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The Pre-Litigation Timeline depicted in the figure summarizes the patent dispute resolution process under the Biologics Act. The Biologics Innovator and Applicant must exchange certain information within the time periods indicated in the timeline. Within 20 days after the FDA notifies the Applicant that its application has been accepted, the Applicant must provide the Biologics Innovator certain confidential information, e.g., its manufacturing process. After that the Biologics Innovator must provide a set of patents that it could reasonably assert and a series of events follow to decide on which and how many patents will be litigated.  

Preparing for this patent dispute resolution process, as well as for the eventual litigation, requires a substantial amount of advance preparation on the part of both parties. Such planning should be undertaken as early on as possible, in consultation with patent and litigation counsel.

Some exemplary considerations on the part of the Biologics Innovator and Applicant are noted below.

Biologics Innovator

  • Which and how many patents to litigate?
  • Which of the relevant patents are the most important to the company?
  • Are there any patents that need to be licensed from others?
  • Should any patents be licensed to the Applicant?

The Applicant

  • What are the best defenses for the patents that could be asserted?
  • Are any patents appropriate for challenge in the USPTO, instead of in litigation?
  • Do any of the patents expire before any potential launch?
  • Are there any patents that can be licensed from the Biologics Innovator (or others)?