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):

https://www.documentcloud.org/documents/22266051-22-08-26-moderna-v-pfizer-biontech-patent-infringement-complaint

The patents-in-suit in the Massachusetts case are

• U.S. Patent No. 10898574 on the "delivery and formulation of engineered nucleic acids";

• U.S. Patent No. 10,702,600 and U.S. Patent No, 10,933,127, both on a "betacoronavirus mRNA vaccine."

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):

• Moderna's U.S. lead counsel is William F. "Bill" Lee of WilmerHale. He's a legendary patent litigator, and I've repeatedly quoted something he said in 2013: "I'm old enough not to believe in coincidences anymore."

  Mr. Lee is based in Boston, the venue where the complaint was brought.

• Moderna's European law firm is Freshfields, with Netherlands-based Rutger Kleemans having the European lead, and Dr. Frank-Erich Hufnagel (typically Apple's lead counsel in Germany, thus mentioned on this blog on countless occasions; he's based in Dusseldorf) and Munich-based Dr. Nina Bayerl litigating the German enforcement action.

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.

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BioNTech, Pfizer file complaint against CureVac in District of Massachusetts, seeking declaratory judgment of non-infringement of three mRNA patents

This is the first time for FOSS Patents to report on a life sciences case--a first that is warranted by the extraordinary significance of the related dispute. Less than three weeks after CureVac, a biopharmaceutical company headquartered in Germany and funded by (inter alia) SAP co-founder Dietmar Hopp, announced its Dusseldorf patent infringement action against BioNTech over the alleged use of foundational mRNA-related patents in the latter's COVID vaccine (named Comirnaty), BioNTech and its strategic partner Pfizer filed a declaratory judgment action in the District of Massachussetts taking aim at three of CureVac's U.S. patents.

While BioNTech and Pfizer need no introduction anywhere in the civilized world, there as a time when politicians were bullish about the prospects of CureVac delivering one of the first COVID vaccines--if not the first. Then-President Trump even offered a funding bonanza to CureVac--in exchange for which the company would have had to relocate to the U.S. at least with respect to its work on a coronavirus vaccine. Alarmed by those overtures, the German federal government became minority shareholder, and the European Commission--together with the European Investment Bank--entered into a financing agreement with CureVac. In the end, CureVac wasn't among the winners of the race, though the company is working on a next-generation COVID vaccine that may ultimately be approved.

The question on which it is still too early for me to take a position is whether CureVac is a "sore loser" who is now attempting a patent shakedown of the glorious winner of the race to the first truly effective COVID vaccine--or whether BioNTech was "standing on the shoulders of giants" from the get-go, in which case CureVac would clearly be entitled to substantial compensation. It is potentially a multi-billion dollar question, and it would be wrong to harbor prejudice toward one party or the other, as the idea of patent law is not to reward success in the marketplace but to incentivize research and development. It's not a ball game where you just count the goals. It's a lot more complex and nuanced than that. Simply put, if CureVac made a wrong call in its COVID vaccine development, but had the right vision before BioNTech even started to develop Comirnaty, then its case may be perfectly meritorious and patent law may then be more meritocratic than the marketplace. We just don't know yet.

Here's the U.S. complaint:

https://www.documentcloud.org/documents/22121278-22-07-25-pfizer-biontech-dj-non-infr-complaint-v-curevac

CureVac's German complaint is not seeking an injunction--just fair compensation. CureVac emphasized that it never intended to disrupt the development or delivery of COVID vaccines in the midst of a pandemic, and that the company waited even with its complaint for monetary relief until this point. That makes sense.

At the same time, Pfizer and BioNTech have made a strategically very smart move, too:

• With its narrative that portrays CureVac as a sore loser (without using that term), the complaint is directed not only at the court of law (and the jury to be selected further down the road) but also at the court of public opinion.

• Pfizer is headquartered in New York but has a home-field advantage anywhere in the United States, and BioNTech has one of its two U.S. offices in the Bay State--and that's where CureVac's U.S. office is based, so it would be hard for CureVac to get the case transferred to another district.

  As a cross-jurisdictional patent litigation watcher I don't agree with CureVac's choice to bring only a Dusseldorf case. If CureVac had brought the first U.S. case as well, it could have tried to pick the most favorable district. Some of the preferred districts for patent holders (Eastern District of Texas, Western District of Texas, Eastern District of Virginia) would probably not have been defensible choices as they are merely target markets for Pfizer and BioNTech just like, say, the Southern District of Alabama. But CureVac could have sued in the Southern District of New York (Pfizer HQ), which has recently also been a pretty good venue for patent holders to assert their rights, or in the District of Delaware (Pfizer is a Delaware corporation, as are possibly other parties).

• Pfizer and BioNTech are seeking declarations of non-infringement, not of invalidity. That makes sense for two reasons: U.S. juries are very hard to persuade of invalidity contentions, and when you are already being sued in Germany and don't know whether the patentee may at some point throw in an additional prayer for injunctive relief, any determinations by foreign courts that confirm the validity of the patents-in-suit will dissuade a German court from staying the infringement proceedings pending a local invalidity action. Should Pfizer and BioNTech have reasonably meritorious invalidity arguments, they might instead file for PTAB inter partes reviews.

At this point it looks like Pfizer-BioNTech is the more sophisticated side here, which may be attributable to Pfizer's ample experience more than anything else. But litigation tactics won't prove decisive in the event that CureVac truly did pioneer mRNA-related technologies relevant to mRNA-based COVID vaccines.

It also remains to be seen whether CureVac will enforce its intellectual property rights against other COVID vaccine makers, which would be the logical thing to happen if CureVac's patents are truly mRNA-essential, and whether other companies holding mRNA-related patents will sue BioNTech and/or Pfizer.

