Bob Ingratta LifeSciences BC Konrad Sechley Gowlings Peter ...

Bob Ingratta
LifeSciences BC
Konrad Sechley
Gowlings
Peter Fairey
Gowlings
1

The Gowlings Edge…
Full Service Law Firm
Offices across Canada, London England, and Moscow
>700 legal professionals
Extensive depth in:
Litigation - IP and other
Employment advice
Tax advice
Government Relations advice
Commercialization
Advertising marketing
Product liability advice
M&A advice
Largest IP group in Canada
2

Managing Intellectual Property
Patent Prosecution Firm of the Year
(2006-2010)
Trade-mark Prosecution Firm of the
Year (2006-2009)
Patent Case of the Year (2009)
Copyright Case of the Year (2009-2010)
3

Life Sciences
Cost Effective Protection of Intellectual Property
innovation Konrad Sechley PhD
starts

Overview
Introduction
Bioenergy IP trends
Presentation Topic here
Review of proper patent practices
Filing strategies
Tips for reducing costs
5

Why Care About Intellectual Property?
Intellectual Property Rights
= Competitive Advantage
6

What is Intellectual Property?
Assorted rights to exclude others
National in scope
Harmonization through international treaties:
- Patent Cooperation Treaty (global filing treaty)
- Paris Convention (priority right treaty)
7

Types of Intellectual Property
•Patents
• Trademarks
•Copyright
• Industrial Designs
• Integrated Circuit
Topography
• Plant Breeders’ Rights
• Trade Secrets
8

Purpose of the patent system
Applicant:
obtains monopoly to exploit invention for set period
- in most countries 20 years from date of filing
- rights enforceable after patent is granted
Public:
obtains access to information to work invention
- applications typically published after 18 months
9

Why Patent?
Competitive Advantage
Blocking patents
Royalty Stream
Attract Investment
Negotiation – cross license
10

Cons
Expense
- National protection
- Publication – after 18 months
- US may request non-publication*
Definite term – typically 20 years from filing date
Patent does not provide right to practice
- freedom to operate
- regulatory approval
*conditions apply
11

National protection
A patent is only valid in the country within which
it is issued
- each country administers it own patents:
Canadian Intellectual Property Office (CIPO)
US Patent and Trademark Office (USPTO)
European Patent Office (EPO) + each country
Japanese Patent Office (JPO)
etc…
12

Alternatives to Patenting
Trade secrets
- indefinite term
- efforts must be made to keep know-how secret
Publication
- can be used effectively
Petty or innovation patent
- only in certain countries; weaker protection
Trend to “open innovation”
13

Open Innovation
Standards - FRAND
Patent pool
Patent commons
Open source
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Eco-Patent Commons
“…unleashing dozens of innovative, environmentally responsible patents to the public
domain”
“Availability of these patents will encourage researchers, entrepreneurs and companies
of all sizes in any industry to create, apply and further develop their consumer or
industrial products processes and services in a way that will help to protect and respect
the environment.”
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• Patents have an
environmental benefit
• Patents are pledged
• To become a member
must pledge a patent
• If remove patent, no
longer a member
• Patents are not dedicated
to public – can be asserted if required
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Common elements to open access schemes
Involve patents
- to enforce rights against abuse by others
Provide access to collection of patent rights
- management of IP collection required
- agreements, licenses
- some situations require valuation of IP
Need to ensure non-competitive behaviour
- independent third part expert review may be required
Incentive to join - needs to be < cost of not joining
- need to capture key IP
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Published patent applications and patents
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Nature Biotech 24: 643-651 June 2006
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USPTO – Allowance Rate June 2009
USPTO Allowance rate 1975-2009
25

Increase in US allowance rate – will the trend hold?
26

Requirements for Patent
Statutory Subject Matter
Novelty
Inventive Step (non-obviousness)
Utility
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Statutory Subject-Matter
CA EP US
• an idea X X X
• a method of doing business X X ~Y
• abstract theorems X X X
• computer program ~Y ~Y ~Y
• methods of medical treatment X X Y
• medical use Y Y N
• higher life forms X* Y Y
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Utility
Real world, specific, credible utility
described in the Patent Application
No patents for inventions that defy scientific
principles (e.g. perpetual motion)
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New in view of any public disclosure before
application filed
- Single disclosure
Novelty:
Invention
A + B + C
A + B + C
A + B + C
Prior disclosure
A + B
A + B + D
A + B + C
New?
Yes
Yes
No
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Inventive Step:
Not obvious in view of any public disclosure
before application filed
Multiple disclosures can be considered
Invention
Disclosure 1
Disclosure 2
Inventive?
A + B + C
A + B
B + D
Yes
A + B + C
A + B
B + C
Yes
Not obvious combine 1 + 2
A + B + C
A + B
B + C
No
Obvious combine 1 + 2
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Public Disclosure (Prior Art)
Made available to public by:
Publication
Public use
Sale/offer to sell (US)
Oral disclosure (conference proceeding; thesis defense)
Grant applications (e.g. NSERC, CIHR, DOE etc)
Internet postings
Disclosure must be:
Non-confidential
Enabling
Grace period in some countries
32

