Day 1 - Monday, November 9, 2020

Pre-Conference Primer*
Life Sciences IP Due Diligence 101 – Preparing Your Due Diligence Checklist and Managing the Process from Soup to Nuts

Nov 9, 2020 8:00am – 9:45am

Speakers

Philip I. Datlow
Director and Senior Counsel II Human Pharma Patents and Intellectual Property
Boehringer Ingelheim USA Corporation (Ridgefield, CT)

Gloria Fuentes
Executive Director, Corporate Transactions
Merck (Kenliworth, NJ)

Jessica Jamieson
Vice President, IP Therapeutic Head, Hematology
Takeda (Chicago, IL)

9:45
Co-Chairs’ Opening Remarks – A Look Back and a Look Ahead: Examining Key Developments Impacting Life Sciences IP Due Diligence in the Last Year
10:15
Evaluating COVID-19’s Impact on Biopharma Deal Making and Valuation of IP Assets
11:15
Morning Coffee Break
11:30
Conducting Due Diligence in the Age of “Six Feet Apart”: Strategies for Performing a Robust Virtual/Remote IP Due Diligence Review
12:15
Networking Luncheon for Speakers and Delegates
1:15

Interactive Case Study

Avoiding Missteps When Conducting IP Due Diligence in Connection with Distressed Companies and Distressed Assets
2:00
Uncovering Red Flags in IP Ownership and Solving Conundrums Caused by Government Funding Initiatives on IP Rights and Evaluation
3:00
Afternoon Break
3:15
Unique IP Due Diligence Considerations for Medical Devices, MedTech, and Artificial Intelligence
4:15
Mitigating International Legal Risk: IP Due Diligence Considerations for Global Deals
5:00
Conference Adjourns

Day 2 - Tuesday, November 10, 2020

7:30
Registration & Continental Breakfast
8:00

VALUATION

Assessing the Intricacies of Deal-Related IP Valuation
9:15

Money Talks

An Interactive Interview with a Private Equity Expert and Venture Capitalist on the Ins and Outs of Securing Funding for Life Sciences Companies
10:15
Coffee and Conversation
10:45
Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process
11:30
“War Stories” on Due Diligence Gone Wrong: When Defective IP Due Diligence Wrecks the Deal
12:15

Interactive Ethics Lab

Overcoming Common Challenges and Ethical Dilemmas in Life Sciences IP Due Diligence
1:15
Main Conference Ends – Lunch for Workshop Participants Begins

Post-Conference Workshop

Freedom to Operate BootCamp:
A Comprehensive Tactical Guide to Mastering the FTO Search

Nov 10, 2020 2:15pm – 5:30pm

Speakers

Keisha Hylton-Rodic
Attorney
Hylton-Rodic Law PLLC (Washington, DC)

Olga Kay
Senior Patent Counsel
Roche (San Francisco, CA)

Day 1 - Monday, November 9, 2020

9:45
Co-Chairs’ Opening Remarks – A Look Back and a Look Ahead: Examining Key Developments Impacting Life Sciences IP Due Diligence in the Last Year
Jen Grant Moitoso

Jennifer Grant Moitoso
Vice President, US Head of IP
Takeda

Henry H. Gu
Vice President, Chief IP Counsel
Akebia Therapeutics, Inc. (Cambridge, MA)

In the year since we last met, there have been numerous developments influencing the life sciences industry, including new lawmaking initiatives, a presidential election, and the COVID-19 pandemic which has created a palpable shift in the way many companies approach business transactions. Our esteemed co-chairs will kick off the event with an exploration of the last year’s most significant developments that are impacting life science company pipelines, reshaping future business analyses and influencing the strategies and decisions made during the IP due diligence process.

