Intellectual Property Considerations During Product Development

Intellectual Property Considerations
During Product Development April 28, 2012

Agnes Juang SABPA 7th Annual Biomedical Forum

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1. Patent Quiz

2. Identifying IP

3. Protecting IP

4. Assessing 3rd Party Risk

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. 4

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


Your Novel Idea – A Coated Stent

Prior Art Your Invention

• 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


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


Patents vs. Trade Secrets
• Patents • Trade Secrets
– Rights granted by U.S. Patent – Rights easily obtained
& Trademark Office – Inexpensive
– Expensive – No public disclosure
– Must fully disclose invention – Rights can last forever
– Rights last only 20 years • But rights are lost as
– Right to exclude others from secrecy lost
practicing inventions – Right to prevent
• Regardless of whether misappropriation
copied or independently • Can’t stop copiers or
derived 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.
– 94% of venture-backed start-ups own patent or application
– Venture-backed start-up holds in average 25 patents &
applications


Consider the Patented Improvement

Drug-eluting
Covered Covered
Nitinol Stent Nitinol
Stent Nitinol
Stent Stent

   
Patent 1 Patent 2 Patent 3 Your
Patent


Protecting IP and Product Development
• Use non-disclosure agreements • Keep detailed inventor notebooks
and assignments with third parties

• Complete an invention disclosure
form
• Secure ownership with employee • Save and date prototypes (or
contracts and consulting photographs)
agreements • Involve the IP team at this stage


Protecting IP and Product Development
• File before public disclosure
– U.S. provides a one-year grace period.

1 year

Public Disclosure Deadline to File

– Most countries bar patent upon public disclosure.

Public Disclosure = Deadline to File

– Public disclosure before filing can lead to lost rights.


Requirements For Patentability

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?


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


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.”


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!


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


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)


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;
Your Invention
wherein:
said layer of drug eluting
compound is uniformly
deposited about the outside
surface of said stent.

Does your invention infringe Claim 1?

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;
Your Invention
wherein:

X
said layer of drug eluting
compound is uniformly
deposited about the outside
surface of said stent.

Therefore, no literal infringement of Claim 1!

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!


Agnes Juang, Ph.D., J.D.
Thank You! Agnes.Juang@knobbe.com

Intellectual Property Considerations During Product Development

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