Day 1 - Thursday, November 29, 2018

7:30
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks
8:45
Realities and Illusions of Patent Strength: Analyzing Legal Developments Impacting IP Validity
9:45
Will the Real Inventors Please Stand Up: Ensuring Proper Inventorship in an IP Due Diligence Analysis
10:45
Coffee and Conversation
Take advantage of this extended networking break and see how many people you meet. Your next legal team, business  partner, or client could be right in the conference room; it is up to you to find them!
11:15
Examining the Due Diligence Inner Sanctum
12:00
Networking Luncheon
1:15
Sizing up the Competition: Conducting Thorough and Cost-Efficient Freedom to Operate Analyses
2:30
Decision Drivers — The Private Equity Perspective with:
3:15
Refreshment Break
3:45

EARN CLE ETHICS CREDITS

Be in the Room Where it Happens: Knowing how to Effectively and Successfully Communicate with the IP Due Diligence Team
5:30
Conference Adjourns to Day 2

Day 2 - Friday, November 30, 2018

7:30
Continental Breakfast
8:15
Money Talks — Venture Capitalist Spotlight with:
8:30
Co-Chairs’ Opening Remarks and Recap of Day One
9:00
The Best Things in Life are NOT Free: Assessing the Intricacies of Deal-Related IP Valuation
10:00
Grab Some Coffee and Business Cards
10:30
Fireside Chat on Global Factors Influencing IP Due Diligence with:
11:15
Data Rooms with a View: Eyeing E-room Strategies for IP Due Diligence Projects
12:00
Pointing the Finger: When Defective IP Due Diligence Wrecks the Deal
12:45
Networking Luncheon for Workshop Participants

Day 1 - Thursday, November 29, 2018

7:30
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks

Drew Holmes, Ph.D.
Senior Patent Attorney
Novartis Pharmaceuticals Corp. (East Hanover, NJ)

Donna Meuth
Associate General Counsel – Intellectual Property
Eisai Inc. (Andover, MA)

Jennifer Zarutskie Sieczkiewicz
Vice President, Chief Intellectual Property Counsel
Wave Life Sciences (Cambridge, MA)

You are in for a rare treat as our stellar co-chairs — who together bring more than 50 years of IP due diligence knowledge, skill, and war stories to the table — take you on a tour of their diligence experiences at various size companies from both the business and IP perspectives.

8:45
Realities and Illusions of Patent Strength: Analyzing Legal Developments Impacting IP Validity

Paul Alloway
Vice President & Head of Legal
Foghorn Therapeutics (Cambridge, MA)

Donna Meuth
Associate General Counsel – Intellectual Property
Eisai Inc. (Andover, MA)

Melanie R. Rupert
Partner, Life Sciences IP Litigation Global Co-Chair, Talent Development
Paul Hastings (New York, NY)

In the past year, there have been numerous changes — lawmaking, regulations, and court decisions — influencing the life sciences industry. This panel will explore how these changes will impact the strategies and decisions made during the IP due diligence process.  

  • Diving into patent eligibility for method of treatment claims in light of Vanda Pharmaceuticals
  • Analyzing on-sale bar concerns in light of the Supreme Court’s grant of certiorari in Helsinn
  • Deciphering evolving standards for demonstrating divided and induced infringement
  • Asserting and defending against post-grant proceedings
    • Analysis and impact SAS Institute and related jurisprudence
    • Balancing conflicting burdens of proof between district courts and the PTAB
  • Evaluating exclusivities and their effects on patent term
  • Exploring the status of sovereign entities and IP challenges
  • Revisiting inequitable conduct and unclean hands: Therasense, Gilead v. Merck, purge, and supplemental examination

9:45
Will the Real Inventors Please Stand Up: Ensuring Proper Inventorship in an IP Due Diligence Analysis

Catherine Eckenswiller
Legal Counsel – Intellectual Property & Agreements
VBI Vaccines Inc. (Ottawa, CA)

Kimya Harris, Ph.D.
Vice President, Head of Intellectual Property and Legal Affairs
KSQ Therapeutics (Cambridge, MA)

Ryan Murphey
Counsel
Ropes & Gray LLP (New York, NY)

  • Identifying necessary steps in ensuring accurate and timely-recorded assignments
  • Locating, reviewing, and preserving all employment agreements, collaboration agreements, licensing agreements, grant contracts, and other agreements potentially affecting ownership rights
  • Analyzing potential obviousness type double patenting challenges
  • Understanding the role of Bayh Dole and Government-funded projects relative to the concept of inventorship
    • Determining whether a project is “Government funded”
    • Exploring Government funding in early-stage research vs. late-stage
    • Understanding Marchin rights as to access and pricing

