Life Sciences IP Due Diligence

Registration and Breakfast

Opening Remarks from Co-Chairs

Tashica Williams Amirgholizadeh, Ph.D.
Senior Associate General Counsel, IP,
IP Alliance and Due Diligence (IPADD), Team Lead
Gilead Sciences, Inc.

Hilary Libka
Chief IP Counsel, Associate General Counsel
Memorial Sloan-Kettering Cancer Center

Michael Penn
Vice President, IP
BlueRock Therapeutics

Investors Roundtable

Navigating the Shifting Tides of Pharma and Biotech Investments: Unraveling Market Dynamics and Strategic Insights for Success

Nithya Desikan
Operating Principal
Gurnet Point Capital

Luba Greenwood, J.D.
Managing Partner
Dana Farber Cancer Institute Venture Fund, Binney Street Capital

Mary Lynne Hedley, Ph.D.
Venture Partner
Third Rock Ventures

Matthew S. Rizzo
General Partner
OrbiMed Healthcare Fund Management

Moderator:

Brenda Herschbach Jarrell, Ph.D.
Partner | Chair of Life Sciences Group
Choate, Hall and Stewart LLP

In this roundtable, investors will delve into the intricacies of market dynamics and the constantly evolving pharmaceutical and biotech investment climate. By delving into these nuanced topics, attendees will become equipped with a deeper understanding of market dynamics, investment climate challenges, and strategic considerations essential for successful investments in the pharmaceutical and biotech sectors.

• Identifying areas of significant M&A activity and emerging investment opportunities in life sciences IP
• Considering strategic alliances and royalty monetization
• Outlining what investors wish inventors knew before coming to the table
• What do investors want to see in patents and IP strategy?
• What non-IP factors are the most important?
• When is the strength of the patent the bottom line and when do other factors (such as regulatory exclusivity or clinical trial results) prevail?
• Identifying areas of significant M&A activity and emerging investment opportunities in life sciences IP
• Demystifying investor risk assessment, preferences and their target areas for investment or acquisition
• What financial valuation methods do investors use?
• Navigating the balance between risk mitigation and growth potential
• Examining the unique challenges faced by biotech companies in securing funding
• Uncovering strategies to enhance capital availability and attract investor interest
• Appreciating how investors are considering the impact of the price control provisions on IP under Inflation Reduction Act in today’s deal-making.
• How are price controls and patents linked?
• Assessing the dynamics and benefits of investor involvement in different stages of company growth

US-EU Cross Border IPDD Part I

Cracking the UPC Code: Exploring the Significance of Unitary Patents and the Unified Patent Court for U.S. IP Due Diligence Strategies

Hon. Rian Kalden
Presiding Judge, Court of Appeal
Unified Patent Court

Professor Willem Hoyng
Chairman, Advisory Committee of the UPC
Member, Drafting Committee of the UPC
Hoyng Rokh Monegier

As life sciences and technological innovations continue to transcend borders, understanding the implications of this groundbreaking forum becomes paramount for successful due diligence practices.

During this panel designed exclusively for U.S. life sciences IP due diligence practitioners, session leaders will delve into the intricacies of the Unified Patent Court (UPC) and explore its far-reaching impact on the way you conduct IP due diligence, even across the Atlantic.

Morning Networking Break

US-EU Cross Border IPDD Part II

Navigating the Key Life Sciences IP Updates Shaping the Landscape of U.S.-EU Deals: Common Cross Border Due Diligence Pitfalls and How to Avoid Them

DeAnn F. Smith
Partner
Foley Hoag LLP

Bo Han
Vice President, Intellectual Property
Orbital Therapeutics

Dr. Christian Helbig
Patent Attorney
Hoefer & Partner Patentanwälte mbB

It is becoming increasingly imperative to stay well-informed about new IP laws when conducting due diligence. Following the previous session on the unitary patent system, this session will explore other significant European updates as relevant for conducting strategic due diligence to avoid pitfalls. The speakers will discuss fundamental aspects of a comprehensive due diligence, while also delving into unique European issues, and compare and contrast with U.S. considerations, including:

