Licensing of public sector Intellectual

Property Rights (IPRs) for public good:

Experiences from the ICMR, New Delhi

Dr Sadhana Srivastava
Scientist E
Intellectual Property Rights Unit
Indian Council of Medical Research
Department of Health Research , New Delhi
E-mail: sadhana_s@ymail.com
 Agenda of my talk

About ICMR
Policies to promote innovation
Case study
Conclusions

Intellectual Property Rights Unit, Indian Council of Medical Research

Indian Council of Medical Research, New Delhi
 ICMR
ICMR is the premier national national
organisation for planning, promoting, co-
ordinating and conducting biomedical
research in India established in 1911
To undertake and support basic,
epidemiological, applied and operational
research in the areas of national public
health importance using tools including
those of modern biology
Better Health Through Research

Intellectual Property Rights Unit, Indian Council of Medical Research

 ICMR

Acquire new knowledge through the

conduct and support of biomedical research
that would have a bearing on improving the
health of Indian people
Carries out its mandate though its 27
Institutes/Centres, extramural research
projects and through active industry, and
international collaboration

Intellectual Property Rights Unit, Indian Council of Medical Research

 ICMR INSTITUTES

MRC
IOP HQRS

IRMS CJILMD

ICPO RMRI

NIOH NICED

IIH NIN

NIRRH FDTRC

EVRC NCLAS

GRC VCRC

NIV TRC

NARI NIE
RMRCs
CRME
RMRC Intellectual
RMRCProperty
RMRCRights Unit,
RMRC Indian Council
RMRC of Medical
RMRC Research
 Research Programmes
Permanent Institutes of ICMR Grantin-aid Projects

Intramural Extramural
20 Discipline-
specific Institutes
Universities
6 Regional Centres
Medical College

Research Institutes

Hospitals
 Mandate of the DHR
The DHR aims at bringing modern health technology to people by
encouraging innovations related to diagnostics, treatment
methods as well as prevention- vaccines.
Translating the innovations into products/ processes by
facilitating evaluation/ testing in synergy with other departments of
MOH&FW as well as other science departments.
Introducing these innovations into public health service
through health systems research.

Apart from basic functions of ICMR such as

Stewardship,
Knowledge generation
Utilization and management of knowledge
Research capacity strengthening
Resource mobilization for research

Indian Council of Medical Research, Department of Health Research

 Why worry about public sector
product development?
Private sector largely profit oriented and market-
driven
Products for diseases of poor largely ignored
Public sector has capacity and experience for
innovations that could lead to products and
processes for public health
It has limited capacity in product development
Requires legal, economy and policy instrument
for transferring technology from research to
industry partners
Industry partnering is vital
Indian Council of Medical Research, New Delhi
 ICMRs policies
for promoting affordable health care
 Chronology of events
Setting up of Technology Transfer Unit in 1996
at the ICMR headquarters
Formulated Guidelines for Contract Research,
Consultancy and Technical Services in 1996 .
Establish IPR Unit at the ICMR HQrs in 2000.
IPR Policy in 2003.
Revised Guidelines for Sponsored and
Collaborative R&D in January 2006.
Setting up Translational Research Units in all
ICMR Institutes/Centres (2009)
IPR Policy revised 2013
 ICMR/DHRs Policy Framework

All these policies designed to further the goals

and objectives of ICMR/DHR viz., to promote
affordable health care through indigenous
health products, processes and other systems

Indian Council of Medical Research, New Delhi

 Initiation of IPR activities at ICMR
Biomedical scientists-not oriented towards
protecting IP
Philosophy - new knowledge disseminated
through publication
Hardly any IP ptoection/patenting done
WTO/GATT-globalization-pressure on cost of
health care through patented medicines
Policy makers-return on investments in R&D
Promote innovation and also solve national
health problems
 Intellectual Property Rights Policy

The IPR Policy of the

ICMR formulated by the
IPR Unit was released
and adapted by the Union
Ministry of Health &
Family Welfare,
Government of India in
2002

Indian Council of Medical Research

 Mission Statement on
Intellectual Property

The ICMR recognizes and supports new intellectual

property development and technology transfer as
integral components of its mission and asserts that
the guiding principle governing the conduct of
these activities shall be the prompt and efficient
availability of the products developed for the
service of its mission

Indian Council of Medical Research, New Delhi

 Objective
Promoting a culture of identifying and
protecting new knowledge that could lead
to IP generation for new products and
processes for promoting health care in
India.
Awareness
Identification
Protection
Commercialization of IPR of the Council (Intra and
Extramural Research)
 IP Policy
It is based on the principle that the intellectual
property generated by an ICMR employee is
owned by the Council but that any revenue
generated is shared with the employee inventor*
All new IP generated with Councils support
belongs to ICMR*
Patents are filed in the name of
scientist(s)/inventor(s) and rights assigned to the
ICMR
* only for intramural research

