Intellectual Property Information

Japanese Guideline Change regarding Medical Activities

The possibility of Patent protection for medical related inventions has recently become more flexible.

Established under the Patent System Subcommittee of the Industrial Structure Council Intellectual Property Committee, the Medical Activity Working Group (WG) has discussed how methods related to Medical Activities are applied to the Patent Law. The WG has recently published the draft report as an outcome of the discussion over the past year, on November 2004.

The draft prepared by WG has recommended that methods for manufacturing medicines or medical materials from human biological materials (e.g. blood, urine, skin, hair, cell, tissue) are to be the subject for patent protection even if these methods would be directed to the manufactured medicines or materials which would be returned to the same person.

Based on this recommendation, the Examination Guidelines would be expected to be amended to include the methods for manufacturing medicines (e.g. hematopoietic drug, vaccines, gene recombinant drugs) or medical materials (e.g. cultured epidermal sheets and artificial bones) from human biological materials which have been removed from a human body. The following is summary of the changes reported in the recommendation.

First of all, medical activities by doctors would not become the subject matter for patent protection under the Japanese Patent Law. However, the protection for the invention regarding Medical Activity is expanded for the following two categories.

The first category is "operation methods of medical apparatus" which represent how medical apparatus works functionally or systematically for certain purpose such as functional imaging method of f-MRI (Functional-MRI) or PET (Positron Emission Tomography) involving multiple chronological steps). Since "operation methods of medical apparatus" may be patentable as a method invention or system invention, the scope of the protection would be broadened.

The second category is "methods for deriving new advantageous effects from medicines specifically for the purpose of production and distribution of medicines" characterized by new combination of medicines, or dosage or dosing interval of medicine (such as a method of treating Hepatitis C infection with the combination of interferon alpha and ribavirin, which has potent synergistic effects). For this second category, for the time being, these types of inventions could be protected as a product invention. In the near future, certain types of method invention would be also protected.

Recently, on Feb 24, 2005, the Japanese Patent Office announced the preliminary new guideline related to Medical Activities regarding the above described two categories. The JPO prepared some examples, which meet their proposed new guideline. For the first category, "operation methods of medical apparatus", if claims were rewritten so as to exclude the term such as human body or a part of human body from claims, these amended claims may be patentable as operation methods of medical apparatus. For the second category, it is up to whether the specific combination of two drugs or the specific amounts of usage of the drugs show superior or unexpected effect compared with the known product or usage. If these specific usages can provide the superior or unexpected effect, these usages of drugs can be protected as patents. These revisions of the Guideline would be effective for pending applications when the JPO publishes the final guideline on the web in the near future.