Agenda
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Day 1 — Main Conference
February 9, 2027
Breakfast and Registration
Co-Chair Welcome
Legislative Review: Understanding how Life Sciences Legislation and Agency Policy are Reshaping Your IP Due Diligence Checklist
John NappiAssistant General CounselPharmaceutical Research & Manufacturers of America
Throughout 2026, personnel changes at key agencies and legislative activity at the federal level made waves through the life sciences industry. With midterm elections, senatorial retirement, and legislative proposals on the horizon, we anticipate much more to come.
From trade policy, to IP rights, to drug pricing – federal activity and the regulatory structure touch every element of life sciences deal making. This session will break down the impact of key changes on how to approach life sciences IP due diligence in 2027.
Morning Coffee Break
Jennifer Friel GoldsteinHead of Relationship ManagementFirst Citizens Innovation Banking
Life sciences IP due diligence is one piece in the puzzle that is life sciences dealmaking. Market dynamics and pressures, individual priorities, and potential opportunities rule the day, and provide the critical context in which these diligence processes are undertaken.
In the wake of J.P. Morgan’s 44th Annual Healthcare Conference, this session will cover:
- Reviewing the last year of deals, mergers, acquisitions, and licensing in the life sciences
- Assessing the growth of deals in 2026 as compared to last year’s predictions
- Anticipating the outcomes of 2027 following J.P. Morgan’s predictions
- Understanding how royalty monetization has entered the fold
- ANI Pharmaceuticals v. CG Oncology
Lunch
Christine Rea PrihodaCounsel, Strategic Transactions and M&AGilead Sciences Inc
Dealmaking is driven by two primary forces: the market, and the regulatory schema in which the market is functioning. This roundtable session will bring business leaders and lawyers together to discuss the harmonies, dissonances, and opportunities that occur when these two forces meet.
Donna MeuthAssociate General Counsel Intellectual PropertyEisai Inc.
In June 2026 the Supreme Court ruled in Hikma v. Amarin, deciding that generic drug makers using skinny labeling did not inherently infringe on method-of-use (MOU) patents without clear, affirmative action to “bring about the desired result” of patent infringement. In this ruling, the Supreme Court has added another layer to the diligence surrounding MOU patents.
This session will discuss:
- Identifying whether skinny labels are sufficiently “active” to induce infringement
- Determining which skinny labels may or may not survive a motion to dismiss
- Comparing and contrasting ‘explicit encouragement’ with omission on a skinny label
- Evaluating susceptible patents
Afternoon Networking Break
Kathleen GershCo-Chair, Life SciencesLoeb & Loeb LLP
Victoria Pedanou, PhD JDCounsel, Global Biologics Intellectual Property, Legal, Ethics & Business IntegritySanofi
ODP remains unsettled—if not chaotic—at the PTAB and in the courts. In Ex parte Baurin and Ex parte Baumeister, PTAB panels reached opposing determinations.
In an Appeals Review Panel (ARP), the USPTO reversed the PTAB determination in Baurin and squared both Baurin and Baumeister as unpatentable in view of ODP. Now, with both cases on appeal to the Federal Circuit, suitors and targets alike face considerable ODP uncertainty as they attempt IP due diligence reviews. For practitioners on both sides, risk and value hang in the balance.
This session will discuss:
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Analyzing the ODP harassment argument
- Cellect
- Allergan
- Arkose
- Jentoft
- Van Ornum
- Mates
- Corteva
- Blanchard
- Fallaux
- Hubbell
- Assessing patents for potential ODP problems
- Identifying ODP red flags in a patent portfolio
- Understanding the implications of ODP for an IP due diligence review
- Advising clients of risk in the midst of uncertainty
Navigating a Narrower Section 101 Landscape: What It Means for Innovation, Investment, and IP Due Diligence
Michael B. HarlinPartner | Intellectual PropertyNeal, Gerber & Eisenberg LLP
Michael PennVice President, IPBlueRock Therapeutics
Since 2010, a series of Supreme Court decisions have narrowed the framework around subject matter eligibility (SME) for patents. Eligibility is at the crux of patent value and investment interest, and without a clear structure governing patent approval, applicants and assessors are at odds. With new legislation on the horizon, a reliable framework may be coming into focus.
This session will discuss:
- Understanding the USPTO’s April 2026 memorandum encouraging patent applicants to submit separate declarations supporting “subject matter eligibility” (SMEDs) in response to §101 rejections
- Unpacking the Patent Eligibility Restoration Act (PERA) and what it means for SME going forward
- Assessing patent portfolios for eligibility under the current framework
- Identifying potential disqualifying factors in patents yet to be approved, and the impact on exclusivity timelines
End of Day 1
Day 2 — Main Conference
February 10, 2027
Breakfast and Registration
Co-Chair Welcome
Reshaping the Pie Chart: Understanding the Expanding Role of Trade Secrets and Copyright in Life Sciences IP Due Diligence Assessments
While patents remain the cornerstone of successful IP portfolios, trade secrets have steadily grown in importance. Now, with AI algorithms joining the fray, copyright has taken a small but notable place in the conversation.
