Biosimilars & Innovator Biologics

In celebration of seventeen years of industry leadership, we’re debuting an in-house roundtable series designed to foster intimate, high-impact discussions among legal peers. Join fellow in-house counsel, regulators and trusted law firm partners in a rotating roundtable format built for real talk, rapid idea exchange, and strategic benchmarking on today’s most urgent challenges in the biosimilars and biologics landscape. Bring your toughest questions, boldest insights, and lessons learned. This is your best chance to connect, collaborate, and get candid at the start of this event. The roundtable hosts will rotate tables every 30 minutes to maximize networking opportunities and idea-sharing on the following topics:

1. Skinny Labeling and Induced-Infringement Liability: Evolving Legal Standards and Implications for Launch Planning, Labeling, Marketing Strategies, and Litigation Risk with Skinny Label Carveouts
2. Mastering the Changing BPCIA Landscape: Reviewing Litigation, Damages, Pricing and Settlement Negotiation Strategies
3. Navigating the New PTAB: Investigating How the Clampdown of IPRs and PGRs Is Reshaping Patent Owner and Challenger Strategies

Be sure to join this engaging and interactive opening session as our panelists assess how landmark policy changes; FDA draft guidance; procedural and substantive changes at PTAB; shifting IP strategies, global market pressures, and other regulatory updates are shaping the landscape. This session will provide a comprehensive breakdown of the past year’s most critical legal, regulatory, and commercial developments and explore what’s ahead for 2026 and beyond. Topics of discussion will include:

• Examining the FDA’s plans to apply a risk-based credibility assessment framework to evaluate the use of AI models in support of regulatory decision-making
• Evaluating the impact of Medicare drug pricing negotiations and IRA policies relating to biosimilar adoption and market access
• Navigating evolving patent litigation, carveouts and skinny labeling
• Exploring global harmonization efforts and the competitive landscape shaping adoption
• Predicting the future of biosimilars and next-gen biologics as competition intensifies

Biosimilar pricing, approvals, and regulatory oversight are entering a new era of uncertainty. Will policy shifts accelerate adoption, or will deregulation introduce new market complexities? As the administration rolls out executive orders and potential reforms, the industry must anticipate shifts in pricing, access, and oversight. Changes in the landscape regarding interchangeable biosimilars only compound this uncertainty. Join us for this critical discussion as we examine:

• Assessing the IRA’s future and its impact on pricing and competition
• Evaluating whether FDA will adopt a less-stringent review process under new leadership
• Examining recent changes in the FDA’s approach to interchangeable Biosimilars and the impact thereof
• Unpacking recent developments and current trends relating to interchangeable biosimilars and implications for the future

The “safe harbor” provision in US patent law safeguards certain activities from patent infringement lawsuits. The defense applies to acts that are “solely for uses reasonably related to the development and submission of information” to the FDA under regulations for drugs or biologics. In addition, subjective intent or alleged alternative purposes are irrelevant when determining whether the safe harbor applies. What matters is whether the act was for a use “reasonably related” to the development or submission of information to the FDA.

Join us in this discussion as we discuss recent Safe Harbor case law and critical elements of the Safe Harbor defense, such as:

• Determining what is and is not shielded by the safe harbor
  • Analyzing the broad interpretation of the term ‘solely’ for regulatory purposes and the implications for patent enforcement
  • Exploring Biosimilars and Biologics perspectives on the scope of conduct covered by safe harbor
• Exploring where safe harbor defenses are sustained – and where they are being defeated
  • Allele Biotechnology and Pharmaceuticals v. Regeneron Pharmaceuticals, Inc.
  • Protecting third party manufacturing activities for the purpose of filing for approvals

As lifecycle strategies for biologics evolve under frameworks such as the BPCIA and IRA, innovators are increasingly turning to manufacturing patents and trade secrets as critical lines of defense. In addition, protecting biologics manufacturing processes presents unique legal and scientific challenges—particularly where claims risk allegations of “inherent” infringement based on similarities in end-product characteristics.

Join us in this session as we examine how manufacturing patents are being deployed to preserve exclusivity and how courts are evaluating infringement theories rooted in process overlap, analytical characterization, and product-by-process claims. Topics for discussion include:

• Antibody production technology overview
• Drafting durable manufacturing claims to avoid design arounds and/or overbreadth while preserving enforceability
• Factors to consider for trade secret protection of manufacturing patents
• Coordinating protection strategies with regulatory submissions
• Utilizing litigation over process patents

As AI rapidly integrates into biologics research, regulatory strategy, patent analytics, and competitive intelligence, biosimilar developers face a new layer of legal and strategic uncertainty. AI-assisted molecule design and formula improvement, inventorship, patent landscaping and litigation modeling promise efficiency and insight. However, it also raises questions about inventorship, ownership, enablement, obviousness, trade secret protection, and data governance.

Join us we explore strategies and challenges that are associated with harnessing AI’s potential. We will also review best practices for mitigating the operational and litigation risks that are inherent in emerging AI technology. Topics for discussion include:

• Examining governance structures for responsible AI implementation
• Exploring contractual risk allocation with AI vendors and design partners
• Installing IP safeguards and documentation practices
• Reviewing litigation defensibility and evidentiary best practices
• Implementing Cross-functional coordination among legal, design, compliance, and executive teams