• Assessment of validity/enforceability of target company IP and its scope of protection, including loss of exclusivity projections, taking into account patent and regulatory exclusivities in US and EU
• Ownership and transferability, including appropriate chain of title and priority issues
• Exclusivity and third party SPCs
• Freedom to operate issues
• Special European employee inventor compensation legislation (examples DE, FR, CH)
• Best practices for effective coordination between outside and in-house counsel during diligence

Patents, Price Controls and the IRA: Understanding the Impact of the Inflation Reduction Act on IP Due Diligence Analyses in the Life Sciences Industries

Caitlin E. Olwell
Counsel
Akin Gump Strauss Hauer & Feld LLP

Ha Kung Wong
Partner
Venable Fitzpatrick LLP

Jeffrey L. Kopacz
SVP | Head of IP & Contracts
SalioGen Therapeutics

The profound implications of the pricing controls in the Inflation Reduction Act (IRA) on pharmaceutical and biotech innovation are of such concern that a lawsuit has been filed, challenging the law’s constitutionality. As such, it is imperative that life sciences IP transactional attorneys understand the affect the IRA is having on profitability, innovation, and deal-making strategies now. Topics of discussion will include:

• Understanding how price negotiation may circumvent pharmaceutical patent values
• How is the value of IP impacted when drugs are not approved for Medicare/Medicaid formularies?
• How does renegotiation affect the value of the drug’s patent?
• Evaluating the influence of the IRA on mergers, acquisitions, and licensing agreements
• Discussing proactive measures to adapt to the IRA and optimize business strategies
• Practical strategies for safeguarding IP value when your drug is selected or likely to be selected for negotiation
• Interpreting the CMS guidance on the implementation of the IRA
• Update on the lawsuits challenging the IRA
• Exploring the balance between government control and industry innovation
• Analyzing the potential consequences of price controls on patents and profits
• Assessing the implications for research and development budgets and innovation
• Anticipating long-term effects on portfolio strategies and early-stage companies

Networking Lunch

Protecting Innovation and Unleashing Market Opportunities: Best Practices and Strategic Insights for Validity and Scope Analyses

Lawrence Cogswell, Ph.D.
Principal
Hamilton, Brook, Smith & Reynolds P.C.

Len S. Smith
Principal
Transformative Legal

Adam Poulin-Kerstien
Vice President, Intellectual Property
Mersana Therapeutics

Henry Gu
SVP, Head of Intellectual Property
Zentalis Pharmaceuticals

The validity and scope analysis in IP due diligence for life sciences transactions serves as a crucial tool to protect investments, safeguard competitive advantage, assess market opportunities, and ultimately – the results may be used to enhance deal negotiations. Conversely, an insufficient validity and scope analysis can have severe consequences because if important aspects are missed or overlooked, gaps or weaknesses in the IP could be exploited by competitors or result in legal challenges, potentially leading to financial losses, disputes, or even the loss of exclusivity. Therefore, a comprehensive and meticulous validity and scope analysis is essential.

Topics of discussion will include:

• Discovering the newest practices for comprehensive scope and validity analyses
• Unpacking recent and relevant legislation and caselaw on patentability: the Supreme Court’s Amgen v Sanofi case on written description; the proposed Patent Eligibility Restoration Act of 2023, and more
• Unpacking recent caselaw on non-obviousness and novelty
• Understanding how the scope of the IP assists in evaluating the market opportunities
• The importance of going beyond the identification of weaknesses in the IP by proposing appropriate solutions, e.g., a reissue application, secondary patents, or a terminal disclaimer
• Evaluating whether a license is needed/how to arrive at the royalty
• Accounting for this in the negotiations and the ultimate agreement
• Considering estoppel, inequitable conduct and forum shopping and distilling the impact on deal negotiations
• What impact will the PTAB reformations proposed by the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act have on the valuation of patents?

Leveraging FTO Analyses for Strategic Deal Negotiations: Maximizing Value and Mitigating Risks in Life Sciences IP Transactions

Donna Meuth
Associate General Counsel IP
Eisai Inc.

