Intellectual Property for Engineers

knobbe.com
Intellectual Property for
Engineers
January 14, 2014
UC Irvine

2© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved.
Overview
1. Background
2. Patent Quiz
3. Identifying IP
4. Protecting IP
5. Assessing 3rd Party Risk
6. Conclusions

©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3
BACKGROUND

Why have a patent system?
• First Patent Law – 1790
• Stimulate Innovation
• “Quid pro quo”
 Give full, public disclosure
 Receive exclusive rights
• Patents are just one form of “Intellectual Property”
 Intangible property rights

Who cares?
• Inventors
• Employers
• Investors
• Entrepreneurs
Which is you?

Benefits
• Often the most valuable assets of a start-up company.
– Can be critical to obtain financing/investment
• Allows idea sharing without risk of losing rights.
– Publish papers and demonstrate prototypes
• Protect Market
– Enforce rights to prevent unauthorized use.
• Injunction
• Damages ($)
• Source of revenue
• Defensive purposes

PATENT QUIZ

Patent Quiz – True or False?
• A patent application can be updated after it is filed to
incorporate new features.
• Liability for infringement can be avoided as long as
you don’t intend to infringe.
• Patent attorneys are always engineers or have some
technical background.

IDENTIFYING IP

Identifying Intellectual Property
• Patents - Right to exclude others from making, using, selling,
etc.; can help you obtain exclusivity in your market niche
(www.uspto.gov)
– Does not give patent owner right to make, use or sell
invention
• Commonly patented features:
– The device itself
– Key components
– Systems that include the device as well as other parts
– Method of manufacturing
– Method of using
– Materials (drugs, biologics, alloys, plastics, etc.)

Identifying Intellectual Property
• Trademarks - Right to prevent use of marks that are
likely to confuse consumers; can greatly enhance
marketing strategies (www.uspto.gov)
• Copyrights - Right to prevent unauthorized copying,
distribution, etc. of authorship works
(www.copyright.gov)
• Trade Secrets - Protect internal methods, materials;
right to prevent unauthorized use (can protect against
use of proprietary information)

Trademark Examples – Words and Names

Trademark Examples – Designs and Logos

Trademark Examples - Slogans

Trademark Examples - Colors
“NEXIUM and the color purple as applied to the capsule are registered
trademarks of the AstraZeneca group of companies.”

Where is the IP?

Your Novel Idea – A Coated Stent
• Prior Art: Uncoated, bare metal stent
• Problem to Solve: Preventing restenosis
• Patentable Idea: Stent (100) having drug (or protein,
etc.) deposits 106 on metal struts (102) to inhibit
restenosis
Prior Art Your Invention

Potential IP Protection
• A new drug eluting stent
– Patent – configuration of the drug eluting stent,
drug itself, method of depositing the drug on the
stent, method of deploying the stent in a body
– Trademark – product name – “Guardian Stent”
– Copyright – Instructions For Use, Product
Literature, Training Video, software
– Trade secret –method of manufacturing a kink-
resistant introducer sheath

Patents vs. Trade Secrets
Patents
• Rights granted by U.S. Patent
& Trademark Office
• Expensive
• Rights last only 20 years
• Must fully disclose invention
• Right to exclude others from
practicing inventions
– Regardless of whether
copied or independently
derived
Trade Secrets
• Rights easily obtained
• Inexpensive
• Rights last as long as
information is maintained
confidential
• No public disclosure
• Right to prevent
misappropriation
– Can’t stop copiers or
independent derivation

Patents vs. Trade Secrets – How to Choose
• Can invention be reverse engineered?
• What if secret is leaked?
• Will company seek private investment?
• Most technology is protected with patents.

2008 Berkeley Patent Survey
Percentage of Start-Up Companies
Holding U.S. Patents & Applications
39%
24%
82%
67%
76%75%
94%97%
0%
20%
40%
60%
80%
100%
All respondents Biotechnology Medical Devices Software/Internet
Overall population of companies (D&B) Venture-backed companies
Berkeley Technology Law Journal, vol. 24:4, pp. 1255-1328, April 16, 2010.

2008 Berkeley Patent Survey
Average Number of U.S. Patents & Applications
Held By Start-Up Companies
9.7
18.7
4.7
15
1.7
5.9
25.2
34.6
0
10
20
30
40
All respondents Biotechnology Medical Devices Software/Internet
Overall population of companies (D&B) Venture-backed companies
Berkeley Technology Law Journal, vol. 24:4, pp. 1255-1328, April 16, 2010.

