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Moderna failure to invalidate Arbutus Biopharma patents may open the door to vaccine infringement action

Date: 7 December 2021

The US Court of Appeals for the Federal Circuit upheld the previous decision of the Patent Trials and Appeals Board (PTAB) regarding the validity of Arbutus Biopharma patent No's 8,058,069 ('069) and 9,364,435 ('435).

 

The patents relate to lipid nanoparticles for nucleic acid delivery and the Moderna COVID 19 vaccine is known to delivery mRNA into cells via lipid nanoparticles. During proceedings Moderna stated that there was a "substantial risk" that Arbutus may enforce their patents against the Moderna vaccine.

 

The Moderna mRNA vaccine has been one of the biggest success stories of the pandemic and is one of only three vaccines approved for use by the Food and Drug Administration in the United States and one of four approved by the European Medicines Agency. The sales for 2021 from the Moderna COVID 19 vaccine are estimate to be in the region of $18 billion.

 

Moderna sought invalidity of the Arbutus Biopharma patents on the grounds of obviousness. At the PTAB, all of the claims of the '069 patent were found valid and, for the ‘435 patent, claims 7–8, 10–11, 13, and 16–20 were found valid and claims 1–6, 9, 12, and 14–15 invalid.

The US Court of Appeals for the Federal Circuit upheld the PTAB decision regarding '065 and dismissed Moderna's arguments regarding '435 due to lack of standing. The reference to "lack of standing" relates to a procedural matter in which Moderna had to demonstrate that it had a right to appeal in the first place.

 

As stated in the judgement:

 

"Our precedent generally makes clear that, as in all appeals before this court, an appellant seeking review of a Board decision in an IPR must have “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the [appellee], (3) that is likely to be redressed by a favorable judicial decision.”

 

The appeal against the decision of the Inter partes review (IPR) was filed in November 2019, i.e. before Moderna could have conceived that they may use certain technologies to create a vaccine against COVID 19. It was held that, while they now know that there is a risk of infringement, they could not have met the requirements above at the time of filing the appeal. It was deemed therefore that Moderna did not meet the requirements during the entire time that the appeal was pending.

 

In light of the decision to uphold the validity, at least in part, of the Arbutus Biopharma patents, it paves the way to a potential suit against the Moderna vaccine. This comes as Moderna is already embroiled in a dispute with the National Institute of Health (NIH) in the US which claims that three of its scientists should have been named as inventors on the Modrna vaccine patent. This is denied by Moderna which claims that only its scientists should be named inventors. If it is found that the NIH scientists are inventors and Moderna intentionally left them off the patent application, then it may lead to the patent being invalidated. Alternatively, it may be that Moderna owes the NIH royalties for the work done by their scientists.

 

These are not the only disputes surrounding COVID vaccines and, given that they are both high profile and highly profitable, legal battles surrounding the vaccines may continue for some time to come.

 

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