Inventions like drugs, medical devices, and wastewater treatment plants are subject to the same patent statues as those that fall outside of the public health sphere, but their significance raises specific policy questions without clear-cut answers. While strong patent protection helps pharmaceutical companies recoup R&D costs so they can continue to develop new high-risk treatments, low-cost access to drugs may be deemed more important during a public health crisis. The COVID-19 pandemic and the race to develop vaccines illustrates the conundrum found at the intersection of patent law and public health.
In his paper “Patent Law and Public Health,” Sean Seymore, Centennial Professor of Law at Vanderbilt Law School, argues that federal courts have “abandoned their gatekeeping function” for protecting public health in patent cases.
“There was a time when public health-related inventions received special treatment from both the Patent Office and the courts,” Seymore writes. “However, the law has evolved such that outright denials of patents solely to protect public health now seem implausible.”
“Patent Law and Public Health” offers an alternative solution.
The Affirmative Defense of Patent Unenforceability
Seymore’s paper argues that courts can render patents unenforceable (permanently or temporarily) in certain circumstances through the affirmative defense of patent unenforceability, specifically in cases where plaintiff-patentees are engaged in misconduct related to their invention that jeopardizes public health. “Public health would essentially become an affirmative defense to patent infringement,” he writes.
Unenforceability doctrine has roots in the concept of “unclean hands” – the notion that a plaintiff will not be granted relief for acts of bad faith – which dates far back in U.S. history. Affirmative defenses in patent cases involving unclean hands may involve dealings with the Patent Office, extending the patent beyond its scope in an anticompetitive way, or other forms of misconduct generally branded “unclean hands.”
This doctrine had been stagnant for years until a 2018 case involving pharmaceutical giants Gilead Sciences and Merck, wherein the Federal Circuit held that unclean hands could apply for pre-litigation business misconduct. “(The case) has reinvigorated the unenforceability defenses and paves the way for courts to use them to protect public health in patent cases,” Seymore writes.
Scenarios Where Patent Unenforceability May or May Not Succeed in Court
Dietary supplements – taken regularly by 3 out of 4 Americans, according to the FDA – do not have to be proven safe and effective before marketing. Supplement makers can make dubious claims about safety and efficacy, so long as they have the proper disclaimers on their packaging. “If a dietary supplement is patented, this can fuel dubious claims and exacerbate a consumer’s confusion about safety and efficacy,” Seymore writes. Inventors that use false or misleading advertising may run afoul of unclean hands in a patent infringement suit.
Conversely, a pharmaceutical firm that poaches a scientist from a rival to gain “negative know-how” (i.e., past mistakes, failed tests, dead ends) while racing to create a vaccine during a COVID-like public health emergency might not have a subsequent patent deemed unenforceable in related litigation. Meeting the threshold of “egregious misconduct” for hiring away an employee to fast-track progress in an emergency could be difficult to prove.
Seymore’s final example involves a pharmaceutical firm that requires licensees of its patented HPV vaccine to purchase a particular syringe for each dose – a syringe manufactured and sold by a subsidiary of the firm. Such an arrangement would likely constitute patent misuse, moving a court to render a patent unenforceable in any related infringement case.
Balancing Public Welfare and Innovation
Seymore notes in his conclusion that denying patents to protect public health is no longer a plausible course of action – “such heavy-handedness disrupted the delicate balance of two competing policy objectives in patent law – enhancing public welfare and promoting innovation.” Within the current world of patent law, unenforceability helps achieve that balance.
“Patent Law and Public Health” is forthcoming in Notre Dame Law Review.
