Dr. Ravi Dhar Summarizes Technology Transfer India 2016

BRIEF SUMMARY OF TECHNOLOGY

MANAGEMENT IN INDIAN ACADEMIC

ORGANIZATIONS

Ravi Dhar, Ph.D., f-STEM

in.linkedin.com/pub/ravi-dhar/18/71b/895

(Email: [email protected])

Technology Trasnfer in India & Loopholes 1

IPR Workshop, JIPMER, Puducherry

Sept. 10, 2016

Modified on 20/9/2016… 9/20/2016

http://www.google.co.in/url?url=http://marksmanhealthcare.com/category/medical-devices/&rct=j&frm=1&q=&esrc=s&sa=U&ved=0ahUKEwjrv4z8o9XOAhWMP48KHd2HCmUQwW4IMDAN&usg=AFQjCNHm6GemPQQ270SO4iMKEF_W3vBeTg

Acknowledgements

Technology Trasnfer in India & Loopholes

2

DBT

BIRAC

ICMR

NII

NIH

USDA, JHU, NYU

Dr. M.K. Bhan

BU {Drs. Gerald Keusch, Ashley Stevens; & Altaf Lal}

Kellogg’s Business School, Center for Biotechnology, North Western University

Nature Biotechnology, International Journal of Technology, Bio-Materials, Nature Nano-technology , MIT Technology Review, MedGadget

Various Websites (USPTO, IPO, EPO) , Books, NYT

Several 0ther Colleagues

9/20/2016


World is full of Problems or Challenges

in Health, Agriculture, Environmental sectors

which need solution/s

Finding Solutions would lead to

Innovative Ways or Products or

Technologies

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Technologies are Generated by an

Act of Mind

The commodity Developed or produced is

thus called as

Intellectual Property

The legal rights to the property or products

developed

is called as Intellectual Property Rights (IPR)

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Intellectual Property Rights (IPR)


5

Property or products like drugs, vaccines, medical devices, biochemical reagents (for bio-medical research etc.), ‘produced’ as a result of creativity or an act of mind comprise IPRs.

National & International Treaties & Regulations govern, ownership of such property or products

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Due to Legal Rights

IPRs generate greater interest to

find Solutions to Problems

& develop Technologies

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Products or Inventions or Technologies:

An example

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( Courtesy image:National Science Foundation, USA)

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9/20/2016 Technology Trasnfer in India & Loopholes 9

Relationship between Technology

Development & Commerce


Problems Big or Small

Need Solutions

Finding Solutions would lead to

innovative Products &

with Related Education &

Mentoring lead to

Tech

no

logie

s/Solu

tions C

om

merce

Commercial Activity,

Entrepreneurship & Jobs

9/20/2016


Technology Development Needs

Careful Thinking & Funding


R&D in Academia or Industry

Basic & Applied Research

Funding

(Public or Private or

Venture Capital, Angel Investors)

Both Applied or Basic Research result

in Innovative, Sustainable Product Development for

Public Consumption

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13

Innovation/ Proof of Concept/ Product

Validation/Product Development/Sale

Deliberate on Royalty issues

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http://www.google.co.in/imgres?imgurl=http://3.bp.blogspot.com/_yKVZJyKmgJ8/ScCoL05FkuI/AAAAAAAAAIg/__vfJSGvC7o/s320/smiling-blueberry-cartoon-face-thumb2776085.jpg&imgrefurl=http://anbie.com/data/happy-catoon-face.html&h=300&w=300&sz=31&tbnid=Agre8cOh1D7KZM:&tbnh=116&tbnw=116&prev=/images?q=smiling+face+cartoon&zoom=1&q=smiling+face+cartoon&hl=en&usg=__r7Cx_FmnngA4WWEtVP_xt5t9wDo=&sa=X&ei=o4n8TOfQO8KqrAfvo7TECA&ved=0CBwQ9QEwAQ

Innovation & Enterprise Individuals/

Universities/ Key Players

Institutes/

Industries

Invention/ Technology

Investment

Enterprise/Start up Company

Royalty Reap the Fruits of Innovation if

the product is commercialized


14

Contribution to Economy

IP

Protection/

Patents

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How do we generate

Intellectual Property?

