Transcript Patent Protection & Technology Transfer

Patent Protection &
Technology Transfer
By Todd L. Juneau
Washington, D.C.
www.nathlaw.com
Engineering Research Center for Computer Integrated Surgical Systems
and Technology
Seminar of 18 October 2001
What is a patent?
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Grant of the right to prevent others from making,
using, selling, or importing the claimed invention
for 20 years from filing an application for patent
A technology asset recognized by the financial
community and useful for raising capital
A two year legal odyssey for inventors
A new boat for patent lawyers ($10K to $40K)
A tool for corporations to define markets
A tool for Universities to raise money
What is in a patent?
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Abstract
 Filing date
 Background
 How to make and use the invention
 Examples
 Claims
Secrecy
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Confidentiality Agreement
 Determine amount to show and tell:
– First Meetings, only the abstract
– Due Diligence Meetings, entire application
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Disclosure to public:
– General Rule: Disclosure Kills
– Exception: 1 year Grace period in U.S.
– Exception: 6 mo. EPO, JPO research
Claims define the property
What is claimable?
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Compounds
Compositions
Formulations
Processes
Methods of Use in
Treatment
Diagnostic Methods
and Kits
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DNA, RNA
Proteins, Enzymes
Genes, vaccines
Industrial processes
Plants
Animals
Examples of Compounds
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Amgen - EPO
 Lilly - hGH, Humulin
 Scios – bradykinin
antagonist peptides
 Erasmus Univ.,
transgenic goat for
enzyme deficiency,
proteins in milk
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Washington University
Lens cell line
Onco Mouse
– Harvard to DuPont, DuPont
to PHS for noncommercial
use
– http://ott.od.nih.gov/textonl
y/oncomous.htm
– U.S. Pat. Nos. 4,736,866,
5,087,571 and 5,925,803
Compounds …
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Breast Cancer Genes
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US 5,747,282 which
covers BRCA1,
chromosome 17
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US 5,837,492 which
covers BRCA2,
chromosome 13
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‘492 patent claims
– normal gene & mutated
gene(s) in general
– a specific claim to gene
with 39 specifically defined
mutations
– cloning and expression
vectors, transformed cells,
and methods of producing
the BRCA2 polypeptides,
PCR primers
Compositions, Formulations,
and Processes
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Chakrabarty, bacteria
US 4,535,061and
US 4,259,444
 Lactobacillus
 Doxil® (liposomal
doxorubicin HCl Alza)
 Engerix-B® (r-Hep B
vaccine - SKB)
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Bioinformatics
 Celera Discovery
System(TM)
 Compugen
Diagnostics
Cystic fibrosis gene patent US 5,776,677
PsA Test for Prostate Cancer US 5,242,802
Metastatin Pharmaceuticals, BPH Assay for
Precursor to Prostate Cancer 6,054,320
Surgical Devices
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Medical Needle U.S. Pat No. 6,001,084
 Abdomino-Pelvic Lavage U.S. Pat. No.
5,336,171
 Trans-cutaneous Analyte Monitoring, U.S.
Pat. No. 5,632,310
 Syringe with Retractable Needle, U.S. Pat.
No. 5,843,034
Robotic Surgery
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6,246,898 Method for carrying out a medical
procedure using a three-dimensional tracking and
imaging system
 6,246,200 Manipulator positioning linkage for
robotic surgery
 6,231,585 Device for stabilizing a treatment site
and method of use
 6,231,526 System and method for augmentation of
surgery
Robotic Surgery …
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6,223,100 Apparatus and method for performing
computer enhanced surgery with articulated
instrument
 6,206,903 Surgical tool with mechanical
advantage
 6,201,984 System and method for augmentation of
endoscopic surgery
 6,198,794 Apparatus and method for planning a
stereotactic surgical procedure using coordinated
fluoroscopy
Claim define the Value
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U.S. Patent No. 6,001,084 to Riek et al.
