Discover why intellectual property is a critical asset to your company. Within the context of current economic uncertainty, this series covers cost-effective strategies for securing IP and patent rights to enhance the market value and competitive position of your life sciences or ICE company.

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2. IP Best Practices
for Life Sciences Companies

3. Introductory Remarks
An IP portfolio can be used in a variety of ways
to provide a tangible asset for a company.
To be able to use your IP portfolio to carve out a
niche, generate profit through royalties, or to
attract potential investors, the patents must be
well supported, provide coverage for any current
or future commercial product/process and
preferably also provide broad coverage.
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4. What Is Intellectual Property ?
• Patent
• Trademark
• Copyright
• Industrial Designs
• Trade Secret
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5. Patents
• Provides the right to exclude others from
making, using, and selling a product or process
during the term of the patent
• In exchange for a fully enabling disclosure of the
“best mode” of practicing the invention
• Term of the issued patent is 20 years from date
of filing
• Patent rights are territorial
• An issued patent does not necessarily grant you
the right to practice your invention
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6. Why Patent?
Patents may be used to generate value for a company
• Competitive advantage to prevent copying – gain market share
• Blocking patents as barrier to market entry - force competitors
from market
• Generate income via royalty stream
• Attract investment – increase value of a company
• Negotiating for possible cross-licensing
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7. Value of IP Portfolio
A viable start-up company usually has a small niche
where they excel at a certain technology e. g. small
molecules, medical devices.
Companies, usually start-up companies, adopt a
strategy to use their IP as a tangible asset for
evaluation to investors or purchasers for a potential
acquisition.
Patents therefore form a large part of the value of the
company.
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8. Deciding What to Patent
As a business asset, value depends on other
factors beyond simply technical merit:
• Is it so novel that broad claims are likely to issue?
• Can you block others - effectively preclude others
from copying?
• Is it difficult for competitors to “design around”?
• Can infringement be easily detected?
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9. Filing Strategy – what to think about
Value = Validity + Scope of Claims
• Business Plan
• Vendible Product
• Claim Scope
• Market Analysis
• Patentability Analysis
• Ownership
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10. What is Involved?
• Information gathering
• Public disclosure?
• Determine inventorship
• Understand the invention
• Drafting the patent application
• Prosecution of the application
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11. Determine Inventorship
• Who contributed to the subject matter of the claims ?
• What is their relationship with the company/
institution, e.g. employee, contractor
• When was the invention created?
• Joint inventors – anyone who contributed to at least
one claim
• Naming the correct inventors is important – a patent
that fails to identify the true inventors may be held
invalid and unenforceable
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12. Ownership
Increased value when IP is owned by a single entity
 Employment Agreements/Contracts in place before IP is
generated
 Assignment Agreements when research is done by third
party
 Joint Collaborations – IP considerations
 Grants/funding for research – IP ownership by others
• All ownership of IP should be determined before the
research is conducted and before patents are filed.
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13. Be Aware of Potential “Bars” to Patenting
• Public disclosure (e.g. publication, poster at a
conference), public use or offer for sale may be a bar to
obtaining a patent
• 1 -year grace period in US; Europe and most other
jurisdictions require absolute novelty
• Any of “bar” actions start the clock ticking
• Use Non-Disclosure Agreements with appropriate
description
• Using NDAs also avoids the potential for the other party
filing for a patent on the same or similar ideas
• File the patent application early, if possible
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14. Patentability Analysis – should you spend the money ?
• Identification of potential novelty and inventiveness
• Areas for investment of R&D
• Identification of competing technology
• Patents that need to be circumvented
• Identification of possible collaborations/partners
• Identification of possible license/cross-license options
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15. Prior Art Searching?
• No duty to search for prior art
• But must disclose relevant prior art of which you
are aware
• Searching patent publications prior art may have
implications related to willful infringement for
patents found, since considered “on notice”
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16. Drafting the Patent Application
• Understand the invention both technically and in its
commercial context
• Prepare a sufficient and enabling disclosure; beware
of discussing the prior art
• Provide claims of varying scope; less vulnerable to
prior art cited during prosecution and even after
issuance, and thereby highly enforceable
• The claims of the issued patent define the legally
enforceable scope of the patentee’s rights
• Draft different types of claims (product, i.e.
compound, medical device, method, use) as
appropriate to the invention
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17. Obtaining the Desired Claim Scope
• What is the vendible product?
Support in the patent for the product itself, examples of
synthesis of compounds, in vitro data, clinical trials, etc.
• What are the variants?
When possible, allow some time to research variants of the
product so that the scope of the patent specification can be
expanded.
• What are your competitors doing?
Ideally, the claims should both protect your product and
exclude your competitors from working around the patent. This
requires an expanded patent specification support by research.
• What is your niche?
Do the claims of your patent build on your portfolio to carve out
a niche?
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18. Claim Scope
Claim Scope
Product
Variants
Competitors
Portfolio
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19. Scope of coverage - example
Broad Scope
Narrowing Scope for Group A
Narrowing Scope for Groups A, X, Y, W, R4
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20. Obtaining Desired Claim Scope
Filing of a full and complete disclosure
• You can only get protection for what you have done and shown in the
description and what you can soundly predict based on what you have
done.
