Patent Protection & Technology Transfer By Todd L. Juneau Washington, D.C. Engineering Research...
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Transcript of Patent Protection & Technology Transfer By Todd L. Juneau Washington, D.C. Engineering Research...
Patent Protection & Patent Protection & Technology TransferTechnology 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?What is a patent?
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?What is in a patent?
AbstractFiling dateBackgroundHow to make and use the inventionExamplesClaims
SecrecySecrecy
Confidentiality AgreementDetermine amount to show and tell:
– First Meetings, only the abstract– Due Diligence Meetings, entire application
Disclosure to public:– General Rule: Disclosure Kills– Exception: 1 year Grace period in U.S.– Exception: 6 mo. EPO, JPO research
Claims define the propertyClaims define the property
What is claimable?What is claimable?
Compounds Compositions Formulations Processes Methods of Use in
Treatment Diagnostic Methods
and Kits
DNA, RNA Proteins, Enzymes Genes, vaccines Industrial processes Plants Animals
Examples of CompoundsExamples of Compounds
Amgen - EPO Lilly - hGH, Humulin Scios – bradykinin
antagonist peptides Erasmus Univ.,
transgenic goat for enzyme deficiency, proteins in milk
Washington University Lens cell line
Onco Mouse– Harvard to DuPont, DuPont
to PHS for noncommercial use
– http://ott.od.nih.gov/textonly/oncomous.htm
– U.S. Pat. Nos. 4,736,866, 5,087,571 and 5,925,803
Compounds …Compounds …
Breast Cancer Genes US 5,747,282 which
covers BRCA1, chromosome 17
US 5,837,492 which covers BRCA2, chromosome 13
‘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, Compositions, Formulations, and Processesand Processes
Chakrabarty, bacteria US 4,535,061and US 4,259,444
Lactobacillus Doxil® (liposomal
doxorubicin HCl - Alza)
Engerix-B® (r-Hep B vaccine - SKB)
Bioinformatics Celera Discovery
System(TM) Compugen
DiagnosticsDiagnostics
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 DevicesSurgical Devices
Medical Needle U.S. Pat No. 6,001,084Abdomino-Pelvic Lavage U.S. Pat. No.
5,336,171Trans-cutaneous Analyte Monitoring, U.S.
Pat. No. 5,632,310Syringe with Retractable Needle, U.S. Pat.
No. 5,843,034
Robotic SurgeryRobotic Surgery
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 …Robotic Surgery …
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 ValueClaim define the Value
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. …Riek et al. …
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. …Riek et al. …
there being inside the protective surface a dome-shaped 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 TransferTechnology Transfer
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 TransferTech Transfer
Prior to 1980 - <250 patents per year1999
– 3,914 new license agreements – 417 new product introductions – 18,617 active license agreements– $35 billion in sales of licensed items
Bayh Dole Act, 1980Bayh Dole Act, 1980
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 TransferTechnology Transfer
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)
Medical Device, Diagnostic, Kit Development– Generally less expensive to develop– Faster to approval
Converting Information to Converting Information to AdvantageAdvantage
Identifying the foundation technology.– Client interviews.
Surveying the terrain/competitors.– Competitive
monitoring– IPR searches
Developing a strategy.– Identifying business
goals
Securing IP rights.– Domestic and
international Converting rights to
riches.– Licensing,
Enforcement of Market
Raising CapitalRaising Capital
Federal Grants Venture Capitalists,
– Usually require animal data
Foundation Grants Friends and Family
Incubator Facilities Corporate Partnering Law Firm Funding Personal Checkbook
University LicensingUniversity Licensing
Name R&D (millions) # of patents # of start-ups U of Washington $528 34 25 MIT $713 134 17 Stanford $391 64 15 Univ of CA. System $1,580 206 13 Penn.State $353 19 9 Cal. Tech. $153 40 9 Rutgers $154 25 7
Univ of Minnesota $247 66 6
Product StoriesProduct Stories
1. 8Mbps transmission in copper phone lines
2. Cohn Cardiac Stabilizer
3. CyberMark Smart Card®
4. Fast ForWord® Training Program
5. FibreKor® Dental Material
6. Google Internet Search Engine
7. Green Steel
8. Lycos® Internet Search Engine
9. MG98 Cancer Therapeutic
1. NaturaTM Hearing Aid
2. NiAl Memory Material
3. OXSILAN®: Non-Toxic Corrosion Prevention
4. Panretin® Topical Treatment
5. Periostat®
6. Permeable Preactive Barrier Wall Technologies
7. Pink Beauty Potentilla
8. Quad 7TM Weed Control
9. StormVisionTM Software
10. Taxol® Cancer Drug
Big WinnersBig Winners
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 YouThank You
www.nathlaw.comwww.nathlaw.com