Tournament: Meadows LD Scrimmage | Round: 2 | Opponent: Peninsula AI | Judge: Kuppahally, Anusha
Novice AC.docx
1
2
3
4
5
6
7
8
Novice AC
I affirm
–
Resolved: The member nations of the World Trade Organization ought to
reduce intellectual property protections for medicines.
Because the resolution asks what we
ought
to do, my value is Morality.
The
criterion
for determining morality is minimizing suffering. No coherent theory of
justice or morality can deny that suffering is morally bad. Each of us knows from our
own experiences that suffering is a moral evil, and that other people experience
suffering in the
same way we do. Therefore, if we regard everyone’s pain as morally
equal, we are obligated to minimize the amount of suffering people experience.
Moreover
, maximizing
utility
is the only way to affirm equal and unconditional human
dignity.
Cummiskey ’90
-
David Cummiskey. Associate Philosophy Professor at Bates College.Kantian Consequentialism. Ethics, Vol. 100, No.
3. 1990.
http://www.jstor.org/stable/2381810.
We must not obscure the issue by characterizing this type of case as the sacrifice of indiv
iduals for some abstract “social entity.” It is not a question of some persons having to
bear the cost for some elusive “overall social good.” Instead, the question is whether some persons must bear the inescapable
cost for the sake of other persons. Rober
t Nozick,
for example, argues that “to use a person in this way does not sufficiently respect and take account of the fact that he is a
separate person, that his is the only life he has.” But
why is this not equally true of all those whom we do not save th
rough our failure to act?
By emphasizing solely the one who must
bear the cost if we act, we fail to
sufficiently
respect
and take account of
the many other separate
persons
,
each with only one life, who will bear the cost of our inaction.
In such a situat
ion, what would a
conscientious Kantian agent, an agent motivated by the unconditional value of rational beings, choose? A morally good agent r
ecognizes that the basis of all particular duties is
the principle that “rational nature exists as an end in itse
lf” (GMM 429). Rational nature as such is the supreme objective end of all conduct
.
If one
truly
believes
that
all rational beings have
an
equal value
, then
the
rational
solution
to such a dilemma
involves maximally
promoting the lives and liberties of as
many
rational beings
as possible
(chapter 5). In order to avoid this conclusion,
the non
-
consequentialist Kantian needs to justify agent
-
centered constraints. As we saw in chapter 1, however, even most Kantian deontologists recognize that agent
-
centered
co
nstraints require a non
-
value
-
based rationale. But we have seen that Kant’s normative theory is based on an unconditionally valuable end. How can a concern
for the value of
rational beings lead to a refusal to sacrifice rational beings even when this woul
d prevent other more extensive losses of rational beings?
If the moral law is
based on the value of rational beings and their ends, then what is the rationale for
prohibiting a moral agent from maximally promoting these two tiers of value? If I
sacrifice s
ome for the sake of others, I do not use them arbitrarily, and I do not deny
the unconditional value of rational beings.
Persons may have “dignity
,
that
is, an unconditional and
incomparable worth” that
transcends
any
market value
(GMM 436),
but
persons
al
so
have a fundamental
equality that dictates that some must sometimes give way for the sake of others
(chapters 5
and 7). The concept of the end
-
in
-
itself does not support the view that we may never force another to bear some cost in order to benefit other
s. If one focuses on the equal
value of all rational beings, then equal consideration suggests that one may have to sacrifice some to save many.
Contention 1:
Covid
-
19
The only way to solve the pandemic is global vaccination, but current production is
wo
efully short.
Public Citizen 3/29
-
Public Citizen “Public Citizen is a nonprofit consumer advocacy organization that champions the public
interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works
for the people
–
not
for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country. We don’t participat
e in partisan
political activities or endorse any candidates for elected office. We take no government or cor
porate money, which enables us to remain
fiercely independent and call out bad actors
–
no matter who they are or how much power and money they have.”, “Waiver of the WTO’s
Intellectual Property Rules: Facts vs. Common Myths,”
Public Citizen Global Trade
Watch Series
. March 29, 2021. Accessed Aug. 10, 2021.
https://www.citizen.org/article/waiver
-
of
-
the
-
wtos
-
intellectual
-
property
-
rules
-
myths
-
vs
-
facts/ AT
The
COVID
-
19 public health disaster and resulting economic crises
won’t end
anywhere
unless people ev
erywhere are
vaccinated.
Despite this obvious truth,
rich countries with only 14 of the global population have secured preferential access to over 50 of projected global vaccin
e
supplies.
