by Dennis Crouch
I just talked about the new Moderna v. Pfizer patent infringement lawsuit with my patent class. I showed them Claim 1 of asserted US10898574. One student who has some biotech background offered the insight: “Wow, that claim is really broad … effectively covers the industry standard.”
- Read the Complaint. Asserting U.S. Patent Nos. 10,898,574, 10,702,600, and 10,933,127.
Another student suggested that equitable estoppel may be an issue. Back in 2020, Moderna indicated that it would not be asserting its patents during the midst of the COVID-19 pandemic. In particular, Moderna made the following public statement: “while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic.”
Apparently for Moderna, the pandemic was over by March 8, 2022. As such, Moderna is only seeking monetary damages “for Defendants’ infringement occurring on or after March 8, 2022.” The complaint also carves out “sales to the U.S. government that are subject to 28 U.S.C. § 1498 or to the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC).” US Gov’t sales would require a separate action under Section 1498 in the Court of Federal Claims. Apparently a simultaneous lawsuit has been filed in Germany.
The complaint does not seek injunctive relief, so this is directly about the size of the damage award. Although I have no direct knowledge of this, I suspect that there were some limited negotiations and the competing offers differed by more than an order of magnitude.
The technology here all centers genetically modified mRNA with code for a particular polypeptide of interest (e.g., the spike protein). Claim 1, of the ‘574 patent, for instance claims a method to get the cell to start producing the protein by administering the mRNA. Here, the claim calls for simultaneously introducing N1-Methylpseudouridine, which serves to suppress immune response and increase protein production. Claim 2 of the same patent is directed to a pharmaceutical composition of “lipid nanoparticles” that encase the mRNA.
Patent litigator Bill Lee (Wilmer Hale) is representing Moderna. Pfizer has not yet filed an appearance.
DC: “ The technology here all centers [around] genetically modified mRNA with code for a particular polypeptide of interest (e.g., the spike protein).”
Just to be clear, none of the claims in this patent are limited to a particular nucleic acid sequence, whether expressed as a direct sequence or “coding for” a polypeptide.
Seems quite a risky move for Moderna. I think this should put pressure on Wilmer for not screwing over Moderna. Pfizer may very well have prior patents that they may not have been intending to assert but now they have to. Moderna may lose their patent protections now..
Moderna may lose their patent protections now.
This matters less than one might think. Firstly, ModeRNA has data exclusivity on top of their patent protection, so they are shielded from generic competition even if they lose all of their patents. Secondly, these vaccines are not easy to manufacture (much harder than traditional, protein-based vaccines), so there are barriers to market entry for competition that go beyond legal barriers. Finally, patents are business tools, and like any other tool, they frequently get broken in the course of business. That is just a part of the business, like freezers or lipid mixers wearing out in the course of use.
Seems quite a risky move for Moderna.
I agree that it is a risky move, but on balance I think that it is the right sort of risk. A company that never takes risks will never grow. You are correct that suing Pfizer materially increases the likelihood of breaking ModeRNA’s patent estate, but it also materially increases the likelihood of increasing the revenue from an ultimately negotiated license and settlement agreement. For the reasons listed above, the downsides of breaking the patent estate are less than one might expect, while the upsides of increasing the revenue stream are potentially large. I think that ModeRNA is making the right business decision here.
Just curious, but even if Pfizer has patents Moderna infringes that may not affect the validity of Moderna’s patents, and might it not even encourage a cross-license settlement avoiding validity tests? Also, if Moderna’s patents are that broad and valuable, might a generic drug manufacturer try to challenge their validity or breadth anyway?
[Similar questions re the CRISPER patents mess?]
Re the prior blog on corporate patent application cheapness, this is an example of the reverse. This Moderna US10898574 patent is 103 columns long, has the longest applicant prior art dump I have ever seen, and the mere 10 claims are probably not including related cases, as this already complex family history on page one suggests:
“Continuation of application No. 15 / 379,284 , filed on Dec. 14 , 2016 , now Pat . No. 9,950,068 , which is a division of application No. 14 / 337,513 , filed on Jul . 22 , 2014 , now Pat . No. 9,533,047 , which is a continuation of application No. 13 / 897,362 , filed on May 18 , 2013 , now abandoned , which is
continuation of application No. 13 / 437,034 , filed on Apr. 2 , 2012 , now Pat . No. 8,710,200 . FOREIGN PATENT DOCUMENTS a CA CA 2028849 A1 9/1991 2473135 A1 6/2003 ( Continued ) OTHER PUBLICATIONS ( 60 ) Provisional application No. 61 / 470,451 , filed on Mar. 31 , 2011”
In addition to all of that there is a sequence listing (although it’s not a particularly large file).
