Even though the significance of biotechnological firms' patent rights was widely appreciated well before the outbreak of the COVID-19 pandemic, the very scale of the new and promising COVID-19 vaccines has transformed it into a new dimension. Also the range of financial revenues that COVID-19 vaccines generated for the firms was substantial1. It has incentivized all firms involved to strive to get as much of this vaccine pie as possible.

  1. The firms involved have engaged in a series of lawsuits regarding the infringement of valid patents, esp. the ones concerning the LNP and mRNA technologies, made by the firms' rivals (who sometimes happened to be their former collaborators).
  2. In August 2022 Moderna, well known as a manufacturer of one of the top COVID-19 vaccines, i.e. Spikevax, started a legal battle2 with its main rivals, Pfizer and BioNTech, by filing lawsuits both in the US and in Europe (in Ireland, Belgium, the Netherlands and in the UK)3. The main reason for these legal actions was that - allegedly contrary to their legal obligations - the defendants had made use of the technologies and chemical compounds that were covered by Moderna's valid patents without even trying to negotiate the purchase of a license.
  3. The more specific Moderna allegations included: a) the rival firms' use of the LNP platform (lipid nanoparticles) to encapsulate mRNA (messenger RNA technology) in order to bring them to the targeted cells, b) the replacement of uracil with N1-methylpseudouridine in the vaccine mRNA (chemical alteration of the uridine-based vaccine to avoid detrimental immune system's response)4. Given the seriousness of these allegations, it is no wonder that Moderna has decided to take some steps to address the alleged infringements.
  4. At first, in the early months of the pandemic in 2020, Moderna started with a pledge not to enforce its patent rights during the pandemic. However, in 2022, as there were clear signs that the pandemic was almost over, the company decided to revise its pledge and announced that it will, among other things not seek to remove Comirnaty (Phizer/BioNtech's vaccine) from the market or press for the injunction against its future sales, it will not seek a cut of Pfizer/BioNtech's sales for the US government nor will it seek damages on account of the same or claim damages from the latter, and it would not claim damages for infringements occurred before March 8, 2022.5
  5. The pledge not to seek removal or injunction was apparently the most ambitious one but, on the other hand, it is easy to imagine how detrimental to Moderna's public image would be to act otherwise.
  6. This is why, instead of pressing for an injunction, Moderna decided to seek compensation and damages, including royalties and lost profits incurred since March 8, 2022.
  7. The most contentious issue in this case and in some other vaccine-related ones, was the patent right to the LNP and mRNA mechanisms. These are the very mechanisms without which the vaccines could hardly exist. The patent right constituted the main subject matter of a series of lawsuits brought by various biotech firms, for instance, Arbutus Biopharma and Genevant Sciences, Alnylam, Promosome LLC. The main problem depicted in the suits constituted an infringement of the plaintiffs' patent rights by their rivals.6
  8. In February 2022 Arbutus Biopharma and Genevant Sciences, both firms, filed a lawsuit against Moderna and its Spikevax vaccine. They claimed that Spikevax was produced and offered for sale with the infringement of six plaintiff's patents7. The main claim referred to the defendant's infringement related to nucleic acid-lipid particles and lipid vesicles, as well as compositions and methods for their use8. It is these right lipid compositions and delivery method (LNP) that allegedly brought about the expected and desired response from the immune system. In their view, the unauthorized use of these compositions and LNP method was in clear breach of US patent law and warranted suitable royalties for the infringement in question. No wonder that in this case the plaintiffs sought proper compensation rather than an injunction or other means of blocking the production, sales and distribution of the said vaccine. The plaintiffs allegedly decided to opt for a court route for the lack of any meaningful Moderna's response to their licensing proposals. It is worth to notice that both companies used to collaborate at an earlier time.
  9. In the second lawsuit in April 2023, this time against Pfizer and BioNTech, Arbutus sued these firms for an unauthorized use of its LNP technology protected by its five patents. The basic claim was that the LNP mechanism that Pfizer/BioNTech uses in the production of its vaccine (Comiranty) was indispensable for its final success. Arbutus claimed that it had been working on the LNP delivery systems for years and licensed the technology to various companies.9 The firm claimed damages, including reasonable royalties from the defendants.
  10. Quite recently (June 2023), Promosome LLC decided to sue Moderna, Pfizer and BioNTech, accusing these firms of infringing Promosom's patent related to messenger RNA technology. Promosome claimed that in 2009 scientists affiliated with the company, i.e. D.Edelman, V.Mauro, S.Chappell and Wei Zhou "discovered a method for increasing protein expression by making small changes to the mRNA that could affect the amount of protein produced without altering the amino acid sequence encoded by the mRNA".10 What needs to be emphasized here is that, according to the filings, these scientists granted the company an exclusive license to this patent, which means that the method was patent-protected (known also as '179 Patent).
  11. In March 2022 Alnylam, a biotech firm, filed two separate suits against Moderna and Pfizer, claiming that these companies' vaccine manufacturing processes made use of the technology covered by Alnylam's patent related to biodegradable cationic lipids11. The patent known as a so-called 933 Patent "claims a class of cationic biodegradable lipids that can be used in the formation of LNPs for the delivery of an active agent, including mRNA".12 Alnylam is not seeking an injunction on the production, distribution and sales of the vaccine in question but instead wants a "fair compensation" for the use of its technology.
  12. As far as Moderna is concerned, the company does clearly not share this view and claims that the LNP mechanism in its vaccine was greatly improved, if compared to its Alnylam's counterpart. That is why Moderna categorically rejected Alnylam's claims13.
  13. Setting aside some technical details involved, and to summarize the main aspects of these lawsuits, let's try to focus on some of their legal aspects which seem to be of great importance in the years to come.
  14. First, it is hard to overestimate the importance of legal instruments such as patents in business. But for them, it could be hardly possible to incentivize firms to invest such huge sums of money in R&D activities. This is even more true when it comes to biotech firms.14 No wonder then that a number of firms active in the field (app.30) impatiently await a final resolution of the patent disputes mentioned above. Valid patents for the owners of mRNA and LNP mechanisms will certainly bring them large sums of license fees.
  15. Second, let's focus on Moderna's unusual legal defense which is based on a piece of old US legislation. This defense consisted in "absolving"any defendants from patent infringement lawsuits, should such lawsuits interfere with the supply of war materials during World War 1. Under Moderna's interpretation of this particular US legislation, Arbutus lodged the lawsuit against the wrong party, because instead of suing Moderna, it should have brought its action against the US government. What is even more surprising, this view was shared by the US government but for slightly different reasons. In view of the US government, even if we assume for the sake of argument that Moderna violated plaintiffs' patents, as long as it acted within the terms and conditions of its contract with the US government (as a part of the Operation Warp Speed), it should be released from the responsibility for the alleged violations.15
  16. Therefore, the problem of a defense basing on contracts with public authorities has gained importance now and may shift the responsibility for patent right infringement from the government contractors to the government itself.
  17. At the time of completing the text it has been publicly announced that the 2023 Nobel Prize in Physiology or Medicine has been awarded to Katalin Karikó and Drew Weissman "for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19"16.
  18. An interesting question is whether the fact of Nobel Prizing for these two scientists will be made to an argument in the legal disputes, or will have any impact on the results of the disputes.


