Covid patent fight is about greed, not human health

I suppose I shouldn’t be surprised: one of the companies that developed mRNA vaccines for Covid-19, Moderna, has just sued the companies who make the competing mRNA vaccine, Pfizer and BioNTech, claiming that Pfizer/BioNTech is violating its patents.

Pfizer was surprised though, according to news reports. (Or at least they said they were.)

Moderna had announced, back in 2020, that they wouldn’t enforce patents on their vaccine during the pandemic, but they seem to have changed their mind. Apparently, billions of dollars in profits isn’t enough: they’ve decided the time is right to try to grab even more money.

Let’s make no mistake here: this is purely about greed. Apparently Moderna understands this, since they proudly advertised their earlier plans not to enforce patents on the Covid-19 vaccine. They realized that the public good will generated from such an announcement was valuable.

Not that valuable, apparently.

It’s not even clear that Moderna should have been given the patents it holds. According to a recent story in Science, the key technology behind one of Moderna’s patents was invented, and patented, years earlier by two scientists, Drew Weissman and Katalin Karikó, at the University of Pennsylvania. Their work discovered a way to modify the RNA in the vaccine that would make it much more effective. (Here’s a link to the patent.)

As I wrote last year, patenting the Covid-19 vaccine is unethical. At the time, the US had announced support for a “vaccine waiver” that would allow any country to develop vaccines against Covid-19 without licensing the technology from one of the companies that currently holds a patent. That policy sounded too good to be true–and apparently it was, because no such waiver is in effect now.

The patent system is a creation of modern governments, and they don’t have to let companies get away with this. The profits of a few companies are far, far less important than the lives of millions of people. Allowing companies to restrict Covid-19 vaccine development is, crudely put, defending money over human lives. Maybe it’s time for the international community to institute the vaccine waiver, at least until the pandemic is truly over. 

And make no mistake: even though we have vaccines now, they still need improving, and better vaccines will save lives. Patent disputes will slow down or even prevent work on better vaccines, since the patent holders will have a monopoly. Even the threat of a lawsuit can stymie progress; after all, why would someone invest time and effort on a vaccine that they might never be able to deploy?

Moderna is far from the first company or institution to let greed guide their actions: way back in 2010, I wrote about how MIT and Harvard had filed a patent that was, as I wrote at the time, both inappropriate and harmful. In that case, MIT and Harvard had an incredibly broad patent on a human gene, NF-kB, which plays a key role in our immune system’s response to infections. Granting a patent on NF-kB, as the US Patent Office did, was akin to granting a patent on all drugs that affect nearly any human gene. The universities licensed the patent to Ariad Pharmaceuticals, who filed a lawsuit the day the patent was granted. Neither Ariad nor MIT developed any treatments, but they initially won $65.2 million just because of the patent. (Need I point out that the Harvard and MIT work was mostly funded by the public?)

Fortunately, in the 2010 case, an appeals court threw out the patent, ruling that people and companies cannot patent human genes, because genes are products of nature, not inventions. The mRNA patents, though, don’t fall in this category.

Should I also mention that much of the basic research behind mRNA vaccines was also funded by the public? Or that NIH (and therefore the US government) has patent rights to some of the technology behind the Moderna vaccine?

Moderna, Pfizer, and BioNTech looked like heroes when they first announced their vaccine results–and in some ways, they were. The world was desperate for vaccines against Covid-19, and the mRNA vaccines have saved millions of lives.

But my message to Moderna is simpler: you’re already making billions in profits on the Covid-19 vaccine, so don’t be such greedy assholes. And don’t be evil: drop the lawsuit.

Patenting the Covid-19 vaccine is wrong

The world has recorded at least 166 million cases of Covid-19 and over 3.4 million deaths, according to the Hopkins coronavirus dashboard, and the true numbers are certainly far higher. The only way we will defeat this virus is through vaccines, and fortunately science has delivered the goods, with multiple highly-effective vaccines now being produced. In some countries we are turning the corner: in the U.S. cases have been steadily declining since mid-winter, and are now at their lowest level since last June.

Unfortunately, in many countries the virus is raging unchecked, and vaccines are in very short supply. We won't defeat SARS-CoV-2 until the whole world has adequate supplies of vaccines.

One barrier to wider, more rapid distribution of vaccines is patents. The companies that are making the vaccines have patents on them, which means that no one else can manufacture the vaccines without paying license fees. 

The human species doesn't have time for this nonsense. The profits of a few companies are far, far less important than the lives of millions of people. And yet many governments, including most EU countries, are standing firm behind the patent system. Crudely put, they are defending money over human lives. 

