December 19, 2019
Medical Product Outsourcing
By Mareesa A. Frederick; Courtney A. Bolin
In the textile industry, medical textiles represent one of the fastest growing segments of the market. Driven by a demand for new innovative products, the medical textile industry is constantly evolving and looking for ways to improve the efficacy and wearability of medical products. However, as with many textiles, commercializing a medical textile can be prohibitively expensive—the manufacturing equipment is costly, research budgets can balloon, and the timeline to reach the market is frequently unpredictable. In addition to the costs of developing a medical textile, companies also must obtain U.S. Food and Drug Administration approval before selling their products in the domestic market; this process can take years.
Companies may seek to overcome these barriers by outsourcing parts of the manufacturing process to partner companies or universities—this kind of arrangement is often referred to as a horizontal supply chain. A horizontal supply chain can be beneficial because it fosters a more collaborative environment that helps get a finished product to market faster. For example, when companies work together, there is more specialized expertise and varied approaches to problem solving—which can reduce upfront costs, lead to an improved finished product, and allow for more competitive pricing later on. However, from a legal standpoint, working collaboratively can also create problems.
In this article, we highlight how collaboration can affect patent rights, and provide suggestions that may help companies avoid problems arising out of improperly including or excluding an inventor from a patent application.
The Legal Implications of Working Collaboratively on Inventorship
In the United States, patents grant the right to exclude others from making, using, selling, offering for sell, or importing the patented invention. Essentially, obtaining patent rights provides the patent holder an opportunity to enter the market exclusively and profit from the invention before his or her competitors. Another benefit of obtaining patent protection is that patents can be sold or licensed to others, which means that a company can profit from their patented invention even if they do not manufacture it themselves. In order to obtain a patent, the invention must meet the legal requirements of patentability. In this article, we focus on the legal requirement that the true inventor(s) must be named in the patent application.
Conception of any idea begins with an inventor—an individual who had a light-bulb moment, offered a solution to a problem, or had a spark of creativity. However, identifying the inventor (or joint inventors) is not always a straightforward task. This is especially true in the medical textile industry where scientists at different companies often collaborate.
There are several requirements to keep in mind when determining whether one is a joint inventor. Each of these requirements must be satisfied:
Establishing collaboration, contribution, and the significance of that contribution is highly fact-specific and requires a close look at the work of each individual participating in the collaboration. Thus, collaborating companies must have measures in place to track individuals’ contributions to product development and ensure that each company understands their right to any resulting patents from the collaboration.
Avoiding Legal Issues Caused by Incorrect Inventorship
In view of the legal requirements required to be a joint inventor, good record-keeping is important to collaboration. Good record-keeping may take different forms for certain companies; however, there are some general guidelines that we suggest for recording and tracking the product development process:
By taking measures to maintain good records and clear contracts, collaborating companies are better equipped to file patent applications naming the proper inventors and reduce the likelihood of future disputes. Although the initial undertaking of putting record keeping systems and contracts in place between the parties can be daunting, these measures are essential to collaborating on product development and maintaining healthy long-term business relationships.
Originally printed in Medical Product Outsourcing on December 19, 2019. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
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