ITC: A Strategic Forum for Biologics Patent Owners

ITC: A Strategic Forum for Biologics Patent Owners

For manufacturers of biologics and biosimilars facing potential patent litigation in the U.S., the Biologics Price Competition and Innovation Act (BPCIA) imposes a complex statutory scheme that restricts the timing and control of disputes in federal district court. While biosimilar applicants often rely on the U.S. Patent Trial and Appeal Board (PTAB) for patent challenges, an alternative exists that moves faster and sidesteps many BPCIA hurdles: the International Trade Commission (ITC).

Why the ITC Matters

• Speed. ITC investigations conclude in 16‑18 months, far quicker than district‑court proceedings.
• No patent dance. The ITC does not require a pre‑exchange of patents, allowing reference product sponsors (RPS) to assert any number of patents after new information emerges.
• Robust remedies. Exclusion orders enforceable by U.S. customs effectively act as injunctions, while cease‑and‑desist orders bar sales of infringing products already in the country.
• Broader discovery. The ITC can compel in‑rem discovery, even from foreign entities, and may apply adverse inference if a biosimilar applicant refuses to comply.

Strategic Advantages for Second‑Phase Patents

The ITC can resolve second‑phase BPCIA disputes before the FDA approves an abbreviated biologic licence application (aBLA), thereby avoiding the 180‑day preliminary‑injunction requirement that often forces patent owners to wait until the biosimilar is commercially available.

Key Barriers to ITC Access

1. Jurisdiction. The RPS must demonstrate a significant domestic industry—substantial U.S. investment related to the asserted patents. Merely manufacturing abroad and importing does not suffice, though most RPS engage in domestic post‑marketing activities that meet this threshold.
2. Imminence of importation. The ITC requires evidence that the aBLA applicant’s products will be imported or sold in the U.S. imminently. The extent of this imminence remains unresolved by the Federal Circuit, and an aBLA filing alone may not be enough.
3. Pleading requirements. ITC complaints demand detailed claim charts and fact pleadings. However, the Office of Unfair Import Investigations can review draft complaints confidentially and advise on deficiencies before filing.
4. Discovery burdens. While the ITC’s discovery scope is broad, it also imposes significant time and cost commitments on RPS.

Balancing the Decision

Biologics patent owners should weigh the ITC’s rapid resolution and powerful remedies against its discovery obligations and jurisdictional hurdles. In many cases, the ITC offers a compelling supplement—or alternative—to BPCIA and district‑court litigation.

Contact Us

Filko Prugo – Chair, Life Sciences IP Litigation Group, Ropes & Gray, New York
✉️ filko.prugo@ropesgray.com

Charlotte Jacobsen – Partner, Life Sciences IP Litigation Group, Ropes & Gray, New York
✉️ charlotte.jacobsen@ropesgray.com

Matt Rizzolo – IP Litigation Partner, Ropes & Gray, Washington, DC
✉️ matthew.rizzolo@ropesgray.com

Henry Huang – IP Litigation Associate, Ropes & Gray, Silicon Valley
✉️ henry.huang@ropesgray.com