The US Gov't Paid For Moderna To Develop Its Vaccine; But Moderna Wants To Keep The Patent All To Itself

from the no dept

Folks may know that when Jonas Salk created the polio vaccine he chose not to patent it, and when asked who owns the patent on it, responded: "Well... the people I would say. There is no patent... Could you patent the sun?"

Whenever people bring this up, patent maximalists -- especially those in the pharma world -- like to come up with all sorts of excuses about how that was "different" somehow. My favorite excuse was that he did this because "the public had funded the vaccine."

Fast forward to today. Moderna, somewhat famously, helped produce one of the very first COVID vaccines using its mRNA technology. It's a great thing (I got two Moderna shots in my own arm as soon as I could). You may have heard a lot about Moderna as well. While the company had been around for a decade, this vaccine is its first product on the actual market. It had been experimenting with mRNA technology, but hadn't actually come out with anything until the COVID vaccine.

But -- and this is the important part -- it was the US government, and by that we mean "the US public," who mostly funded Moderna's COVID vaccine... and it was actually US government employees who did a lot of the important work. At the beginning of the pandemic, the US government gave Moderna $483 million dollars to work on the COVID vaccine. A few months later it gave another $472 million.

Also, Moderna now admits that US government employees were critical to the development of the vaccine:

Moderna acknowledged that scientists at NIH's National Institute of Allergy and Infectious Diseases (NIAID) played a "substantial role" in developing Moderna's messenger RNA (mRNA) vaccine...

So, "the public" funded this vaccine, and the public -- via the government which represents us -- helped do the scientific work necessary to make the vaccine.

But Moderna wants the patent. Indeed, it initially refused to even share the patent with the US government. Last month there was a bit of a legal fight as the NIH did the legal equivalent of asking Moderna "WTF?"

The vaccine grew out of a four-year collaboration between Moderna and the N.I.H., the government’s biomedical research agency — a partnership that was widely hailed when the shot was found to be highly effective. A year ago this month, the government called it the “N.I.H.-Moderna Covid-19 vaccine.”

The agency says three scientists at its Vaccine Research Center — Dr. John R. Mascola, the center’s director; Dr. Barney S. Graham, who recently retired; and Dr. Kizzmekia S. Corbett, who is now at Harvard — worked with Moderna scientists to design the genetic sequence that prompts the vaccine to produce an immune response, and should be named on the “principal patent application.”

Moderna disagrees. In a July filing with the United States Patent and Trademark Office, the company said it had “reached the good-faith determination that these individuals did not co-invent” the component in question. Its application for the patent, which has not yet been issued, names several of its own employees as the sole inventors.

Apparently the NIH and Moderna had been "negotiating" about this when Moderna made that filing. As this went public and people (rightly) started calling Moderna out for this bullshit, Moderna took a half step backwards and claimed that it was willing to share the patent with the US government (and said "Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic.")

But, it seems like we should go a step further: there's no reason to patent this. I have no problem with Moderna getting plenty of profit for its important role in developing the vaccine. And, it is. The company went from having losses every quarter through last year, to making billions in profit this year. It made over 7 billion in net income (not gross) this year through the first three quarters.

That's not because of its patent. It's because it's producing something that is important to humanity, which governments are more than willing to pay for, and which remain in high demand globally.

So, don't try to hog it. Don't try to hog it from the US government. But don't even try to "share it" with the US government. Share it with everyone. Let the people "own" it by refusing to patent it at all. After all, would you patent the sun?

Filed Under: covid-19, nih, ownership, patents, vaccines
Companies: moderna

Pharma Giant Fails To Mention -- For 18 Years -- That US Government Helped Fund A Key Patent Used In Drug That Has Generated $53 Billion In Sales So Far

from the reasonable-terms dept

It's no secret that drug prices are often high, and continue to rise -- by 32% in the past five years according to one analysis. It's only natural that many should be willing to pay even exorbitant amounts for drugs. If there is the hope of a cure, or at least of some relief from pain and symptoms, for themselves or their family, most people would probably put that above money.

