licensing of public sector intellectual property … sessions/dr. sadhana...licensing of public...

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: [email protected]

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


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


RMRCs

MRC

HQRS

IRMS

NIN

NICED

TRC

GRC

EVRC

IIH

RMRC RMRC CRME

NIE

VCRC

CJILMD

RMRI

NIOH

NIRRH

NARI

NIV

IOP

ICPO

RMRC RMRC RMRC RMRC

ICMR INSTITUTES

FDTRC

NCLAS

Research Programmes

Intramural Extramural

Permanent Institutes of ICMR

20 Discipline-

specific Institutes

6 Regional Centres

Grant–in-aid Projects

Universities

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


ICMR’s 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/DHR’s 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

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


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

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 Council’s 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


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


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 ICMR’s technology management professionals


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


IP Policy

Where further research and development is not necessary to realize the technology’s 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


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


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

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.


SUMMARY OF ICMR’S TECHNOLOGIES COMMERCIALIZATION

PATENTS/TECHNOLOGIES ASSIGNED TO BCIL

No of Assigned technologies (2007

onwards) : 53

Commercialized: 2

PATENTS/TECHNOLOGIES ASSIGNED TO NRDC

No of Assigned technologies (2007

onwards) : 8

Commercialized: 0 * 3 techs assigned prior to 2007 were commercialized

• Technologies commercialized by ICMR (IPR Unit):3


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


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 β-Thalassemia Syndromes (RDB KIT)

It uses the principle of PCR and Reverse Dot Blot hybridization for detection of common Indian β-Thalassemia Syndromes

Easy method for detection of six common Indian β-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

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.


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.


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.


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


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.


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.


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


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.


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.



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

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

licensing of public sector intellectual property … sessions/dr. sadhana...licensing of public...

Documents