Ongoing outbreaks
anywhere
allow the virus to mutate, threatening
the whole world with
vaccine
-
resistant variants
or more deadly or easily spread variants. Governments invested billions to create the vaccines. But, there is a dire shortage
, with
no end in sight. As we enter the second quarter,
about one billion doses hav
e been produced in 2021. We need 10 to
12 billion to reach global herd immunity
.
And
we will need far
more if
, like flu vaccines,
they
must be repeated or
require
booster shots.
In every region, there are existing firms that could gear up production and go
vernments willing to invest in expanding supply. But WTO rules require
countries to guarantee pharmaceutical corporations monopoly control. More than 100 countries support a temporary, emergency s
uspension of these WTO rules, so more
vaccines, treatments a
nd diagnostic tests can be manufactured in as many places as possible. The United States and a handful of other WTO members a
re blocking the waiver:
They won’t even agree to negotiate about waiver language to address whatever concerns that they may have wi
th the current text. Donald Trump started this self
-
defeating
blockade. President Joe Biden must reverse it to speed the end of the COVID
-
19 pandemic.
The v
accine
shortfall causes widespread death and poverty.
Public Citizen 3/1
-
Public Citizen “Public Citizen is a nonprofit consumer advocacy organization that champions the public interest
in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people
–
not for big
corpor
ations. Founded in 1971, we now have 500,000 members and supporters throughout the country. We don’t participate in partisan
political activities or endorse any candidates for elected office. We take no government or corporate money, which enables us
to re
main
fiercely independent and call out bad actors
–
no matter who they are or how much power and money they have.”, “Backgrounder: WTO
-
Required Monopolies for Pharmaceutical Corporations Obstruct Global Production of COVID
-
19 Vaccines and Treatment,”
Public
Citizen Global
Trade Watch Series
. March 1, 2021. Accessed Aug. 12, 2021.
https://www.citizen.org/article/wto
-
required
-
monopolies
-
for
-
pharmaceutical
-
corporations
-
obstruct
-
global
-
production
-
of
-
covid
-
19
-
vaccines
-
and
-
treatments/ AT
It is obvious that curr
ent production capacity cannot supply enough vaccines for the entire world. Many
people in low
-
and middle
-
income
countries
around the globe
will not get vaccinated until at least 2022
unless the world manufactures many more doses, according to
the British
Medical Journal.
The world’s poorest
countries
may wait until 2024 for mass immunization
, if it happens at all,
reports the Economist Intelligence Unit.
The
global vaccine apartheid
unfolding right now
could cost millions of lives and push tens of million
s
more
into poverty.
The devastation will be felt for a generation. A new International Chamber of Commerce report concluded that the world could
face economic losses of
more than $9 trillion under the scenario of wealthy nations being fully vaccinated by
mid
-
2021, but poor countries largely shut out. Wealthy countries like the United States
would bear nearly half of that hit. Vaccinating just half of low
-
and middle
-
income countries’ populations could reduce global losses by $5.5 trillion.
A waiver provide
s legal certainty
that
unlocks global production.
Public Citizen 3/29
-
Public Citizen “Public Citizen is a nonprofit consumer advocacy organization that champions the public
interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the
people
–
not
for big corpor
ations. Founded in 1971, we now have 500,000 members and supporters throughout the country. We don’t participate in partisan
political activities or endorse any candidates for elected office. We take no government or corporate money, which enables us
to re
main
fiercely independent and call out bad actors
–
no matter who they are or how much power and money they have.”, “Waiver of the WTO’s
Intellectual Property Rules: Facts vs. Common Myths,”
Public Citizen Global Trade Watch Series
. March 29, 2021. Acces
sed Aug. 10, 2021.
https://www.citizen.org/article/waiver
-
of
-
the
-
wtos
-
intellectual
-
property
-
rules
-
myths
-
vs
-
facts/ AT
Most critically, there simply is not enough supply to go around now or for every year in the future during which the whole wo
rld will nee
d regular COVID vaccination to keep the
virus under control. Thankfully,
scores of countries are ready to invest in building new or repurposing existing
production capacity.
That is why more than 100 countries support a waiver of the WTO’s Agreement on Tra
de
-
Related Aspects of Intellectual Property (TRIPS).
These countries seek certainty that if they adjust their
domestic
laws and practices
to support that investment by
providing access to the necessary technology, they will not get dragged into
expansive W
TO
litigation
or face retaliatory sanctions
from countries claiming WTO violations.
The waiver will
also
serve as a worldwide
buffer against the political pressure and legal harassment to which Big Pharma subjects
countries
that seek to promote affordable
access to medicines.¶ In many countries, the
regulatory authorities that had to approve
domestic use of
various
vaccines
and other COVID
-
related medical products
have significant information from the
firms that they could share with skilled teams from loca
l universities, government agencies
and pharmaceutical manufacturers
—
if they were not obliged by WTO rules to guarantee monopoly control of it.
