Welcome to the Oxford Undergraduate Law Podcast where we discuss the law and its implications
on our relationships, our markets, and our futures.
I'm Siobhan.
And I'm Bianca, and we're your hosts for this series.
Today we are incredibly honoured to be speaking with Professor Justine Pillah.
Professor Pillah is co-chair of the faculty's Health, Law, and Emerging Technologies research
group.
She wrote her PhD in Patent Law and is the author and editor of several books in the
field of intellectual property.
As well as IP, she teaches law and technology on a number of graduate and undergraduate
courses for the faculty.
So to start off, what is IP law?
Well, IP law is formally part of the law of personal property.
So broadly speaking, it confers rights, which are defined under statute, in intellectual
creations such as inventions and authorial works.
So for patents, the rights conferred enable the inventors of the protected invention to
prevent anyone else from making, selling, importing, or otherwise commercialising their
inventions in the territory of the protecting state for a limited period of 20 years.
So I guess one thing that's maybe important to note is that unlike other property rights,
you have to apply formally for a patent.
And to get one, you need to disclose your invention so the world knows what it is that
they're prevented from using while the patent exists.
And also so that the world then has the information that they need to use your invention after
the patent expires.
The normative foundations on which IP law stands has been the subject of considerable
criticism.
How do we justify IP law?
Yeah, no, there has, there has.
And remembering also that IP law and the world in which it operates have changed a lot over
the years, making it something of a moving target that we're trying to justify.
So IP laws today impact society and the political economy a lot more than when first introduced
hundreds of years ago.
And this inevitably affects also our understanding of them and whether they can be justified,
as you say.
And IP law, you know, today especially is hugely important to global and local industry,
with IP licensing alone accounting for over 5% of global trade.
So when we think about this justificatory issue, you know, it's worth bearing in mind
that patents themselves support entire industries such as the biotech industry and are a key
driver of research and development, including in the medical and pharmaceutical fields.
So just to give some sort of, you know, flavour for this, in 2020 alone, so in last year alone,
over 14,000 medical tech patent applications and over 8,500 pharmaceutical patent applications
were filed in the European Patent Office alone.
So that's more patent applications in medical tech than in any other field.
So there are a lot of patents in the world, and they're very important to society and
to industry and the economy.
So what are some justifications in favour of IP law?
Well, I mean, views differ among people, as you might expect, and jurisdictions are depending
a lot also on the IP regime.
So I think for patent law, justifications typically focus on the public interest and
societal benefit.
So the idea is that society benefits from access to new inventions, such as new vaccines
and new antiviral treatments, and that patents help secure that access for the public by
removing two significant hurdles that inventors would otherwise face in the hope that doing
so that removing those hurdles will encourage them to invent things of social benefit.
So the first hurdle that inventors face is cost, including risk.
In advanced technological fields like vaccine development, you can't just go into your
shed and have a go.
You need to be highly skilled, you need to have access to certain materials and equipment,
and you need to be prepared to work for a long time without any guarantee of success.
So to bring a drug to market, you need to spend a lot of money and have a lot of upfront
sort of investment, I guess, to cover the costs of all the work that's required.
And you also, even if you successfully devise a product, you also need then to get regulatory
approval from the state, which requires a lot of clinical trials to demonstrate your
product safety and efficacy.
And then of course, you know, having devised a vaccine, an idea for a vaccine and got the
relevant regulatory approval, you need to actually introduce the invention into practice
by manufacturing and distributing doses of the vaccine that you've devised, all of which
requires further time and investment.
So this is not an endeavour that people undertake or could be expected to undertake without
some hope at the end of recovering their costs and making a profit.
And vaccines are a really good case in point.
So by way of example, in 2019, the top 10 pharmaceutical companies reportedly spent
82 billion US dollars on developing potential vaccines and treatments.
So it's a lot of money.
And it's when inventors come to commercialise their inventions that they face their second
impediment, which is free riding by others.
So inventions are not like chairs or tables.
