Ranges for Interdependent and Interactive Components Can Be Tricky to Derive

MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

Before Lourie, O’Malley and Stoll.   Appeal from the Patent Trial and Appeal Board.

Summary: A presumption of obviousness based on overlapping ranges requires showing that the overlapping range is actually taught by the prior art.

Moderna petitioned for IPR against an Arbutus patent directed to stable nucleic acid-lipid particles comprising a nucleic acid.   Moderna contended that all of the ranges for the components in the claimed nucleic acid-lipid particle were disclosed or taught by the prior art, and that a presumption of obviousness should therefore apply.  The PTAB disagreed that the presumption applied because the prior art expressly disclosed the ranges for only three out of the four sub-components of the claimed composition.  Moderna derived the overlapping range for the sub-component with no specific disclosure in the prior art by making certain assumptions about the other three sub-components.  The PTAB rejected Moderna’s argument, noting that the claimed range for the fourth sub-component was not necessarily disclosed based on broader ranges for the other three components.  The PTAB found the claims are not unpatentable as obvious.  Moderna appealed.  

The Federal Circuit first addressed standing, noting that a party’s participation in the underlying IPR before the PTAB is insufficient by itself to confer standing on that party to appeal.  The Federal Circuit explained that a specific threat of infringement is not required, but it is sufficient for the appellant to show that it has engaged in, is engaging in, or will likely engage in activity that would give rise to a possible infringement suit.  The Federal Circuit found Moderna demonstrated a risk of suit by Arbutus based on the combination of its own activities in developing the COVID-19 vaccine, Arbutus’s broad public statements about its extensive patent coverage in the area, and Arbutus’s refusal to grant a covenant not to sue.

The Federal Circuit then affirmed the PTAB’s decision that the asserted claims were nonobvious.  In particular, the Federal Circuit agreed that a presumption of obviousness did not apply because Moderna failed to show that an overlapping range was actually taught by the prior art.

Editor: Paul Stewart

Written by: Shelley Chen & Hans L. Mayer