Patent Application
Description
Fully describe invention including drawings
Best mode (US; & machines for Canada)
Full description needed for priority
Avoid quick and dirty provisionals
Claims
Give scope of protection
Can be for a method, apparatus, product
Series of numbered paragraphs
- independent claims gives broadest protection
- dependent claims give progressively narrower protection
33

You have an invention – now what?
Comprehensive invention disclosure
Maintain confidentiality
Conduct a patent search (in-house/externally)
Patentability opinion – may be oral or written
Draft proper application
- use patent agent to draft application
Determine inventorship
Check employment/contactor agreements
Obtain executed assignments early
- include language to execute future documents
If done properly will decrease future costs significantly
34

Maintaining Confidentiality
Avoid publicly disclosing your invention
Consider Non Disclosure Agreements (NDAs)
- if NDA not an option then file application first
If prior public disclosure is unavoidable, grace
periods are available in some countries
35

Who is an inventor?
Person who “conceives” invention
- complete performance of the mental part of
the inventive act
- not just desired result
- means to achieve result must be provided
Determined by what is claimed
- inventorship may change during prosecution
Can have multiple inventors
36

Who is not an inventor?
Person provides:
- routine technical contribution
- moral or financial support
- general idea of desired result stimulated
research
Different from authorship
37

Determining inventorship is important
Patents have been invalidated by having
incorrectly named inventors
Potential infringers have avoided infringement by:
- licensing rights from non-listed inventors, and
- amending inventorship at a latter date in court
38

Ownership
Co-owner’s rights without consent of other co-owner:
- work invention
- assign (Canada v. US)
- licence invention – US only
Employer’s rights
Inventor owns patent rights – except:
- express contract that employer owns rights
- employee hired for expressed purpose to invent
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Where and when to file?
What to file?
Initial
filing date
Options at one
year anniversary
•File in CA, US, EP etc
•File International (PCT) application
•File in non-PCT countries
Upgrade application
•File in CA, US, EP etc
PCT national phase 30 months from
Initial filing date
40

US Provisional, CA informal filing - advantages
Can be done at the last minute
- scientific paper/poster presentation (with upgrading)
- do not file grant proposal
- refile with complete application ASAP
Reduced paper work after filing
Can evaluate technology during priority year to see
if application to be retained
Can obtain an extra year from filing date
- 21 year term
US provisional not published
CA informal will publish, but can be withdrawn
41

Provisional, informal filing - problems
Not a mechanism to reduce cost
- application must be re-filed after one year
Provisional may not qualify as priority application
- must satisfy written description requirement
(e.g. New RailHead US, #02-1028 July 30,2002)
Need to ensure a “complete” application is filed
- if file quick and dirty, refile complete application ASAP
May delay examination by year
Reduced paperwork
- recommend getting assignments filed
42

Commercialization Considerations
Where to file priority application?
- US provisional or regular
- market/investor needs
- Canada informal or regular
- cost effective,
- can accelerate examination
- can use Patent Prosecution Highway
-UK
- can request early search
-PCT
- no further data to be added
- if prior art an issue (one year grace period)
43

Patent Cooperation Treaty
PCT application
- reserve right to file in over 140 countries
Can claim priority (Paris Convention)
Can delay procedure before National Offices
- up to 20 or 30 months from earliest priority date
- advantage: delays filing costs from 12-30 months
- disadvantage: delays examination by up to 2.5 years
2 phases:
International phase
National phase
44

Patent Cooperation Treaty
International phase - Chapter I
- application searched
- search report and application published at 18 months
- preliminary examination provided
- claims can be amended
Can enter National Phase at any time
Can delay entry up to 30 months in most countries
- determine markets where application needs to be filed
- obtain commercialization partners
- if search report negative, can drop application
45

Patent Cooperation Treaty
Chapter II – must be requested
Extends proceedings to 30 months in some countries
Examination carried out by Canadian Office
Applicant may respond to preliminary examination
Final examination report published (IPRP)
Examination helpful in deciding further filing strategy
May enter National phase any time during PCT
46

Where and when to file?
Initial
filing date
Options at one
year anniversary
•File in CA, US, EP etc
•File International (PCT) application
•File in non-PCT countries
Upgrade application
•File in CA, US, EP etc
PCT national phase 30 months from
Initial filing date
47

Considerations
Market size
Cost
Manufacture
- will invention be worked in country?
Sales presence
- can you monitor potential infringers?
Competitors
48

Controlling prosecution costs
Technologies with significant prior art:
- invention more difficult to argue
- costs increase
- claims scope is narrow
- strength of claim increases
Provide timely instructions
Provide input regarding inventive step
- Examiner interviews
Evaluate portfolio regularly
- license or abandon as needed
49

Top tips for reducing costs
1. Determine FTO early - design research program
2. Comprehensive invention disclosure
3. In-house patent searches
4. Oral patentablity opinion
5. Draft proper application (will save costs downstream)
6. Address inventorship & ownership issues early
7. File strategically
8. Use cost reducing options effectively (PCT, EPO)
9. Good communication with your patent agent
10.Re-evaluate your patent portfolio regularly
50

Thank You
Konrad Sechley PhD
Gowling Lafleur Henderson LLP
Vancouver, BC
604-443-7610
konrad.sechley@gowlings.com
montréal ottawa toronto
hamilton waterloo region calgary vancouver moscow london