And world
-
class pharmaceutical
firms already are making generic versions of new cutting
-
edge HIV
-
AIDS medicine
s and pumping out vaccines based on the platform that, for instance, the Johnson and Johnson
vaccine uses.
Manufacturing capacity is widespread around the world.
Public Citizen 3/29
-
Public Citizen “Public Citizen is a nonprofit consumer advocacy organizat
ion that champions the public
interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the
people
–
not
for big corporations. Founded in 1971, we now have 500,000 members and supporters throug
hout the country. We don’t participate in partisan
political activities or endorse any candidates for elected office. We take no government or corporate money, which enables us
to remain
fiercely independent and call out bad actors
–
no matter who they are
or how much power and money they have.”, “Waiver of the WTO’s
Intellectual Property Rules: Facts vs. Common Myths,”
Public Citizen Global Trade Watch Series
. March 29, 2021. Accessed Aug. 10, 2021.
https://www.citizen.org/article/waiver
-
of
-
the
-
wtos
-
int
ellectual
-
property
-
rules
-
myths
-
vs
-
facts/ AT
In the press and on Capitol Hill, Big Pharma is pushing a Big Lie. The claim is that a lack of manufacturing capacity, not ph
armaceutical corporation’s monopoly intellectual
property (IP) protections, are thwart
ing greater production of COVID
-
19 vaccines. A related argument, with decidedly racist overtones, is that COVID
-
19 vaccines are too
complicated for producers in developing countries to make successfully. The reality is that
in every region of the world, th
ere are
multiple producers that could be greatly increasing global vaccine supplies
if the technology and know
-
how
were shared.¶ Just in Africa, “Biovac and Aspen in
South Africa,
Institute Pasteur in
Senegal,
and Vacsera in
Egypt
could rapidly retool factories to make
mRNA vaccines,” notes a group of medicine
-
production experts in a recent Foreign Policy article. Indeed, a former Moderna director of chemistry revealed that with enou
gh
technology transfer and know
-
how
-
sharing, a mo
dern factory should be able to get mRNA vaccine production online in, at most, three to four months. The Serum Institute in
India
already is slated to produce the AstraZeneca and Novavax vaccines, while Moderna declined to partner with a qualified
Banglade
sh
i vaccine maker, claiming
its engineers were too busy to focus beyond U.S. and EU production. In Latin America, existing facilities in
Brazil, Argentina
and
Mexico
under contract to
monopoly holders are already pumping out vials, and in countries like
Ch
ile and Colombia
, the pharmaceutical industry has
expressed
willingness to kickstart
vaccine
production.
¶
Existing and planned contract manufacturing
arrangements prove facilities in developing countries
certainly
can produce COVID
-
19 vaccines.
But
unless
technology and know
-
how are shared more openly, the monopoly holders maintain absolute control over how much can be produced, what the price is a
nd where it will
be sold. So, 91 of the Johnson and Johnson vaccine that South African firm Aspen will manufactu
re must be shipped for sale outside South Africa, according to South Africa’s
WTO Counselor. And the Serum Institute is barred from supplying upper
-
middle
-
income and high
-
income countries with the AstraZeneca vaccines it makes, meaning
AstraZeneca can art
ificially segment the global market and ensure that it is the only supplier of the Oxford vaccine in the most profitable nati
onal markets, according to Doctors
Without Borders.¶ Most critically, there simply is not enough supply to go around now or for eve
ry year in the future during which the whole world will need regular COVID
vaccination to keep the virus under control. Thankfully, scores of countries are ready to invest in building new or repurposi
ng existing production capacity. That is why more than
1
00 countries support a waiver of the WTO’s Agreement on Trade
-
Related Aspects of Intellectual Property (TRIPS). These countries seek certainty that if they adjust their
domestic laws and practices to support that investment by providing access to the neces
sary technology, they will not get dragged into expansive WTO litigation or face
retaliatory sanctions from countries claiming WTO violations. The waiver will also serve as a worldwide buffer against the po
litical pressure and legal harassment to which Big
Pharma subjects countries that seek to promote affordable access to medicines.¶ In many countries, the regulatory authorities
that had to approve domestic use of various
vaccines and other COVID
-
related medical products have significant information from t
he firms that they could share with skilled teams from local universities, government
agencies and pharmaceutical manufacturers
—
if they were not obliged by WTO rules to guarantee monopoly control of it. And world
-
class pharmaceutical firms already are
ma
king generic versions of new cutting
-
edge HIV
-
AIDS medicines and pumping out vaccines based on the platform that, for instance, the Johnson and Johnson vaccine uses.