Alicia Russo
Partner, Chair of IP Transactional Group
Venable Fitzpatrick LLP

Erica Norey
Senior Counsel, Intellectual Property for Global Business Development & M&A
Sanofi

In today’s competitive landscape, conducting comprehensive freedom-to-operate (FTO) analysis is vital to identify potential patent infringement risks. However, it’s equally important to go beyond mere risk assessment and leverage the results of FTO analysis to inform strategic deal negotiations. During this session, topics of discussion will include:

• Exploring different types of FTO analysis
• Competitor-specific, feature-specific, and comprehensive
• Avoiding the pitfall of searching only the claims without due consideration for the details in the specification
• The advantages and disadvantages of using patent search software
• Cost-efficient strategies for conducting an FTO in a crowded space (e.g., CRISPR)
• Knowing the next steps when the target gets sued close to the closing date
• Formulating strategies to address potential infringement risks based on claim constructions
• Assessing the risk of injunctive relief and quantifying that risk
• The importance of going beyond the identification of weaknesses in the IP by proposing appropriate solutions, e.g., contacting the competitor to purchase or license the patent; designing around the competitors patent; or challenging the competitor patent in a post-grant proceeding
• What impact will the PTAB reformations proposed by the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act have on the valuation of patents?
• Discussing how to potentially assess and value the need for a license
• How to approach negotiations

Afternoon Networking Break

The Best and Newest Strategies for Ownership and Inventorship Analyses

Lisa Hillman, Ph.D.
Partner
Lathrop GPM

Lindsey Wanner
Associate General Counsel, IP Alliance and Due Diligence
Gilead Sciences Inc.

Nicole Grimm
Legal Director, IP
Alnylam Pharmaceuticals

Daniel Margolis
Partner
Allen & Overy LLP

Topics of discussion include:

• Ensuring that the inventors have been properly listed on the patent application or issued patent:
• In the event of errors in non-provisional applications, asking whether an ADS or a continuation application is the better solution
• In the event of errors in issued patents, analyzing the best approach for filing a petition to correct inventorship
• Reviewing which errors cannot be corrected, and if reissue or reexamination is not available or desirable, how to quantify this risk in the deal
• Appreciating foreign filing:
• Considering whether the applicant of the PTC is the right owner, whether they have the right to claim priority, and any resulting prior art issues
• Verifying whether the patent been maintained in good force
• If the patent is not maintained in good force, what are the revival options?
• Determining ownership: have there been valid and inclusive assignments?
• Going beyond the licensor and looking to consultants, CROs, or other third parties for proper assignment
• Patent ownership when R&D staff departs
• Considering ownership and inventorship for products developed with the assistance of federal funding

Networking Cocktail

Conference Adjourns

Registration and Breakfast

Opening Remarks from the Co-Chairs

Tashica Williams Amirgholizadeh, Ph.D.
Senior Associate General Counsel, IP,
IP Alliance and Due Diligence (IPADD), Team Lead
Gilead Sciences, Inc.

Hilary Libka
Chief IP Counsel, Associate General Counsel
Memorial Sloan-Kettering Cancer Center

Michael Penn
Vice President, IP
BlueRock Therapeutics

Business Leader’s Roundtable

Unlocking IP Valuation: Retrospective Insights from the Deal-Makers on Working with Outside Counsel and How to Value IP

Samir Patel
Associate General Counsel, Global IP
Viatris

Jens Bitsch-Norhave
VP Transactions & Innovation Partnering
Johnson & Johnson Innovation LLC

Michael R. Myers, Ph.D.
VP Due Diligence
Eli Lilly Research Labs, Eli Lilly & Co

Moderator:

Tashica Williams Amirgholizadeh, Ph.D.
Senior Associate General Counsel, IP,
IP Alliance and Due Diligence (IPADD), Team Lead
Gilead Sciences, Inc.

