The Japan Patent Office (JPO) has published a set of revised guidelines on 23rd October 2009 that deals with the patent office examination practice of medicinal invention specified by “dosage and administration”, and of an invention relating to a medical activity. This brief article will look at the former guidelines. We believe this advancement in patent granting procedure for medicinal inventions would have a bearing in the Malaysian patent grant practice.
Traditionally, a medical use invention of a compound or composition has been protected as a pharmaceutical composition or a therapeutic agent which is defined by an ingredient compound and a medical use thereof or as a diagnostic product. But any invention relating to a “medical activity” conducted by a medical professional, such as invention of a method for surgery, therapy or diagnosis of a disease in a human (or animal) was not considered as industrially applicable and therefore not patentable (similar situation under the Malaysian Patents Act).
However, there is an increase in worldwide research in advanced medical technologies. In response to these developments, the Japan Intellectual Property Strategy Headquarters set up the “Advanced Medical Patent Exploratory Committee” to recommend manners of patenting such technologies to JPO. On the basis of the recommendations, JPO published the new guidelines.
In the Examination Guidelines, a medicinal invention is regarded as novel when there is a difference between the invention and conventional medicine in application to a specific disease with a specific dosage and administration. “Medicinal Invention” means an invention of a product which is intended to provide a new medicinal use of a material, based on discovering an unknown attribute of the material. “Material” means a component used as an active ingredient, including a compound, a cell, a tissue and a chemical substance (or a group of chemical substances) whose chemical structure is not specified, such as an extract from a natural product, and a combination thereof.
“Medicinal use” includes an application to a specific disease in which dosage and administration such as dosing time, dosing procedure, dosing amount or administration areas is specified.
Examples of patent claims that are now acceptable as inventions in Japan:
- A therapeutic agent for asthma containing compound A wherein 30-40 µg/kg of compound A is orally administered to humans once per 3 months.
- A therapeutic agent for ovary cancer containing compound A as an active ingredient wherein 100-120 µg/kg of compound A is administered to the particular site Z in human brain.
Source: JPO
Note: Whether such patent claims would be considered patentable in Malaysia
is not clear as the Malaysian Patent Office has not issued any guidelines
in this area.
The Japanese guidelines would be an encouragement for pharmaceutical companies or even medical professionals to apply for patents for medicinal inventions if they discover an invention where dosing time, dosing procedure or area of administration and which discovery is not obvious. New practices in traditional medicine would also benefit from this development.
Please contact us if you require more details.
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