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Product-by-Process Analysis Applies to Method of Treatment Claims

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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Lights Turned Out on Validity Finding

Finding that the Patent Trial and Appeal Board’s (PTAB) anticipation and obviousness decisions resulted from an erroneous interpretation of the claim language and a misunderstanding of case law, the US Court of Appeals for the Federal Circuit vacated the PTAB’s decision and remanded for further consideration. Technical Consumer Products v. Lighting Science Group Corp., Case No. 19-1361 (Fed. Cir. Apr. 8, 2020) (Stoll, J.). Life Science Group (LSG) owns a patent directed to a replacement light emitting diode (LED) light fixture. The claimed LED light fixture includes (1) a ring-shaped heat sink disposed around a heat spreader and (2) a combination of the heat sink, the heat spreader and an outer optic that has “an overall height H and an overall outside dimension D such that the ratio of H/D is equal to or less than 0.25.” Technical Consumer Products, Inc.; Nicor, Inc.; and Amax Lighting (collectively TCP) petitioned for inter partes review (IPR), arguing the...

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Room Temp Prior Art Has Chilling Effect on Broadening Claim Language

In a case involving a patented method for purifying antibodies, the US Court of Appeals for the Federal Circuit determined that the process of chilling a composition to below room temperature could be found both obvious and anticipated by a process that purified that composition at room temperature. Genentech, Inc. v. Hospira, Inc., Case No. 18-1933 (Fed. Cir. Jan. 10, 2020) (Chen, J) (Newman, J, dissenting). Genentech owns a patent related to a method of purifying antibodies. It was known in the art that this could be accomplished by running an antibody solution across a chromatography column coated with protein A. The antibodies bind to protein A while impurities and the rest of the composition pass through the column. The antibodies are then released from protein A by washing the column with a low pH solution. However, this process was known to release small amounts of the protein A from the column, contaminating the otherwise-purified antibody solution....

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