Medical Device Commercialisation Training Program
Last week I had the pleasure of going to the medical device commercialisation training program (part 1) at Wollongong's Innovation Campus. It was a highly worthwhile day with lots of examples, a great deal of useful content, and application process information. As always I include the disclaimer at the top of this web page-- any errors in my note taking are my own. The notes are ill-formatted but I hope this does not detract from readability. I've tried to maintain some consistency throughout. The notes are my interpretation of what was said, notes from the board, and separate thoughts/reflections of my own on occasion.
Introduction
Deep tech innovations
Redfern. 70 companies
Industry-agnostic, not just medical.
Life sciences, devices, diagnostics, robotics/hardware, enterprise software
500 patents in building
70 start ups
110M private and public funding
UTS, UNSW, USyd, ANU
Incubator Process:
Pre-acceleration
Acceleration
Incubation
NSW Health (resmetal, next cochlear)
THREE COURSES:
Ignition IP – base level skill (being informed)
Ignition Health – 12 week course (work in teams). Break down biases.
- Customer discovery – finding the right business model
- Team based
- Experiential learning
- Lots of customer interviews
- Scientific method to the market
- What are the assumptions making around
- What are the pain points
Ignition CORE – Flagship. Run for 3 years. Intensive commercialisation course
- Commercial aspects of building your medtech business
o Intellectual property management
o Market analyses and customer archetypes
o Product development
o Regulatory and reimbursement strategy
o Financial modelling
o Valuation
- Ignition show case. 300 people. 950K of awards
50 graduates
11 companies
$20M in public/private funding
An Introduction to Intellectual Property
Gavin Recchia
Principal Patent Attorney
Davies Collision Cave (law firm)
- Process, device, method
What is IP?
- Trademarks etc
- Innovation is only good as your ability to exploit it
- How can you apply, an application, and a scenario that is used
- Draw benefit to the exclusion of others
- How is the public good best served by my work and its dissemination?
- What is the public good?
o Turning into clinical advance and turned into clinical setting
o Not really to go to journal but what else?
o IP protection and publication
§ Protect or perish ; publish or perish?
- In the patent you are publishing in more detail than you can imagine.
o Patent protect first, and then publish
- Product of thought, creativity, and intellectual effort”
o Industrial, scientific, literary, artistic fields
- Intellectual property rights are those right available to protect knowledge
- Intangible assets
o More difficult to quantify and define but most important (as opposed to trucks)
§ Australia has invested in tangibles not intangibles OECD (share of GDP)
o Not good on R&D and other intellectual property products
- Seems to be a cultural things.
- Patent filings: applications. Australia is flat. Zero growth.
- AU medical device innovations
o Health costs, population increases
§ Pressure to innovate in healthcare increases
o Have skills and track record
o Cochlear, REsMed (sleep medicine and non-invasive ventilation—sleep apnea), Compumedics (neurological), Optiscan, Impedimed (bio for lymphedema)
o (1) Copyright, (2) trademarks, (3) industrial design, (4) patents
- Copyright
o Exists automatically. Protects literary and artistic
o Dramatic works, musical works, Recordings and broadcast
o Published editions
o Protects the expression of something and not the idea itself
§ Demonstrate that they COPIED your work, not independent creation
§ In workplace it depends on your contract
o Control over restricted acts (reproduction, sale, performance)
o They are exclusive rights—right to stop someone else from reproducing
o International in scope
o Lifetime of the author +50-70 years after their death
o Can be licensed like a key to a house
o Protects expressions and not ideas
- Branding
o Trademarks
o Logo
o Registered names
o Domain names
o Copyright in and logos
o Registered Trademark
§ One registered and the other asserted by common law
§ Stand out in the crowd
o Trademarks:
§ Word, phrase, symbol, shape, color, scent, sound
· Associates sign and image with a service
· Coca-cola
§ Can be registrable
§ Threshold of distinctiveness
§ Lifetime – indefinite
§ Use or lose
· Cadbury – colour purple- it work
· BP tried to do it for green- did not work
· Harley Davidson—sound of HD
· Sound of lion in Metro Mayer (movie)
· Apple symbol- woolworths, household goods, NO from apple
o Apple was on green trucks of woollies and white in apple
§ Aldi is example of almost predatory
· Against substantially identical or deceptively similar designs
· Keep paying fees to that country
· Different in each country (geographic)
· Coca-cola—150 countries….
