Safety Considerations in the Application of Patents Regarding Novel Food Material

Generally speaking, to be patentable in China under the Patent Law, a food material shall be characterized as being novel, inventive, and practically appli­cable, while it does not fall into categories like scientific discovery or animal and plant varieties.

The Regulation of “Novel Food” in China 143 or public interest according to the Patent Law.^[533] Admittedly, a material that is patentable does not suggest that it is also safe, since in some cases it is not the invention itself but the methods of its application that violates the legal require­ments. Nevertheless, when it comes to a patent application for a food material or a material intended to be used in food production, the review for granting a patent is also expected to play the role of “safety valve” to ensure food safety. First, given that no patent shall be granted for an invention that contra­venes any law, the reviewer is supposed to consider the Food Safety Law if the applicant applies for a patent for novel material used in a food product. That is to say, he/she is obliged to refuse the application if the novel material does not comply with the food safety requirement. As a matter of fact, the current most disturbing food safety issue in China is the abuse of chemical substances in comparison to biological contamination in western countries.

Second, for a novel food material, whether the applicant is obliged to present the safety assessment for applying patent is still a disputed subject.^[534] A strict opinion argues that to apply a patent for a food material, it is necessary to present the safety assessment issued by the health department. This means the applicant shall apply an approval for food material according to Measures on the Safety Review of Novel Food Material and then apply for patent on the basis of officially assured safety. As argued by opponents, such a requirement is too burdensome for the applicant since the two administrative procedures are time consuming and thus discourage innovation. Therefore, it relies on the applicant to claim the safety in the description. Otherwise, there will be a negative review if the description lacks a safety statement. Comparatively, the second opinion is more practically applicable and closer to the purpose of the Patent Law, namely to encouraging inventions.

Third, as a remedy, it is also essential to mention the possibility of invalidat­ing a patent in the case that the patented food material is regarded as unsafe with newly proved evidence. As required in the Measures on the Safety Review of Novel Food Material, a novel food material shall be re-reviewed if a doubt is raised about its safety as science and technology develop or there is exist­ing evidence that shows that its safety is questionable. If the follow-up review confirms the safety issue with the patented food material, anyone can ask to invalidate the patent. Interestingly, the revised Food Safety Law has provided a co-governance principle to encourage all stakeholders and the public to take part in food safety assurance. Within this context, not only the reviewer for

granting patent rights but also anyone else can take advantage of invalidation to make sure of the safety of novel food material.

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