IP SPOTLIGHT 14 April 2021

Inventions in the chemical, life sciences and pharmaceutical fields differ from mechanical inventions due to their need for the invention to be confirmed by experiments. Many of these experiments are carried out after filing, to confirm inventions predicted but not fully explored in at the time of filing. Previously when prosecuting patents in China, both the China National Intellectual Property Administration (“CNIPA”) and the courts took a relatively strict position against post-filing supplementary data and submitting experimental data generated after the filing date in support of the patentability of inventions was not permitted. However, recent changes to the Patent Law and Guidelines for Examination have established that post-filing data for demonstrating the patentability of the claimed inventions shall not be prohibited. The recent Economic and Trade Agreement between the Government of China and U.S. (published 16 January 2020) firmly confirms that “China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings”. The result of this is that the CNIPA recently announced the “Revised Patent Examination Guidelines”, which came into force from 15 January 2021. As a result of the Revised Guidelines, if the claimed invention was a technical effect predictable or expected on the basis of the original specification as filed, then the examiner should review any supplementary experimental data submitted in support. However, they do not have to accept the data if they do not think the disclosure was sufficiently predictable based on what was in the original specification at the filing date.

The first example describes a claim directed to a compound. The application describes the compound as having the effect of lowering blood pressure and provides methods of measuring the compound’s blood pressure lowering activity, but experimental data was not disclosed in the application at filing. The Revised Guide states that the examiner should consider the applicant’s post-filing data demonstrating the compound did lower blood pressure as predicted. The second example describes a claim directed to compounds having formula I. Data in the application at filing shows the IC 50 of the compound’s antitumor effect is in the range of 10-100 nM. The specification of the second example also describes the methods for determining the antitumor effect. The applicant submitted post-filing data to demonstrate the compound is inventive, and comparison data showing that the compound has an IC 50 of 15 nM in treating tumours, while the reference prior art compound has an IC 50 of 87 nM. The Revised Guide requires that in this scenario, the examiner should consider the post-filing data when determining the inventive step of the claim. We therefore suggest that, to provide a clear basis for the submission of post-filing data in China, it is good practice to describe the technical effect as well as the methods for determination thereof in the application at the time of filing.

DR PENNY FARBEY Special Counsel

SUBMITTING POST-FILING DATA DURING PATENT PROSECUTION IN CHINA

The Revised Guide provides two examples relating to pharmaceutical inventions.

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