In this interactive roundtable, those responsible for greenlighting or killing the deal will share exclusive insights on the importance of IP in deal-making for the life sciences, the factors that influence deal evaluations, and effective communication strategies during negotiations. Topics of discussion will include:

• Working with the company’s bottom line: which IP due diligence red flags are deal-breakers, and which are salvageable from the business perspective?
• When is a license the better option over a merger or acquisition
• What considerations lead to an M&A vs. a license and/or collaboration?
• What questions outside counsel can ask towards developing an IP opinion that is tailored to the company’s goals and vision
• Exploring the value equation: unraveling the methodologies and considerations for valuing intellectual property assets
• What type of valuation consultations or assessments are the most helpful
• The key challenges and opportunities in deal-making from the business perspective specific to the IP due diligence process

Bespoke Due Diligence: Tailoring IP Due Diligence to the Transaction to Achieve the Ideal Balance of Diligence Depth and Cost-Efficiency

William Vickery
Director of Due Diligence
Servier

Gabriel J. McCool, Ph.D.
VP, Legal and IP
ReNAgade Therapeutics

Robert H. Underwood
Partner
Hogan Lovells LLP

• Assessing the nuanced spectrum of life sciences IP due diligence needs for different transactions (e.g., licensing, M&A)
• Identifying key risk factors that demand in-depth examination and scrutiny
• Examining the relationship between the thoroughness of a life sciences IP diligence and the mitigation of risks.
• Employing AI-powered search and screening techniques to detect potential risks and opportunities, while carefully evaluating the cost-benefit ratio of the obtained results.
• Knowing the the right questions to ask stakeholders to establish consensus on the appropriate level of analysis tailored to each transaction
• Developing the acumen to adapt the diligence to align seamlessly with evolving timelines or objectives of the transaction.
• Managing expectations regarding diligence at the outset
• Taking into account the concepts of privilege and trade secrecy:
• Developing precise guidelines and/or contracts for information sharing and handling of documents between target and acquirer to prevent unauthorized usage or misappropriation of information obtained during the due diligence process

Morning Networking Break

Appreciating the Finer Points of IP Due Diligence When the Transaction Involves AI, ML or Platform Technologies

Emily Gardel
Associate Director, Patent Attorney
Dyno Therapeutics

Rebecca L. Simmons, Ph.D.
Counsel
McNeill Baur PLLC

Daniel G. Rudoy, Ph.D
Shareholder | Executive Committee Member
Wolf, Greenfield & Sacks, P.C

Platform technologies and AI and machine learning (ML) hold great promise for addressing complex diseases. However, the patentability of these technologies remains uncertain, and ownership of the AI model or ML software, the data, and the end product must be carefully diligenced and their value critically negotiated. In this session, topics of discussion include:

• Identifying patentability and patent strategies for AI and ML innovations
• Asking where patent protection is the most needed
• Considering the timeline for patent approval against the rapidly evolving AI and ML landscape
• Analyzing novelty in a saturated space and how to distinguish from the prior art
• When does it make sense to generate your own data versus buying data
• Considering data bias and strategies towards ensuring the best data set is used
• Ensuring that the data is fully owned by the seller, can be used for the purpose you want the data for, and that no data privacy laws have been violated
• Best practices for negotiating ownership, inventorship, and royalties
• For IP generated through the project, rights to preexisting IP, and parties’ rights upon termination of the collaboration
• What if the output or discovery is more lucrative than either party anticipated?
• How to correctly name the inventors when multiple people are involved in developing and running the AI model or ML
• Considering exclusive and non exclusive licenses and assignments

Exploring the Regulatory Aspect of IP Due Diligence: Examining the Implications of Recent Developments at the FDA on IP Due Diligence

Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C

Michael K. Stern
Of Counsel
Covington & Burling LLP

Brian Stone
Associate General Counsel, Global Legal-Regulatory
Viatris

Topics of discussion will include:

• Creating and valuing exclusivity and patent term extension forecasts as part of the IP due diligence
• Knowing which questions to ask to determine which patent should ultimately receive the patent term extension
• How to navigate orphan drug exclusivity post Catalyst
• Unpacking Jazz Pharmaceuticals lawsuit against the FDA for granting orphan drug exclusivity to Avadel’s narcolepsy drug on the basis of clinical superiority
• CMS’s guidance on orphan drug exclusivity and the IRA’s price control provisions
• Learning the current landscape for Orange Book listing requirements as applied to REMS or device patents
• Unpacking Jazz Pharmaceuticals lawsuit against Avadel relating to the listability of REMS patents
• Strategies to protect against the risk
• Understanding the role of FDA classifications and designations in triggering price control negotiations under the Inflation Reduction Act
• Navigating compliance challenges and implications for regulatory strategies

