Before I could even get one cup of coffee down the hatch this morning, I was hit with a barrage of emails, texts, and phone calls asking me for quotes concerning the press release issued by Moderna regarding their decision to sue BioNTech/Pfizer for patent infringement relating to the insanely profitable SARS-CoV-2 mRNA “vaccine” products marketed by BioNTech/Pfizer (“Comirnaty” – licensed but not actually marketed in the USA). What I had hoped to do today was put on my work clothes and go pick up the ditch trencher that I had reserved so that we can get fiber optic cable laid down between the various buildings that form our farm compound, including the new recording studio. And to try to finish editing on the book – “The lies my government told me and the better future coming”. But no, once again the tyranny of the urgent has ambushed me, and like a shakedown in a NY City alley, I must comply.
Let’s dive into this. I have done the diligence, reviewed the (amazingly superficial) press coverage which has been printed on this topic, and have already responded to three different interview and statement requests. Hopefully, by putting my thoughts down in the form of a substack article, I can just refer future inquires to this analysis.
Among the many things I have learned about the corporate (and academic) press over the last three years it is how completely incompetent they are when it comes to being able to read and understand patents. This really became apparent during the concerted efforts made by corporate press, scientific press (including the NEJM), wikipedia editors, and U Penn/BioNTech seeking to claim that Kariko and Weissman came up with the invention , to Paul Offit making derisive statements in a podcast interview and in the New England Journal of Medicine. All of which intentionally and willfully disregard the nine issued patents (for which I am a co-inventor) which refute these claims. Note that Paul Offit, for example, is employed by the same university as Kariko and Weissman (UPenn), and for which patent UPenn receives quite significant patent royalty payments. This one by STAT news is particularly egregious. “Loose idea” – 9 issued US patents?
As a bit of background and context on this, it is useful to know that many organizations believe that, in order to obtain necessary recognition to be awarded a Nobel Prize (in medicine or chemistry), it is important to stage a press campaign to promote the discovery and associated scientists. The series of interviews and events leading up to the (unsuccessful) attempt to obtain the Nobel for Kariko and Weissman appear to have been an example of such a campaign, and since the issued patents directly contradicted those claims of original inventorship, for this reason alone it was necessary to demean and gaslight my contributions and to write me out of history, as was clearly attempted.
But back to the Moderna lawsuit. Let’s take a moment to provide some key details relating to patent law, as there are a few things that one must understand to interpret the new claims being made by Moderna against BioNTech.
- Just because a patent has been filed, successfully prosecuted, and issued by the US Patent and Trademark Office, that does not mean that the patent holder (or licensee) has the right to practice that patent. In short, the US PTO does not determine whether the inventor (or licensee) has “freedom to practice”. In the case of the very many mRNA vaccine-related patents which have yet to expire, none have been granted broad claims to the core technology and idea of mRNA being used for vaccines. That is because the idea and the first demonstration (“reduction to practice”) of the idea in a mammal was performed in 1989-1990, and is described in patents for which I am a named inventor. Those patents have now aged out, they are no longer able to be enforced (in a commercial sense), and so those ideas and technology are now “public domain” – in other words, everyone owns them. Moderna, BioNTech, Pfizer and CureVac are able to “practice” those inventions because the patents have expired. Not because they are the original inventors. If those patents had not expired, these companies would not be able to commercially practice them without a license to do so.
- What BioNTech, Moderna, and CureVac currently hold, in terms of issued patents, are what is known as “derevitive” or downstream patents. That is to say that they have obtained patents for aspects which were not claimed in the original patents. These are largely “composition of matter” patents, which is to say that they have claimed specific chemical modifications or biologic sequences not claimed in the original patents. Again, if those original patents had not yet expired, these companies could not “practice” these inventions without obtaining a license to practice the original inventions. They could still get their modifications patented, but could not use those modifications to produce a product. Only after the original patents expired were they free to make products using those original inventions. Merck and Vical essentially never developed mRNA vaccine technology further after I left Vical, but they were quite aggressive in keeping anyone else (including me) from doing so. As a side note, my only compensation (ever) for my contributions in this regard was one US (Susan B Anthony) dollar. So I have no financial dog in this fight. I just object to the slander, defamation, and active attempts to write me (and my contributions) out of history.
- In filing a patent, if one fails to properly cite the prior literature (including previously issued or filed patents), then your patent can be readily invalidated. Likewise if you fail to include someone as an inventor who made a substantive contribution (even something relatively small) on the list of inventors. Fail to cite either prior relevant literature or contributing inventors is grounds for invalidation. As is listing someone as an inventor who did not make a substantial contribution. Furthermore, the order of author names on patents are irrelevant. From the point of view of patent law, all named inventors are considered equivalent, each are able to practice all aspects of the patent, and all must agree to an exclusive licensing agreement (or have signed agreements assigning their rights to someone else, such as their employer- which was my case).
- The general rule of thumb in filing lawsuits for patent infringement (which lawsuits are EXTREMELY expensive to prosecute) is that one should wait to file until there is enough profit to make the effort worthwhile. Generally at a minimum a few million dollars, and usually this is rarely done unless there are hundreds of millions of dollars at stake. So, if you think that someone may have infringed on your patent, you wait in the shadows until the time is right.
So, now Moderna has decided that the time is right to seek damages from BioNTech and Pfizer for patent infringement on a few of its many patents.