ucl lecture - 06 february 2017
TRANSCRIPT
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Dr James Stones6 February 2017
AN INTRODUCTIONTO
INTELLECTUAL PROPERTY
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|An Introduction to Intellectual Property | 6 February 2017 2
Who am I?• BSc Chemistry – Imperial College (1989-1992)
• PhD Chemistry – Imperial College (1992-1996)“[4+2] cycloaddition reactions of conformationally restricted tethered trienes and dienynes”Supervisors - Prof. Donald Craig (IC) & Dr Mark Ford (AgrEvo)
• Joined patent profession in 1996
• Certificate in Intellectual Property (1997)
• European Patent Attorney (2005)
• Chartered Patent Attorney (2006)
• Became a partner at Beck Greener in 2010
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My Firm• Patent, trade mark & design attorneys• IP litigators
• Based in Holborn (adjacent Gray’s Inn Gardens)
• Established 1867 – 150th anniversary!• Oldest firm of patent attorneys (in continuous existence) in England
• 22 fee earners, incl. 11 partners – unusual model• 55 people in total
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What are we going to talk about today?PART 1 Introduction to intellectual property (IP)
(45 min)
- Break -
PART 2 Case study
(20 mins)
PART 3 Initiating a pharmaceutical start up
IP aspects to consider
(40 min)
Questions
An Introduction to Intellectual Property | 6 February 2017
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PART 1
Introduction to Intellectual Property
An Introduction to Intellectual Property | 6 February 2017
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What is intellectual property?
“…the fruits of mental creativity…”
Some “fruits” are protectable by Intellectual Property Rights (IPRs)
Territorial – country-by-country
Limited duration (except registered trade marks)
PART 1 - An Introduction to Intellectual Property | 6 February 2017
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Different types of IPR
Patents
Trade marks
Designs
Copyright
PART 1 - An Introduction to Intellectual Property | 6 February 2017
Non-technical
Technical
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What is a trade mark?
PART 1 - An Introduction to Intellectual Property | 6 February 2017
“badge of origin”
A sign capable of distinguishing goods/services of one source from another
In theory, anything can be a trade mark
To be registrable, must be capable of graphical representation
Words (e.g. NUROFEN) Logos (e.g. )
Shapes (e.g. )
Company name & product names
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What is a registered design?
PART 1 - An Introduction to Intellectual Property | 6 February 2017
Protects the look of a product, including:
• Appearance
• Shape
• Configuration (or arrangement of parts)
• Decoration
Does not protect the way the product works
Legal right to stop others from commercialising products having same orsimilar design - same “overall impression”
Packaging & implants/applicators/devices
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What is copyright?
PART 1 - An Introduction to Intellectual Property | 6 February 2017
Legal right to stop others from copying a work
A "work" may be:an original literary, dramatic, musical & artistic work
a film, sound recording & broadcast
Typographical arrangements (e.g. the layout of a paper or webpage)
Arises automatically - not registered (in UK)
Possibly least relevant to pharmaceuticals – website, packaging, inserts & marketing
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What is a patent?
PART 1 - An Introduction to Intellectual Property | 6 February 2017
A legal right to stop others from commercialising your invention
“commercialising” = making, using, selling & importing
In return, must disclose invention to the world
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What is an invention?
PART 1 - An Introduction to Intellectual Property | 6 February 2017
An “invention” is typically a product or a process
To be patentable, an invention must be:
Technical Novel
Not obvious Capable of being made or used in industry
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Technical Subject Matter
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• Compounds (e.g. APIs, excipients, etc.)
• Compositions/formulations (e.g. coating preparations, dosage forms, etc.)
• Kits (e.g. combination treatments, treatment & applicator, etc.)
• Devices (e.g. implants, applicators, syringes, etc.)
