Dr. Ravi Dhar on "Technology Transfer: an overview- 2014"

22.11.2012 RD_BIRAC_THSTI_IPR 1

An overview

on

Technology Transfer

(Part-I)

Ravi Dhar, Ph.D., f-STEM

([email protected])

28.10.2014

16/4/2014 RD_AAU-Gauwhati_October-2014

Resource

Acknowledgements

NIH PubMed

Scientific Community across world

Memorial Sloan Kettering Cancer

Center

DBT

BIRAC Library Service

NII

Various Websites

Nature Biotechnology

& other Journals

Biotech News (DBT)

Healthcare Biotechnology, CRC Press

GHI & OTT, Boston University

OTT, NIH

2

Resource Acknowledgements

• Nature Biotechnology

• J. Commercial Technology

• Dr. Ravi Dhar: (www.biospectrumindia.com/biospecindia/news/156942/a-bill-promises)

• LESI

• NII/ BU/NIH/MSK

• BIRAC

• Various websites

16/4/2014 3 RD_AAU-Gauwhati_October-2014

http://www.biospectrumindia.com/biospecindia/news/156942/a-bill-promises






Technologies:

Drug Molecules/ Vaccines/ Self disposing

Stitches/ Medical Devices/ GM Crops

Glybera formally became the first gene therapy to

be approved in a regulated market, as the

European Commission gave the rubber stamp to

the treatment for the ultra-rare inherited disorder

lipoprotein lipase deficiency (LPL) (November,2012)

Therapeutic Antibodies/Disease testing kits/ Pace

maker

Stem Cells used for carrying toxic drugs for cure

of Brain cancer


Quote on Technology-

"This 'telephone' has too many shortcomings to be seriously considered as a means of communication.

The device is inherently of no value to us." [Western Union internal memo, 1876]

(http://darrel.knutson.com/jokes/quotes/misquotes.html)



Industrial Revolution

Knowledge Revolution

“Technology transfer is the process of

developing practical applications of the

results of scientific research which are easy

to handle, are of societal relevance & are

affordable”.

Conceptually the activity has been practiced for many years. In

ancient times, Charka, Archimedes or Arabian technologies were

notable for applying science to practical problems.

However, in the present times, the volume of research is very high, so are the

failures (e.g., Vioxx) which should be kept in mind”


Technology transfer is the process by which basic

science research and fundamental discoveries are

developed into practical and commercially relevant

applications and products.

Technology Transfer personnel evaluate and manage

invention portfolios, oversee patent prosecution,

negotiate licensing agreements and periodically review

cooperative research agreements already in place.

Part of the technology transfer process involves the

prosecution of patents which is overseen by the national

Patent and Trademark Office.

Individuals with advanced degrees in the biomedical

sciences are needed to review and process patents in

the biotechnology field.

Source: Unknown


Forms in which Knowledge is transferred:

General Information 17%

Specific Information 56%

Procedures/Practice 27%

Hardware Objects 28%


Basic Science Research Fundamental Discoveries

Commercially

Relevant

Applications


Innovation Individuals Universities Institutes Industries Invention/ Technology Investment Enterprise

Royalty Reap the Fruits of Innovation


Relevance in Current Global Scenario Requirement of people friendly technologies

for health care etc. Growth of biotech institutes

Increase in number of skilled & semi-skilled people Increase in international & national collaborations



Technology Transfer Process

New Drug Molecule/Vaccine/Therapeutic Agent (Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical

Evaluation (Toxicity + Animal & Human Studies)>

Invention Disclosure

Assessment/ Screening

Patent Protection

Negotiation Licensing & Monitoring

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

Product Development & Commercialization/Marketing

Revenue & Monitoring

Technology Transfer Process Research gives rise to a Technology

Pre-Disclosure



Protection

Marketing to Find or Form A Licensee

Existing Business* *Form Start-Up Business/Company

Licensing & Monitoring

Commercialization


Deduct Expenses & A Part Reinvested in Research & Education

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



India

Technology Scenario in India

Historic Pre-independent India Post Independent India


Technology Transfer in India (Historical)

Life Philosophy : Vasudeva Katumbham (the universe is my home; concept of selflessness)

Technologies in ancient India: Kajal; Ashoka Pillar; surgical methods & tools; concept of “ 0 “ etc.

Documentation poor or eroded !!

Let us change now!