· If not used for more than 3 years then it can be taken away from you
o Demonstrate using it as a trademark
o Sufficient reputation developed within
§ TRADEMARK EXAMPLE
· 818621
· Word: ResMed
· Class 10
§ 562396
· Word: VPAP vPAP
· Class: 10
· Certain subset of goods and services
§ 1158806
§ Samba
§ Class: 10
§ Different applications
o Another trademark 796827 Samba, Bon Food Class:30 coffee
o Samba x 2
o Wind surfer, eski, Kleenex, hoover, windsurfer, post-it notes (3M)
§ Trademark rights on that word
§ SO familiar that they buy your product but not too familiar that they buy others also
o Not Prima Facie Registrable
§ Kind, quality, quantity, intended purpose, value
§ Geographical origin, time of production, any characteristic of product
o Advantages
§ Exclusive right to use trade mark and to obtain relief for infringement
§ Authorised use
§ Maintenance of trademark by renewal
§ Customs provisions
§ Deterrent effect of registration
§ Policing of trademarks register by Registrar of Trade Marks
§ Rights to assign/ record interest
o Disadvantages
§ Procedure
§ Time and cost
§ Obligation to maintain and police registered trade mark
· Non-use issues
· Renewal requirements
§ Update changes
§ Pay fees to maintain each year
· Apply -1-2K
o Make your trademark stand out
§ Distinctive, memorable
· Fanciful or coined terms, arbitrary marks
· Avoid descriptive or generic terms
§ Gianturco-Rubin Stent, Taxus Stent, Taxus Liberte
o Avoid generecising mark
o TMs and Business names
§ Cannot register a business name unless y ou have done a trademark search. Because you can have a business name, a domain name, but trademark can belong to someone else.
- Industrial Design
o Protects visual appearance of an article
§ Does not protect functionality
o Monopoly over appearance
§ As indicated by representations
§ Lasts for about 10 years
o Shape of a device (appl trademark ipads, syringes etc)
o Shape, pattern, configuration, ornamentation
o Cars, tyres, tyre treads
o Protects appearance but NOT functionality (so you need a patent also)
o Applied to medical devices, electronics, vehicles
o Prevents direct reproduction of design
o Can be obtained quickly
o Add to commercial value of a product
§ Attractive and appealing, marketability
o Catheter, wheel chairs, movement devices, stretches, stents, mesh, walking frames
o TWO DESIGNS: AU 321356 vs AU 319213 (very similar). Swivel with steering variation.
o Simply protects DIRECT COPYING
o One thing to say you can do it, another to say it is WORTHWHILE endeavour to get IPx
- Trade Secrets
o Need to control disclosure or use of information
§ Technical data, business information..
o Must be kept confidential
o Not reverse engineerable
o Are not property
o Can suffer from leakage
o Duration- as long as you keep the secret
o Coca-cola… 2-3 people who know… cannot go on same plane… confidential
o 17 years (original patent)
- Patent Overview
o Protect functionality of products, methods or processes
o Idea must be:
§ New: novel
§ Inventive: not obvious
§ Not excluded
· Exclusionability of patents
o Provides exclusive right to prevent others exploiting the invention
§ Does not provide freedom to operate
o Philosophy
§ Promote R&D and innovation in industry
§ Offering a reward to the inventor
§ For the right to publish details of the invention
§ So the public may eventually use it
§ And other may work around it
· Lasted 600 years
o Monopoly of 20 years – limited duration
o Contract between inventor and state – quid pro quo
o Territorial in scope
o Requirements
§ Patentable subject matter
§ Novelty
§ Inventive step/ innovative step
§ Specification
§ Utility
o Formal application/ examination process
o Difficult: novelty and inventiveness… to prove… this is the prior art
o Innovation Patents
§ 8 year monopoly right
§ Protect innovations
§ Obtained quickly 4-6 years
· But these were new but not really INVENTIVE
o Problem is that it was highjacked by big players not SME
§ Commercially useful assets
§ Barrier to entry
§ Likely to cease to exist given gov report
§ Road barrier court case
· Substantial contribution to innovation (flexible road barrier)
o Durapost vs Delnorth
o Road post of spring steel with barb!
