Managing and Exploiting

Health Innovation and

Intellectual Property at AHS

For a Better Tomorrow

Dr. Thach Lang, PhD, LLB

Health Technology Assessment & Innovation

Research, Innovation and Analytics Division

2

Overview

Innovation and IP in healthcare

Processes, pathways and framework development for

evaluation and advancement of innovation and IP

Strategies, valuation and metrics in assessing IP and

innovation to inform business development

and decision making

Disruptive Innovation

Case Studies

Questions

3

What is innovation in healthcare?

• “People creating value through the implementation of new ideas” J. Wycoff, Co-Founder, Innovation Network

• The design, invention, development and/or

implementation of new or altered products,

services, processes, systems, organizational

structures, or business models for the purpose of

creating new value for customers and financial

returns- Advisory Committee on Measuring

Innovation in the 21st Century Economy(2007)

• An invention is a new discovery (i.e. IP) new to the world or new to the industry - new knowledge

• Intentional introduction and application of knowledge new to healthcare to benefit patients and health system

4

Intellectual Property • Refers to creations of the mind: inventions;

literary and artistic works for which exclusive

rights are recognized

• E.g. Materials, technologies, products, data,

IT, software, know-how, patents, databases,

copyright, trademarks, design rights,

expertise, trade secrets, copyright

• AHS IP Policy (established Mar 2011) and

Procedure Manual

• RIA Division responsible for IP administration

in accordance with Policy

• Support and foster a culture of knowledge,

innovation, and research to benefit patient

health, healthcare delivery and effective

business operations

5

Why is innovation and IP important to healthcare

• HI continues to be driving force in the quest to balance cost (sustainability) and

health care quality

– Critical component of business productivity and competitive survival

– Contribute to health system sustainability, efficiency and health outcome

– Technological innovations present vast opportunities for 1) product innovation –

the introduction of new types of goods and services for the external market and

2) process innovation – enhancement of internal production processes for

goods and services

• IP is the economic engine of progressive countries, particularly in knowledge-based

economies

• IP rights can drive job creation, economic growth, innovation, and investment and is

a key element in long term thinking for the future

– Benefits associated with IP and innovation development – but there are risks:

strategize, evaluate, due diligence, value money

6

Ranking of Canada Based On Innovation Factors

• Canada ranked 11th overall:

– R&D intensity: 24th (Israel 1st)

– Productivity: 11th

– High-tech density: 16th (US 1st)

– Researcher concentration: 13th

– Manufacturing capability: 32nd

– Tertiary efficiency: 1st

– Patent activity: 23rd (Taiwan 1st)

Bloomberg's Global Innovation Index, Jan. 2014

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Context of AHS for Health Innovation

AHS is focused on improving quality and sustainability of the health system

but technology commercialization is considered ancillary activity

Health innovation has potential to contribute to health system performance

and improvement

The process for those wishing to partner with AHS to advance health

innovation through research and development (R&D) is largely unclear, and

supportive mechanisms have yet to be implemented

R & D activities are different activities from those in which a company with

a mature technology would engage in----- those process are established by

and delivered through AHS CPSM

Health innovation developments are different from those processes

established for technologies considered for public funding at the provincial

level

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FUNCTION

AHS

PROGRAM

OR

SERVICE

disease

prevention

health

promotion screening diagnosis intervention continuing

care

palliative public

health CDM

rehabilitation

Knowledge Application & IP Management

FUNCTION

AHS

PROGRAM

OR

SERVICE

disease

prevention

health

promotion screening diagnosis intervention continuing

care

palliative public

health CDM

rehabilitation

disease

prevention

health

promotion screening diagnosis intervention continuing

care

palliative public

health CDM

rehabilitation

Health Technology Assessment and Innovation UNIT

Research/Invention Innovation Assessment Use Evaluation

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Research and

Development

Experimental

Technology

Innovative

Technology

General Use

Obsolescence/

Replacement

Use

Time

Technology Diffusion in Health Care

HTR

HTA

HTI

Innovation

Disinvestment

Obsolescence Licensing

IP protection

10

CE

RTA

INT

Y O

F

EV

IDE

NC

E

EFFECTIVENESS

Evidence certain

Effective

Uncertain evidence

Not effective

Evidence certain

Not effective

Uncertain evidence

Effective

Promising

technology

Ineffective

technology

Technology

to be

adopted

2. Reassessment

4. Innovation

3. Access with

Evidence Development

5. Education &

Dissemination

Certainty of evidence and effectiveness

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Innovation: Risks and Uncertainties