Recently, in a surprising move, President Biden announced support for a "vaccine waiver" that would allow any country to develop vaccines against Covid-19 without licensing the technology from one of the companies that currently holds a patent. The UK is now considering supporting a waiver as well, but other countries in the European Union and the G20 have come out against any waivers. The EU position seems to be that if you can't pay, you can't have the vaccine, even if your own scientists have the expertise to manufacture it themselves.

I've been an outspoken critic of patents for many years, including gene patents (which never should have been allowed in the first place) and software patents (which are frequently filed for trivial ideas and often used primarily to create lawsuits), but patents on the Covid-19 vaccine are objectionable for a different reason: they're unethical. If companies persist in enforcing them, the governments that approved the patents should simply invalidate them.

I know that many people will tell me I'm naive for suggesting this. I have heard their arguments before, many times. These include claims that without the patent system, companies simply won't invest in new inventions, and the public will suffer. These claims are, bluntly put, wrong.

In a famous 1955 interview, Jonas Salk, the inventor of the polio vaccine, was asked by journalist Edward Murrow who owned the patent. 

“Well, the people, I would say," Salk replied. "There is no patent. Could you patent the sun?" 

And yet despite not being patented, the polio vaccine was successfully produced and distributed, and as a result humans have essentially eliminated polio from the world. (It still persists in a handful of countries, due to political and economic reasons as well as vaccine resistance.)

Just a few days ago, epidemiologists Gregg Gonsalves and Gavin Yamey (from Yale and Duke) published a public call for a "people's vaccine," which would require waiving patent rights on Covid-19 vaccines. They point out that vaccine waivers are just one step among several that we need to take, as a species, if humans are going to defeat this pandemic. So if I'm naive, I guess I'm in good company.

Why do we have the patent system at all? When you think about it, the patent system is a government-supported, guaranteed monopoly on a commercial product. The only possible reason for governments to support this is that the citizens of their countries will benefit. The patent system was never designed to guarantee the profits of private corporations and law firms–but of course these groups have profited immensely from patents, and they have created an entire ecosystem to defend the status quo.

But I digress. The Covid-19 pandemic is a worldwide health crisis that surpasses anything we've seen since the 1918 influenza pandemic. Stopping the pandemic, and ending the suffering and death of millions of people, will require getting vaccines into most of the world's population, whether they live in rich countries or poor ones. Patents and the licensing fees that come with them can only slow down this process.

That's why enforcing patent protection on any Covid-19 vaccine is unethical. The companies that are claiming patents could fix this by announcing that they will offer their technology for free to anyone in the world, but we can't expect that to happen. President Biden's announcement that the U.S. supports a patent waiver, and the UK's likely announcement of a similar position in the coming days, are a great move in the right direction. Let's hope that the rest of the world's governments follow suit.

Can you patent a fraudulent stem cell method? Yes!

Woo-Suk Hwang talks to reporters after
fraud is revealed. Photo: Reuters.

At first I thought the Patent Office was having a little fun. Was it an April Fools Day joke?  No, it's only February - and the U.S. Patent Office never kids around.

What did they do? They issued a patent to Korean scientist Woo-Suk Hwang for a method to create human embryonic stem cells by cloning.  The problem is, Hwang's "invention" was one of the most famous frauds of the past decade. His publications in 2004 and in 2005, in the journal Science, are labelled in bright red letters as retracted, and Science wrote its own separate notice explaining

"the authors of two papers published in Science (2, 3) have engaged in research misconduct and that the papers contain fabricated data."

Hwang's apparent triumph, becoming the first scientist to create human embryonic stem cells in the lab, made him a national hero in South Korea, for a short time.  He was soon appointed the director of a new stem cell research center. But things quickly unraveled beginning in November 2005, when Hwang's co-author Gerald Schatten, a stem cell researcher at the University of Pittsburgh, announced that he was ending his collaboration with Hwang over ethical concerns. By January, Hwang admitted to publishing fake data, but blamed his junior colleagues. Hwang was fired from Seoul National University (SNU) in 2007 and later convicted of bioethical violations and embezzlement. The official investigation by SNU found that Hwang's laboratory

"does not possess patient-specific stem cell lines or any scientific basis for claiming to have created one."

So you wouldn't think this would be approved for a patent, no?  Is the patent office paying any attention at all?  As reported by Andrew Pollack at the New York Times, the patent office does indeed know Hwang's history, and the patent is 

"definitely not an assertion by the U.S. government that everything he is claiming is accurate."

Well, I must say I'm relieved to hear that. Hwang himself admitted the data were fake! As I've written previously, the USPTO simply can't keep up with biotechnology, and the courts don't do any better. In this case, it's hard to imagine a more obvious example of a patent that should be denied: the papers were retracted, and the lead scientist lost his job after his own university concluded that the data was fabricated. And yet the patent office is standing by their decision. What are they thinking?

