The U.S. Court of Appeals for the Federal Circuit left a question hanging over the marketing of Pfizer Inc.’s Ruxience, a biosimilar to Genentech Inc.’s Rituxan (rituximab). Saying that Pfizer didn’t have standing when it appealed in January 2019, the appellate court dismissed the New York company’s appeal of two inter partes review decisions in which the Patent Trial and Appeal Board (PTAB) upheld several claims in two of Japan-based Chugai Pharmaceutical Co. Ltd.’s patents. In accordance with a settlement agreement with Genentech, a wholly owned subsidiary of Roche Holding AG, Pfizer launched its biosimilar in January 2020. Although Roche is the majority owner of Chugai, the Tokyo-based company wasn’t a party to the Genentech settlement. In its appeal, Pfizer said Chugai was likely to accuse its biosimilar of infringing the patents because the biosimilar uses protein A chromatography and the patents “concern methods of purifying proteins involving the use of protein A chromatography.” While that may be, the Federal Circuit said Pfizer was not in danger of an infringement suit when it filed the appeal, as the FDA didn’t approve Ruxience until six months later. To have standing to appeal a PTAB ruling, a party must be able to show that it “was suffering a cognizable injury at all stages” of the appeal, the Federal Circuit said.
Australia’s Therapeutic Goods Administration is now publishing both the active and nonactive ingredients of drugs and biologics in the online summaries posted to the Australian Register of Therapeutic Goods (ARTG). In the past, only active ingredients were listed in the ARTG summaries. The inclusion of nonactive ingredients will help “people make better-informed choices about the products they use,” the TGA said.