A generic drug company decides to settle a Hatch- Waxman patent infringement claim brought against it by a branded drug company, and as part of that settlement agrees to defer entry of its generic product until a date pressed by the brand during negotiations. The settling generic, however, insists that its licensed entry date accelerate if another generic product enters the market first. That ''accelerated entry'' clause would, in effect, ensure that the settling generic would be among the first generics on the market. Importantly, the settling generic does not know if any other generic company will settle with the brand at all, let alone on similar terms. Sometime later, a second generic company does settle with the same brand over the same product and patent. The brand presses for the same entry date, and once again, the generic seeks and obtains the same condition that accelerates its licensed entry date if another generic enters earlier. Thereafter, a third generic company enters into a similar settlement agreement with the brand.
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Originally published in the Pharmaceutical Law & Industry Report, The Bureau of National Affairs, Inc.
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