afmr meeting april 21, 2009 indrani mukharji, ph.d. executive director northwestern university...
Post on 28-Dec-2015
214 Views
Preview:
TRANSCRIPT
AFMR meetingApril 21, 2009
Indrani Mukharji, Ph.D.
Executive Director
Northwestern University
Technology Transfer
Academic Technology Transfer
What we doWhy we do itHow we do it
What we have achievedChallenges we face
IM/2/28/09
What we do
Facilitate commercialization of innovative university technologies from the bench to the market for
public use and benefit by
implementing university intellectual property policies
IM/2/28/09
Why we do itBayh-Dole Act [Public Law 96-517]
December 12, 1980 mandated
Technology Transfer of inventions arising from federally sponsored research
We do it forMarket launch of new product for public benefit Entrepreneurship leading to new businesses
Sustaining an innovative cultureNew source of revenue
Local absorptivity IM/2/28/09
How we do it
Technology and market evaluation
Make decision on protection (patent, copyright, trademark)
Promote to attract commercial partner
Business development for new companies
Structure, negotiate, and sign license deals
Invention DisclosuresData from AUTM Survey
0
100
200
300
400
500
600
2006 Inv
2007 Inv
MIT
Ha
rvar
d
Du
ke
Co
rnel
l
NU
U o
f C
hic
ag
o
Sta
nfo
rd
Pe
nn
Characteristics of Academic Inventions
Highly embryonic with long development phase Assessment of value or success difficult
Invention may be ahead of market demand
Market or customers not always clearly defined Inherent high-risk
IM/2/28/09
Patent
A patent gives to its owners the right to exclude others from making, using, selling, offering for sale, or importing the patented invention for the term of the patent, which is 20 years from the filing date, subject to the payment of maintenance fees.
A patent is a limited property right granted by the government in exchange for sharing the details of the inventions with the public.
A patent may be sold, licensed, assigned, or abandoned.
Patent enforceability depends on ability to detect Infringement, and ability to withstand litigation
Patent should not expire before product launch, and technology should not be obsolete before patent issues
Patent Protection
Patent Criteria
Novel and enablingMust have utilityNon-obvious to one
skilled in the art
Patent Claims
CompositionProcessMethod of useNew use
Design patents
When to File Patent Applications
For worldwide protection, patent application must be filed before any public disclosure
Oral presentation Poster presentation Published article Abstracts, if enabling, in conference proceedings Public demonstration of a prototype
For US patent protection only, patent application must be filed within 12 months of public disclosure
Patents are active for 20 years from the date of first filing
IM/2/28/09
Patent Applications
Provisional Patent Application less expensive to file
not examinednot published renders only 12 month protection, and must be converted within 12 months to utility application
Utility Application published 6 – 12 months after filing dateexamination leads to Office Actions (patent prosecution)takes 4 – 10 years to issueexpensive
IM/2/28/09
Patent Expenses
Worldwide Protection for 30 MonthsProvisional applications $1,500 – $7,000
Utility applications in U.S. only $8,000 - $15,000Patent Cooperation Treaty (PCT) extra $4,000
U.S. Prosecution and MaintenanceProsecution cost in U.S. $ 15,000 – $ 35,000
Patent maintenance $5,000 for each issued patent
Nationalization to Continue Worldwide ProtectionEPO $50,000+ (plus translation costs)
Canada, Australia, Japan etc. extra $3,000 - $20,000Annuities for 17 years $5,000 – 25,0000 / year
IM/2/28/09
What makes less sense to patent?
Targets, mechanism of action without novelty of composition or useNew use of countertop medication or deviceResearch tools, e.g., Animal models, Cell linesNew use of a patented composition where patent
owner has no interest in the new use
(no freedom to operate)
IM/2/28/09
Inventors in Patent
Inventors include those who conceived and intellectually contributed to the enablement or reduction to practice
Not the same as journal authorship
Incorrect inventorship may cause patent invalidation
Inventorship may be corrected anytime before patent issues
Tech Transfer Office is responsible to make it correct
IM/2/28/09
What happens to my IP if I move
To another university – Original IP or patent rights remain with first university. Additional research done at the next university may be sole or joint property, determined by the Tech Transfer offices. For joint property an Inter-institutional Agreement is signed by both universities to decide on the sharing of the work and the cost. Royalty, if any, is shared with inventors according to each institutions Patent Policy
To industry – Original patent rights remain with university. If research continues at company, company may want to negotiate a license for original patent rights. Any royalty received by university will be distributed to all inventors according to university Patent Policy.
