Introduction

On December 26, 2025, the Supreme People’s Court (“SPC”) issued a final judgment in the highly anticipated invalidation dispute concerning’s semaglutide patent. The SPC revoked CNIPA’s Invalidity Decision No. 57950. Subsequently, on May 11, 2026, the China National Intellectual Property Administration (“CNIPA”) issued a new examination decision (No. 630010), officially maintaining the validity of the patent.

The case has attracted substantial attention from the pharmaceutical industry because semaglutide is one of the world’s most commercially successful GLP-1 drugs, and because the judgment provides important clarification regarding:

· the admissibility of late-filed supplementary experimental data; and

· the standards for evaluating inventive step in pharmaceutical and chemical patent cases.

The decision is expected to significantly influence future patent prosecution and invalidation practice in China.

Background of the Case

Semaglutide is a long-acting GLP-1 analogue developed by Novo Nordisk. Through specific structural modifications, the drug achieves a significantly prolonged half-life and enables once-weekly administration.

The modifications include:

· replacing alanine at position 8 with alpha-aminoisobutyric acid (Aib) to resist degradation by DPP-4 enzymes; and

· linking the lysine side chain at position 26 to a C18 diacid through a -Glu-AEEA-AEEA spacer to strengthen albumin binding.

Due to semaglutide’s substantial therapeutic efficacy, safety profile, and worldwide commercial success, numerous Chinese pharmaceutical companies have initiated generic drug development projects in anticipation of the expiration of Novo Nordisk’s core Chinese patent ZL200680006674.6 on March 20, 2026.

Among them, initiated an invalidation action before CNIPA.

Timeline of the Case

June 10, 2021

Zhongmei Huadong filed an invalidation request before CNIPA (Case No. 4W115162), alleging:

· nsufficient disclosure; and

· lack of inventive step for claims 1–5.

During the Invalidation Proceedings

Novo Nordisk submitted 18 pieces of counter-evidence, including supplementary experimental data intended to demonstrate:

· that semaglutide-related activity testing had been completed before the priority date; and

· that semaglutide exhibited advantageous properties compared with liraglutide.

August 24, 2022

CNIPA issued Invalidity Decision No. 57950, declaring the patent invalid.

CNIPA held that:

· the specification did not sufficiently disclose technical effects relating specifically to semaglutide; and

· the supplementary experimental data could not be accepted because the relevant technical effects could not be directly derived from the original application documents.

February 1, 2023

Novo Nordisk filed an administrative lawsuit before the, requesting revocation of the invalidation decision.

November 6, 2023

The Beijing IP Court revoked CNIPA’s invalidation decision and ordered CNIPA to reexamine the case.

December 26, 2025

The SPC upheld the first-instance judgment and clarified important standards regarding:

· admissibility of supplementary experimental data; and

· evaluation of inventive step.

May 11, 2026

CNIPA issued Reexamination Decision No. 630010 through a newly formed collegial panel, officially maintaining the validity of the patent.

Key Legal Issues and Court Findings

1. Acceptance of Late-Filed Supplementary Experimental Data

CNIPA’s Position

CNIPA adopted a relatively strict standard, holding that:

· the technical effects proven by supplementary experimental data must already be derivable from the original disclosure; and

· technical effects disclosed for general formula compounds could not automatically extend to specific compounds unless expressly disclosed.

Accordingly, CNIPA refused to accept Novo Nordisk’s supplementary experimental data.

Courts’ Position

Both the Beijing IP Court and the SPC adopted a more flexible and applicant-friendly approach.

The courts held that:

· where technical effects of a general formula compound are explicitly disclosed, it may reasonably be inferred that such effects apply to specific compounds within the claimed scope;

· patentees should be permitted to submit supplementary evidence to confirm such effects; and

· requiring separate experimental disclosure for every specific embodiment would be impractical and unreasonable, especially in pharmaceutical and chemical inventions.

The SPC further clarified that:

· the original specification only needs to establish a “reasonable belief” in the asserted technical effects; and

· supplementary experimental data does not need to have been generated before the filing or priority date.

2. Evaluation of Inventive Step

CNIPA’s Approach

CNIPA effectively linked inventive step to proof of superior or unexpected technical effects over the closest prior art.

Since the supplementary experimental data was not accepted, CNIPA concluded that the claimed invention lacked inventive step.

Courts’ Approach

The courts reaffirmed that inventive step analysis must follow the “three-step approach” under the Guidelines for Patent Examination:

1.   identify the closest prior art;

2.   determine the distinguishing technical features and technical problem solved; and

3.   assess whether the prior art provides technical motivation to arrive at the claimed invention.

The SPC expressly stated that even if semaglutide and liraglutide merely possessed equivalent technical effects, it still would not have been obvious to arrive at the claimed semaglutide solution.

This confirms that inventive step does not necessarily require proof of superior technical effects, but rather depends on whether there exists sufficient technical motivation or inspiration in the prior art.

Key Takeaways

More Flexible Standard for Supplementary Experimental Data

The SPC adopted a more reasonable and flexible standard for accepting late-filed experimental data, particularly in pharmaceutical and chemical cases.

“Reasonable Belief” Standard Confirmed

Applicants may rely on supplementary evidence where the original disclosure reasonably supports the asserted technical effects, even if detailed experimental results are absent.

Supplementary Data Need Not Pre-Date Filing

The SPC clarified that supplementary experimental data does not need to have been generated before the filing or priority date.

Reaffirmation of the Three-Step Inventive Step Analysis

The judgment confirms that inventive step analysis should focus on technical motivation and the three-step approach, rather than solely on whether the claimed invention demonstrates superior technical effects over the prior art.

Significant Impact on Future Practice

This landmark decision is expected to substantially influence future pharmaceutical and chemical patent examination and invalidation practice in China, while also helping align Chinese patent standards more closely with international practice.