Contention II: Innovation
Limiting IP protections
increase
s
the incentive to create new drug
s.
Light and Warburton ’11
-
Donald W. Light Visiting professor at Stanford University and a professor of comparative health
-
care at
the University of Medicine and Dentistry of New Jersey. He is an economic and organizational sociologist who studies health
care systems and
pharmaceu
-
tical policy. and Rebecca Warburton associate professor and a health economist, specializing in the cost
-
benefit analysis of
health
-
related public projects. Her current research primarily concerns assessing the validity of in
dustry
-
sponsored estimates of the cost of drug
development, and assessing the costs and effects of patient safety improvements. She has a PhD in economics from the Universi
ty of London
(1995), and an M.Sc. in economics from the London School of Economics (
1980); School of Public Administration, University of Victoria, British
Columbia, “Demythologizing the high costs of pharmaceutical research
BioSocieties
(2011) 6, 34
–
50. doi:10.1057/biosoc.2010.40; published
online 7 February 2011. JH
Industry executiv
es, well supplied with facts and figures by the industry’s global press network, awe audiences with staggering figures for th
e cost of a single trial, like tribal
chieftains and their scribes who recount the mythic costs of a great victory in a remote pass
where no outside witnesses saw the battle.
Companies tightly control access to
verifiable facts about their risks and costs, allowing access only to supported economists at consulting firms and universiti
es, who develop methods for showing how large costs
and risks are; and then the public, politicians and journalists often take them at face value, accepting them as fact. The gl
obal press network never tells audiences about the
detailed reconstruction of RandD costs for RotaTeq and Rotarix that found costs a
nd risks were remarkably low up to the large final trials, and that concluded the companies
recovered their investments within the first 18 months (Light et al, 2009).
The
companies could now sell these vaccines for rotavirus for one
-
tenth their Western price and
still earn profits. ¶
Pharmaceutical
companies have a strong vested interest in maximizing figures for RandD and supporting centres or researchers who help them do
so
. Since the Kefauver hearings in 1959
–
1962,
the
industry’s
principal
justification for
its
high prices
on patented drugs
has been the
high
cost of Rand
D
,
and it has sought further government protections from normal price competition.
These include increasing
patent terms and extending data
exclusivity, without good evidence that these measures increase innovation (National Institute for Health Care Management, 20
00; European Commission for Competition, 2008
(28 November); Adamini et al, 2009). Industry leader
s and lobbyists routinely warn that lower prices will reduce funds for RandD and result in suffering and death that future
medicines could reduce. Marcia Angell, the former editor of the New England Journal of Medicine, describes this as ‘ya kind o
f blackmai
l’ (Angell, 2004, pp. 38
–
39). She quotes
the president of the US industry’s trade association as saying, ‘Believe me, if we impose price controls on the pharmaceutica
l industry, and if you reduce the RandD that this
industry is able to provide, it’s going to
harm my kids and it’s going to harm those millions of other Americans who have life
-
threatening conditions’. Merrill Goozner, former
chief economic correspondent for the Chicago Tribune, points out that
no other research
-
oriented industry makes this
kind
of
argument
(Goozner, 2004). In fact,
they do the opposite: when profits decline, they redouble
their research efforts to find new products that will generate more profits
.
Not to do so
guarantees
their
decline
.
The industry’s view of European ‘price controls’ (actually, large
-
volume discounts) is that they do not allow recovery of huge RandD
costs so that Europeans are ‘free riders’ on Americans and force US prices higher to pay for unrecovered costs the ‘free ride
rs’ refuse to pay. This claim has been shown not to be
supported by industry and government reports and to be illogical as well (Light and Lexchin, 2005).
IP stifles innovation by allowing firms to prevent new competition from entering the
market, driving
down the incentive for R and D.
MSF ’17
–
Médecins Sans Frontières Doctors Without Borders
-
Médecins Sans Frontières (MSF) is an international, independent, medical
humanitarian organisation that delivers emergency aid to people affected by armed conflict,
epidemics, healthcare exclusion and natural or
man
-
made disasters., “A Fair Shot for Vaccine Affordability: Understanding and addressing the effects of patents on access to ne
wer vaccines,”
September, 2017. Accessed Aug. 12, 2021.
https://msfaccess.org/sites/default/files/2018
-
06/VAC_report_A20Fair20Shot20for20Vaccine20Affordability_ENG_2017.pdf
AT
Patents are in
creasingly an issue for development of newer vaccines
Patent activity in the field of vaccine development and manufacturing has been increasingly recognised as problematic over th
e past 15 years, according to manufacturers
interviewed for this report. Inte
rnational organisations with vaccines expertise such as WHO and Gavi, the Vaccine Alliance, have similarly noted that patent
thickets are an
increasing concern for vaccines.16
For medical products
such as PCV and HPV vaccines,
patent barriers
can
slow the
development process,
increase costs, increase uncertainty and deter or even block other manufacturers considering
entering the market.
