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.”
Docs:
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.
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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.
Why was $20 billion spent developing a COVID-19 vaccine when Moderna, back in 2016, already taught one of ordinary skill exactly how to do it without requiring undue experimentation?
Most of that money was spent scaling production. You have to teach the world how to make and use an invention to get a patent, but you do not have to teach the world how to make and use it at scale. Teaching how to make and use a small batch is enough to satisfy the enablement requirement. Nevertheless, if you want to solve a global pandemic, the scaling is important.
Wasn’t the government the only one to purchase the mRNA ‘vaccine’ and then distribute. And were not other special government acts such as tranching tons of money Warp speed! to pfizer also involved? I’m a little surprised that Pfizer didn’t figure out some government contract immunity – i.e., we were ordered by the government to infringe – take your action to the claims court removal theory. Meh, the super IP lawyers at big pharma letting me down.
That argument has been presented. It remains to be seen whether it will succeed.
It’s also not clear it’s an actual defense to “patent infringement” (vs. an argument that the federal government should pay the defendants’ damages).
Did the defendants try to join(?) Uncle Sam? Does this mean the case needs to be transferred?
I hope Congress comes up with some kind of automatic mandatory licensing arrangement for patents similar to what was done for copyrights, i.e. mechanical licenses for covers of songs. Patents should not inhibit research into areas pertaining to critical technology preventing extinction level events. There is an obscure provision in the PCT treaty blocking enforcement of patents for these kind of critical technology like the technology to prevent a pandemic. Anybody know more about the PCT provision out there?
PCT Treaty is not self-enforcing as US law.
You would need a US law reflecting the PCT clause that you seek.
Also the plaintiff isn’t seeking an injunction i.e., there is no “inhibiting” here??
Indeed – and also, there is no inhibiting research anyway.
Now, if one wants to turn around and profit from that research, and in doing so violates the nature of the patent right…..
Why? They are only fighting over money and bragging rights. Here, however, they are fighting over additional payments to the ‘co-inventors’ at CDC and NIH, Fauci. Probably says it all.
“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.”
The pandemic is not over.
From link to osfhealthcare.org
***
With President Joe Biden formally declaring on May 11, 2023, the end to both the COVID-19 public health emergency and the national state of emergency, does that mean COVID is over?
The simple answer is no. COVID-19 is still a pandemic, and the virus continues to mutate into other variants, infecting people and in some cases, resulting in death.
The U.S. Centers for Disease Control and Prevention (CDC) is still reporting more than 85,000 cases in the U.S. every week, resulting in hospitalizations and deaths in the thousands. The numbers continue to decline, but the virus is still a concern.
…
***
NOIP,
Just saw a newclip on the EG.5 (Eris) strain.
Even as a “variant of interest,” COVID is largely now merely another type of ‘flu,’ and while perhaps technically still a pandemic, the level of impact really only is a concern for those with severe co-morbidities (as would be most any virus).
Note that the court broadly defined betacoronavirus to include later-invented forms.
Prof. C., I think you meant “later-discovered” forms. Hopefully no one is out there deliberately inventing new forms of coronavirus.
… gee, maybe you have head of this thing called Gain of Function.
Yeah, gee-nius, I have, and I don’t agree that modifying properties of an existing virus is tantamount to inventing a new one.
Also, the Court agrees with my terminology. See p. 10 (term does not exclude betacoronaviruses “discovered or developing post-filing.”).
That statement of the court does not vouch for your attempted point here.
Not even close.
This doesn’t even merit a response, but against my better judgement, I’ll just point out that Moderna’s own Markman briefing refers to “betacoronaviruses discovered after October 21, 2016” (p. 12). I wonder if they have any experience with the subject. Who can even really say, right?
Your comment was: “Hopefully no one is out there deliberately inventing new forms of coronavirus.”
My response was directly on point to human action.
That means invention, not discovery.
Your wanting to submit non-sequiturs of what others may have done have nothing to do with the point of our exchange.
Use your “better judgement” on that.
It’s night time, and the ships are in motion.
O’Tay Pumpkin.
ModeRNA really drew the lucky straw (or the unlucky one, depending on how you look at it) by getting Nicole Erin Kinsey White as the examiner for this case. I doubt that there is even a single other examiner in AU1648 who would not have rejected this claim on written description grounds.
I agree that the Markman construction of “betacoronavirus” is good for ModeRNA in that Pfizer could win SJ of non-infringement if “betacoronavirus” were construed as “betacoronaviruses in existence as of the filing date.” Nevertheless, Pfizer should easily be able to tank the claim as a reach-through based on that construction. ModeRNA is not going to win on this claim, one way or the other.
That seems quite possible. But I also wonder, because they are doing this via a functional limitation of “encoding …”. If they were claiming a betacoronavirus directly, I agree it would likely be a slam dunk. The functional limitation seems to give them more wiggle room though.
It also seems a bit similar to Myriad in that what they really want to get coverage for is information—the particular encoding of this or that protein, such as a spike protein. Without having any knowledge or expertise in this field whatsoever, I’m going to venture that, once you have the right information at hand, constructing the actual composition to encode it with mRNA is fairly routine.
