US appeals court rules against Johnson & Johnson in Remicade patent dispute with Pfizer
The US Court of Appeals for the Federal Circuit on Tuesday upheld an earlier decision by the US Patent and Trademark Office (PTO) that had invalidated a Johnson & Johnson patent on Remicade (infliximab). The ruling stems from patent infringement lawsuits initially brought by Johnson & Johnson against Celltrion and Pfizer's Hospira unit, which holds exclusive marketing rights to Celltrion's Remicade biosimilar Inflectra (infliximab-dyyb) in the US. According to the latest verdict, the appeals court agreed with the PTO that the antibodies covered by the '471 patent had already been disclosed in an earlier patent.
Johnson & Johnson, which earlier in the day reported that fourth-quarter Remicade sales had fallen 9.7 percent year-over-year to just under $1.5 billion, saw its shares decline as much as 4.2 percent after the appeals court decision. The earlier PTO ruling was similar to one that had been handed down in a separate proceeding around the same time in 2016 by the District of Massachusetts Federal Court, which had determined that the '471 patent was invalid.
Commenting on the appeals court decision, Johnson & Johnson said it was disappointed in the ruling, and suggested the verdict could impact other drugmakers because it hinged on how related applications should be handled at the PTO. "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, adding that it was "committed to helping ensure Remicade remains accessible and affordable to patients."
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Meanwhile, Pfizer spokesman Thomas Biegi stated it was "a good day for patients battling chronic diseases." Pfizer, which launched Inflectra in the US in late 2016 after the biosimilar had received FDA approval, also recently filed an antitrust lawsuit in the US accusing Johnson & Johnson of pushing insurers to agree "to 'biosimilar-exclusion' contracts that effectively block coverage for Inflectra and other infliximab biosimilars." Biegi suggested that "Johnson & Johnson 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."
Remicade, which generated US sales of $4.8 billion for Johnson & Johnson in 2016, also faces biosimilar competition from Merck & Co. and Samsung Bioepis' Renflexis (infliximab-abda), introduced in the US last July following FDA clearance a few months earlier.
In related news, the PTO ruled last week that Johnson & Johnson's sole unexpired patent protecting the cancer drug Zytiga (abiraterone) is not patentable. For additional analysis, read ViewPoints: Patent setback threatens momentum loss for Johnson & Johnson ahead of prostate cancer showdown.