• Disclosure of all contemplations of the invention.
• Demonstration of utility through test results whenever possible.
• Carrying out the right tests and trials to ensure broad coverage in the
patent.
Lack of full disclosure can lead to unduly narrow claims and
possible invalidity of the patent.
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21. First Filing
• Typically, Canadians file first in US, many investors
show preference to US filings
• Can file a Provisional application for lower fees while
preserving early “priority date”; convert to Regular
application within next 12 months; delays
examination, however:
• The Specification of the Provisional application as filed must
provide support for claims once converted
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22. Patent Applications – options for filing
• U.S. Provisional Application
To be filed when a disclosure is imminent
Should be as detailed as possible or priority claim may be invalid
Avoid unless necessary due to budget and publication constraints
• PCT (Patent Cooperation Treaty) Application
International Application holding a filing date and place in nearly every
country in the world
30 month deadline for selecting jurisdictions in which to obtain protection
Search Report and Written Opinion/Report on Patentability issued
• European Application
Single Examination for EU Member Countries
Validation in selected jurisdictions
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23. Prosecution
• A well prepared specification and claims can
make prosecution “cleaner” which can reduce
costs
• Be aware of File Wrapper Estoppel in US
• Duty of candor in US applies during entire
pendency of application
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24. Scope of Protection in all jurisdictions
Market Analysis
Value is increased if protection is obtained in all relevant
jurisdictions
• Where is the market for the product?
• 20 year term
• Look to future markets and growing economies
• Where is the product manufactured?
• Prevent manufacture of product by others in strategic locations
• Import/Export Regulations
• Where are my competitors? Where is the R&D market?
• Which jurisdictions are more patent friendly?
• Importation
• Policing
• Litigation/Damages
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25. Scope of Protection
Consumer Markets
• USA High Population, Disposable Income, Quality of Living
• Europe High Population, Disposable Income, Quality of Living
• Canada Disposable Income, Quality of Living
• Japan Disposable Income, Quality of Living
• China Highest Population, Increasing Disposable Income
Producer Markets
• China Low cost manufacturing
Competitors
• Russia/Eurasia Advanced Education, Natural resources
• Australia Advanced Education, Natural resources
Enforcement
• China Emerging policing and government backing regarding
enforcement
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26. Post-Filing Considerations
• Event Timeline – for research and funding
• Maximizing Niche Protection – cover your
products
• Maximizing Maneuverability
• Freedom-to-Operate
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27. Post-Filing Timeline
First application filed
12 Months – PCT Application/Regular Application
18 Months – Publication of First application
30 Months – National Phase Entry of PCT Application
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28. Post-Filing Strategy
Timeline for selecting jurisdictions:
• 1 year from priority date – regular filed application
• 30 months from priority date – PCT application
Delay in time allows for:
• Funding
• Research/Test Results
• Partnering/Selling
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29. Maneuverability - Pending Applications
• Pending applications allows for amendment to scope of
claims, providing support in application as filed
• Ability to amend claim scope may capture changes in
research and/or product development
When looking to use IP to increase value for acquisition,
keep patent applications pending as long as possible.
Allows for new owner/licensee to amend the claim scope
of the pending application. Amending claims of allowed
patent much more difficult and restricted.
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30. U.S. Strategy
• Consider continuation practice
• Obtain allowed claims to narrow scope and then file
continuation patent directed to broader claim scope.
• Pending application provides for possible adjustment to the
claims based on actions of competitors.
• Terminal Disclaimers/Double Patenting.
• Continuation-in-Part Applications for improvements.
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31. Canadian Strategy
• No Continuation practice.
• No Terminal Disclaimers.
• Voluntary Divisional applications for broader
claims likely to invalidate divisional and even the
parent on grounds of double patenting.
• Forced Divisional applications.
• 5 year delay for requesting examination.
• 2 year backlog at Patent Office.
• Amendment after allowance.
• Reissue – 4 year deadline.
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32. Improvements
• Expand IP niche by filing patent applications protecting related
subject matter to fence out a greater area of protection.
• Forces competitors to deal with a larger number of patents
during licensing or possible litigation.
• Parent application publishes 18 months after priority date.
• If claiming priority to parent application subsequent application
must be filed within 12 months.
• If possible, file improvement patents before parent application
publishes although it shortens extension of protection.
• If improvement applications filed after parent publishes the
parent application may be cited against the improvement patent
during prosecution in rendering the improvement obvious.
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33. Freedom to Operate
• Issue of a patent does not grant you the right to sell the product
without potentially infringing another patent.
• A patent issued on an improved device requires the licensing of
the patent on the original device before sale of the improvement
may be made.
• A Freedom-to-Operate opinion is jurisdictional whereas a
patentability opinion is based on references published
worldwide.
• Potential for cross-licensing.
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34. Final Comments
In view of the many pitfalls resulting in weak or invalid patents
it is extremely important to invest in IP counsel as early as
possible. Direction of research should be monitored and IP
tailored to obtain a broad portfolio with strong patent
protection.
Investment made early in IP can save money and time in the
long run and add value to your portfolio.
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35. Thank You
Victoria Heppell
Patent Agent
Tel: 416 862 4312
Email: victoria.heppell@gowlings.com
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