Biosimilar and Biologic Litigation
Analysis Group provides rigorous economic and scientific analysis to support stakeholders in high-stakes biologic and biosimilar disputes. Drawing on our multidisciplinary teams and understanding of the complex scientific, regulatory, and commercial landscape unique to biologics, we offer end-to-end consulting and expert support across pre-litigation analysis, litigation, and arbitration involving originator biologics, biosimilars, and related technologies.
We have advised both small and large pharmaceutical and biotechnology firms in matters concerning patent disputes, market entry, exclusivity challenges, pricing strategy, commercial success, irreparable harm, antitrust considerations, and damages quantification tied to biologics and biosimilars. Our teams combine scientific acumen, economic rigor, and legal fluency to help clients navigate critical disputes in this evolving space.
Our Capabilities
- Patent Infringement and Exclusivity Challenges – Evaluation of patent portfolios related to biologics and biosimilars, including market exclusivity claims under the BPCIA, patent linkage, and litigation involving claims of infringement, invalidity, or non-infringement
- Commercial Success and Irreparable Harm – Assessment of commercial success in the context of secondary considerations of patent validity, and investigation of the likelihood of irreparable harm in situations of potential biosimilar entry and court considerations with respect to injunctions on entry
- Market Entry, Pricing Strategy, and Competitive Impact – Analysis of the impact of biosimilar entry on market dynamics, pricing, and formulary placement; assessment of bundled discounts, rebate strategies, and formulary positioning impacts; evaluation of market share shifts, substitution patterns, prescriber behavior and manufacturer commercial strategy in response to biosimilar launches
- Damages in IP, Contract, Commercial, and Antitrust Disputes – Analysis of damages, including lost profits and reasonable royalties, in various contexts, such as for matters related to an alleged violation of intellectual property rights, breach of contract, commercial disputes, and antitrust and competition issues involving biologics
- Regulatory and Labeling Disputes – Support in disputes involving labeling, interchangeability, and extrapolation of indications, including economic impact modeling of alternative regulatory scenarios
- False Advertising, Customer Confusion, and other Lanham Act Violations – Evaluation of false or misleading advertising; assessment of the potential for customers to be confused by marketing communications; and disputes between biologics and biosimilars involving trademarks, trade dress, and trade names
- Technology Transfer and Contractual Disputes – Evaluation of contractual obligations and licensing terms associated with biologic manufacturing, biosimilar development partnerships, and supply agreements
Scientific and Technical Experts
Specialists in biologic development, biosimilar comparability, pharmacokinetics/pharmacodynamics, manufacturing process validation, and analytical similarity assessments
Drug Development and Commercialization Experts
Experts in clinical and regulatory pathways for biologics and biosimilars, including trial design, manufacturing plans, approval strategies and timing, and market access challenges across global jurisdictions
Economic Experts
Professionals skilled in market modeling, damages estimation (lost profits, price erosion, royalties), competitive effects, intellectual property analyses, class certification considerations, and forecasting of biologic and biosimilar adoption trends
Regulatory Experts
Advisors with expertise in FDA and EMA guidelines on biosimilars, BPCIA litigation frameworks, and exclusivity periods (e.g., 12-year exclusivity and patent dance provisions)
Licensing and Contract Experts
Support for disputes involving co-development, co-marketing, contract manufacturing, supply/distribution agreements, and breach of biologics-related licensing terms, including evaluations of commercially reasonable efforts
Former Biotech and Pharma Executives
Experts with decades of experience in biologics strategy, supply chain operations, pricing and access planning, and regulatory compliance
Marketing and Branding Experts
Academic and practitioner experts with substantial experience analyzing firms' marketing activities
Clinical Experts
Healthcare practitioners with experience using/prescribing biologics and biosimilars in various therapeutic areas
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Publishing Emerging Economic Trends: Humira and Adalimumab Biosimilars Competition -
AG Feature Biosimilar Litigation Considerations: Economic Factors in Intellectual Property and Antitrust Cases -
Case OutcomeNippon Shinyaku Co., Ltd., et al. v. Sarepta Therapeutics, Inc., et al. -
Publishing FDA’s Biosimilarity Guidance Holds Uncertain Implications -
Case OutcomeRegeneron Pharmaceuticals, Inc. v. Amgen, Inc. -
Publishing Economic Considerations Related to Biosimilar Market Entry
