Protecting The Platform: Trade Secret Protection For RNA Biotech Companies
By Robert Frederickson and Josh Eibelman, Goodwin
RNA therapeutics have moved firmly into the mainstream of drug development. The American Society for Gene and Cell Therapy estimated that roughly 1,300 RNA therapies are actively sitting in the global research pipeline as of May 2026, and, according to IQVIA Research, RNA licensing deal volume exceeded $17 billion in 2025. As investment, licensing, and collaboration accelerate, the intellectual property question widens: companies need to protect not only the drugs they patent but also the technical know-how that makes their platforms work.
Patents have been the workhorses of intellectual property protection for biotechnology and pharmaceutical companies for decades. For biotechnology companies focused on RNA-based therapeutics, however, a patent portfolio alone may not protect all of the information that gives a platform its commercial edge. Trade secret protection needs to be treated as a parallel discipline, designed into how companies conduct R&D, collaborate, manufacture, use AI tools, and manage employee mobility.
Patents And Trade Secrets Protect Different Value
Patents and trade secrets are sometimes characterized as “opposite” forms of intellectual property protection. On the one hand, patents are public disclosures of inventions and innovation. In exchange for that public disclosure, the government grants the patent owner the right to exclude others from making, using, or selling the inventions claimed for a fixed period of time (e.g., 20 years in the U.S.). Patents are written instruments issued by the government, and the scope of coverage is defined — in words — by the claims. Most relevant to pharmaceutical companies, patents are generally used to protect innovative compositions, sequences, constructs, formulations, and methods.
Trade secrets protection, on the other hand, extends to information that has value because it is kept secret. Unlike patents, trade secrets are not issued by the government and can evolve over time. While lawyers often argue about the precise contours of trade secret protection, generally speaking, trade secret laws protect any form of information that has value because it is maintained as confidential using reasonable means. Those same laws prevent others from “misappropriating” another company’s trade secrets. Although laws vary by jurisdiction, misappropriation generally refers to the acquisition or use of another’s trade secrets by improper means, which can include anything from corporate espionage or theft to violations of confidentiality or nondisclosure agreements. Unlike patents, however, trade secret laws do not prevent others from reverse engineering another company’s trade secrets through legitimate means. Indeed, the law encourages lawful reverse engineering efforts.
As a result, pharmaceutical and biotechnology companies often grapple with decisions about whether and to what extent to use patents or trade secret laws to protect their innovation. With the emergence of RNA therapeutics, we are now seeing an increased focus and reliance on trade secret laws for certain forms of innovations.
The Value Of RNA Therapeutic Platform Technologies Extends Beyond The RNA Drug
Thirty years ago, pharmaceutical companies developing innovative small molecule drugs relied almost entirely on patents to protect the value of that drug. For the innovator pharmaceutical company, the primary driver of value was the chemical structure of the active ingredient. The formula and structure of the drug would be published eventually, likely well before commercialization. Competition was fierce and once a structure published, the drug and close analogues would be easy to copy by others. As part of the life cycle management, pharmaceutical companies would seek to unlock other sources of value, such as new formulations or methods of treatment. For the most part, patents were purpose-built and well suited for protecting the final drug substance, drug product, and methods of treatment.
More complex modalities, like RNA therapeutics, are different. To be sure, there is still considerable value in therapeutic RNA sequences and RNA-based companies continue to secure patents to cover those end products. But the value in RNA therapeutics extends well beyond a specific nucleotide sequence.
Most notably, design rules, untranslated-region choices, capping or modification strategies, process parameters, analytical methods, troubleshooting knowledge, data from unsuccessful experiments, and manufacturing processes have value, particularly because that information often can be used for the discovery and development of different drugs. Similarly, delivery and formulation knowledge may include lipid identity and purity, component ratios, buffer conditions, mixing and flow parameters, encapsulation efficiency, particle attributes, and process tolerances. Additionally, manufacturing knowledge may include in vitro transcription inputs and conditions, purification order, in-process controls, hold times, scale-up adjustments, impurity controls, and deviation resolution methods. Patents are less adept at protecting this type of information, both because of inherent limitations of patents and the difficulty associated with identifying potential acts of infringement.
Improvements like this to an RNA drug discovery and optimization platform — i.e., increasing efficiencies, speed, and optimization discovery and development strategies — are the types of information that are quintessentially within the realm of trade secret protection.
Collaboration Multiplies The Points Of Exposure
There is another important reason trade secret protection is more important for RNA therapeutics. Companies that focus on discovering and developing RNA therapeutics often need to partner with and rely on third-party specialists at the different stages of discovery, development, manufacturing, and commercialization of their products. For the most part, these strategic relationships require information sharing. At the discovery stage, for example, an RNA biotechnology company may need to enter into collaborations with large pharmaceutical companies to secure funding that advances programs. Partnerships and licensing agreements with lipid nanoparticles and other delivery companies may be required. Contract development and manufacturing organizations may need to be brought in to refine processes or make clinical and commercial supply of RNA drugs. The importance of having robust trade secret protection increases with each third party that is brought under the tent.
Many trade secret lawsuits between biotechnology companies involve former partners or potential partners. The specific technologies and facts vary, but the generalities are the same: during the partnership (or during potential partnership talks) an RNA company shares insight about formulation data, manufacturing parameters, development plans, and lessons from failed experiments with a prospective partner; the transaction falls apart or comes to a natural end, and months later the former (or prospective) partner begins pursuing a program that looks uncomfortably familiar. In many instances, that cause for concern is enough to launch a lawsuit.
How Companies Can Protect Their Innovations
RNA companies should treat trade secret protection as an operational discipline that complements patents and protects valuable know-how throughout research, manufacturing, collaboration, AI use, and employee mobility. Because RNA development depends on portable technical knowledge and frequent information sharing, companies should identify what they own, control what leaves, and verify what enters. Companies that build these practices into day-to-day workflows can collaborate more confidently, preserve competitive value, and respond more effectively when disputes arise.
About The Authors:
Robert Frederickson is a partner in IP litigation practice and co-chair of the Life Sciences Disputes Group at Goodwin. He is a nationally recognized trial attorney and a leading expert on intellectual property disputes for life sciences, technology, medical device, and financial services companies. He has dual degrees in economics and computer science, and he earned his JD, cum laude, from Boston College Law School. Among many honors, highlights include recognition as a “Key Lawyer” for patent litigation by The Legal 500, 2021–2023, and repeatedly appearing as a “Rising Star” in Super Lawyers Magazine, 2013–2022, a distinction awarded to less than 2.5% of eligible attorneys.
Josh Eibelman is a law clerk in Goodwin’s litigation department. Before joining Goodwin, Josh was a judicial extern for the Honorable Judge Indira Talwani for the U.S. District Court for the District of Massachusetts. During law school, he was senior submissions editor of the Berkeley Business Law Journal, a pro bono member of the Homelessness Service Project, and participated in the IP Practicum at the Berkeley Center for Law and Technology’s Life Sciences Law & Policy Center. He graduated from Cornell University for his undergraduate degree and UC Berkeley Law for law school. He worked in the biotech industry prior to law school.