o More difficult to invalidate than standard patent as no inventive step enquiry.
o Useful for small things in increment
§ Lucentis by Novartis
· Ranibizumab treating AMD macular degeneration
· Prefilled syringes containing products with dosage amounts
· Not chemical, not syringe but TWO THINGS
· 8 AU innovation patents ($500M sales in 2015)
· Versus Bayer product [became a strong tool]
o Patent-eligible Subject matter
§ New machines, devices
§ New compositions
§ New use of known object, substances etc
§ Methods of doing things
§ Processes for making things
· Improved processes for making known things
§ Combinations of known things
· Synergy or unexpected interaction
§ Can use SAME device for a different application (method patent)
o Australia: NRDC case (1950s)
§ Artificially created state of affairs
§ In a field of economic endeavour
§ * cannot patent genes which are same as sequence in nature
§ Needs to be $
§ Can’t patent nature
o Europe
§ Methods of treatment by surgery or therapy, and diagnostics, practiced on a human or animal body excluded
o US
§ Anything made by man under the sun (1980s)
§ A beer barrel on a head
§ US Patent 5,443,036 (cat and beams)
· Laser beam on a wall get cat to exercise
§ Just because you can get a patent it doesn’t mean you should.
- If not an enforceable invention DO NOT patent it.
- Does it align with business plans.
o Must align with commercial objectives
- Not always:
o Medical treatments
o Diagnostics
o Software
o Ecommerce and business methods
o Gene sequnces
- Typucally
o Machines, devices, hardware
o Processes, techniques, methods
o Compositions, materials
o GMOs (Except animals?)
- Kit, collocation, working directions etc
o Generally a kit of parts none of which are novel, is not patentable
o Very important in diagnostics field
- Case Study: B Braun Melsungen AG
o Family business since 1839
o Safety IV catheters
o Invention borne out of AIDS treatment
o Prevention of needlestick injuries
o Sales in excess of $500M
- Case Study: Ultimate Medical (Aussie)
o Laryngeal masks and other airways management
o T-Bag
o Single use oxygen enhancement device
o 2013 acquired by Teleflex
- Case study: Nurofen
o Boots developed Ibuprofen (1961)
o Launched in 1969
o Patent expired in 1980s
o Exclusivity in improvements
o Value in trademark maximised
Different Types of IP and IP Rights
Why is IP important?
- No one is giving the $ to you after the fact
- Proprietary knowledge of a business
- Most important asset owned
- Large industries are founded on IP
- Gives competitive edge in marketplace
- Software: copyright in code
- Pharmaceutical: Patents on drugs and their uses
- Nike: Swoosh (nike label) Just do it.
- Expensive process. Prevents copying and freeloaders. Recoup product costs
o Feasibility study and market research
o Prototyping and product development
o Marketing
o Developing manufacturing/ distribution capabilities
- Example: cost of bringing pharmaceutical to market is $800 million
o Dimasi, Hansen and Grabowski (2003)
- Valley of death – lack of funding
- As development goes up, funding goes down
- Government funding initially and then private sector funding kicks in
- Market monopoly
o License invention to have a revenue stream
o Negotiation tool
§ Offering cross licensing
- Defence against other people’s rights
- Directors’ Obligations
o IP assets represent a disproportionate amount of a company’s value
o Need to manage and take steps to protect IP in your company
o A director may be personally liable if they direct an organisation to commit an infringement of third party IP
How to talk about your secret sauce without giving it away
Value, usefulness, monotone, who are you speaking to? Technical low-down, know your audience
- What is the unique inventive step that needs to be protected
- Know the boundaries
- Everything else can be shared
- Know your audience- craft the story.