It's less obvious why drug prices are so high in the first place. The standard response from the pharma industry is that companies need incentives to develop new treatments, and these are typically in the form of the high prices they can charge. Although plausible, it overlooks the important contribution that publicly-funded research makes here. Many new drugs are made possible thanks to ground-breaking early work by academics in universities or institutes, not in companies. That's not something that Big Pharma likes to talk about, as this post from James Love on the Bill of Health blog reminds us:

This is a story about U.S. patent number 6,958,335, and how it took more than 18 years for Novartis to acknowledge National Institutes of Health (NIH) funding in a key patent for Gleevec, allowing Novartis to shape the narrative regarding its role in the development of Gleevec, and also to avoid demands that Novartis make the invention "available to the public on reasonable terms," which is an obligation under the Bayh-Dole Act.

Gleevec is one of the drug industry's biggest successes. An article on the Nature site explained back in 2008:

Some say it's a miracle drug. Others call it a silver bullet. Gleevec, also marketed internationally as Glivec and sometimes referred to by its chemical name imatinib, entered the medical world with a bang. This medication was initially approved for use by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of chronic myelogenous leukemia (CML), a rare form of cancer that affects certain types of white blood cells.

That "miracle drug" has meant big money for Novartis. According to the Bill of Health blog post, by the end of 2018, the cumulative sales for Gleevec exceeded $53 billion. Love notes that as an invention that was partially funded by taxpayers, Novartis ought to have made the invention "available to the public on reasonable terms". That would presumably have translated to a lower price, and possibly to more people taking the drug, and more lives being saved. Those didn't happen, because Novartis didn't acknowledge the NIH funding until now, a mere 18 years late. Sadly, this is not an isolated case of forgetfulness, as Love points out in his conclusion:

[Knowledge Ecology International] has written the NIH on several occasions to identify cases where inventors have failed to acknowledge federal funding in patent applications. Such cases have not been difficult to find. In the 1990s, Congress and [US Department of Health & Human Services] investigated such failures to disclose, and found widespread non-compliance with disclosure mandates, and lax oversight. This is an area where new Congressional oversight would be welcome, particularly as the question of the federal role in drug development is being spun by various parties.

That's worth bearing in mind the next time Big Pharma tries to justify eye-watering drug prices because of the innovative research required to create them.

Follow me @glynmoody on Twitter, Diaspora, or Mastodon.

Filed Under: drugs, gleevec, glivec, nih, patents, pharmaceuticals, public funding, reasonable terms
Companies: novartis

NASA Follows NIH To Make All Research It Funds Open Access

from the good-to-see dept

We've written in the past about how the National Institute of Health (NIH) requires any research it funds (and it funds a lot) to be published under open access rules via its own PubMed Central platform after a certain period of time. There have been some efforts in Congress to require other government funded research to go down the same path, and some other agencies have worked on some similar ideas on their own. Now, NASA has announced that it will be requiring all research published via the $3 billion NASA spends each year to to also be published on the PubMed system (and also within in 12 months, as the NIH requires)

The provisions of NASA’s policy on articles track with those in the current NIH Public Access policy, and will require NASA-funded researchers to deposit articles into the PubMed Central database, to be made accessible with no more than than a 12 month embargo. However, the NASA plan notes that, “publishers may petition for longer embargo periods, but strong evidence of the benefits would be needed.” This language is notable, as it seems to suggest that any determination of changes in embargo length will be measured against the public good, rather than specific industry concerns.

Also, it looks like the plan will include efforts to make the raw data more available as well:

One final item that is tucked away at the end of the NASA plan, but is worth noting: the Agency will explore the development of a “research data commons” along with other departments and agencies, for storage, discoverability, and reuse of data with a particular focus on making the data underlying peer reviewed scientific publications resulting from federally funded scientific research available for free “at the time of publication.” This is an idea that appears to be gaining traction in the federal agency community, and is well worth tracking closely.

It's good to see more government agencies moving in this direction. It would be even nicer to see shorter time frames for the embargo, and even further commitment to releasing the data beyond just "exploring," but this is good for science, data, learning and innovation.

Filed Under: federally funded research, nasa, nih, open access

Do Nature's Publishers Even Read Their Own Articles About Open Access?

from the funny-that dept

Just a few weeks ago we wrote about scientific publishing giant Nature's somewhat abhorrent open access policy, where it's telling researchers at universities that require open access publishing that they need to get a waiver from that policy. So it seems rather strange to see that very same Nature, just days later, publishing an article about open access, in which it talks about how two of the largest funders of scientific research today, Wellcome Trust in the UK and the National Institute for Health (NIH) in the US, are starting to punish grant recipients who don't follow through on open access obligations. Both of those organizations require certain open access standards, but apparently have mostly just trusted researchers to follow through. Not any more:

Now they are done with just dangling carrots. Both institutions are bringing out the sticks: cautiously and discreetly cracking down on researchers who do not make their papers publicly available.

