In a case relating to use of recombinant human interferon-β (IFN-β) proteins for the treatment of viral diseases, the US Court of Appeals for the Federal Circuit ruled that a “product-by-process” analysis applies even when the product-by-process limitation is nested within a method of treatment claim. Biogen MA Inc. v. EMD Serono, Inc., et al., Case No. 19-1133 (Fed. Cir. Sept. 28, 2020) (Linn, J.). The claims at issue relate to a method of treating a viral condition, a viral disease, cancers or tumors by administration of a pharmaceutically effective amount of recombinant IFN-β. The claims contained a product-by-process limitation that partially defined the recombinant IFN-β in terms of the method or process by which it is made: a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of . . . It was undisputed that native IFN-β proteins comprise sequences...

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