• Packaging
• Methods of manufacture
• Uses/methods of treatment
Technical subject matter in pharmaceuticals includes:
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Uses/Methods of Treatment
PART 1 - An Introduction to Intellectual Property | 6 February 2017
Therapeutic, surgical and diagnostic methods excluded from patentability in most countries including EPO
Socio-ethical and public health reasons – protect patients
Important exceptions include USA & Australia
• Secondary infringement – supplying means essential to work invention
Cosmetic methods not excluded at EPO
Claim “purpose-limited” product claims?
• Formulation X for use in the treatment of condition Y
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Novelty
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State of the art is:
• everything made available to the public
• anywhere in the world
• by any means
• before the effective date of the invention (filing/priority date)
Usually prior publications but also presentations and public use
Is the invention new?
Assessed in view of the state of the art
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Inventive step
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Skilled person is:
• Hypothetical
• Ordinary practitioner – not an expert
• Aware of all relevant art and common general knowledge
• Capable of combining teachings BUT only if art suggests combination
• Has no creative/problem-solving ability
An invention is inventive if not obvious to the skilled person over state of the art
Various approaches – EPO uses “problem/solution” approach
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Supplementary Protection Certificates
PART 1 - An Introduction to Intellectual Property | 6 February 2017
Compensate for delays in obtaining marketing approval
Does not extend term of patent as such
Protects specific authorised product and any use of the active ingredient in an authorised pharmaceutical product
Enters into force when patent expires and lasts for up to 5 years – paediatric extension?
Requirements
• Valid patent that protects the active ingredient• MA to place active ingredient on market as a pharmaceutical
MA must be the first MA for the active ingredient
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Know How
PART 1 - An Introduction to Intellectual Property | 6 February 2017
Practical information – usually not patentable
How to implement an invention – best practice
Example - optimisation of a formulation
• Choice/amounts/proportions of excipients• Exact coating thickness• Manufacturing techniques
Can be very valuable
May not be written down
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How to get a patent?
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Novelty search by EPOt = ~6 - 12 months
Publicationt = 18 months
Substantive examinationt = ~2 - 5 years
Grantt = ~4 - 5 years
Renewal feesuntil t = 20 years
Devise invention
(Pre-filing novelty search?)
File patent application t = 0
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Likely costs and timings?
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Prepare & file GB priority application t = 0£3K - £6K
Official search (without review) t = 6 months£400
PCT application (including search) t = 12 months £3K - £4K
PCT national phase (each country) t = 30 months £1K - £5K
Examination (each country)£2K - £6K
Grant (each country) t = 4 to 5 years£500 - £1K
Renewals (most countries annual) until t = 20 years £200 - £800
Budget for 5 countries (US, EP, CA, AU & JP) to grant? £50K - £60K
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Anatomy of a patent
PART 1 - An Introduction to Intellectual Property | 6 February 2017
Specification – legal document
• DescriptionIntroduction – sets sceneDiscussion of preferred embodimentsExamplesDrawings
• ClaimsDefine scope of protection
• AbstractSearch purposes
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A claim is a statement that defines the invention, i.e. the “boundaries” of protection
Two types of claim:
Independent claim
• Stands alone
• Essential features only
Dependent claim
• Refers to an independent claim
• Preferred features
• Defines fall back positions
What is a patent claim?
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Claims – scope (ringfencing)
Independent Claim 1 Prior art
1Dependent Claim 2
Dependent Claim 3
(not allowable)
Prior art 2
(not allowable)
INVENTION
DISCLAIMED (outside claim scope)
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PART 2 – Case study
PHLORALStep 1 - Consider an Invention Disclosure
Step 2 - Review prior art identified by inventors
Step 3 - Identify novel features
Step 4 - Identify advantages of invention over art
(15 mins)
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Case study - Phloral
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New delayed release coating for site specific drug release in colon
Prednisolone tablets (200 mg; 5 wt % active) coated to 8.3% weight gain with mixture (30:70) of high amylose (70%) starch & enteric polyacrylate (Eudragit S)
Prior art - Lancaster & Wheatley 1989 (D1); US5422121; & US5294448 (D3)
Starch = faecal inoculumStarch control = no faecal matter
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Case study - Phloral
PART 2 - An Introduction to Intellectual Property | 6 February 2017
Novel features of Phloral
• Combination of starch and Eudragit® S
• Proportion of polysaccharide to film forming polymer?
