When evaluating the novelty of claims in life sciences and pharmaceutical, compared with EPO, the examination practice in China is more stringent when determining whether i) a technical feature has a limiting effect on a pharmaceutical-use claim; and ii) whether a disclosure of the prior art affects the novelty of the claim.
I. Limiting effect of a technical feature on a pharmaceutical-use claim.
For a method for treatment of diseases, it is a patentable subject in the United States, but not in EPO or China. Instead, EPO allows the method for treatment of diseases to be modified into a use-related product claim (e.g., compound X for use in the treatment of diseases Y). China allows the method for treatment of diseases to be modified into a pharmaceutical-use claim (i.e., Swiss-style).
The Guidelines for Examination in EPO (Part G-Chapter VI-5, March 2021) recites that, “Therapeutic uses of a substance/composition may be based not only on the treatment of a different disease but also on the treatment of the same disease by a different therapeutic method differing for example in the dosage, administration regime, group of subjects or route of administration (G 2/08).”
In contrast, the Guidelines for Examination in China (section 5.4, Part II, Chapter 10, 2017) recites that, “The distinguishing features merely present in the course of administration do not enable the use to possess novelty.” Accordingly, when evaluating the novelty of a pharmaceutical-use claim, some technical features that have limiting effects on a method for treatment of diseases will no longer have the limiting effect on the pharmaceutical-use claim, and such technical features therefore cannot confers novelty on the claim.
According to the current examination practice in China, to determine whether a certain technical feature has a limiting effect on the pharmaceutical-use claim, the key is to determine whether the feature has an impact on the pharmaceutical process. Generally, it is considered that:
– substance, disease to be treated (indication), dosage form and unit dose (dosage in one package) are limiting features;
– administration regime (dosage, duration, frequency), different mechanisms of action of the same disease, etc. have no limiting effects;
– route of administration is controversial, depending on whether it affects the dosage form;
– the subject of administration is also controversial, depending on whether it affects the indication.
Therefore, when the applicant intends to incorporate technical features to confer novelty on a pharmaceutical-use claim, care should be taken to select technical features that have a limiting effect on the claim. In the following, this will be further discussed in conjunction with Case 1.
Brief description of claim 1 and D1:
Claim 1 relates to the use of ADAMTS13 in the manufacturing of a medicament for the treatment of coagulopathy in mammals by subcutaneous administration, wherein ADAMTS13 is in a therapeutically effective amount from 20 to 4,000 activity units per kilogram body weight.
D1 discloses that ADAMTS13 can treat coagulopathy in mammals. At the same time, D1 also mentioned that ADAMTS13 can be administered by subcutaneous or other routes.
The examiner stated that, although D1 did not disclose the claimed therapeutically effective amount of ADAMTS13, such technical feature is not a pharmaceutical feature and therefore has no limiting effect on the pharmaceutical use of claim 1. Therefore, the claim is not novel in view of D1.
In this case, the original claim 1 relates to a method for treatment of diseases. Since the method for treatment of diseases is not a patentable subject, the applicant amended it to a Swiss-style pharmaceutical-use claim. The main technical features of claim 1 include a) known substance: ADAMTS13; b) route of administration: subcutaneous administration; c) subject of administration: mammal; d) indication: coagulopathy; e) administration dosage: therapeutically effective amount of ADAMTS13.
According to the current examination practice, for a pharmaceutical-use claim, the feature e) of claim 1 (i.e., administration dosage) is not a pharmaceutical feature (since it does not affect the pharmaceutical process), and has no limiting effect on the pharmaceutical use of claim 1. However, it is generally considered that the unit dose (dosage in one package) has a limiting effect on the claim (since it can affect the pharmaceutical process and then the product). Therefore, as an option, the applicant may consider modifying the administration dosage to a unit dose.
In examination process of the case, the examiner and the applicant argued over whether D1 disclosed the “subcutaneous administration” of ADAMTS13, which indicates that the examiner defaulted that the route of administration of “subcutaneous administration” has a limiting effect on the pharmaceutical use of claim 1, and speculated that different routes of administration have an impact on the dosage form, thereby affecting the pharmaceutical process and the product made therefrom.
In addition, even if D1 does not disclose the feature c) of claim 1 (i.e., subject of administration: mammal), since the feature does not affect the indication, it has no limiting effect on the pharmaceutical use of claim 1.
II. Impact of a disclosure of the prior art on the novelty of the claims.
With respect of the novelty of a compound, the Guidelines for Examination in China (section 5.1, Part II, Chapter 10, 2017) recites that, “For a compound claimed in an application, if it has been referred to in a reference document, it is deduced that the compound does not possess novelty, unless the applicant can provided evidence to verify that the compound is not available before the date of filing.” The relevant recital in the Guidelines for Examination in EPO are as follows (Part G–Chapter IV-2, March 2021): “Subject-matter can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Art 54(1), if the information given is sufficient to enable the skilled person, at the relevant date (see G-VI, 3) and taking into account the common general knowledge in the field at that time, to practise the technical teaching which is the subject of the disclosure (see T 26/85, T 206/83 and T 491/99).”
By comparing the above-mentioned provisions in China and EPO, it can be seen that China has stricter requirements for determining that the disclosure of the prior art does not destroy the novelty of the invention. In the following, this will be further discussed in conjunction with Case 2.
Brief description of claim 1 and D1:
Claim 1 relates to a protein construct comprising a Factor VIII molecule and a PEG attached to the Factor VIII via carbohydrate moieties of Factor VIII.
D1 involves the attachment of PEG to Factor VIII via the amino acid moiety. D1 provides a detailed description of examples and protocols for attaching PEG to the amino acid moiety of Factor VIII. At the same time, D1 mentioned in one place in the specification that PEG can also be attached to the carbohydrate moiety of FVIII. However, D1 does not provide any examples of attaching PEG to the carbohydrate moiety of FVIII or any other description of the solution.
The applicant argued that D1 only proposes an idea that PEG can be attached to the carbohydrate moiety of FVIII, while does not disclose any reaction conditions or feasible ways to realize this idea. The applicant stated that there are many differences between the reaction conditions for attachment via amino acid moieties and via carbohydrate moieties.
Also, the applicant submitted a large amount of experimental data in an attempt to prove that the “protein construct with PEG attached to the carbohydrate moieties of FVIII” (i.e., the protein construct as claimed in claim 1) is not available before the date of filing. Therefore, the applicant believes that D1 does not disclose the protein construct claimed in claim 1, and claim 1 is novel in view of D1.
However, the examiner is of the opinion that since D1 objectively records that “PEG can also be attached to the carbohydrate moiety of FVIII”, regardless of whether D1 provides reaction conditions or examples, D1 clearly discloses a protein construct with this structure. Therefore, the claims are not novel in view of D1. The examiner did not accept the experimental data provided by the applicant to prove that the protein construct is not available before the date of filing.
In this case, the protein construct claimed in claim 1 is a compound. The applicant tried to argue for the novelty of claim 1 by providing evidence to verify that the compound is not available before the date of filing. However, the examiner did not accept the evidence provided by the applicant. It can be seen from this case that for the compound that has been referred to in a reference document, although the Guidelines give an exception where the reference document does not destroy the novelty of the compound (that is, to verify that the compound is not available before the date of filing), as in the case of this case, the probability of success of this approach is rather low. Generally, the examiner considers that as long as the reference document objectively records the structure of the compound, it indicates that the compound has been disclosed and is not novel.