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U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira, a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine.
In June, Amgen, the world’s biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that the patents in question should not have been granted in the first place for Humira, an injected rheumatoid arthritis treatment with annual sales approaching $14 billion.
In declining to review the patents, the agency said “we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges.”
Amgen said it still plans to challenge the legality of the patents.
“Although we are disappointed by the PTO’s decision, we continue to question the validity of the patents,” the company said in a statement. “We look forward to presenting our position in court.”
Source : Reuters
18 – January – 2016