Topic 2: Topic 2: Formulation and Development of a National IP Formulation and Development of a National IP

Strategy: Needs Assessment VS. Needs Strategy: Needs Assessment VS. Needs Identification, Formulating the Strategy Document:Identification, Formulating the Strategy Document:

Protection of Cutting-Edge Medical Technology Protection of Cutting-Edge Medical Technology in Japanin Japan

Shinjiro OnoYuasa and Hara

(Former Deputy Commissioner Japan Patent Office)

Oct 27-28, 2009WIPO Pacific Conference on National IP Strategies for DevelopmentManila

YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING

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OutlineOutlinePhase-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 – 2005Phase-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

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Phase-1 OutlinePhase-1 Outline

IP Strategy Formulation in JapanRelated Policies (Needs Assessment)Historical BackgroundTokyo High Court DecisionCabinet Office Task Force Discussions

– Major Debates– Conclusion of the Task Force 2005

Examination Guidelines – 2005

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Rapid Progress of IP StrategyRapid Progress of IP Strategy

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Intellectual Property Strategy Intellectual Property Strategy HeadquartersHeadquarters

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

Chairman --- Prime Minister KOIZUMI

Members --- All Ministers and 10 Experts from Academic and Industrial Sectors

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IP Strategic ProgramIP Strategic Program Planning Planning

Ministry ofMinistry ofForeign AffairsForeign Affairs

WTO, WIPOWTO, WIPO

DraftDraftIP Strategic IP Strategic

ProgramProgram

DraftDraftIP Strategic IP Strategic

ProgramProgram

IP StrategyIP Strategy HeadquartersHeadquarters

Ministry ofMinistry ofHealthHealth

Medical, Medical, DNA…DNA…

Program Planning

Ministry ofMinistry ofFinanceFinance

CounterfeitsCounterfeitsMinistry ofMinistry ofEdu, Culture, Edu, Culture,

Sports, Sports, Science & Science & TechnologyTechnology

CopyrightCopyright

Ministry ofMinistry ofEconomyEconomy

Trade & IndustryTrade & Industry

Patent/Patent/TrademarkTrademark

IP Strategic IP Strategic ProgramProgram

IP Strategic IP Strategic ProgramProgram

Consultation

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(1) Studying the Desirable Way of Providing Patent Protection for Medical Treatmenti) 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)

IP Strategic Program 2004 IP Strategic Program 2004 Needs identificationNeeds identification

Patenting Inventions Relating toPatenting Inventions Relating to Medical ActivitiesMedical Activities

(Prime minister cabinet office Task Force)(Prime minister cabinet office Task Force)

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Member of the Council for Science and Technology PolicyPresident, National Cardiovascular CenterChairman of board of directors, Kyowa Hakko Kogyo Co.ltd.Professor, Graduate School of Medicine, Nagoya UniversityAttorney, Founding PartnerProfessor, Aomori University,Faculty of Sociology and a commentatorExecutive member of Japan Medical AssociationProfessor, Chiba University, Faculty of Law and EconomicsProfessor, Hokkaido University, Graduate School of LawDirector, AnGes MG, Inc. and a member of Intellectual Property HeadquartersManaging Director, Takeda Pharmaceutical Co.ltd. (Japan Pharmaceutical Manuf

actures Association)

A List of Members of the TaskA List of Members of the Task Force 2005 on the Protection of Force 2005 on the Protection of

Patents of Medical-Related ActivitiesPatents of Medical-Related Activities

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

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Related PoliciesRelated Policies

Forward-Looking Policies (Needs)– 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

Backward-Looking Policies– Patent is a monopoly preventing access to

medical activities

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Historical BackgroundHistorical Background 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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R&D Expenditure95.2 billion yen,

4.91%/sales in 1975Number of No ｖ el Drug

6 drugs

R&D Expenditure746.2 billion yen,

8.60%/sales in 2000Number of No ｖ el Drug

32 drugs

The effects of “Substance patent System” The effects of “Substance patent System” in 1976 on Pharmaceutical Industry in 1976 on Pharmaceutical Industry

1960 20001976.1 1988.1

“Substance Patent System” came into effect

“Term extensions for Pharmaceuticals Patent” came into effect

1980

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Medical ActivitiesMedical Activities 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)

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Judgment of April 11, 2002 Case regarding the invention of “Process an

d 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

Tokyo High Court DecisionTokyo High Court Decisionin the suits against the JPO’s Board in the suits against the JPO’s Board

decision for rejectiondecision for rejection

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Tokyo High Court Decision-2Tokyo High Court Decision-2

Reasons 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

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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.)

Cabinet Office Task Force 2005 Cabinet Office Task Force 2005 Discussions Discussions Needs assessmentNeeds assessment

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Major Debates (Major Debates (Needs AssessmentNeeds Assessment))

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

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Why are process claims of Why are process claims of medical activities really needed?medical activities really needed?

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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Conclusion of the Task Force 2005Conclusion of the Task Force 2005 (Final Report; (Final Report; Formulating the Strategy DocumentFormulating 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

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A method for controlling the operation of a medical device1. 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 action2) of a medical doctor and/or an influence3) on the human body by a device is not considered to be a method for controlling the operation of the medical device.

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, etc3) an incision and/or excision of a specific part of a patient by a device, etc4) 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.”

Gist of Examination Guidelines (April 15th 2005)

Medicinal Inventions1. 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.

