Update on mRNA Vaccine Patent Litigation

We previously reported on patent infringement litigations between Alnylam and Moderna.  Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna.

First, in a patent action brought by Alnylam Pharmaceuticals, Inc. (“Alnylam”) against Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively, “Moderna”), the parties entered a Joint Stipulation and Motion for Entry of Final Judgement of Non-Infringement.  Alynlam had previously alleged that Moderna’s COVID-19 vaccine products, marketed as SPIKEVAX® infringed U.S. Patent Nos. 11,246,933 and 11,382,979.  Moderna subsequently brought non-infringement and invalidity counterclaims related to Alynlam’s patents.  On August 21, 2023, the court entered a Claim Construction Order defining the following three key terms for all asserted claims: “branched alkyl,” “branched C10-C20 alkyl,” and “R13 is a branched C10-C20 alkyl.”  Following the court’s ruling, on August 25th, both parties entered the Joint Stipulation and Motion for Entry of Final Judgement of Non-Infringement.  Alynlam concluded that “the foregoing claim constructions preclude it from obtaining a judgment in its favor with respect to infringement by the Accused Products of the Asserted Claims as currently formulated” and, as such, the parties jointly “stipulate[d] and agree[d] to the entry of a final judgment that Moderna’s Accused Products as currently formulated do not infringe the Asserted Claims of the Patents-in-Suit.”

In a second action, BioNTech SE (“BioNTech”) and Pfizer Inc. (“Pfizer”) filed inter partes review (IPR) petitions before the Patent Trial and Appeal Board (the “PTAB”) directed at two patents owned by ModernaTX, Inc.: U.S. Patents Nos. 10,933,127 and 10,702,600 (collectively, “the ‘127 and ‘600 patents”). The ‘127 and ‘600 patents are directed to “the use of mRNAs encoding any spike protein or spike protein subunit of any betacoronavirus, formulated in a broadly claimed lipid delivery system, to induce an immune response.” BioNTech and Pfizer allege four counts of patent invalidity on the basis of prior art and request cancellation of the majority of the claims of both patents.  The deadline for an institution decision on both petitions is March 2024.

Stay tuned to Big Molecule Watch for more updates on this litigation.