10:15
Evaluating COVID-19’s Impact on Biopharma Deal Making and Valuation of IP Assets

Donna Meuth
Associate General Counsel Intellectual Property
Eisai (Cambridge, MA)

Melanie R. Rupert
Partner
Paul Hastings (New York, NY)

The COVID-19 pandemic has given rise to new approaches to IP and innovation, however at the same time we have seen calls to ban patents on drugs, diagnostics and treatments out of concerns over profiteering. This panel will address how the latest COVID-19 developments are impacting considerations for IP due diligence. Topics of discussion include:

  • Examining how the recent pandemic has affected biopharma deal-making and addressing what lasting implications we can expect to see in the longer term
  • Understanding how COVID-19 has spurred new thinking about patent strategies and the evaluation of IP assets
    • How has this year’s crisis forced patent owners to think differently about how they use their patents, and how is this impacting the evaluation and valuation of IP assets during a due diligence?
    • How could IP evaluation be impacted by government mandated price controls, patent pools or compulsory licenses on COVID-19 related products?
  • How should attorneys be counseling their clients in terms of navigating this unprecedented situation?

11:15
Morning Coffee Break
11:30
Conducting Due Diligence in the Age of “Six Feet Apart”: Strategies for Performing a Robust Virtual/Remote IP Due Diligence Review

Andrew K. Holmes
Patent Attorney
Novartis Pharmaceuticals (New York, NY)

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

Due to this year’s pandemic, many of us have had to quickly adapt to a “new normal” which relies largely on virtual and remote business operations. This panel will share strategies that life sciences companies can employ to successfully conduct virtual or remote due diligence reviews going forward.

  • Conducting a robust due diligence review from start to finish by adjusting corporate policies and procedures
  • Developing strategies for overcoming challenges relating to:»Inaccessibility to hard-copy documents and the need to share large amounts of data
    • Remote coordination of due diligence teams
    • In person meetings being moved online
    • Virtual communications among multiple parties (attorneys, BD, scientists, etc.)
  • Mitigating new risks that arise through the use of new and alternate diligence methods (e.g. cyber security risks, data security risks, etc.)

12:15
Networking Luncheon for Speakers and Delegates
1:15

Interactive Case Study

Avoiding Missteps When Conducting IP Due Diligence in Connection with Distressed Companies and Distressed Assets

Rekha Hanu
Vice President, Associate General Counsel & Chief IP Counsel
Akorn Pharmaceuticals (Lake Forest, IL)

Yingying Zeng
Legal Director, Patent Attorney
Merck (Rahway, NJ)

The sale of IP assets during a bankruptcy can be a very lucrative transaction for both buyer and seller, however, for those who are unfamiliar with the complexities of the U.S. bankruptcy process, there are potential hazards involved in this type of deal. This interactive case study will walk you through a mock deal scenario and shed light on topics including:

  • Understanding what specific due diligence needs must be considered when engaging in the acquisition of IP assets from a distressed life sciences company
  • Addressing the different due diligence considerations involved when the distressed seller is seeking to reorganize versus liquidate
  • Gaining a full understanding of Bankruptcy Code Section 365(n) and the rights of a licensee under bankruptcy to continue the use of Intellectual Property
  • Assessing the increased complications that come into play when acquiring foreign IP assets from a bankrupt US company

2:00
Uncovering Red Flags in IP Ownership and Solving Conundrums Caused by Government Funding Initiatives on IP Rights and Evaluation

Patricia A. Carson
Partner
Kirkland & Ellis LLP (New York, NY)

Jennifer K. Gregory
Assistant General Patent Counsel - IP Transactions
Eli Lilly and Company (Indianapolis, IN)

Henry H. Gu
Vice President, Chief IP Counsel
Akebia Therapeutics, Inc. (Cambridge, MA)

Red Flags:

  • What are the key questions to ask and red flags to look for when seeking to identify the true owner of the IP?
  • Have potential third-party rights been properly assessed?
  • Has there been a valid and inclusive assignment of patents to the licensor?

