Due Diligence Strategy for In-house Counsel Jen Sieczkiewicz, Ph.D., J.D. Research & Business Development Counsel

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


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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.


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Landscape Analysis

Freedom-to-Operate (FTO) – key jurisdictions Composition cleared? Manufacturing cleared? Risks?

Competitors and Competitive Technologies


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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)


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.

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Due Diligence Strategy for In-house Counsel Jen Sieczkiewicz, Ph.D., J.D. Research & Business Development Counsel