Evolution of Innovations in India (Recent) Three Key Players (1907 - 2014):

Industry Tata Iron & Steel(1907) Hindustan Aeronautics(1940) First IBM imported(1961) Indian Railway Reservation System(1987) Software Development (1986) Issuance of H-1 Visas to Indian’s

Universities Thomson Engineering College, Calcutta, Bombay, Madras(1947) IISc Bangalore(1911), C.V. Raman gets Nobel Prize (1930) IIT (1949), Computer Society of India(1965), ERNET (1986)

Government Telegram(1951), Railways (1953) Atomic Energy Commission(1948) APSARA(1956), SRO(1961) Automation Committee Report(1972) SLV Launch(1980), PSLV Rocket(1994), Moon mission (2008) SW Technology Parks(1991), PSVL, Mars Mangalyaan (2014) Biotechnology Revolution (1998 onwards)


Protection of Inventions: Pre-independent

India

Technology dissemination inhibited/ plugged by modifying the Labor Welfare Rules in British India - 1942


Post Independent India

o It takes little while to build up resources

o Affordable Drugs o Patent Laws of 1970 o Lack of Funding in S&T sector

o Agriculture was a priority

o Governance problems


Post Independent India (Recent)

Public research – Quest for self reliance. Military, health care, agriculture … Socialist economic policy within a democratic political framework…..

Central control.. State production – control of private production. No focus on technology transfer. Change of direction in 1991…


Effect of Economic growth (I)

24 years of successive growth phase Successive upward movement in technology application Access to global technologies accelerate “in- licensing” in several sectors. Engineering, chemicals, life science products, mining and metals.. significant technology up gradation. Combined efforts of public and private sector.


Current Status (I)

India has many things to do as it gets in the frontline of economic powers – one of them is accelerating technology transfer process and mechanism

Narrow the distance between today’s reality and tomorrow’s potential.


Private sector Research (I) Size limits commitment to Research.. 1991 policy allows global private investment in research Joint ventures stimulate technology transfer Indian companies with licensing track record known for accelerated research investment. Myth that technology sourcing will limit in-country capability is broken.. India Inc., accesses several global technologies in frontier segments, many from global public research enterprises.


Biotech Sector (I) National Biotech Policy National Policy of Human Clinical Trials National/ State Tech Parks & Incubators Policy on Stem Cells National Biotech regulatory Authority?? ASSOCHAM Delhi Declaration 2006 Improved Sales Tax Laws Efforts for One Window Clearance!

(www.cerna.ensmp.fr/Documents/AM-JR-MHZ-BiotechReport.pdf)



Cena_hand.pdf


Black Hole Rips a Star; Courtesy : NASA


(Source: Nature Biotechnology)

Biotech Clusters in India Bangalore Hyderabad Ahmadabad Delhi Pune


Current Hub Of Biotech Activity in India - Bangalore


Western India : Revenues US $ 800 million Aurangabad : Agri-/bio-manufacturing;

Mumbai : Bio-pharmaceuticals & Stem Cell Research;

Ahemdabad/ Baroda : Agri-biotech, Bio-pharmaceuticals, Enzymes,

Bio-information & Contract Research

Pune : Agri-biotech, Bioinformatics, Bio-processing,

Stem Cell Research & Vaccines

Southern India : Revenues US $ 600 million

Chennai : Bioinformation, Bio-pharmaceuticals,

Genomics, Marine Biotech. 48 Firms

Hyderabad : Vaccines

Mysore : Bio-diesel Bangalore : Industrial Biotech

Northern India : Revenues US $ 130 million

Delhi/ Gurgaon/ Noida : Agri-biotech, Bio-fuels, Genomics

Lucknow : Bio-information & Bio-pharmaceutics 48 Firms

115 Firms

120 Firms


Emerging Trends in Research Models(I)

Indian S&T strength Trends in technology development Enabling mechanisms Emerging segments for technology leadership Research models – cross country, cross functional Contract and collaborative research


Enhanced level of risk taking in research (I)

Positive change to risk averse mindset 80s and 90s- demonstrate Indus entrepreneur success in silicon valley – 6% of total value come from indus entrepreneurs.. India joins global consortium with significant funding and long term commitment …. (telecom, public health(AIDS), genomics, environment)..


Have we discovered Original Drug Molecules ? A) Negative Attitude: Generally ‘NO’ few years ago! Why ! (Chalta Hai Attitude) ? B) Positive Attitude: 10 out of 60 molecular or protein structures of

genomes of infectious diseases solved in India

Ranbaxy Dr. Reddy’s Biocon Panacea (5-6 Drug Molecules for FDA approval in USA : Progress) ????


