WORKSHOP B: BIOSIMILARS U.S.

Dec 2, 2019 1:00pm – 4:00pm

Think Tank on Filing Biologics Applications in the US: IP and Regulatory Considerations for BLAs and aBLAs

PART 1: EXPLORING THE U.S. BIOLOGICS PRICE COMPETITION INNOVATION ACT (BPCIA)

The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated pathway for companies to bring biologic drugs to market that are biosimilar to previously approved branded reference products by relying on clinical studies that were performed by the reference product sponsor (RPS).

  • Exploring the approval and patenting process for biologics in the U.S.
    • The BLA vs. a BLA
  • Understanding how the Biologics Price Competition Innovation Act (BPCIA) works
  • Examining the FDA’s current approach for establishing interchangeability relative to European practices

PART 2: DISTRICT COURT VS. PTAB FILINGS: TRADITIONAL LITIGATION AND IPRS — TIMING, RISKS AND STAYS

In the U.S., biosimilar patent cases are litigated in the United States District Courts as well as the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB).

Unlike traditional District Court litigation in the U.S., the PTAB offers a patent challenge resolution mechanism known as inter partes review or IPR. IPRs offer biosimilar and generic drug manufacturers the benefit of challenging innovator patents with comparative haste and efficiency to traditional District Court litigation.

  • Analysing recent District Court decisions
    • The Sandoz decision and its progeny
  • Understanding the advantages for applicants to resolve prior art invalidity disputes via IPRs at the PTAB
  • Appreciating the timing for applicants to file petitions for IPRs relative to filing BLA and BPCIA litigation
  • Reducing risk by challenging patents in advance of launching biosimilars at risk

PART 3: MOCK SCENARIO

In this mock exercise, we will take the position of a European pharmaceutical manufacturer seeking to launch a biosimilar product in the U.S. We will take you through the steps for preparation and examine:

  • Costs
  • Pros and cons of avoiding the patent dance
  • Timings
  • Litigation challenges