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Dr James Stones6 February 2017

AN INTRODUCTIONTO

INTELLECTUAL PROPERTY

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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

PART 1 - An Introduction to Intellectual Property | 6 February 2017

• 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

PART 1 - An Introduction to Intellectual Property | 6 February 2017

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

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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?

PART 1 - An Introduction to Intellectual Property | 6 February 2017

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?

PART 1 - An Introduction to Intellectual Property | 6 February 2017

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

PART 2 - An Introduction to Intellectual Property | 6 February 2017

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

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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