Government Funding:

  • Has government funding been involved and appropriately disclosed? And if so, what effect will this have?
  • Examining the U.S. v. Gilead case determining government ownership of the HIV prevention drug Truvada for PrEP
  • Assessing whether any COVID-19 related patents have been developed under government funding initiatives and what the impact will be on companies’ rights to them
  • Understanding how to look at the role of government funding when conducting due diligence on a deal: What should you look for in the government contracts? How should you evaluate the work that was done? Etc.

3:00
Afternoon Break
3:15
Unique IP Due Diligence Considerations for Medical Devices, MedTech, and Artificial Intelligence

Jeremy Bond
Senior Counsel, Device Patents U.S. Global Intellectual Property Dept.
Sanofi (Cambridge, MA)

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

Jeff Mann
Senior Vice President, General Counsel and Secretary
Cantel Medical (Little Falls, NJ)

Moderator:

David Dykeman
Co-Managing Shareholder & Patent AttorneyCo-Chair, Global Life Sciences & Medical Technology Group
Greenberg Traurig, LLP (Boston, MA)

The IP that protects medical devices and AI are different from that of pharmaceuticals and biologics, and thus must be evaluated differently during a deal. This panel will address the unique considerations that companies face when approaching IP due diligence projects involving medical devices and inventions based on AI.

  • Understanding the ways in which medical devices have different due diligence standards and considerations from pharmaceuticals and biologics
  • Addressing challenges relating to the inventorship and ownership of AI, as well as the reliability of IP rights related to AI technology
    • How do these questions affect the valuation of the IP?
  • How is the USPTO considering whether it should make changes to how it handles examinations of applications for AI patents?
  • Unique considerations when conducting due diligence analyses of trade secrets involved in deals with companies that own medical devices or AI (such as drug discovery platforms, drug formulation technologies, etc.)

4:15
Mitigating International Legal Risk: IP Due Diligence Considerations for Global Deals

Yu-Ming Dammann
Associate General Counsel
Gilead Sciences (Seattle, WA)

Janet Xiao
Partner
Morrison & Foerster LLP (San Francisco, CA)

  • Identifying due diligence landmines that U.S. practitioners should avoid when doing deals globally
  • Assessing how the new CFIUS regulations are increasing government scrutiny over foreign investment in U.S. biotech companies, and the impact this has on due diligence relating to deals with such companies
  • Evaluating foreign IP assets based upon the specific rules for their jurisdiction

5:00
Conference Adjourns

Day 2 - Tuesday, November 10, 2020

7:30
Registration & Continental Breakfast
8:00

VALUATION

Assessing the Intricacies of Deal-Related IP Valuation

Valuation of life sciences IP is a highly complex and important undertaking as it is often the real driving force behind a given transaction. The valuation process has evolved overtime and several analytical tools have been developed to assist in the valuation process. Topics to be discussed include:

  • Assessing valuation trends, the perceived value of intellectual property and the prices being paid»Understanding the influence of international markets relative to price
  • Incorporating a valuation calculation into your life sciences diligence review
  • Assessing valuation models and adjusting for value drivers such as: regulatory exclusivities, pending legislation, follow-on development, and competing IP•Considering criteria that can impact the overall value of the deal
  • Working with experts in niche fields in connection with valuation

9:15

Money Talks

An Interactive Interview with a Private Equity Expert and Venture Capitalist on the Ins and Outs of Securing Funding for Life Sciences Companies

Bernard P. Cooney, III
Senior Partner, Capital Formation
Flagship Pioneering (Cambridge, MA)

Partnering with an investment firm to secure funding is an essential and valuable tool to facilitate business expansion and accelerated growth for your life sciences organization. While private equity firms can deliver tactical financial backing and business alliance, venture capital funds can provide a significant capital enhancement for startups. During this interview, our experts will provide insights on topics including:

  • Identifying optimal timing in a life sciences company’s lifecycle to partner with a PE fund versus a VC fund
  • Learning how to assess your portfolio while making it desirable for institutional investors
  • Understanding the factors impacting VC investment decisions and qualities VCs look for from their IP counsel
  • Recognizing capital structure and governance considerations
  • Considering alternative or complimentary sources of funding, e.g. structured and venture lenders, royalty monetization, or intellectual property linked funding

10:15
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!