They don't have actual physical form.
They're intellectual creations or ideas for doing something useful, like producing a substance
that can drain the body to fight a virus.
And like all ideas in the digital environment, especially once disclosed, they can be reproduced
and used by any number of people at the same time at low cost.
So in principle, a company might spend years and billions of dollars devising a vaccine,
securing regulatory approval for it and introducing it to market only to have other companies
come in and reverse engineer the vaccine or get a copy of its recipe to produce their
own doses for sale in competition with the inventor.
And the result will then be a vastly diminished market for the inventor and reduced opportunity
to recover its initial drug research and development costs.
So yeah, so that's where patents come in.
They by giving inventors an exclusive 20 year window in which to exploit their inventions,
they create an opportunity for inventors to recoup their costs and make enough profit
to continue being motivated to invent.
So in this way, they provide incentives for people working in resource intensive industries
like medical research and development to develop their socially useful products such as vaccines
and essential medicines.
And they also, if you like, represent something of a reward for the people who do invest time
and money in devising these useful inventions.
And some might say too that by preventing free riding, they promote norms of commercial
fairness and moral dealings.
So you might say it's not right if you spend a lot of time and money, great commercial
risk devising something as valuable as a vaccine, then I can simply come along, take your idea,
produce doses of your vaccine and make a lot of money that would otherwise be made by you.
So I guess this is essentially a utilitarian or instrumentalist justification for the patent
system with a bit of an unjust enrichment or equitable dimension thrown in as well.
So the message of the patent system to inventors or would be inventors is compete among yourselves
to invent and will reward whoever succeeds with a limited commercial monopoly provided
your invention is sufficiently new and useful and that you publish it immediately so that
even before your patent is granted, the world knows about your invention and can learn from
it and try and build on it.
I guess that there do exist more fully fledged moral arguments for IP law that are based
on the nature of intellectual creations as expressions of a person or products of human
labour but these arguments I think are less prominent for patents than for other types
of IP such as copyright.
The utilitarian arguments which you've just mentioned have often been criticised for a
lack of empirical evidence in support of them.
How much weight should we give to these criticisms?
Well I think it's true, I mean I think that you know there are a whole lot of assumptions
that underpin this kind of justification.
The assumption for example that but for the incentive of a patent, you know the promise
of this limited commercial opportunity to exploit one's patented technology, people
wouldn't have the necessary motivation to try to invent new and useful inventions.
And that's an assumption that we make but it's never really tested empirically because
we've had a patent system for so many hundreds of years so we've never actually been in the
situation of not offering this commercial incentive and seeing how it does affect for
example rates of innovation and invention.
We also assume that you know the carrot has to be so big, the incentive has to be so big,
we have to have this monopoly lasting for 20 years and the monopoly has to you know
give people this right to prevent all of these different things, making and selling and importing
and what have you and again but for you know a carrot of this size people wouldn't have
the relevant incentive and it's just not known.
I think people generally accept though that it's more likely to be true for as I say resource
intensive industries like you know like the pharmaceutical and medical industries because
of the very high costs of for example developing a vaccine but also of getting the necessary
regulatory approval that needs to be gotten in order to have you know permission from
the state to actually introduce what are potentially very dangerous products into the market.
It is generally accepted that they're more likely to be valid for some areas of technological
research than for others.
I mean for example an industry where there really is a lot of question about whether
this is valid is the software industry where it's thought that actually you know it's
enough just to be first to market with your product in order to recoup enough of the commercial
you know the profit that you need to recoup in order to be motivated to go on and try
and come out with a new software product but that doesn't really work so well in the
pharmaceutical and medical industries I think.
If we are to assume that IP law has a weak normative foundation in terms of its utilitarian
benefit can we rely on another justification?
So firstly I mean I should probably say that some people might dispute the idea that the
pattern law does have a shaky normative basis but even if it does let's assume that it
does I think you know I think you would recognize from your own studies in jurisprudence recently
that there is a philosophical question here about law in general.
