Andy Cairns - Access to Funding Liverpool SME Workshop
IP and Innovation Presentation Lang v2
1. 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. 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. 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. 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. 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
7. 7
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
8. 8
FUNCTION
AHS
PROGRAM
OR
SERVICE
disease
prevention
health
promotion
screening diagnosis intervention continuing
care
palliativepublic
health
CDM
rehabilitation
Knowledge Application & IP Management
FUNCTION
AHS
PROGRAM
OR
SERVICE
disease
prevention
health
promotion
screening diagnosis intervention continuing
care
palliativepublic
health
CDM
rehabilitation
disease
prevention
health
promotion
screening diagnosis intervention continuing
care
palliativepublic
health
CDM
rehabilitation
Health Technology Assessment and InnovationUNIT
Research/Invention Innovation Assessment Use Evaluation
10. 10
CERTAINTYOF
EVIDENCE
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
11. 11
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
12. 12
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.
14. 14
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
17. 17
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 (
18. 18
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/ex
ecution
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
Commercializati
on/
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
19. 19
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.
20. 20
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
21. 21
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
22. 22
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. 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
24. 24
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
25. 25
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
26. 26
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
27. 27
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
5
Unique technology
Substitute technology
Testing of the
invention
Production
skills/equipment
Pre-commercial term
of development
Marketing 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. 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. 29
0%
50%
100%
0% 50% 100%
Opportunity
Risk
Risk and Potential Opportunity Assessment Based on Critical Factors
0%
50%
100%
Risik ofak tor
REAL-TIME DOSE
RECONSTRUCTIO
N USING
DYNAMIC
SIMULATION AND
IMAGE GUIDE
ADAPTIVE
INTEGRATED
EXTERNAL BEAM
RADIOTHERAPY
AND MRI SYSTEM