Clinical benefit

Safety and effectiveness over the short and long term when used in the „real

world‟

Value for money

cost effectiveness or utility placed on health gains and the opportunity costs of

those gains

Adoption and diffusion

Eligible patients, anticipated uptake rates, whether the

technology is a replacement for an existing technology or an

addition to current practice

Affordability

Overall cost to the health system, taking

into account any savings that may be

realized

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Dimensions of Innovation in Healthcare

• Environmental and operational dimensions motivate or

affect the introduction/adoption of healthcare innovation

• Operational dimension: e.g. improvement of clinical

effectiveness, efficiency, aging population, nursing

shortage, patient satisfaction, profitability, patient safety,

improved quality and cost-effectiveness.

• Environmental dimension: e.g. physician acceptance,

organizational culture, regulatory, policy, ethical, IP,

legal, resource, infrastructure, partnerships.

13

External Ecosystem for Health Innovation

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AHS Virtual Network of Innovation Centers

and Health Innovation Network

Health Innovation Network

AHS organized

TOR, Mandate, Vision,

Regular monthly meetings

Advancing Health Through

Technology and Collaboration

Identify challenges and

develop pathways to advance

innovation

Members: AHS (HTAI, CPSM)

AH, IAE, AITF, AIHS, GRH,

MEDEC, IHE, Ad hoc as necessary

i.e. Ivey International Centre for

Health Innovation, GE, Major

projects

15

How Can Innovators Work with AHS?

16

1

2

3

4

Innovation Portal Process

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Objectives of the Innovation Portal

Provide a focal point for driving health innovation: identification, prioritization, selection,

implementation, and evaluation of health innovations.

Use both a push and pull model for encouraging well-evidenced technologies and innovations

in response to the health needs of Albertans, the strategic priorities of AHS, and economic

prosperity (creating health and wealth)

Provide capacity and infrastructure for AHS Strategic Clinical Networks to address their major

transformational challenges and priority areas

Provide expertise and guidance to front-line clinicians and staff in rural and urban settings, and

co-ordination of similar innovation work/interests occurring province wide.

Identify and prioritize clinical needs within AHS that should be targeted with innovative

approaches and knowledge application

Identify relevant resources to support these innovations and provide expertise.

Identify and conduct early assessments of new and emerging health technologies.

Determine whether a full Health Technology Assessment (HTA) is needed or whether relevant

information can be contextualized to AHS from existing partners (

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IP Process: from Conception to Commercialization

Point of Entry for

Innovation/Tech

• HTAI, Innovator

• Knowledge exchange, inventiveness

Disclosure of Innovation/IP

• Innovator, HTAI, Research Office, Legal

• ROI

• Disclosure

IP Assessment/

Evaluation

• HTAI, Consultation

• Literature review, search report, patentability opinion, copyright/trademark registerability

• Market/end user/needs assessment, freedom to operate opinion

Resourcing, Recommendatio

n, Approval

• HTAI, Innovator, TDO, Program area, CPSM, Funder

• Briefing, project charter, business plan, KT/KM, advisory

Support, Management, Due Diligence

• HTAI, Legal, Consultant

• FTO, infringement report, response to OA, patent specification, letters of support, grant/funding IP planning/strategy, assignments, POA, IP documentation/execution

IP Administration/

Management

• HTAI, Legal, Leaders office, Finance, External

• Invoicing, tracking, audit, budget

• Patents, trademark, copyright, etc

Reduction to Practice/Implem

entation

• Innovator, HTAI

• Prototype, model, testing, validation, refinements

Commercialization/

Broker

• Innovator, Stakeholders, Leaders

• Commercialization plan: OEM application strategy, licensing/selling strategy, partnering/JV, spin off creation, combination, seeking funding

Hold/Stop

• Leaders Office, HTAI, Program area

• Notification, Summary of finding

AED

• HTAI, AH, EAE, SCNs

HTA

• AH, IHE, University,

SCNs

Invoice requisition/Entry

• HTAI

Review

• HTAI

Approval

• Leaders office

Payment

• Finance

Monitoring/tracking/

record keeping

• HTAI, Legal

Budgeting/reporting/dashboard

• HTAI, Leaders office, Audits

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Outputs, Outcomes, and Impacts • Clinical Adoption: % of projects that have reached the point that they have received regulatory approval

for human use.

