Importance Of Patents In The Life Sciences Industry

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?


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)


Medical Device DevelopmentCenter for Devices

Radiological Health



Investigational New Device (IDE)

•MANUFACTURING •VALIDATION

510K

Pre Market Approval

(PMA)

Clearance

Approval

Good Laboratory Practices

Good Clinical Practices

Quality System Regulations (QSR)


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


R&D ExpendituresPublicly Traded Companies


R&D ExpendituresComparison to other industries


Pharma Landscape

Source: AXA Framlington* Value of products losing patent protection as a percentage of total company sales over next five years


The Valley of Death

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Pre

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Ph

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Ph

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e I

I

Ph

as

e I

II

ND

A A

pp

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Po

st

Ma

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tin

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TIME

CO

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VC Investment IPO Window

PRE 2000 PRE 2000TODAY TODAY


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


Competitors

Enemies

Public

Customers

Employees

Vendors

Why have IP?

Know-HowIdeas

Inventions


Competitors

Enemies

Public

Customers

Employees

Vendors

Why have IP?

Know-HowIdeas

Inventions


How to read claims

Boss! The claims, the claims!!!


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


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



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



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.


Opinion of Counsel


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?


TYPES OF IP OPINIONS

Freedom to operate

The scope, validity, and enforceability

Confirming ownership

Confirming transferability


Due Diligence


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


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


Patent Valuation

Conduct due diligence

Cited art

Scope of claims

Types of claims

Likelihood of obtaining claims

Communication from USPTO


Valuation of Patents


Value of an issued patent vs. a patent application

Presumption of validity


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



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



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


Contact information:

Michael R. Samardzija, PhDPartner

Bracewell & Giuliani LLP711 Louisiana Street

Suite 2300Houston, TX 77002

(713) [email protected]

©2009 Bracewell & Giuliani LLP

Date post:	04-Dec-2014
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Importance Of Patents In The Life Sciences Industry

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