I mean a hallmark of liberal democratic states is that they don't simply ignore laws when
it's convenient to do so.
So I think the default position would generally be that where you have laws in place for example
pattern laws guaranteeing that any person who does devise a new and useful invention
and makes it available to the world will be rewarded with this you know this property
right this limited monopoly right and where you have people relying on those laws as drug
companies surely do in undertaking their you know their research and development in this
field that those laws should be either enforced consistently and according to their terms
as a matter of the rule of law or repealed or amended by appropriate democratic processes.
So I think that's a yeah I think that that would generally be the position that we would
take and you know and the only exception to that really would be or might be where the
laws are plainly morally abhorrent or where the circumstances is just so desperate sufficiently
desperate to require desperate measures you know as in times of war but even then I mean
there's a complication here and it's a legal and a political complication which is the
TRIPS agreement so the TRIPS agreement is an international agreement which contains
detailed provisions on patents that all WTO countries are required to comply with and
so an important question is what TRIPS permits and whether its provisions allow states simply
to you know to refuse to grant patents because you know it feels that actually in this particular
case they're not they're not normatively justified or indeed to repeal by appropriate democratic
processes their you know entire patent regimes and I think the answer is that it really doesn't
and so the second question if you like is whether the TRIPS agreement offers some other
solution to whatever problem it is that the patent system is perceived to to cause in
the context of COVID for example.
Do different jurisdictions have different justifications for IP law and does this influence
the IP laws substantive IP laws across different jurisdictions?
I think the general understanding of patent systems is pretty similar across jurisdictions
and again you know having just referenced TRIPS this is helped to some extent at least
by the international norm setting agreements like TRIPS but there are perhaps some subtle
differences that yeah that I would probably say reflect wider differences in our view
of property rights in general and also of innovation which are two sort of key concepts
of relevance in the patent context patents being a form of property and also patent systems
generally being understood as as existing to support innovation by encouraging invention
so for example you know US writing on patents tends to reflect sort of traditional liberal
views about property and innovation as being inherently good for society so property and
the pricing mechanism is thought to be good because it supports free market economies
that ensure that goods and services the goods and services protected by the property rights
end up in the hands of the people who value them most and also thought to be good for
society because you know by supporting free market economies they disperse property rights
disperse power throughout the community among individual buyers and sellers rather than
concentrating it in the hands of the state which is you know what we like in liberal
democratic systems and innovation which is what according to this instrumentalist justification
patent systems promote is is according to this sort of traditional liberal view good
for society because it supports a culture of experimentation and and eccentricity and
anti-authoritarianism and it results in the diffusion of new ideas that benefit to the
benefit the public so I think on that sort of US view if I can sort of describe it in
those terms that US sort of traditional liberal view of patent systems provided patent systems
operate in the way that other property systems operate by supporting a free market economy
and promoting this culture of innovation then they should be good for society and the way
for patent systems to do this is generally said is to offer generous incentives actually
to would-be inventors and then just ensure that market conditions you know exist that
are conducive to the efficient allocation of patented products and other technologies
I think that's a you I would describe that as a quite you know quite a North American
view of the cathedral and in Europe you know there's a lot of that thinking to we subscribe
also to that kind of thinking but perhaps a little bit less in that perhaps in Europe
were a little bit more influenced by fundamental rights and and and even in the UK you know
as a result of our now ended membership of the EU and so perhaps you know in keeping
with that we're more inclined to adopt a kind of constitutional mindset that sees IP not
only in economic and sort of free market terms but also in terms of constitutional values
such as human dignity and the right to life and public health though you know whether
those different perspectives have any practical impact is a different question but I think
you can see those subtle differences actually I would say in the way that we think about
patent systems shifting the topic slightly I think it's important to consider IP law
in the context of our current pandemic and the role it plays COVID-19 has taken millions
and millions of lives and especially today we can see the disproportionate effect the