First Indigenous Non-Chemical Entity First Homegrown NCE (New Chemical Entity): Name : Balaglitazone (DRF: 2593) – a Drug Properties : Anti-type 2 Diabetes Drug Jointly developed by : a) Dr. Reddy’s Laboratories (India) b) Rheoscience (a Dutch Pharma Co.) (“The Times of India, New Delhi, India; August 2nd, 2007)

2012: Issues??????


The future as we perceive (I)*** India will be among the major out-licensing destinations. Focus on cutting edge research – telecom, aerospace, information technology, applications, human health, biotechnology, natural resource management…. Global collaborative research will be the focus. Public research will complement private research with resources and basic research capabilities. Technology transfer will be augmented through responsive, accountable technology management organs. Global investment will drive Indian research for global good. 22.11.2012 RD_BIRAC_THSTI_IPR 41

The future as we perceive (I)(Contd)

India will a strong destination for in-licensing and out-licensing Public and private resources will complement future research efforts International investments will drive technology transfer growth Ethical, responsible and value based technology management will drive economic growth.



Think Big

How to Protect Inventions ?


Secrecy

Secure

data

Strengthen

Technology

Importance of Proof of Concept

Before demonstrating proof of concept (POC)- Low value Once POC demonstrated – product value increases


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 Upscale License Monitor Royalty


Showcase your Technologies to the market Participate in Trade Shows Organize Trade Shows Publish Articles Write Technology available in business journals Advertise new inventions in web based market places to expose people to availability Arrange conferences to highlight scientific & technology transfer achievements


Technology Valuation


Value Grid mapping of Technology / Product Portfolios


Traditional Technology Valuation Cost Method Industry Standard Royalty Rates Discounted Cash Flows Relief from royalty Decision trees Additional Valuation Considerations: Citation Analysis Technology Strength Innovation Cycle Time Technology Cogency Sustainability in Opposition


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



Technology Mapping/Transfer

Identify Organization

Identify Technology

Identify Industrial Partner

Negotiate

Transfer to Industry

Negotiate

Follow up on a technology

- Maintain close rapport with the inventor - Update your database on invention disclosures - Understand the modifications - Be in close touch with industry - Identify the players in commercial sector


Protection of Innovations Patenting

Confidential Disclosure Agreements (CDAs) Licensing

All of the above


Patents Novelty Inventive step Enablement :- no requirement of “undue experimentation” Industrial Applications


Technology Transfer Process Research

Pre-Disclosure



Protection

Marketing to Find or Form A Licensee

Existing Business* *Form Start-Up Business/Company


Commercialization


Reinvest in Research & Education


22.11.2012 RD_BIRAC_THSTI_IPR 58 Source: http://www.rti.org/pubs/WFU_TTreport.pdf

16/4/2014 59 RD_AAU-Gauwhati_October-2014

Level of

Maturity

of Technology

Is Essential for

consideration for further

Development by a

Licensee

Technology Screening/ Evaluation Technology Maturity Competing Products Competing Patents Competing R & D Market Barriers Commercialization Strategy Considerations Potential Targets (V. Imp.: Outsourcing only under Strict Confidential Agreement)


Technology Transfer Process Technology

(A Vaccine/Therapeutic Agent/GM Crop/Medical Devices etc)

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



Patent Protection


Technology Transfer

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

Product Development, Production & Commercialization


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

16/4/2014 RD_AAU-Gauwhati_October-2014 61

University/ Institute/

Organization

Established or

Start-up

Company

/Entrepreneur or

a

Big Company

Technology/Innovation 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-

5. up Company

6. MoUs_NDA : TTO or Attorney or Agencies

7. Licence , DA : TTO or Attorney

8. Exchange Know-how_MoUs : You and Industry

9. Demand Signing Amount : You + Industry+ University

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

11. Freedom to Operate Analysis : TTO/ Patent Attorney

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

13. Milestone Payments : You + University

14. Industry will Manufacture, Commercialize, Market Product

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



Value of Technology (Drug/Vaccine/Medical Device/GM Crop)

Proof of Concept

Untested Product/

Animal or Field Trials

Product Level(Low)

High Category

Concept/HighValue

Low Category/Low Value

Tested Product /

Human Clinical Trials

Phase I

Product Level (Better)

Value Low

Value Preposition

Debatable

Value Debatable??

