YUASA
AND
HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Oct 27-28, 2009
WIPO Pacific Conference on National IP Strategies for Development
Manila
Topic 2:
Formulation and Development of a National IP
Strategy: Needs Assessment VS. Needs Identification,
Formulating the Strategy Document:
Protection of Cutting-Edge Medical Technology in Japan
Shinjiro Ono
Yuasa and Hara
(Former Deputy Commissioner Japan Patent Office)

 Phase-1 Oct, 2003 – April, 2005
Task Force on the protection of Medical-Related
Activities – IP Policy Headquarters of the
Cabinet Office
Revision of Examination Guidelines – 2005
 Phase-2 Nov, 2008 – May, 2009
Task Force on the protection of cutting-edge medical technology
Final Report – May 29, 2009

Draft Revision of Examination Guidelines –
2009 August 6, 2009

Invitation for Public
Comments
1






– Major Debates
– Conclusion of the Task Force 2005

2

3

Members --All Ministers and 10 Experts from
Academic and Industrial Sectors
Chairman --Prime Minister KOIZUMI
Vice-Chairman --Chief Cabinet Secretary
Minister of State for Science and
Technology Policy
Minister of Education, Cultures,
Sports, Science and Technology
Minister of Economy, Trade and
Industry
4

Program Planning
IP Strategy
Headquarters
Draft
IP Strategic
Program
Consultation
Ministry of
Finance
Ministry of
Counterfeits
Sports,
Ministry of
Trade & Industry
Copyright
Patent/
Trademark
IP Strategic
Program
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(Prime minister cabinet office Task Force)
IP Strategic Program 2004 Needs identification
(1) Studying the Desirable Way of Providing Patent Protection for
Medical Treatment i) While giving sufficient consideration so as not to have a bad influence on medical activities that should be equally performed under trustful relationships between patients and medical practitioners, the GOJ will set up a forum for extensively discussing the treatment of medical activities under the Patent Law, from the viewpoint of driving the progress of useful and safe medical technologies that will contribute to raising the level of citizens’ health care, such as allowing patients to receive more advanced medical treatment. The GOJ will draw a conclusion early in FY 2004.
( Council for Science and Technology Policy, Ministry of Health, Labor and
Welfare, and Ministry of Economy, Trade and Industry )
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Member of the Council for Science and Technology Policy
President, National Cardiovascular Center
Chairman of board of directors, Kyowa Hakko Kogyo Co.ltd.
Professor, Graduate School of Medicine, Nagoya University
Attorney, Founding Partner
Professor, Aomori University,Faculty of Sociology and a commentator
Executive member of Japan Medical Association
Professor, Chiba University, Faculty of Law and Economics
Professor, Hokkaido University, Graduate School of Law
Director, AnGes MG, Inc. and a member of Intellectual Property Headquarters
Managing Director, Takeda Pharmaceutical Co.ltd. (Japan Pharmaceutical
Manufactures Association)
The “Task Force on the Protection of Patents of Medical-Related Activities” was established in Oct. 2003 under the Intellectual Property Policy Headquarters of the Cabinet Office (from Oct. 2003 to Nov. 2004.)
Experts from Ministry of Health, Labor and Welfare as well as Japan Patent
Office attended as witness
7


– Patent encourages innovations and investments in R&D
– Failure of patent protection discourages
Japanese industry from investing money to develop inventions relating to medical activities

– Patent is a monopoly preventing access to medical activities
8

 Patent Act of 1959 (JPL) Art. 32
–
–
–
–
–
Excluded from Patentability
(1) foods or non essential grocery items
(2) medicines and processes for mixing two or more medicines
(3) chemical substances
(4) substances to be produced by nuclear transformation and
(5) inventions liable to contravene public order, morality or public health.
 1975 Revision
– (1) (2) (3) removed from the exclusion
 1995 Revision
– (4) removed from the exclusion
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1960 1976.1
1980 1988.1
2000
“Substance Patent System” came into effect
“Term extensions for Pharmaceuticals
Patent” came into effect
R&D Expenditure
95.2 billion yen,
4.91%/sales in 1975
Number of No ｖ el Drug
6 drugs
R&D Expenditure
746.2 billion yen,
8.60%/sales in 2000
Number of No ｖ el Drug
32 drugs
10

 JPL Art. 29: Industrial Applicability
Case Law JPO Examination Guidelines
– An invention of a method for treating the human body or therapy and diagnostic method is not considered as being taken to be capable of industrial application.
 EPC Art. 52(4) Industrially inapplicable:
EPC 2000 (Dec, 2007); Art. 53(c) Exceptions to Patentability

(Up-stream limitation)
 US Patentable Subject matter
Section. 287(c): to immunize medical practitioners from an infringement suit
(Down-stream limitation)
11




