Licensing from Government Labs - An NRC-IBS Perspective

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6 Δεκ 2012 (πριν από 4 χρόνια και 9 μήνες)

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Licensing from Government Labs

An NRC
-
IBS Perspective




Scott Ferguson

Business Relations

ACCT


November 14, 2006


A National Institution

Staff
: Approx. 4300 employees; 1500

visiting / guest workers

Expenditures

2005
-
06:
$835 million

Income

2005
-
06: $
166 million


National R&D
Infrastructure

R&D
Training

Technology
Development

Technology
Diffusion

Incubators
and Start
-
up
Support

Regional
Innovation
Systems

National
Standards and
Codes

Information
Networks

Technology
Transfer

Commercialisation
and New Company
Creation

Research
Programs

An Integrated Approach

Innovation

Systems

Research

Value

Biotechnology at NRC:

An interdisciplinary and horizontal management
approach

NRC Life Sciences Portfolio




Biotechnology Research Institute

(BRI), Montreal



Institute for Biodiagnostics

(IBD), Winnipeg



Institute for Biological Sciences

(IBS), Ottawa




Institute for Marine Biosciences

(IMB), Halifax




-

Institute for Nutrisciences and Health

(INH), Charlottetown



Plant Biotechnology Institute

(PBI), Saskatoon



Genomics and Health Initiative

(GHI)


NRC Partner Institutes, Programs



-

National Institute for Nanotechnology

(NINT)



-

Steacie Institute for Molecular Sciences

(SIMS)



-

Industrial Materials Institute

(IMI)


-

Industrial Research Assistance Program
(IRAP)


Institute for

Biological
Sciences



Health Sciences Sector


Infectious Disease Diseases of the Ageing


Immunobiology Glycobiology Neurobiology

…a premier global institute in the application of

neuro
-

and glycosciences to reduce the impact of

age
-
related and infectious diseases

Our Value Proposition

Enhance Impact
Through Integration

Infectious diseases

Age
-
related
neurological diseases

Disease diagnosis and
intervention

Convergence
technologies

Proteomics

Glycobiology

Genomics

I B S

NRC

What is Technology
Transfer ?

Technology Transfer is a managed process of transferring
inventions (not necessarily patentable), copyright, trade secrets,
know
-
how, designs, written works, samples, biological materials,
and technical information from an originator to an adopter in an
organization that can maximize its value to the end
-
user

Technology Transfer
Objectives


The commercialization of discoveries and know
-
how ensures
pay off for Canada



From collaborative R&D, through licensing and the creation of
new enterprises, NRC pursues wealth creation through
innovation

Collaboration


Collaborative research projects are undertaken with partners in
industry, universities and other research organizations



A key objective is to accelerate time to market with the project
deliverables/milestones


for new technologies and/or
improvements to existing products or processes



Often, licensing agreements arise from collaborative research;
in such cases the terms of the agreement reflect a client’s
contribution in developing the technology



Project costing is shared between partner and NRC


partner
can normally expect to have in
-
kind and/or cash contributions

Licensing


IP Sources


NRC developed technologies and AIP
derived from CRADA arrangements



Novel technologies related to the research areas of the
biotechnology sector group


Biopharmaceutical products typically at early stage (pre
-
clinical)


Biodiagnostics, agri
-
food, aquaculture and environmental
technologies at or beyond proof
-
of
-
principle stage




Licensing Terms


NRC seeks industrial partners best positioned to exploit NRC
-
developed
technology. License agreements are generally granted in return for up
-
front
payments and/or royalties based on sales. MARs, milestone payments and IP costs
and management are negotiated. Start
-
up equity position is possible in lieu of some
of these costs



Exclusivity, field of use, territory of exploitation, sub
-
licensing, management of the
IP, etc. are negotiable based on the technology in question and other factors
impacting on commercialization


Some Considerations:


The Canada clause


concept is to maximize benefits for Canada. Typically preference is given
to Canadian firms or multinationals with a Canadian presence, followed by companies that will
exploit technology to greatest degree in Canada (e.g. Canadian based R&D, manufacturing, etc.)



Due diligence


claw
-
back clause with principle of ensuring timely exploitation of technology

Partnering with
Government Labs


Much the same as partnering with universities, research
organizations, and/or small life sciences companies, but:



Inventions are governed by the
Public Servants Invention Act

(PSIA) and
become property of the Crown



Government employees ARE subject to conflict of interest guidelines
governed by the criminal code




We can take an equity position when forming new companies to
commercialize a technology, but this is under specific and limited conditions
as required by the
Financial Administration Act
(FAA).