Indian Council of Medical Research

 IP Policy
IP generated with ICMR support in extramural
projects by non-ICMR scientists will be generally
owned by ICMR, but negotiable
IP generated jointly through institute-industry
partnership can be jointly owned through an MOU
Institute-industry partners could even transfer the
technology to a third party for commercialization
through licensing
Royalty sharing by inventors negotiable

Indian Council of Medical Research

 Major Objectives
To develop and implement a royalty policy at ICMR
institutions that encourages innovative scientists
and technology generators through a system of
royalty sharing and reward system
To create and maintain a database on the patents
and other innovations of the Council as also related
data
To advise the Ministry of Health, Government of
Indian government on IP related issues concerning
public health
To forge appropriate strategic alliances with
national and international S&T agencies to develop
and market its new inventions and develop
professional knowledge networks for ICMRs
technology management professionals

Indian Council of Medical Research

 IP Policy
Pursue an active policy of ensuring most
rapid and efficient availability of new
products/technologies developed with ICMR
support by seeking of IP right protection
within and outside India
Ensure that as an agency of the Indian
government, the basic mission of research is
not compromised by its efforts to
commercialize new technologies
Promoting R&D is given priority to filing
patents
Indian Council of Medical Research
 IP Policy
Where further research and development is
not necessary to realize the technologys
primary use and future therapeutic, diagnostic
or preventive uses, patents may not be
sought and instead can be commercialized
through non-patent licensing
In some cases it may be put in public
domain

Indian Council of Medical Research

 Patent Procedures
All new inventions of the Council reported to
IPR Unit
Inventions that could be protected will be
reported through an Invention Disclosure
Form
Once the IP is found patentable, techno-legal
support provided for IP protection
Filing and maintenance of patents done
centrally at the IPR Unit
All costs borne by the ICMR

Indian Council of Medical Research

 Licensing Policy and
procedures
Licensing policy clearly laid down
Scientists encouraged to have written agreement
like MTA before a project is undertaken
Licensing policy decided on a case-to-case basis
For industry-sponsored research, MOU drawn up
before the project is initiated
Licensing negotiations done centrally by the IPR
Unit
ICMR retains the right for royalty-free
license for Government of India use

Indian Council of Medical Research

 Achievements
Over 100 New Invention Reports were filed with
the IPR Unit from ICMR supported research - intra
and extramural scientists.
After thorough in-house and external global due
diligence search about novelty, about 106
patents were filed in India and abroad.
A total of 49 patents were granted primarily from
intramural inventions.
 Achievements (contd)
A total of 40 patents are maintained of which 07 are
International and the rest National patents.
There are a dozen technologies at various stages of
translation and product development.
Technology Transfer Agreements with NRDC, New
Delhi and BCIL, New Delhi renewed with suitable
clauses added for timelines, targets and
accountability etc.
Organized two workshops for ICMR/non-ICMR
scientists on IPR as also trained ten Women Scientists
of DST.
 Contd..
Offered training to both ICMR scientists as also the
DST women scientists.
Provide policy support to Govt. and other agencies
like the WHO, WTO etc. on IPR, health and access
issues.
Conduct workshops, conferences, exhibitions to
sensitize scientific community and other potential
users on IPR and technology transfer issue.
To assess market potential of existing technologies
of the Council.
 Achievements (contd)

