Day 1 - Thursday, November 2, 2017

Registration and Continental Breakfast
Co-Chairs’ Opening Remarks and Laying Out Hypothetical Deal Scenario

Adda Gogoris
Hueschen & Sage PLLC (Kalamazoo, MI)

Tom Irving
Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Jennifer Zarutskie Sieczkiewicz, Ph.D.
Associate General Counsel, Corporate
Biogen Inc. (Cambridge, MA)

In this welcome session, our co-chairs will summarize the facts of the hypothetical deal scenario that will lay the groundwork for the main conference. The interactive sessions of the main conference will track the facts provided in the mock diligence scenario, and with the aid of the provided background paperwork, our speakers will examine the various aspects of due diligence both from the acquirer (“suitor”) and the target points of view. The co-chairs will encourage questions and comments during the sessions to bolster the learning environment.

Preparing the Due-Diligence Checklist and Forming your Team

Margo Furman, Ph.D.
IP Counsel, R&D and New Products
Shire Pharmaceuticals (Lexington, MA)

Jennifer Zarutskie Sieczkiewicz, Ph.D.
Associate General Counsel, Corporate
Biogen Inc. (Cambridge, MA)

Thomas F. Poché, Ph.D.
Vice President and Associate General Counsel, IP
Allergan (Parsippany, NJ)

Ha Kung Wong
Fitzpatrick Cella Harper & Scinto (New York, NY)

For this session, we will divide the audience into small groups and each group will design a diligence team and prepare a checklist based on the provided fact pattern. One representative from each group will present the team’s checklist, and our panel of diligence experts will discuss the most important aspects of creating a cost-effective, practical roadmap as well as determining and selecting the best/most effective team members. Due diligence investigations are essentially open-ended, but need to produce a specific output — an assessment of the risks the business will have to manage in this transaction should it complete the deal.

Grab Some Coffee and Business Cards
Analyzing the Current Patent Landscape: AIA, Post-Grant Proceedings, Evolving Jurisprudence, and the Effects on Patent Strength

Matthew Blischak
Vice-President and General Counsel, Global Specialty IP Litigation
Teva Pharmaceuticals (Horsham, PA)

Adda Gogoris
Hueschen & Sage PLLC (Kalamazoo, MI)

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

  • Verifying proper choice-of-law employed during prosecution of post-AIA claims, particularly in the case of “mixed applications” governed by AIA transition provisions 3(n)(1) and 3(n)(2)
  • Ensuring proper declarations were filed in view of pre- and post-AIA requirements
  • Balancing the pros and cons of initiating an IPR vs. PGR. vs. obtaining an invalidity opinion
    • Evaluating the lower burden for PTAB proceedings and the relationship with parallel district court/Federal Circuit proceedings
  • Eyeing the challenges underlying patent term extension
  • Investigating induced infringement post Halo
  • Diving into divided infringement and method claims
  • Evaluating patent eligibility issues for bioproduct claims

Uncovering Red Flags in Ownership and Inventorship

Jeremy Cubert
VLP Law Group LLP (Gaithersburg, MD)

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

Len Smith
Transformative Legal, LLC (Phoenix, AZ)

  • Establishing chain of title and present patent owner
    • Sovereign immunity issues in AIA proceedings involving university inventors and university rights
    • Identifying proper inventorship
      • Reviewing how target acquired the IP and possible additional interests
    • Verifying all assignments have been properly and timely executed and recorded
      • Attempting to correct missing assignments
      • Unique issues with university-related assignments
      • Date of assignment, number of inventors, and right to claim priority under EPO law. UK national law, and other international jurisdictions
  • Assessing potential third party rights
    • Performing a title search to uncover potential liens
    • Existence of sublicenses to unrelated parties
    • Reviewing all collaborative agreements, license agreements, supply and distribution agreements and any other agreements as well as private grants affecting the target’s IP rights
    • Assessing whether government funding has been involved and appropriately disclosed
    • Missing inventors: assignees or licensees may not infringe

Diving into the Patent Portfolio: Examining the Scope, Patentability, Validity, and Enforceability

Andrew Allen
Director, Legal Counsel-Intellectual Property
Dr. Reddy’s Laboratories Ltd. (Princeton, NJ)

