We previously discussed Japan Patent Office (JPO) examination guidelines on what is patentable as “medicinal use” in respect of “dosage and administration” of chemical entities. In this article, we shall look at the standard of JPO on the patentability of medicinal materials (cells, etc) derived from living organisms which are publicly known.
Although Patent Law of Japan (and Malaysia, in this respect) does not allow patents for methods of surgery, therapy or diagnosis of a human or animal body, it is still possible to obtain patents for certain categories of medicinal use of materials. Let us see some examples of allowable patents:
- Medicinal materials (cells, etc) derived from living organisms which are publicly known, but whereby a medicinal use is novel.
E.g., (Patent Claim) An implant material for treatment of cardiac infarction,which contains cell sheets consisting of A-cells. This is patentable if, from the state of the art as of the patent application filing date, it is not possible to predict that cardiac function is recoverable and the symptom of cardiac infarction is reduced by transplantation of A-cells, although it is publicly known that cell sheets are obtained from A-cells and that they are used as implant materials.The relationship between the A-cell and recovery of cardiac function should not have been known at the date of filing of the patent application and there is no motivation or suggestion for use of cell sheets consisting of A-cells for treatment of cardiac function.
- Medicine characterized in a medicinal use of cells specified by manufacturing process.
E.g. (Patent Claim) An anti-cancer agent comprising cells as an active ingredient obtained by the following process consisting of the steps of:
- culturing W-cells obtained from a human body in medium A containing 0.1–0.2 weight % of protein X for 5 to 10 hours and collecting them, and
- disseminating the collected cells in step (i) on an extracellular matrix Y,culturing them in medium B containing 0.1 – 0.2 weight % of protein 2 for 24 to 48 hours, and collecting them.
Such an invention is patentable if:
- it is found that the anti-cancer agent containing cells obtained by the process consisting of the steps (i) and (ii) as an active ingredient inhibited angiogenesis peculiar to a cancer tissue and diminished the cancer growth. This is patentable even though the use of the cells is known for conventional medicinal use (immunosuppression).
- the use of living cell lines for medicinal purposes is patentable provided it can be shown such use was not known at the date of filing the patent application. But the patent claims to be allowed need to be very specific in nature.
This article is intended only to provide an alert service on matters of concern or interest
to readers and should not be treated as legal advice on the issues discussed. For specific queries on IP matters, please contact us for further assistance.