[authors: Wenhan Liu and Yan Wang]
Related Laws and Regulations
The Chinese Patent Law provides in Article 5(1) that no patent right shall be granted for any invention-creation that is contrary to the laws or social morality or that is detrimental to public interests. This prohibitive regulation is formulated in order to prevent an invention-creation that may disturb normal social order, lead to crimes, or result in other factors threatening social stability from being granted a patent right1.
Likewise, the Food Safety Law is formulated to guarantee food safety and to ensure the health and safety of the general public. The Food Safety Law specifies the definition of food in Article 150 that: food means any substance that has been processed or not processed that is suitable for eating and/or drinking, including substances traditionally used as food and Chinese herb medicine, excluding substances solely used for disease treatment. Further, the Law provides Article 38 prescribing that it is prohibited to add medicine to food produced or traded, unless the added substance is traditionally considered as both food and Chinese herb medicine. Moreover, the catalogue of substance considered as both food and Chinese herb medicine is developed and published jointly by the National Health and Family Planning Commission (NHFPC) and National Medical Products Administration (NMPA).
Patent practice relating to the field of chemistry frequently sees a patent application for a product in the food industry involving a compound and/or composition, where the compound and/or composition itself has a preventive and/or therapeutic effect, yet the application intends to protect a use as food. It is controversial whether or not such a patent application complies with Article 5(1) of the Chinese Patent Law. This article intends to discuss the examination practice on this matter based on actual cases taken as examples.
Example Cases
Case 1
Claim 1 of the application recited as below, and was rejected:
“1. Use of a composition comprising arachidonic acid and/or a compound having arachidonic acid as a constituent fatty acid in preparation of a functional food composition or a health food composition for ameliorating depressive symptoms caused by aging-related reduction in mental and physical functions, wherein …”
The Decision of Rejection and the Notification of Reexamination indicated that “depressive symptoms caused by aging-related reduction in mental and physical functions” described in the claims and the description include both a depressive state of normal population and a depressive state of patients suffering from depression. The description does not distinguish whether the depressive state is a pathologic depressive state or a normal depressive state. Therefore, the technical solutions according to claims 1-17 and the description violate the provisions of the Food Safety Law which prohibit claiming that a food or health food has a preventive and/or therapeutic effect.
The applicant then modified the claims and the description, limiting the depressive symptoms to “of non-depressed patients”, excluding preventive and therapeutic functions for diseases from the use as food and health product, thereby overcoming the defect pointed out in the Decision of Rejection and the Notification of Reexamination. The modified description overcomes similar defects noted by the above-mentioned rejection and review notices by excluding preventive and therapeutic functions for diseases from the use as food and health product by deleting the phrase “caused by mental diseases, neurological diseases …”, limiting the “depressive symptoms” to be “of non-depressed patients”, and deleting the description of diseases. Eventually the Decision of Rejection was revoked, and a patent right granted.
The allowed claim recites as below:
“1. Use of a composition comprising arachidonic acid and/or a compound having arachidonic acid as a constituent fatty acid in preparation of a functional food composition or a health food composition for ameliorating depressive symptoms of non-depressed patients caused by aging-related reduction in mental and physical functions, wherein …”
Case 2
Claim 1 of the application recited as below, and was rejected:
“1. Use of a formulation comprising at least one active agent in preparation of a medicament for treating, ameliorating or preventing an Obsessive Compulsive Disorder (OCD) or an OCD group mental disorder and condition in an individual in need thereof, wherein the active agent comprises: …
3. The use according to claim 1, wherein the formulation further comprises ice cream, frozen food or yogurt.”
The Decision of Rejection indicated that the original Claim 3 and some disclosure of the description (see paras. 16, 41, 63, 64, 97, 116, and 117-118) did comply with Article 5 of the Chinese Patent law. The petitioner made amendments accordingly, and cancelled original Claim 3 in particular. The examiner alleged in the preliminary review that the amended claims overcame the deficiencies noted in the Decision of Rejection; however, the description still contained the defect pointed out under Article 5 of the Chinese Patent law.
In response, the petitioner submitted the replacement sheets for the full text of the amended description, modifying and removing the disclosure relating to carriers in the form of foods in Paragraphs 16, 41, 63, 64, 97, 116, and 117-118 specified in the Decision of Rejection, thereby overcoming the deficiencies of the description as indicated by the Decision of Rejection under Article 5 of the Chinese Patent law. The afore-mentioned Decision of Rejection was revoked.
As can be seen from the decision of the reexamination, a technical solution described in the specification of the application relating to food or health food is not allowed to involve a preventive and/or therapeutic effect. That is, a technical solution (claim) relating to a preventive and/or therapeutic effect of a food and/or health food must be modified; otherwise the technical solution/claim will be determined to go against Article 5(1) of the Chinese Patent Law.
Reflection
Referring to the above cases, a technical solution described in the description concerning food or health food shall not involve a preventive and/or therapeutic function for diseases. But it remains controversial whether or not a technical solution of the use of a same compound in preparation of food and in preparation of pharmaceutical products is allowed. Taking the following claims as an example:
Claim 1: Use of a compound X in preparation of a food product.
Claim 2: Use of a compound X in preparation of a medicament for treatment of depression.
Pursuant to the relevant regulations of the Food Safety Law, it is prohibited to add medicine to food. Now that the compound X has been used as a drug, is the technical solution of the compound X used as a food still approvable?
In this regard, we believe that a major difference between defining in a single technical solution both use of treating diseases and use as food (e.g., the technical solution of “use… in preparation of a functional food composition or a health food composition for ameliorating depressive symptoms …”) and defining the use of treating diseases and the use as food in different technical solutions is that, the technical solution defining both the use of treating diseases and the use as food implies that the compound added to the food at least satisfies the standards of medicaments, e.g., in terms of the dosage of the compound, which is prohibited under the Food Safety Law; while such a deficiency is not evident in a case of defining the use of treating diseases and the use as food in different technical solutions. Therefore, to answer the foregoing question, it is possible that the technical solution of the compound X used as a food is acceptable in patent practice when such a use is defined in a different claim.
Suggestions for drafting
In drafting the application document, it is recommended that the description of food and/or drink, health food, medicament, and symptoms are respectively included in different technical solutions, with the symptoms being divided into symptoms due to diseases and symptoms not caused by diseases, and each described in combination with the afore-mentioned food and/or drink, health food, medicament.
Moreover, with a function of treating hypertension and hyperglycemia, the product may be drafted as a health food “contributing to maintaining a healthy blood sugar level”, “contributing to maintaining a healthy blood pressure level”, and the like. Since the function pertains to the functions prescribed in the Catalog of Health Functions Allowed to be Claimed by Healthcare Foods - Non-Nutrient Supplements (2022) (Draft for Soliciting Public Opinions), it is desired to draft the application document to avoid the possible deficiencies under Article 5 of the Chinese Patent Law and to seek a larger scope of protection.
Further, even if the examiner notes a deficiency under Article 5 of the Chinese Patent Law during the prosecution, the deficiency can be overcome by amending the claims. For a technical solution cancelled for this purpose, the applicant may consider filing a divisional application so that the corresponding technical solution is pending.
In summary, based on current practice, claims directed to both food and medicament can be determined by the examiner to violate Article 5 of the Chinese Patent Law. In the future, the examination criteria for such claims would become clearer as relevant cases increase. The applicant can then decide on an appropriate drafting manner in light of the examination criteria, and modify the expression in a more suitable manner accordingly.
1Yin Xintian. Introduction to the Patent law of China (Abbridged) [M]. Beijing: Intellectual Property Press, 2011.
