Biotechnology
The rapidly-growing area of biotechnology requires focused capabilities and strategic management of IP. Benesch’s Intellectual Property group provides careful drafting of patent applications, skillful procurement of worldwide patent and trademark rights, counseling and negotiating license and distribution agreements, effecting technology transfers, and advising on litigation interferences, International Trade Commission actions, and other inter partes matters to ensure optimal protection and exploitation of our clients’ valuable technologies. Our lawyers have assisted clients in a wide variety of biotechnology fields, including: diagnostic and therapeutic; drug delivery systems; drug discovery; medical devices; and pharmaceutical treatment, to name a few.
Services Include:
- Patent searching, including state-of-the-art searches and right-to-use searches
- Preparing and prosecuting patent applications relating to a wide variety of inventions
- Drafting and negotiating patent-related agreements, including licensing
- Advising on patent infringement, validity, and enforceability issues
- Prosecuting and defending patent infringement actions, interferences, and §337 actions
- Valuation of intellectual property
Recent Representative Engagements Include:
- Drafted and/or prosecuted cases dealing with peptide compositions; contrast enhancing agents and liosomal delivery vehicles; liposome technology; diagnostic arts (methods of diagnosing Alzheimer’s, tumors, AIDS); and anti-tumor agents, specifically those relating to b-cells, and various biomedical devices
- Drafted and negotiated numerous patent licenses relating to the manufacture, sale and distribution of medical devices, including:
- An exclusive, royalty-bearing patent license agreement for the manufacture and sale of licensed products for endoluminal treatments;
- A license and distribution agreement relating to artificial heart systems with provisions allocating responsibilities for regulatory approval in the U.S. and Europe; and
- A license and distribution agreement relating to absorbable implant technology with provisions addressing the improvements that may be jointly developed by the parties
Experience
- Represented Hospira, Inc., a subsidiary of Pfizer, Inc., Celltrion, Inc. and Celltrion Healthcare Co., Ltd. adverse to Janssen Biotech, Inc. in litigation in federal court related to a biosimilar version of Janssen’s multi-billion dollar drug Remicade®. The case involved the first biosimilar monoclonal antibody to be approved by the FDA, and is one of the earliest cases filed under the Biologics Price Competition and Innovation Act (BPCIA).*
- Assisted with appeals of two highly publicized motions for summary judgment that invalidated a pharmaceutical company’s patent related to the infliximab antibody. The district court litigation ended with a second win in the form of a judgment of non-infringement related to the second patent asserted in the case.*
- Represented Sandoz Inc. in a patent litigation regarding a biosimilar version of Amgen’s drug Neulasta®. The litigation was successfully terminated when Sandoz obtained an order dismissing Amgen’s related declaratory judgment.*