This Moderna… patent… has the longest applicant prior art dump I have ever seen…
You must not have reviewed many pharma patents. I agree that this one is long, but nothing like the longest I have ever seen. It is regrettable that the CAFC has chosen to craft rules that favor burying the examiner under a mountain of art, but that is the state of the law. For continuations of continuations in an important pharma patent family like this one, several pages of prior art citations are pretty much par for the course.
Truly. I mentioned the sequence listing above and it is in fact included in Paul’s column count. A mere 17 sequences. Other Moderna applications have listings of thousands of sequences.
The ballooning of IDS references in a large patent family (or across a number of technologically related families) is unavoidable once the various applications enter prosecution at the national stage. The minimal diligence requires cross citation of the cited references and (some would argue) office actions themselves. The references pile up quickly. Is there a ton of redundancy and not really relevant stuff in that list? No doubt.
Thanks Dozens, and yes, gratefully, I never had to look at the cited prior art list for a patent issuing from such a lengthy chain of serial continuations and divisionals since Lemelson’s heydays, much less in such an important pharmaceutical patent.
HEY DONALD DUCK,
It seems your information was given to you by the very person you were counsel to. SO why would the ….. hide all your prosecutions if they weren’t in it with you.
When my cousin told me how he was able to know when his car had reached the correct position in his garage, and I found it was one of your prosecutions, I shared that on this blog, and FB. SO it is very possible you may have taken over for Malcolm. The reason I say this was not you in the beginning is because you aren’t bald, and neither is Eddie.
I don’t know if Pfizer will want to raise this as a defense because they could be on the wrong end of it in the future, but the PREP Act might protect them for anything during the time when their vaccine had an EUA.
From my very basic reading on the case and patents, it also sounds like one major issue will be about the role of government scientists in the invention of these patents and questions about their ownership of these patents because of that.
So, let’s say when I was hit by the Car, I got hurt bad. My whole right side was busted up. They even claimed because I was tossed around it caused my brain to shake around. I invent, you steal thinking I am an easy mark
42 USC CODE STATUTE 1201 SAYSYOU HAVE BROKEN THE LAW.
You have denied me my fundamental civil rights under the ADA ACT.
I have more ideas. As a matter if fact you even took some to market.
So now I have a lawsuit that has been on the books longer than your conspiracy.
I agree regarding breadth of claim 1. The modified mRNA is claimed in terms of function, not structure, and uses a relative descriptor — increased production and “substantially reduced” innate immune response.
I share your distaste for all of that functional fluff. As Judge Rich wrote in In re Ruschig, 343 F.2d 965, 973 n.8 (C.C.P.A. 1965), “attorneys often write compound claims including a statement of some inherent property,.. [but w]here the balance of the claim fully identifies the compound… and the property is inherent, we fail to see that such statements add anything to the claim definition of the named compound.” Still and all, while such functional fluff writing does not really add anything to the claim’s validity, I do not see that it should necessarily subtract anything either, so long as the structural definitions in the claim are sufficient.
Here the claim requires that one administer the mmRNA to the cell, and that the mmRNA contain 1-methyl-pseudouridine. Had no one ever administered mRNA containing 1-methyl-pseudouridine to a cell before for therapeutic purposes? Is the modification of the mRNA with the 1-methyl-pseudouridine sufficient by itself to achieve the unexpected results on which patentability was predicated? I do not actually know the answers to those questions, but if the answer is “yes” in both instances, then the claim should still hold good, even if it is full of a bunch of fluff verbiage that I would prefer had been omitted.
Excellent analysis of the situation, particularly the second paragraph.
I do not disdain using functional language. I was just commenting on the breadth and why. Sometimes in biotech, functional language is the only way to avoid claiming too narrowly and giving a gift to potential infringers.
It worked so well in Amgen v. Sanofi, or Juno v. Kite.
Sadly, true.
In the Moderna complaint, they allege that the functions recited were attributed the use of 1-mehtyl-pseudouridine.
Relative descriptors like “effective amount” should be treated as means plus function.
Why?
Because you “feel” like it?
It seems though that you are confused on a multitude of legal concepts.
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