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Journal of Intellectual Property Law

Abstract

Approximately one in every ten Americans lives with diabetes, a condition that inhibits the body’s ability to regulate blood sugar. The majority of those with diabetes rely on insulin injections to control the condition and avoid the dire health consequences that can quickly result from insufficient insulin. The price of insulin has risen 700% in the past two decades, with burdensome if not disastrous consequences for individual patients and for public health more generally. Federal law provides a pathway for manufacturers of follow-on pharmaceuticals, including insulin, to obtain abbreviated approval from the FDA without repeating costly clinical trials by showing that the follow-on product is sufficiently similar to the name-brand product. Because of the complexity and expense of manufacturing insulin, such a showing is extremely difficult unless the manufacturer of the follow-on product has access to information about how the name-brand product was produced. Manufacturers of name-brand insulin and similar products rely on patent protection for the products themselves and on trade secrecy to protect their manufacturing processes. Because trade secret protection is not time-limited (i.e., protection lasts as long as the holder of the secret economically benefits from the information and takes reasonable steps to preserve secrecy), would-be manufacturers of cheaper follow-on insulins are deterred from entering the market. This note explains how a scaling back of trade secret protection for insulin manufacturing processes would enable more manufacturers to enter the insulin market, thus increasing competition and driving prices down. This note is timely because the insulin pricing crisis is ongoing, and intervention in the intellectual property space would likely have a significant ameliorating effect on a problem that causes substantial loss of life and productivity, as well as billions of dollars every year

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