Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v. Hikma Type Litigation

Pharmaceutical companies have long sought to protect their exclusive rights to market drugs in a myriad of ways including creating patent thickets and evergreening. This article describes a two-step strategy by which pharmaceutical companies attempt to keep market exclusivity and delay generic entry. This new strategy can work in tandem with ANDA litigation and FDA labeling requirements to reclaim exclusive rights that might have been lost via patent protection.

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