Biosimilars & Innovator Biologics

• Diving deep into Regeneron’s BPCIA litigation against Celltrion, Samsung Bioepis, Formycon, and Mylan for each of their proposed biosimilars of EYLEA
• Exploring Regeneron’s motion to establish multi-district litigation encompassing the aflibercept BPCIA cases
• Learning the latest biologic patent litigation strategies:
• Timing the lawsuit and seeking preliminary injunctions to block accused infringer’s at risk launch
• Learning the latest biosimilar patent litigation strategies:
• Appreciating when and how courts find permanent injunctions appropriate before receiving FDA approval
• Analyzing the decision to argue against a PI versus not launching at the end of the market exclusivity period

Navigating the intricacies of biosimilar settlements and launches pursuant to the BPCIA requires a consideration of the Federal Trade Commission and legal concepts such as reasonable damages. Even outside of the BPCIA, the FTC and, to a lesser extent, the ITC, are keeping a close eye on mergers within biopharma and alleged antitrust and anticompetitive practices. In this comprehensive session, topics of discussion will include:

• Understanding how courts are interpreting reasonable royalties, lost profits, and post judgment damages
• Applying that judicial cadence to your litigation or settlement strategy
• Learning the newest strategies for negotiating launch triggers and volume limitations in compliance with the law, avoiding costly litigation and associated penalties
• Reviewing the FTC’s approach to drug listings in the orange book and the evolution of pay-for-delay Examining recent listing and relisting of drugs in the Orange Book
• Understanding how this is influencing the dynamics of drug patenting and market exclusivity
• Analyzing recent antitrust lawsuits in the life sciences on pricing strategies, anticompetitive behavior, and life cycle management
• Reviewing recent life sciences M&As that have been challenged by the FTC and DOJ

High manufacturing costs, complex reimbursement dynamics, and market competition are three of the onerous hurdles that biosimilar companies must currently navigate to become and remain sustainable. In this session, biosimilar business leaders will offer insights towards crafting a sustainable business model within the challenging economics of the current US healthcare landscape. Topics of discussion will include:

• Exploring the role of Pharmacy Benefit Managers in formulary placement and reimbursement decisions.
• Discussing strategies for negotiating favorable access and reimbursement rates for biosimilars against originator biologics.
• Examining potential barriers to formulary inclusion and reimbursement, including payer preferences and rebate structures.
• Analyzing the impact of pricing strategies on biosimilar profitability, considering factors such as list price, net price after rebates, and cost-effectiveness.
• Discussing innovative pricing models and contracting approaches to enhance biosimilar market competitiveness while maintaining profitability.
• Considering the implications of Average Sales Price (ASP) and its role in pricing negotiations and revenue forecasting.
• Assessing the competitive landscape and pricing pressures posed by originator biologic manufacturers.
• Examining the influence of originator biologic manufacturers’ incentive strategies such as bundling deals and loyalty programs, on biosimilar market dynamics.

In this exclusive interview, the APJs will answer questions touching on:

• Fintiv and the current policy relating to discretionary denials of institution
• How the Judges consider denials (e.g., serial petitions, parallel petitions, 325(b))
• Recent Director Review decisions relevant to discretionary denials
• The new Guidance on obviousness and the new Guidance on written description and enablement, post-Amgen v. Sanofi
• The latest statistics for types of challenges brought and types of patents challenged
• Best practice tips, i.e., what judges find helpful, unhelpful, the secondary considerations

• Analyzing recent cases that impact the patentability of biologics
• e.g., Amgen v. Sanofi, Kite v. Juno, and Daiichi Sankyo v. Seagen Inc.
• Reviewing the recent USPTO guidance on obviousness; the post-Amgen guidance; and the notice of proposed rule-making with respect to discretionary denials
• What if any changes to current filing and litigation strategies should be considered in light of the above?
• Understanding the advantages for applicants to resolve prior art invalidity disputes via PTAB proceedings
• Establishing standing to appeal in an IPR or PGR in connection with BPCIA and the FDA approval process for biosimilars
• Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation
• Analyzing biosimilars filings and recent PTAB decisions, e.g., the PTAB challenges relating to SOLIRIS and STELARA

• Learning the fundamentals of the “patent dance”
• Considering the Purple Book and how it can be used to inform venue selection and litigation and launch strategy
• Enumerating the factors to consider when choosing between the BPCIA, the PTAB and district courts:
  • E.g., where are parties filing, why, and has that changed recently?
  • Comparing the different standards of proof, timing, and the how the choice of venue impacts damage relief
  • Reading the tea leaves with respect to the Regeneron multi-district litigation: will MDLs become common and how could the possibility of an MDL impact venue selection?
• Reviewing preliminary injunctions and the concept of irreparable harm, from the innovator and biosimilar perspective:
  • Understanding how irrepealable harm is being quantified, and how it plays out in multiple markets, patents, and patent families
  • Appreciating the differences between BPCIA and ANDA litigation with respect to stays and PIs

• Learning the fundamentals and core terminology:
• Defining AI and machine learning (ML)
• Understanding what distinguishes traditional AI from generative AI
• Understanding how generative AI is revolutionizing areas like drug discovery, bioinformatics, and personalized treatments relative to traditional AI in the life sciences
• Knowing the key legal concepts to consider with respect to patent protection for AI-aided drug discovery and development
• Understanding AI capabilities towards accelerating regulatory approval:
• AI in clinical trial optimization and the collection of patient data
• AI in the manufacturing of biologics and biosimilars
• The FDA’s new AI based safety evaluation tool to help demonstrate biosimilarity

• Navigating corporate buy-in for DEI in company culture and practice amidst state legislature and political pressures advocating against DEI implementation
• Encouraging diversity and inclusion in innovation
• Exploring the USPTO’s various diversity initiatives for female patentees
• Exploring the consequences of biased data sets in clinical research and the importance of diversity in research
• Promoting diversity, equity, and inclusion in legal practice:
• Exploring the USPTO’s Notice of Proposed Rulemaking, seeking to expand the admission criteria to practice before the PTAB