Higher Value

Preposition

Field Tested Product/

Human Clinical Trials

Phase III

Technology Transfer Agreements

MoUs : Memorandum of Understanding

CDAs : Confidential Disclosure Agreements

MTAs : Material Transfer Agreements

IIAs : Inter-institutional Agreements

CRADAs : Coop. Research & Develop. Agreement

(sponsored research agreements)



Technology Transfer Offices

Technology Transfer Offices

Organizational Structure


Technology Transfer Offices Different Models India: DRDO, Delhi NII, Delhi CSIR, Delhi IISC, Bangalore U.S.A. BU NIH Stanford MIT NYU SUNY


Deficiencies in the Current Tech Transfer System/ Offices - Need of a Data Bank for our Patents & Technologies - Learn how to Identify & Evaluate technologies - Promote commercialization of these technologies - Faculty and students should foster an entrepreneurial environment - Least interactions between the research community, corporate and financial communities at the moment - Absence of a Regional Technology Transfer Capital Finance Pool of the of the participating organizations/countries; and - Invest assets in venture capital partnership and co-investment opportunities as per requirement of the region. - Build capacity to train personnel in Technology Transfer Issues - Understand the conflict of interest issues - Manage technologies generated at participating organizations


Restructuring the current Technology Transfer Offices Change in mind set Technology transfer office should be separated from institutes so as to function independently People with multi-skilled capability need to run the show Decentralize


Capabilities of the Staff in Modern Technology Transfer Offices Patience & Good Attitude People friendly Capability to multitask Capacity to maintain confidentiality Should understand science Should understand legal implications Should have capacity to sit for long hours on computer searches



Support Groups For

Technology Transfer

Framing Technology Transfer Groups for Support

India Government support : DBT, CSIR, ICMR, IARI Private Partners e.g. : Sathgaru, Skyquest

U.S.A. !!! AUTM !!!


National Knowledge Commission

(“Be recognized as a player in the creation, application and dissemination of knowledge”)

*******

National Innovation Foundation (more than 100 technologies registered from India & Abroad)


Global Aspects of Technology Transfer

The impact of WTO-TRIPS on developing countries Update on Bayh-Dole and its impact on development of useful health technologies** The role of compulsory licensing and parallel trade in biotechnology diffusion Key issues in ensuring availability of health products in developing countries International treaties and technology transfer Case studies from developing countries Barriers for technology transfer to developing countries New research methods for analyzing technology transfer Technology transfer for bio-terrorism


Corporate Technology Transfer Debates Technology Used for Import Substitution

•Interest of MNCs : Price & Accounting Problems •Restrictions on export •Gave rise to Indian Patent Laws of 1970 •However, in Medicine we still see Significant Import Substitution

Technology used for Export •Interests Aligned – both want best technologies •Dominant pattern with Globalization •Laws of 1970’s disappeared

(http://www.who.int/intellectualproperty/events/en/JohnBarton.pdf)


Public Private Partnerships Question of Survival Question of Self Esteem Some of us are inquisitive Some of us genuinely want India to progress PPP is sensible to utilize resources of both groups


Developed World Public Sector

Developed World Private Sector

Developing World Private Sector

Developing World Public Sector

The Public Private Partnerships

The New Paradigm

(http://www.who.int/intellectualproperty/events/en/JohnBarton.pdf)


BIRAC

Organizational Structure (as in BU) Technology Transfer Protects intellectual property: Patenting; marketing of technologies; and negotiation of licenses with industry or faculty start-ups. Innovation and Entrepreneurship Advice, guidance and support to those in the research community exploring the possibility of starting a new company. Business Incubation Offers early-stage companies state-of-the-art office space, laboratories and a host of support services for launching new technology ventures. Corporate Business Development Seeks to establish partnerships with industry around the creation and development of Institute or Universities’ applied technologies. Venture Capital Investments Invests Institute assets in top tier venture capital funds, makes co-investments in early-stage companies and raises capital for Institute start-ups. (http://www.nii.res.in/faculty-06/RaviDhar.htm)


http://www.bu.edu/otd/transfer/index.html

http://www.bu.edu/otd/innovation/index.html

http://www.bu.edu/otd/incubation/index.html

http://www.bu.edu/otd/development/index.html

http://www.bu.edu/otd/vc/index.html


Possible Organization for Developing

Technology Transfer Office

in

Academic Environment

for India

Director/ Head

Technology Transfer (Identify an Invention for Protection)

