Observation of china's first drug patent link litigation case

1 Preamble

On August 5, 2022, the Supreme People's Court issued a second-instance judgment in China's first drug patent link litigation case, Sino-Foreign Pharmaceutical Co.

The project involved was Edilexol softgels, which were developed by Roche's Japanese Sino-foreign Pharmaceutical Co.

The defendant in the case was Wenzhou Haihe Pharmaceutical Co.

On November 8, 2021, the plaintiff, Sino-Foreign Pharmaceutical Co.

3 Case verdict

The verdict

The second instance judgment

4 Case observation

Patent Declaration

After the original research was approved for listing in China in December 2020, 5 pharmaceutical companies have submitted listing applications

The four types of patent declarations are different, among which the patent declarations of the first two pharmaceutical companies were made before the original patent was invalidated, and the last two pharmaceutical companies made

R&D strategies of pharmaceutical companies

The earliest litigation time of the case was November 8, 2021, and on December 30, 2021, during the trial of the case, the State Knowledge Bureau issued an invalidation decision No.

Wenzhou Haihe Pharmaceutical Co.

Trial cycle

The case lasted eight months from the formal acceptance of the Beijing Intellectual Property Court on November 8, 2021, to the first-instance judgment pronounced on April 15, 2022, and then to the final judgment of the second-instance trial on August 5, 2022, which is destined to be a milestone

The legal status of the patent in question

Although the patents in question had been declared invalid by the State Intellectual Property Bureau before the first instance judgment was pronounced, the Beijing Intellectual Property Court and the Supreme People's Court still conducted substantive trials

The Beijing Intellectual Property Court held that although the patent right involved in the case had been declared invalid by the State Knowledge Bureau, the invalidation decision was still within the time limit for filing a lawsuit, and considering that both parties in the case were advocating substantive trial and other factors, the court still judged

The Supreme Court held that "although the patent rights involved in the case have been declared invalid by the State Intellectual Property Office, both Sino-foreign Pharmaceutical Co.

It can be seen that the legal status of patent rights that have not undergone a final judicial ruling is not recognized in the judicial system, and even if the State Intellectual Property Office makes an invalidation decision, it will not affect the court's trial
before the final trial procedure is completed.

References:

1.
Patent information registration platform for listed drugs in China

2.
Chemical Drug Catalog Collection of Drug Evaluation Center of State Drug Administration

3.
Patent database of the State Intellectual Property Office

4.
Civil Judgment of the Second Instance of Civil Second Instance of Sino-foreign Pharmaceutical Co.
, Ltd.
and Wenzhou Haihe Pharmaceutical Co.
, Ltd.
(2022) SPC Zhimin Zhong No.
905

5.
Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial Implementation)

6.
The Supreme Intellectual Property Tribunal Renders a Second Instance Judgment on China's First "Drug Patent Link" Case.
Intellectual Property Finance, 2022