New Chemical Patent Disclosure Requirements in China
Patentable Subject Matter Requirements Unchanged
Section 2.2 of the new Guidelines concerning "Medical Use of Matter" is unchanged from the previous version:
If the medical use of the matters is to diagnosis or cure a disease, a patent cannot be granted therefrom according to Patent Law, Art. 25-1-3. But if theyChinese practice in this regard appears to roughly correspond with European claiming practice requiring "use of compound A for the manufacture of a medicament for treating disease X."
are used to manufacture medicines, a patent may be granted in compliance with the Law.
Chemical Disclosure Requirements
With regard to the disclosure requirements for chemical patent applications, the underlined material below has been added to Section 3.1.3 regarding "Use of the chemical product:"
For a chemical product invention, the use and/or the effect of use of that product should be completely disclosed. Even for a chemical compound that is novel in its structure, at least one use should be described.
If persons skilled in the art cannot predict the use and/or the effect of use that can be carried out by the invention based on the current state of art, the specification should describe to persons skilled in the art the qualitative or quantitative experimental data to prove the use and/or the effect of use carried out by the technical solution of the invention.
For a novel pharmaceutical compound or pharmaceutical composition, the practical medical use or pharmacological function as well as the effective amount and the method to use should be described. If persons skilled in the art cannot predict the medical use and/or the pharmacological function that can be carried out by the invention based on the current state of art, the specification should describe to persons skilled in the art the qualitative or quantitative data from the laboratory experiments (including animal tests) or clinical experiments to prove that the technical solution of the invention can solve the technical problem expected to be solved or the technical effect expected to be achieved. The effective amount and the method of use or preparation should be described to the extent that could enable persons skilled in the art to carry out [the invention].
For those data to show the effect of the invention, the method to detect such effect should be described if there exist different detection method that lead to different results. If this is a special method, a more detailed description should be made as to enable persons skilled in the art to carry out the method.
With regard to "Sufficient Publication of Chemical Product Invention," Section 3.3 now also requires
For a use of a chemical product invention, the chemical product used, the method of use and the effect achieved should be disclosed in the specification so as to enable persons skilled in the art to carry out the use invention. If the produce used is a novel chemical product, the description regarding to the product in the specification should be in compliance with the relevant requirement set forth in § 3.1 of this Chapter. If persons skilled in the art cannot predict the use based on the current state of art, the specification should describe to persons skilled in the art the experimental data to prove that the substance can be utilized in such use and can solve the technical problem to be solved or the effect to be achieved.In addition a new requirement appears to have been added under Section 3.4.2 stating that the written description requirement must be met at the time of filing:
Because chemical arts belong to experimental subjects, most inventions need experimental verification. Therefore, the specification should generally include embodiments, for example, the preparation and application embodiments of the product.It appears from these excerpts that there will be some additional disclosure requirements with regard to the "effect achieved" or "effective amount" of pharmaceuticals, at least in connection with the technical problem to be solved. However, whether these new requirements might correspond to a "best mode" requirement for experimental data pertaining to effect (such as drug activity data) remains to be seen. As Richard points out, "In the Chinese legal system, the interpretation and/or application of a particular regulation can be more important than its wording."
. . . (2) To decide whether the specification is sufficiently made known to the public, the decision is based on the original specification and the subject matter recited in the claims. The embodiments and the experimental data submitted after the filing date may not be considered.
Novelty of Medical Use Claims
Section 5.4 of the new Guidelines state that "A known product cannot be deemed as a new product simply because a new application is submitted." This section also also appears to include new considerations for novelty of claims directed toward medical use for a chemical product, including
- Whether the claimed use is substantially different from a known use. An invention which differs only in expression from a known use does not possess novelty;
- Whether the claimed use is directly indicated by the mechanism or pharmacological function of a known use. A use directly equivalent to a known mechanism or pharmacological function does not possess novelty;
- Whether the claimed use is a genus covering a known specific use. A known specific use shall destroy the novelty of the use genus; and
- Whether the features involved in the use of the chemical product, such as administration mode, route, amount and time intervals, etc., make any difference to the manufacture of the medicine. Distinguishing features only relating to the administering process cannot render the use novel.
Since the "substantially different" standard in the first item would apply to inventive step, rather than novelty, it appears that the first provision may be intended to simply remind examiners that there can be different names for very similar medical uses of the same use. Similarly, the "not directly equivalent" standard would also appear to apply more to inventive step than novelty in the second item. The prior art effect of a specific use against a generic use in the third item also appears to merely codify standard practices. The fourth item appears to attempt to distinguish between medical treatment claims, which are not patentable in China, and manufacture use claims ("use of compound A for the manufacture of a medicament for treating disease X") which are patentable in China.Please feel free to contact us for a copy of the relevant sections of the new Chinese Guidelines discussed above.