In May this year, Janssen Biotech – a subsidiary of Johnson & Johnson – filed a complaint in the District of New Jersey against biosimilar developer Samsung Bioepis’ Renflexis, claiming it infringed on three manufacturing patents of its top-selling mAb Remicade (infliximab).
But now Janssen has withdrawn all three claims after reviewing the SB200000001-207 document, received from Samsung Bioepis detailing Renflexis’s manufacturing process.
“All claims and defenses pending between the parties related to the alleged infringement of the ’600 patent, the ’056 patent, and the ’083 patent under 35 U.S.C. § 271(e)(2)(C)(ii) are dismissed, and that dismissal is with prejudice only with respect to all claims and defenses related to the cell culture and downstream purification processes as described in the documents bearing production numbers SB200000001-207,” Janssen stipulated and agreed to in a court document dated November 10.
The three J&J patents referred to are:
- US 7,598,083 (“Chemically defined media compositions”)
- US 6,900,056 (“Chemically defined medium for cultured mammalian cells”)
- US 6,773,600 (“Use of clathrate modifier, to promote passage of proteins during nanofiltration”)
Sansung Bioepis spokesperson Mingi Hyun said the withdrawal of the lawsuit is “a win for American patients, as it marks a positive step towards improving patient access to biosimilars in the United States,” in a statement sent to Biopharma-Reporter.
“At Samsung Bioepis, we remain committed to driving positive change in the healthcare system through the development of affordable, high-quality biosimilars. We will continue to take all necessary measures to ensure our biosimilars reach the patients who need them most.”
Renflexis became the second infliximab (after Celltrion and Pfizer’s in April 2016) to be approved in the US after receiving the regulatory thumbs up earlier this year.
Janssen still has a case ongoing against Celtrion over US ‘083, which has not been withdrawn.