Judgment of April 11, 2002
Case regarding the invention of “Process and device for optical representation of surgical operations”
Tokyo High Court upheld the JPO’s Board decision for rejection of patentability of an invention of medical method for not being capable of industrial application
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 Distinction between medicines/medical devices and medical treatment
 Possible risks for medical practitioners to be subjected to patent infringement liability without any statutory measures to immunize them from suit (The Patent Law does not provide such preventive measures)
 No choice but to consider that the Patent
Law does not recognize patentability of medical treatment and to deem the inventions involving medical treatment to be industrially inapplicable
13

 Agenda ( Needs Identification )
– Patentability of methods relating to medical activities in general
 Issues taken into consideration:
– Redefining the scope of medical methods, reflecting on the progress made in the areas of regenerative medical techniques, gene therapy, diagnostic methods, surgical robots, delivery systems, etc.
– Balancing the interests of the health science industry against the public interests (medical practitioners, patients, consumers, etc.)
14

 Argument of the Opposition
– An incentive by patent protection is not required for promoting medical technology.
“Medicine is a benevolent art.”  Medical activities are performed for relieving patients from diseases based on mutual trust between a doctor and a patient.
– Restriction on access to medical activities
– Possible increase in medical expenses
– More frequent litigation
– Conflict of interest
– Safety concerns
 Counter Arguments
15




What is the difference in the scope of claim relating to invention, between “Medical devices or Medicines” and “Process of medical treatment”?
Can we expect “Indirect Infringement”?
Can we expect “Indirect Infringement” in case of no “Direct Infringement” by immunization (Down-stream limitation)?
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(Final Report; Formulating the Strategy Document )
 Basic concept:
– Patent protection of medical activities appears to be premature.
– Patent protection, as an incentive to industries , is important, particularly in the fields of medical devices and medicines.
 Consensus:
– Techniques relating to an action of a medical doctor should be industrially inapplicable inventions (i.e. maintaining of the status quo).
– The patent protection of the following inventions should be made clear in the Examination Guidelines :
(1) methods for controlling the operation of a medical device
(2) techniques related to a method of generating new effects of medicines
17

Gist of Examination Guidelines (April 15th 2005)
A method for controlling the operation of a medical device
1. A method for controlling the operation of a medical device is industrially applicable as long as the function of the medical device is represented as a method.
2. The method including an action 2) influence 3) of a medical doctor and/or on the human body by a device is not considered an to be a method for controlling the operation of the medical device.
Medicinal Inventions
1.
A medicinal invention means “an invention of a product” of use inventions.
4) It is, therefore, considered to be industrially applicable.
2. A medicinal invention having a medicinal use specified by combination of medicines or by dosing interval and/or given dose is also industrially applicable, and its patentability is examined from two viewpoints: a compound (group of compound) and a medicinal use.
1) New Guidelines were made available to the public on April 15 th 2005
2) an action by a medical doctor to operate a device in order to provide medical treatment in accordance with a symptom, etc
3) an incision and/or excision of a specific part of a patient by a device, etc
4) In Japan, “a use invention" is an invention based on a discovery of a new method of using a product focused on a particular property of the product. As for a use invention in a medicinal field, it must be claimed as “an invention of a product.”
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 First and second medical use
“ An invention of a product” of use inventions
(product type claim: medicine)
 US:
Process Claim except new compounds
 EPC: Swiss type claim (Revision of EPC shall permit to protect a new medical use of a compound already known as a medicine without claiming of Swiss type claim);
EPC 2000 (Dec, 2007) same as Japan
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Comparison among the Trilateral Offices
Method for treatment of human body by surgery
-method for anesthesia
-method for surgery
Method for treatment of human body by therapy
-method for gene therapy
-method for radiotherapy
-method for dialysis treatment
- method of dosing
-method of stimulating heart by pacemaker
Diagnostic method Medical devices
(method for inspection/measurement )
-gene diagnosis
-endoscopy
-medical devices themselves
-method of producing medical devices
-method for
NMR inspection,
X-ray inspection, or blood-pressure check
（ getting only interim results for diagnosis ）
Medicines
-chemical substance
-medicinal composition for cancer therapy
-dosage form
-kit
-method of producing medicines
*a medicinal invention comprising;
(i) a compound, and
(ii) a medicinal use
*a medicinal invention having a medicinal use specified by;
(i) combination of medicines, or
(ii) dosing interval and/or given dose
-method for controlling -method for controlling -method for controlling the operation of a micro the operation of a the operation of a MRI operation robot system pacemaker device
-method for controlling the operation of a medical device
JP + JP
EP
US
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Method for controlling the operation of Medical Device
Method for controlling the operation of a medical device
An action of a medical doctor and/or an influence on the human body by a device are not indicated a moving, opening and/or closing of an moving elements
[the function of the medical device represented as a method]
OK a generating a pulse toward human body a detecting a signal from human body an action of a medical doctor
NG an influence on the human body
[A method for controlling the operation of a medical device]
A method for controlling an artificial eye system provided with an extracorporeal device………, comprising the steps of:
………, and transmitting the signal for use in the electrical stimulation to the electrode buried in the retina.
[A method for treatment of the human body by surgery or therapy]
A method for giving stimulus to a retina by an artificial eye system ………, comprising the steps of:
………, and transmitting the signal for use in the electrical stimulation to an electrode for retina to transfer to the retina, wherein stimulus of the picture information is given to the retina of the patient by the artificial eye system.
an influence on the human body by a device

