The case concerned Atorvastatin, a cholesterol-lowering medicine sold by Pfizer under the brand name Lipitor.
Ranbaxy was the first company to apply for US regulatory approval to sell a generic version of the drug. It was consequently entitled to a 180-day period during which no other applicant for the generic drug could receive approval.
However, there was initially uncertainty over whether Ranbaxy would receive final approval on time. In December 2010, Ranbaxy India, its US subsidiary and Teva USA entered into an agreement governing what would happen if Ranbaxy was unable to use its exclusivity.
Under the agreement, Ranbaxy would selectively waive or relinquish its exclusivity in favour of Teva USA if Teva issued a valid “Ready Date Notice” after satisfying stipulated conditions concerning regulatory approval and its readiness to launch the drug.