Dec 6, 2021Legal
Fresh From the Bench: Latest Federal Circuit Court Cases


Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021)

For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range. In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges.

Below, we discuss two of those cases in our “Also This Week” section. For our write-up on last week’s Indivior case, see here. In this case, the issue is whether a patent claiming a number that was specifically disclosed in the patent satisfied the written description requirement. Based on the facts of this particular case, the Federal Circuit affirmed a district court finding that it did not.

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The Federal Circuit issued two precedential decisions concerning the inter partes reviews filed by Moderna against patents owned by Arbutus Biopharma. The cases concern Moderna’s COVID-19 vaccine.

ModernaTx, Inc. v. Arbutus Biopharma Corp., Appeal No. 2020-2329 (Fed. Cir. Dec. 1, 2021)

The Federal Circuit affirmed a PTAB finding that certain claims from Arbutus’s U.S. Patent 9,364,435 were not invalid as obvious.  The patent claimed certain ranges of different lipids in a nucleic acid-lipid particle.  The prior art disclosed two of those types of lipids in ranges that overlapped the range claimed in the patent.  Moderna argued that the third lipid could be deduced from simple subtraction.  Based on this argument, Moderna argued that the presumption of obviousness should apply pursuant to In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).  The Board found otherwise, and the Federal Circuit affirmed.

First, the Court addressed the issue of standing, and found that Moderna had Constitutional standing to pursue an appeal.  Even though Arbutus had not lodged a specific threat of infringement, the totality of statements that Arbutus had made publicly established that there was a live case or controversy.  Moreover, Arbutus had done nothing to disabuse Moderna or the Court of those concerns.

Having found standing, the Court proceeded to the merits.  The Court agreed with the PTAB that Moderna’s arguments were overly simplistic, and took too many assumptions in concluding that the third range was ascertainable through simple subtraction.  The Court held that the presumption of obviousness for overlapping ranges therefore did not apply, and the Board has properly ascertained that the patent was not obvious based on the facts of record.

The Court’s decision can be found here.

ModernaTx, Inc. v. Arbutus Biopharma Corp., Appeal Nos. 2020-1184, -1186 (Fed. Cir. Dec. 1, 2021)

In this parallel case, the Federal Circuit dismissed an appeal concerning an IPR based on Arbutus’s U.S. Patent 9,364,435, which the PTAB had also held was not invalid as obvious.  At the time the appeal was filed, the patent was owned by Protiva Biotherapeutics, Inc.  It appears the patent may have been transferred to Arbutus during the appeal.  To establish Constitutional standing, the appealing party must establish that it had standing as of the date the appeal was filed, and that a case or controversy has continued throughout the appeal.  Unlike in the case above, Protiva had not given Moderna any indication it might file an infringement suit against Moderna.  Moderna was also a licensee of the patent as part of a patent license that covered a number of patents.  The Court dismissed the appeal because “Moderna lacked standing at the time the appeal was filed.”

The Court’s decision can be found here.

By Nika Aldrich

Edited by: Scott D. Eads and Nika Aldrich, Schwabe Williamson & Wyatt

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