Networking Lunch

From Distress to Success: Mastering the Enhanced IP Due Diligence Needed to Safely Acquire Distressed yet Promising Life Sciences IP Assets

Mercedes Meyer
Attorney
Banner Witcoff

Julia Frost-Davis
Shareholder
Greenberg Traurig LLP

Kristin K. Going
Partner
McDermott, Will & Emery LLP

• Discovering the critical buy side/sell side considerations
• Understanding the scope of intellectual property assets associated with the distressed company, including patents, trademarks, copyrights, trade secrets, and proprietary technology
  • Considering whether “blocking patents” or very broad claims should kill the deal
  • If the patent is likely invalid, learning how to assess litigation risk and cost
• Rethinking patent continuation strategies in light of Sonos Inc. v. Google LLC, 20-06754 WHA, 2023 WL 6542320 (N.D. Cal. Oct. 6, 2023)
• Understanding how the scope of the IP assists in evaluating the market opportunities
  • Strategies for broad functional claims versus genus claims
  • Dealing with questionable support in the specification
• Exploring how to value the portfolio of alternative claims (e.g., MPF, Jepssen) and secondary patents

Networking Break

Anti-Trust Enforcement in the Life Sciences: Examining Impact, Trends and Best Practices for Incorporating Anti-Trust into Your IP Due Diligence Checklist

Samantha R. Morelli
Partner
Kirkland & Ellis LLP

Kevin Noonan, Ph.D.
Partner | Co-Chair Biotechnology and Pharmaceuticals Practice Group
McDonell Boehnen Hulbert & Berghoff LLP

Since 2022, the FTC and anti-trust division of the DOJ have been increasingly investigating and challenging M&A in the life sciences: the proposed Optum-Amedisys deal; Amgen-Horizon; PfizerSeagen; and Merck-Prometheus, to name a few. This session will explore the anti-trust concerns from these cases and extrapolate their impact on IP due diligence and deal-making for the future.

ETHICS

Demystifying Privilege and Confidentiality in Pre- and Post-Acquisition Due Diligence: A Case Study

Aaron Pereira
Senior Director, Patents, Global IP
Ferring Pharmaceuticals

Michael P. Kahn
Partner
Akin Gump Strauss Hauer & Feld LLP

Kathleen Gersh
Partner
Loeb & Loeb LLP

IP due diligence presents challenging privilege and confidentiality questions arising from the communications between buyer and seller, mainly before the deal is signed but also in the transition period after the deal is signed.

The fast-paced speed with which deals are often concluded also complicates the issue, but parties who inadvertently or erroneously waive privilege or share confidential information for the sake of enticing a buyer may face significant consequences in the future, especially if the deal ultimately falls through and non-protected communications later become discoverable. In this case study, the speakers will take you through the privilege and confidentiality perils in both pre- and post-acquisition.

• Defining attorney-client privilege, confidential information, trade secrets, the work-product doctrine, and the exception: the common interest doctrine
• Contrasting cases where the common interest doctrine was or was not upheld by the court
• Reviewing all types of communications (emails, memos, powerpoint slides, counsel opinions, etc) and analyzing how and when transmission of same can be considered a waiver of privilege or confidentiality
• The importance of discussing and establishing clear procedures at the outset
• How will confidential information be used, who will have access to it, and what will be done with the information upon completion of the due diligence?
• Considering confidentiality and non-disclosure agreements
• Advising business partners regarding what they can/cannot do with the confidential information obtained.
• Unpacking the possibility of breaches in the transition period after the deal is signed
• To whom is the duty of confidentiality owed in the transition period?
• How to maintain confidentiality with respect to Know-How
• Considerations when drafting confidentiality agreements and obligations regarding term and disclosure

Conference Concludes