Does Moderna Therapeutics need to invalidate Arbutus Biopharma’s LNP patents?

Zachary Silbersher

Update July 23, 2020: Moderna loses IPR for ‘069 patent. All 22 claims of patent upheld. Decision is available at PTAB website here for AIA Review Number IPR2019-00554.

Update July 28, 2020: We published a post addressing whether Moderna’s COVID-19 vaccine is using Arbutus’ patents here.

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We previously blogged about an ongoing patent fight between Moderna Therapeutics ($MRNA) and Arbutus Biopharma ($ABUS).  That fight could implicate whether Moderna’s pipeline depends upon technology that is patented by Arbutus.  Moderna has sought to invalidate three patents owned by Arbutus, and has so far met with mixed success.  Who is winning this fight?

As we previously discussed, Moderna’s pipeline relies upon drugs that harnesses a patient’s own protein-making machinery to essentially manufacture its own therapeutic protein.  One method is through lipid nanoparticles, or LNPs.  Moderna previously licensed mRNA delivery technology using LNPs from a small Canadian company called Acuitas.  Acuitas had itself acquired a license to this technology from Arbutus.  Arbutus subsequently claimed that Acuitas’ sublicense to Moderna was improper, and won a preliminary injunction in Canada against Acuitas’ sublicense. 

In connection with this settlement, in a February 22, 2018 press release, ArbuFtus stated: “The settlement stipulates that the four non-exclusive viral vaccine sublicenses previously granted to Moderna are the only sublicenses to survive. These four sublicenses, previously granted by Acuitas to Moderna under the pre-April 15, 2010 Arbutus LNP patent families, are each limited to a specific viral target. Moderna has no other rights to Arbutus’ broad suite of LNP intellectual property.”

Right around that time, Moderna began challenging the validity of patents owned by Arbutus that appear to cover its LNP technology.  On February 21, 2018, Moderna filed a petition for inter partes review (IPR) against Arbutus’ U.S. Patent No. 9,404,127.  On March 5, 2018, Moderna filed another IPR against Arbutus’ U.S. Patent No. 9,364,435.  And on January 9, 2019, Moderna filed a third IPR against Arbutus’ U.S. Patent No. 8,058,069.

Two of those IPRs have now reached final decisions, and the third remains pending.  In the first IPR against the ‘127 patent, Moderna prevailed.  On September 10, 2019, the PTAB issued a Final Written Decision that invalidated all claims of the patent.  In the second IPR against the ‘435 patent, Moderna had mixed results.  On September 11, 2019, the PTAB issued a Final Written Decision that invalidated some of the claims (1–6, 9, 12, 14, and 15), but upheld the validity of other claims (7, 8, 10, 11, 13, or 16–20).  

We anticipate that appeals will be filed in both of these IPRs.  The time to notice appeals to the Federal Circuit will expire before mid-November.  To the extent the parties do not reach some form of settlement beforehand, Arbutus is likely to appeal both IPR decisions, and Moderna is likely to appeal the PTAB’s decision to uphold certain claims of the ‘435 patent.  To the extent that the Federal Circuit upholds the final decisions of the PTAB, then theoretically Moderna will not have to worry about the ‘127 patent or several invalidated claims from the ‘435 patent. 

For the third IPR against the ‘069 patent, on July 24, 2019, the PTAB granted institution of Moderna’s petition.  The ‘069 patent is a parent of the ‘435 patent.  Does that mean that the results of the IPR against the ‘435 patent may read-through to the IPR against the ‘069 patent?  Quite possibly. Both IPRs rely upon the same prior art, and more importantly, they also rely upon the same three prior-art combinations as grounds for challenging the claims.  Put another way, those features of the ‘435 patent that were deemed patentable over those same prior art combinations should, theoretically, survive a validity challenge in the IPR challenging the ‘069 patent.

Putting that aside, the biggest takeaway right now is that at least some claims of one patent (the ‘435 patent) have been upheld by the Patent Office.  In light of that decision, the next immediate question is whether Moderna is using technology covered by those claims.  That would include claims 7, 8, 10, 11, 13, or 16–20 of the ‘435 patent.

This raises another related question, namely, why did Moderna file these IPRs in the first instance?  Arbutus has not sued Moderna for patent infringement of any of the three patents challenged by Moderna.  Thus, Moderna’s choice to file the IPRs was not purely a defensive reaction to contain a lawsuit.  If that was the case, it would be harder to conclude that Moderna was particularly concerned that it was necessarily using Arbutus’ LNP technology. 

Rather, by filing the IPRs pre-emptively, does that mean Moderna may have concerns that its LNP technology may infringe Arbutus’ patents?  If so, now that the ‘435 patent’s validity has been upheld, those concerns would presumably be exacerbated.  That does not mean that Moderna is necessarily infringing the ‘435 patent.  Indeed, Moderna may have already explored a means of designing around it.  That said, it is also not clear why Moderna waited several months before filing an IPR against the ‘069 patent, given that it had already issued at the time Moderna filed its first two IPRs.

To the extent appeals to the Federal Circuit are taken, the anticipated briefing may shed greater light on whether Moderna will need to reach an agreement with Arbutus to protect its pipeline from claims of patent infringement.