Analysis of Test Data Protection System in Pharmaceutical Intellectual Property

When it comes to pharmaceutical intellectual property rights, even among those who specialize in intellectual property rights, most people can only think of "patents. However, patents are only one form of drug intellectual property protection. In addition, there are many different types of intellectual property protection forms. One of them that has attracted more and more attention from domestic pharmaceutical companies is the "drug data protection system".

The Origin and Significance of Experimental Data Protection System

As a special commodity, drugs are related to people's health, and even life-threatening. Therefore, most modern countries choose to implement strict drug administrative approval and management systems. Under this system, if a drug is to be approved for marketing, a large number of preclinical and clinical trial data must be submitted, with a wide variety, strict requirements and a long process. In this process, drug manufacturers have to invest a lot of manpower, material and financial resources. Compared with other industries, the product listing cycle of the pharmaceutical industry is terrible. Some economists pointed out after research that for a new biopharmaceutical, it takes at least 13-16 years of data exclusive period to enable the original research drug manufacturer to recover the huge cost in the research and development process. If there is not enough drug data exclusive protection period, it is difficult to imagine that the original research drug manufacturer will have the motivation to develop new biopharmaceuticals in the case of weak patent protection.

For new drugs, in the approval process, drug manufacturers must submit various types of drug test data (including clinical trial data) to the administrative approval agency to prove the effectiveness and safety of the drug; for generic drugs, there is no need to repeatedly submit clinical trial data, but only bioequivalence data that proves that it has the same quality and efficacy as the original drug, for example, in accordance with the provisions of China's "Drug Registration Management Measures", for chemical drugs, if raw materials or preparations with existing national drug standards are to be listed for approval, then only bioequivalence test data and relevant clinical trials at home and abroad need to be submitted. Data review, without the need to conduct clinical trials on their own. Such regulations can greatly speed up the approval and marketing of generic drugs, which is obviously beneficial to reduce monopoly and reduce drug prices. However, from another point of view, the original drug manufacturers have made great efforts and costs to develop new drugs, while generic drug manufacturers do not need to conduct expensive and time-consuming clinical trials, which seems unfair and has dealt a blow to the research and development momentum of the original drug. At the same time, as the research and development cycle of new drugs is getting longer and longer, when new drugs are on the market, the 20-year patent protection period is often very few. In the long run, it is bound to seriously affect the enthusiasm of original drug manufacturers to develop new drugs. In order to better promote drug research and development, various developed countries have taken a variety of measures to further strengthen the protection of original research drugs, one of which is the drug data protection (Data protection) system, which is also called the exclusive right of drug trial data (Pharmaceutical Test Data Exclusivity).

The trial data protection system originated from the Drug Price Competition and Patent Compensation Act of 1984 in the United States. It was born to balance the interests between the original research drug manufacturers and the generic drug manufacturers. The simplification of the drug approval process has caused potential losses to the original drug manufacturers. Therefore, the positive significance of drug data protection to the original drug manufacturers is beyond doubt.

The experimental data protection system and the patent protection system are parallel and complementary to each other, but the focus is different. On the one hand, it embodies the protection and reward of new drug development achievements with clinical trials as the core, on the other hand, it also effectively ensures that newly developed and marketed drugs can enjoy a market monopoly period roughly equivalent to patent protection. The practice of implementing the trial data protection system in the United States so far shows that this system does better balance the interests of new drug developers, generic drug manufacturers, the public and other parties, so it is accepted by all interested parties.

Specific Connotation of Drug Data Protection

Up to now, drug data protection does not have a relatively unified and clear definition and protection object like patent protection. From the current TRIPS and the practice of various countries in the world, it can be roughly summarized as follows: drug manufacturers (especially original drug manufacturers) have a certain period of exclusive right to the test data submitted by drug regulatory agencies during the drug research and development process, during this period, the drug regulatory authority shall not grant marketing authorization for the generic drug based on the data, and the drug regulatory authority shall prevent the data from being used for improper commercial purposes. In addition, according to different regulations in different countries, there will be some other requirements for drug data protection, such as drug regulatory agencies must not disclose the data, etc.

The specific content of drug data protection in China involves the following levels:

(1) Protection subject: drug regulatory agency, in China is the State Food and Drug Administration.

(2) Protection object: drug test data, in our country specific provisions for undisclosed data or other data.

(3) Scope of protection: for innovative drugs, including new chemical entities (New Chemical Entity, NCE), new dosage forms, new indications, biological products, etc., only new chemical entities are protected in China.

(4) Duration of protection: The provisions on the duration of protection vary greatly from country to country, ranging from 6-12 years in our country.

(5) Protection methods: my country and developed countries do not allow third parties to rely on the data to apply for the listing of generic drugs as the main protection method, and some countries mainly prevent the improper commercial use of the data as the main method.

China's test provides protection against the system's status.

China's drug trial data protection started late, although it joined in 2001.TWOWhen the commitment is included.TRIPsThe obligations set out in the framework of the Marrakesh Agreement Establishing the World Trade Organization, including the Agreement on China's AccessionWTOReport of the Working Group282~284Section also has clear provisions for the protection of test data, also in.2002Regulations on the Implementation of the Measures for the Administration of Drugs promulgated in35For the first time, a drug data protection system has been established, and on this basis.2007The Measures for the Administration of Drug Registration formulated in20Article provides a six-year data protection period for drug data, but there are no implementation methods and rules.

In order to further promote drug innovation and the development of generic drugs, and improve the drug test data protection system, the State Drug Administration recently drafted the "Drug Test Data Protection Implementation Measures (Interim) (Draft for Solicitation of Comments)", the reform opinion extends the scope of test data protection from the original only "drugs containing new chemical components" to "innovative drugs, rare disease drugs, children's special drugs, improved new drugs for rare diseases and children's special drugs, and innovative therapeutic biological products". The specific protection period is shown in the following table:

It can be seen that in the future, the innovative research and development of rare disease drugs, children's special drugs, and therapeutic biological products will be greatly assisted.