17 A recent analysis by Chandrasekharan et al. found 106 Patent Cooperation Treaty (PCT) applications “potentially relevan
t to the
manufacturing of pneumococcal vaccines”† and 93 patents applications “relevant to the manufacturing of HPV vaccines.”18
The patent applications and discussions with manufacturers indicate that
broad monopolies are being pursued
for these vaccines,
through
tactics such as
using overly general language in patent claims
concerning the scope of the inventions. According to national criteria,
many of these patents or applications could be challenged or rejected due to their weak technical merits. With p
atents sought for PCV and HPV vaccine technology in major and
emerging markets, like Brazil, China, Europe, India, and the US, governments and other stakeholders seeking to encourage comp
etition and access to affordable vaccines must
consider how to mitiga
te the constraints that pending and granted patents in developing countries place on the ability of potential competitor vacc
ine manufacturers to develop
or sell competitor vaccines.
Contention 3: Medicine Prices
IP undermines competition and keeps
medicine prices high.
MSF ’17
–
Médecins Sans Frontières Doctors Without Borders
-
Médecins Sans Frontières (MSF) is an
international, independent, medical humanitarian organisation that delivers emergency aid to people
affected by armed conflict, epidemi
cs, healthcare exclusion and natural or man
-
made disasters., “A Fair
Shot for Vaccine Affordability: Understanding and addressing the effects of patents on access to newer
vaccines,” September, 2017. Accessed Aug. 12, 2021.
https://msfaccess.org/sites/default/files/2018
-
06/VAC_report_A20Fair20Shot20for20Vaccine20Affordability_ENG_2017.pdf
AT
Intellectual property undermines competition and keeps prices high¶ As MSF has seen repeatedly for medical products critical
to our operations,
competition
among multiple manufacturers is a proven way to reduce prices and increase access.
Without
competiti
on,
single suppliers can set prices high, and limited supply options leave vulnerabilities,
including dependence on a sole manufacturer’s ability to maintain consistent supply.
The effects of IP
monopolies like patents on competition and supply for pharmac
eutical products are well documented.11,12,13 Yet, as increasingly recognised, and discussed in more detail
within this document, patent
-
based monopolies can also be a barrier in the field of vaccine production and have posed challenges to vaccine developm
ent for decades.¶
Traditional narrative of technology transfers and lack of consideration of patent barriers ¶ Prior experiences of developing
vaccines for diphtheria, whole
-
cell pertussis, polio,
measles, mumps, influenza, rubella, and yellow fever in Wor
ld Bank
-
classified low
-
and middle
-
income countries had suggested that patents do not play a major role in
modifying the behaviour of vaccine manufacturers. Historically, these vaccines have been developed using conventional egg
-
based and cell culture
-
base
d methods generally not
protected by patents. In these cases, the process of manufacturing and key ‘know how’* was considered a barrier to entry for
new competitors.14¶ When looking at the
manufacturing experiences of some older vaccines, this perception i
s an oversimplification. The development of the hepatitis B vaccine, for example, dating back nearly half a
century, faced patent barriers resulting in monopolies and high prices.15 The two manufacturers of recombinant hepatitis B va
ccines, Merck and Smith
Kline Beecham, needed
licences to more than 90 patents from universities, public institutes and private companies to produce their vaccines. Despit
e the contributions of publicly funded RandD, product
prices at introduction were as high as $40 per dose for t
his 3
-
dose regimen (equivalent to more than $87 per dose in real terms in 2016).¶ Patents are increasingly an issue for
development of newer vaccines¶ Patent activity in the field of vaccine development and manufacturing has been increasingly re
cognised as
problematic over the past 15 years,
according to manufacturers interviewed for this report. International organisations with vaccines expertise such as WHO and G
avi, the Vaccine Alliance, have similarly noted that
patent thickets are an increasing concern
for vaccines.16¶ For medical products such as PCV and HPV vaccines,
patent barriers
can
slow the
development process, increase costs, increase uncertainty and deter
or even block other
manufacturers
considering entering the market.
