Development Process and Obstacles of Drug Patent Link System in China

Patent Linking System (Patent Linkage) refers to a system that links the listing registration of generic drugs with the patent protection of patented drugs. It was first created in 1984 in the United States "Drug Price Competition and Patent Period Recovery Act" (Hatch-Waxman Act). Broadly speaking, drug patent links include drug patent registration and information disclosure, drug patent declaration and notification, litigation and waiting period, drug patent period compensation, drug data protection for successful applicants challenging patents, etc. Through the design of the system, on the one hand, it accelerates the marketing speed of generic drugs, on the other hand, it promotes the enthusiasm of research and development of innovative drugs, so that innovative drugs continue to appear and generic drugs continue to follow up, it is considered to be a balanced system design. At present, although my country's "Drug Registration Management Measures" has established the embryonic form of the patent link system, it basically stays at the conceptual level, and both the legislative provisions and the implementation effect are far from mature.

Establishment of Drug Patent Link System in China

In fact, before 2002, the issue of drug patent protection was not stipulated in the laws and regulations on drug management. The "Measures for the Administration of Drug Registration (Trial)" promulgated on October 30, 2002 and implemented on December 1 of the same year was China's first regulation on patent issues in drug registration and approval. Article 18 stipulates that the applicant shall provide a description of the patent and its ownership status in China for the drug or the prescription or process used for registration, and submit a guarantee that the patent of others does not constitute infringement, and promise to be responsible for the possible infringement consequences. Although the law provides for a patent disclosure and declaration system, in practice, it does not really link patents and drug registration approval.

From 2002 to 2016, although the measures for the Administration of Drug Registration have been revised many times, the overall thinking and framework for solving the patent problems in the examination and approval of drug registration have not changed in essence. it only has some elements of drug patent link, but it is still far away from the real drug patent link system.

According to the "Relevant Policies on Encouraging Drug and Medical Device Innovation and Protecting the Rights and Interests of Innovators (Draft for Comments)" issued by the State Food and Drug Administration on May 12, 2017, when a drug registration applicant submits a registration application, the innovative drug shall be subject to patent registration within the specified scope, and the generic drug applicant shall declare the original research drug patent and its ownership status, and submit a description of the drug patent situation and non-infringement statement to the CFDA, and inform the relevant drug marketing license holder and patentee of the content of the non-infringement statement within 20 days after filing the registration application; If the patentee believes that his patent right has been infringed, he shall file a patent infringement lawsuit with the judicial authority within 20 days after receiving the notification from the applicant, and request CFDA to set an approval waiting period for the application involved, so that the drug involved can continue to be subject to substantive examination but cannot be finally approved, until a judicial decision is made or the parties settle.

On October 8, 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices, which clearly stated that it is necessary to explore the general direction of establishing a drug patent link system. Programmatic document.

On October 23, 2017, the State Food and Drug Administration issued the Measures for the Administration of Drug Registration (Revised Draft), in which Article 98 mentioned: When the applicant submits a drug marketing license application, it should be clear whether the Chinese government is involved The invention patent recognized by the government, the status of the patent involved and whether there is infringement, and inform the patentee of the relevant patent within the prescribed time limit that the corresponding drug involving the patent is submitting a marketing application; the relevant system for the link between drug review and approval and drug patents shall be formulated separately. The above-mentioned policies indicate that the direction of China's exploration and establishment of drug patent link pilot work has gradually become clear.

On April 3, 2018, the State Council issued the Opinions on Reforming and Improving the Supply Guarantee and Use Policy of Generic Drugs. The Opinions pointed out that it is demand-oriented to encourage imitation of clinically necessary, effective, and short-supply drugs, and encourage imitation of major drugs. Drugs needed for the prevention and treatment of infectious diseases and rare diseases, drugs needed to deal with public health emergencies, drugs for children, and drugs that have not yet applied for registration one year before the expiration of the patent; drugs that are newly approved for marketing or have passed the evaluation of the consistency of the quality and efficacy of generic drugs are included in the catalogue of drugs listed in China; anti-monopoly law enforcement in the field of intellectual property rights is strengthened to prevent the abuse of intellectual property rights and promote the listing of generic drugs while fully protecting drug innovation.

On July 10, 2018, the State Intellectual Property Office pointed out in the third quarter regular press conference that my country's domestic invention patents accounted for nearly 70%, but there are still in core technology fields including medical technology. There are shortcomings, and the fourth revision of the Patent Law will continue to improve the drug patent related system, explore the establishment of a drug patent link system, and shorten the time to market for drugs.

Obstacles in the design of China's drug patent linkage system

1. Lack of restrictions on the scope of drugs and types of patents registered

The procedure of drug patent linkage shall be the patent registration of the patent by the patent owner of the drug, on the basis of which the subsequent drug registration application shall be examined for patent linkage. The current "Drug Registration Management Measures" currently does not limit the scope of registered patents, at the same time, the "Relevant Policies (Draft for Comment)" and "Opinions on Deepening Reform and Encouraging Innovation" stipulate the content of the "Listed Drug Catalogue" and the "Notice on Publicly Soliciting Opinions on the Framework of the" China Listed Drug Catalogue "" The "China Listed Drug Catalogue (Draft for Comment)" does not restrict the scope of drugs registered for patents.

