dr eyal bressler © 2009 1 aspects of bio-medical instrumentation patents maximizing the value of ip...
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Aspects of Bio-Medical Aspects of Bio-Medical Instrumentation PatentsInstrumentation Patents Maximizing the Value of IP in Times of ChangeMaximizing the Value of IP in Times of Change
Dr. Eyal Bressler
WWW.BRESSLER.CO.IL
Bio-Medical Engineering National Student Conference
June 18, 2009 Faculty of Engineering, Tel Aviv University
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DUPONT Patents
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MorningstarTM
by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
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Dow Patents
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MorningstarTM
by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
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MONSANTO Patents
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MorningstarTM
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Teva Patents
MorningstarTM
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by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
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Aspects of Bio-Medical Aspects of Bio-Medical Instrumentation PatentsInstrumentation Patents
Dr. Eyal Bressler
WWW.BRESSLER.CO.IL
Bio-Medical Engineering National Student Conference
June 18, 2009 Faculty of Engineering, Tel Aviv University
Maximizing the Value of IP in Times of ChangeMaximizing the Value of IP in Times of Change
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Dr. Eyal Bressler PhD INTA, AIPPI, (Biotechnol.) LLB (Hebrew University)Dr Joe Wyse PhD (Genetics) (London University) Dr Lior Itzhaki PhD (Chem.) (Bar Ilan University)Dr. Jeremy Rutman PhD (Mater.) (Harvard, Technion Universities) Dr. Keren Hagai PhD (Mol.Bio) (Tel Aviv University)Dr Yael Uziel, Ph.D (Immuno-bio.) (London University) Eva Soller MSc (Biolo.) (Cornell University) US patent agent Dr. Michael Meyklyar PhD (Physics) (Khazan University, Weizmann Inst.)Dr.Yael Eshet MD, B.Sc. M.Sc. ( Medicine) (Tel Aviv University)Dr Smadar Bressler PhD (Phys. Chem.) (Hebrew University)Dr. Richard Schultz (Chem.) (Harvard, Berkeley Universities)Dr. Yariv Pinto PhD. (Chem.) (Hebrew University) Jessica Bressler, Adv. M.A (Oxford). LLB Eyal Shilon, Adv. LLB Liat Perl, Adv. LLB
Of counsel Prof. Raffi Goren,. James de Rothschild Professor of Horticulture (Hebrew University)
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Pat. Appl (US PCT & EP) (Priority Date)
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ICP A61B*, by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
Fling Medical Devices - IsraelFling Medical Devices - Israel
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9 PCT - TotalPCT - Medical Devices
Years
Sales
20101
PLATEAU
LOG
LAG
DECLINE
by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
WW Pat. Appl. Medical devics (A61B*) PCT Stage
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Total PCT Filing
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by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
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by Dr Eyal Bressler & Co., 2009, Based on ILPTO
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Big MedTech & Pharma needs more Innovation to meet the drastically changing markets niche …
e.g., 510(k)- regulated disposable ambulatory materials and thus devices
by Dr Eyal Bressler & Co., 2009, Based on ILPTO
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Triadic patent families1 over GDP,2 2005
Notes: Patent counts are based on the earliest priority date, the inventor's country of residence and fractional counts.
1. Patents all applied for at the EPO, USPTO and JPO. Figures for 2005 are estimates.
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Triadic patent families per million population, 2003
Notes: Patent counts are based on the earliest priority date, the inventor's country of residence and fractional counts.
Patents all applied for at the EPO, USPTO and JPO. Figures for 2005 are estimates .
Only countries/economies with more than 20 families in 2005 are included.
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CASE STUDY
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Regi
onUS
A / E
U
Cost
s, C
ompa
nies
Val
ue
1994 1999 2003 2007
WW marketIdea – polymeric disposables
Proof of concept
SALES (disposables)
Portfolio of Products (IPO IL)
IP
Additional Patents
IL Hospital + Hebrew U JerusalemIdea – metal ware
Proof of concept
Product (Karl Strotz DE)
SALES (Sialoendoscope) FDA
EU market
Idea – LASER ware
Proof of concept
Product (Incubator IL)
SALES (Laser Surgery)
IP
CE, FDA
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Examples of FDA-categorized Examples of FDA-categorized Medical TechnologiesMedical Technologies
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24Years
Sales
20101
(50% of patents are dead after 10 yrs)
PMA-regulated drugs
510(K-)regulated medical devices
BEP 10 yrs
BEP 4 yrs
BEP 2 yrs
NP
V
NP
V
NP
V
SE-(non-)regulated medical devices
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Sep.11 Type CrisesSep.11 Type Crises
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Sep. 11 Type CrisesSep. 11 Type Crises
by Dr Eyal Bressler & Co., 2009, Based on USPTO Official Data
by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
1.5%/Yr, 10%
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1930s Type Crises1930s Type Crises
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by Dr Eyal Bressler & Co., 2009, Based on USPTO Official Data
1.3%/Yr, 4%
1930s Type Crises1930s Type Crises
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0500
1000150020002500300035004000450050005500
Pat. Appl. (US EP PCT & JP)
Pat. Granted (US & EP)
Undifferentiated human, animal or plant cells, e.g. cell lines;
Tissues; Cultivation or maintenance thereof; Culture media therefore
IPC C12N5* via DelphionTM database
More than 25,000 Patent Applications on Stem Cells,
About 6,000 Granted Patents (US & EP) .