Did you scan and email a document recently? You might owe $1000 to a patent troll.

We've seen how badly the U.S. patent system is broken when it comes to gene patents.  The recent U.S. Supreme Court case overturning Myriad Genetics' patents on the human breast cancer genes, BRCA1 and BRCA2, was a step in the right direction.  But the problem goes much deeper than that.  The U.S. Patent and Trade Office (USPTO) simply can't keep up with technology, and as a result its lawyers keep granting patents that they just don't understand.  As a result, completely obvious ideas end up as patents, inhibiting innovation and keeping beneficial technology out of the hands of the public.  This is just the opposite of what the patent system is supposed to do.

It's not only gene patents that confuse the USPTO.  They also fail miserably when it comes to computer technology.  Some years ago, they issued a patent for scanning in a document and emailing it.  This idea is so obvious that it probably was "invented" by thousands of people back in the early days of scanners, and most of them probably didn't think to patent it.  But one guy did, and now his patent is owned by a patent troll: a company that doesn't make anything, but threatens to sue everyone in sight to extort money from them.

And now we have a law firm that is going around demanding $1000 in licensing fees from everyone who scans a document and then emails it.  ArsTechnica wrote about this back in April, and again in May when HP decided to fight back, pointing out that HP was selling printers that could scan and email documents before the patent in question was granted.

But that's kind of not the point, is it?  The USPTO should never have granted this patent, which was just for the idea of scanning and emailing - the inventor didn't build anything, nor did he create some novel technology.  Patenting ideas for computer programs as "business methods," which the patent office started allowing back in the 1990s, opened the floodgates to patent trolls, and we're suffering the consequences today.

And now, surprisingly, two U.S. states are fighting back.  In the past week, Vermont's and then Nebraska's attorneys generals have sent letters telling the patent troll (a company called MPHJ and its lawyers, a firm called Farley Daniels) to leave their citizens alone, as the Washington Post reported this week.  They might win, too, using a new law in Vermont that lets victims of patent trolls sue back.

The problem is that we have a large and powerful industry of patent lawyers who are deeply invested in the current system, and fight tooth and nail against any attempt to change it.  Perhaps the recent egregious over-reaching by some greedy folks, including those who hold patents on human genes, will finally make it clear that the patent system is broken and in desperate need of major reform.

Supreme Court bungles the science in DNA patent decision

[This is slightly modified from my post 2 days ago at Forbes.]

The Supreme Court ruled this week that Myriad Genetics doesn't own your DNA after all.  Myriad holds patents on the BRCA1 and BRCA2 genes, which are linked to an increased risk of breast and ovarian cancer, and they charge exorbitant fees for their DNA diagnostic test of those genes.  As I've written before (such as this 2012 Clinical Pharmacology article), Myriad didn't invent the genes, and the patents should not have been granted.  So in large part the Supreme Court got it right.

But they got the science wrong, as any geneticist reading today's decision will realize immediately. In the very first paragraph, they make no less than three errors of fact.  First, they write:

"The nucleotides that code for amino acids are 'exons,' and those that do not are 'introns.' "

Not correct.  Here's the facts: when making DNA into a protein, the cell copies DNA into RNA.  Big chunks of the RNA are spliced out and discarded.  Those are "introns."  What remains is "exons."  That's it.  The nucleotides that code for amino acids are contained within the exons, but they are not the same thing. It's not unusual for 25% or even 50% of the nucleotides in the exons to be ignored when stringing together amino acids to make a protein.

Error number 2 comes next, when the Court writes:

"They [scientists] can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA)."

Wrong again.  cDNA stands for complementary DNA, because the DNA produced is the complement of the original strand. This means that each nucleotide is replaced with its complement: A and T are complementary, and C and G are complementary.  The court gets this right later on in the ruling.

Just after this, they write:

"cDNA contains only the exons that occur in DNA, omitting the intervening introns."

Ouch! Wrong again.  cDNA simply means a complementary copy of DNA, which doesn't have anything to do with exons.  If you make a cDNA from a mature messenger RNA transcript, then yes, it will contain only the exons.  But you can make cDNA from other parts of the genome, and from other types of RNA transcripts.

There are more errors further down in the decision. For example, they write that "Nucleotides that do not code for amino acids, in contrast, are known as 'introns.' "  This just compounds one of the errors above.  They also used the term "pre-RNA" instead of the correct term "pre-mRNA."  I could go on.

It's troubling that the highest court in the land can't get even the basic facts of molecular biology right when writing a decision that has such fundamental importance to genetic testing, the biotechnology industry, and health care.  I cannot pretend to know who they got to do their biology background research, but any genetics graduate student could have done far better.