Examination Guidelines 2005Examination Guidelines 2005

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Medical Use Claim of substances or Medical Use Claim of substances or compositions in Japancompositions in Japan

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 anesthesia

Method for treatment of human body by　 therapy

Diagnostic method

-gene diagnosis

-endoscopy -method for gene therapy

-method for radiotherapy

-method for dialysis treatment

- method of dosing

-method of stimulating heart by pacemaker

(method for inspection/measurement )

Method for treatment of human body by surgery

-chemical substance

-dosage form

-kit

-method of producing medicines

-medical devices themselves

-method of producing medical devices

Medical devices

-method for NMR inspection, X-ray inspection, or blood-pressure check

（ getting only interim results for diagnosis）

EP

-method for surgery 　　　　

Medicines

JPJP

US

+

-method for controlling the operation of a MRI device

-method for controlling the operation of a pacemaker

-method for controlling the operation of a medical device

-method for controlling the operation of a micro operation robot system

*a medicinal invention having a medicinal use specified by; (i) combination of medicines, or (ii) dosing interval and/or given dose

*a medicinal invention comprising; (i) a compound, and(ii) a medicinal use

-medicinal composition for cancer therapy

Examination Guidelines 2005Examination Guidelines 2005

Method for controlling the operation of a medical device

a detecting a signal from human body

a generating a pulse toward human body

[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

[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.

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]

an action of a medical doctor

an influence on the human body

OK NG

Method for controlling the operation of Medical DeviceMethod for controlling the operation of Medical 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].

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. α

type

anticancer agent

A pharmaceutical composition for treatment of hepatitis C patient

having an alpha-type genotype

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

βtype

γtype

δtype

Ａ Ｂ

ＡＢ

anticancer agent

anticancer agent having a remarkable effect

Medicinal InventionsMedicinal Inventions

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Phase-2 OutlinePhase-2 Outline

Nov, 2008 – May, 2009

Task Force 2008 on the protection of cutting-edge medical technology –

IP Policy Headquarters of the Cabinet Office

Final Report – May 29, 2009

Draft Revision of Examination Guidelines – August 6, 2009

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IP Strategic Program 2008IP Strategic Program 2008 Considering a Desirable Protective Approach in tConsidering a Desirable Protective Approach in the field of cutting-Edge Medical Technology, suche field of cutting-Edge Medical Technology, suc

h as iPSC Technology. h as iPSC Technology. Needs identificationNeeds identification

In FY2008, the GOJ will promptly launch a discussion on a In FY2008, the GOJ will promptly launch a discussion on a desirable approach to providing appropriate patent protectidesirable approach to providing appropriate patent protection in the fields of on in the fields of cutting-edge technology, such as iPSC tcutting-edge technology, such as iPSC technology,echnology, which is widely applicable to the medical field a which is widely applicable to the medical field and for which international competition in R&D and in obtainnd for which international competition in R&D and in obtainment of intellectual property have been intensifying.ment of intellectual property have been intensifying.

From this discussion, the GOJ will draw a conclusion at an From this discussion, the GOJ will draw a conclusion at an early date in light of the application of early date in light of the application of the Examination Guithe Examination Guidelines for patents revised in April 2005delines for patents revised in April 2005 and and the trend of dithe trend of discussions on the protection of patents for cutting-edge mescussions on the protection of patents for cutting-edge medical technology in the international communitydical technology in the international community. .

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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

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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

Technical fieldsNationality of applicants

Japan foreign US

Apparatus for Chemo Radiotherapy

13 1 1 14

Outside Artificial Organ ( Ex. Apparatus for Dialysis)

3 9 6 12

Method for Magnetic Resonance Imaging

2 10 4 12

Others 21 17 12 38

The total 39 37 23 76

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Proposal of the Report 2009

ProductsManufacturing

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

Use invention

Medicine with a specific dosing

interval or given dose,

having a remarkable

effect

Current practice ○ ○ ○

New ○ ○ ○ ○ ○

Proposal clarification clarification Newly clarification newlyNot

appropriate

Example [1] [2] [3] [4] [5] [6]

(*) for purposes other than medical ones

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[1] (DDS: Drug Delivery System)

Thermo sensitive nano-particle anticancer agent

Local heating apparatus

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[2] Composition comprising cultured mucous membrane cell for generative treatment of a cornea

before transplant 1 month after transplant

cultured mucous membrane cell

Regenerative treatment for a cornea

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[3] Medicine adopting a specific dosing interval and/or given dose, having a remarkable effect

Sun Mon Tue Wed

Thu Fri Sat

Original dose Every morning →Standing 30 minutes before breakfast to avoid side effect

Restrict patient’s life style

Decreases side effect and improves a quality of life

New dose

Once a week

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[4] Method of Cell Inducing Differentiation and Purification

Inducing differentiation

Purification

Neuron stem cell

Hematopoietic stem cell

Mesenchymal stem cell

mixture

iPS cell

Only neuron stem cell

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[5] Method of removing blocked material in a blood vessel (not patentable)

* using a catheter with two cutting blade

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Thank youThank you- Thank you for your kind attention- Thank you for your kind attention

- I would be pleased to answer any questions- I would be pleased to answer any questions

- You may contact me at:- You may contact me at:ono-ch@yuasa-hara.co.jpono-ch@yuasa-hara.co.jp

URL: http://www.yuasa-hara.co.jpURL: http://www.yuasa-hara.co.jp

YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING