by Dennis Crouch
Moderna filed a patent infringement lawsuit against Pfizer and BioNTech in August 2022, alleging that the defendants COVID-19 vaccine infringes three patents related to Moderna’s mRNA vaccine technology. United States Patent Nos. 10,898,574, 10,702,600, and 10,933,127. The lawsuit centers around two key components of Moderna’s mRNA platform that it claims Pfizer copied – the use of modified nucleosides like 1-methylpseudouridine and the encoding of a full-length coronavirus spike protein. Moderna asserts that it pioneered these innovations years before the COVID-19 pandemic and patented them between 2011-2016. The complaint alleges Pfizer and BioNTech initially tested different vaccine designs but ultimately chose to copy Moderna’s approach, despite being aware of Moderna’s patents. In the lawsuit, Moderna is seeking monetary damages for patent infringement but not injunctive relief taht would remove the Pfizer vaccine from the market. Although Moderna pledged not to enforce its COVID-19 patents during the pandemic, it signaled in March 2022 that expected companies to respect its intellectual property rights going forward.
In its response, Pfizer denied Moderna’s allegations of patent infringement and explained that it independently developed its COVID-19 vaccine without copying Moderna’s technology. Pfizer argues that Moderna’s patents are invalid because of the way they reach beyond Moderna’s actual contributions to mRNA technology and improperly claim fundamental discoveries made by other scientists. In this vein, Pfizer raises several affirmative defenses, including invalidity and non-infringement of the asserted patents. Pfizer also asserts defenses based on implied license, waiver, and acquiescence stemming from Moderna’s public pledge not to enforce its COVID-19 patents during the pandemic. As is usual, the answer also includes counterclaims that mimic the affirmative defenses — seeking declarations that the patent claims are invalid, not infringed, and unenforceable against Pfizer. Here, these particular pleadings are rather limited and, for the most part, generally assert “35 U.S.C. 101, 102, 103, and/or 112.”
The case is slowly moving forward in before Judge Richard Stearns with a trial rougly set for Fall 2024. Most recently, Judge Stearns issued a claim construction order following a Markman hearing. As is common, the patentee did not ask for any construction, the defendants asked the court to define several terms. Some of the proposals ask for broad definitions of certain terms (that would help Pfizer prove invalidity); while others sought narrow definitions of other terms (that would help Pfizer avoid infringement). I tried to note the impact of the various constructions below. As you can see, each party won and lost arguments, but in the whole this looks like a good decision for Moderna.
- The court adopted a broad definition of “unmodified mRNA” suggested by Pfizer that includes a statement that “Unmodified may, but does not always, refer to the wild type or native form of a biomolecule.” (This will help Pfizer prove invalidity)
- For the term “betacoronavirus,” the court rejected Pfizer’s argument that it is limited to betacoronaviruses in existence at the time of filing. The court found the intrinsic evidence indicates the term encompasses betacoronaviruses discovered after the filing date. (This will help Moderna prove infringement)
- The court construed “S protein” as simply “spike protein, a structural protein forming a spike.” It declined to include functional limitations proposed by Pfizer. (This will help Moderna prove infringement)
- The court construed “open reading frame” to apply to both DNA and mRNA. Pfizer had suggested limiting the term to just DNA contexts. (This helps Moderna prove infringement).
- The court construed the term “mRNA” to mean “messenger RNA, i.e., a ribonucleic acid (RNA) that encodes a polypeptide and can be translated to produce the encoded polypeptide.” This roughly aligns with Moderna’s proposed construction. Pfizer had asked that for a definition that included mRNA as a “template for encoding” a polypeptide. (It is not clear to me the impact of this ruling, however it likely favors Pfizer’s invalidity arguments focusing on whether certain prior art references sufficiently disclose mRNA).
For those of you new to claim construction, the district court is charged with defining terms used in the patent claims when they are a bit too unclear, or when the parties are disputing over their meaning. The basic approach is that the court should provide the meaning that would a person of ordinary skill in the art would give to the terms at the time of the invention, and after reviewing the claims, the specification, and the prosecution history. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Extrinsic evidence such as dictionary definitions and expert opinion can play a role, but is usually secondary to the intrinsic evidence. This ruling on claim construction is really setting of the stage, with the real action coming soon via summary judgment motions and eventually the trial.
In my analysis above, I noted some inference about the impact of the various claim construction rulings. Please note that the parties have not yet briefed these issues and so we’ll see what happens. There may be an immediate summary judgment motion, but I don’t see that as likely until the close of discovery. It is important to remember that claim construction is not a final determination on infringement or invalidity, but simply provides interpretations of disputed terms that will be used in those later determinations. In addition, parties often ask a court to reconsider its claim construction.
Although Pfizer obviously does not want to be liable for patent infringement here, Pfizer also holds and is seeking numerous patents on its own related technology. I expect that Pfizer’s invalidity arguments will be targeted toward specific concerns with the Moderna patents rather than attempting to substantially expand the law. We might see a different strategy if a non-profit or consumer-focused group had filed. We saw the latter in the Supreme Court’s 2013 Myriad decision.
= = =
Claim 1 of the ‘600 Patent is directed to the mRNA composition designed to encode a betacoronavirus spike protein or subunit, formulated in a lipid nanoparticle.
1. A composition comprising: a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle.
Note that the court broadly defined betacoronavirus to include later-invented forms. This leaves the claim open to enablement and written description challenges.
The ‘574 patent claims methods of using modified messenger RNA (mmRNA) with reduced immune activation properties compared to unmodified mRNA and also a slightly different composition claim. Unlike the ‘600 patent, these do not focus on the spike protein but are more generic versions of using the mRNA technology.
1. A method of producing a polypeptide of interest in a cell in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising a modified messenger RNA (mmRNA) such that the mmRNA is introduced into the cell, wherein the mmRNA comprises a translatable region encoding the polypeptide of interest and comprises the modified nucleoside 1-methyl-pseudouridine, and wherein the pharmaceutical composition comprises an effective amount of the mmRNA providing for increased polypeptide production and substantially reduced innate immune response in the cell, as compared to a composition comprising a corresponding unmodified mRNA.
2. A pharmaceutical composition comprising: a plurality of lipid nanoparticles comprising a cationic lipid, a sterol, and a PEG-lipid,
wherein the lipid nanoparticles comprise an mRNA encoding a polypeptide, where in the mRNA comprises one or more uridines, one or more cytidines, one or more adenosines, and one or more guanosines and wherein substantially all uridines are modified uridines.
Finally, the ‘127 patent claims methods of administering a composition comprising mRNA encoding a betacoronavirus spike protein formulated in a lipid nanoparticle. These claims specify percent ranges for ionizable cationic lipid, neutral lipid, cholesterol, and PEG-modified lipid components in the lipid nanoparticle.
1. A method comprising administering to a subject a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle in an effective amount to induce in the subject an immune response to the BetaCoV S protein or S protein subunit, wherein the lipid nanoparticle comprises 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % cholesterol, and 0.5-15 mol % PEG-modified lipid.