Bad Medicine: Moderna Sues Pfizer, BioNTech for Patent Infringement

Bad Medicine: Moderna Sues Pfizer, BioNTech for Patent Infringement

Sometimes a case comes along that tests both the limits of the law and the moral and ethical scope of an era.

Moderna’s suit against Pfizer and partner firm BioNTech appears to be such a case—and the downstream effects of the verdict, pro or con, may have repercussions in US patent law for decades or even centuries to come.

Moderna’s suit against Pfizer and partner firm BioNTech

Moderna’s case hinges on the use of messenger RNA (mRNA) to “train” individual cells in the human body to deliver an immune response to specific stimuli. The company asserts it spent over a decade devising and perfecting the mRNA technology used in vaccines for a number of coronaviruses, most notoriously COVID-19, patenting the technologies involved between 2010-2016. Moderna asserts that Pfizer and BioNTech used Moderna’s research as the backbone of Pfizer’s COVID vaccine without proper compensation, leaving the companies open to suits in the US, Germany, and elsewhere.

As evidence, Moderna claims that Pfizer took FOUR different COVID-19 vaccines into clinical trials, but the one that emerged as the Pfizer vaccine is the one that went on to be administered some 358 million times in the United States. (Moderna is in second place at over 228 million doses.)

As of this writing, Moderna has not assigned a dollar figure to the damages to which the company believes it is entitled.

Meanwhile, Pfizer claims that the Moderna case has no legs and that Pfizer/BioNTech’s COVID-19 vaccine was a result of Pfizer’s own efforts and intellectual property. The New York Times quotes a Pfizer spokesperson as being “surprised” to learn of the action, which was filed simultaneously or near-simultaneously in US District Court in Massachusetts and in the Regional Court of Dusseldorf, Germany, but said the company was “confident” of its ability to defend against the suit.

What does the law say?

What does the law say?

According to US law, anyone can sue anyone else, at any time, for any reason, with relatively few limitations. For example, you can’t sue the US Government unless the government agrees to accept the suit. In theory, you could sue someone because you want to give them $100,000,000, and they don’t want to take it, so you take them to court to compel them to accept the money as the result of a court order. The idea may seem outlandish or even cartoonish on its face, but in practice, it could happen—and the plaintiff good chance of win.

Turning specifically to intellectual property law, patents exist for a reason: namely, so the creators and owners of a given innovation can profit from it for a reasonable amount of time before the innovation passes into the public domain and free use for all. Until the patent expires, as long as the patent owner(s) keep up with their registrations and vigorously defend their IP, they are presumed to have full rights to determine who can use their IP, how it can be used, and what it’s going to cost the user for access rights to the patented IP (aka licensing).

Biotech cases like this one present unique hurdles to clear for the plaintiff

Biotech cases like this one present unique hurdles to clear for the plaintiff. Moderna must be able to demonstrate that the mRNA sequencing they used to produce a working coronavirus vaccine was wholly unique and unknown prior to their patent becoming public knowledge. Moreover, Moderna must be able to prove that it was their specific application of technology and processes to a specific application of mRNA that made the vaccine possible, which of course is precisely the argument they’re making.

DNA strand patterns

Here’s where this starts to get really abstruse and more than a little weird: There are specific limits on what you can and cannot patent with regard to biotech. For example, you generally can’t patent naturally occurring DNA strand patterns, human stem cells, or a complete human being, even if you came up with a method of creating any of the above wholly divorced from what we’d consider “usual” processes for creating human life. If, however, you were able to create any of the above through artificial means, it is at least theoretically possible that you could patent the process to do so, if not the ultimate result of the process, as long as you could conclusively demonstrate the patentability, utility, novelty or non-obviousness, usefulness, and lack of prior use of the process. While I don’t know much about German patent law, I can only assume similar mechanisms are in place to govern patents.

Thus, in the eyes of the law, Moderna has a case, provided they can prove their arguments to a judge and/or a jury who may not and likely does not have the scientific background required to properly evaluate and test these claims empirically.

What does the moral argument say?

What does the moral argument say?

What the law says versus what ethics and morality say are often two very different things. We can generally acknowledge that killing and theft are bad things, but the law holds specific cutouts known as “affirmative defenses” to actions that would otherwise be considered criminal. A couple of examples include state-sanctioned execution for capital offenses and the notion of “civil forfeiture,” in which someone suspected or accused of a crime has their property taken by the jurisdiction in which the alleged crime occurred. I’m not going to argue the relative morality or lack thereof in these actions; I’m only presenting them here as conceptual examples of the difference between what’s legal and what most people would consider moral.