Jeffrey Ellison
Clark & Elbing (Boston, MA)

Forrester Liddle
Director of Intellectual Property
Jounce Therapeutics (Cambridge, MA)

  • Evaluating patent strength in light of recent jurisprudence
    • Analyzing ability to withstand judicial and technical challenges
    • Keeping up with the evolving § 101 standard
    • Effect of obvious-type double patenting on patent term post-Gilead
  • Considering depth and breadth of patent coverage
    • Ensuring the patent covers the commercialized product
    • Confirming the broadness of the claims satisfy the desired scope
    • Reviewing specification for available options to expand claim scope
    • Making sure the worldwide portfolio meets your needs and no key jurisdictions are missing
  • Reviewing Orange Book listings, eligibility, and potential regulatory roadblocks
  • Determining eligibility for patent term extension
  • Ensuring the patent/application is consistent with the information in the invention disclosure
    • Determining if any missing information has been publicly disclosed or sold
  • Pondering pending legislation re: exclusivity for NCE, orphan drugs, biologics, and antibiotics (GAIN Act exclusivity)
  • Confirming the granted or patentable pending claims actually cover the commercial embodiment to be developed and sold
  • Eyeing enforceability
    • Reviewing pending or concluded litigation involving the patent
    • Potential exclusivity challenges and timing of exclusivity challenges
    • Evidence of possible inequitable conduct
    • Spotting possibility of divided infringement

Focusing on Freedom to Operate: Analyzing the Market

N. Nicole Stakleff
Pepper Hamilton LLP (Pittsburgh, PA)

Letitia Walker
Legal Director - Patents
Merck & Co., Inc. (Rahway, NJ)

Richard Yoon
Director of IP
Microvention, Inc. (Tustin, CA)

  • Sizing up the competition: locating the relevant players in the space
    • Examining potential third-party blocking patents
      • Weighing the risk of infringement and potential injunction
      • Collecting proper search terms and identifying search forums for an extensive infringement analysis
  • If there is no commercialized product
    • Utilizing figures in the patent representing the commercialized product
    • Ability to obtain a product sample to perform FTO analysis
  • Investigating whether infringement searches and analyses were already conducted and whether written opinions were obtained
  • Examining license/assignment agreements, settlement agreements, employment and consulting agreements, and active litigations

Afternoon Networking Break
Deals Gone Wild: Real-Life Horror Stories of IP Due Diligence Missteps

Yu-Ming Dammann, Ph.D., J.D.
Product Attorney
Gilead Sciences, Inc. (Foster City, CA)

Jennifer K. Johnson, J.D.
Head of Legal & Intellectual Property
Blaze Bioscience, Inc. (Seattle, WA)

Alicia A. Russo
Fitzpatrick Cella Harper & Scinto (New York, NY)

In this interactive panel, our expert faculty will discuss real-life examples of deals that failed miserably as a result of IP due diligence or where a lack of thorough due diligence prevented the deal from going through, or worse, ending up in debilitating litigation. The discussion will focus on what happened during the due diligence process, during the life of the deal, what ended up killing the deal, and how these issues can be avoided. Our panelists will also discuss current litigations resulting from failed due diligences.

Conference Adjourns to Day 2

Day 2 - Friday, November 3, 2017

Continental Breakfast
Co-Chairs’ Opening Remarks and Recap of Day One
Show Me the Money: Strategies to Overcome Valuation Challenges

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

Janice Klunder
Vice President - Intellectual Property Endocrinology Research & Development Peptides
Ipsen Bioscience Inc. (Cambridge, MA)

Andrew W. Williams
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

  • Aligning with business team on business reason for the deal and where they are placing the value
    • Effectively summarizing the IP risks while considering the broad, overall goal
    • Comparing methods for early vs. late-stage transactions
    • Working with inside business teams vs. outside personnel
  • Impact of the Affordable Care Act and the current state of drug pricing
  • Best practices for working with VCs
  • Reviewing regulatory and exclusivity risks
    • Analyzing evolving case law, political dynamics, healthcare legislation
  • Possible deductions to the proposed value
    • Questionable ownership
    • Patent not covering commercial product
    • Infringement dangers from marketing product
    • Other diminishments of patent strength such as possibility of inequitable conduct
  • Pushing forward despite a negative diligence
    • Addressing and shifting risk in the agreement
    • Representations and warranties
    • Evaluating if the product or company is of value without the IP
      • Determining if you can recoup investment selling the product as is

