Biotechnology and Biologics
Kenyon regularly handles biotechnology matters for clients ranging from major biotechnology companies to start-ups to leading universities and research institutes. Kenyon is helping clients prepare to navigate the biosimilars pathway, or determine whether other routes toward filing and approval may be preferable. Our extensive studies on patent portfolios relating to antibodies and human growth hormones, many of which involve the seminal patents for the first-generation biosimilar targets, our knowledge of the patent landscape in this sector, and our experience with the complex statutory framework in this area position us to accurately assess potentially relevant patents and products.
We have worked on cases involving:
- use of stem cells as vehicles for gene therapy, stem cell isolation, culturing, and differentiation techniques;
- therapeutic and reproductive cloning;
- use of adult mesenchymal stem cells and their associated factors for use in cardiac repair;
- use of stem cells as pacemaker delivery systems; and
- isolation and culturing of amniotic derived stem cells and their therapeutic use in treatment of a number of disorders including those of the liver and pancreas.
Our litigators have decades of experience conducting high-stakes bench and jury trials on behalf of leading brand and generic manufacturers, and have achieved favorable outcomes in litigations involving blockbuster drugs and damages claims worth billions of dollars.
We help our clients achieve their commercial goals for first-to-file and other crucial drug innovations, and are versed in every aspect of clearing a product’s path to market, including:
- defending a product’s market position;
- handling formulation and process clearance through trial and appeal;
- securing patent protection;
- providing API, formulation, and manufacturing process clearance;
- drafting detailed statements; and
- navigating regulatory hurdles.
For more information related to our life sciences, chemical, and materials practice, please click here.