Protection of inventions relating to a dosage or an administration scheme in China: possible but only in certain cases

Like many other offices, the Chinese Patent Office does not grant protection to inventions relating to a method of therapeutic treatment. However, as in many countries with this type of exclusion, it is possible to protect the use of a medicine in the treatment of a disease.

But what about inventions relating specifically to a new dosage or a new administration scheme, when the use of the drug in the disease of interest is already known?

Provided an appropriate formulation is used, this type of invention does not seem to be strictly excluded from patentability in China. However, according to the examination guidelines of the Chinese Patent Office, the technical features involved only in the administration of the drug should not be considered for the examination of novelty and inventive step.

Should we therefore conclude that inventions relating to a dosage or an administration scheme have no chance of being patented in China?

Not necessarily. The technical features involved in the manufacture of the drug product may be considered for the examination of novelty and inventive step, which is related to the particular wording accepted in China for therapeutic use claims (such as so-called “Swiss” type, which mentions the manufacture of the drug).

Therefore, whenever it is possible to associate the new technical characteristic (i.e. the new dosage or the new administration schedule) with the manufacture of the medicinal product, the novelty of such a claim may be invoked on this basis. It should be noted that the Chinese Patent Office seems to remain reluctant to grant patents for this type of invention.

For example, changes in the route of administration, such as changing from oral administration to subcutaneous injection, can sometimes involve changes in drug formulation, which must be made when preparing the drug. The characteristic of the mode or route of administration could then be taken into account for the examination of novelty

Similarly, if a new dosage is found and the use of this new dosage involves a modification of the drug manufacturing process, this dosage may be considered as a limiting technical characteristic and distinguishing the object of the claim from the art prior.

Thus, a claim having a dosage range depending on the patient’s body weight and an interval between two administrations (two aspects that can only be managed during administration) as a distinctive element was rejected by the Supreme Court of China, while a claim having a dosage range in mg (independent of the patient, and likely to be taken into consideration during the manufacture of the medicinal product) as a distinctive element has been validated by the Intermediate People’s Court of China.

In view of the above, it appears that it is difficult to protect inventions whose subject matter relates to a dosage or an administration scheme in China. However, it is still possible to seek protection for some of these inventions if the claims are drafted in such a way that it is possible to argue that the technical feature relating to the dosage or the route of administration a role in the manufacture of the drug.

In view of the public health issues at stake and the colossal research investments required in the pharmaceutical field, it is to be hoped that the Chinese practice concerning the protection of inventions relating to a dosage or an administration scheme will become more flexible as c is the case in Europe.

In the meantime, our teams are at your disposal to assess, on a case-by-case basis, the chances that your inventions relating to a dosage or an administration scheme can be protected in China, in particular before entering the national phase in this country. .

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