While legally Moderna is entirely within their rights, and indeed their obligations as patent holders, to vigorously defend their IP from alleged misuse or misappropriation, there is a moral quandary here as well.

I am by no means anti-patent, but for Moderna to pursue this case at this specific time is really not a great look to the general public. There is a huge gap between what Moderna legally can and should do, and the apparent ethical and moral problem presented by insisting on prosecuting one’s rights to a patent when the result could lead to potentially millions of deaths, such as when a global pandemic like COVID-19 continues to rage. One could argue that morally, Moderna has an obligation not to prosecute its rights in such circumstances, the rights of the patent holder notwithstanding.

Further complicating the situation is that Moderna stated at the onset of the pandemic that it wouldn’t press its patent rights while COVID-19 remained a global pandemic crisis. However, on March 7th, 2022, the company backpedaled on that promise citing a global oversupply of its COVID vaccines, although the statement Moderna put out at the time did leave loopholes and gaps.

First, the company promised it would never prosecute its patents in 92 poor and developing countries. Second, Moderna stated it would not seek damages for any infringing behavior prior to March 8th, 2022. Third, Moderna specifically excluded breakthroughs made while partnering with the National Institutes for Health on developing effective coronavirus vaccines at taxpayer expense, stating that the baseline architecture which made these breakthroughs possible already existed due to the patented processes from 2010-2016. And fourth, and perhaps most confoundingly, Moderna is not calling for the Pfizer/BioNTech vaccine to be pulled from the market under injunction.

The problem with this case isn’t so much the law as the optics.

The problem with this case isn’t so much the law as the optics.

Biotech-based patent cases are notoriously difficult to prosecute successfully. That’s not to say it’s impossible or that it shouldn’t be attempted by any means, but a useful analogy might be explaining the function and workings of a nuclear fission bomb to a caveman. Again, understand this is in no way intended as a statement or slur against the average intelligence or scientific aptitude of the average judge or jury, but a demonstration of how simplistic and refined an explanation of the technology in question may need to be in order to convey properly to make the case. “It go boom” isn’t going to be much use, but that’s basically where you’d have to start to properly explain how and why the specific biotech in question is eligible for patent protection and what makes it novel and useful in a way someone with an average high-school education could readily understand.

More than that, the COVID-19 pandemic, while it seems to be waning, is far from over, continuing to claim lives all over the world. We still have global supply chain problems, rampant illness, and people who only just recover from one strain of COVID before the next one flattens them, sometimes right into the grave. In the face of that, and given Moderna has been reticent to disclose exactly what damages it is seeking from Pfizer/BioNTech, one could argue this is a really bad time to be picking this particular fight from a moral standpoint.

Who’s got the high ground here?

Who’s got the high ground here?

Before I get into this, let me stress once again that I’m by no means anti-patent, at all!

That would be antithetical to my profession as a patent attorney and my passion for protecting innovators.

The fact is, no matter who’s ultimately in the right, the moral lens through which Moderna’s action and the timing of it are viewed is probably going to come into play here, in a way that’s rarely seen in patent cases.

If this goes to a jury trial, the judge can and likely will order the jurors to only consider the relative merits and facts of the case, but jurors are human. Currently, there’s not a lot of popular sentiment on the side of Big Pharma, as anyone who watched the Theranos and Martin Shkreli trials play out in the courtroom and the media knows. Prospective jurors who harbor such biases are unlikely to be able to fully shake them off, regardless of the court’s instructions.

Claim the COVID-19 vaccines

If Pfizer/BioNTech can prove their processes are sufficiently unique from Moderna’s to stand up to scrutiny, Moderna may end up losing a lot more money than they claim the COVID-19 vaccines have already cost them, especially if the defendants countersue. If Moderna prevails in open court, they’re still likely to lose in the court of public opinion because it’s going to look like, at best, sour grapes for being the #2 vaccine based on their own technology, and at worst, a cash grab in the middle of a global public health crisis.

No matter how this plays out, though, someone’s going to come out of it feeling very ill.

ABOUT JOHN RIZVI, ESQ.

John Rizvi is a Registered and Board Certified Patent Attorney

John Rizvi is a Registered and Board Certified Patent Attorney, Adjunct Professor of Intellectual Property Law, best-selling author, and featured speaker on topics of interest to inventors and entrepreneurs (including TEDx).

His books include “Escaping the Gray” and “Think and Grow Rich for Inventors” and have won critical acclaim including an endorsement from Kevin Harrington, one of the original sharks on the hit TV show – Shark Tank, responsible for the successful launch of over 500 products resulting in more than $5 billion in sales worldwide. You can learn more about Professor Rizvi and his patent law practice at www.ThePatentProfessor.com

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