- Their pain points, their problems.
- Customer vs physician.
- Don’t care about the technology—but it is the impact.
- What value do you create?
- Potential investors, partners, buyers
o Cook Medical
o Meet people to work with
- What’s in it for you?
- What’s in it for them?
- Can they replicate what you do?
- To sign an NDA or not?
- Medtronic or Boston Scientific
- A lot of investors will NOT sign NDAs. No time.
- VC – institutional seasonal investors. No opportunity to steal ideas and go elsewhere but Medtronic might.
o With a larger corporate have an NDA.
o Very first meeting you would not sign an NDA. Getting to know you.
o Due diligence process… NDA would be signed.
o If patent not granted yet, be low key (20 year monopoly)
- Have a logical story. Share the vision.
o Problem: how many, where, how bad?
o Solution
o Market: size and opportunity, service delivery
o Traction
o Defensibility
o Business model
o Pricing
o Timeline
o The Ask
o * What is the impact—that is what it comes down to.
- Business Model Canvas
Customers:
- Users (hospital, physician?)
- Choosers (hospital, physician?)
- Payers (admin, patient?)
- * That jobs do they need to get done. Could be social or emotional jobs. Admin. What are KPIs you have to meet? Patient satisfaction rating.
- Customer jobs: A, B, C. There are gains and there are pains.
- Customer interviews that are face to face.
o Body language is a big indicator.
Value Propositions:
- What is your offering?
- What pains are relieved?
- What gains do you create?
- *Is your solution a Vitamin vs Pain Killer
Match Value propositions to customers
- Clayton christenssen, milk shakes, time….what wearing… with who?
- Staying in store? Innovators Dilemma
- Half of milkshakes sold by 8.30am MCDONALDS
- Nearly all had a long commute to work
- Boring…stuck in traffic, peckish, limited by hands… (pain relievers)
o Gains: quick, convenient, guilt-free MATCH (Gain creators)
PATENTS: What do I have to do?
Novelty
- Has this thing ever been done before?
- Anywhere in the world before?
- Prior art
- Prior art must contain an “enabling disclosure”
- Subject matter of patent application is compared against publications and prior use from anywhere in the world
Inventiveness
- The invention must involve creative thought or ingenuity
- “If this exact thing hasn’t been done before (i.e. it is novel), what is the difference (i.e. step) from what was done before what is being done now? Is that step inventive?”
- Is it obvious?
- Non-obvious… but to whom?
o Hypothetical person skilled in the art (PSA)
- Thresholds differ in different jurisdictions
Australia
- We look at common general knowledge
o Would I directly be led to do this because I thought it was going to work
US
- Reasonable expectation of success
Europe
- Obvious to try
Description
- Invention must be fully described
- Description must provide “best method” of performing the invention
- Claims must not be too wide, considering what is disclosed in the specification
- US: must enable the working of the invention, and show the applicant was “in possession” of it
Patent Claim
- Describe the invention in ONE sentence
- Think about the advance mad over the state of the art
- Think about different possible embodiments to avoid being too narrow
Groundbreaking
A light emitting device compromising: an electricity conductive medium adapted to emit light when an electric current is passed therethrough
Or
An electrical conductor adapted to emit light
EXERCISE: Fire, Candle, Gas Cylinder-à light bulb
Like a table cloth—do you trim to table… better to start bigger than small.
Don’t have to say it up front… JUS TNEW invention is!!
Google 23 and me…
Provisional (12 months)
- Never published
- Title, owner [secret document]
- Can roll that over as often as you like
Complete (international application) - WIPO
- Publication begins 6 months after… specification will be published
- WIPO
- 18 months (preliminary search and opinon)
- One person will assess but not 100% binding (knockouts at that point)
Then national phases
- US, EP, AU, CA, JP, CN (national examination and grant)
- Country level examined application and granted
PCT application
- 152 countries are covered
- Gives you 18 month additional to choose countries in which to pursue patents
- Official international search
- Provisional patent is recognised internationally
- Grace period for filing a patent application after public disclosure
- Protect for self-disclosure
- 12 months to file complete patent
Patent application might be in process but DO NOT put a DESIGN application in because it will be disclosed within 6 months. While Patent applications is 12-18 months.