SUMMARY OF ICMRS TECHNOLOGIES

COMMERCIALIZATION
Technologies commercialized by ICMR (IPR Unit):3

PATENTS/TECHNOLOGIES PATENTS/TECHNOLOGIE
ASSIGNED TO BCIL S ASSIGNED TO NRDC

No of Assigned
technologies (2007
onwards) : 53
Commercialized: 2
No of Assigned
technologies (2007
onwards) : 8
Commercialized: 0
* 3 techs assigned prior to 2007
were commercialized
 Achievements (contd)
Several technologies have been transferred to the
industry for product development which include;
Device for visualizing cancerous lesions transferred to M/s
Smart Scientifics, Ambala
Reverse dot blot kit for diagnosis of Thallaseamia to M/s
Imgenex, Bhubneswar under contract manufacturing,
after entering into a MoU
Fertility assessment kits transferred to M/s HLL Lifecare
Ltd. a Thiruvanthapuram
Bti based larvicide for antimalaria to various companies.
Monoclonal antibody detection kit for Chlamydia
trachomatis to Mumbai based company M/s Accurex India
 Achievements (contd)
Some technologies are on the final stage of
technology transfer:
1. Autologous grafting for burn patient with M/s
Virchow India Ltd. Hyderabad
2. Resazurin reduction test to predict sperm fertilizing
potential (RRT)
3. RT-PCR for Dengue
4. An anti-neoplastic Compound
5. A herbal anti-hypoglycaemic compound for
controlling diabetes
6. Redesigned model of cycle rickshaw.
 Translational Units
During last two years, 26 Translational Units have been
established in various ICMR Institutes/Centers to create
Mechanisms for translational processes.
Fifty-two technologies/processes have been identified for first
phase of translational process and action initiated.
29 technologies as diagnostics for various Diseases.
5 for vaccines.
5 mosquito control products.
3 for prevention of occupational hazards.
5 process development.
2 leads for drug developments.
2 Health systems programmes.
1 early warning system for Japanese encephalitis
 Some technologies of ICMR/DHR
Fertility Assessment Kits
Indulsa - a kit for estimation of estrone
glucuronide in urine (E1G) by ELISA.
Corpulisa - a kit for estimation of
pregnanediol glucuronide (PdG) in urine.
Luteolisa - a kit for estimation of
leutinizing hormone (LH) in urine by
ELISA.
Follilisa - a kit for estimation of follicle
stimulating hormone (FSH) in urine by
ELISA.
The technology is in process of being
transferred to M/s HLL Health Care,
Thiruvanthapuram.
Diagnostic kit for detection of -
Thalassemia Syndromes (RDB KIT)
It uses the principle of PCR and
Reverse Dot Blot hybridization for
detection of common Indian -
Thalassemia Syndromes
Easy method for detection of six
common Indian -Thalassemia
mutation along with two abnormal
hemoglobin's HbS and HbE in a single
step with great accuracy, without using
radioactive isotopes and hazardous
reagent.
An Indian Patent (no. 194149) has
been granted.
 Some technologies of ICMR/DHR
Resazurin Reduction Test (RRT) for
assessment of metabolically active sperm
In the presence of mitochondrial
dehydrogenase enzymes, resazurin
(a blue colored chemical) converts
into resorfin, a pink colored
product, in the semen sample .
The intensity of the color is directly
proportional to the quality of the
sperm in the sample.
An Indian Patent Application has
been filed.
Monoclonal Antibody for
Chlamydia trachomatis infection
This Indigenous diagnostic assay
has been developed using
hybridoma technology from an
Indian patient's isolate.
Developed antibody can be used
for detection of serovar D of
Chlamydia trachomatis infection
found in female genital tract.
A patent (No.246263) has been
granted by Indian Patent office.
 Some technologies of ICMR/DHR
An antibacterial and antiviral
compound
The invention primarily relates to a
novel compound effective against
drug sensitive, multiple
drug resistant and extensive drug
resistant strains of
MycobacteriumTuberculosis, other
bacterial strains and viral
pathogens(HIV).
An Indian as well as PCT Patent
application has been filed.
Cultured Epithelial
Autograft (CEA) for burns
The product is useful for resurfacing
of II and III degree burn wounds.
It employs an innovative process of
fool-proof and cost-effective
attenuation protocol for feeders used
for faster proliferation of keratinocytes
isolated out of a small initial skin
biopsy from the burns patient.
An Indian Patent (No.2086/DEL/2009)
has been filed.
 Some technologies of ICMR/DHR
New drug formulation for malaria
It can be used as gametocidal and
schizontocidal drug.
It can be employed against
Plasmodium vivax malaria and P.
falciparum malaria
It treats malaria without any side
effects.
An Indian patent (no. 189970) has
been granted
Indian Council of Medical Research, New Delhi
ELISA based diagnostic test
for Rota viral diarrhea
Useful for detection of rotavirus from
the fecal samples of diarrhea
patients
Rapid, easy to perform, highly
sensitive and specific.
Helpful to avoid unnecessary usage
of antibiotics.
An Indian patent (no.187163)has
been granted.
 Case Study for
commercialization-
Magnivisualizer
 Magnivisualizer
It is diagnostic device which has been
developed by one of the ICMR
research lab i.e. Institute for Cellular
and Preventive Oncology, Noida.
It is used to visualize the cancerous
lesion of uterocervix
It magnifies and illuminates the cervix
to see the lesion at very early stage
and extremely useful for primary
health centre.
For successful technology transfer the
Council entered various agreements
like Non Disclosure agreement,
licensing agreements with well defined
terms and conditions and setting of
milestones.