According to statistics, the proportion of generic drugs in China has reached 96%. If all drugs are allowed to register patents, almost all patent disputes between drugs, including patent disputes between generic drugs, may enter the patent link examination process. As a result, drug patent disputes will increase sharply, which will not only bring heavy examination burden to the drug review and approval process, but also lead to vicious competition among pharmaceutical manufacturers using the drug patent link system, delay the launch of competitors' drugs and reduce the accessibility of drugs.

Secondly, the current drug patent linkage system does not limit the patent types of drug registration patents.

Pharmaceutical patents include compound patents, crystal patents, preparation patents, pharmaceutical composition/compound preparation patents, method patents, use patents, equipment patents, production device patents and even design patents. Among these patents, equipment patents, production device patents, design patents and other patent types that are weakly related to the safety and effectiveness of drugs should not be included in the scope of registered patents. Patent protection in every detail is not conducive to the healthy competition of the pharmaceutical industry and the accessibility of the public.

2. Failure to ensure the reliability of the patent information of the Orange Book

Patent challenges and infringement lawsuits, no matter which main line, must be based on the patents listed in the orange book, so the reliability of the patent information in the orange book is particularly important. On the one hand, patent information must be true and accurate, and on the other hand, patents must also be able to cover the corresponding marketed drugs.

However, although China released the first edition of the Catalogue of Listed Drugs at the end of 2017, which is also called China's own orange book by the industry, it discloses a lot of information about drugs, including the patent number and expiration date of relevant patents, but it does not clarify the mechanism of correction and objection of patent information. In fact, it is difficult for CFDA to fully verify the numerous and numerous patent information. After all, the declaration of orange peel patent information is unilaterally completed by the original research and development pharmaceutical factory. Whether such patent information can withstand scrutiny will determine the credibility of the entire patent linking system.

3. The legal basis of tort litigation is not clear.

As one of the main lines of the "infringement litigation", is for generic pharmaceutical companies to submit listing applications for infringement litigation, China to establish a patent link system, the biggest obstacle is the lack of "proposed infringement" (artificial act of infringement) provisions. The so-called "proposed infringement" refers to the act of anyone submitting an application for new drug registration or generic drug registration to the drug administrative supervision and administration department during the drug patent protection period of others, which constitutes an infringement of patent rights.

At present, item 5 of Article 69 of China's Patent Law stipulates that "any of the following circumstances shall not be regarded as infringement of patent right: manufacturing, using or importing patented drugs or patented medical devices in order to provide information needed for administrative examination and approval, and manufacturing or importing patented drugs or patented medical devices specially for them", this provision is called the "Bolar Exception" of China's Patent Law (the "Bolar Exception" is intended to allow generic drugs to carry out research during the patent period of the original research drug, so as to be listed in time after the expiration of the patent period). However, the industry has different opinions on whether the application stage for drug listing and production belongs to the scope of the "Bolar Exception" and whether it belongs to the proposed infringement, the mainstream view is that the act of submitting a listing application does not constitute an infringement, so such an infringement lawsuit is likely to lose the possibility of success due to the lack of a rights basis.

4. Insufficient incentives for patent challenges

Under the patent linking system, one of the major incentives to encourage generic pharmaceutical companies to launch patent challenges is the rule that gives market exclusivity incentives to those who challenge success, and the term "market exclusivity" here refers to the exclusive market for generic drugs, I .e. the drug regulatory authorities refuse to approve the listing of other generic drugs during a certain period of exclusivity.

In China's existing regulations, the reward for successful challengers is embodied in the experimental data protection system of Article 2 of Decree 55: drugs that successfully challenge patents are given a data protection period of 1.5 years; During the data protection period, the review agency will no longer approve other applicants' applications for listing on the same variety, except for the data obtained by the applicant himself. However, data protection periods are not the same as market exclusivity. First of all, if the challenge is successful, you can enjoy the data protection period. When many generic drug companies challenge and succeed, then these generic drugs can obtain the data protection period and there is no so-called monopoly. Secondly, according to this clause, as long as other generic drug applicants submit self-obtained data, it is possible to obtain the approval of the drug administration department, so is the submission of consistency evaluation data self-obtained data? If the answer is yes, then the data protection period cannot prevent these latecomers from entering the market. In this way, the benefits of the data protection period to the successful challengers will be discounted, and it may be difficult to achieve the expected encouraging effect.

Summary

Any system design is not omnipotent, and the interest game triggered by the drug patent link system is also eternal. The charm of the patent link system lies in this dynamic balance with no definite result. This balance depends on the game strategy of the original research drug and generic drug applicants after comprehensive consideration of patent type, protection intensity, length of effective patent period, drug market situation, etc. After the establishment of the patent link system, there will be key interest game points, which require subsequent policy adjustments and loopholes.