## Facts

- Xiangbei Welman Pharmaceutical Co., Ltd. (Xiangbei Welman) obtained a Chinese patent directed to a new antibiotic compound.
- Xiangbei Welman asserted that the feature distinguishing its antibiotic from the prior art was a safety-testing protocol it developed to confirm the compound’s safety.
- Xiangbei Welman did not include the details of that testing protocol in the patent application, believing disclosure would reveal proprietary know-how and that regulatory drug-approval requirements would assure the public that the antibiotic had been tested and deemed safe.
- Beijing Double-crane Pharmaceutical Co., Ltd. (Double-crane), a competitor, initiated proceedings before the Patent Re-examination Board of the State Intellectual Property Office (the Board) challenging the patent’s validity.
- The Board revoked Xiangbei Welman’s patent, reasoning that the patent application was too thin and provided no support showing that the antibiotic satisfied the requirement of inventiveness.
- Xiangbei Welman sued Double-crane and the Board seeking to overturn the revocation; two lower courts upheld the Board’s decision.
- Xiangbei Welman appealed to the Supreme People’s Court of China.

## Issues

1. Whether a pharmaceutical patent satisfies the inventiveness requirement when the alleged technical advance lies in an undisclosed safety-testing protocol rather than in technical teaching contained in the patent specification.
2. Whether expected or actual regulatory safety review for a new antibiotic can substitute for disclosure in the patent application when assessing inventiveness.
3. Whether the Board and the lower courts properly revoked the patent based on the application’s failure to provide evidence supporting inventiveness.

## Decision

- The Supreme People’s Court upheld the revocation of Xiangbei Welman’s patent.
- The court agreed that the patent application, as filed, did not provide the necessary technical disclosure to demonstrate inventiveness.
- The court rejected the attempt to rely on an undisclosed safety-testing protocol to supply the inventive contribution while keeping the protocol out of the patent.
- The court also rejected the argument that drug regulatory approval processes could stand in for patent disclosure or cure a lack of disclosed support for inventiveness.

## Legal Principles

- Inventiveness is judged on the technical content presented in the patent application (claims and specification), not on internal know-how withheld from the application.
- A patentee cannot secure exclusive rights based on a purported technical contribution that is not communicated to the public through the patent disclosure.
- Regulatory review for safety and efficacy serves a different purpose than patentability review and does not replace the patent law requirement that the application itself support inventiveness.
- If the applicant treats key technical steps (such as a testing protocol) as proprietary and omits them from the application, the applicant bears the risk that the patent will be found unsupported and invalid.

## Conclusion

In *Beijing Double-crane Pharmaceutical Co., Ltd. v. Xiangbei Welman Pharmaceutical Co., Ltd. and Patent Re-examination Board of the State Intellectual Property Office, China 2011*, the Supreme People’s Court sustained the administrative revocation of Xiangbei Welman’s antibiotic patent because the application did not disclose the testing protocol the patentee claimed made the invention inventive, and regulatory approval expectations could not replace the patent’s disclosure-based showing of inventiveness.