You can only claim for when it is granted.
Picket fences… broad
Modify… 20 + 20 years + 20 years… keep developing
Key points:
- Should be filed before disclosure
- Grace periods
- Provisional 12 months… The clock is ticking… Complete 12 months (max)
- Information/data collecting exercise is ongoing and subject to time pressures
- Must include all subject matter
- Must file in each country of interest
How much data?
- In vitro vs in vivo data
- Breadth of exemplification vs spectrum
- Don’t have to test every single embodiment
- In vivo data is not needed IF a sound prediction can be made
- IN vivo data may be needed as support for examination
Depends on tech
Depends on stage of the patent process
Extrapolation is admissible
Useful starting point:
- Would you be convinced of the claims made in light of the supporting data?
Cannibis. Medical cannabis.
Against the law
Reproducing a human.
Hold the patent from distribution. Socio-ethical legal issues.
Not against the law. Moral obligations for human harm.
Timing and Cost Management
- Defer costs where possible
o Combine applications where possible
- Avoid unnecessary costs
o Extension fees
- Seek external funding
o Government grants
o Sensible country selection
§ Follow the money
· Primary markets
· Manufacturing
§ Consider patentability exclusions
o Rationalise portfolio
Regular evaluation
- Patent priority profiling
- Deadline for internationalisation: 12 months after t
- Deadlne for nationalisation: 30/31 months from beginning
Select what to patent
- Business/commercial value
o What is the lijely value of the technology
o Will exclusivity provide a competitive advangtage
o Does the technology align with commercial objectives
- Legal strength
o What is the inventive step over the prior art
- The higher the regulatory bar to product approval to more the patent strategy is important
o Timing
o Countries
o Disclosure over time
A balancing act:
1. Cut your cloth and go broad
Broad: scope of potential monopoly, prior art against others, flexibility to change course, ability to bury lead idea
Narrow: simplar examination, greater certainty of ouotcome, reduced expeince, improved prospect of availability
Picket fences strategy:
CORE component (then expand)-- NUROFEN
BAYER: compound (termite protection). Expire patent and expand patent list.
STRaTEGIES:
- Aggressive / licensed strategy
o Patent everything
- Blocking strategy
- Defensive strategy
- Fencing strategy
- Land mines
- Scorched earth
o Put everything in and others cannot use it either
Discovery or invention
- “Every scientific discovery if made technologically applicable, becomes an invention.
- Continuous assessment of findings and developments
o Checkpoints, e.g. group/lab meetings conference, manuscript
- Do not try to evaluate inventiveness
- Searching patent and non-patent literature
- Invention disclosure forms (use it)
- Consultation with patent attorney
What is an invention?
2. Conception.
3. Reduction to Practice
IN science it can be done in reverse… if engineerings 1-2 steps… or same time!
Conception:
- Formation in the mind
- Definite and permanent idea
Reduction to Practice
- Constructing invention
- Testing
- Testing of embodiments
- The invention need not be perfect
- Not all embodiments need to be tested
Constructive reduction to practice
- Full clear concise and exact terms, to enable a person in the art relevant to it to make and use it
Who is entitled?
- The inventor
- Someone entitled through the inventor
- Entitlement vs ownership
Inventorship matters:
- Revoking a patent is almost impossible
- Critical to identify inventors and ensure correct entitlement
Medical Device
- Include software
- Operations of a health system
- A tool, diagnostic, device
- Process
- Public funding- ignition core… medical devices fund (state government fund) 6-8m$
WILL HIRD – Chemical Engineering
- What constitutes inventorship?