virus has on the developing world so when the vaccine which is patented plays such an
important role in stemming the effects the drastic effects of such a pandemic can the
utilitarian justifications still bear any weight yeah well so in a way that's you you
so that's putting another way the question that you asked before isn't it I mean you
know how can we justify the enforcement of patents in you know during a pandemic and
I sort of turned that around and said well you know in a liberal democratic state how
can we justify just deciding not to you know not to enforce laws that exist and you know
suggested though then that actually one justification that we might that we might put forward even
in a liberal democratic state is if we believe that enforcing patents is morally abhorrent
in some way because I think I hope we would all agree that none of us has it you know
that that we shouldn't be we shouldn't be enforcing morally of our laws so I guess you
know maybe you know maybe maybe a question to ask is whether or not the enforcement of
patents over covert treatments is is morally abhorrent and if it is maybe then that would
be a justification just for for suspending those patents I don't know I mean certainly
not helping vulnerable people access medicines that they need is morally abhorrent I'm sure
we all agree with that but I guess the question really is whether patents are to blame for
that and whether it whether you know patents are the reason for the slow and unequal roll
out of vaccines that we're seeing which I assume is the is is somehow what's motivating
your your question about this but but what's causing that so you know some people do say
patents they say well patents you know patents give drug companies this monopoly over the
manufacture and distribution of vaccines and that monopoly prevents other companies you
know including in developed countries from manufacturing and distributing distributing
generic versions of you know of the vaccines for their own communities so surely you know
suspending patents is the solution because it would enable those generic drug manufacturers
around the world to increase the production and distribution of vaccines and thereby solve
the problem which is the slow and unequal distribution of vaccines but but I think there
is a bit more to it than that and maybe and maybe you know we need to understand you know
what more to it there is in order to devise an appropriate solution so I mean people say
and it's you know again it's sort of goes back to this difficulty of of knowing the
facts on the ground of establishing empirically what the situation is but people say and the
drug industry says that vaccines are complex products that require more to produce safely
than just you know the recipe for producing them which by the way is disclosed in the
patent and you know particularly for like the messenger RNA vaccines such as the Moderna
and Pfizer ones which are very difficult to replicate by a generic drug manufacturer without
additional know-how and technology and without expert assistance on the ground and and drug
companies say all of this can only all of this additional knowledge and know-how and
technology and expert assistance on the ground can only feasibly be provided by them by by
those you know Moderna's and Pfizer's and original and originator drug companies under
a licensing scheme they have to be provided under terms of course and and that means under
a licensing scheme and that you know to allow generic versions of their vaccines to be produced
without that kind of support and oversight i.e. outside of a proper licensing system
would be dangerous because you'd end up with people producing vaccines that they don't
have without the relevant you know technology and know-how and expertise which creates a
risk that there would be dangerous vaccines dodgy vaccines being produced and made available
to the public which of course is not what we want. So that's very tricky though because
then it suggests that we need not only to suspend patents if you like so that anybody
can manufacture them but we need to to ask those originated drug companies to ensure
that anybody who wants to manufacture them has you know has their support has expert
is provided by them with expertise and technology and know-how and you really can't ask private
i mean companies of private entities you can't ask private entities if you like just to work
to do all of that for free and actually Italy i don't know if you've seen in the paper
recently but but there's been a report in the last week that Italy has been wanting
to establish vaccine manufacturing sites in its territory i mean to supply its own population
but also to supply the rest of the EU because of the trouble that the EU is having in securing
vaccine doses and it's been in talks with a number of you know of manufacturers of the
messenger RNA vaccines including Moderna but Moderna has reported they said that it just
can't it can't support the establishment of Italian manufacturing sites because it just
doesn't have the capacity to oversee the transfer of technology required to produce its vaccine
to those manufacturing sites in Italy or to staff the sites with required expertise so
what can we do what a potential solution maybe be to leverage domestic manufacturing for
vaccines which require less complex expertise for example the Johnson and Johnson vaccine
or the AstraZeneca vaccine which uses technology that we're more familiar with or would it
be to require some sort of compulsory licensing scheme so yeah absolutely potentially potentially