1. See https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-pfizer-hit-with-new-patent-lawsuits-over-covid-vaccines-2023-06-06/, https://fingfx.thomsonreuters.com/gfx/legaldocs/gdvzqorngpw/PROMOSOME%20MODERNA%20LAWSUIT%20complaint.pdf

2. See Moderna v. Pfizer, 22-cv-11378; see also: Moderna Sues Pfizer and BioNTech for Infringing Patents Central to Moderna's Innovative mRNA Technology Platform, MODERNA, August 26, 2022; for some interesting details, see, for instance, Pfizer, BioNTech Vow "Vigorous" Defense vs. Moderna Patent Lawsuit, GEN: Genetic Engineering and Biotechnology News, September 26, 2022.

3. Most recently, Moderna also filed a lawsuit at Dusseldorf Regional Court. See Fraiser Kansteiner, Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report", Fierce Pharma, Jul 11, 2023.

4. On some doubts concerning validity of this claim, see Jon Cohen, Scientists question Moderna invention claim in its vaccine dispute, Scienceinsider, 29 August 2022; See also very informative release by D.Curley, A. Easey (Pennington, Manches, Cooper): The Moderna v Pfizer-Biontech COVID-19 vaccine dispute: a brief explanation (November 30, 2022);

5. See MODERNA, op.cit. note 1.

6. Interestingly enough, it was Alnylam whose legal action in March 2022 preceded the one taken by Moderna. In its filings, the firm accused both Moderna and Pfizer of formulating their vaccines using Alnylam's proprietary LNP drug delivery technology. The firm was seeking "fair compensation" for this infringement. This legal move was repeated by Alnylam in 2023. (See Nicola deFendis, Alnylam files a new set of lawsuits against Moderna and Pfizer over COVID-19 vaccines, EndPoints News, May 30, 2023.

7. See Arbutus Biopharma Corp v. Moderna Inc, US District Court for a District of Delaware, no 1: 22-cv-00252.

8. See Anthony King, Moderna sued over COVID-19 vaccine-related patents, Chemistry World, March 10, 2022.

9. See Catherine Offord, Pfizer and BioNTech Sued for Patent Infringement Over mRNA Vaccine, BioSpace, April 13, 2023.

10. See for instance Tristan Manalac, Moderna, Pfizer Hit with New COVID Vaccine Patent Lawsuits, BioSpace, Jun 7, 2023. See also Natallie Rocha, Moderna, Pfizer sued over technology developed by San Diego researchers that made COVID-19 vaccine possible, The San Diego Union-Tribune, June 6, 2023; Black Brittain, Moderna, Pfizer hit with new patent lawsuits over COVID vaccines, Reuters, June 6, 2023;

11. Known as 933 Patent and issued by the USP&TO in February 2022.

12. Cited from Mark Keown, UPDATE: Alnylam Seeks "Fair Compensation" for Lipid Technology Used in mRNA COVID-19 Vaccines, BioSpace, March 17, 2022. Basic description based on the UPDATE.

13. See Mark Keown..., op.cit., passim.

14. On the importance of patents for the biotech firms, see, for instance, Scott Berinato, Moderna v. Pfizer: What the Patent Infringement Suit Means for Biotech, Harvard Business Review, September 26, 2022.

15. See for instance Black Brittain, US Backs Moderna, Says Government Should Face the COVID-19 Vaccine Lawsuit, Reuters, February 15, 2023.

16. https://twitter.com/NobelPrize/status/1708780262883017166?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1708780262883017166%7Ctwgr%5Ebe9af57f023353412b1354081b4582ceeda9a7d8%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fpulsembed.eu%2Fp2em%2F-DOe2pEGi%2F

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