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Intellectual Property Considerations
During Product Development
Agnes Juang
April 28, 2012
SABPA 7th Annual Biomedical Forum
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1. Patent Quiz
2. Identifying IP
3. Protecting IP
4. Assessing 3rd Party Risk
1. Patent Quiz
2. Identifying IP
3. Protecting IP
4. Assessing 3rd Party Risk
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 4
Patent Quiz – True or False?
• A patent grants the inventor the right to make, use, sell, and
import his or her invention?
– False
• The person who pays for the inventing owns the patents.
– False
• A method of performing a medical procedure may be patented.
– True
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5
Patent Quiz – True or False?
• Improvements to old technologies may be patented.
– True
• A patent application can be updated after it is filed to incorporate
new features.
– False
• Liability for infringement can be avoided as long as you don’t
intend to infringe.
– False
1. Patent Quiz
2. Identifying IP
3. Protecting IP
4. Assessing 3rd Party Risk
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7
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
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Potential IP Protection
• A new drug eluting stent
• Patent
Configuration of the drug eluting stent, drug itself, delivery system, 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
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9
Patents vs. Trade Secrets
• Patents
– Rights granted by U.S. Patent
& Trademark Office
– Expensive
– Must fully disclose invention
– Rights last only 20 years
– Right to exclude others from
practicing inventions
• Regardless of whether
copied or independently
derived
• Trade Secrets
– Rights easily obtained
– Inexpensive
– No public disclosure
– Rights can last forever
• But rights are lost as
secrecy lost
– Right to prevent
misappropriation
• Can’t stop copiers or
independent derivation
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 10
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.
– 94% of venture-backed start-ups own patent or application
– Venture-backed start-up holds in average 25 patents &
applications
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 11
Consider the Patented Improvement
Stent Nitinol Stent
Covered
Nitinol
Stent
Drug-eluting
Covered
Nitinol
Stent
Patent 1 Patent 2 Patent 3 Your
Patent
1. Patent Quiz
2. Identifying IP
3. Protecting IP
4. Assessing 3rd Party Risk
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 13
Protecting IP and Product Development
• Use non-disclosure agreements and assignments with third parties
• Secure ownership with employee contracts and consulting agreements
• Keep detailed inventor notebooks
• Complete an invention disclosure
form
• Save and date prototypes (or
photographs)
• Involve the IP team at this stage
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 14
Protecting IP and Product Development
• File before public disclosure
– U.S. provides a one-year grace period.
– Most countries bar patent upon public disclosure.
– Public disclosure before filing can lead to lost rights.
Public Disclosure Deadline to File
1 year
Public Disclosure = Deadline to File
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 15
Invention as claimed must be
(a) Novel, and
(b) Non-obvious
with respect to the “prior art.”
How do you know what is in the “prior art”?
Why would you care?
Requirements For Patentability
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 16
Searching – Why bother?
• Searching is not required, but helps:
– Assess patentability
– Assess freedom-to-operate (risk)
– Identify key competitors
– Develop design arounds
• Types of searches
– Do-it-yourself (Internet, Google Patents,
Trade Journals, Medical Databases)
– Professional searching (former Examiners)
– Industry searching for marked products
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 17
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.”
1. Patent Quiz
2. Identifying IP
3. Protecting IP
4. Assessing 3rd Party Risk
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 19
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!
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 20
Survey Competitive Landscape
• 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
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 21
Reading Claims
• Assess risk of infringing competitor’s patents
• Compare competitor’s patent’s claims to your product
• Claims consist of a series of limitations or elements
– All limitations (or, in some cases, their equivalents) must be present
for infringement
– All limitations must be performed by the same entity (with
exceptions)
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 22
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.
How To Read A Claim
Your Invention
Does your invention infringe Claim 1?
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 23
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.
How To Read A Claim
Your Invention
X Therefore, no literal infringement of Claim 1!
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 24
Take Home Points
• Maintain accurate and dated records of invention
• Use agreements with consultants, contractors, and employees
• File applications before public disclosure
• Understand patent landscape and analyze risk early
• Monitor IP and product development trajectories
• Consider all forms of IP protection
• Your IP attorney can help!
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 25
Thank You! Agnes Juang, Ph.D., J.D.
Agnes.Juang@knobbe.com