Relinquish IP or patent rights - If university is no longer interested to pursue patent protection, university relinquishes its ownership rights in IP to all inventors, thereby claiming no part of the revenue after release
IM/2/28/09
Inter-university collaboration
May occur via Exchange of research tools or reagents – Material
Transfer Agreements (MTA) outline terms and render protection if needed
Joint grant application Sponsorship of inter-university research projects by
Foundations or Industry Use of instrumentation, facility, or data analyses
Inventions should be reported to each institution Tech Transfer offices by the respective inventors
IM/2/28/09
Inter-institutional Agreements
Negotiated and signed by tech transfer offices for joint inventions that delineate the management of the IP evaluation, patent filing and prosecution, marketing to industry, license negotiations, litigation matters, and sharing of the costs and revenue.
IM/2/28/09
License
A license is a contractual agreement which is granted by the patent owner (the licensor) to the licensee to use the patent rights to make, use, sell, offer for sale or import, usually in return for a royalty or other payment.
It is common for companies to enter into numerous license agreements associated with the production of a single product.
A license may be exclusive or non-exclusive
IM/2/28/09
Licensing
Best to remain flexible and reasonable
No fixed formula - Every deal is different
Seek partners based on interest, compatibility, resources and willingness to develop products for the market
Identify internal champions within existing companies, orform new company for development and commercialization
May need collaborative sponsored research alongside development of technology by Licensee
IM/2/28/09
Deal Breakers
Restriction or ban on publication of research
Publication delays beyond a reasonable period
Restriction on university’s nonexclusive rights for research and teaching to comply with federal guidelines if federally supported research led to invention
Assignment of patents to Licensee
Restriction of research and future development of competing technologies
IM/2/28/09
Who Receives License Revenue?
University receives license revenue according to license terms
University Patent Policy sets the rules for distribution of revenue Sharing revenue with inventors, their departments / centers, and schools is common
An inventor may share his/her income with non-inventor colleagues
Northwestern Policy shares the revenue with inventors, departments, and schools but not with
non-inventor colleagues
IM/2/28/09
Spin-off Companies Entrepreneur
Novel idea or IP AssetManagement
FinancingPersonal, family & friendsSBIR / STTRAngelsCorporate partnershipVenture investment
ExitIPOMerger or Acquisition
IM/2/28/09
Transfer of Therapeutics for Public Use
Old Approach
Direct Licensing to Pharma
Invention disclosure to Northwestern Patent filing by NorthwesternNorthwestern signs License Agreement with
PharmaPatent prosecution in conjunction with PharmaPharma performs all preclinical development
and clinical trialsProduct launch after Pharma gets regulatory
approval
IM/2/28/09
Current Approach
NewCo Formation
Invention Disclosures to NorthwesternPatent filing by Northwestern New company (NewCo) is incorporated with private
capital Northwestern grants license to NewCo NewCo may fund additional research in inventor’s
lab while performing preclinical development on its own or by CRO.
Northwestern may grant additional licenses to NewCo
NewCo files IND, conducts Phase I and/or Phase IINewCo forms partnership with Pharma to conclude
clinical trials or NewCo exits by assigning License to Pharma or NewCo has an IPO
What has been achieved?
Partial list of Therapeutics from University Patents & Licensing
1990s
1990 – Exosurf; Cardiolite
1993 – Betaseron
1995 – Epivir; Zinecard
1996 – Gliadel; Humatrope; Xalatan; Elmiron
1997 - Synthetic Taxol; Benefix; Reopro; Miraluma
1998 – Actiq
1999 – Doxil; Habitrol; Platinol; Ontak; Nutropin/Protropin;
Busulfex
2000s
2000 – Recombivax; Prevnar
2001 – Periostat
2002 – Remicade; Sarafem
2003 – Emtriva; Fabrazyme; Restasis; Kineret;
Botox/Hyperhydrosis
2004 - Erbitux; Menostar; Silvadine; Ziagen; Macugen; Lyrica
2005 – Zemplar; BiDil
2006 – Zolinza; Zostavax; Urocit-K
IM/2/28/09
2007
10 Universities reported license income of more than $50 M
27 Universities reported license income more than $10 m
New York University reported $791 M license income [includes monetization of Remicade]
2006
5 Universities reported license income of more than $50 M
28 Universities reported license income more than $10 m
New York University reported $157 M license income
AUTM License Survey(Association of University Technology Managers)
FY 2007 License Revenue (M)AUTM Survey
$0.00
$20.00
$40.00
$60.00
$80.00
$100.00
$120.00
$140.00
License Revenue
Co
lum
bia
U o
f M
inn
es
ota
U o
f F
lori
da
Ro
ch
es
ter
U o
f M
ass
U o
f C
ali
forn
ia
Wa
ke F
ore
st
No
rth
wes
tern
U o
f W
ash
Sta
nfo
rd
WA
RF
MIT
Challenges
Academic research is not market-drivenNecessity to publish immediately
Little capability for development
Technology Transfer is complex and expensiveManaging expectations
High risk endeavorConflicts of Interest
Public Opinion of Technology Transfer
IM/2/28/09
top related