Neither agency would name those who have been sanctioned. But the London-based Wellcome Trust says that it has withheld grant payments on 63 occasions in the past year because papers resulting from the funding were not open access. And the NIH, in Bethesda, Maryland, says that it has delayed some continuing grant awards since July 2013 because of non-compliance with open-access policies, although the agency does not know the exact numbers.

The report notes that this has resulted in a "noticeable jump in researchers following the rules." That makes sense.

Of course, nowhere in the Nature article does reporter Richard Van Noorden ever bother to mention that his own publication is fighting against those requirements. In fact, the article reads as if it's a strong supporter of open access rules:

Some scientists are not even aware that they could be penalized. Nature's news team contacted Sheila MacNeil, a tissue engineer at the University of Sheffield, UK, who has published hundreds of articles, including a March 2013 paper on making stem-cell lattices for corneal repair that was funded by the Wellcome Trust (I. Ortega et al. Acta Biomater. 9, 5511–5520; 2013). Nature pointed out that the article should be open access but is not. "This is new to me," responds MacNeil, who plans to make the paper available. "Agreeing with open access is easy — making it happen, less so," she says.

Perhaps the Nature "news team" should take a look at how their own publisher is forcing researchers to ignore their open access obligations.

Filed Under: nih, open access, publishing
Companies: nature, wellcome trust

UK Plans To Make All Government-Funded Research Free To The Public Immediately Upon Publication

from the groundbreaking dept

We've discussed the fight in the US over open access to government-funded research in the past. Currently, the NIH requires any NIH-funded paper to be publicly & freely available one-year after it's been published. That gives journals one-year of exclusivity to profit off of the work before it's more widely available. There have been some efforts to block government agencies from requiring such open access, as well as proposals to expand it to other agencies beyond the NIH. We also recently wrote about a proposal in New York to do something similar, but with six-month of exclusivity, rather than a year.

Of course, some people take offense to any such exclusivity, seeing as we're still talking about taxpayer-funded research. Over in the UK, it appears that they're going to go completely in favor of open access, with a plan requiring immediate free access to any taxpayer-funded research. That's big news. Under the scheme, research papers that describe work paid for by the British taxpayer will be free online for universities, companies and individuals to use for any purpose, wherever they are in the world. The plan will be rolled out over the next two years, but by 2014, it sounds like all such research in the UK will be widely available for free.

Unfortunately, not all of the details sounds as good. The proposal tries to make the journals okay with this by forcing researchers to pay an "article processing charge" for each paper they publish, and it sounds like some of those funds go back to the publishers. But, of course, that's putting more of the cost on the universities that fund the research, and there's reasonable fear that this will lead those universities to ration out how many publications are "allowed." Many open access advocates preferred a different plan, that still involved academics doing deals with journals, but which also allowed them to publish the works online. The publishers, of course, weren't happy with that plan.

More open access is definitely a good thing, but I worry about any sort of plan that involves an explicit attempt to prop up a legacy industry that doesn't want to adapt. That seems very likely to create economic waste and to be abused at the cost of the public.

Filed Under: government research, nih, open access, uk

White House Petition Demanding Open Access Requirements For Federally Funded Research

from the sign-on dept

For years we've discussed the issue of open access for federally funded research. Currently, NIH has a program that requires any of the research that receives its funds to be available via public open access databases a year after its published elsewhere. While this still allows federally funded research to be locked up under a questionable copyright for a year, it's certainly better than locking it up for eternity. And while there have been some unfortunate efforts to ban NIH and other government agencies from requiring such conditions, many in academia favor such information sharing.

There is currently a White House petition asking the government to require such free access to scientific journal articles coming out of taxpayer-funded research. The Obama administration has indicated interest in doing this in the past, but has not done so. Forcing the administration to respond to the petition may help nudge them in the right direction. The petition still needs a lot more signatures, though, so get signing.

