Importance of Patent Protection in the Life Sciences Industry
Michael R. Samardzija, PhDPartner
2©2010 Bracewell & Giuliani LLP
Why is IP important to a company?
3©2010 Bracewell & Giuliani LLP
Drug DevelopmentCenter for
DrugEvaluation &
Research
•PRODUCT SAFETY•PRODUCT EFFICACY
•PRODUCT SAFETY•SURROGATE EFFICACY
Investigational New Drug (IND)
•MANUFACTURING •VALIDATION
New Drug Application
(NDA)
MarketingApproval
Good Laboratory Practices
Good Clinical Practices
Quality System Regulations (QSR)
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Medical Device DevelopmentCenter for Devices
Radiological Health
•PRODUCT SAFETY•PRODUCT EFFICACY
•PRODUCT SAFETY•PRODUCT EFFICACY
Investigational New Device (IDE)
•MANUFACTURING •VALIDATION
510K
Pre Market Approval
(PMA)
Clearance
Approval
Good Laboratory Practices
Good Clinical Practices
Quality System Regulations (QSR)
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Drug Development Pathway
UnmetNeed
TargetIdentification
&Validation
ProductConcept
LeadOptimization
&Preclinical
Testing
Preclinical
DesignConcept
Phase I
Safety
Prototype
Phase II
Efficacy
ClinicalPrototype
Phase III
LargeClinicalTesting
FieldInput
Registration
RegulatoryClearance
FinalProduct
ProductLaunch
MarketSupportStudies
MarketedProduct
Time to Market: 10-12 YEARS Investment Capital: US$800MM
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R&D ExpendituresPublicly Traded Companies
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R&D ExpendituresComparison to other industries
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Pharma Landscape
Source: AXA Framlington* Value of products losing patent protection as a percentage of total company sales over next five years
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The Valley of Death
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TIME
CO
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VC Investment IPO Window
PRE 2000 PRE 2000TODAY TODAY
10©2010 Bracewell & Giuliani LLP
Recent Significant M&A TransactionsRoche-Ventana Acquisition
$3.4Billion
Invitrogen-Applied Biosystems
$6.7Billion
Roche-Genentech Acquisition
$46.8 Billion
Gilead-CV Therapeutics $1.3Billion-Renexa (patent rights licensed from Roche originally)
Teva - CoGenesys $400MAlbumin fusion platform for delivery of peptides/proteins, lead in PII for neutropenia
Pfizer - Encysive $191MThelin for PAH marketed in EU
Fujifilm – Toyama $1.1BPhase II influenza treatment portfolio of 12 compounds
11©2010 Bracewell & Giuliani LLP
Competitors
Enemies
Public
Customers
Employees
Vendors
Why have IP?
Know-HowIdeas
Inventions
12©2010 Bracewell & Giuliani LLP
Competitors
Enemies
Public
Customers
Employees
Vendors
Why have IP?
Know-HowIdeas
Inventions
13©2010 Bracewell & Giuliani LLP
How to read claims
Boss! The claims, the claims!!!
14©2010 Bracewell & Giuliani LLP
Types of Claims
Process e.g., method of making a
drug, methods of
use
Machinee.g.,
medical imaging
instrument
Composition of Matter
e.g., new drug
Article of Manufacture
e.g., medical device,
diagnostic kit, drug
formulation
15©2010 Bracewell & Giuliani LLP
IP Strategies – Related Applications
BioPharmaceuticals
Making the molecule(process)
PharmaceuticalCompound (formulation)
Nucleotide, Protein, Antibody Method of Use
Formulation, Efficacy
Fragments, Derivatives, Analogues
New Molecule
Do not overlook the novel research technology that may be inventedon the way to discovering a blockbuster drug
Building a fortress around the basic invention/technology
16©2010 Bracewell & Giuliani LLP
IP Strategies – Related Applications
Device
Vacuum chamber in which the diamond like coating(blade coating) is applied
Single point cartridge loadingsystem – avoiding upside
down attachment
Indicator strip signaling whenthe shaver is no longer
experiencing "the optimal shave"
Rubberized contour gripfor better handling
New forward pivot designpositioning the blades in
an optimal shaving position
Use of 3 staggered blade gettingprogressively closer to the skin
Mach 3 CoreTechnology
Building a fortress around the basic invention/technology
17©2010 Bracewell & Giuliani LLP
Transitional Phrases
"comprising" is open-ended and does not exclude additional, unrecited elements or steps
"consisting of" excludes any element, step, or ingredient not specified in the claim
"consisting essentially of" limits scope of claim to specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of claimed invention.
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Opinion of Counsel
19©2010 Bracewell & Giuliani LLP
Opinion of Counsel
Need for a license?
Value of license or of the property?
Avoidance of enhanced damages
What is the risk of infringement?
Important business decisionsDo we invest in, buy, or sell the company?
Do we sue?
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TYPES OF IP OPINIONS
Freedom to operate
The scope, validity, and enforceability
Confirming ownership
Confirming transferability
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Due Diligence
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Due Diligence
Searches
Scope of exclusive rights?
Are patents valid and enforceable?
Is there freedom to operate?
Does the company own/have rights to IP?
Is litigation pending/expected?
Patent term expiration
23©2010 Bracewell & Giuliani LLP
Due Diligence
Ask all of the questions (even if they are obvious)
Start from inventorship
Ask to see whether anything had been disclosed before the filing date
Ask if all relevant prior art was cited
See that all maintenance fees had been paid on time
Ask how information was disclosed to other entities
Ask how the compound was transferred to others entities
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Patent Valuation
Conduct due diligence
Cited art
Scope of claims
Types of claims
Likelihood of obtaining claims
Communication from USPTO
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Valuation of Patents
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Value of an issued patent vs. a patent application
Presumption of validity
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Patent Valuation
Obtain a copy of the file-wrapperScope of claimsTypes of claimsWhat was given up during prosecution
Is (or was) there any litigation?Copies of licensing agreements Understanding the patent landscapeExpiration date
28©2010 Bracewell & Giuliani LLP
IP Strategies – Related Applications
BioPharmaceuticals
Making the molecule(process)
PharmaceuticalCompound (formulation)
Nucleotide, Protein, Antibody Method of Use
Formulation, Efficacy
Fragments, Derivatives, Analogues
New Molecule
Do not overlook the novel research technology that may be inventedon the way to discovering a blockbuster drug
Building a fortress around the basic invention/technology
29©2010 Bracewell & Giuliani LLP
It is worth investing, make sure
that you have adequate protection.
There are many ways to protect
you innovations.
Build a fortress not a brick.
Take Steps Toward Success
30©2010 Bracewell & Giuliani LLP
Contact information:
Michael R. Samardzija, PhDPartner
Bracewell & Giuliani LLP711 Louisiana Street
Suite 2300Houston, TX 77002
(713) [email protected]
©2009 Bracewell & Giuliani LLP