intellectual property considerations during product development

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

© 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


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



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, 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

– 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


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

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



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


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


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


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.”

1. Patent Quiz

2. Identifying IP

3. Protecting IP



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)


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?


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!


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!

Thank You! Agnes Juang, Ph.D., J.D.

[email protected]

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