Moderna has reached a settlement to pay up to $2.25 billion to resolve its ongoing patent dispute with Roivant and Arbutus Therapeutics. The agreement brings relief to Moderna after recent setbacks, including regulatory challenges and concerns over its financial stability.
The patent conflict centered on Moderna’s use of lipid nanoparticle technology in its mRNA-based COVID-19 vaccine. Arbutus claimed that Moderna used this protected technology without a proper license during the pandemic response. A court order last week rejected two main defenses from Moderna, leaving only the argument that Arbutus’ patents did not sufficiently enable someone skilled in the field to replicate the delivery method.
Under the settlement terms, Moderna will pay an upfront sum of $950 million. An additional $1.3 billion may be paid if Moderna wins an appeal related to limiting liability through government-contractor immunity statutes. This legal strategy had previously failed when Delaware District Judge Joshua Wolson ruled that such immunity should benefit the government directly rather than the general public, as would be the case with broad vaccination efforts. Moderna is currently appealing this decision.
Financial analysts at William Blair noted that the settlement amount was less than many investors feared, as some expected potential liabilities approaching $5 billion. According to their statement, "the company has certainty it is well funded through multiple late-stage oncology readouts" anticipated this year.
The resolution comes at a critical time for Moderna, which recently faced negative news such as the FDA's refusal to review its mRNA flu vaccine application due to concerns about trial design and adequacy. Following discussions with regulators, Moderna secured an agreement for a narrower review of its vaccine application, with a decision expected in August.
In its latest earnings report, Moderna stated it expects Phase 3 data for intismeran—a neoantigen therapy for melanoma—later this year and mid-stage results for renal cell carcinoma and early findings in pancreatic and gastric cancers.
Earlier this year, Moderna announced it would stop running late-stage vaccine trials amid increasing skepticism in the U.S., cut three pipeline programs, and arranged non-dilutive loan financing to support its balance sheet.
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