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The Updated Novelty Examination Criteria of the Compound
Sherry Zhang Chemistry & Biotechnology Department Patent Attorney
Welcome to Linda Liu & Partners on air! This is patent attorney Sherry Zhang.
The CNIPA issued an announcement on the Revision of the Guidelines for Patent Examination on December 14, 2020, which has applied to all pending patents since January 15, 2021.
This revision mainly focuses on patent applications in the chemical and biological fields.
Now, let’s take a look at the revised section about the Novelty and Inventive Steps of Compound in the Guidelines.
For the revision of the Novelty of Compound, it mainly clarifies the examination criteria of “the compound does not possess novelty” and “the compound does not possess novelty under presumption”.
For the revision of the Inventive Steps of Compound, it improves the examination criteria of Inventive Steps of Compound.
Let’s start with the updated examination criteria of “the compound does not possess novelty”.
If the chemical name, molecular formula (or structural formula) and other structural information of a compound has been disclosed in a reference document that the person skilled in the art can conclude that the claimed compound has been disclosed, then the compound does not possess novelty, unless the applicant can provide evidence to prove the unavailability of the compound before the date of filing.
For “the compound does not possess novelty under presumption”, it provides that
If the structural information in the reference document is insufficient to distinguish the claimed compound from that disclosed in the reference document, but in combination with other information disclosed in the reference document, including physical/chemical parameter(s), the manufacturing process and experimental data, etc., the person skilled in the art has reason to presume that the claimed compound and the compound in the reference document are substantially the same, then it can be presumed that the claimed compound does not possess novelty, unless the applicant can provide evidence to prove that the claimed compound is distinct from the compound in the reference document in structure.
It should be noted that the evidence provided by the applicant should focus on the difference in structure rather than the availability of the structure from the reference document.
So, how to understand these criteria of “the compound does not possess novelty under presumption”?
We can put it this way: when presuming the claimed compound does not possess novelty, examiners are requested to comprehensively consider the information including physical/chemical parameter(s), the manufacturing process and experimental data disclosed in the reference document, based on which examiners can conclude that the person skilled in the art has the reason to make the presumption that the claimed compound and the compound in the reference document are substantially the same
The experimental data is a new factor to be considered.
It means that examiners will consider more factors before making a conclusion in the future.
This is good news for the applicant, as more evidence including experimental data can be used to argue for the novelty of the compound.
But sometimes the experimental data disclosed in the reference document may not completely correspond to the experimental data in the invention. Therefore, it may be difficult for the examiner to conclude that the claimed compound is distinct from the compound in the reference document.
The Guidelines doesn’t show any examples in this part, so how to use the information disclosed in the reference document to conclude the claimed compound does not possess novelty is still unknown.
We may need to wait until we see the Office Actions in practice.
That’s it for the discussion about the Novelty of Compound in the revised Guidelines. If you have any question please feel free to contact me. As a leading IP law firm in China, we are always glad to help. This is Sherry Zhang. Thank you for listening. See you next time.
