Infliximab - USA

On Jul 30, 2018, US District Court of Massachusetts ruled that Celltrion’s biosimilar Inflectra (infliximab-dyyb) didn’t infringe Janssen’s patent.

The ruling involved J&J's U.S. Patent No. 7,598,083, which claims cell culture media compositions used to produce infliximab. Janssen does not allege literal infringement of the '083 patent. Rather, Janssen argues only that Celltrion's accused media infringe claim 1 under the doctrine of equivalents. It is undisputed that the accused media contain all 52 ingredients required by claim 1, as well as additional ingredients. However, several of the claimed ingredients are present in the accused media in amounts that fall outside the literal concentration ranges recited the claim. Janssen argues that the amounts of those ingredients used by Celltrion are not substantially different from the amounts claimed in claim 1 and, therefore, the accused media infringe the patent under doctrine of equivalents. The defendants deny the allegations and have moved for summary judgment of non-infringement on the grounds that Janssen's asserted scope of equivalents would ensnare the prior art.

District Court Judge Mark Wolf in his 104-page ruling held that the “defendants are entitled to summary judgment of non-infringement of the '083 patent because Janssen has not produced sufficient evidence to prove that the scope of equivalents would not ensnare the prior art.” In essence, the court finds that no reasonable factfinder could conclude that the hypothetical claims that Janssen relies upon to avoid ensnarement would have been patentable because they were obvious rather than inventive. Undisputed and strong evidence compels the conclusion that a person of ordinary skill in the art (a "POSA") would have had the ability and motivation to combine familiar ingredients from prior art cell culture media compositions in predictable concentrations to create what Janssen claims as its hypothetical invention. Moreover, the POSA would have predicted the combination's successful results. Therefore, ensnarement bars Janssen from prevailing under the doctrine of equivalents.

Janssen previously focused on its allegation that the defendants infringed its U.S. Patent No. 6,284,471 covering the infliximab antibody. In 2016, this court invalidated the '471 patent for obviousness-type double patenting.

FDA approved Inflectra in April 2016 and Pfizer, who has U.S. rights to the drug from Celltrion, launched the drug in Nov 2016. Then Pfizer in Sep 2017 filed a complaint in a US District Court in Pennsylvania alleging that J&J is using "improper exclusionary tactics" to maintain dominance in the US market for its blockbuster Remicade (infliximab) despite recently introduced biosimilar competition.