Moderna, one of the global leaders in developing a safe and effective vaccine to combat COVID-19, appears poised to get through clinical trials with a vaccine that is based on mRNA technology. As was recently announced, Pfizer demonstrated a 90% effectiveness with its vaccine, which is also based on mRNA technology. If all stays on course, Pfizer and Moderna may be the first two market entrants with vaccines, using the non-traditional mRNA technology.

But in order for at least Moderna’s mRNA technology to function properly, it needs a “delivery system.” Specifically, Moderna’s COVID-19 vaccine introduces “mRNA-1273” molecules into the recipient via a delivery system that protects the mRNA in the bloodstream and allows for entry into cells. Once inside the cells, the mRNA-1273 molecules act like computer code and instruct the cells to produce the characteristic COVID-19 spike proteins. The immune system identifies the spike proteins as antigens and builds its defenses against those antigens in preparation for the potential exposure to the actual COVID-19 virus.

Arbutus Biopharma owns certain patents relating to lipid-nanoparticle “delivery systems” for mRNA molecules. These delivery systems essentially wrap the molecules in balls of fat to both disguise them, thereby preventing attack by the immune system, and to allow the target cells to readily ingest the mRNA molecules. Moderna lost its sublicense to those disputed patents in 2016 and then (before the pandemic) sought to invalidate the patents through three USPTO inter partes review (IPR) proceedings that were decided earlier this year.

This post examines the procedural history and status of those proceedings.

On July 23, 2020, the Patent Trial and Appeal Board (“PTAB”) for the United States Patent and Trademark Office issued a final written decision upholding the claims of Arbutus Biopharma Corporation’s U.S. Patent No. 8,058,069 (“the ’069 patent”) from a challenge by Petitioner Moderna Therapeutics, Inc.[1]

The PTAB specifically determined that Moderna failed to show, by a preponderance of the evidence, that claims 1-22 of the ’069 patent were unpatentable under 35 U.S.C. § 103. The ’069 patent’s claims relate to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.”[2]

Moderna sought to invalidate the ’069 patent on two grounds, each of which the PTAB rejected. On the first ground, Moderna argued claims 1-22 were anticipated or obvious by International Application Publication No. 2005/007196 (“the ’196 PCT”) and United States Application Publication No. 2006/0134189 (“the ’189 Publication”). On the second ground, Moderna contended claims 1-22 were anticipated or obvious by Arbutus’s prior disclosures in light of two pieces of non-patent literature.[3][4]

This is the third final written decision in a series of IPRs brought by Moderna against Arbutus patents, and it is also the first final written decision with an entirely negative result for Moderna. Moderna’s first IPR ended in success, with the PTAB invalidating Arbutus’s US Patent No. 9,404,127 (“the ’127 patent”)[5]; but Moderna’s second IPR, concluded with mixed results, with the PTAB invalidating some claims of Arbutus’s US Patent No. 9,364,435 (“the ’435 patent”) and upholding others.[6]

Importantly, Arbutus’s ’127, ’435, and ’069 patents are similar to the extent they claim stable nucleic acid-lipid particles (SNALP) and methods of delivery. These patents appear to cover liquid nanoparticle (LNP) technology, which can be used to deliver messenger ribonucleic acid (mRNA) to cells. In the past, Moderna has indirectly licensed such LNP technology from Arbutus, but it has recently begun to develop its own proprietary LNP technology.

After the PTAB’s ruling on the ’069 patent, Moderna stated it “is not aware of any significant intellectual property impediments” toward products it intends to commercialize, including mRNA-1273. Indeed, whether Moderna is infringing Arbutus’s patents during its development of a COVID-19 vaccine is unknown, but it is worth noting that Arbutus has not brought any patent infringement actions against Moderna.

The IPRs for the ’127, ’435, and ’069 patents have each been appealed to the Court of Appeals for the Federal Circuit (CAFC), and Moderna’s appeal brief for the case involving the ’069 patent is due this month. In an event that could be viewed as related to its failed challenge to the ’069 patent, Moderna stated last month it will not enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic” while the pandemic continues.[7] However, it remains to be seen whether another company could – or would – enforce its COVID-19 related patents against Moderna during this pandemic or otherwise.

[1] Moderna Therapeutics, Inc. v. Arbutus Biopharma Corp., No. IPR2019-00554, 2020 WL 4237232 (P.T.A.B. July 23, 2020).

[2] LIPID FORMULATIONS FOR NUCLEIC ACID DELIVERY, US PAT 8058069.

[3] Lin et al., Three-Dimensional Imaging of Lipid Gene-Carriers: Membrane Charge Density Controls Universal Transfection Behavior in Lamellar Cationic Liposome-DNA Complexes, 84 BIOPHYSICAL J. 3307–16 (2003) (“Lin”).

[4] Ahmad et al., New Multivalent Cationic Lipids Reveal Bell Curve for Transfection Efficiency Versus Membrane Charge Density: Lipid-DNA Complexes for Gene Delivery, 7 J. GENE MED. 739–48 (2005) (“Ahmad”). Ex. 1007.

[5] Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc., No. IPR2018-00680, 2018 WL 4362415 (P.T.A.B. Sept. 12, 2018). [Note: Protiva was a wholly-owned subsidiary of Arbutus.]

[6] Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc., IPR2018-00739 (P.T.A.B. Sept. 11, 2019).

[7] https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19