Patent Rights
• What right does a utility patent confer?
– The right to exclude others from making, using,
selling or importing the invention
– For 20 years from earliest filing date
• Patents do not provide a right to practice!
– Never say, “We don’t have any risk of getting sued
because we own the patent on our product.”

Consider the Patented Improvement
Stent Nickel-
Titanium
Stent
Covered
Nickel-
Titanium
Stent
Drug Eluting,
Covered,
Nickel-Titanium
Stent
   
Patent
1
Patent
2
Patent
3
Your
Patent

PROTECTING IP

Protecting IP and Product Development
• Public Disclosure Can Prevent Patentability
– U.S. – One Year Grace Period
– Everywhere Else – Must File Beforehand
• Non-Disclosure Agreement
• Always better to file before disclosing

Deadlines for Filing Patents
Public Disclosure Deadline to
File Patent Application
1 year
Public Disclosure
=
Deadline to
File Patent Application
U.S.
Rest of
World

Protecting IP and Product Development
• First-to-Invent* vs. First-to-File
– U.S. changed to a
First-Inventor-to-File
system 3/16/2013
• Keep detailed lab notebooks
• Complete invention disclosure forms
• Save and date prototypes (or photographs)

Requirements for Patentability
Invention as claimed must be
(a) Novel, and
(b)Non-obvious
with respect to the “prior art.”
Prior art includes earlier patents and printed publications
How do you know what is in the “prior art”?

Searching – Why Bother?
• Searching is not required, but helps:
– Assess patentability
– Assess freedom-to-operate (risk)
– Identify key competitors
– Develop design arounds

Searching Strategies
• Key word searching
– www.google.com/patents
– patft.uspto.gov
– www.delphion.com
– Key words – “coated stent
restenosis” or “drug eluting stent”
• Competitor / assignee
searching
• Journals / literature
• Hire a professional

Contents of a Utility Patent
• Cover Page (title, abstract,
searching classification, prior art,
etc.)
• Figures
• Description
– The patent must be
written in full, clear, concise
terms to enable one of
ordinary skill in the art to
make or use the invention.
– The patent must describe
the best mode
contemplated by the
inventor for practicing the
invention (time of filing).
• Claims

Claims
What is claimed is:
1. A drug eluting prosthesis, comprising:
a stent comprising an expandable substrate adapted for implantation in a
vessel of a body; and
a layer of drug eluting compound fixed to an outside surface of said
stent;
wherein:
said layer of drug eluting compound is uniformly deposited about the
outside surface of said stent.
2. The drug eluting prosthesis of Claim 1, wherein the expandable
substrate is made from a nickel-titanium alloy.
3. The drug eluting prosthesis of Claim 1, wherein the drug eluting
compound comprises a drug configured to prevent restenosis.

ASSESSING 3RD PARTY RISK

Survey Competitive Landscape
• Patents only provide a right to exclude,
not a right to practice
• How to identify possible risk:
– Searching
– Patent marking on competitor
products and labeling
– Receiving a letter from a competitor
• It is best to identify problem patents
early, before product design is frozen!

• Who is likely to conduct initial risk
assessment?
YOU!

• What can you do if you find a problem
patent?
– Design-around
– License
– Document internal analysis
– Opinion of counsel
(noninfringement, invalidity)
– Challenge the patent
– Wait
– Drop the project

Reading Claims
• Assess risk of infringing competitor’s patents
• Claims consist of a series of limitations or elements
• All limitations (or, in some cases, equivalents thereof)
must be present for infringement
• All limitations must be performed or provided by the
same entity (with exceptions)
• Compare competitor’s patent’s claims to your product

How to Read a Claim
What is claimed is:
1. A drug eluting prosthesis,
comprising:
a stent comprising an expandable
substrate adapted for implantation in
a vessel of a body; and
a layer of drug eluting compound
fixed to an outside surface of said
stent;
wherein:
said layer of drug eluting compound
is uniformly deposited about the
Your Invention
Does your invention infringe Claim 1?

How to Read a Claim
What is claimed is:
comprising:
stent;
wherein:
Your Invention

How to Read a Claim
What is claimed is:
comprising:
stent;
wherein:
Your Invention
XTherefore, no literal infringement of Claim 1!

CONCLUSIONS

What to Expect
• Maintain accurate and dated records of invention
• Use agreements when working with consultants and
contractors.
• File applications before making public disclosures
• Understand patent landscape and analyze risk early
• Your patent attorney can help!

