Document Type
Article
Publication Date
2025
Abstract
No patent lasts forever. When intellectual property rights expire, a canonical principle states, all benefits of their ownership cease. But patents may cast a long shadow after they are gone, hindering the advent of immediate competition upon their expiration. The law acts unevenly in these circumstances, leading to questionable intellectual property and public health policies. Ordinarily competitors cannot make and use a patented invention until the patent's term has concluded. This delay ordinarily extends the effective period of exclusivity that the patentee enjoys. However, a statutory safe harbor shields from infringement acts undertaken "solely for uses reasonably related" to Food and Drug Administration (FDA) approval efforts. Congress intended the safe harbor, the only practically operative exception to patent rights ever enacted, to promote immediate generic availability upon the conclusion of patent term.
Ordinarily competitors cannot make and use a patented invention until the patent’s term has concluded. This delay ordinarily extends the effective period of exclusivity that the patentee enjoys. However, a statutory safe harbor shields from infringement acts undertaken “solely for uses reasonably related” to Food and Drug Administration (FDA) approval efforts. Congress intended the safe harbor, the only practically operative exception to patent rights ever enacted, to promote immediate generic availability upon the conclusion of patent term.
Courts construe the safe harbor to exempt from infringement a wide range of activities. Current rulings allow manufacturers to use drugs or devices pa-tented by others for as many non-regulatory uses as they wish, for as long as they desire, and even if the FDA is never informed of them, so long as the court concludes that the infringing act bore a perceptible relation to the FDA approval process. So conceived, the safe harbor creates a paradox. It too often defers patent litigation and the public benefits that result from it, including judicial rulings that clarify patent boundaries and invalidate weak patents. Intended to promote the rapid approval and distribution of generic drugs, an expansive safe harbor instead promotes delay and uncertainty.
This Article calls for a reframing of the safe harbor, not as a windfall for generic manufacturers, but rather as a mechanism intended to promote public health. Analysis of the safe harbor provides additional insights into the temporal dimension of patent infringement. Agencies other than the FDA entertain regulatory aspirations but face patent conflicts. Extended lead times for product development also diminish the prospects for prompt market entry by competitors after patent expiry. Other specialized rules for pharmaceutical patent law that delay patent litigation should be reconsidered. Finally, this Article calls into question infringement suits brought by owners of expired patents.
Scholarly Commons Citation
Thomas, John R., "Patent Infringement in Time" (2025). Georgetown Law Faculty Publications and Other Works. 2665.
https://scholarship.law.georgetown.edu/facpub/2665