- “Conception is the touchstone to determining inventorship”
- Without contribution the invention would not have been made
Courts:
- Material effect on invention
- Part of a collaboration
- Practical implementation of a mere idea
- “But for”
- Conception of the solution
Not indicators:
- Using teaching of prior art
- Normal skill in the art
Single inventor:
- Fewer problems
- Rarely applicable in modern high tech
Joint inventor:
- Where two or more individuals collaborate on an invention
- Each individual makes some but not all of the contribution
- Owned in equal amounts
- Subagreement about revenue on how to distribute among inventors entitled
Case Study:
- HARRIS vs CSIRO
- Collaborative project between D and H
- H was considered to be an inventor.. materially affected the ultimate invention was
o Entitlement
o H challenged D…
Patent Owners:
- Not normally the inventors
- Chain of the title, normally from inventors to other entitites via:
o Contract of employment
o Assignment
o Other legal contract or agreement
o Check obligations
- An inventor is always an inventor but owners come and go
- Inventors are rewarded
Organisation IP Policy
- Created by staff
Research (Organisation IP Policy)
- Ensure ownership does not conflict with assessment of student
Entitlement:
- No true inventor was names
- One or more additional inventors should have been named
- No clear chain of title
- CRC
- Invention not conceived in course of employment
Case: Ethicon Inc v. U.S> Surgical Corp
- Dr Yoon developed trocar equipped with safety device
- Ethicon sued US Surgical
- Mr Choi helped but not informed
- US Surgical found out about Choi
- Obtained a retroactive license
- Corrected inventorship of patent
- The US Surgical ended up on the patent
Perform inventorship determinations
- Interview contributors
- Collect collaborating evidence
- Prepare time line/fact sheet
- Obtain approval of fact sheet from contributors
Assess inventorship
Collaborations:
- Disclosing results of research to a company
- NDA from the University
- NDA for exchange of materials (MTA) materials transfer agreement
- Complete invention disclosure form/ pre-disclosure form
- Documented notebooks
Public disclosure
- Kills off validity of payments
- Europe, China doesn’t use a grace period (70%). Australia does.
- No public disclosure
- Discrete about details of invention
- Not publically disclosed prior to patent application
What happens when YouTube clips are made available for Kickstarter funding… courts put them up.
Cohen-Boyer patent (US 4237224)- public disclosure…
Commercialisation people wanting to hold back but academics want to impact
Computer related innovation
- Patent protection
- - function of a program, function of hardware
- Protection of function and routine itself
Copyright
No need for registration
Can protect source code, executable code
Circuit Layout
Example: Resmed AU2016204561: “System and method for determining sleep stage”
Example: AU2013319705
- Contradiction between thought and feeling
- Mental health care support device, system, method, program
o “automatic thought and feeling inpuot unit
- What is patentable
You can keep something away from public view (blackbox it)
- E.g. trade secret for google rank page (patented, then IPO)
- But today Google might not release the additional smarts
How can you stop someone else from doing something
Patent 1: patented compound
Patent 2: a new method of using the company (application of hair for minoxidil)
** Minoxidil (new use of a known substance)
n Unexpected, needs to be inventive…
In the tech space: e.g. RFID and the use; Bluetooth
Right to exclude others from practicing invention
- Making
- Using
- Selling
- Offering to sell
- Import
Relates to the patented invention
- Looks to claims
- Right to license or assign
- Infringement action can only be brought after patent grant
INFRINGEMENT EXEMPTION
Research use exemption
- Experimentation
- Experimental purposes
Regulatory exemption
Prior user rights
- Secret use before priority date
If in the eye of public interest you can go forward and use the technology.
Patent Landscape
- Patentability and freedom to operate are different things!
- Different to protecting your intellectual property
- ** Freedom to operate sometimes means you need to get a license to sell your process/product
Freedom to operate
- Has nothing to do with whether or not you have a patent
- Nothing to with the strength of your patent position
- Relates to ability to commercialise your technology
o Will you infringe some else’s patent right?
- Determining FTO is not trivial
FTO
- What markets are you interested in
- Markets of partners/licensees?
- What level of comfort do you want or need?
- What level of comfort do inventors/licensees want or need?
- What is your technology now?
- What developments of your tech are your planning?
TWO PARTS:
- Specific patent search strategy
- Patent claim analysis
- - jurisdiction by jurisdiction analysis
1983 – Ben Lexin—wind keel (closed with blankets)
FTO—look if a patent has expired.
