Regulatory counseling is critically important to be coupled with intellectual property solutions for product development & commercialization of regulated products from initiation through post-launch phases. In regulatory law, the goal is to demonstrate substantial equivalence and a lack of differentiation to other existing products. In contrast, proving novelty and non-obviousness over existing inventions is foundational to secure patent protection. Careful coordination of these legal strategies and related public communications is fundamental to business success.

For example, USDA recently published information on a proposed rule indicating they will consider how a product of nature is interpreted for purposes of patent eligibility under 35 USC §101, as part of their criteria for meeting the definition of “bioengineered” and disclosure requirements under the National Bioengineered Food Disclosure Standard. Potentially, obtaining a patent on technology used to develop food products could sway a determination by the agency that the food is not “found in nature” and therefore required to be labeled as bioengineered. Integration of IP and regulatory legal strategies is important to avoid unintended consequences and meet business goals.

Cassie J. Edgar, Chair of the Regulatory & Product Development Law practice group, brings decades of in-house counsel IP and regulatory experience, both US and global. Intellectual property focuses on everything from freedom-to-operate to patent strategy and enforcement. Regulatory law concentrates on regulatory approvals, stewardship, and compliance. Cassie’s goal is to help clients through both IP and Regulatory decisions that best fit their business goals whether that be on a local, national, or global scale.

Cassie’s specialty practice includes:

• Global intellectual property including patent prosecution, patent marking, enforcement, licensing, and litigation. Litigation may encompass anything from IPR/PGR/federal litigation support, and coordinating global revocation and opposition proceedings.  
• Global regulatory law including managing biotechnology communications & crisis management, compliance, stewardship, regulatory data package generation, and obtaining regulatory permits and approvals with USDA, FDA, EPA and global regulatory agencies necessary for U.S. sales.
• Product Development strategic planning across plant and animal industries including stages & gateways management, portfolio management, project management, and launch & post-launch planning integrating IP & regulatory solutions.
• Business Development including developing legal solutions for your business with the specific needs of regulated products in mind, coordinating business, IP and regulatory requirements during the startup phase and discovery research, subsequent funding rounds, licenses, JVs and M&A activity.