- Expanding your due diligence checklist to consider and assess trade secrets as part of the IP portfolio
- Analyzing the security of key trade secrets
- Enforceable confidentiality
- Robust NDAs
- On- and off-boarding procedures
- Identifying copyright concerns with AI and other development algorithms
- Ensuring R&D pipelines are free of potential leaks
Thomas L. IrvingSenior PartnerThe Marbury Law Group, PLLC
We’ve all been there. Your deadline is fast approaching, and there’s a mountain of IP to get through.
Don’t panic!
In this session experienced practitioners will walk you through the tips, tricks, and tools you need to complete a robust life sciences IP due diligence when you don’t have time to dawdle.
Morning Coffee Break
Peering over the Edge: Understanding how the Looming Life Sciences Patent Super-Cliff will Shake Up Your IP Due Diligence Review
Alicia A. RussoPartnerVenable LLP
2030 is poised to bring on a patent super-cliff that could cost the industry upwards of $300 billion, with some estimates surpassing even that high value loss. As patents — for both small and large molecule – drugs are about to expire, and their exclusivity ends, industry practitioners are wondering what the future looks like for existing patent portfolios, portfolio growth, and M&A activity in the buildup.
- Assessing existing patent portfolios, as well as target patents, and preparing for the large scale loss of exclusivity
- Anticipating the impact of the patent super-cliff on M&A activity before 2030
- Strategizing around the patent super-cliff to limit damage to the bottom line
- Breaking down what this means for the future of small molecules as well as the growing biosimilars market
- Looking to Keytruda’s 2028 expiration as a guiding post for future activity
Lunch
Robert FurlaniAssistant General Counsel & Chief Patent Counsel Ligand Pharmaceuticals
Gregory A. MorrisPartnerProskauer Rose LLP
The context in which IP due diligence is undertaken can change your approach. Understanding how the diligence report will be utilized in a deal is fundamental to developing a successful strategy, checklist, and timeline.
This session brings business development leadership front and center to discuss the ins and outs of what’s a go, what’s a no go, and what can kill a deal in the making.
Rana SawayaSenior Director - Assistant General Counsel - IPRegeneron Pharmaceuticals Inc
Keith SyversonDirector, IP Transactions Novartis
The life sciences industry has seen a sharp increase in dealmaking with Chinese companies in recent months. Shorter clinical trial timelines, easier regulatory hurdles to clear, and significant research and development in China have led to high interest from American and European pharma companies.
Though lucrative, these deals come with additional concerns that must be considered and assessed when undertaking the due diligence process that is central to the deal.
This session will discuss:
- Understanding the clinical trial boom and why it has spurred so much activity in China
- Unpacking the latest changes to the BIOSECURE Act and how they impact your due diligence checklist
- Comparing the Chinese regulatory schema to that of the country under the laws of which your company was created or organized and identifying additional necessary steps for home country approval
- Anticipating potential Complete Response Letters (CRLs) from the FDA due to insufficient clinical trial diversity, facility manufacturing deficiencies, or other unmet FDA requirements
- Looking to European and other multi-national companies to benchmark and compare Chinese dealmaking strategies
Afternoon Networking Break
Money Money Money: Government Funding, Bankruptcy, and How to Ensure your IP Survives in a Hostile Funding Environment
Svetlana PavlovicCounselAkin Gump Strauss Hauer & Feld
Research, development, mergers, acquisitions, pipelines, etc. – all critical components of the business of the life sciences industry – boil down to funding.
As federal funding for scientific research has dramatically shrunk, companies have had to look to other sources to facilitate the future of the industry. However, funding can often come with conditions on IP, which can place a thorn in the paw of a good deal.
On the other end of the life sciences corporate lifecycle, bankruptcies can mean the death of a company, but there may be salvageable IP to keep alive.
This session will break down the full life cycle of a company, from initial funding to bankruptcy and everything in between, to highlight the ways IP is impacted and injured by funding conditions.
Topics of discussion include:
- Considering the threat of Bayh-Dole when accepting government funding
- Understanding and identifying the contractual caveats and conditions at play when your company, or your target company, has used alternative funding sources in product development
- Foundations
- Other company investment
- Venture capital
- Flagging instances of litigation funding, and analyzing the underlying agreements made
- Untangling happens to existing IP when a company goes belly-up
Christine NorrisSenior Corporate Counsel, Intellectual PropertyCharles River
Caitlin E. OlwellPartnerAkin Gump Strauss Hauer & Feld
It’s everywhere – in under a year AI has become an unavoidable reality across every industry. With AI seeping into the bones of every player in a life sciences deal, it’s imperative that diligence processes understand the ways that AI has impacted the industry.
This session will discuss:
- Identifying patents that are in danger of, or have been formed from, data scraping and the litigation threats that may come as a result
- Ensuring statements made using AI tools are accurate, especially when AI has been used in patent preparation or prosecution
- Developing tools to spot AI usage in patent preparation and prosecution
- Fact-checking your AI tools when relying on them for analysis, summaries, or research
- Keeping an eye out for hallucinations in AI responses
- Determining where and when it is safe to use AI tools in the various steps of life sciences IP due diligence.