17 A recent analysis by
Chandrasekharan et al. found 106 Patent Cooperation Treaty (PCT) applications “potentially
relevant to the manufacturing of pneumococcal vaccines”† and 93 patents applications “relevant to the manufacturing of HPV va
ccines.”18¶ The patent applications and
discussions with manufacturers indicate that
broad monopolies are being pursued for
these
vaccines, through tactics
such as using overly general language in patent claims concerning the scope of the inventions.
According to national criteria, many of these
patents
or applications
could be challenged or rejected
due to their weak technical merits.
With patents sought for PCV and HPV vaccine technology in major and emerging markets, like Brazil, China,
Europe, India, and the US, governments and other stakehol
ders seeking to encourage competition and access to affordable vaccines must consider how to mitigate the
constraints that pending and granted patents in developing countries place on the ability of potential competitor vaccine man
ufacturers to develop or
sell competitor vaccines.¶
Patents undermine competition throughout PCV and HPV vaccine manufacturing and beyond¶ Patents can act as barriers throughout
vaccine development, manufacturing and
administration processes. PCV and HPV vaccine products are prote
cted by a series of patents and patent applications, covering all aspects including starting materials,
composition, process technologies, and methods of using vaccines, including age groups, vaccine presentations and schedules.
Potential competitor
vaccin
e
manufacturers
considering entering the market may
face patent challenges “in any step of the development
process starting from preclinical RandD, to scale up, formulation and licensure in the markets of
choice, and hence may alter their decision pathways
...
at each step.”19¶ The typical strategy for a
vaccine
manufacturer seeking a patent monopoly
is to
use broad, non
-
specific claim language to define
what
they claim is
the invention
. Many of those patents and applications do not merit patent protection accor
ding to national laws, and many are used mainly
to
maximise the scope of monopoly.
¶
Starting materials
¶
Starting materials patents cover the inputs/initial ingredients for making a vaccine, including
various chemical reagents, host cells, vectors, and DNA
and/or RNA sequences of various types. These inputs are highly likely to be required for vaccine production. If the rights to
use these materials in vaccine
manufacturing are not obtained by a company, it may be very difficult to ‘design around’ the need f
or these materials. These materials have often been patented years ago and they may now be in the public
domain, as is the case for PCV and HPV vaccines.
¶
Several patent applications were filed on HPV vaccine starting materials from the mid
-
1990s. For inst
ance, Merck filed a patent application on the basic HPV
DNA,20 covering the most common antigen types HPV 16 and HPV 18. The application attempts to protect recombinant DNA sequence
s encoding the important antigenic proteins of papillomavirus and purified
virus
-
like particles comprised of the recombinant proteins. It also tries to cover the methods of making and using the recombinant
proteins. Merck additionally filed a patent application seeking monopoly
protection over virus
-
like particles containing HPV
18.21 Where granted as claimed, these patents could block anyone who plans to develop alternative HPV vaccines during the pat
ent term. These two Merck
applications, where granted, should have started to expire around the world beginning in 2015
-
2016.
¶
A nu
mber of newer patent applications since the 2000s on HPV vaccines are also related to starting
materials. It is a common practice to file such ‘second
-
generation’ applications to seek additional commercial advantages. For instance, GSK filed a patent appli
cation22 claiming modified DNA sequences of HPV
which provide enhanced levels of expressed antigen. This patent would expire in 2023 where granted. Another example is a GSK
patent application23 related to cross
-
reactivity, where HPV 16 and HPV 18
-
containin
g constructs can be used in a vaccine that protects against other HPV antigens besides 16 and 18. The detailed effects of the
se newer patent applications on follow
-
on development of alternative HPV
vaccines require further analysis.
¶
Vaccine composition
¶
V
accine composition patents typically seek to cover the resulting combination of immunologically important parts of the vaccin
e,
plus associated materials, such as adjuvants, buffers and preservatives. These types of patents can potentially have strong b
loc
king effects.
¶
One of the key patents that Pfizer is seeking for its PCV13 product
relates to the vaccine’s composition.24 See more details on this PCV13 patent application and why it represents an unwarrante
d obstacle to pricelowering competition for PCV
in the PCV13 patent opposition case
study.
