product patent layout, mining and protection to a higher level, starting from the creation of a real hard core, and choosing more professional and experienced personnel and teams for the writing of such core patents.

　　What if I encounter a dispute?

Li Ying believes that the first choice is to raise the "confirmation of fall" in the matter of initiating a "confirmation of fall" or "confirmation of fall" first.

Because the latter does not affect the proposal of the former, it can also provide more options for yourself.

From the time cost point of view, the administrative adjudication procedure can generally obtain the ruling result within 6 months, while the litigation procedure takes relatively longer time.

　　For generic drug companies, Wu Lili's suggestion is to "pick up a shotgun and go to the battlefield."

If generic drug companies want to enter the market early, they can lock in their generic targets as soon as possible through due diligence and other methods, conduct stability analysis on the related patents of the generic targets, and raise patent challenges at the right time on the premise of sufficient evidence to be invalid. , Clear the obstacles on the road of imitation.

　　Li Ying proposed to make good use of Article 12 stipulated by the Supreme Court, which prohibits the abuse of litigation rights by the original research drug companies.

"This is a new remedy policy that has been added to the judicial channels for all generic drug companies."

　　Wu Lili suggested that both the original research drug company and the generic drug company should make good use of the rules of the game.

The provisions of the patent linkage system are very clear. Generic drug companies can evaluate the feasibility of the fourth type of declaration before applying for the market, or they may choose the third type of declaration next to them, or conduct licensing consultations to choose the second type of declaration.

The original research drug company must be aware of its core patents, self-check stability early and prepare contingency plans for invalidation. "If the 45-day opposition period is not prepared in advance, it will be caught off guard when it comes to fighting."

　　Faced with the finalization of China's patent linkage system, Li Ying said that judicial and administrative channels will help generic drug companies and original research drug companies to stop disputes during the approval stage of generic drug listings, and promote civilized competition and healthy development of the pharmaceutical industry. Looking forward to the golden age of Chinese pharmaceutical companies in the next 5 to 10 years."