Celltrion Asks for Summary Judgment of Non-Infringement in Inflectra Case

April 12, 2018
The Center for Biosimilars Staff

In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.

In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.

Janssen, maker of the reference infliximab, Remicade, has claimed that the biosimilar developer infringed on a patent, which covers chemically defined media compositions for the culture of eukaryotic cells, in producing Inflectra.

In support of its motion, Celltrion said that Janssen’s patent is not new and that the court should terminate the case based on ensnarement, or the principle that prior art (elements of patented information that are already publicly available) restricts the scope of what the alleging party can assert under the doctrine of equivalents (a legal rule holding that, while a product may not literally infringe on a patented invention, the product may have elements that are equivalent to those described in a patent).

According to Celltrion, if Janssen wants to claim that Celltrion infringed on Janssen’s patent through the doctrine of equivalents, Janssen should have the burden of proving that the scope of equivalency does not encompass any prior art related to the patent.

“There is every reason for the Court to consider ensnarement on a motion for summary judgment” in this case, according to the motion, especially given the fact that GlaxoSmithKline has already disclosed the same ingredients, at concentrations that overlap heavily with Janssen’s patented ingredients and concentrations, elsewhere. These overlapping ranges establish a case for the obviousness of Janssen’s invention, says Celltrion.

The motion proposes a deadline of May 10, 2018, for Janssen to file its opposition, after which Celltrion would file its reply brief by May 28, 2018.

In October of 2017, the court denied Celltrion’s motion to dismiss this case for lack of standing.