Transcript Document

Innovation @ VCOM
Advancement in
healthcare is enabled
by Innovation
Topics
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Michael Miller Background
VCOM-CCI Alliance
How Commercialization Works
Policies and Procedures
Cleveland Clinic Resources Available
Michael Miller Background
• BS, MS Math & Physics
• 30+ years experience in development and
commercialization of high tech
• Fortune 500 companies, startups
• Technology Business Management Consultant; Mentor
• High Tech Business Founder, CEO, CIPO
• Virginia Tech Intellectual Properties
• Economic Development Commission, Workforce
Investment Board
• Technology Columnist for Valley Business Front
• FATHER OF JESSICA MULLER
Cleveland Clinic
• 4th largest hospital system in US
• 2nd largest group medical practice in US
(Mayo is #1)
• >40,000 employees, mostly in Cleveland
• 3,000 staff physicians, 1,500 residents
• 120 specialties and subspecialties
• ~4 million patient visits per year
• ~100,000 admissions
• #1 for Cardiac Care for past19 years
Cleveland Clinic Innovations
• Started in 2000 to commercialize
inventions by Cleveland Clinic Inventors
• 66 startups, $750M equity investment
• 450 technology licenses
• 2,200 patent applications; 525 issued
patents
• Cleveland Clinic Healthcare Innovations
Alliance formed in 2010
Cleveland Clinic Healthcare
Innovation Alliance
• The Healthcare Innovation Alliance is a
program to manage the innovation and
commercialization functions for hospital
systems, academic institutions and
corporate partners across the country. We
leverage the size and capabilities of the
collective Alliance to improve the visibility
of innovative products and to expedite
commercialization.
Cleveland Clinic Healthcare
Innovations Alliance
Cleveland Clinic Healthcare
Innovations Alliance
VCOM MISSION
The MISSION of the Edward Via College of Osteopathic Medicine
(VCOM) is to prepare globally-minded, community-focused
physicians to meet the needs of rural and medically underserved
populations and promote research to improve human health.
To foster a culture of faculty growth and institutional excellence
through Annual review and research on new developments in
medical education, new delivery models and technology; and
Support for faculty research, innovation, and scholarly work in
the areas of biomedical, clinical, educational, public health and
health policy research.
To advance scientific knowledge through medical research.
Priority 1: Biomedical Research
Priority 2: Clinical Research
Priority 3: Educational Research/Osteopathic Principals and Practice
Unique Position
VCOM is uniquely qualified and positioned to introduce
innovation into Osteopathic Practice:
• Will soon be the largest osteopathic college in the US
• Novel educational process and practice opportunities
• Target underserved populations
• Low budgets mean improvisation
• Improvisation is innovation
• Access to the entire Appalachian region
• Access to Cleveland Clinic Innovation Alliance
Medicine is Innovation
Bloodletting surgical instruments
Former President
George Washington
Medicine needs Innovation
Medical Innovations
Medical Innovations
Medical Innovations
Medical Innovations
Medical Innovations
Important
pharmaceutical
for control of
blood pressure
Unintended Consequences
• Why do Americans eat so much beef?
Medical Innovations
• Physician in Apalachicola, FL
• Researched tropical diseases
• Outbreak of malaria and
yellow fever in 1841
• Theory of “Bad Air”
• Patented ice-making machine
to create cool air for patients
John Gorrie
What about the beef ?
• His ‘air conditioning’ invention did not cure
malaria, but was used to create refrigerated
rail transport cars
• Allowed (for the first time) butchered beef to
be transported from the stockyards in the
midwest to consumers in eastern cities
• Oh, and we got air conditioning in our
houses, too.
Innovation Process
Innovation does not happen for its own sake; the
point is to push the innovations out to the public
where they can be used for the good of all.
That means that somebody has to make money.
(Not) The Process
Yay! A Product
You have a brilliant idea
Magic
Happens
See you in Sweden!