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Conservative politicians shouldn't join Greens and communists in calls for compulsory licensing of COVID/mRNA vaccine patents

This post is a departure from my blog's industry focus that I wouldn't have contemplated if not for the highly unusual circumstances we're facing in the COVID-19 pandemic. The scientific aspects of pharmaceutical patents are above my head, but that also applies to the heads of those politicians proposing compulsory licensing of such patents in the current situation.

I just became aware of a disconcerting statement by the chairman of the center-right European People's Party (EPP) group in the European Parliament, Manfred Weber MEP (Christian Social Union, CSU), quoted in a German newspaper article (my translation):

"If need be, admitted vaccines must also be made by others on the basis of compulsory licensing."

This is the same Manfred Weber who lent unconditional support to the EPP's Axel Voss MEP with respect to upload filters (EU Copyright Reform). In other words, he wants IP overenforcement against kids who upload videos from a private party to YouTube, with some commercial music playing in the background, but he wants to deprive the companies who made a miracle happen--the availability of multiple COVID-19 vaccines after such a short time--of their rights.

His party, the CSU, is the regional sister party (comparable to the Minnesota Democratic-Farmer-Labor Party vs. the Democratic Party) of Chancellor Angela Merkel and European Commission President Ursula von der Leyen's party, the Christian Democratic Union (CDU). It's unlikely that he would toss out such an idea if it hadn't at least been floating around in those circles.

The EU is obviously in deep-shit trouble. In yesterday's New York Times there was an article entitled Slow Pace of Vaccinations Pushes Europe Toward Second Economic Slump. The numbers speak a clear language: as of the start of February, Israel had administered at least one dose of a COVID-19 vaccine to almost 60% of its population, the United Arab Emirates to approximately 35%, the UK to approximately 15%, the U.S. to approximately 10%, and the EU only to about 2%-3%. As I explained early last month, the EU's purchasing decisions were wrong at any given point in time just based on then-available information (New York Times Coronavirus Vaccine Tracker)--and liability issues do not serve as an excuse, as it's simply a reality in a seller's market that not only prices but also other terms are impacted by the demand-supply discrepancy. And money could have solved the problem at the right time by enabling certain companies to invest in European manufacturing capacities early on--just what ex-president Trump achieved with his Operation Warp Speed program.

German and other EU politicians shouldn't make themselves ridiculous by sometimes arguing in the same interview that the U.S. can outvaccinate the EU because it's such a large country, and Israel does so because it's a small country. Some politicians sound like those communist leaders did in the late 1980s before the fall of the Iron Curtain.

The problem is not going to get solved anytime soon, though I was surprised by the good news regarding the Russian Sputnik V vaccine, which appears to beat all other adenovirus vector-based COVID vaccines by a wide margin by using a different vector for the second (booster) jab (and both vectors appear to be unharmful human adenovirus strains)--the EU may end up importing that one. Meanwhile, the virus keeps mutating at a pace that makes it hard to follow. Yesterday, for instance, the BBC reported that the UK just found "more coronavirus cases with 'concerning' mutations."

A crisis is a terrible thing to waste. The EU should learn its lesson and reform itself. Brexit has its first success story (outvaccinating the EU by a factor of 5), and the EU will make things only worse if it doesn't think things through. The Daily Mail was never the EU's best friend, but in this article the British newspaper quotes media from all over Europe, including some very EU-friendly ones, who concluded they can't defend the indefensible anymore with respect to the EU's temporary intentions to put border controls in place between the Republic of Ireland and Northern Ireland in order to enforce vaccine export restrictions (which are, by the way, the epitome of "vaccine nationalism" as opposed to people being all for a coordinated EU effort, but criticizing what went wrong).

Even to only toss out the idea of compulsory licensing in this particular context is an insanity.

In the tech sector, I'm against injunctive relief except maybe under the most egregious of circumstances. Just yesterday I stressed again that patent remedies must be proportionate. And I'm not ruling out at all that maybe, further down the road, some general mRNA-related patents might prove overbroad--and compulsory licensing might be needed on antitrust grounds, should there be a clear and present danger of only one or two companies ultimately being able to make that new generation of vaccines (and potentially other types of mRNA-based medications).

But in the current situation, there simply isn't an economic case for compulsory licensing of COVID-19 vaccine patents. (To be clear, patent remedies are only available after publication of the related applications, and COVID-19 is too new for anything to have been published yet, but there are some general mRNA-related patents and patent applications that BioNTech might be able to enforce already against anyone plagiarizing their COVID-19 vaccines.)

The cost of lockdowns and similar restrictions is so high that there's enough money to be made not only for the companies that invented the vaccines but also by those who merely manufacture them. The recent deal between Pfizer partner BioNTech and Sanofi (which invested in BioNTech two years ago) shows that solutions can be worked out at the negotiating table. It's not just about immediate revenue opportunities: every contribution to what may help to solve the COVID-19 problem generates political goodwill and nice publicity.

What governments should do is incentivize such partnerships by making offers that enable both the inventor and the manufacturer to be generously rewarded. There's this saying that you sometimes achieve more with a gun and a smile than with a smile alone. In this case, however, the solution is money, not governmental heavyhandedness like in a plan-based Soviet-style economy.

I have to stress again that what I just wrote was only about COVID-19 vaccines. I do very much believe in the compulsory licensing of standard-essential patents (SEPs), as most of my readers know. But there's a difference between a couple or a handful of patents reading on a COVID-19 vaccine, with enormous risks taken, and the hundreds of thousands of patents one could theoretically assert against a smartphone maker or automotive company--and no single one of which patents truly protects a major investment in research and development.

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