Covid vaccines have changed the course of the pandemic. They
prevented over 1 million deaths in the US and over 10.3 million
hospitalizations in 2021. But what's equally impressive was
the speed and efficiency in which they were created.
I've never seen the level of intensive collaboration, like
wanting to try and figure this out, between public private
partnership form in my 20 year career.
However, the groundbreaking collaboration might be giving
away to another looming battle on the horizon. A battle over
who truly owns the Covid vaccine.
We are following a developing story. Moderna, the drugmaker
locked in a fight with the NIH over its Covid vaccine.
These two entities have essentially been partners on the
Covid vaccine. But now they are in a battle over one of the key
patents behind it.
Patents have historically been viewed as important in part
because they assure the company that if they are successful in
getting the drug to market that they stand to have essentially a
monopoly on the rights to sell that drug for a certain period
of time, typically say around 20 years.
Whenever there is a blockbuster drug, there are disputes about
who owns it, who owns variations of it, who owns it for how long
and in what context. We are likely to see these battles
playing out in the US courts and in international courts for a
long time.
Controversy over Covid vaccine patents has grabbed the
attention of the world and the likes of President Biden and
Bill Gates. And its outcome could have ramifications on how
the world ends the pandemic.
Like any other invention, vaccines are often covered by
patents that provide legal protection against imitation.
That's because investing in pharmaceutical research can be
an expensive and risky gamble. On average, developing a new
drug can range from less than $1 billion to more than $2 billion
per drug. Yet, just under 14% of all drugs and clinical trials
eventually win approval from the FDA to make their way to the
market.
There are tons and tons of research and development or
patents or papers or initiatives that get spun up that never
really go anywhere, that don't really see light a day. I did a
general search on Google patents. Anybody can do this.
Looked at vaccines for Covid, right? I found one that's known.
I just literally said, "how many other patents are sort of kinda
like that?" The number that got spit out on Google patents was
134,000 patents that you would never know, never seen them,
never heard about them, that all were somehow related to research
in the area that led ultimately to that patents that's in the
market.
A successful pattern, however, can often result in a big
payoff. Not only does it give the inventor the sole right to
produce and sell their products, but it also allows them to earn
royalties whenever their patent is used to create a product.
Patents have historically been presented as a way to reward a
company that has developed and brought a drug to the market snd
to compensate it for all of the costs that were incurred in
getting it to the market. They stand to have essentially a
monopoly on the rights to sell that drug for a certain period
of time, typically say around 20 years,
Lawsuits over valuable pharmaceutical patents have been
common throughout history.
A fair percentage of the litigation that happens in the
United States relates to pharmaceutical patents. Our
legal system spends a lot of time trying to figure out who
owns what and what are the boundaries of those rights.
Pharmaceutical patents, if they lead particularly to Blockbuster
medicines, have a lot of money at stake. So that means there a
lot of resources to hire lawyers to try to argue over who owns
what.
In November 2021, a similar conflict broke out over the
COVID-19 vaccine, putting Moderna at odds with the US
government. Moderna collaborated with the researchers at the
National Institute of Health, a federal agency to develop their
vaccine, Spikevax. When Maderna excluded the NIH researchers as
Co-inventors in a central patent covering the mRNA sequence, NIH
publicly challenged the patent arguing that three of its
scientists made meaningful contributions to its research.
When you have large industry, you have government and you're
trying to blend commercial interest with governmental
do-good interest, there's always going to be some kind of natural
tension. That's to be expected.
They are arguing over methods of stabilizing the spike protein
within the vaccine. So it's critically important to the
Moderna vaccine, who actually owns that. If the government is
listed on the patent, then it has remarkable control over what
the parties can do with it.
While Maderna eventually backed down in their fight against the
NIH, the dispute could foreshadow more to come. Another
dispute can potentially rise over NIH's patent for the spike
protein that allows the vaccine to induce a stronger immune
response. While companies like Pfizer paid money to obtain a
license from NIH, Moderna did not. But it could also be facing
another patent infringement lawsuit by Arbutus biopharma
Corp, a company with a similar patent on its delivery system.
