Patent Dance Disclosures: Discovery During the Patent Dance and Beyond

This webinar will cover strategies and considerations for discovery provided during pre-litigation disclosures under the BPCIA (the so-called “patent dance”) and in BPCIA litigation.  We will discuss the following topics:

• Basic overview of disclosures made before litigation during the patent dance, including:
  • reference product’s disclosures of what patents it will assert against the biosimilar applicant (the “3A list”)
  • detailed statement regarding infringement and response to the biosimilar applicant’s detailed statement regarding invalidity or unenforceability (the “3C statement”)
  • biosimilar applicant’s detailed statement (the “3B statement”), list of patents it may assert (the “3B list”)
• How courts have dealt with disputes regarding sufficiency of pre-litigation disclosures
• How patent dance disclosures have been used later in BPCIA litigation and IPRs 
• Special issues arising in discovery during BPCIA litigation