Filed Under: nih, open access, petition, research, white house

Rep. Doyle Introduces Bill To Provide Public Access To Publicly Funded Research

from the good-for-him dept

We were quite disappointed last month to see that Rep. Darrell Issa -- who has done lots of excellent work to encourage more open access to government information -- was sponsoring a bill that would close off open access to government funded research. This is an important issue that we've been following for years. Government funded research means that taxpayer money funded that research... and yet because of ridiculous policies by gatekeeper journals, the public has almost no access to that information. The whole situation is ridiculous. The journals get free labor: they never pay for articles (and, in some fields, academics actually have to pay the journal to get published), they never pay for the peer review. So they get free content and free editing. Then, as part of getting published, they require the researchers to give the journal their copyrights and usually bar them from using that same research elsewhere. Finally, they then sell these journal subscriptions at insane rates: often tens of thousands of dollars a year for a subscription. Only large university libraries and research institutions will pay those fees. It's a huge scam and it's why a ton of academics are boycotting publishing giant Elsevier, (infamous for its fake journal division).

The issue in these bills is that there has been a movement to require any research that is federally funded (taxpayer funded) to be placed in an open access repository one year after it was published. The National Institute of Health (NIH) who funds billions in research every year, has had this policy going for a few years (though journals have even tried nasty tricks, like requiring academics to pay them to "deposit" their own papers into these open repositories). This kind of rule makes plenty of sense: we're talking about publicly funded research after all. It should be open to the public. Giving the journals a one-year headstart on publishing the papers seems like more than enough for them to make money (again, from the "free" content they get).

Except... the journals hate this because they want their lifetime-plus monopoly on this information (which, I'll emphasize once again that they do not pay for). So they've been pushing various bills that would outlaw such open access requirements. And, somehow, they got Darrell Issa to back the latest version of this bill.

Thankfully, however, Rep. Mike Doyle -- who has a long history of being really good on copyright issues -- has introduced a counter bill to Issa's bill (pdf) called the Federal Research Public Access Act of 2012. It really is the mirror image of the Issa bill.

the Federal Government funds basic and applied research with the expectation that new ideas and discoveries that result from the research, if shared and effectively disseminated, will advance science and improve the lives and welfare of people of the United States and around the world; and the Internet makes it possible for this information to be promptly available to every scientist, physician, educator, and citizen at home, in school, or in a library.

The bill would require that all federal agencies establish policies that encourage open and free access to federally funded research. One hopes that Rep. Issa will rethink his position on his bill, and recognize that Doyle's bill is much more aligned with Issa's stated goal (and long-shown commitment) to more open access to government information.

Filed Under: darrell issa, mike doyle, nih, open access, public funding, research
Companies: elsevier

Unfortunate: 'Open' Advocate Darrell Issa Sponsoring Bill That Will Close Off Open Access To Gov't Funded Research

from the tragic dept

For years, we've pointed out the ridiculousness of various attempts to lock up federally funded research. If anything, it would seem that research that is federally funded should be required to be open to the public. After all, the public paid for it. And, in fact, a few years back, the National Institutes of Health (NIH) instituted a program that said that any research funded by NIH had to be offered in an open access manner by 1 year after its publication date. The "issue" here is that the big academic journals have the greatest scam in the world running: they don't have to pay writers (and, in some fields, the writers actually have to pay them) who submit their papers. They don't have to pay other academics to do peer review, as that's done for free. So all of their content isn't paid for. But... they do require that the writers hand over their copyright, and then lock it up in journals that are crazy expensive -- and totally inaccessible to the average person who isn't affiliated with a university library willing to shell out the cash.

That's not good for science or innovation. And, when it's on federally funded research, it's almost criminal.

So, the NIH had this open access requirement, which was then augmented by a Congressional requirement. The 1 year still lets journals get crazy monopoly rents... but even then, many journals have sought ways to make these open access requirements difficult. For example, if you click that link, you can see how the American Psychology Association tried to charge the academics who wrote for it $2,500 to "deposit" their publication to PubMed to satisfy the NIH requirement.

So, for years, the big publishing houses have been trying to get Congress to pass a law to lock up federally funded research. In the past, this effort was led by Rep. John Conyers -- who has received lots of campaign contributions from the big publishers. A few years ago, the Obama administration actually suggested it was leaning in the other direction -- and actually requiring all federally funded research to be open access, rather than just NIH. That would be huge... but of course, the big publishers won't allow that to happen. They even made the ridiculous argument that open access requirements would harm transparency in government. Yeah. Don't even try to understand it, because it doesn't make sense.

Tragically, it appears that a new version of this bill has been introduced... called the Research Works Act. It's a pretty short bill, but here's the key part:

No Federal agency may adopt, implement, maintain, continue, or otherwise engage in any policy, program, or other activity that--

(1) causes, permits, or authorizes network dissemination of any private-sector research work without the prior consent of the publisher of such work; or

(2) requires that any actual or prospective author, or the employer of such an actual or prospective author, assent to network dissemination of a private-sector research work.

