Pre-litigation Preparation and Strategy for Pharmaceutical Patents and Exclusivity

This practice note outlines preemptive steps that should be considered by in-house and outside counsel to maximize a drug company’s regulatory and patent exclusivities and the company’s chances of success in future patent litigation against generic drug applicants.

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Related Content

• Marketing Exclusivities for Prescription Drugs
  Understand the parameters of non-patent exclusivities for prescription drugs in the United States.

• Hatch-Waxman Safe Harbor Checklist
  Review the applicability of the Hatch-Waxman Act’s safe harbor provision to the drug development process, from pre-submission to post-submission.  

• FDA Drug Regulatory Activity Tracker
  Track FDA regulatory activity related to the development of pharmaceuticals, including generic drugs.

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