written description requirement & how entrepreneurs can monetize their ip, and what ip...

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Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech industries May 8, 2010 Myers Wolin, LLC 1 Hay Yeung Cheung Myers Wolin, LLC Entrepreneur’s Day May 8, 2010

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Page 1: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Written description requirement  &

How entrepreneurs can monetize their IP, and what IP strategies might work

against major players in healthcare and biotech industries

May 8, 2010 Myers Wolin, LLC 1

Hay Yeung CheungMyers Wolin, LLC

Entrepreneur’s Day May 8, 2010

Page 2: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Written Description Requirement• Independent of the Enablement Requirement• Intended to ensure that the inventor was actually in

possession of the invention at the time of the application was filed.

• Application specification (“spec”) provides support for the claimed invention including each element and/or step.

• “spec” “speculation”

May 8, 2010 Myers Wolin, LLC

Page 3: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Written Description Requirement• Compliance with the written description requirement

is a question of fact which must be resolved on a case-by-case basis. Standard: Whether there is sufficient written description

to inform a skilled artisan that applicant was in possession of the claimed invention.

• Typical written description requirement issues: Whether new or amended claims are supported by the

description of the invention in the application as filed. Whether a claimed invention is entitled to the benefit of

an earlier priority date.

May 8, 2010 Myers Wolin, LLC

Page 4: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Written Description RequirementExamples of non-compliance of written description

requirement:– In an unpredictable art, such as biochemistry, describing

only one member within the group, where the group contains a wide variety of members.

– The claims require an essential or critical feature which is not adequately described in the specification.

Tips: Obtain as much information as possible from inventors,

such as partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function.

May 8, 2010 Myers Wolin, LLC

Page 5: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

How entrepreneurs can monetize their IP, and what IP strategies might work

against major players in healthcare and biotech industries

May 8, 2010 Myers Wolin, LLC 5

Example applications in this field may range from genetic engineering, CT and MRI scanners to applications allowing physicians to remotely diagnose or view medical records of patients.   

Companies that invest in biotech & healthcare IT related applications include: Pfizer, Genentech, GE, Philips, EMC,  NetApp, Oracle, etc. 

Page 6: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

May 8, 2010 Myers Wolin, LLC 6

Class 128, Surgery (includes Class 600)

First-Named Assignee 2005 2006 2007 2008 2009 Total

INDIVIDUALLY OWNED PATENT 260 305 209 194 181 1149

OLYMPUS CORPORATION 32 31 30 25 39 157

MEDTRONIC INC. 21 41 26 20 29 137

GENERAL ELECTRIC COMPANY 13 19 25 34 42 133

CARDIAC PACEMAKERS, INC. 15 24 25 23 43 130

BOSTON SCIENTIFIC SCIMED, INC. 8 19 13 18 35 93

RESMED LIMITED 20 28 14 10 18 90KONINKLIJKE PHILIPS ELECTRONICS N.V. 16 20 13 20 20 89

SIEMENS AKTIENGESELLSCHAFT 10 7 14 17 41 89

SCI-MED LIFE SYSTEMS, INC. 23 27 18 11 4 83

Number of Patents

Page 7: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

May 8, 2010 Myers Wolin, LLC 7

Class 128, Surgery (includes Class 600)

Page 8: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

May 8, 2010 Myers Wolin, LLC 8

Class 435, Chemistry: Molecular Biology and Microbiology

First-Named Assignee 2005 2006 2007 2008 2009 Total

INDIVIDUALLY OWNED PATENT 121 155 122 100 141 639

UNIVERSITY OF CALIFORNIA 54 50 59 29 33 225

GENENTECH, INC. 24 44 39 14 20 141

AJINOMOTO COMPANY INCORPORATED 16 23 42 31 28 140

E. I. DU PONT DE NEMOURS AND CO. 10 35 42 22 27 136

US DEPARTMENT OF HEALTH & HUMAN SERVICES 17 35 32 21 23 128

APPLERA CORPORATION 46 33 23 17 0 119

WISCONSIN ALUMNI RESEARCH FOUNDATION 15 18 23 20 29 105

GENENCOR INTERNATIONAL, INC. 20 21 17 32 10 100

MILLENNIUM PHARMACEUTICALS, INC. 26 26 23 8 14 97

Number of Patents

Page 9: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

May 8, 2010 Myers Wolin, LLC 9

Class 435, Chemistry: Molecular Biology and Microbiology

Page 10: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

May 8, 2010 Myers Wolin, LLC 10

Class 424, Drug, Bio-Affecting and Body Treating Compositions (includes Class 514)

First-Named Assignee 2005 2006 2007 2008 2009 Total

INDIVIDUALLY OWNED PATENT 262 304 262 221 234 1283BRISTOL-MYERS SQUIBB COMPANY 75 111 88 88 92 454

PFIZER INC. 128 84 72 51 56 391

WYETH 42 69 76 72 94 353

ASTRAZENECA AB 65 72 62 76 63 338

HOFFMANN-LA ROCHE INC. 34 48 67 73 83 305

MERCK + CO., INC. 35 48 67 61 93 304

UNIVERSITY OF CALIFORNIA 38 58 46 44 42 228

ELI LILLY AND COMPANY 40 42 52 44 48 226

SCHERING CORP. 37 36 47 43 61 224

Number of Patents

Page 11: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

May 8, 2010 Myers Wolin, LLC 11

Class 424, Drug, Bio-Affecting and Body Treating Compositions (includes Class 514)

Page 12: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Individual inventors are by far the largest producers of patents.

However, big corporations are much more successful in deriving revenues from patents.

- Resource- Infrastructure- Experience- Industry Network

12May 8, 2010 Myers Wolin, LLC

Page 13: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Monetizing IP

• Value of the IP to the company– Market exclusivity

– Licensing revenue

– Collaborative relationships

– Position company for purchase and/or investment

– Advertising/Marketing value

• IP Valuation– Discounted Cash Flow Model

– Black-Scholes Option Pricing Model

– others

13May 8, 2010 Myers Wolin, LLC

Page 14: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Packaging and Pooling• High tech product may

contain many components, and each component may be covered by many patents.

• Well packaged portfolio is more valuable.

• Patent pool can reduce costs and risks.

14May 8, 2010 Myers Wolin, LLC

Page 15: Written description requirement & How entrepreneurs can monetize their IP, and what IP strategies might work against major players in healthcare and biotech

Create and Maintain an IP Strategy

• Establish an IP budget• Designate a liaison• Educate engineers and management• Engineers should be reminded to

protect their innovations• Management should encourage

innovation• Proactive management of pipeline• 1-5-10-20 year horizon• Establish a public reputation of an IP

rights holder, defender and enforcer

15May 8, 2010 Myers Wolin, LLC