Janssen Biotech Inc. has asked a U.S. District Court in Boston to order an expedited trial to determine whether its patent for Remicade has been infringed by Celltrion Inc., which recently received approval from the Food and Drug Administration to produce a biosimilar version of the treatment for autoimmune disease.

The request in an April 12 letter to Judge Mark Wolf comes after the judge indicated that he would be reluctant to institute a preliminary injunction to stop Celltrion from bringing its biosimilar to market on schedule in October and would prefer a trial on the merits and then an injunction.

“In light of the court’s comments, plaintiffs have decided not to seek a preliminary injunction,” said Gregory Diskant, a partner with Patterson Belknap Webb & Tyler LLP in New York. “Instead, plaintiffs request that the court hold an expedited trial on the merits of the ‘083 patent dispute so that plaintiffs’ request for a permanent injunction can be adjudicated by October 2, 2016.”

Such an expedited trial “would avoid the irreparable harm that would be caused by defendants’ commercial launch,” Diskant said.

Diskant asserted that since the February 9 hearing, plaintiffs have compiled powerful evidence that the defendants’ cell culture media infringe the ‘083 patent under the doctrine of equivalents.

“Defendants admit that their cell culture media contain every single one of the 52 required ingredients and 7 of the 9 optional ingredients required by the ‘083 patent. They also admit that the amounts of these ingredients fall within the range of concentration claimed by the ‘083 patent for 49 of the 61 ingredients."

He said the only infringement dispute relates to the relevance of the 12 differences in concentration ranges – a limited number of differences given the overwhelming overlap between the patent and the defendants’ media.

"We now have scientific evidence that these few differences in concentration are insubstantial," he said.

Diskant asserted that Janssen’s evidence is in the form of scientific experiments recently completed by ExcellGene SA, a Swiss biotechnological research firm.

“The ExcellGene experiments, which took months to execute due to the complexity of the technology involved, closely track the experiments disclosed in the specification of the ‘083 patent. The ExcellGene scientists created precise copies of defendants’ cell culture media, and then modified the concentration of each of the 12 ingredients that fall outside the ranges claimed in the ‘083 patent, one after the other, so that they fall literally within the claimed range.

“For each modification, the scientists then tested whether there was any impact on the relevant performance variables. The data show (and the ExcellGene scientists conclude) that the differences are not substantial: ‘[N]one of the variant media tested . . . showed a significant difference in performance’ compared to the defendants’ cell culture media. The defendants’ cell culture media infringe the ‘083 patent under the DOE.

Diskant asserted that an expedited trial on the merits is especially reasonable and practical here, as it would advance the court-ordered schedule by only five months. “Plaintiffs filed this action more than a year ago and discovery on the ‘083 patent is already well underway. The parties have already agreed to a schedule under which a trial on plaintiffs’ claims under the ‘083 patent would be held in February 2017, less than one year from now. Plaintiffs believe it is readily possible to move the trial date up from February 2017 to September 2016 in order to have their claim for a permanent injunction on the ‘083 patent resolved before defendants’ threatened launch date.”

Diskant noted that because defendants’ product was only approved last week and plaintiffs’ experiments were only recently completed, it has not yet had the opportunity to consult with
defendants on this request for an expedited trial.

“We intend to meet and confer with defendants shortly on this proposal. In the event that defendants oppose, plaintiffs will submit a formal motion in support of this request.”

Dennis J. Abdelnour, a partner with Kirkland & Ellis LLP, who is the lead counsel for Celltrion, declined to comment on whether Celltrion would oppose the request for an expedited trial.

Janssen’s complaint against Celltrion was filed March 2015 and was one of the first filed under the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA created an abbreviated regulatory pathway for the approval of biosimilar versions of biologics. It also created a set of dispute resolution procedures to facilitate the orderly resolution of patent disputes before a biosimilar product enters the market.

Janssen’s complaint alleges that Celltrion has refused to follow the dispute resolution procedures under the BPCIA.

“After bringing two premature (now dismissed) declaratory judgment actions outside the provisions of the BPCIA, defendants have sought to short-circuit the BPCIA process by withholding required information, refusing to participate in required procedures, and threatening to seek penalties if plaintiffs did not file this action before the time called for by the BPCIA.”

Celltrion has “further thwarted the BPCIA patent dispute resolution process by serving a premature ‘notice of commercial marketing,’” the complaint says.

The patent dispute involves six patents including the antibody patent (U.S. 6,284,471), the fistulating Crohn's patent (U.S. Patent NO. 7,223,396), the methods of producing antibodies patent (U.S. Patent No. 5,807,715), the chemical cell growth media patents (U.S. Patent Nos. 7,598,083 and 6,900,056) and the purification patent (U.S. Patent No. 6,773,600).

"Janssen understandably wants to accelerate the trial so that it can receive a decision that Celltrion infringes its patents before Celltrion enters the market with its biosimilar," said Zach Silbersher, a founding partner with the law firm Kroub, Silbersher & Kolmykov PLLC and its affiliated boutique investment advisory firm Markman Advisors in New York.

Silbersher said Janssen claims that it has powerful evidence that Celltrion’s proposed Remicade biosimilar will infringe the ‘083 patent.

"That patent is directed to a cell culture media, and the independent claim requires 61 necessary and optional ingredients. That is quite a lot of limitations for a single patent claim, but according to Janssen, Celltrion has admitted that their product has all 52 ingredients of those that are necessary. However, the ingredients also have specific concentration ranges. Apparently, Celltrion also admits its biosimilar product falls into the concentration ranges for 49 of the 61 ingredients."

If Celltrion and the judge agree to an expedited trial, it "will focus on those ingredients that fall outside of the claimed concentration ranges." He added that since Janssen cannot prove infringement of those elements literally, it will have to rely on the doctrine of equivalents.

Silbersher said "proving infringement under the doctrine of equivalents is not easy. It has highly factual, and often comes down to a real battle of the experts. Janssen claims it has the scientific experiments to back it up, but Celltrion is likely to show up to trial with arguments showing that those experiments were, somehow, flawed.

"For an investor, having someone be in attendance at the trial, and listening to the judges reactions, could be critical to predicting the outcome of this case. In many cases, judges will not give rulings from the bench, but in this case, given Celltrion’s impending launch date, Judge Wolf may be inclined to do so."

—To reach the reporter responsible for this story please contact Dan Lonkevich at 707 318-7899 or at dan@thepatentinvestor.com