Advanced therapies such as cell and gene therapies have the potential to transform the treatment of genetic disorders, autoimmune conditions, cancer, rare diseases, neurodegenerative disorders, and other areas of unmet medical need. Sterne Kessler helps innovators develop intellectual property strategies that protect breakthrough therapies, platform technologies, manufacturing innovations, delivery systems, and next-generation product candidates throughout the development lifecycle. We also help innovating companies and businesses assert their intellectual property and/or defend against competitors in litigation and engage in pre-litigation strategies.
Sterne Kessler advises biotechnology companies, emerging growth ventures, research institutions, investors, and established life sciences organizations developing advanced therapies such as cell therapies, gene therapies, RNA therapies, genome editing technologies, engineered immune cell therapies, regenerative medicine platforms, nucleic acid technologies, and related biologic innovation in all aspects of intellectual property.
Our team includes more than 50 advanced degrees and Ph.D.s in science and engineering disciplines, and our experience encompasses molecular biology, genetics, genomics, immunology, cell biology, virology, bioinformatics, pharmacology, chemical engineering, and related disciplines. This technical foundation allows us to counsel clients on complex innovations where scientific, regulatory, manufacturing, and IP considerations often intersect.
Protecting Innovation Across the Advanced Therapy Ecosystem
Advanced therapy companies often require coordinated protection across platform technologies, therapeutic products, manufacturing processes, delivery systems, clinical applications, and follow-on improvements. We work with clients to develop patent portfolios that support long-term business objectives while anticipating future development pathways, competitive challenges, and potential disputes.
Our experience includes technologies involving:
| Technology and Product Areas | ||
| Cell therapies | Gene therapies | CAR-T and other engineered immune cell therapies |
| T-cell and NK-cell therapies | Stem cell therapies and engineering | Regenerative medicine |
| Genome editing | CRISPR and gene-editing platforms | Gene delivery and gene regulation technologies |
| Viral vectors | Non-viral delivery systems | RNA, RNAi, antisense oligonucleotides (ASO), and siRNA therapeutics |
| Next-generation immunotherapies | Cell engineering platforms | Cell manufacturing and processing technologies |
| Bioprocessing and scale-up innovations | Biomarkers and companion diagnostics | Personalized and precision medicine approaches |
IP Strategy from Discovery Through Commercialization
Advanced therapy companies face significant IP considerations at every stage of development. Patent protection may extend beyond the therapeutic molecule itself to encompass delivery vectors, improved expression constructs, manufacturing processes, formulations, administration strategies, dosing regimens, methods of treatment, biomarkers, companion diagnostics, and other follow-on innovations.
We help clients:
- Develop and prosecute global patent portfolios for cell therapy, gene therapy, gene editing, and related biotechnology platforms
- Identify potentially patentable innovations throughout research, preclinical development, clinical development, and commercialization
- Protect both platform technologies and product-specific innovations with an eye to a diversified and defensible patent portfolio as well as longevity of patent protection
- Develop lifecycle management strategies that account for future product generations and follow-on improvements
- Evaluate freedom to operate and competitive patent landscapes
- Support financing, investment, licensing, and strategic collaboration opportunities
- Support IP diligence for partnerships, acquisitions, and commercialization transactions
- Maximize opportunities for extension of patent term and product marketing exclusivities
Clients turn to Sterne Kessler to help them transform scientific breakthroughs into strategic intellectual property assets that support investment, partnerships, commercialization, and long-term growth.
Patent Litigation and Disputes Across Forums
- Freedom to operate analyses
- Validity and non-infringement opinions
- Patent portfolio evaluations
- Inter partes review (IPR) proceedings
- Post-grant review (PGR) proceedings
- Ex parte reexaminations
- District court and ITC litigation
- Federal Circuit appeals
- Strategic enforcement and defense planning
By combining our team’s patent prosecution, licensing, post-grant, litigation, and appellate perspectives, we help clients build and take advantage of portfolios intended to support both innovation and long-term competitive positioning.