Dealing with someone else’s patent
- Determine importance
- Determine freedom to operate
- Can I work around?
o Identify elements of the claim that you can change or avoid
- Invalidate the patent
o Find prior art that invalidates problematic claims
§ “novelty KNOCK-OUT reference”
o Ideally a single document or disclosure
- License the patent
Patent searching
- Should form part of any literature survey
- Should form part of your R&D planning
- Patent applications are published at about 18 months from filing
- Searching is never 100% determinative- depends on searcher’s skills and expertise
o Languages
- Not one size fits all
Who are our competitors? Patent landscape
Where are the white spaces in R&D? Name
What is company X or inventor Y patenting? Patent family
IN which countries has patent protection been obtained or being pursued?
Is the claimed invention new?
Could we potentially be sued for patent infringement?
* atlasian
Databases:
Uspto.gov
Ep.espacenet.com
Wipo.int/
IP Australia
Google Patents
Vagueries
- Purposeful. NGOs. Competitors.
- Needs to be reproducible.
- Identify the technical field.
- Enable the invention to be repeated
Need to disclose everything or just keep it as a trade secret.
Scope of protection, clearly mark out territory
Japan, China, South Korea
Machine translation via Google
China’s move dramatic because gov funded innovation cycles
Patent Specification
- Tech Field
- Background
- Summary of the Invention
- Brief Description of Drawings
- Detailed Description
- Examples
- Claims
- Drawings
Patent claims are numbered
- Preamble + characterising features
o Define the invention
- Claim set begins broad and narrows
- Different claim types
Case: B Braun vs Multigate
Retractable needle
- Two different needle retraction devices. So broad claim meant that they could capture same thing differently… same function and different method.
Apple Samsung (IP barrister lawyers)
Exercise: drink carrying device
- Prior art search: drink carrier
- The drink carrier scenario
- Drink carrier could fold into a small convenient size
- Australian Patent: 2005289364
- Breadth goes a lot further than normal requirement
- Patent and design protection
Trademark:
- Not about the product but descriptive of it sort of
Part 4
Everything that can be invented has been invented.
- Cost
- IP portfolio – what is it doing for you?
IP Services
- IP creation and identification
o Identify IP and its full potential
o IP audits
o IP mining
o Branding development
- Securing IP rights
o Drafting and prosecuting patent applications
- IP Agreements
o CDAs/NDAs, licensee, assignments, MTAs, CRAs
- IP enforcement
Investment
- IP due diligence
- IP portfolio enhancement for exit
- Improved IP operational efficiency and effectiveness
Fundraising
Patent attorneys:
- Draft a patent
- Technical qualification (science, engineering, technical competence)
- Drafting and prosecuting apps
- searching
- Advice / analysis
- IP law specialists
- 70K in 3 countries (Europe, Asia, US); 7 apps 2-3K bills each; TOO MUCH $
Old School
- Do research
- Review Output (maybe)
- Capture IP (if still can)
- And then work out what we will do
Aligning R&D and IP
- Tech and market are well understood
- Business plan is in place
- Commercial strategy is agreed
- IP landscape is identified and analysed
- Required IP portfolio is defined
- R&D planned to create the IP portfolio required to achieve the strategy
IP Landscape
- Raise awareness
- Quick to file, quick to abandon
- Proper management of non-patent IP
- Patents splits by application to facilitate licensing
- Strategic publication where appropriate
Conception and Technical Design
Anatomy of a patent portfolio
60% of patents collapse over time because they cannot afford the maintenance
- High core value
Good idea?
- Don’t tell anyone
- Consider brief literature
- Consider obligations
o Employer, collaborator, sponsor
- Report in invention disclosure
Tools and processes:
- NDAs
- Notebooks and journals
- Invention disclosure
- Right creation
NDAs
- Don’t talk to people’s lawyers, you should talk to people who are interested in the actual technology
- Maintain detailed records
- Date, diagonal line through page if blank
- Ink only
- Pre-disclosure forms