USPTO Instituted Four Patent Reviews Against Janssen
Healthcare firms face heightened scrutiny of drug patents as regulators move to review treatment claims.
Updated on Sept. 28, 2026 in Healthcare
On September 9, 2026, the U.S. Patent and Trademark Office issued a notice of institution for four inter partes reviews targeting patents held by Janssen Biotech. The proceedings challenge methods for treating psoriatic arthritis and ankylosing spondylitis.
Why it matters
These reviews create significant uncertainty for pharmaceutical holders, as the institution suggests a reasonable likelihood that at least one claim in each challenged patent will be invalidated. Operators in the pharmaceutical sector must now account for increased litigation risk and potential loss of market exclusivity.
The USPTO instituted 4 inter partes review proceedings against Janssen's golimumab patents, evaluating claims that the firm had previously asserted in a 17-patent lawsuit. The agency found a reasonable likelihood of petitioner success on at least 1 challenged claim.
The players
Janssen Biotech
A subsidiary of Johnson & Johnson, this firm develops specialized pharmaceutical products and maintains a significant portfolio of treatment-related patents.
U.S. Patent and Trademark Office
The federal agency responsible for granting patents and conducting administrative proceedings to assess the validity of existing claims.
Accord BioPharma
A developer of biosimilar and specialty pharmaceutical products focused on expanding access to complex medications.
The details
The USPTO's decision follows petitions filed on March 20, 2026, by Accord BioPharma, Intas Pharmaceuticals, and Bio-Thera Solutions. While Janssen previously filed a lawsuit in the District of Delaware on March 3, 2026, it later dismissed specific method-of-treatment patent counts from that case. These regulatory reviews now run in parallel to the ongoing litigation, where a motion for a preliminary injunction remains pending.
Timeline
March 3, 2026: Janssen filed a lawsuit against Accord and Bio-Thera.
March 18, 2026: A judge entered the dismissal of specific patent counts.
March 20, 2026: Petitioners filed four inter partes review petitions.
September 9, 2026: The USPTO issued a notice of institution for the four IPRs.
Market Landscape
This action follows the standard mechanism of the America Invents Act's inter partes review process, which enables challengers to bypass traditional court litigation to invalidate patent claims. It underscores a broader industry trend where biosimilar developers utilize regulatory reviews to weaken intellectual property barriers established by patent holders.
Firms should monitor whether ongoing patent litigation is being paralleled by administrative reviews, as this dual-track strategy can force companies to adjust their legal and commercial defenses simultaneously. Evaluate the vulnerability of your current patent portfolio to similar inter partes review challenges if your business relies on method-of-treatment claims.
The takeaway
The move to institute reviews demonstrates that even asserted patents face high risks of challenge via administrative channels. Operators should audit the strength of their method-of-treatment claims and track the pending injunction motions in the District of Delaware to anticipate shifts in market competition.
Further reading
For more on industry regulatory trends, see the Healthcare section.
