Patents take the form of public letters that the U.S. Patent and Trademark Office (USPTO) actively disseminates. Whether these documents sufficiently provide the public with notice of the technologies they describe, as well as the proprietary rights that they assert, has been subject to long-standing debate. Many commentators conclude that patents are often filed too early in the research and development cycle, are deliberately drafted in a vague or obtuse manner, or are simply too numerous. As a result, identifying the relevant patent landscape is not just difficult for technology implementers, but possibly undesirable as a matter of innovation policy. Yet prior scholarship has seldom acknowledged current statutory mechanisms to improve the notice function of patents after they issue. This Article endeavors to fill that gap.
Congress has long encouraged intellectual property rights holders to identify their patents on the products they sell. Patent marking has traditionally occurred on physical products or their packaging, although it has been recently extended to Internet-based virtual marking. The marking statute stipulates that patent proprietors that fail to mark face severe remedial restrictions when challenging infringers. Congress has assigned the Food & Drug Administration (FDA) a part in providing patent notice as well. In keeping with federal legislation, the agency maintains two publications, commonly known as the Orange and Purple Books, that act as a patent clearinghouse for approved drugs and licensed biologics.
The role of a patent within the marketplace provides perhaps the most valuable form of notice that that instrument may offer. Yet the marking statute and FDA publications suffer from some apparent flaws. In combination they project a failure to identify all patents that are relevant to the product, favor patent trolls, involve dubious practical workings, promote misleading advertising, and impose punitive sanctions in comparison to the notice requirements of peer intellectual property rights. For its part, the FDA has proven an untutored and unreliable patent publicist for the past four decades.
This Article offers specific suggestions to improve the notice functions of patents after they issue. It calls for the USPTO to develop and populate its own virtual marking database that correlates individual patents with the marketplace. It also encourages the FDA to take further steps to counter abuses of the Orange and Purple Books and to accelerate their patent notice functions. Finally, this Article takes broader lessons from this effort, offering pathways for policymakers to look beyond the patent instrument as they endeavor to improve the patent system’s notice functions.
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Copyright (c) 2023 Professor John R. Thomas