The in-house viewpoint on due
diligence for IP acquisition, including
best practices for messaging results
to management
Jen Sieczkiewicz, Ph.D., J.D.
Research & Business Development
Counsel
Biogen Inc., Cambridge MA
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DISCLAIMER
These materials have been prepared solely for
educational purposes and reflect only the
personal views of the author and not of her
employer Biogen Inc. Further, the presentation
of these materials does not establish any form
of attorney-client relationship with the author,
nor does it constitute individualized legal advice.
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30,000 Foot View
• As corporate counsel, knowing the law and IP status
isn't enough!
• To be successful and trusted by business executives,
counsel needs to understand the business operations
and perspective, and speak their language.
• Your role: to identify risk and help the client
evaluate that risk and its potential impact on
the business.
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Agenda
• IP Acquisition
– Due Diligence
– Patent Landscape Analysis
• Messaging to the Business
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IP Acquisition – In-House View
• Will the asset give us the strong position that we want?
– Evaluate exclusivity (IP strength) and freedom-to-operate
– Examine ownership, derivation
Approach: How will a generic/biosimilar invalidate? Will it keep out
“close competition”?
• What should we be paying for this asset? Is it a money pit?
– Separate risks that money can solve, and those it cannot
– Up to business to decide which risk it wants to take, you inform on
consequences of each path
• Manage risks and expectations vs. need for
speed and budget
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Discussion Point
Managing risks and expectations vs.
need for speed and budget in due
diligence/landscape analysis
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My preferred approach:
DEAL ENDS
No
DEAL IDEA
“First Look” IP
Diligence





Gather information early
o Size of transaction
o Timing
o Degree of comfort needed and
when
o Understand product, market,
technology, etc
o Get IP landscape from licensor;
discuss with them
Prepare “assumed LOE” based on
composition per se or method of
treatment patents and RDP
o Use info from licensor, free or
library-paid patent databases
Form preliminary assessment of
technology /competitive landscape
o IPD Analytics, Thomson Cortellis
o Google
Perform brief prelim. FTO
o (USPTO, PCT, Espacenet, Thomson)
Summarize using “first look” template
TERM
SHEET
Yes



Formal Due
Diligence
CLOSING
Continue gathering information re:
timing, progress, what is needed.
o Engage outside counsel for
formal patent, FTO search
 Leverage what you
know from “first look”
Send checklist to other party:
Update results using formal template
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Messaging – In-House View
• The decision makers trust you know the
details, but they need the key metrics to
make a decision.
– Loss of exclusivity date
– Licenses they might need
– White space for more inventions
• A-C Privilege and Litigation Fodder
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Discussion Point
How do you communicate in a
business-friendly way without
jeopardizing privilege?
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One Approach Follows…
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Due Diligence Readout
This readout is based on the information
provided to us by the Target Company/Licensor
and by our legal analysis of the same. We have
based our analysis on our current understanding
of the applicable laws, which are subject to
change over time. This readout should thus be
relied upon only as of the date of this slide deck.
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Projected LOE Date – Summary
Patent
• Brief description of key types IP (composition,
method) on which LOE is based and then LOE
date (noting if applicable that up to 5 years of
extension could be available)
Regulatory
• List current RDP terms unless launch date known;
US – 12 years from launch if biosimilar, 5 years if
generic
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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Projected LOE Date Alternative
Approach
Extendable
up to 7.5
yrs from
approval
30-mo stay
Earliest date for generic entry
5-yr NCE Exclusivity
20XX
20XX
20XX
Generic (ANDA)
Challenge possible (if
s.m.)
20XX
20XX
2025
Patent
expires (w/o
Ext)
2027
2028
App, if granted,
expires
Patent expires (w/
Ext)
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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Landscape Analysis
Freedom-to-Operate (FTO) – key jurisdictions
 Composition cleared?
 Manufacturing cleared?
 Risks?
Competitors and Competitive Technologies
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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Executive Conclusions
Brief one-line synopsis of IP position, supported by:
Good or Excellent
Aspects
•
•
Composition of
Poor or Missing
Aspects
•
Manufacturing
matter claims until
process may be
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covered by Company
Potential Implications of
Poor or Missing Aspects
•
Third party IP may have to
license, increasing royalty
stack. May need to delay
launch until expiry.
•
Similar therapeutic may be
available by 2020 that we
cannot block with current
IP.
•
Need to obtain
assignments from
potentially missing people.
X patents
RDP expected to be
available until X
•
Company Y is
assuming launch of
producing a prodrug
Y.
that may not be
covered by
composition claims.
•
Ownership chain has
break
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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Keep as Backup Slides the
Details…
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Details of Key Patents/Patent
Applications
Detailed summaries of key patents in key
jurisdictions. Focus on why they provide
meaningful exclusivity (or why they do not, e.g.,
they claim a formulation that likely can be
‘invented around, an indication that could be
‘skinny labeled,’ etc.).
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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Opportunities to Strengthen our
Position
Summarize any opportunities to improve the
existing filings, and the potential for new IP to
be generated in the future.
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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