1. Medical needle
 with a cannula tube whose distal end is cut
obliquely to a sharp tip,
 with a coaxially mounted tubular protective
element in the cannula tube
 which can be moved axially from a forward
position against a spring force into a rear position
Riek et al. …
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and which is closed at its distal end by a
transparent, blunt protective surface that projects
in the forward position distally beyond the tip and
in the rear position is behind the tip, and
 an optical system in the protective element having
a distal lens for observation of the protective
surface from the inside,
 characterized by the fact that the protective
surface is arched forward at its distal end, that the
protective element is hollow up to the arched area
of the protective surface
Riek et al. …
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there being inside the protective surface a domeshaped interior hollow cavity,
 the lens of the optical system inside the protective
element being at an axial distance from the
protective surface,
 and in the distal, front position of the protective
element, the tip of the cannula tube lies in an area
in which the arched protective surface makes a
transition into the cylindrical, external casing
surface of the protective element.
Technology Transfer
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formal transferring of new discoveries and
innovations resulting from scientific research
conducted at universities to the commercial
sector
 1) the disclosure of innovations; 2) patenting
the innovation concurrent with publication of
scientific research; and 3) licensing the rights
to innovations to industry for commercial
development
Tech Transfer
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Prior to 1980 - <250 patents per year
 1999
– 3,914 new license agreements
– 417 new product introductions
– 18,617 active license agreements
– $35 billion in sales of licensed items
Bayh Dole Act, 1980
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Royalties earned by academic institutions are
reinvested in the University
 new opportunities for graduate students, buy
research equipment, or fund new research
 pay for a portion of the legal fees associated
with patenting and licensing as well as
technology management staff
 portion of the revenues is shared with the
university inventor
Technology Transfer
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Drug Development
– $500 million/drug to develop
– 12-15 years from lab to approved drug in U.S
– Drug Development failure rate is high (1 in 5-10,000)
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Medical Device, Diagnostic, Kit Development
– Generally less expensive to develop
– Faster to approval
Converting Information to
Advantage
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Identifying the foundation
technology.
– Client interviews.
 Surveying the
terrain/competitors.
– Competitive
monitoring
– IPR searches
 Developing a strategy.
– Identifying business
goals
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Securing IP rights.
– Domestic and
international
Converting rights to
riches.
– Licensing,
Enforcement of Market
Raising Capital
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Federal Grants
 Venture Capitalists,
– Usually require animal
data
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Foundation Grants
 Friends and Family
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Incubator Facilities
 Corporate Partnering
 Law Firm Funding
 Personal Checkbook
University Licensing
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Name
R&D (millions)
U of Washington
$528
MIT
$713
Stanford
$391
Univ of CA. System $1,580
Penn.State
$353
Cal. Tech.
$153
Rutgers
$154
# of patents
34
134
64
206
19
40
25
# of start-ups
25
17
15
13
9
9
7
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Univ of Minnesota
66
6
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$247
Product Stories
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8Mbps transmission in copper
phone lines
Cohn Cardiac Stabilizer
CyberMark Smart Card®
Fast ForWord® Training
Program
FibreKor® Dental Material
Google Internet Search Engine
Green Steel
Lycos® Internet Search Engine
MG98 Cancer Therapeutic
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NaturaTM Hearing Aid
NiAl Memory Material
OXSILAN®: Non-Toxic
Corrosion Prevention
Panretin® Topical Treatment
Periostat®
Permeable Preactive Barrier
Wall Technologies
Pink Beauty Potentilla
Quad 7TM Weed Control
StormVisionTM Software
Taxol® Cancer Drug
Big Winners
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Michigan State University, $160 million, two
cancer-related patents (Blumenstyk 1999)
 University of Florida $37 million, Gatorade
 Iowa State University $27 million, fax
algorithm
 Stanford University, $143 million, recombinant
DNA gene-splicing patent, Odza 1996
Thank You
www.nathlaw.com