*Calculated on base of Jan-June 2009
*
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Log Log toto Plateau Plateau
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Plateau - Coalescence Log - Expansion by Dr Eyal Bressler & Co., 2009, Based on Delphion TM
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Plateau Plateau toto Decline Decline
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CoalescenceExpansion
2006 2008 2010
Contraction
Log Plateau Decline
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Follow me!Follow me!Me Too!Me Too!
Me, Not You!Me, Not You!©
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Years
Sales
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LOG
LAG
INNOVATION CURVEINNOVATION CURVE
Follow Follow MeMe!!
Me TooMe Too! !
PLATEAU
DECLINE
Me, Not YouMe, Not You!!
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Three ClocksThree Clocks
The Patent clock
The Business Plan clock
The R&D clock
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Patent life cyclePatent life cycle
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Dichotomy: Patent Span Dichotomy: Patent Span vsvs Costs Costs
$5,000 $7,000$25,000
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Project (RD&C) life cycleProject (RD&C) life cycle
Proof of Concept
Patent applications
Market Proof
Market research
Product FDA SALES
I n v e n t i o n
HelsinkiProduct
R&D C o m m e r c i a l i s a t i o n R&D C o m m e r c i a l i s a t i o n
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Follow me! Follow me! Innovative Research: Innovative Research: Antibiotics, Transistors, Computing meansAntibiotics, Transistors, Computing means
Me Too!Me Too!Market-oriented developmentsMarket-oriented developments: : synthesis of…, RF-comm., PCs,synthesis of…, RF-comm., PCs,
Me, Not You!Me, Not You!©
Commercial/litigation-based aspects: Commercial/litigation-based aspects: Freedom-to-operate, infringement & Freedom-to-operate, infringement & IP IP receivershipreceivership- Chap. 11., - Chap. 11.,
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Freedom-to-operateFreedom-to-operate
A
B*
C P
Focusing on competitors/Strategic Partners’ IP for FTO lacunas
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PatentPatentMonopoly rights are granted to the owner preventing others from using the patented technology for a limited period in a specific country
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InfringementInfringement
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IP IP receivership / Bankruptcyreceivership / BankruptcyGeneral Motors, 16,018 US Pat., 1,742 EP Pat., 2,791 DE Pat ,.YET merely current 461 US Appl…
General Motors, Granted US Pat. (PDs)
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Connecting RConnecting R&&D (FM) to D (FM) to Commercialization (M2)Commercialization (M2)
• T0 (provisional) should cover feasible applications of the molecule• Proof of concept, reduction to practice• PCT: Cover validated moieties, backbones and applications.
Remove all other non validated aspects • Work on the removed aspects and file them separately.
RR&&DD
RR&&DD
If you disclose If you disclose Me TooMe Too material in the material in the Follow MeFollow Me patent you will patent you will killkill your own your own Me TooMe Too patent patentIf you break the thread between If you break the thread between Me TooMe Too and and Follow MeFollow Me you will be you will be anticipatedanticipated by someone else! by someone else!
CommercializationCommercialization
CommercializationCommercialization
Take care not to self cannibaliseTake care not to self cannibalise! ! 30 months after T0 enter the National Phase
Marketing plan should be readyInitiation of regulatory approval process
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Connecting R&D (FM) and Comm. (M2) to Connecting R&D (FM) and Comm. (M2) to Changing Markets (IS)Changing Markets (IS)
RR&&DD
RR&&DD
• If you break the thread between Me Too, Follow Me to Me, Not You! you will be anticipated by someone else!
• If you disclose Me, Not You! material in either Me Too or Follow Me patents you will kill your own Me, Not You! patent
CommercializationCommercialization
CommercializationCommercialization
Take care not to self cannibaliseTake care not to self cannibalise! !
SurviveSurvive
SurviveSurvive
• 3rd or 4th generation IP [Non-, Standard-, Protocol-Pats. etc]
• 2nd use patents
• Business modeling (in the US only)
• IPing Completing products, methods, materials etc
• filing FTO killers, Aggressive litigation, buying others IP…
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Conclusions• Less Patents for fewer Key Players; • In scope of Innovation, turning back 20 yrs or more;• Changing markets (changing niches, towards credit/cost
efficiency products, increasing role of regulatory);• Switching Patentability to FTO IP strategy; • 4th generation patents & Me, Not You! strategy; • More likely the “1930 Crisis” type: targeting to the
cinema & chewing gum emerging niches.
Thank You All!