¶
There are numerous other examples of vaccine composition patents and these may also warrant further analysis for the effects
they may have on competition. For example, Pfizer, GSK and other
companies have further
filed a series of patent applications claiming different aspects of PCV compositions including those covering up to 20 and 26
valent PCV vaccines.25
¶
Process
technologies
¶
Patents related to vaccine process technologies grant monopolies on the way a vaccine is manufactured. The specific manufactu
ring methods depend
on the type of vaccine. Many different patents and patent applications have been identified that cover or attem
pt to cover various aspects of vaccine process technologies. ¶ For
example, basic conjugation technology needed for PCV manufacturing is patent protected in at least six countries.26 This pate
nt is broad and non
-
specific, blocking competitors
from using a
general process for combining several vaccine elements (a polysaccharide, e.g., derived from a Pneumococcus, activated with a
specific organic compound and then
joined to a carrier protein) to obtain a conjugated immunogenic product. These patents have alr
eady begun to expire as of 2016. Until expiry, a vaccine manufacturer wanting to
offer a more affordable PCV is required to address this barrier in countries where the patent has been filed or granted.¶ Som
e other examples of patents filed by different
app
licants claiming different process technologies related to PCV production may also warrant further analysis to assess their p
otential impact on competition for PCV
vaccines.27¶
Methods of using vaccines
¶
‘Methods of use’ patents seek a monopoly on the way
a product is used, for example how a vaccine is
administered to children. Depending on the specific claim language, this can include patents on various vial presentations, d
ose regimens, populations or age groups covered,
other elements related to the pres
entation and packaging of the vaccine itself, or the use of the vaccine in people.¶ These patents are highly problematic beca
use they may
undermine the ability of Ministries of Health and clinicians to practise medicine and immunise children in the most ap
propriate way, free from any potential patent infringement
risks. Additionally, these patents may also make potential competitors liable if their product labels and package inserts inc
lude information on dosage regimens or methods of
use that are under the
scope of the concerned patents. This can be the case even if more affordable competitor vaccine products themselves do not in
fringe on an originator’s
patents on a given vaccine.¶ One example of this is a GSK patent application28, which essentially seeks
a monopoly on administering PCV after a child has received tetanus
and/or diphtheria vaccines.* This ‘preimmunisation’ claim term is particularly broad; many national immunisation programmes c
ould have a national vaccination protocol
through which a child
may receive tetanus or diphtheria vaccines before getting PCV.¶ If granted, this patent may have a strong blocking effect on
the use of any alternative PCV
in national immunisation schedules. GSK has applied for this PCV patent in Great Britain (withdrawn
in 2011), Brazil, Eurasian Patent Organisation and Morocco.29 The
application was also filed, but subsequently withdrawn, in various other jurisdictions, including Australia, Canada, China, G
ermany and the European Patent Office, South Korea,
and abandoned
in India, following pre
-
grant opposition.30 It has already been granted in South Africa.31¶
Patents related to age groups
¶
Patent claims
can also cover specific age groups to which the vaccine can be administered. If granted, these patents can restrict co
mpetition by blocking other manufacturers from selling
vaccines for administration to the specified (and likely necessary) age groups. For example, the European Patent Office grant
ed a patent32 to GSK for a method of using a ‘two
dose’ HPV16/18 vaccine.33
The patent application includes a patent claim stating that the vaccine is formulated for administration ‘to a subject 14 yea
rs of age or below’.34 It
indicates a monopoly on immunising people who are 14 years old or younger, which covers the full age rang
e of girls recommended by WHO to receive HPV vaccines.35 This
may well be a patent that blocks competition in Europe and prevents competitor manufacturers from offering more affordable ve
rsions of HPV vaccines that protect against
these two critical strain
s of HPV. In its PCT application36, the initial claims of the equivalent patent are even broader, covering the use of the con
cerned method for females
aged ‘25 years or under’, ‘9 to 25 years’, ‘9 to 14 years’, ‘15 to 19 years’ and ‘20 to 25 years’, thereb
y seeking to cover all possible vaccination schedules for the full ranges of
ages for whom HPV vaccine would be most effective.¶
Patents related to vaccination schedule and presentation
¶
Dose regimens
are formalised schedules by which medicines or vaccines
are administered, including the dose of the vaccine, the number of doses in a period of time and the time between
doses. The patenting of these regimens, including for vaccines, effectively grants a patent holder a monopoly that inhibits t
he development o
f competitor products that may
need to be administered in the same or a similar dosing regimen, and undermines the ability of medical professionals to presc
ribe the most medically sound regimens based on
health needs.¶ For example, a GSK patent application
on the HPV vaccine37 contains very broad claims. The technology in this GSK patent application covers both bivalent* and
