Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts

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):

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

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.

Tuesday, July 26, 2022

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.

Wednesday, February 3, 2021

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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Wednesday, January 6, 2021

Compared to the EU's COVID VaxGate, Watergate was merely a transgression: two questions of life or death the EU can't answer satisfactorily

I already mentioned in my first post this year about the EU's miserable failure to buy COVID-19 vaccines (as compared to the U.S., Canada, the UK, Israel, and Bahrain), primarily because the French government didn't want the EU to buy too many doses from non-French companies. That scandal now has a far higher profile, with two of the three parties in Merkel's governing coalition already having voiced criticism in public. Many politicians and reporters in other EU member states haven't understood the significance of this yet. Even France itself will suffer far more from the consequences of Macron's worst initiative than it ever stood to gain.

Merkel and Macron are the Axis of Evil. Many thousands of Europeans will die because of their failure. That's why this is so much worse than Watergate. The EU's VaxGate amounts to political mass murder.

Two questions about COVID-19 vaccine purchases force the EU Commission, the Merkel government, and all their apologists (especially but not only in state-owned media) to be evasive (or to lie):

  1. German newsweekly Der Spiegel cited anonymous sources involved with the EU's vaccine procurement effort as saying that Macron (apparently even personally) told the EU not to buy the 500 million doses of Pfizer/BioNTech's vaccine that could have been in the November 11, 2020 purchase agreement. At that point, Pfizer/BNT had reported amazing Phase 3 results and were clearly ahead of everyone else, and other governments had already secured huge amounts of that vaccine several months earlier. But Macron didn't want an American-German joint project to save Europe from COVID, so he vetoed anything that would have resulted in Pfizer/BNT selling more doses to the EU than French Sanofi, which at that point had already fallen far behind.

  2. A closely related question they can't answer is why the EU signed a deal with slow-moving Sanofi (which won't be able to ship before late 2021, if ever) on September 18, but with front runner Pfizer/BNT almost two months later--while other major purchasers (U.S., UK, Israel etc.) had done so way earlier.

    The difference of two months actually understates the asymmetry by far. One has to look at how much progress a given research project had made at the time. The EU signed with Pfizer/BNT only after they reported stellar results from their Phase 3 study, while Sanofi got a yuuuge contract before it even had any Phase 1 results to show. This is like if one athlete got the Olympic gold medal before the race even starts, while another won't get it until after crossing the finish line ahead of the rest of the world.

These two questions get asked. Obviously, the EU apologists and Merkel sycophants among European political reporters wouldn't raise such tough questions. But there are plenty of unbiased reporters out there, and the analytically stronger ones among them have figured out that those two questions get to the heart of the problem.

If anyone points to the need for diversity (of vaccines, and also of vaccination technologies), that's not wrong but fails to address the above questions. You could have had diversity and still could have placed the right bets. That's simply the combination those other buyers, such as the U.S., achieved.

Diversity is related to costs. But that's a smokescreen. The cost of those COVID lockdowns in Europe is so high that even if the EU had matched offers by the Trump Administration and Israel, and even if they had contractually committed to such quantities in the aggregate of multiple vendors that they could have vaccinated every EU citizen ten times, it would have been cheap compared to the costs of those lockdowns. To put this into perspective, Pfizer/BNT gets about 12 euros per dose from the EU. That's about 25 per vaccinated person. Multiply this by four (other vaccines actually cost less, or even much less), and you arrive at a cost of €8 billion for Germany (approximately 80 million inhabitants), where the cost of a protracted lockdown amounts to hundreds of billions of euros as Dr. Daniel Stelter and other economists have pointed out. Frankly, "penny-wise and dollar-foolish" is a gross understatement when you're dealing with a cost to Europe that is practically in the trillions of euros versus a cost in the billions.

One of the things you'll hear from the EU Commission is that they deny any political reason behind the Sanofi deal. Let's give them the benefit of the doubt that they had a reasonable basis to assume Sanofi would deliver (it actually ran into serious problems after the deal). But the question is not whether the Sanofi deal might have made sense if viewed in isolation. What neither the EU nor the Merkel Administration have denied so far is that the French government prevented the EU from upping the purchase volume in its Pfizer/BNT deal, especially as it was signed after Phase 3 and at a point when Sanofi was far, far behind. That was just pharma protectionism and nationalism on the French government's part--which will cost many thousands of lives this year, make many people suffer COVID symptoms, make people lose their jobs, and make companies go out of business.

Under President Nixon, people died because of a war he had inherited. The Merkel-Macron Axis of Evil (as Merkel simply supported what Macron was doing) will be responsible for countless deaths in 2021.

One of the "red herrings" in this context is that they say they'll eventually get enough for every EU citizen to be vaccinated, and the current bottleneck is manufacturing capacity. Yes, and that's why the EU's decisions were so terrible. At a minimum, by placing a large order early on, rather than the same quantity later, or a smaller quantity first and a reorder later, you make sure your orders are high up in the queue. Also, if the EU had committed to 500 million doses when it signed the Pfizer/BNT deal (which had obviously been under negotiation for more than a couple of days, but it would always have been easy to just modify a couple of numbers in the contract), Pfizer/BNT would have had a basis for investing sooner and more aggressively in additional European manufacturing capacity.