Case 1: A new combination of effective components has a remarkable effect.
[Claim 1] An anticancer drug formulated by combining a compound A [publicly known] with a compound B
[publicly known].
anticancer agent
Ａ anticancer agent
Ｂ anticancer agent having a remarkable effect
Ａ
Ｂ
Case 2: Medicine adopting a specific dosing interval and/or given dose has a remarkable effect on a specific group of patients .
[Claim 1] A pharmaceutical composition comprising a compound A [publicly known] as an effective component for treatment of hepatitis C patient having an alpha-type genotype, which is administered at an initial dose of
5.0mg/kg to 10.0mg/kg, followed by a dose of 0.3mg/kg to 0.5mg/kg on alternate days.
A pharmaceutical composition for treatment of hepatitis C patient having an alpha-type genotype
α type administered at an initial dose of
5.0mg/kg to 10.0mg/kg, followed by a dose of
0.3mg/kg to 0.5mg/kg on alternate days
β type
γ type
δ type

23

Considering a Desirable Protective Approach in the field of cutting-Edge Medical Technology, such as iPSC Technology. Needs identification
 In FY2008, the GOJ will promptly launch a discussion on a desirable approach to providing appropriate patent protection in the fields of cutting-edge technology, such as iPSC technology, which is widely applicable to the medical field and for which international competition in R&D and in obtainment of intellectual property have been intensifying.
 From this discussion, the GOJ will draw a conclusion at an early date in light of the application of the Examination
Guidelines for patents revised in April 2005 and the trend of discussions on the protection of patents for cutting-edge medical technology in the international community .
24

The application of the Examination Guidelines
2005 for Patents revised in 2005-1;
April, 2005 – June, 2008
 A method for controlling the operation of a medical device; number of patents: 76
 Medicine adopting a specific dosing interval and/or given dose has a remarkable effect on a specific group of patients; number of patents: 0
 A new combination of effective components has a remarkable effect; number of patents: 1
25

The application of the Examination Guidelines
2005 for Patents revised in 2005-2;
April, 2005 – June, 2008
A method for controlling the operation of a medical device
Nationality of applicants
Technical fields
Japan foreign US
Apparatus for Chemo
Radiotherapy
Outside Artificial Organ
( Ex. Apparatus for Dialysis)
Method for Magnetic
Resonance Imaging
Others
13
3
2
21
1
9
10
17
1
6
4
12
14
12
12
38
The total 39 37 23 76
26

Current practice
New
○
○
Proposal clarification clarification
Example
[1]
Products
Use invention
Medicine with a specific dosing interval or given dose, having a remarkable effect
Manufacturing a medical product by utilizing raw material collected from a human being
Methods for measuring structures or functions of the human body*
Surgery or therapy and diagnostic methods on the human body
○
○
[2]

○
Newly
[3]
○
○ clarification
[4]

○ newly
[5]


Not appropriate
[6]
(*) for purposes other than medical ones
27

[1] (DDS: Drug Delivery System)
Thermo sensitive nano-particle anticancer agent
Local heating apparatus
28

[2] Composition comprising cultured mucous membrane cell for generative treatment of a cornea cultured mucous membrane cell
Regenerative treatment for a cornea before transplant 1 month after transplant
29

[3] Medicine adopting a specific dosing interval and/or given dose, having a remarkable effect
Original dose Every morning →
Standing 30 minutes before breakfast to avoid side effect
Sun Mon Tue Wed
Restrict patient’s life style
Thu Fri Sat
New dose
Once a week
Decreases side effect and improves a quality of life
30

[4] Method of Cell Inducing Differentiation and Purification
Inducing differentiation
Neuron stem cell
Hematopoietic stem cell
Mesenchymal stem cell iPS cell
Purification mixture Only neuron stem cell
31

[5] Method of removing blocked material in a blood vessel
(not patentable)
* using a catheter with two cutting blade
32

YUASA
AND
HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
- Thank you for your kind attention
- I would be pleased to answer any questions
- You may contact me at: ono-ch@yuasa-hara.co.jp
URL: http://www.yuasa-hara.co.jp
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