Note the use of "private-sector research work." There's a definition for that:

PRIVATE-SECTOR RESEARCH WORK- The term 'private-sector research work' means an article intended to be published in a scholarly or scientific publication, or any version of such an article, that is not a work of the United States Government (as defined in section 101 of title 17, United States Code), describing or interpreting research funded in whole or in part by a Federal agency and to which a commercial or nonprofit publisher has made or has entered into an arrangement to make a value-added contribution, including peer review or editing. Such term does not include progress reports or raw data outputs routinely required to be created for and submitted directly to a funding agency in the course of research.

This is tragically bad drafting in that depending on how you interpret the commas, it almost certainly means that the NIH requirements and anything similar would be barred. That is, it appears to define federally funded research as "private sector research work," if it's going to be published by a private journal. The Association of American Publishers sure was quick to celebrate the bill, making it clear that it was exactly what they wanted: a ban on forcing works they publish into open access models. Of course, the language is purposely vague so that if you misread it, you might think it doesn't include government-funded works. That's not true. It simply doesn't include government produced works, which are public domain by definition and couldn't be thus limited anyway.

Furthermore, the bill appears to create a new copyright-like "right" for publishers outside of copyright itself. That is, it grants the final say in permission to the publisher, rather than the copyright holder. So, even in a case where an author retains the copyright, or retains distribution rights, this bill could potentially grant the publisher extra rights out of thin air.

The real tragedy here? The bill's sponsor is Rep. Darrell Issa -- who's based much of his recent political career on the claim that he wants more open government. Yes, the same Darrell Issa who put forth the SOPA/PIPA alternative, the OPEN Act, with its awesome open website that allows for direct feedback on the bill. And he's behind the open access to Congressional hearings video that we just talked about.

This bill seems to go against everything that he's said he stands for on related issues, and people are definitely noting how odd this seems.

There's no two ways about it. This is a bad and dangerous bill that will only serve to lock up important, taxpayer-funded research. As we've discussed in detail in the past, such locking up of research does tremendous harm to important scientific research, puts people in harm's way and slows down innovation. It's tremendously disappointing that Rep. Darrell Issa would be behind such a bill. It really does seem to go against everything that he stands for.

Filed Under: copyright, darrell issa, federally funded research, nih, open access, publishers, research

NIH Won't Let Others Supply Life Saving Drug Even Though Genzyme Can't Make Enough

from the patents-costing-lives dept

Earlier this year, we wrote about the situation with a petition to the National Institute of Health (NIH) to let other companies produce Fabrazyme, a drug that treats Fabry disease. Fabry disease is an enzyme deficiency that can create very serious problems in those who have it -- including kidney failure and heart attacks. Genzyme holds the patent on Fabrazyme, but has a problem: it can't produce enough of the drug. That means people die. A group of Fabry patients petitioned the NIH to see if other companies could be allowed to produce just a little more Fabrazyme. They didn't ask to break the patent. All they wanted was to let others make the drug, and pay Genzyme a royalty. On top of this, it's worth noting that the key research for the development for Fabrazyme wasn't actually done by Genzyme, but was done by the Mount Sinai School of Medicine and was financed with taxpayer money from the NIH.

At the time, we doubted the petition would be approved -- and indeed, the NIH has rejected the petition. An opening was left for an appeal, if another petition is filed by a company that wants to make Fabrazyme, rather than the patients (you know, the folks actually suffering). As the statement of Robert Weissman from Public Citizen makes clear, this is a ridiculous situation:

Why is NIH resorting to legal gymnastics to avoid exercising its legal authority to ensure an adequate supply of an important medicine? NIH agrees Genzyme is failing to produce an adequate supply of the important medicine Fabrazyme. It is plain that removing the patent monopoly on the drug is a necessary condition to enabling other potential manufacturers to enter the market. Yet NIH chooses to deny a request to issue open licenses for the Fabrazyme patents -- a request for which it has undisputed legal authority -- on the Alice-in-Wonderland, self-justifying grounds that there are as yet no competing suppliers. Of course there are no competing suppliers -- why would any firm try to enter a market it believed closed by a patent monopoly?

Filed Under: fabrazyme, fabry disease, nih, patents
Companies: genzyme, nih