Overview
- The March 11 Director memorandum adds discretionary factors for IPR and PGR that look to U.S. manufacturing ties of accused products and of the patent owner’s competing products, along with domestic investment.
- The guidance broadens what counts as manufacturing by directing parties to address component origins, any post‑production processing abroad, and which devices qualify as the relevant products for method claims.
- Petitioners that qualify as small businesses receive special consideration, with references to SBA size standards and USPTO small‑entity criteria, and are urged to identify their status in filings.
- The policy takes effect immediately for proceedings where the patent owner’s discretionary‑denial brief deadline has not passed, prompting near‑term adjustments in petition and defense strategies.
- Scholarly commentary flags potential conflicts with TRIPS Articles 3 and 27 and raises notice‑and‑comment and major‑questions concerns, noting Federal Circuit precedent limits judicial review of institution decisions.