Digital Healthcare - U.S. IP strategy
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U.S. IP Strategy for Digital Healthcare
Transcript of Digital Healthcare - U.S. IP strategy
U.S. IP Strategy for Digital Healthcare
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Digital Health Trend
Source: 2016: The Health Moonshot Movement (http://startuphealth.com/reports)
Digital Health Funding Snapshot
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Top 10 Digital Health Deals of 2016
Source: 2016: The Health Moonshot Movement (http://startuphealth.com/reports)
DIGITAL HEALTHCARE
Software + Electronics + Mechanics
Biotech + Chemistry + Medicine
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Digital Healthcare – IP Perspective
What is Digital Healthcare?
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Tech Convergence – New IP Opportunities
Digital Healthcare
Genomics/Proteomics
Mechanical Sensors
Chemistry/Medicine
Health IT/Services
Software/ Apps
Big Data/Algorithm/
AI
Telehealth/Mobile/GPS
Medical Imaging
Jawbone (Activity Monitor) FootLogger (Shoe Sole for Fitness Tracking)
Mimo (Baby Status Monitoring) SmartyRing (Smart Ring)
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Examples of Wearable Devices
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Wearable Forerunner – Fitbit
• 22.3 Million units sold
• 23.2 Million active users
• 2016 Revenue: $2.2 billion
• Wearable tech market share: 34%
US 8,818,753 – Methods and systems for processing social interactive data
US 9,198,604 – GPS power conservation using environmental data
US 9,196,964 – Hybrid piezoelectric device
US D749,002 (design) – WristbandHealth Tracker
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Fitbit Patent Portfolio
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Fitbit Patent Portfolio
Source: Mandi Gingerich et al, Fitbit
Alta Teardown, Chipworks 2016
(http://www.chipworks.com/about-
chipworks/overview/blog/fitbit-alta-
teardown)
• U.S. International Trade Commission (ITC) litigation:
– Jawbone sued for Fitbit’s trade secret misappropriation.
– ITC: Fitbit did not misappropriate Jawbone's trade secrets.
• U.S. Federal Patent litigation:
– Fitbit sued for Jawbone’s patent infringement.
– Fitbit’s two patents are invalidated under §101 (patent eligible subject matter).
Fitbit v. Jawbone
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Vs.
1. Freedom To Operate (FTO)
– Any potential infringement?
– Any risks to be sued?
2. Ownership & Transferability
– Owner of your IP?
3. Validity & Enforceability of IP
– Protect target product?
– Strong IP?
– Patent, Design Patent, Trademark, Trade Secret
Main IP Points to be Checked
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• Investigation to determine if you infringe patents of others
• Expensive process but necessary for commercialization
Freedom To Operate (FTO)
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• Keytruda: Merck’s cancer immunotherapy
• Annual sales: ~$700M
• Merck settles with BMS to pay $625M for past patent infringement.
• In addition, Merck pays royalty for future sales.
Patent Infringement Case
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vs.
• Samsung Galaxy: Sued for utility and design patent & trade dress infringement
• Apple design patents: Round corner designs
• Damages: $1B $399M remanded $??
Design Infringement Case
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vs.
• Oculus (Facebook): Sued for breach of non-disclosure agreement (NDA) and copyright infringement
• Damages: $500M (District Court, TX) for TM and copyright infringement
TM/Copyright/Trade Secret Case
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• Source: PwC 2016 Patent Litigation Study (May 2016)
FTO - Patent Damages in U.S.
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Source: http://ptopatenttrials.com/2012/05/20/uspto-post-grant-opposition-costs-a-forum-conveniens-for-
invalidity-disputes/
FTO – U.S. Litigation Costs
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• Assess potential litigation risks in U.S.
• U.S. litigation is very expensive!
• Conduct FTO Search
– Conduct patent searches regularly
– Search competitors’ patents
• Monitor screened patents/applications
• Keep search/review record
– Patent search/review assessment
• Consult patent counsel
FTO – ID Infringement Risks
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1. Who is owner of IP?
a) Determine true inventors – Assignment
b) Incorrect inventorship – enforceability?
