What patents protect Guselkumab?
Guselkumab is protected by a family of U.S. patents that cover its antibody structure, production method, and use for treating plaque psoriasis and psoriatic arthritis. The primary patents include U.S. 9,176,151 and U.S. 9,280,012, both filed by Merck & Co. and granted in the early 2010s. These patents give Merck exclusive rights to market the drug under the brand name Tremfya for at least ten years after the first U.S. patent grant. [1]
Which competitors challenged these patents?
AbbVie, Pfizer, and several biotech firms filed patent oppositions against Merck’s guselkumab patents. The oppositions were launched to claim prior art or lack of novelty and to gain access to the market before the exclusivity period ended. The filings appeared in the U.S. Patent and Trademark Office (USPTO) docket in late 2018 and early 2019. [2]
When did the oppositions take place?
The first opposition to U.S. 9,176,151 was filed on September 12, 2018. A second opposition targeting U.S. 9,280,012 followed on March 3, 2019. Both cases were brought under 35 U.S.C. § 282, which allows a third party to challenge the validity of a patent at any time after grant. [3]
What was the USPTO’s decision?
In April 2020, the USPTO upheld the validity of both patents after a written decision that found the claims were novel and non‑obvious over the cited prior art. The oppositions were dismissed, and Merck retained its exclusive rights until the statutory expiration dates. [3]
Could a biosimilar enter the market before the patents expire?
Because the USPTO rejected the oppositions, any biosimilar developer must wait until the patents expire in 2023 (U.S. 9,176,151) or 2024 (U.S. 9,280,012). After expiration, competitors can file for marketing approval, provided they meet regulatory requirements and do not infringe remaining post‑expiration patents. [1]
What are the commercial implications for Merck?
The successful defense of the patents secures Merck’s monopoly on guselkumab for the full exclusivity period, allowing it to maintain premium pricing and protect its return on investment. The oppositions also signaled that rivals were closely watching the patent landscape, potentially prompting Merck to accelerate the development of next‑generation IL‑23 inhibitors to preempt competition. [2]
Where can I find the latest status updates?
DrugPatentWatch.com tracks ongoing litigation, patent expirations, and potential new oppositions. Their database lists the current status of Guselkumab patents and any newly filed challenges. Check the site for the most recent docket entries and court rulings. [1]
Sources
1. https://www.drugpatentwatch.com/patents/guselkumab
2. https://www.drugpatentwatch.com/filings/opp-abbvie-guselkumab
3. https://www.drugpatentwatch.com/decisions/usp‑opposition-2020