Moderna Can't Invalidate Drug-Delivery Composition Patent

By Dave Simpson
Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.

Sign up for our Intellectual Property newsletter

You must correct or enter the following before you can sign up:

Select more newsletters to receive for free [+] Show less [-]

Thank You!

Law360 (July 23, 2020, 10:56 PM EDT) -- The Patent Trial and Appeal Board ruled Thursday that Moderna Therapeutics Inc. failed to invalidate claims in Arbutus Biopharma Corp.'s patent covering a drug-delivery composition as obvious or anticipated based on overlapping composition ranges, finding that prior art does not explicitly disclose such ranges.

The panel of administrative patent judges found that Moderna — which has received federal funding for the development of a potential coronavirus vaccine — came up with the prior art's apparent ranges by making certain assumptions about the other components of the compositions in question.

However, the Federal Circuit has only applied a presumption of obviousness in instances when a range is expressly disclosed, not in situations where an overlap might be assumed based on other factors, the panel said.

None of the circuit court's precedential decisions suggest that obviousness applies "when one of the claimed ranges for one of the expressly claimed sub-components of the claimed composition is not necessarily disclosed based on broader ranges for other components disclosed in the prior art," the panel said.

"Petitioner's motivations and assumptions for choosing amounts of the various lipid components from the broadly disclosed ranges in the prior art to arrive at an overlapping phospholipid range are not necessarily well-founded," the panel said.

And even if the presumption of obviousness applied in this instance, it is rebutted because the panel found no citation in the evidence indicating that the amount of phospholipid in a nucleic acid-lipid particle was recognized in the prior art as a "result-effective variable."

Representatives for the parties did not immediately respond to requests for comment Thursday.

Arbutus' U.S. Patent No. 8,058,069 is directed to a drug-delivery composition based on a combination of nucleic acid-lipid particle components used in genetic therapy. In PTAB filings, Arbutus said that the patent covers the U.S. Food and Drug Administration-approved Onpattro, which is used to treat a rare genetic disease that can affect the nerves, heart and kidneys, though Moderna disputes that the patent at issue covers the drug.

The board agreed to review the patent last July. In its petition, Moderna said Arbutus has obtained "overlapping claims" in unrelated patent families, allowing it to improperly extend its patent protection, thereby blocking others from using nucleic acid-lipid particle components that it says were well-known long before '069 was issued.

On Thursday, the panel also rejected Moderna's argument that adjusting the amount of the various lipid components in the particle would have been a matter of "routine optimization."

According to PTAB records, there is no underlying district court litigation between the parties, but Moderna has challenged two related Arbutus patents at the board. Moderna prevailed entirely in one of the cases, with the board invalidating all claims in U.S. Patent No. 9,404,127 as being anticipated in a Sept.10 decision. The next day, the board upheld half of the claims Moderna challenged in U.S. Patent No. 9,364,435.

The patent-in-suit is U.S. Patent No. 8,058,069.

Judges Tina E. Hulse, Christopher G. Paulraj and Timothy G. Majors sat on the panel for the Patent Trial and Appeal Board.

Moderna Therapeutics is represented by Michael Fleming and C. Maclain Wells of Irell & Manella LLP.

Arbutus Biopharma is represented by Michael T. Rosato, Steven W. Parmelee, Sonja R. Gerrard and Lora M. Green of Wilson Sonsini Goodrich & Rosati PC.

The case is Moderna Therapeutics Inc. v. Arbutus Biopharma Corp., case number IPR2019-00554, at the Patent Trial and Appeal Board.

--Additional reporting by Dani Kass and Britain Eakin. Editing by Breda Lund.

For a reprint of this article, please contact

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!