• Drug?
• Coating thickness?
Advantages of Phloral
• Accelerated release in colonic conditions
• Resistant to pancreatic enzymes (despite presence of amylopectin)
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Case study - Phloral
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Claim 1 as granted (EP2018159B):
• Not just starch – other plausible polysaccharides
• Not just Eudragit® S – other plausible enteric polymers
• Not limited to drug, proportions or coating thickness (dependent claims)
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PART 3
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Initiating a pharmaceutical start-up
IP aspects to consider
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IP Aspects
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Set up company• Form company & register domain name
primary and secondary domain names – block others from using similar names?• Register company name as a trade mark
potentially one of most valuable assets• Set up website
obtain rights to web design from designerif/when updated - keep copies of previous webpages?
Employees• Contracts of employment• Confidentiality
protect all confidential information – not just trade secrets & know how, etc.also marketing, finance, future plans, etc.
• Ownershipassign inventor rights to company
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IP Aspects
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Outside contractors• Confidentiality
Approach under NDAs or after filing first application – preferably both• Ownership
assign inventor rights to company
Start research• Keep detailed records of research
addition data for post grant proceedingsreproducible experimental protocolsinterference in US
• Third party patents?research exemption apply?
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IP Aspects
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
IP management• Records & diary system
case status & monitor deadlines• Invention disclosure system
invention disclosure form & system for review• Filing system
prosecution/oppositions/revocations• Portfolio management
maintain commercial focus during prosecution & review entire portfolio regularly• Database
store contracts/assignments/licences/invention disclosures
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IP Aspects
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Products• Mark with patent (application) number
puts infringer on notice - damages• Register product name as trade mark and domain name
Commercialisation• Freedom to operate
Searches in at least primary countries of interest - reasonable business risk• Infringement opinion
If relevant patents identified, get an opinion from an expert• Work around
If infringement likely, can you work around the patent?• Licence
If no work around, can you get a licence?
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IP Aspects
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Watches• Patent watches
Keep an eye on competitors and technical fieldMonitor status of potentially relevant cases
• Trade mark watchesKeep an eye on attempts to register the same or similar trade marks
Lifecycle management• Plans for expiry of your patent
SPCs – paediatric extensionsDevelopments – other products in pipeline“Evergreen” inventions not allowed
• IP portfolio management
Approaching potential investors
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Approaching potential investors
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Potential investors want to know exactly what they are paying for
Investigations referred to as “due diligence”
Generally focuses on three issues:
1. Ownership
2. Enforceability - scope/strength of protection
3. Freedom to operate
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Ownership
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Decided by national law
In UK, ownership is determined by statute (not contract of employment)
For UK-resident inventors, the inventor is first owner unless:
• employed and invention made during the course of the employee’s normal duties, or during duties specifically assigned to him/her; or
• has special obligation to further interests of employer – typically more senior people (e.g. director)
In these cases, first owner is the employer
Employee inventors & non-employed inventors (e.g. contractors) can assign
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Enforceability
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Does the IP adequately cover the intended product/process?
Does the IP adequately block generic products?
What disclosures have taken place?
Have novelty searches been carried out?
If so, is there any particularly relevant prior art?
Validity opinions in place?
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Freedom to operate
PART 3 – Initiating a pharmaceutical start-up | 6 February 2017
Before commercialisation, FTO searches MUST be carried out in each country
Have FTO searches been carried out?
If so, has any potentially relevant third party IP been identified?
Validity opinions in place?
Indemnity/insurance
Not only IP – also supply/distribution agreements
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Questions
An Introduction to Intellectual Property | 6 February 2017