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Patent Protection & Patent Protection & Technology TransferTechnology Transfer

By Todd L. Juneau

Washington, D.C.

Engineering Research Center for Computer Integrated Surgical Systems and Technology

Seminar of 18 October 2001

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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

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What is in a patent?What is in a patent?

Abstract Filing date Background How to make and use the invention Examples Claims

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SecrecySecrecy

Confidentiality Agreement Determine 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

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Claims define the propertyClaims define the property

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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

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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/onc

omous.htm– U.S. Pat. Nos. 4,736,866,

5,087,571 and 5,925,803

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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

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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

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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

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Surgical DevicesSurgical Devices

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

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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

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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

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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

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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

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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.

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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

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Tech TransferTech Transfer

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

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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

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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

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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

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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

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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

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Product StoriesProduct Stories

8Mbps transmission in copper phone lines

Cohn Cardiac Stabilizer

CyberMark Smart Card®

Fast ForWord® Training Program

FibreKor® Dental Material

Google Internet Search Engine

8. Green Steel

Lycos® Internet Search Engine

10. MG98 Cancer Therapeutic

• Natura TM 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

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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

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Thank YouThank You