Friday, August 26, 2022

Moderna files patent infringement actions against Pfizer and BioNTech in Massachusetts and Dusseldorf over COVID-19 vaccine, seeking only damages and carefully excluding 92 poorer countries

One month ago, I noted--in my first blog post ever on a life sciences patent case--that "Pfizer-BioNTech is the more sophisticated side [than CureVac], which may be attributable to Pfizer's ample experience more than anything else." And I was wondering "whether other companies holding mRNA-related patents will sue BioNTech and/or Pfizer." That question has just been answered: Moderna just announced that they filed parallel patent infringement complaints against Pfizer and BioNTech "for infringing patents central to Moderna's innovative mRNA technology platform" in the United States and Germany.

The U.S. complaint was filed with the United States District Court for the District of Massachusetts, which is precisely the venue Pfizer and BioNTech picked for their declaratory-judgment action against CureVac; the German action was filed with the Dusseldorf Regional Court (CureVac's choice).

The patents-in-suit were filed between 2010 and 2016. In 2010, Moderna began building a "foundational platform"--according to its CEO Stéphane Bancel (a native of France who now lives in the United States)--and in 2015 and 2016, Moderna specifically obtained patents on its "work on coronaviruses." COVID-19 is colloquially referred to as "the coronavirus" but it's called SARS-CoV-2 for a reason: there was an earlier SARS (severe acute respiratory syndrome) coronavirus, and there are also non-SARS coronaviruses (such as one that causes the same symptoms as the common cold).

Moderna's press release reads like a textbook example of corporate social responsibility: not only does it stress that no injunction is being sought (which is also what CureVac was very clear about), but Moderna is not even "pursuing monetary damages on sales to the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92)." Such a carve-out is exemplary, if not unprecedented. Also, "[n]one of the patent rights which Moderna is seeking to enforce relate to any intellectual property generated during Moderna's collaboration with the National Institutes of Health to combat COVID-19. That collaboration began only after the patented technologies at issue here were proven successful in clinical trials in 2015 and 2016."

The complaint also doesn't relate to "sales to the U.S. government that are subject to 28 U.S.C. § 1498" or to sales prior to March 8, 2022. Moderna once made a pledge for the duration of the pandemic, but made it clear earlier this year that the time had come to get compensated.

Another interesting aspect of Moderna's press release is the unusually detailed description of the infringement allegations:

"First, Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna's innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax®. Moderna scientists began developing this chemical modification that avoids provoking an undesirable immune response when mRNA is introduced into the body in 2010 and were the first to validate it in human trials in 2015.

"Second, and again despite having many different options, Pfizer and BioNTech copied Moderna's approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged."

Here's the U.S. complaint (this post continues below the document):

The patents-in-suit in the Massachusetts case are

Interestingly, the law firms and even some of the key attorneys representing Moderna against Pfizer and BioNTech have previously represented Apple against Samsung and other companies (more recently, just in defensive cases, but originally on the enforcing side):

It remains to be seen who will represent Pfizer and BioNTech; most likely, the same attorney as in the CureVac case: Dr. Christine Kanz of Hoyng Rokh Monegier.

Pfizer and BioNTech are now facing infringement actions brought not only by a company whose initial effort to create a COVID-19 vaccine failed (CureVac), but also one by a company that delivered one of the very best COVID vaccines: Moderna. A "sore loser" narrative wouldn't work in this context.

I'm a "mix-and-match" vaccinee: I started with AstraZeneca's vaccine, followed by BioNTech's Comirnaty (which was the plan from the beginning), and in January I got a Moderna booster. I have great respect for all the parties to Moderna v. Pfizer & BioNTech, and will read the answer to the complaint with great interest. At this early stage, Moderna makes a fundamentally stronger first impression than CureVac for various reasons, and they'll definitely have a better story to tell in court. That said, an alleged infringer is innocent until proven liable.