Research

Legal Protection/Patent


Practical leads/

PoC/

Invention/Product

File a Patent/

License the

Technology; or

Sell Technology

Develop & Manufacture

Product (commercial activity)

Company/

Enterprise

En

trep

ren

eu

rship

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Innovators desire or demand:

Legal protection for innovations;

Compensation + Awards to keep their

innovative spirit going

Governments of various countries agreed to do the

needful

Net Result:

These regulations keep the “fire in the genius going”

Technology Trasnfer in India & Loopholes 16 9/20/2016


Innovations should be: Purposeful

Affordable

Useful for an individual or society

Sustainable

Easy to use

Safe to use

Easy to manufacture

Approved by Society

Should have component of Corporate Social

responsibility

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Technology Management & Transfer A complex process involving series of well thought of steps:

1. Research

2. Pre-Disclosure

3. Invention Disclosure

4. Assessment

5. Protection

6. Upscale

7. Make a Start-up Company or Use Existing Company

8. Licensing

9. Marketing & Commercialization

10. Revenue Generation

11. Royalty Sharing or Charity?


18

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19

Invention

TTO Disclose Invention to Patent Office (PO)

Review & Approval at PO

Protect Intellectual Property (Patent)/Grant

Find Potential Licensee/Industrial Partner

NDA/CDA/ License

Upscale/Prototype/Clincal or Field Trials

Production/ Marketing & Commercialization

Royalties Tech

nolo

gy M

ana

gem

ent Pro

cess

Linear

Model

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Technology Management Process 1. Idea/Proof of Concept : Technical Assessment

2. File a Patent (Prior Art Search: Novelty/non-Obviousness/Utility) / (Publish Manuscript)

3. Grant Process at Patent Office : Be patient

4. Find an Industrial Partner : Be Patient or float your Start-up Company

5. MoUs_NDA : TTO or Attorney or Agencies

6. Licence , DA : TTO or Attorney

7. Exchange Know-how_MoUs : You and Industry

8. Demand Signing Amount : You + University

9. Furnish Data (Importance of Record Book): You + Industry

10. Freedom to Operate Analysis : TTO/ Patent Attorney

11. Industrial Partner will Validate Data>Upscale>Pilot run

12. Milestone Payments : You + University

13. Industry will Manufacture, Commercialize, Market Product

14. Distribution of Royalty on Sales : You + University + Industry



What India Needs to become more

Innovative?

Innovations need platforms as they are emerging in the

world’s most advanced countries, and India has the

potential to capitalize on this platform as well.

In fact, our performance to date has been low in certain

disciplines . Nonetheless, we observe a gradual change.

Our innovative_commercialization record has been weak; we have a limited

ability to harness risk capital; we have a shortage of critical, highly skilled talent;

and our slow regulatory approvals process could limit the pace of development.

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Technology Trasnfer in India &

Loopholes 22

Types of Inventions/Technologies

From Social angle (Social Impact)

Social : (=cheap, easy to use; “Jugaad”?)

From Scientific angle (Technical Impact)

Incremental: (=small but useful innovations)

Disruptive : (=great path-breaking inventions)

Futuristic : (=as used by space agencies)

From Business Angle (Business Impact)

Sustenance of economy

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Role of Freedom to Operate (FTOs) Searches

in a

Research Area

Why do we Search? To retrieve information which is required to answer specific questions

How we Search?

What do we Search?

Identify Keywords or write the Key string

Any document or information related to questions


Why do we search patents?

o Is a given invention patentable?

o Do the patent rights already exist for a given

product/process?

o Is a given patent valid?

o Which technologies exist in a given field of

technology?

o Who is active in a given field of technology?


• Is a given invention (claimed in a patent application) patentable?

Patentability Search

• Do patent rights exist on which a given product risks infringing?

Freedom-To-Operate Search

• Is a given patent valid?

Validity/Invalidity Search

• Which technologies exist in a given field of technology?

• Who is active in a given field of technology?