The Real Process
You have a
brilliant idea
Horrendous
amounts of money
Yay! A Product
FDA
APPROVAL
You have forgotten
the original idea
Even more money
Money
Where
does the
money
come
from?
Investors
Intellectual Property
protection and
management
minimizes risk to
investors, making our
innovations more
attractive than others
Intellectual Property
Article I, Section 8
“The Congress shall have power to…promote the
progress of science and useful arts, by securing
for a limited time to authors and inventors the
exclusive right to their respective writings and
discoveries”
Intellectual Property
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Distinct from tangible items
More abstract than other types of property
Products of the mind
Types
• Patents (Title 35, U.S. Code)
• Trademarks (Title 37, U.S. Code)
• Copyrights (Title 17, U.S. Code)
• Trade Secrets (State law)
Intellectual Property
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Patents – inventions of functional and ornamental design
• design, plant and utility
• provisional applications
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Trademarks – identifies source or origin of product
• words, brand names, slogans, graphics/logos
• e.g., Nike logo, “We bring good things to life”, VIOXX
• should seek federal registration (®)
• use ™ for non-registered marks
Intellectual Property
▪ Copyrights – literary and artistic impressions or arrangement
• protects medium from copying by others
• identifies author’s specific expression
• e.g., articles, videos, computer programs
• protection is automatic; use © with year and name of owner
▪ Trade Secret – protection from unfair appropriation of
information
• any information (e.g., software, formulas) that: provides
competitive advantage; not available to public; and treated as
confidential
Patents
▪ Utility
• demonstrated use or proposed use one of “ordinary skill
in the art” would believe
▪ Novelty
• not fully described in one patent or publication > 1 year
before you filed (the “prior art”)
▪ Non-obviousness
• whether one skilled in the art at the time of the invention
would have had a rational basis to combine prior art to
reach the claimed invention
Patents
▪ Enablement
• one of ordinary skill can carry out the invention without
“undue experimentation”
▪ Best mode
• provides best known way of making and using the invention
when application was filed
Patents
Patents are not
technical
publications,
they are legal
documents
US Patent 5,255,452
Method and means for creating anti-gravity illusion
US Patent 5,433,036
Method exercising a cat
Patenting
Provisional
Application
Filed: $2-4K
Office Action #1
Received: Response
Filed: $2-4K
Nonprovisional
Application Filed:
$7-10K
12 Months
Office Action #2
Received: Response
Filed: $2-4K
20-30 Months
PCT International
Application Filed $4-5K
18 Months
National Phase
Applications Filed:
$25-30K
20-30 Months
Notice of Allowance
Received: Issue Fee
Paid: $2K
Continuation
US
Application
Patent
Filed (?)
Issued
6 Months
National Phase
1st Office Action
Received: Response
Filed $3-4K
12 Months
6 Months
National Phase
2nd Office Action
Received: Response
Filed $3-4K
12 Months
6 Months
3 Months
Regionalized
In EP
6 Months
EP, JP, AU, CA
Notice of Allowance
Received: Issue Fee Paid:
$4K
Foreign Patent
Issued
VCOM Process
IDEA
DISCLOSURE FORM
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Potential Protection?
Requires further research
Marketing/Licensing
Abandon
EVALUATION
ACTION
PLAN
IP Policy
*Watch for an update to be signed in near future
1. Inventor
discloses Ideas
and assigns to
VCOM
2. IP Office
manages
protection and
marketing
3. License
revenues split
50/50 between
Inventor(s) and
VCOM
The IP Office will do all the heavy lifting
Cleveland Clinic Resources
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Innovations Staff
Alliance Partners
Cleveland Clinic Lerner Research Institute
Taussig Cancer Center
Medical Device Solutions (MDS)
In Conclusion…
Working together,
we can make sure
VCOM innovations
are managed so
they have the best
chance to make a
difference in the
practice of medicine