legally you know it should be and you know it takes us back to trips you know and i said
that trips doesn't allow states actually just go around and decide that they're not going
they're going to suspend their patents or even repeal via democratic process their entire
patent raging but it does allow some mechanisms that might help here and one mechanism as
you say is compulsory licensing so under the trips agreement a state can in in a national
emergency or other extreme circumstances can just authorise the use of a patented technology
such as a vaccine without getting the patentees permission on terms you know reasonable terms
that that it decides in order to secure the technology access to the technology by its
local population so a question is well why aren't all the states who need access to these
vaccines granting compulsory licenses in respect of the in respect of the patterns and the
answer or one answer is is well two answers are generally given firstly oh because they
those states would need to introduce laws to do that because you can only to to grant
a compulsory license requires a national law okay but but secondly and perhaps you know
and this is the sort of political impediment they say oh they're they're scared of sort
of backlash from the the wealthy countries that stand to benefit from you know from from
not having their you know from from having their from licensing the patterns according
to market terms on on for a price that's going to be higher than the price that's paid under
a compulsory license which is a sort of political impediment so that's sort of so compulsory
licensing is in principle there and can be used but apparently states don't want to use
because they don't want to annoy that the US and the UK and the UK I guess though the
other thing though is that just getting a compulsory license is not going to solve the
problem because it's not enough for companies to have the right to manufacture they need
all this additional expertise and know-how and and and technology which can only apparently
be provided by the originated drug companies and you don't get that under a license you
can't a compulsory license if you like can't compel it only covers the patented technology
it can't compare you can't compel under compulsory license a company to provide all of that additional
stuff that is required to to actually that might be required actually to manufacture
so but there are other things that government going back to your question about what is
the solution then if it's not compulsory license not compulsory licensing or not only compulsory
licensing I mean I think you know you've mentioned you mentioned to me previously I think this
you know this really important point which is that actually you know the whole justification
for patent systems is built on the idea that if we want these companies to assume this
cost and this enormous risk of spending billions of dollars every year in an attempt to devise
vaccines and risking failure then we have to offer them this incentive but of course
in this context a lot of the cost and the risk that has been assumed by these drug companies
in developing the vaccines has been underwritten by states through public investment and so
if if so the states have funded a lot of their sort of research and development of these
vaccines and so the question is well why didn't those states then sort of you know secure
certain legal commitments or one question is why didn't they secure certain legal commitments
from the beneficiaries of the public funding at the time at which they offered the public
funding and the states I mean there are many things that the states could have done that
would help they could have required the sharing of information you know by any successful
drug company with with other generic drug manufacturers in the event of devising a
a successful vaccine they could have of course have capped the price AstraZeneca has capped
the price of its of its vaccine doses to three to four dollars per dose during the period
of the pandemic so that could have just been required for all all all drug companies that
managed to produce successfully a vaccine there were many other things that they legal
commitments that governments could through law essentially contract law have secured
from the beneficiaries of their public funding but which they didn't do they could have
required that IP the IP be licensed on certain terms as well they didn't do that and now
they're all there's all this discussion about somehow trying to extract those commitments
exposed you know after the fact so yeah I guess the point is it's just not clear it's
not clear to what extent the problem that there's a problem with patent law here on
the one hand and and to what extent if you like there's just a problem for example with
the government failing to take sufficient responsibility for public health of its own
population and of the global community it's interesting to discover that our government
could have done more to stem the drastic effects of this pandemic that's all the questions
that we have today thank you so much for joining us no problem yeah no problem well it was
it was lovely to speak to you both thank you for having me that was professor Pilla speaking
with us on IP law patents and vaccines for more interesting legal discussions and writings
visit the OUULJ's blog and read our annual publications in the next episode we will be
discussing family law with professor Rachel Taylor and professor Shazia Chaudhary