J&J Appeals Remicade Patent Ruling as Pfizer Readies Biosimilar

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By John T. Aquino

Oct. 31 — Johnson & Johnson Oct. 28 appealed a district court’s decision invalidating claims of one of the patents covering its blockbuster arthritis treatment Remicade as Pfizer Inc. readies its Remicade biosimilar Inflectra for launch next month ( Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. , Fed. Cir., No. 15-01449, 10/28/16 ).

The U.S. District Court for the District of Massachusetts held Aug. 17 antibodies claimed in U.S. Patent No. 6,284,471, which expires in 2018, were already disclosed in an earlier patent ( 10 LSLR, 8/19/16 ). The Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) had earlier reached the same conclusion about the patent claims’ validity. J&J appealed the district court’s ruling to the U.S. Court of Appeals for the Federal Circuit.

These rulings, if affirmed, would effectively take away J&J’s argument that that Pfizer’s Inflectra infringes the patent. If the invalidity decisions are reversed and the patents are determined to have been infringed, Pfizer would likely be found to owe J&J licensing fees for Inflectra. Either way, the ultimate rulings will add another chapter to the growing history of biosimilar litigation.

J&J filed another suit against Pfizer and the Korean-based manufacturer Celltrion Inc. in the same federal district court for infringement of another Remicade-related patent, U.S. Patent No. 7,598,083, and a decision in that case is expected within a month.

J&J’s global revenues for Remicade (infliximab) reached their peak in 2014 at $10.4 billion and declined 2.4 percent in 2015 due to competition from European biosimilars.

J&J: Pfizer Biosimilar an ‘At Risk Launch.’

A J&J spokeswoman told Bloomberg BNA in an Oct. 31 e-mail, “We will continue to defend our intellectual property rights and view Pfizer/Celltrion’s commercial launch prior to the outcome of these appeals to be an at-risk launch.” She added that J&J also is continuing the appeal process of the PTAB decision, for which opening arguments were held Sept. 28 and a decision is expected within the next three months. A Pfizer spokeswoman declined Bloomberg BNA’s e-mail request for comment.

Inflectra to Cost 15 Percent Less

A biosimilar is a biologic drug product that is highly similar to a Food and Drug Administration-approved biologic, such as Remicade. The Biologics Price Competition and Innovation Act provides an abbreviated approval pathway for biosimilars that partly relies on data submitted for FDA approval of the original biologic, also known as a reference product (RP). In April, the agency approved Celltrion’s Inflectra as a biosimilar of Remicade ( 10 LSLR, 4/15/16 ). Pfizer’s Hospira has exclusive U.S. marketing rights to Inflectra, which is made by Celltrion.The cost for a biosimilar is expected to be less than the RP because of reduced development costs as a result of the abbreviated approval pathway. Pfizer, in its announcement of the expected November launch, said Inflectra will be shipped at a 15 percent discount to current wholesale prices for Remicade.

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 appeal documents are at http://src.bna.com/jKr.

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