Protecting Your Life Sciences Trade Secrets

Trade secrets are indispensable to an intellectual property protection program. For the life sciences industry, trade secrets work hand-in-hand with patent protection to ensure that others cannot freeload on a company’s investments in innovation.

Trade secret information is often found in a variety of technology areas. Importantly, trade secrets do not need to meet statutory requirements for patentability (novel, nonobvious) so long as they provide economic value to the company by being held secret. For the life sciences industry, some important categories of trade secret information may include:

• Therapeutic targets and related modalities
• Assays and testing methods (e.g., protocols for detecting important biomarkers)
• Manufacturing procedures and equipment configuration (unique fermentation or purification techniques)
• Proprietary cell lines, unique strains of bacteria or years
• Formulation and/or formulation strategies
• Software and algorithms
• Research data and experimental results
• Development plans and strategies
• Supplier/vendor information
• Unpublished inventions

Under both federal and state law, a trade secret owner must demonstrate that they have taken reasonable measures to protect their secrets from disclosure. While there is no one-size-fits-all answer to what constitutes reasonable measures, there are a number of factors that are commonly taken into account:

• Existence of a trade secret policy
• Use of non-disclosure agreements for employees, consultants, and anyone else with access to company confidential information
• Limiting trade secret access to only those individuals with a need to know
• Restrictions on physical access to facilities
• Restrictions on access, printing, and sharing of electronic resources
• On-boarding and off-boarding procedures
• Employee education on protocols for protecting company confidential information

In adopting protocols for protecting trade secret information, it is important to take into consideration the practicalities of keeping the information secret. While in some cases it may be that the number of people who need access to the information can be strictly limited to a handful of employees, in other cases there may be a number of employees exposed to the information in order to perform their work responsibilities.

In any agreements permitting access to trade secret information, those agreements should address the following:

• Restrictions on use, dissemination, or disclosure of trade secret information
• Ownership of all trade secret information, including trade secrets generated under the agreement
• Prohibitions on use of third-party confidential information
• For employee or consultant agreements, notice of whistleblower rights must be provided
• Return/destruction of any company confidential information upon termination

It is also important to have a clear understanding of what constitutes the trade secret(s) that are important to the company. Key considerations include:

• Protocols for identifying potential important trade secret subject matter
• Protocols for ensuring trade secret information is not inadvertently published or otherwise disclosed
• Strategic consideration of what innovative subject matter should be patented and what should be kept as a trade secret
• Practicality of keeping information confidential

This article appeared in the 2025 Life Sciences IP Tool Kit.