State-of-the Art Search


Technology Management

&Transfer


27

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Proof of Concept Legal Protection

Validation In house Experimental Production

MARKET SALES

Components of Technology Management

Clinical Trials/Field Trials

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Technology Transfer Process Technology

(A Vaccine/Therapeutic Agent/GM Crop etc)

(Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical Evaluation (Toxicity + Animal & Human Studies)>

Invention Disclosure

Assessment/ Screening

Patent Protection

Licensing & Monitoring

Technology Transfer

(Active Pharmaceutical ingredient> Drug Product(Dosage & Delivery Systems)> Analytic Methods> Stability)

Product Development & Commercialization

Revenue & Monitoring

(http://www.nii.res.in/faculty-06/RaviDhar.htm)


29

University/

Institute/

Organization

Start-up Company

/Entrepreneur or a

Big Company

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Technology Transfer Support Systems

is essential

Technology Transfer Offices in Indian Academic

Environment


31

R&D Organizations

CSIR

ICMR

IARI

DRDO

DBT

BIRAC

CSIR Tech

IISC, Bangalore

Universities (?)

ISRO

DRDO

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Disposal of Technology


32

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Disposal of Technologies

We may get a Patent for a Technology or License it to an

Industry after :-

Evaluation : Apply “Go- No Go –Kill” concept (on the

basis of maturity/market requirement etc)

Upscale

License after Valuation

Production

Monitor

Sales & Royalty


33

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Technology Valuation


Loopholes 34

Acthar Gel for infantile spasms ?

9/20/2016

Value Grid mapping of Technology /

Product Portfolios


Loopholes 35 9/20/2016


Technology Transfer Strategies in Indian Institutions TT Component Model-I Model-I Model-III Model-IV Model-IV

Technology Y Y Y Y Y

Invention Disclosure Y Y Y Y Y

Invention

Assessment

? ? ? Y Y

Patent Protection Y Y ? Y N

NDA N N ? Y Y

DA N Y Y Y Y

Licensing Agreement Y/? Y Y Y Y/N

Revenue deals Y/? Y/? Y/? Y Y

Sharing Know-how ?? ? Y Y Y/N

Monitoring N ? N Y Y/N

Technology Transfer Y Y Y Y Y

Product Development N N N Y Y

Commercialization N N N Y N

Revenue collection Y Y* Y Y Y

Y= Yes; N= No (RD_JIPMER_2016)

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Deficiencies in Technology Management

Half hearted approach to Technology Management or

Transfer Due to deficiencies in Skilled manpower in

Universities or R&D organizations

Indian Academic Organizations should develop a central

Directory to log in the title of their Technologies for further

Action or support they need

We should learn from ISRO/ DRDO/ Private Pharmaceutical

or Biotech Industries

Challenging Areas in Tech Management


38

IP Mining

FTOs

Technology Mapping

Infringements

Licensing

Institutional IP policies

How to gel Public and Private effort ??

IP rights are being felt as a burden to innovation?

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Improved Quality of Science needs: 1) Big Budgets & Political will 2) Pool of Skilled Manpower 3) Technology Platforms 4) Intense & meaningful Collaborations

9/20/2016

Organizations with Integrated Innovation & IP Management have High Quality (economically

valuable) Patent Portfolios

Patent Quality Impact on Performance

(+)

High Potential

(++)

Innovation

Leaders

Losers

(-)

Activists

(--)

(low) (high)

Patents/R&D Expenditure Ernst, 2008; Chicago


40

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Example: Technology Transfer in Private

R&D Sector (2016)

Micronet (spin-off), University of Munich Inst. Of

Immunology (2012) Multiple Myeloma Drug (MMD)

Candidate

Boehringer Inc (CT) further develops MMD as

BI_836909

(drug targets B-cell maturation antigen)

Amgen given rights for Clinical Development, Transfer

Manufacturing & Global Regulatory Filing

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Market

Research is

Very Important

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Loopholes 44

Thank you

Questions? ([email protected])

9/20/2016

Health & Medicine

Dr. Ravi Dhar Summarizes Technology Transfer India 2016