building an effective ip portfolio without breaking the bank - john sadler, cervel neurotech
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Building an Effective IP Portfolio without Breaking the Bank - Presentation by John Sadler, Vice President, R&D, Cervel Neurotech delivered at the marcus evans Medical Device R&D Summit June 2014, held in Las VegasTRANSCRIPT
Managing an IP Portfolio
Without Breaking the BankJohn SadlerJune 2014
Before we beginBefore we begin…
I am not an attorney I am not an attorney I do have a great deal of relevant experience in multiple markets
The ideas in this presentation should help you work ff ti l ith IP l t l th t more effectively with IP counsel – not replace that
interaction
When in doubt, consult your IP attorney
GoalsGoals
Improve patent portfolio cost-effectivenessImprove patent portfolio cost effectivenessEvaluate and tune a patent portfolioManage an invention pipelineManage an invention pipeline
Review: What is Intellectual Property?Review: What is Intellectual Property?
Patents Trademarks Copyrights Trade SecretsPatents, Trademarks, Copyrights, Trade SecretsNot just patents! You have options.
The Patent Bargain: Disclose your invention in exchange for a limited monopoly
IP is an offensive weaponA Sword, not a ShieldIf you rest on your rights, you may lose themIP d t di tl t t f l it ll ti f IP does not directly protect you from lawsuits or allegations of infringement
More ReviewMore Review
P t t t ifiPatents are country-specific
Patent Cooperation Treaty provides some commonality
“Defensive value” If there is a credible threat of countersuit or invalidationIf there is a credible threat of countersuit or invalidationA filed patent or portfolio has some deterrent valueIn a crowded field, claim scope and validity tend to suffer
Some industries thrive on cross-licensing
What makes a patent valuable?What makes a patent valuable?
V lid l iValid claims
…that result in a working invention,g
…that have (or will have) market value somewhere,
…that are not easy to work around,
for which infringement can be detected…for which infringement can be detected
What makes a claim valid?What makes a claim valid?
S t d b th t hiSupported by the teachings
Clearly states the nature of the inventiony
Not anticipated by prior art
Not previously published or disclosed
Equitable conduct on the part of the claimantsEquitable conduct on the part of the claimants
Note: SCOTUS has been active on this topic lately
Patent / App EvaluationPatent / App Evaluation
Criterion RatingCriterion RatingDo we practice this invention?How likely are we to practice in future?yDoes a competitor practice this invention?How likely is a competitor to practice in future?How easy is it to detect infringement?How sure are we that the claimed invention works?How hard is it to work around the claims?How broad are the claims?H h d l d h f thi ?How much coverage do we already have for this?(Issued patent) Is the patent valid?(Issued patent) How long until expiration?(Issued patent) How long until expiration?
Where to FileWhere to File
Where the markets areWhere the markets areMarket = Need + Ability to PayWhere competitors have a marketp
Where competitors manufacture or have filedWhere investors are located or want you to fileWhere investors are located or want you to fileFile your best patents more broadly than the weaker onesonesOnly the US and AU allow “method of treating patient” claims
When to FileWhen to File
When potential claims have valueWhen potential claims have valueBe cautious about speculative claiming – invest in doing the research insteadresearch instead
Prior to public disclosure or offer for saleIn the US you have 1 year grace Not so OUSIn the US, you have 1 year grace. Not so OUS.
File provisional apps early and update them!
Alternative to Filing PublishAlternative to Filing - Publish
Consider publication when:Consider publication when:You need freedom to operate It’s difficult to detect infringementgClaim space is crowded (potential claims are narrow)
PS: Cheapest way to establish a priority date!
