Post on 03-Jan-2016
Due Diligence Strategy for
In-house Counsel
Jen Sieczkiewicz, Ph.D., J.D.Research & Business Development Counsel
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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 real 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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Viewpoint on IP Acquisition
• Provide robust diligence to secure defendable assets• Evaluate exclusivity (IP strength) and freedom-to-operate• Examine ownership, derivation (details in CLE paper)• Approach: How will a generic/biosimilar invalidate?
• Outcome of diligence will impact terms of license• Separate risks that money can solve, and those it cannot
• Manage risks and expectations vs. need for speed and budget
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DEAL IDEA “First Look” IPDiligence
TERM SHEET CLOSINGFormal Due
Diligence
DEAL ENDS
No
Yes
Gather information earlyo Size of transactiono Timingo Degree of comfort needed and
wheno Understand product, market,
technology, etco Get IP landscape from licensor;
discuss with them Prepare “assumed LOE” based on
composition per se or method of treatment patents and RDPo Use info from licensor, free or
library-paid patent databases Form preliminary assessment of
technology /competitive landscape o IPD Analytics, Thomson Cortelliso Google
Perform brief prelim. FTOo (USPTO, PCT, Espacenet, Thomson)
Summarize using “first look” template
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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How to Summarize Results?• The following slides represent an output inside
counsel might use in presenting the results of diligence
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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 genericAll slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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Projected LOE Date Alternative Approach
5-yr NCE Exclusivity
20XX20XX 2025
Generic (ANDA) Challenge possible (if
s.m.)
20XX
30-mo stay
Extendable up to 7.5 yrs from approval
20XX
Patent expires (w/o
Ext)
202720XX
App, if granted, expires
2028
Earliest date for generic entry
Patent expires (w/ Ext)
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
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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.).
Details of Key Patents/Patent Applications
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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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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Conclusions• Statement on whether the quality of exclusivity is sufficient
to continue with deal• Supporting points (brief –examples below – may put on
separate slide)
All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE
Good or Excellent Aspects
Poor or Missing Aspects
Potential Implications of Poor or Missing Aspects
• Composition of
matter claims
until 2059
• RDP expected to
be available until
X assuming
launch of Y.
• Manufacturing
process may be
covered by
Company X
patents
• Company Y is
producing a
prodrug that may
not be covered by
composition
claims.
• Ownership chain
has break
• 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.