Multiple reports surrounding Maderna's patent complications
haven't helped with the company's dwindling performance
in the market. In October 2020, Pfizer was also sued by a low
biotechnology and pharmaceuticals for allegedly
using their proteins in their vaccine testing that infringe on
their existing patent.
I do anticipate going forward that we're gonna see more
lawsuits and disputes arise over COVID-19 vaccine patents. I
think at some level, it's pretty much unavoidable.
We are likely to see these battles playing out in the US
courts and in international courts for a long time to come.
The Covid vaccine patents can also pose other threats beyond
legal conflict. Patents within the US also extend throughout
the world thanks to an international agreement known as
TRIPS. Some experts argue this is why vaccines are less
accessible in the lower income countries.
The existence of patents and specifically, intellectual
property protections does two things. One is it limits how
much manufacturing there can be of that product or that vaccine.
And the other thing that it does is it keeps the price of that
product and vaccine artificially high or keeps it high enough
that it limits the ability of other countries in the world,
particularly low, middle-income countries to be able to purchase
those vaccines.
In response, calls to waive the patents on Covid vaccines have
continuously gained traction throughout the world.
Some of the recent ideas that have been floated include things
known as patent waivers, which is basically saying okay, you
may have a patent but we're going to administrate and say
that patent no longer gives you protection to market. You have
to give your recipe away to everybody in an effort to get
more vaccines out there to help get us as a global economy back
on their footing.
In October 2020, India and South Africa first brought the matter
to the spotlight after formally proposing the WTO to waive
intellectual property rules over the Covid vaccines. While
patents might have a place in the normal world, the hope is
that the pandemic could force countries to consider an
exception.
Until we have full vaccination around the world, we're going to
continue to see new variants arise. And every time there's a
new variant, we're going to realize very quickly that it's
not possible to contain that variant in just one part of the
world.
The world can't wait. Certainly can't wait 20 years the patent
to end, but it can't even wait for the period of time necessary
to get through the existing waiver processes.
There is also the question of ethics. The US government played
a major role in funding the vaccine. Research from 2021
discovered that most of the technology used for the Covid
vaccine was mostly funded by the public sector. So is it ethical
for drug companies to make a profit off of their patents?
The reason that public investment happens is that we're
trying to protect the public from new diseases, protect and
improve the health of the public. And so I do think there
are some major concerns with specific companies making large
amounts of profits from drugs that were developed, in part
with the federal government's support. And moreover, when the
health of the public is also suffering at the same time.
But not everyone is in support of a patent waiver. Critics
argue that such an unprecedented move will only have dire
consequences in the long run.
If we create that slippery slope, patents are devalued
because legally they're not protected in the more global
level. We're going to be disincentivizing innovation at a
massive, massive level.
There is also conflicting opinion on whether a waiver can
actually improve global vaccine distribution. Bill Gates also
originally spoke out against the patent waiver, arguing that
there are problems beyond patents that stay in the way of
global vaccination, although he later reversed his position.
If you don't have the actual healthcare infrastructure that
can deliver those. You don't have the logistics and
transportation components that are there. Having a billion
vaccines sitting in a warehouse of a lab that's developing it
will do no good for getting us back to normal.
While the debate remains a hot topic among scholars throughout
the world, many expressed doubts on whether a patent waiver can
actually come to fruition.
The likelihood that at a global level, because it is not a US
decision, it's a global World Intellectual Property
Organization decision to be clear, that we will get to a
point where we're going to say, "Yeah, we're going to use a
TRIPS waiver in this case," I doubt it very seriously.
I think we had the best hope of it was last year when there was
a proposal that was put forward at the WTO and the Biden
administration had supported it. But we had European countries
that objected to those patent waivers.
No matter the outcome, the current debate over intellectual
property will have a lasting impact on global public health.
This is not the last pandemic and it's not the last epidemic.
We are going to face these questions of how we encourage
innovation, how we make sure it spreads through the world in an
accessible manner. These are issues that will plague us long
after Covid-19 hopefully, God willing has been solved and
we've learned to live with it.