Declare Building Order Units Stage for Moderna v. Pfizer Vaccine Patent Showdown

by Dennis Crouch

Moderna filed a patent infringement lawsuit towards Pfizer and BioNTech in August 2022, alleging that the defendants COVID-19 vaccine infringes three patents associated to Moderna’s mRNA vaccine know-how.  United States Patent Nos. 10,898,574, 10,702,600, and 10,933,127. The lawsuit facilities round two key parts of Moderna’s mRNA platform that it claims Pfizer copied – the usage of modified nucleosides like 1-methylpseudouridine and the encoding of a full-length coronavirus spike protein. Moderna asserts that it pioneered these improvements years earlier than the COVID-19 pandemic and patented them between 2011-2016. The criticism alleges Pfizer and BioNTech initially examined completely different vaccine designs however in the end selected to repeat Moderna’s strategy, regardless of being conscious of Moderna’s patents. Within the lawsuit, Moderna is in search of financial damages for patent infringement however not injunctive reduction taht would take away the Pfizer vaccine from the market. Though Moderna pledged to not implement its COVID-19 patents through the pandemic, it signaled in March 2022 that anticipated corporations to respect its mental property rights going ahead.

In its response, Pfizer denied Moderna’s allegations of patent infringement and defined that it independently developed its COVID-19 vaccine with out copying Moderna’s know-how. Pfizer argues that Moderna’s patents are invalid due to the way in which they attain past Moderna’s precise contributions to mRNA know-how and improperly declare basic discoveries made by different scientists.  On this vein, Pfizer raises a number of affirmative defenses, together with invalidity and non-infringement of the asserted patents. Pfizer additionally asserts defenses primarily based on implied license, waiver, and acquiescence stemming from Moderna’s public pledge to not implement its COVID-19 patents through the pandemic.  As is common, the reply additionally contains counterclaims that mimic the affirmative defenses — in search of declarations that the patent claims are invalid, not infringed, and unenforceable towards Pfizer.  Right here, these explicit pleadings are fairly restricted and, for probably the most half, typically assert “35 U.S.C. 101, 102, 103, and/or 112.”


The case is slowly shifting ahead in earlier than Decide Richard Stearns with a trial rougly set for Fall 2024. Most just lately, Decide Stearns issued a declare building order following a Markman listening to.  As is widespread, the patentee didn’t ask for any building, the defendants requested the court docket to outline a number of phrases.  Among the proposals ask for broad definitions of sure phrases (that may assist Pfizer show invalidity); whereas others sought slender definitions of different phrases (that may assist Pfizer keep away from infringement).  I attempted to notice the impression of the varied constructions beneath. As you’ll be able to see, every celebration received and misplaced arguments, however in the entire this seems to be like an excellent choice for Moderna.

  • The court docket adopted a broad definition of “unmodified mRNA” recommended by Pfizer that features a assertion that “Unmodified could, however doesn’t at all times, discuss with the wild sort or native type of a biomolecule.”  (It will assist Pfizer show invalidity)
  • For the time period “betacoronavirus,” the court docket rejected Pfizer’s argument that it’s restricted to betacoronaviruses in existence on the time of submitting. The court docket discovered the intrinsic proof signifies the time period encompasses betacoronaviruses found after the submitting date.  (It will assist Moderna show infringement)
  • The court docket construed “S protein” as merely “spike protein, a structural protein forming a spike.” It declined to incorporate practical limitations proposed by Pfizer.  (It will assist Moderna show infringement)
  • The court docket construed “open studying body” to use to each DNA and mRNA. Pfizer had recommended limiting the time period to only DNA contexts. (This helps Moderna show infringement).
  • The court docket construed the time period “mRNA” to imply “messenger RNA, i.e., a ribonucleic acid (RNA) that encodes a polypeptide and might be translated to supply the encoded polypeptide.” This roughly aligns with Moderna’s proposed building.   Pfizer had requested that for a definition that included mRNA as a “template for encoding” a polypeptide.  (It’s not clear to me the impression of this ruling, nonetheless it seemingly favors Pfizer’s invalidity arguments specializing in whether or not sure prior artwork references sufficiently disclose mRNA).

For these of you new to say building, the district court docket is charged with defining phrases used within the patent claims when they’re a bit too unclear, or when the events are disputing over their which means.  The essential strategy is that the court docket ought to present the which means that may an individual of unusual talent within the artwork would give to the phrases on the time of the invention, and after reviewing the claims, the specification, and the prosecution historical past. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Extrinsic proof similar to dictionary definitions and knowledgeable opinion can play a task, however is often secondary to the intrinsic proof.  This ruling on declare building is admittedly setting of the stage, with the true motion coming quickly through abstract judgment motions and finally the trial.

In my evaluation above, I famous some inference concerning the impression of the varied declare building rulings. Please notice that the events haven’t but briefed these points and so we’ll see what occurs.  There could also be a direct abstract judgment movement, however I don’t see that as seemingly till the shut of discovery.  You will need to do not forget that declare building isn’t a ultimate willpower on infringement or invalidity, however  merely gives interpretations of disputed phrases that might be utilized in these later determinations. As well as, events typically ask a court docket to rethink its declare building.

Though Pfizer clearly doesn’t need to be responsible for patent infringement right here, Pfizer additionally holds and is in search of quite a few patents by itself associated know-how.  I anticipate that Pfizer’s invalidity arguments might be focused towards particular issues with the Moderna patents fairly than making an attempt to considerably increase the regulation.  We would see a special technique if a non-profit or consumer-focused group had filed. We noticed the latter within the Supreme Court docket’s 2013 Myriad choice.

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Declare 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 studying body encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle.

Notice that the court docket broadly outlined betacoronavirus to incorporate later-invented types.  This leaves the declare open to enablement and written description challenges.

The ‘574 patent claims strategies of utilizing modified messenger RNA (mmRNA) with decreased immune activation properties in comparison with unmodified mRNA and in addition a barely completely different composition declare. Not like the ‘600 patent, these don’t give attention to the spike protein however are extra generic variations of utilizing the mRNA know-how.

1. A technique of manufacturing a polypeptide of curiosity in a cell in a topic in want thereof, comprising administering to the topic a pharmaceutical composition comprising a modified messenger RNA (mmRNA) such that the mmRNA is launched into the cell, whereby the mmRNA includes a translatable area encoding the polypeptide of curiosity and includes the modified nucleoside 1-methyl-pseudouridine, and whereby the pharmaceutical composition includes an efficient quantity of the mmRNA offering for elevated polypeptide manufacturing and considerably decreased innate immune response within the cell, as in comparison with 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,

whereby the lipid nanoparticles comprise an mRNA encoding a polypeptide, the place within the mRNA includes a number of uridines, a number of cytidines, a number of adenosines, and a number of guanosines and whereby considerably all uridines are modified uridines.

Lastly, the ‘127 patent claims strategies of administering a composition comprising mRNA encoding a betacoronavirus spike protein formulated in a lipid nanoparticle.  These claims specify p.c ranges for ionizable cationic lipid, impartial lipid, ldl cholesterol, and PEG-modified lipid parts within the lipid nanoparticle.

1. A technique comprising administering to a topic a messenger ribonucleic acid (mRNA) comprising an open studying body encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle in an efficient quantity to induce within the topic an immune response to the BetaCoV S protein or S protein subunit, whereby the lipid nanoparticle includes 20-60 mol % ionizable cationic lipid, 5-25 mol % impartial lipid, 25-55 mol % ldl cholesterol, and 0.5-15 mol % PEG-modified lipid.