Discussion on Drug Patent Link System

Talking aboutdrug patent link system

Pharmaceuticals are important products that are closely related to public health and social welfare, and are also one of the concentrated areas of intellectual property conflicts. There is a dispute between the original research and generic drug companies in the drug market, which is concentrated in their patent infringement disputes. The drug patent linkage system refers to the patent of the generic drug applied for approval for listing and the original drug it imitates."Link up. To put it simply, it is to confirm whether the technical scheme of the generic drug falls into the patent protection scope of the original drug during the examination and approval of the generic drug, so as to solve the possible patent infringement problem in advance before the generic drug is put on the market.

On October 17, 2020, the National People's Congress passed the fourth amendment to China's Patent Law, which will take effect on June 1, 2021, with Articles 42 and 76, respectively, making principled provisions on compensation for the validity of drug patents and drug patent linking.. For a patent for a new drug invention that has obtained marketing authorization in China, the patent administration department of the State Council may, at the request of the patentee, grant a time limit compensation. In the case of a dispute arising from the patent right related to the drug applied for registration, the relevant parties may bring a lawsuit to the people's court. The drug regulatory department of the State Council shall, in conjunction with the patent administrative department of the State Council, formulate specific measures for the settlement of patent disputes in the stage of drug marketing license examination and approval and drug marketing license application, which shall be implemented after being submitted to the State Council for approval.

This is the first time in my country's patent law to appear the legal provisions of the drug patent validity compensation and the establishment of the drug patent connection system, which is an important step for my country to gradually establish the drug patent link and supporting system.

What is the role and significance of the drug patent link system?

The drug patent linkage system is the mutual link between the administrative examination and approval of the drug regulatory department and the judicial decision. The goal of the drug patent link system is to clarify whether the drug is infringed or to make an early warning of infringement before the drug is approved in a more efficient way, so as to avoid infringement disputes after the drug is approved and avoid substantial losses to both parties.

The construction of a drug patent linkage system in line with national conditions usually has the followingThe significance of the four aspects: protecting the patent rights of original research drugs; encouraging generic drug patent challenges; establishing a standardized drug market access order to prevent malicious competition; and resolving patent disputes before the occurrence of established infringements, which is conducive to reducing the cost of social violations.

How do pharmaceutical companies respond to changes in the pharmaceutical patent system?

For the original research enterprises, to do a good job of high-value patent layout, the formation of a strict and efficient patent protection network. Establish an early warning and prevention and control mechanism, pay regular attention to China's listed drug patent information registration platform, timely judge whether the registration information of generic drug enterprises is infringing or not, and if the infringement of generic drugs is determined, file a lawsuit or administrative ruling in accordance with the drug patent link system.

For generic drug companies, do a good job of information research and preparation, patent infringement risk assessment is one of the most important links, generic drug companies should check the status of all relevant patents of generic drugs, determine whether these patents will constitute obstacles to the product market, and according to the evaluation results combined with the system, choose the appropriate strategy.

The implementation of the drug patent term compensation and drug patent linkage system puts forward higher requirements for the patent work of pharmaceutical companies. Both original drug research companies and generic drug companies must pay more attention to the creation, application, protection and management of patents.