Reexamination Board (PRB) on this case provides the guidance for the judgment on whether the invention relating to embryonic stem cells is contrary to the social morality and shall not be granted the patent right or not.
The patent application (Application n° CN 03816184.2) under discussion, filed on July 11, 2003, with a claimed priority date as of July 11, 2002, was published on October 25, 2006. The Application relates to a system of components for generating glial cells in vitro, which uses primate pluripotent stem (pPS) cells or human embryonic stem (hES) cells as the raw material.
During the substantive examination stage, the Examiner made a final rejection for the reason that the application involves the use of human embryos for industrial or commercial purposes, which is contrary to social morality, and thus falls into the scope of the unpatentable subject matter as prescribed in Article 5.1 of the Patent Law.
The applicant filed a request for re-examination with the PRB. In the request the applicant amended the claims and further defined that said constructed cells do not include pPS cells and embryonic stem cells directly decomposed from human embryos or blastocysts. The applicant stated that the claims explicitly excluded pPS cells and embryonic stem cells directly decomposed from human embryos or blastocysts and thus do not involve the use of human embryos for industrial or commercial purposes. The applicant also argued that the use of constructed pPS cells is not contrary to social morality, and that cell lines originally derived from human embryos and the use thereof have already been accepted widely and protected by the patent rights. The cell lines of H1 and H7 used in the examples of the specification can be obtained through the commercial channels before the priority date, and it is not necessary to use the human embryos, therefore the claimed invention is not contrary to the social morality and should be granted the patent right.
The substantive examination department still held in the Note of Interlocutory Examination Opinion that constructed hES cell lines all need to use human embryos, destroy human embryos, thus involving the use of human embryos for industrial or commercial purposes and resulting in violation of social morality.
After the re-examination, the panel of the PRB revoked the Decision of Rejection and gave the following opinion: cell lines used in the invention belong to already constructed, mature and commercialized cell lines. In addition, the claims of the application explicitly exclude the related technical solutions of pPS cells and embryonic stem cells directly decomposed from human embryos or blastocysts. In short, the contents involving the use of human embryos for industrial or commercial purposes have been deleted from the application document, and only the contents that are related to constructed, mature and commercialized cell lines are maintained. Thereby, the application is not contrary to social morality as prescribed in Article 5.1 of the Patent Law and shall be granted the patent right.
Regarding the application of Article 5.1 of the Patent Law, the panel pointed out further that it is not suitable to trace, without limit, the source of the manner for obtaining the raw material. The raw materials used by the application are H1 and H7 of hES cell lines, they are constructed hES cell lines and can be proliferated infinitely in vitro. There exists approaches in the prior art to obtain such mature and steady cell lines, and it is not suitable to track down the manner for obtaining the first of such cell lines in the world.
Whether an invention related to embryonic stem cells is contrary to social morality and shall not be granted the patent right is a long-term dispute in the examination practice. The judging principle of the PRB on this case provides guidance for the examination practice of this category.
- The key issue for judging whether an invention in relation to embryonic stem cell is contrary to social morality is whether the invention is related to the use of human embryos for industrial or commercial purposes or not.
- The inventions in relation to the embryonic stem cells are also generally related to the optimized culture for the human embryonic stem cell lines, such as maintain, amplification, enrichment, inducing differentiation and modification method for hES cells. When the invention only relates to the already optimized culture of the hES cell lines and the hES cells are the constructed, mature and conventionally known cell lines, it is not suitable to reject the application only for the reason that obtaining such stem cells is contrary to social morality. The application belongs to this kind of situation.
- When the invention-creation is related to biological materials derived from human beings, tracing the source of the biological material will definitely lead to human body or human embryos. Therefore, it is not reasonable to limitlessly track down the manner in which the raw material was obtained. On the one hand, in order to limit the abuse of the human embryos, a cautious attitude to deal with inventions in relation to stem cells is correct. On the other hand, the intrinsic advantage of stem cells makes themselves to be a favourite for the basic research as well as medical treatment. Therefore, opening the patent protection for the invention relating to the constructed, mature and conventionally known stem cell lines can promote technology development and benefit mankind.