10:45
Coffee and Conversation
Take advantage of this extended networking break and see how many people you meet. Your next legal team, business  partner, or client could be right in the conference room; it is up to you to find them!
11:15
Examining the Due Diligence Inner Sanctum

Drew Holmes, Ph.D.
Senior Patent Attorney
Novartis Pharmaceuticals Corp. (East Hanover, NJ)

John Krayacich
Vice-President & Head, Business Development & Licensing
Novartis Pharmaceuticals Corp. (East Hanover, NJ)

Frederick K. Young, Ph.D.
Due Diligence Head CM and NS
Novartis Pharmaceuticals Corp. (East Hanover, NJ)

Get an inside view from members of the IP due diligence group at Novartis as they share their perspectives on the entire diligence process. This oneof- a-kind roundtable discussion will provide insights on:  

  • Developing best practices for potential targets to “put their best foot forward”
  • Avoiding pitfalls during the diligence process
  • Identifying desired qualities for outside counsel
  • Managing budgets
  • Maintaining proper relationships both within and outside of the company

12:00
Networking Luncheon
1:15
Sizing up the Competition: Conducting Thorough and Cost-Efficient Freedom to Operate Analyses

Mark D. Kafka
Associate Director, Assistant General Counsel
Genentech, Inc. (South San Francisco, CA)

Ahmed Mousa, J.D.
Vice President, Licensing, IP & Legal Affairs
Pieris Pharmaceuticals Inc. (Boston, MA)

Alicia A. Russo
Partner
Venable Fitzpatrick

  • Exploring sources beyond patent databases: best practices for conducting effective landscape searches
  • Balancing the threats of blocking patents: potential infringement vs. potential injunction
  • Benchmarking with competitors: monitoring their activities while weighing the risks of your projects
  • Developing strategies for working the FTO results into the direction of the business
  • Understanding when to use written opinions

2:30
Decision Drivers — The Private Equity Perspective with:

Lacy Kolo, Ph.D.
Director, Tech and IP Advisory
Houlihan Lokey (McLean, VA)

Dr. Kolo, editor of the renowned treatise on Intellectual Property and Technology Due Diligence counsels her clients on technology and IP-based transactions, mergers and acquisitions, IP-backed capital formation, and restructuring. Grab a seat as Dr. Kolo discusses the ins and outs of valuation from the private equity point of view. Learn how to assess your portfolio while making it desirable for institutional investors.

3:15
Refreshment Break
3:45

EARN CLE ETHICS CREDITS

Be in the Room Where it Happens: Knowing how to Effectively and Successfully Communicate with the IP Due Diligence Team

Target

Thomas L. Irving
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP (Washington, DC)

Jennifer Zarutskie Sieczkiewicz
Vice President, Chief Intellectual Property Counsel
Wave Life Sciences (Cambridge, MA)

Gary J. Speier
Shareholder
Carlson Caspers Vandenburgh Lindquist & Schuman, PA (Minneapolis, MN)

Ha Kung Wong
Due Diligence Head CM and NS
Venable Fitzpatrick

Acquirer

Matt Blischak
Vice President, Intellectual Property Counsel
Roivant Sciences, Inc. (New York, NY)

Alysia A. Finnegan, Ph.D., Esq.
Counsel, Intellectual Property Group
Merck & Co. Inc. (Rahway, NJ)

Mercedes K. Meyer, Ph.D., J.D.
Partner
Drinker Biddle & Reath LLP (Washington, DC)

Len Smith
Principal Counsel and Co-Founder
Transformative Legal (Scottsdale, AZ)

Here is your chance to be a part of the “dueling” deal teams as our team leaders walk you through a mock deal scenario providing best practices for fostering inter- and intra-team communications, and tailored solutions for overcoming top challenges faced by both acquirers and targets. Our teams will dive into all aspects of the diligence process including: preparation, valuation, ethical and privilege issues, as well as tying up necessary strings to complete the IP due diligence phase of the deal process. Be prepared for this highly interactive think tank where everyone participates! Sample topics of discussion include:  