Unique advantage of having all services under one roof


technology
development, legal and IP support, business development

IBS Successes

Commercialized products


Meningitis C vaccine (Total royalty to date in excess of $20M)


Enzymes for pulp bleaching (Total royalty to date exceeds $1M)

Products in clinical trials


Ostabolin
-
C for osteoporosis (Zelos Therapeutics)


Living Skin Replacement therapy (Apopharma)

Spin
-
off / start
-
up companies


Zelos Therapeutics


Zymes Inc

Scientific successes


Excellent papers; featured journals


FASEB J, JBC, Nature


Awards, invited lectures, major grants


Collaborations (NCE’s, international networks)

NRC
-
IBS Success

Meningitis Vaccine

"The fruits of Baxter's partnership with NRC … ultimately reduced the

incidence of meningococcal C disease in the UK by 75
-
85%

across all age groups.”

Serge Messerlian
,

Vaccine Market Manager for Baxter Canada


Approximately 10% of Canadians who contract meningitis will die
and many survivors suffer serious health complications such as
permanent brain damage, deafness and mental retardation.

Two
-
thirds are children under five years old.


NRC
-
IBS has developed a vaccine for Group C meningococcal
disease, currently being marketed in Canada by ID BioMedical
Corporation.


NeisVac
-

-

resulted in sales of $86 million Canadian in the first
year alone. Furthermore, approximately $20 million has been
paid to IBS through its licensing agreement to be reinvested in
Canadian research.


NRC
-
IBS Success

Industrial Bioproducts Alleviating Environmental Concerns

“It was an exciting challenge… by 1993, several research

groups had concluded that improvement of this target

xylanase was not possible.”

Dr. Wing Sung
,

Senior Research Officer



Natural xylanase enzymes a good biochemical approach to reduce the use of
chlorine bleach in pulp mills, but the temperatures and pH levels tolerated by these
enzymes were below those normally encountered in most mills.


NRC
-
IBS' expertise in protein engineering eventually led to the design and
development of enzymes that can function at a higher temperature and pH levels.


To date, they have sold more than a thousand tons of the 1st and 2nd generation
enzymes, processing over 2 million tons of pulp annually in Canadian and US mills.


NRC
-
IBS has received over $1 million in royalty revenues that has reinvested in
ongoing research projects.


Iogen has now proceeded, in partnership with IBS, to
the development of forth generation products.





NRC
-
IBS Success

Zelos Therapeutics


novel approach to bone and other disorders


Zelos is a research
-
oriented, pharmaceutical products development company focused on
bringing to market, therapeutic products based on its novel PTH technology platform


Zelos is in clinical trials with its first injectable product


Ostabolin
-
C™
-

for the treatment of
postmenopausal osteoporosis.


Other potential applications in development include oral delivery of Ostabolin
-
C™ and for the
treatment of psoriasis.


This NRC
-
IBS spin
-
off company has raised over CDN $80 million in financing to develop these
products.







NRC
-
IBS Success

Targeting the Source: Eliminating E.coli O157:H7 from the
Digestive Systems of Cattle


Steve Webb
,

Dow AgroSciences

Project Success Leader


Recently, the
E.coli

0157:H7 bacterium has been of
concern because of its appearance in public water systems
which, it is believed, were contaminated by run
-
off from
fields treated with manure from infected cows


Collaboration with Calgary
-
based Dow AgroSciences
Canada Inc. to develop a natural antibody that would lead
to the elimination of
E.coli

O157:H7 in the digestive tracts
Goal is to express an
E.coli

0157:H7 specific antibody in
plants and then incorporate the plant
-
made antibody into
animal feed.



“Our partnership with IBS is expected to allow this technology to
develop more rapidly into a commercial product.”

Collaborations

Licences

Dow AgroSciences Canada*

Helix BioPharma

Naturally Advanced Technologies

Neurochem Inc.

Protox Pharmaceuticals

Sussex Research Labs.

Variation Biotechnologies Inc.

Apopharma

GSK Canada

Iogen Corp.

Protox Pharmaceuticals

Zelos Therapeutics Inc.


Services

Gangagen Life Sciences

GSK (ID Biomedical)

Iogen Corp.

PhageTech Inc.

Viventia Biotech

Liponex

PharmaGap


Industrial Partners

Canadian Companies

Ablynx

Baxter Biosciences

Baxter Vaccine AG.

Chiron Corp.

Neose Technologies


Baxter Healthcare Corp.

BioVeris

Dow AgroSciences

Neose Technologies

Nicholas Piramal India Ltd.

Zymes

Lexicon Genetics

NABI

International Companies

* 5
-
year Strategic Alliance signed October 2003

IBS Technology

Pipeline

Research
Target Identification
Proof-of-Concept
Lead Development
Animal Trials
Stability Tox/Kinetics
Pre-Clinical
Industrial Evaluation
Clinical Trials
Technology
Engineering Antibodies
Infectious diseases
Neurological diseases
Lipopolysaccharide Based Vaccines
Meningitis B
Otitis media - non typable haemophilus
Datamining Software
Biominer
Litminer
Neuroprotective Strategies
Aβ-binding peptides
BBB transporters (Ab)
BBB antigen
Cancer
vaccine candidate
multi-potent therapeutic