Alternative to Filing – Trade SecretAlternative to Filing – Trade Secret
Consider keeping secret if:Consider keeping secret if:Infringement is hard to detectInvention is difficult to claim in desired localesDesired locales do not respect IP lawInvention is hard to reverse-engineer
NotesM t b t hMust be secret everywhereFor trade secret protection to apply, you must have supporting evidence of efforts to control the secretpp g
Prosecution CostProsecution Cost
US utility filing typically costs $30K-$50K to issueUS utility filing typically costs $30K $50K to issueMuch less if you write and prosecute yourself More if you are a “large entity”y g yAnd then there are maintenance fees…
Foreign filings may cost 2x more“Method of treating human patient” claims are not
i d t id th US d AUrecognized outside the US and AU
Prosecution CostProsecution Cost
Consider preparing and filing your own provisional Consider preparing and filing your own provisional application ($100 plus your time)
Many countries allow cost to be deferredUS provisional application – 1 year, no examinationp pp yUtility model (many countries including CN, EC, Australia)
One way to defer cost in US and get a filing date:US Provisional PCT national phase
Ways to Waste MoneyWays to Waste Money
Prosecuting low-value claimsProsecuting low value claims
Inventor too hands-off
Prosecution delays caused by:Fail re to search prior art diligentlFailure to search prior art diligentlySpeculative claiming – not enough research to know what is critical to making it workFailure to grasp and clearly describe what is novel
Filing in the wrong localesFiling in the wrong localesWhere there is no market for the inventionWhere IP law is not enforced vigorously
More Ways to Waste MoneyMore Ways to Waste Money
Inequitable conductInequitable conductOmitting inventorsFailing to notify PTO of relevant g yprior art
P fid ti lit Poor confidentiality practices
Disclosing invention without Disclosing invention without NDA protectionPoor NDA hygieneReview marketing materials!
Summary: Patent Portfolio ManagementSummary: Patent Portfolio Management
Evaluate patents and applications as a groupEvaluate patents and applications as a groupRank according to value criteriaReview periodicallyp yDefer prosecution to give lower value ideas time to matureAlways look at new opportunities in portfolio contextFocus money and effort on the most valuable applications
Minimize costMinimize costUse provisional or utility model apps where possibleHave inventor write as much of the disclosure as possibleHave inventor write as much of the disclosure as possibleKeep inventor involved in utility app drafting processChoose foreign filing locales carefully
What is an invention pipeline?What is an invention pipeline?
A deliberate way to foster inventions leading to A deliberate way to foster inventions leading to valuable patents
Relies on two-way communication:What fields are under-claimed What ideas fit into valuable fields
P i it b i i htf l b tPrerequisite: be insightful aboutThe needs and problems of the marketYour own and your competitors’ patent positionsYour own and your competitors patent positionsTechnical capabilities of your organization
Invention PipelineInvention Pipeline
Invention Pipeline – how it worksInvention Pipeline – how it works
Analyze market needsAnalyze market needsIdentify key problems and opportunitiesHow could the existing market be disrupted?g pThese should be focus areas for inventing and patenting
Understand competitive IPOver-claimed areas – concentrate on freedom to operateUnder-claimed areas – invent here if possible
Id tif i tf liIdentify gaps in your portfolioDiscuss opportunity areas and rationale with team
M k i t f d titi IPMake inventors aware of own and competitive IPGive filing priority to high-value disclosures
Invention Pipeline NotesInvention Pipeline Notes
Look for claims in Review periodically:Look for claims in supporting technologies!
Safety
Review periodically:Your portfolio statusCompetitive IPy
UsabilityCalibration / accuracy
Competitive IPFTO threatsInventions in process
Energy managementManufacturingAccessories
Lab notebooks
AccessoriesPatient Compliance
Best practicesBest practices
A patent portfolio is an investment portfolioA patent portfolio is an investment portfolioCompare alternativesRe-evaluate periodically
Be aware of competitive IP, Freedom To OperateSearch periodically (this has gotten easier)Maintain a tracking sheet with your attorneyMaintain a tracking sheet with your attorney
Use the attorney-client privilege correctlyGood discoverable document hygieneGood discoverable document hygieneGood NDA hygieneGood lab notebook practicespHave a document retention policy
And audit periodically
Final ThoughtsFinal Thoughts
A patent portfolio is mainly a business tool, not an A patent portfolio is mainly a business tool, not an inventor recognition tool
Maintain a tracking sheetl l t di l i t tAlways evaluate disclosures in context
If you sit on your rights you may lose themIf you sit on your rights, you may lose themLabel your product with applicable patent numbersIf you are sure of infringement, you must act
“Just because you’re paranoid doesn’t mean they aren’t after you”aren t after you
A strong portfolio doesn’t mean that you won’t get suedMaintain current FTO arguments