  • Getting the target’s “IP house” in order
  • Performing an objective review of your portfolio to prepare for the acquirer’s questions while considering how closely to guard privileged information
  • Timing and extent of flaw identification: what to do with known risks in your portfolio? When to identify them up front vs. waiting until the potential buyer asks?
  • Evaluating what the other side is looking for, and drafting a plan to get there
  • Disclosure: determining how much information to relay to the target about flaws when you still want the deal to proceed and understanding potential privilege considerations
  • Assisting the business team with valuation of the patent(s)
  • Identifying risk in a target IP portfolio and effectively conveying this
  • information to the business development team
  • Understanding best ways to submit data to the relevant team, e.g., IP attorney vs non-IP person
   

5:30
Conference Adjourns to Day 2

Day 2 - Friday, November 30, 2018

7:30
Continental Breakfast
8:15
Money Talks — Venture Capitalist Spotlight with:

Ralph W. Carmichael
Chairman & Chief Executive Officer
BŌNWRx Ltd. (Lansing, MI)

Mr. Carmichael has extensive experience as both an attorney and a finance professional, and is the founder of several venture capital firms. Join us and get an inside perspective into the factors impacting VC investment decisions, qualities VCs look for from their IP counsel, and more.

8:30
Co-Chairs’ Opening Remarks and Recap of Day One
9:00
The Best Things in Life are NOT Free: Assessing the Intricacies of Deal-Related IP Valuation

Greg Bell
Group Vice President and Life Sciences Practice Leader
Charles River Associates (Boston, MA)

Geoffrey Taylor Gibbs
Deputy General Counsel, Business, Finance and Innovation
University of California, Office of the President (Oakland, CA)

Forrester J. Liddle Ph.D., J.D.
Director of Intellectual Property
Jounce Therapeutics (Cambridge, MA)

Moderator:

Brenda Jarrell, Ph.D.
Co-Chair of Intellectual Property and Life Sciences
Choate, Hall & Stewart LLP (Boston, MA)

  • Framing the deal: Building a perspective on goals and risks from both sides of the table
  • Evaluating and differentiating between critical and manageable risks
  • Assessing valuation models and adjusting for value drivers such as: regulatory exclusivities, pending legislation, follow-on development, and competing IP
  • Adjusting valuation for the results of the diligence analysis: opportunity and risk
  • Building the deal to maximize value

10:00
Grab Some Coffee and Business Cards
10:30
Fireside Chat on Global Factors Influencing IP Due Diligence with:

Philip Johnson
Former Senior VP for IP Policy & Strategy
Johnson & Johnson (New Brunswick, NJ)

INTERVIEWED BY:

The Honorable Paul R. Michel (Ret.)
Former Chief Judge
United States Court of Appeals for the Federal Circuit (Alexandria, VA)

ACI is delighted to have IP legends Phil Johnson and the Honorable Paul Michel join us for an in-depth discussion and analysis of recent developments in the intellectual property sphere — both U.S.-based and international — and the impact of these developments on business strategies and visions for the life sciences IP diligence process. Take advantage of the unique opportunity to hear their perspectives and walk away with knowledge and skills you can directly incorporate into your diligence practice.

11:15
Data Rooms with a View: Eyeing E-room Strategies for IP Due Diligence Projects

Nicholas Boivin
Chief Intellectual Property Counsel
Forma Therapeutics (Watertown, MA)

Jeffrey J. Ellison, Ph.D.
Partner
Clark + Elbing LLP (Boston, MA)

  • Perfecting the data room checklist
  • Assessing what information should be placed into the data room
  • Drawing the line: determining what and how much information to redact
  • Developing best practices for organization and real-time updating of materials
  • Covering your assets: Strategies for protecting your confidential information with a CDA

12:00
Pointing the Finger: When Defective IP Due Diligence Wrecks the Deal

Drew Holmes, Ph.D.
Senior Patent Attorney
Novartis Pharmaceuticals Corp. (East Hanover, NJ)

Jane M. Love, Ph.D.
Partner
Gibson, Dunn & Crutcher LLP (New York, NY)

When it comes to the next huge deal, get your name in the headlines for leading a successful transaction, not for the “oops-I-didn’t-realize-I-can’t-usethe-trademark.” This panel will discuss real-life situations of IP due diligence errors or omissions resulting in deal failure, litigation, and/or other substantial loss of money. Our speakers will lead an interactive discussion on dissecting the deal, decisions made at critical junctures, as well as what could have been done differently to possibly have resulted result in an alternate outcome.

12:45
Networking Luncheon for Workshop Participants