The problem facing the EU now is that customers such as the U.S., UK, and Israel are ahead of them in the queue. It's not a strict sequence in the sense that the EU wouldn't be served before the others are, but the others get a lot more at this point.

Another red herring that doesn't get better by being repeated also fails to address the real issue: they like to point to logistical issues in various EU member states, and different regions of Germany. While it's plausible that there are now, at the start of the mass vaccination effort, places where the bottleneck is of an organizational nature, it's just a question of one or two months until those minor local and regional shortcomings have been addressed, and then a shortage of supply will be the only major problem. A lethal shortage, that is.

Apart from those points, a German Member of the European Parliament, Merkel minion Peter Liese, said on TV that the Trump Administration and other early adopters of the Pfizer/BNT vaccine accepted weaker indemnification clauses, which caused a delay in the EU. But it's simply a business reality that in a seller's market, it's not just that prices may go up but also that other deal terms may not be the ones a buyer prefers. But who would want to let people die and suffer, and companies go out of business, over an indemnification clause?

Similarly irrelevant is the fact that a group of four countries (Germany, France, Italy, and the Netherlands), who were originally working on a joint-purchasing initiative before they asked (under pressure from Merkel and von der Leyen) the EC to take over, primarily wanted to sign a deal with AstraZeneca in June. That was before the EU's deals with Sanofi and Pfizer/BNT, and there's no evidence that they were going to rely exclusively on Astra.

The excuses I just mentioned are merely diversionary tactics. But some of the apologists are either extremely stupid or liars: they argue that even by the summer, Sanofi was considered to be ahead. The truth is this: you can take any EU decision and look at when it was made, and then you look up the New York Times' Coronavirus Vaccine Tracker, which will show you that Pfizer/BNT and Moderna had actually been in the lead when the EU still prioritized other vendors.

The question is not whether VaxGate is the absolute low in the history of the European Union, and whether countless people will die as a result. The only question is whether they'll be able to somehow mitigate the damage. Yesterday Merkel expressed hopes that the supply situation would improve as a result of additional vaccines being approved. She particularly mentioned AstraZeneca (Dr. Fauci wonders whom to vaccinate with an inferior product), Johnson & Johnson (also a vector-based vaccine, like Astra's), and CureVac. Interestingly, CureVac's technological approach is mRNA, like Pfizer/BNT's and Moderna's, and the EU signed a huge deal with them. But they, too, fell behind at some point. It's possible that major commitments had already been made to CureVac in Europe, besides a direct investment by the German government, just to dissuade them from selling out to Trump. However, the best way to make the right purchasing decisions is to track the progress of the projects--and not to listen to Macron.

It's pretty clear now that the EU and the Merkel Administration will overstate the efficacy and understate the adverse affects of whatever vaccine the European Medicines Agency will approve. After not buying an extra 200 million doses (500 vs. 300) from Pfizer/BNT and another 300 million from Moderna (they've meanwhile bought some, but again the problem is where you are in the queue), even at a point when those companies were the clear leaders, they've proven to be irresponsible and even immoral. So who would care about a lower efficacy of a vaccine or some adverse effects? European citizens are treated terribly by their governments. They'll do anything to cover up for their mistake. Hell is freezing over as Merkel even called Vladimir Putin these days to discuss joint vaccine manufacturing options. Her legacy will be death, disease, and economic destruction. But to the extent they can, they'll mislead people, defend indefensible decisions, and resort to inferior products.

They'll keep saying that no one could know what vaccine would become available first. But when there's a free public resource like the New York Times Coronavirus Vaccine Tracker that provided all of the key facts one needed to know at any given point in time, it's clear the EU simply didn't decide based on the merits of those research projects.

They'll also keep accusing any critic of VaxGate as being a "nationalist" who didn't want a European approach. I, for my part, wouldn't care if the EU's joint-purchasing cartel--a monopsony--had benefited European citizens. Theoretically, it could have. Practically, Brussels means backroom deals and horse trades. And it means you have ruthless people like Macron abusing the system, even to the detriment of his own electorate in this case.

Throughout the year, the numbers, however, will continue to expose the impact of VaxGate. The vaccination gap between countries like the U.S., UK and Israel on the one hand, and the EU on the other hand, will widen for many months at least. The COVID-19 death count will speak a clear language (relative to population size, more people are presently dying from it in Germany than in the United States, which the mainstream media hardly ever mentions). By the end of 2021, it will be easy to see that Brussels backroom shenanigans will have killed many Europeans. And there'll be parliamentary investigations, with particularly a libertarian German party, the FDP, demanding special committees in both the German and the European Parliament.

I've been following COVID-related topics, including the vaccine situation, very closely. When you build a real-time strategy game about a virus during the coronavirus pandemic, you obviously pay more attention than otherwise.

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