Indian Council of Medical Research, New

Delhi
 Level I
Conceptualization of studies Cervical cancer
is the leading malignancy among women in the
developing world
Approaches to health problem:
Lack of cytoscreening programs
visual inspection with acetic acid (VIA): extreme
variation in sensitivity and low specificity
Opportunities: The Magnivisualizer device has
designed to improve the sensitivity of VIA and
reduce the non specific results as much as
possible.

Indian Council of Medical Research,

New Delhi
 Level II
Up scaling of the technology:

Designed to improve the sensitivity of visual

inspection . Ordinary torch light may mask many of
the features of the lesions (e.g. colour, contour
margins etc.). That may result missing some of the
lesions or may interfere with identifying biopsy site.
For different magnification interchangeable
magnifying lenses (1+, 2+ and 4+ dioptre) have
incorporated.
It can be operated on 12 volt rechargeable battery
therefore the device can be used in remote areas
where electricity is a problem
It is light weight (less than 500 grams, excluding
battery) and can be easily carried anywhere.

Indian Council of Medical Research,

New Delhi
 Level III
Technology Evaluation
Continuous interactions with the inventor
is essential
process or product or both
funding source,
improvement or revulationary,
market potential
competitive or alternative products
available,
market size
pre existing companies

Indian Council of Medical Research,

New Delhi
 Level IV
Commercial potential of the Technology

Novel, extremely useful for public health

Low cost, handy and portable
Highly specific and sensitive

we may conclude that the technology has some

business potential.

Indian Council of Medical Research, New

Delhi
 Level IV (contd)
Commercial potential of the Technology

IP Protection .
A design Registration has been done.
An Indian patent application (1216/DEL/2010)
has been filed
As Magnivisualizer is new term coined by the
inventors and the trade name has also been
registered.

Indian Council of Medical Research,

New Delhi
 Office of Controller General of Patents Designs
and Trademarks
Indian Design Application Information Retrieval System

Detail
APPLICATION NUMBER 236817
CBR NUMBER 4564
CBR DATE 20/05/2011 14:16:26
NAME OF ARTICLE A.V. MAGNIVISUALIZER.
NAME OF APPLICANT Indian Council of medical
research
FER DATE 21/07/2011
FILED AT Delhi

Application Status
Application Accepted, Certificate of design has been
printed.
A.V. Magnivisualizer
 Level V
For industrial collaboration
Placed the technology at ICMR website as
ICMR invites potential licensees towards better
health: A device for the detection of early
cancerous lesion of cervical cancer through AV
Magnavisualizer.
Few companies approached for industrial
partnering
Negotiations were made to the Companies and
requested them present their business
proposal.
For commencing serious negotiation the IPR
Unit offered them to enter into an NDA
Indian Council of Medical Research,
New Delhi
 Level VI
Societal or public health relevance
In India, shortcomings in infrastructure and a lack of
trained personals.
AV Magnivisualizer offers an alternative means to detect
most early cancerous and high grade lesions that have a
high potential for progression.
The simple technique of visual inspection by means of
the AV Magnivisualizer can be undertaken even in a
primary health care center with only the additional
requirement is an examination table.
It can be used by Gynecologists/ Nurses/ paramedicals
in govt. infrastructure , Primary healthcare centers in all
over India (45,000 at present), Community Health
Centers (1200 approximately) and District Hospitals.
Even private hospitals and practicing gynaecologists may
also use it for a part of aided visual inspection.

Indian Council of Medical Research,

New Delhi
 Next steps

The Magnivisualizer has been field tested

It is being introduced in several semi-urban
and rural health care setting in India.
The affordable device will help reduce the
load of cervical cancer
This device is being upgraded to expand its
use in other health conditions where visual
inspection could help in the diagnosis and
take preventive steps.

Indian Council of Medical Research, New

Delhi
Licensing Policy and procedures
Licensing policy clearly laid down
Scientists encouraged to have written agreement
like MTA before a project is undertaken
Licensing policy decided on a case-to-case basis
For industry-sponsored research, MOU drawn up
before the project is initiated
Licensing negotiations done centrally by the IPR
Unit
ICMR retains the right for royalty-free license for
Government of India use

Intellectual Property Rights Unit, Indian Council of Medical Research

 Conclusions
The ICMR/DHR committed towards providing
and promoting affordable healthcare for all
Creation of new knowledge and protection is
important for new product development
This commitment should be reflected in the
Intellectual Property Rights Policy and other
institutional policies
Systems for the identification of new innovations
and providing techno-legal support are
important.
Keep the inventors motivated
Indian Council of Medical Research,
New Delhi
Thank you for your attention