10:45
Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process

Kurt R. Karst
Director
Hyman, Phelps & McNamara PC (Washington, DC)

Mercedes Meyer
Partner
Drinker, Biddle & Reath LLP (Washington, DC)

This panel of FDA experts will discuss:

  • A survey of key laws and regulatory exclusivities that attorneys need to be most aware of when doing IP due diligence on a deal
  • Understanding how the latest developments with patent term extensions are impacting IP due diligence decisions
  • Examining changes made to the BPCIA (Biologics Price Competition and Innovation Act) that impact considerations during the due diligence process
  • Assessing the latest activity surrounding the CREATES Act and the future implications on IP-related deals

11:30
“War Stories” on Due Diligence Gone Wrong: When Defective IP Due Diligence Wrecks the Deal

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

Laurence Shumway
Intellectual Property Counsel
Flagship Pioneering (Cambridge, MA)

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.

12:15

Interactive Ethics Lab

Overcoming Common Challenges and Ethical Dilemmas in Life Sciences IP Due Diligence

Jeffrey Kopacz
VP, Intellectual Property
Omega Therapeutics (Arlington, MA)

Ha Kung Wong
Partner
Venable LLP (New York, NY)

Test your ethical skills with a series of anonymous polling questions on sensitive, complex hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in IP due diligence compares to your peers, and benefit from a practical discussion of the polling results and important takeaways for your practice.

1:15
Main Conference Ends – Lunch for Workshop Participants Begins

Pre-Conference Primer*
Life Sciences IP Due Diligence 101 – Preparing Your Due Diligence Checklist and Managing the Process from Soup to Nuts

Nov 9, 2020 8:00am – 9:45am

Philip I. Datlow
Director and Senior Counsel II Human Pharma Patents and Intellectual Property
Boehringer Ingelheim USA Corporation (Ridgefield, CT)

Gloria Fuentes
Executive Director, Corporate Transactions
Merck (Kenliworth, NJ)

Jessica Jamieson
Vice President, IP Therapeutic Head, Hematology
Takeda (Chicago, IL)

What is it about?

This interactive working group will provide an in-depth overview of the key aspects of a comprehensive IP due diligence investigation. In this prelude to the main event, our panel of esteemed diligence counsel will provide a fact pattern and guide attendees in the process of designing an appropriate diligence team and checklist based on the presented scenario. Attendees will receive key insights on

  • Creating a cost-effective, practical due diligence roadmap
  • Identifying and selecting the most effective team members
  • Understanding what questions to ask and when•Tackling common challenges that arise during the due diligence process

*Separate registration required

Freedom to Operate BootCamp:
A Comprehensive Tactical Guide to Mastering the FTO Search

Nov 10, 2020 2:15pm – 5:30pm

Keisha Hylton-Rodic
Attorney
Hylton-Rodic Law PLLC (Washington, DC)

Olga Kay
Senior Patent Counsel
Roche (San Francisco, CA)

What is it about?

Freedom to operate (FTO) is a risk assessment that is a vital to helping businesses understand IP risk, evaluate competitor’s patents, identify third-party rights and assess the likelihood of infringement. There are various ways that companies can conduct FTO searches, and the method chosen often depends on the stage of the product development. This comprehensive masterclass will explore the complexities in the FTO analysis and provide tips and techniques to avoid unexpected traps. Points of discussion will include

  • Protecting the rights on future developments and preserving the freedom to operate
  • Analyzing filings and determining the strength of claims of infringement
  • Evaluating factors to consider when assessing risk of suit
  • Using non-patent resources to assess risk
  • Assessing the Impact of domestic vs. foreign manufacture of the commercial product on risk assessment
  • 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