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

by Dennis Crouch

Moderna filed a patent infringement lawsuit in opposition to 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 elements of Moderna’s mRNA platform that it claims Pfizer copied – using 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 grievance alleges Pfizer and BioNTech initially examined completely different vaccine designs however in the end selected to repeat Moderna’s method, regardless of being conscious of Moderna’s patents. Within the lawsuit, Moderna is looking for 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 in the course of 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 best way 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 based mostly on implied license, waiver, and acquiescence stemming from Moderna’s public pledge to not implement its COVID-19 patents in the course of the pandemic.  As is common, the reply additionally contains counterclaims that mimic the affirmative defenses — looking for declarations that the patent claims are invalid, not infringed, and unenforceable in opposition to Pfizer.  Right here, these specific pleadings are moderately restricted and, for essentially the most half, typically assert “35 U.S.C. 101, 102, 103, and/or 112.”

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The case is slowly shifting ahead in earlier than Decide Richard Stearns with a trial rougly set for Fall 2024. Most not too long ago, 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 will assist Pfizer show invalidity); whereas others sought slender definitions of different phrases (that will assist Pfizer keep away from infringement).  I attempted to notice the affect of the assorted constructions under. As you may see, every get together received and misplaced arguments, however in the entire this appears like a great choice for Moderna.

• The court docket adopted a broad definition of “unmodified mRNA” prompt by Pfizer that features a assertion that “Unmodified could, however doesn’t at all times, check with the wild kind or native type of a biomolecule.”  (This can 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.  (This can 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.  (This can assist Moderna show infringement)
• The court docket construed “open studying body” to use to each DNA and mRNA. Pfizer had prompt limiting the time period to simply 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 may be translated to provide 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 affect of this ruling, nevertheless it probably favors Pfizer’s invalidity arguments specializing in whether or not sure prior artwork references sufficiently disclose mRNA).

For these of you new to assert 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 fundamental method is that the court docket ought to present the which means that will an individual of extraordinary 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 akin to dictionary definitions and knowledgeable opinion can play a job, however is often secondary to the intrinsic proof.  This ruling on declare building is de facto setting of the stage, with the true motion coming quickly through abstract judgment motions and ultimately the trial.

In my evaluation above, I famous some inference in regards to the affect of the assorted declare building rulings. Please observe that the events haven’t but briefed these points and so we’ll see what occurs.  There could also be an instantaneous abstract judgment movement, however I don’t see that as probably till the shut of discovery.  It is very important keep in mind that declare building isn’t a last dedication on infringement or invalidity, however  merely supplies interpretations of disputed phrases that will likely be utilized in these later determinations. As well as, events usually ask a court docket to rethink its declare building.

Though Pfizer clearly doesn’t wish to be accountable for patent infringement right here, Pfizer additionally holds and is looking for quite a few patents by itself associated know-how.  I anticipate that Pfizer’s invalidity arguments will likely be focused towards particular considerations with the Moderna patents moderately than making an attempt to considerably develop the legislation.  We would see a unique technique if a non-profit or consumer-focused group had filed. We noticed the latter within the Supreme Courtroom’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 kinds.  This leaves the declare open to enablement and written description challenges.

The ‘574 patent claims strategies of utilizing modified messenger RNA (mmRNA) with lowered immune activation properties in comparison with unmodified mRNA and likewise 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 way 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 contains a translatable area encoding the polypeptide of curiosity and contains the modified nucleoside 1-methyl-pseudouridine, and whereby the pharmaceutical composition contains an efficient quantity of the mmRNA offering for elevated polypeptide manufacturing and considerably lowered 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 contains 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 elements within the lipid nanoparticle.

1. A way 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 contains 20-60 mol % ionizable cationic lipid, 5-25 mol % impartial lipid, 25-55 mol % ldl cholesterol, and 0.5-15 mol % PEG-modified lipid.