Is Stockpiling Protected By Hatch-Waxman Safe Harbor?

Law360, New York (November 21, 2014, 9:54 AM EST) -- Stockpiling of drugs, particularly generic drugs, to allow commercial introduction immediately after patent expiration is common. While infringement suits contesting this conduct are almost nonexistent, it is still considered an act of infringement. The stockpiling of biologics and biosimilars, which are usually more expensive and take longer to produce than typical generics, may bring this dormant issue into the forefront.

Imagine a scenario where a statutory competitor has stockpiled, at great expense, an inventory of biological product, and just before launch the brand strategically sues for patent infringement. This article examines — and challenges — the notion that stockpiling is infringing...

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