Inventor Notebooks
• Complete, sign and
witness everyday
• Fill in every page
• Attach drawings,
photos, data directly
to lab notebook page and sign
across borders
• Include things to try in the future
• Use care when
describing competitor
products or patents – what you
say could be used against you
later!

Invention Disclosure Form
• Title
• Contributors
• Has invention been
disclosed outside of
the organization?

• Background
• Problem being
solved
• Known Prior Art
• Description of invention
• Include drawings,
photos, copies of
lab notebook,
engineering
drawings, flow charts

• Advantages
• Why would invention
be important to
competitors?
• Possible
modifications and
additional uses
• Signature of contributors
and witnesses

Medical Device Claim Strategies
w Apparatus claims to protect the device or consumable
An endoluminal prosthesis for treating a diseased blood vessel,comprising: a
stent body having a plurality of struts and a plurality of openings between
said struts,said prosthesis having a restenosis inhibiting agent adhered
thereto.
w Claims to instrumentation used to deliver the device
A delivery device comprising an outer sheath,an inner core advanceable
relative to said outer sheath,and a lumen for receiving a guidewire
therein,wherein said inner core is configured to support a prosthesis
thereon.
w System claims for the combination of components
A system comprising: an endoluminal prosthesis having a restenosis
inhibiting agent adhered thereto; and a delivery device for delivering the
prosthesis to a deployment site within a medical patient.

Medical Device Claim Strategies
w Method claims to protect how it’s used in the IFU
A method for repairing a portion of a diseased vascular tissue comprising:
advancing a delivery catheter to a diseased portion of a patient’s vasculature,
retracting an outer sheath of said delivery catheter,and expanding a
prosthesis against a vessel wall in said diseased portion.
w Method of manufacturing claims
A method for manufacturing a drug eluting stent,comprising: laser cutting a
hollow cylinder comprising Nitinol to form a plurality of struts and openings
in said hollow cylinder; depositing a restenosis inhibiting agent on one or
more of said plurality of struts.

How To Read A Claim
What is claimed is:
1. A method of treating a vascular occlusion, comprising:
i) applying a drug eluting coating to a stent;
ii) loading the stent onto a catheter;
iii) inserting the catheter into a patient’s vasculature;
iv) advancing the catheter to a vascular occlusion;
v) deploying the stent at the vascular occlusion; and
vi) removing the catheter from the patient’s vasculature.
Who infringes Claim 1?

How To Read A Claim
What is claimed is:

Joint Infringement
• Where actions are performed by separate entities, but
one entity acts under direction and control of the
other.
– Examples:
• Contractual obligation
• One entity acts as the agent of the other.
• May be very difficult to show Clinician and
Manufacturer are joint infringers.
• Divided infringement = no infringer

How To Read A Claim
What is claimed is:
Divided Infringement

How To Read A Claim
What is claimed is:
i) providing a catheter, the catheter having a stent mounted near
the catheter’s distal end;
ii) inserting the catheter into a patient’s vasculature;
iii) advancing the catheter to a vascular occlusion;
iv) deploying the stent at the vascular occlusion; and
v) removing the catheter from the patient’s vasculature.

Direct vs. Indirect Infringement
• Direct Infringement
– Entity performing steps is the direct infringer.
– Clinicians may be shielded (pure medical
methods).
– Manufacturer generally preferred target.
• Indirect Infringement
– Does one entity provide a product that has no
substantial use except to infringe?
– Does one entity induce the other to infringe?

Indirect Infringement
• Contributory Infringement
– Are there substantial non-infringing uses for
product used to perform method?
• Inducement
– What is evidence that company knowingly induces
infringement with specific intent to infringe?
• User manuals, training materials, videos, web
sites, sales people, marketing materials
• Would method constitute an off-label use?
• Notify inducers to establish knowledge and
intent.

How To Read A Claim
What is claimed is:
i) providing a catheter, the catheter having a stent mounted near
the catheter’s distal end;
ii) inserting the catheter into a patient’s vasculature;
iii) advancing the catheter to a vascular occlusion;
iv) deploying the stent at the vascular occlusion; and
v) removing the catheter from the patient’s vasculature.
Does Company induce Clinician to infringe?

knobbe.com
Orange County San Diego San Francisco Silicon Valley Los Angeles Seattle Washington DC
Andrew Douglas
andrew.douglas@knobbe.com
(949) 721-7623
Shannon Lam
shannon.lam@knobbe.com
(949) 721-6366

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