Further to this, according to the Court, Examiner White “interpreted the claims as being directed to only those betacoronaviruses that were known to exist as of October 21, 2016.” (p. 11) So are you in fact saying the claim interpretation leading up to the failure to reject on 112(a) grounds was wrong? I would tend to agree, but I just want to be clear on what happened during prosecution.
Just trying to square up the information being batted around here…
DC: “ The court found the intrinsic evidence indicates the term encompasses betacoronaviruses discovered after the filing date.”
Koto: “according to the Court, Examiner White “interpreted the claims as being directed to only those betacoronaviruses that were known to exist as of October 21, 2016.”
Sounds like the judge thinks the Examiner construed the claims incorrectly?
Yes, I would agree that’s what the Court thinks—the Examiner’s interpretation was incorrect.
That said, as I’ve pointed out above, the whole framing (no pun) of the issue is a little clunky, in my view at least, because “betacoronavirus” is not being claimed on its own, or directly, but rather indirectly and only as a qualifier to the “S(pike) protein” that is “encoded” by the “mRNA … open reading frame.” Specifically, I find it awkward to decouple “betacoronavirus” from “S(pike) protein” and then try to construe each one in isolation (no pun again). And even if you construe them together, you still have the issue that the betacoronavirus S protein isn’t really claimed affirmatively, but just via the “encoding” functional limitation. The whole thing is kind of ungainly IMO.
I haven’t looked at the specification yet but Moderna’s game for many, many years has been to pick a category of potential targets (e.g., “coronaviruses”), recite massive lists of nucleotide sequences related to that category, and recite mostly boilerplate technology related to RNA expression for interference or protein synthesis. It’s a constant churning machine but their “neat trick” is polluting the well for others and also trying to pull the rabbit out of a hat where they mix and match their disclosure as needed to “capture the moment”, if you get my drift. Suffice it to say that the lawyer-drafted prophetics tend to run waaay ahead of the actual reduction to practice. Lots of interesting work to be done just analyzing the effect of Covid on patent filings by Pfizer, Moderna and other companies. Compare and contrast with other patent system responses to other catastrophic events (including earlier pandemics) and compare and contrast to slower but also predictable hugely disruptive events (e.g., climate change).
The important thing is better online bingo management software, of course.
Just to be super clear, there are two different standards for claim construction: (1) Philips, for use in court; and (2) BRI, for use in prosecution at the USPTO. It is possible for a construction to be right under one standard and wrong under another.
The examiner was supposed to apply BRI. I think that it is indisputable that the examiner did not apply BRI. Obviously, a construction that reads on both coronaviruses already in existence and those yet to come is broader than a construction that reads only on those already in existence. In that sense, she got it wrong. If she had applied BRI, the logical conclusion that would follow is that the application does not describe coronaviruses-yet-to-come, and therefore the claims fail the written description requirement.
I am not sure that the examiner’s construction is wrong under the Philips standard. Clearly the district judge did not agree with the examiner’s narrower construction, but until the CAFC weighs in, we do not know who is wrong as between the examiner and the judge.
Just because they might have rejected based on WD, doesn’t mean that they should have. WD is based on the understanding of a POSITA, and even in 2015 (priority date of the ‘600 patent), we had a really good idea what the overall structure of a betacoronoavirus S protein was. There had already been 2 major epidemics (fortunately, not pandemics – MERS and SARS COV1 were way more deadly than SARS COV2) mediated by betacoronaviruses, so more than a little analysis of the genetic and protein structure had been done. If you are a POSITA with the tools commonly available to the technology, it takes no imagination to recognize when you have a nucleotide sequence that encodes a betacoronavirus spike protein. Importantly, even when these patents were filed, WD would have been pretty solid. We had lots of sequence analysis tools that had already been useful for identifying SARS COV1 as a betacoronavirus – the virus had been fully sequenced by 2003, and by 2004, it was known that the outbreak probably included 2 different variants. The MERS outbreak happened in 2012 – 3 whole years ahead of the priority date of the ‘600 patent. Importantly, we already knew enough about the sequences of SARS COV1 and MERS, not to mention coronaviruses in general, to know that betacoronaviruses were structurally distinct from alpha-, gamma-, and deltacoronaviruses, and that they are the most clinically relevant coronaviruses for humans (betacoronaviruses were also known to cause the common cold). Now, I would have to review the patents for whether they enabled such a range of RNAs, or even whether it was obvious in light of their earlier patents on the base technology. But WD shouldn’t really be an issue (whether it becomes one is a different story – the technical acumen of Americans is generally poor, especially in the context of judicial proceedings, and the ends often justifies the means. See, e.g., the application of 101 to everything.) For what it’s worth, I had to refresh my memory on the timelines on all of this, but I remember very distinctly when SARS COV1 emerged. I was a grad student in the field and it was a HUGE deal. I also had a decent amount of experience in nucleotide and protein sequence analysis. I know first hand that it would not have been a stretch to be able to identify pretty much all nucleotide sequences that encoded a betacoronavirus S protein by 2004 or 2005. Whether those sequences could be used for any given purpose at that time would have been a question. But the priority date of the ‘600 patent was 2015. The tools for sequence analysis were much more powerful by then, so enablement might not have been a problem either. Obviousness might have been a problem by then, though.
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