• Commercialization: % of projects that have reached the point that they have a licensing agreement with a company or they have formed a new company (Spin-offs).

• Number of incubated companies, innovations, industry partnerships, technology transfer initiatives, collaborative agreements, research contracts

• Enabled Funding: % of projects that have been able to generate some follow-on funding.

• Patents: % of projects that have at least one issued patent

• Publications: % of projects that have at least one peer reviewed article

• Academic Career Advancement: % of projects that report promotion or career/educational advancement of at least one investigator

• Pre-commercial procurement: Stimulated the development of future products by helping inform industry about what is needed and how best to develop and launch new technologies.

• Front-end engagement: Improving communication with AHS frontline staff to identify unfulfilled needs and engaging AHS experts and industry specialists from the start of the innovation process.

• Foster innovation: Driven innovation by providing a space in which collaboration with experts and access to insider-knowledge is easily accessible, thereby reducing the risk to innovators and strengthening the foundations for successful development. . Provision of innovation awards on an annual basis.

• Fast-track new products: Reduced the time taken to develop useful technologies and accelerating new products to market in record time.

• Maximize private sector investment: An open innovation model has stimulated innovators and industry partners to invest in technological development.

• Demonstrate success: Provided a successful model for open innovation for AHS and potentially for the public sector more broadly and demonstrated how public procurement can be leveraged to help meet Alberta/Canadian innovation requirements and stimulate Alberta/Canadian industry.

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HTA & Innovation – Opportunities

Support an evidence-informed decision model for managing health

technologies, innovation and IP development

Identify, prioritize, assess innovation and IP for their market potential

and value

Investigate innovative alternatives for current health technology

Promote effective and appropriate uptake of technologies

Validate effectiveness of promising health innovation (field evaluations,

trials and pilot projects)

Protect interest and security of IP on behalf of AHS, researchers,

collaborators to maximize value of investments for the benefit of

patients and AB health system

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Key Stakeholders of the Healthcare Innovation Process

Stake Holders Needs, Wants & Expectations

Physicians and Other Care Givers Improved clinical outcomes,

improved diagnosis and treatment

Patients Improved patients‟ experience,

improved physiological well-being,

reduced waiting time, reduced

delay

AHS Enhanced efficiency of internal

operations, cost, increased

productivity and quality and

outcomes improvement

Innovators

Profitability, improved outcomes

Regulators/Other organizations

Reduced risks and improved

patient safety

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Health Partnership Framework

AH, IAE, AHS, AIHS for WG

Pilots & Trials Early Development

/ Prototype

Market Entry /

Procurement

Discovery /

Invention

Clinical

Practice

Adoption

Basic

Research

Health

Partnership

Framework

Pre-Commercial Development Phases

Translational Research – “Bench to Bedside”

Adapted from HPF

23

Alberta Health Research-to-Practice Continuum

Pre-Commercial Development Phases

Pilots & Trials Early

Development /

Prototype

Market Entry

/

Procurement

Discovery /

Invention

Diffusion /

Clinical

Adoption

Basic

Research

AIHS

AITF

Researchers / Campus Alberta

Translational Research – “Bench to Bedside”

Technology Transfer / Business Accelerators

AHS

Major role

Minor or Future role Adapted from HPF

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Disruptive Innovation Case Study 1: LINAC-MR Project

