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US court upholds ruling that J&J's Remicade patent is invalid

Published on 24/01/18 at 11:52am

The US Court of Appeals for the Federal Circuit has judged that Johnson & Johnson’s patent for its best-selling arthritis drug Remicade (infliximab) is invalid, upholding a previous decision by the US Patent and Trademark Office (PTO) that the antibodies covered by the patent were already disclosed in an earlier patent.

The legal dispute over the patent originated when J&J launched action against Pfizer’s Hospira, which owns US marketing rights to Cellitron’s Remicade biosimilar Inflectra. Pfizer itself accused J&J of soliciting insurers to agree contracts which blocked coverage of biosimilar versions of Remicade, including Inflectra.

J&J was hit hard by the news, with stocks dropping by 4.2%, the biggest intraday decline since 2015. With the release of the company’s fourth-quarter results this week, it also became painfully clear that Remicade’s sales are slowing due to direct competition from cheaper alternatives such as MSD and Samsung Bioepis’ Renflexis, falling 9.7% to 1.47 billion.

“We believe that biopharmaceutical intellectual property protections, such as patents and data protection, enable us to invest in the discovery and development of tomorrow's life-changing and life-saving new medicines,” the company said. It added that it is still “committed to helping ensure Remicade remains accessible and affordable to patients.”

Pfizer was pleased with the decision, calling it “a good day for patients battling chronic diseases,” but added that “J&J continues to use their scheme of exclusionary contracts to maintain Remicade’s monopoly position that prevent patients, payers and providers from the opportunity to benefit from Inflectra.”

Matt Fellows

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