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.)

http://www.uspto.gov/


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)

http://www.uspto.gov/

http://www.copyright.gov/


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

1.75.9

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!

http://ucirvine.cbscollegestore.com/store_contents.cfm?store_id=348&dept_id=8850&product_id=146506

http://ucirvine.cbscollegestore.com/store_contents.cfm?store_id=348&dept_id=7348&product_id=186264



• 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:




wherein:


Your Invention

Does your invention infringe Claim 1?


How to Read a Claim

What is claimed is:




wherein:


Your Invention


How to Read a Claim

What is claimed is:




wherein:


Your Invention

X Therefore, 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?

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