• RT MR guided radiation therapy

• Potential to change the way

radiotherapy is delivered

• AHS owner of IP has a responsibility

to deliver the LINAC/MR to serve

the health needs of Albertans

• Market valuation, prototype 2 in

development

• Phase 2/3 of the project

development, specifically focused

on clinical validation and

commercialization

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LINAC-MR Patent Portfolio

INTEGRATED EXTERNAL BEAM RADIOTHERAPY AND MRI SYSTEM

US PCT CA EP CN JP

MAGNETIC ASSEMBLY AND METHOD FOR DEFINING A MAGNETIC FIELD FOR AN IMAGING VOLUME

US PCT CA EP CN JP AU

RADIATION THERAPY SYSTEM

US PCT CA EP CN JP AU

IMAGE GUIDED RADIATION THERAPY SYSTEM AND SHIELDED RADIOFREQUENCY DETECTOR COIL FOR USE THEREIN

US PCT CA EP CN JP AU KO

REAL-TIME DOSE RECONSTRUCTION USING DYNAMIC SIMULATION AND IMAGE GUIDE ADAPTIVE

RADIOTHERAPY

US PCT CA

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LINAC-MR High-level Process and Commercialization

Plan

Assessing the value: What is the value of the LINAC MR intellectual property?

Risk mitigation:

Can the Linac MR IP be commercialized without infringing on IP rights of others

Commercialization strategy

Deal generating

Financial Valuation of IP:

•Market, income, cost

approaches

•Valuation conclusion

•Freedom to operate assessment

•Infringement opinion

•Re-examination of competitor patents

•Validity opinion

•Upfront costs

•Milestones

•Royalties

•R&D cost sharing

•Equity

•Ongoing Management, eg. Co marketing, ongoing

development

•IP maintenance, protection

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Legal status

0

1

2

3

4

5

Legal position of

strength

Patent term remaining

Breadth of claim

Geographical coverage

Legal proceedings

Monitoring against

infringements

Enforcement means

Patent status

Technology

0

1

2

3

4

5Unique technology

Substitute technology

Testing of the

invention

Production

skills/equipment

Pre-commercial term

of developmentMarketing value

Production of

infringing copycat

products

Identifiable infringing

products

Dependent on licence

agreements

Finance

0

1

2

3

4

5

Future cost of

development

Cost of production

Investment intensity

Business output

maintainability

Contribution to

company profits

Financial capacity to

cover renewal fees

INTEGRATED EXTERNAL BEAM RADIOTHERAPY

AND MRI SYSTEM

REAL-TIME DOSE RECONSTRUCTION USING

DYNAMIC SIMULATION AND IMAGE GUIDE

ADAPTIVE RADIOTHERAPY

Market conditions

0

1

2

3 4

5 Marketing options

Competitive/substitut

e products

Life expectancy

Attainable ultimate

sales price

Potential extra

turnover Market growth rate

Potential licensing

revenue

Knowledge of

commercial

opportunities

Permit/licence

requirements

INTEGRATED EXTERNAL BEAM RADIOTHERAPY

AND MRI SYSTEM

REAL-TIME DOSE RECONSTRUCTION USING

DYNAMIC SIMULATION AND IMAGE GUIDE ADAPTIVE RADIOTHERAPY

Radar Profiles of Two Patent Families: Overall view of Assessment

Factors

28

-

5

3

,

Correlation between patent and

company business strategy

Part of core-technology areas

Licence or sales agreement

Restricting competitive

development

Ensuring "freedom to operate"

Image building

Winning new markets

Securing existing markets

INTEGRATED EXTERNAL BEAM RADIOTHERAPY AND MRI SYSTEM

REAL-TIME DOSE RECONSTRUCTION USING DYNAMIC SIMULATION AND IMAGE GUIDE ADAPTIVE RADIOTHERAPY

Patents Strategic Positioning and Role as Legal Instruments and

Assessment of Financial Value

29

0%

50%

100%

0% 50% 100%

Opportunity

Ris

k

Risk and Potential Opportunity Assessment Based on Critical Factors

0%

50%

100%

Risik ofak tor

REAL-TIME DOSERECONSTRUCTION USINGDYNAMICSIMULATION ANDIMAGE GUIDEADAPTIVE

INTEGRATEDEXTERNAL BEAMRADIOTHERAPYAND MRI SYSTEM

30

Other Innovations: Medical Titration Application

for HF

Heart

failure

31

A mobile decision tool for clinicians

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Innovation: Request and Forms