2. Ownership Transfer - Assignment
– Check chain of title
– Review assignment recordation
– Tip: Obtain signatures as quickly as possible
3. Potential ownership leaks
– Collaboration, Government support, etc.
IP Ownership
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1. Patent Exploitation in U.S.
a) Each joint owner can exploit without
permission of others
b) No duty to share royalties
2. Patent Enforcement in U.S.
a) All joint owners must join suit
b) Other owners can grant license
(circumvention)
Avoid Joint Ownership!
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Three Stages of Patent Acquisition:
A. Invention and Prior Art Search
B. Patent Preparation
C. Patent Prosecution
Acquisition of Strong Patent
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• Two possible approaches:
vs.
1. Alice and Mayo Decisions
2. Novelty
3. Non-obviousness
4. Written description/enablement
5. IDS practice (submission of prior art)
Acquisition of Strong Patent
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• Anticipation and Obviousness– Collect prior art info
– Cross-check references
– Competitor’s patents and publications
• Section 101 Patent Eligibility – Alice, Mayo & Myriad cases
• Inequitable Conduct (Duty of Candor)– Cross-check related applications
– Review inventor publication files
• Enablement and Written Description
Patent Validity
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U.S. Design Patent
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Utility Patent Design Patent
Protects construction or function, not appearance
Protects appearance, not construction or function
Allows product to be marked patent pending
Allows product to be marked patent pending
20 years from the filing date 15 years from issuance
Usually harder to get and more expensive than a design patent
Usually easier to get and less expensive than a utility patent
Allows recovery of infringer’s profits
• Protection: The aesthetic appearance of a product
• Patent Term: 15 years from issuance
• No maintenance fees
Examples of Design Patents
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Assay devices – D676,570 Reagent holders – D665,095
Appearance of pills – D437,407 Computer icon – D613,750
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GUI & Animated Designs
• Nike: US D676,457 – Animated Design
• Apple: US D604,305, D675,639 & D704,212 – GUI
GUI & Animated Design
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Display panel design – D736,250 Animated GUI – D457,164
Monitor display – D635,581 User interface – D725,662
• Trademark: Product/company name, app logo/icon, slogan, trade dress, app sound
Trademark
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Examples of Trademark
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3D configuration with color – Reg. 5,105,411
Orange color mark on exterior– Reg. 4,047,198
Gold color applied to images – Reg. 4,558,121
Blue curved stripe – Reg. 4,570,773
Copyright
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• Copyright Protection
– Idea vs. Expression
– Registration: Not a condition of copyright protection1) Statutory damages, and
2) Attorneys’ fees
• Software Copyright Registration
– Deposit: First 25 and last 25 pages of source code
– Copyright Office Guideline: Copyright Registration for Computer Programs (https://www.copyright.gov/circs/circ61.pdf)
Trade Secret
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• Defend Trade Secrets Act (“DTSA”): April 2016
– Creates a civil/private cause of action for trade secret misappropriation
– Creates a federal cause of action for trade secret misappropriation
– Provides for jurisdiction by the federal courts
• Remedies:
– Damages, unjust enrichment, exemplary damages (up to 3X), attorney’s fees, seizure of trade secrets
Trade Secret
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• Identify proprietary information that is vital to the business
• Identify obvious risk situations
• Implement a corporate policy regarding confidential information/trade secrets
• Confidentiality agreements (CDA’s) with employees – Non-compete provisions
Check non-conventional IP protection options
Check FTO issues regularly
Make sure ownership of your IP
Build strong IP portfolio
Take Home Message
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Questions?
Kisuk Lee이기석
Patent Attorney (U.S./KR), PartnerHarness, Dickey & Pierce
+1-314-446-7670 – work+1-324-775-8771 – cell
[email protected]/ksluspat – IP blog
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