Grab Some Coffee and Business Cards
Pursuing Trade Secret Protection in the Current Anti-Patent Climate

David K. Barr
Arnold & Porter Kaye Scholer LLP (New York, NY)

Kimya Harris, Ph.D.
Senior Director Intellectual Property, R&D
Immunogen, Inc. (Waltham, MA)

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

  • Ensuring company has a robust, up-to-date trade secret procedure
    • Keeping internal procedures on a need-to-know basis
      • Compartmentalizing your portfolio so no single person has access to everything
  • Checking if ownership issues impact trade secret protection
    • Does company have a consulting agreement with the inventor
    • Is the invention already licensed to a competitor of the potential partner
  • Minimizing risk of trade secret misappropriation
    • Keeping proper employment agreements and maintaining assignment records
  • Impact of Defense Trade Secrets Act

Attorney-Client Privilege, Contamination, and Ethical Challenges

Drew Holmes, Ph.D.
Patent Attorney, I&D, NS & Ophthalmology Patents
Novartis Pharmaceuticals Corp. (East Hanover, NJ)

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

Barbara A. Ruskin, Ph.D., J.D.
Legal Counsel, Life Sciences Intellectual Property Specialist
BA Ruskin Law LLC (New York, NY)

  • Avoiding conflicts when evaluating confidential information
    • Considering outside counsel to limit exposure
      • Avoiding temptation to use confidential diligence information in litigation
    • Compartmentalizing the process so no single actor has access to all information
    • Reviewing and updating internal employment agreements
    • Unique challenges arising with international parties
    • Utilizing common interest agreements
  • Obtaining invalidity and non-infringement positions
    • Discussing these opinions with the other side
    • Privilege issues and common or identical legal interest agreements
    • Drafting opinions internally or farming out
  • Dealing with tough ethical decisions while working with less-sophisticated parties
    • Considering disclosure of negative information
  • Setting up e-rooms for confidential data storage
    • Controlling access to the e-room and how data can be downloaded and use
    • Deciding features of e-room
      • User permissions
        – Restrictions on downloading/forwarding material
      • Access points
    • Ensuring ability to permanently delete data immediately when finished
  • Using a neutral third-party evaluator to retain both sides’ privilege

Networking Luncheon for Workshop Participants

Best Practices for Managing the Entire Due Diligence Process from Both Sides’ Perspectives

Nov 3, 2017 2:00pm - 5:00pm



Amy Gallup Klann
Leason Ellis LLP (White Plains, NY)

Douglas Portnow
Wilson Sonsini Goodrich & Rosati (Palo Alto, CA)

What is it about?

This intimate and interactive workshop will cover the ins and outs of the challenges faced by both acquirers and targets. For the target company, the most challenging issues are being noticed by suitable acquirers, and getting their “IP house” in order. Being on top of your IP portfolio is crucial to putting the acquirer at ease, making them more likely to consummate the deal.

For the acquirer, it is all about doing a thorough, cost and time-effective analysis of the target’s portfolio without leaving any crucial stones unturned. However, the biggest challenge can be how to perform the diligence economically when a wrong decision at this stage can end up costing billions of dollars down the road.

This Master Class will provide practical and detailed guidance for both sides on how to plan for and complete an effective due diligence review. Get answers to all of the questions keeping you up at night:

  • Reviewing and understanding the entire patent portfolio
    • Deciding what claims are valuable to whom and why
    • Performing objective review of portfolio to prepare for acquirer’s questions while considering how closely to guard privilege issues
    • When issues arise, what to do, identify them up front vs. wait until the potential buyer asks? Timing of identification
  • Evaluating what the other side is looking for, drafting a plan to get there
  • Determining how to spend limited resources while maximizing value
  • Forming your FTO position
  • Inspecting the target’s house and identifying red flags
    • Determining who has the information you want and how to obtain it efficiently. How to ask? When to ask? If you don’t get it, then what do you do?
  • Benefits of using in-house vs. outside counsel for the IP review
  • Evaluating risks posed and whether they are deal-killers or can be addressed through reduction in valuation