Trade Secrets in Biologic Medicine

Abstract

Can something be both open and secret? That is the conundrum facing society as trade secret rights chafe against patent rights in cutting-edge, biologic medicine. The conflict is unsurprising. Trade secret has emerged as a relatively late bloomer among the family of intellectual property rights and only recently has begun to establish the boundaries of its own space, a process in which it will inevitably knock against other intellectual property doctrines already occupying their own domains. Nor is it surprising that the clash would arise in a fast-moving area of medical science. From insulin products, to cancer treatments, to mRNA vaccines, companies are staking the health of their  companies on biologics.

There is a dearth of legal literature on the topic of trade secrets in the biologic space and almost nothing regarding how trade secrets interact with the patent system in that domain. These scientific and legal areas are sufficiently complex that even the most intrepid scholars fear to tread. This article explains in detailed and accessible language how the systems are working together to the detriment of society.

To address the problem, this article argues that a company receiving a patent on a drug product should be required to disclose the full range of trade secrets necessary to make that drug. As the descriptions below will explain, patent applicants are able to satisfy the patent requirement of providing sufficient disclosure that “one skilled in the art can make and use” the invention, without actually providing the information to do so. The surrounding regulatory systems intended to facilitate sharing of clinical trial data suffer the same problem.

As is frequently said in biologics, “the process is the product.” In other words, the only way to define something derived from elements of living organisms is by describing the process of producing it. Thus, lack of process information is particularly problematic with biologics. Being faithful to the theoretical underpinnings of the intellectual property regimes requires a resolution of this problem and the establishment of a more effective boundary line between trade secrets and patents for biologic medicine.