J&J, Celltrion Remicade Biosimilar Dispute Could Settle, Analyst Says

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By John T. Aquino

J&J and Celltrion could still settle a patent infringement dispute over a biosimilar of the rheumatoid arthritis biologic Remicade, an analyst told Bloomberg BNA in light of a federal district court ruling ( Janssen Biotech, Inc. v. Celltrion Healthcare Co. , D. Mass., No. 15-10698-MLW, 2017 BL 67457, interim opinion 3/2/17 ).

In response to the parties’ request for guidance to facilitate settlement discussions, the U.S. District Court for the District of Massachusetts outlined March 2 what damages Celltrion Healthcare Co. could be required to pay Johnson & Johnson’s Janssen Biotech Inc. if Celltrion’s Inflectra, a biosimilar of Janssen’s Remicade (infliximab), is found to have infringed patents covering Remicade.

Janssen filed its suit under the Biologics Price Competition and Innovation Act (BPCIA), which established an abbreviated regulatory review of biosimilars, highly similar and less costly versions of expensive biologic drugs. The Supreme Court is reviewing the U.S. Court of Appeals for the Federal Circuit’s interpretation of the information sharing provisions of the BPCIA in Sandoz, Inc. v. Amgen, Inc.

In a March 6 email to Bloomberg BNA, Aude Gerspacher, a Bloomberg Intelligence analyst, said a settlement between Sandoz and Amgen is unlikely before the Supreme Court issues its opinion by the end of June. “But I definitely think J&J and Celltrion can settle. Inflectra is already on the market. There’s nothing here really for those parties to wait on with the Supreme Court ruling on the BPCIA,” she said.

A J&J spokeswoman confirmed to Bloomberg BNA in a March 6 email that settlement discussions between the parties are ongoing.

Good-Faith Negotiations Pivotal

The BPCIA outlines exchanges of and negotiations concerning information about the biosimilar and patents it might infringe that should occur between the owner of the biologic and the biosimilar applicant.In its ruling, the district court indicated that Janssen could be entitled to lost profits if Celltrion’s Inflectra is found to have infringed the J&J patent, even though Celltrion makes the biosimilar overseas and the district court has invalidated another Remicade-related patent.

The court also stressed: “In the present record, a reasonable fact-finder could not conclude that Celltrion engaged in the good-faith negotiations required by the BPCIA [Biologics Price Competition and Innovation Act] or in the dispute resolution procedure that is required if no agreement was reached through those negotiations.”

Kevin Noonan, a partner with McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, told Bloomberg BNA in a March 6 email that courts encourage settlements of patent disputes and that, if nothing else, the district court’s ruling sets out how damages would be determined if the court cases resulted in at at least one infringed, not invalid claim.

Noonan, who is on Life Sciences Law & Industry Report's advisory board, indicated the court’s statement concerning overseas manufacture wasn’t a surprise. “The only way making it overseas would matter would be if the product patent had expired and the manufacturing method patent(s) had not, but then importing into the U.S. could still be infringement under the right circumstances,” he said.

J&J: Biosimilar Will Hurt Remicade Sales

In August 2014, Celltrion filed an application with the Food and Drug Administration under the BPCIA for approval to make and sell its own infliximab biosimilar. In March 2015, Janssen filed a lawsuit in the District of Massachusetts against Celltrion and Hospira Healthcare Corp., which has exclusive U.S. marketing rights for Celltrion’s biosimilar, seeking, among other things, a declaratory judgment that their biosimilar product infringes or potentially infringes patents licensed by J&J.

In August 2016, the district court granted both Celltrion’s and Hospira’s motions for summary judgment of invalidity of one of the Remicade patents. Janssen appealed the district court’s and adverse rulings of the Patent and Trademark Office’s Patent Trial and Appeal Board to the Federal Circuit. In June 2016, Janssen filed additional infringement litigation in the district court.

The FDA approved Celltrion’s infliximab biosimilar for sale in the U.S. in April 2016. Hospira’s parent company, Pfizer Inc., began shipment of Celltrion’s biosimilar to wholesalers in the U.S. in late November 2016. J&J said in its Feb. 27 filing with the Securities and Exchange Commission that the biosimilar coming to the U.S. market will result in reduced U.S. sales of Remicade, which accounted for about 9.7 percent of the company’s total revenues. J&J reported 2015 Remicade sales of $6.56 billion, primarily for the U.S. market.

Janssen was represented by Nutter, McClennen & Fish, Boston, and Celltrion by Burns & Levinson, Boston.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The court's opinion is at http://src.bna.com/mJx.

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

Request Health Care on Bloomberg Law