Entrepreneurship &

Business Incubation

Business Development &

Venture Capital

International Technology

Related Collaborations

Technology

Licensing

Assistance of Legal Experts

(India & Participating countries)**

Creation of Technology Bank on

Health/Agriculture/Environment/

Aqua/ Industrial Technologies

Technology Location/

Detection & Evaluation

Sensitization:

Workshops & Training Programs

Subject

Expert

Committees

Technologies from

Universities/Institutes (DBT Funded)

Administrative Offices

at X/ Y/ Z


RD

/2008


Technology transfer Office – India

Separate Office

Separate Officer

Secrecy & Protection of Data

Technology Transfer Policy

Inventorship issues Did the person : Contribute specific ideas that resulted in development Contribute more than labor to one or more of the inventive or technically significant features of the invention Make practical and/or concrete suggestions that contributed to the invention? Provide a specific design or experimental improvement that made the invention operable? Conceive an inventive step or part of the invention that you can identify? Have some role in the final conception of an invention as it is (will be) patented? If answer to one or more questions is “yes” the person is an inventor otherwise he is not an inventor

Other issues: In spite of the fact that a person answers “yes” to the following question, he/ she is not an inventor:- Did his ideas serve as a general goal or objective of the research? Were you retained or employed to reduce the concept to practice? Did you contribute ideas while the invention was being developed, but those ideas don’t contribute to the invention in it’s final form or as disclosed in the patent application


Licensing

Demonstrate the Proof of Concept Network for Commercialization Negotiate Fix Royalties Pay Taxes Enjoy Life


Role of Licensing Office (contd.)

What should not be done ( !!)

- Analysis of prior art - Preparation of Patents - Detailed marketing studies - Preparation of business plans - Calculation of Royalty


Issues in licensing Standstill agreements

Field of use

Scope of agreement

Sub-licensing considerations

Structuring of indemnities


Negotiating Licenses: Issues Determining when/what to negotiate

Strengthening walk-away points and avoiding argument dilution

Detecting and defeating lies

Managing concessions

Value creating and value sharing


Effect of Global Alliances & Current Indian Biotechnology Scenario Warrant Modifications of our of our Technology Transfer Offices

Indian Bio-Tech Market (2007) : US $ 2 Billion (2015) : US $ 20 Billion


Technology Transfer Office is no more in a Room or a Building

Example: JEV vaccine NII + Panacea India Example: (www.meningvax.org)

Meningitis vaccine for Africa [PATH/ WHO+ CDC, UNICEF, MSF, World Bank+ African holders][Price $ US 0.40 per dose] - Dutch Company : to produce PS (protein conjugate vaccines) - NIH, USA : develop conjugation method - Serum Institute of India : to provide TT & manufacture vaccine - Rotavac Technologies related to Agricultural Produce/ DuPont India/GM crops



If India has to change we should integrate!*

Optimization of Resources & Virtual Organizations (Pool Resources from different countries and help each others) DNDi (TB + other) : Drugs for Neglected Diseases Initiative

AERAS : Global TB Foundation (Bill & Melinda Gates) MMV : Medicines for Malaria Venture (1999) VDP : Vaccine Development Program

IPM : International Partnerships for Microbicides (2002)

FIND : Foundation for Innovative New Diagnostics (2003)

BVGH : BIO Ventures for Global Health

PIPRA : Public Intellectual Property resources for Agriculture


What do All These Organizations Do?

To Identify Targets for Development of New Drugs & diagnostics Identify Market Opportunities for Neglected Diseases Work with Companies to build Global Health Strategies Expanded Access to Information & Resources Facilitate New Partnerships Secure Finances for above



Strike a Balance

“Anyone who shows interest in the fellowship,” Dhar says, “should be ready to change his mental orientation, should have determination to spend long hours on patent Web sites, to understand how to support start-up companies, and also develop a

close rapport with venture capital firms.” Boston University Today, University Headlines, October 24, 2006


Acknowledgements DBT BIRAC Library Services Dr. Altaf Lal, US Embassy, New Delhi Dr. Karen H. Antman, BU Dr. Gerald T. Keusch, BU Dr. Ashley Stevens, BU Dr. Catherine Ives, BC FICCI/ CII NIH, USA Dr. Luis Salicrup, NIH, USA AUTM, U.S.A.



Thank You ([email protected])

Dr. Ravi Dhar on "Technology Transfer: an overview- 2014"

Health & Medicine

Transcript of Dr. Ravi Dhar on "Technology Transfer: an overview- 2014"