quadrivalent† HPV vaccines and claims a process of administering a ‘two
-
dose regimen’ consisting of a first dose and a second dose, wh
erein both doses can be either bivalent or
quadrivalent, covering all virus types causing cervical cancer. It is sufficiently broad to affect manufacturers who intend t
o move towards two
-
dose regimen administration for
their bivalent or quadrivalent HPV pr
oducts, while a two
-
dose schedule is currently recommended by WHO for HPV.38 This patent application has been issued in Europe39 for
the ‘two
-
dose’ bivalent HPV vaccine, and the vaccine was approved for marketing by the European Commission in December 2013
. Applications have also been filed in Australia,
Canada, China, India, New Zealand, South Korea and the US. It has been withdrawn in the Philippines and refused in Ukraine.40
¶ In other situations, broad claims in patent
applications could also seek monopo
ly protection over the vial presentation and carry concerning implications for the launch of alternative versions of the vacc
ine by followon
manufacturers. Vial presentation refers to the format of the vaccine, in terms of the number of doses, the volume a
nd the weight contained within one unit of production. For
example, it could refer to a single
-
dose pre
-
filled syringe, a 10
-
dose vial with 2 ml per dose, a 20
-
dose vial and so on.¶ Multi
-
dose vial presentations, where more than one dose
of the vaccine is
contained in a vial, are an advantage for developing country immunisation programmes because they decrease cold chain capacit
y requirements and ease
vaccination programme logistics. Multi
-
dose vials, in general, also have a lower price per dose compared to
single
-
dose vial and/or syringe formats. Pfizer filed a patent
application concerning a multidose vial PCV13,41 which includes broad claims related to specific presentations, including pre
-
filled vaccine delivery devices (such as a syringe) as
well as a v
ial container. If granted as claimed, it might effectively block the development and launching of alternative versions of mul
ti
-
dose vial PCV13 and secure the market of
using such presentations (multi
-
dose vials) for only Pfizer’s product. The monopoly ass
ociated with this patent could mean that public health programmes looking to switch to
multi
-
dose vial PCV13 or a pre
-
filled ‘device,’ such as a pre
-
filled syringe, would either have to stay with a single dose vial format or have to use Pfizer’s version on
ly. This patent
has been granted in Australia, South Korea, the US and by the European Patent Office.42 An equivalent application has also be
en filed in China43 and India44, where the
applications are pending examination.¶ Summary¶
There are many different
aspects
of vaccines that are
being patented, in
many cases undeservingly
so per national laws. These patents pose significant barriers for other manufacturers to enter the market and contribute to a
competitive environment that could help lower prices and
increase access. Taken together, these patents indicate that throughout the vaccine development process and
beyond,
patents pose a threat to affordable vaccines by impeding, and possibly outright blocking
price
-
lowering follow
-
on competition.
In some case
s, potential competitors have opportunities to address and overcome these barriers
providing they have the time, resources, technical know
-
how and an accurate assessment of the vaccine patent landscape.
Poverty and disease are mutually reinforcing, causing
staggering suffering and
injustice.
Hollis and Pogge ’08
-
Aidan Hollis Associate Professor of Economics, the University of Calgary and
Thomas Pogge Leitner Professor of Philosophy and International Affairs, Yale University, “The Health
Impact Fund Maki
ng New Medicines Accessible for All,”
Incentives for Global Health
(2008) AT
In 2004, some 970 million people, around 15 percent of the world’s population, were living below the extreme poverty line of
$1 a day (more strictly defi ned, $392.88 annually)
i
n 1993 Purchasing Power Parity (PPP) terms (Chen and Ravallion 2007, 16579).3 Furthermore, those living below this very low p
overty line fell on average around 28 percent
below it. Th eir average annual purchasing power therefore corresponded to approximat
ely $420 in the US in 2008 dollars.4¶ Th ese are the poorest of the poor. Th e World
Bank also uses a somewhat less miserly poverty line, namely $2 dollar a day, or an annual amount of $785.76 PPP 1993. Th e Ba
nk’s data show that around 40 percent of the
w
orld’s population, or over 2.5 billion people, lived in income poverty so defi ned in 2004,5 with this population falling on
average 41 percent below this higher line.6 Individuals
I;
\
pp
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
\
n this much larger group could buy, on average, about as much in 2004 as could be bought in the US in
2008 for $690.¶ The Effects of Global Income Poverty on Health¶ The effects of such extreme income poverty are foreseeable an
d extensively documented.
It
is estimated that
around 13 percent of all human beings (
830 million
) are
chronically undernourished
, 17 percent (
1.1 billion
)
lack
access to
safe
water
, and 41 percent (
2.6 billion
)
lack
access to
basic sanitation
(UNDP 2006, 174, 33). About 31 percent (
2
billion
)
lack access
to crucial drugs and
25 percent (
1.6 billion
)
lack electricity
(Fogarty n.d., IEA 2002). Some
780 million adults are
illiterate
(UNESCO 2006), and 14 percent of children aged between fi ve and 17 (
218 million
)
are child laborers, more
than half in
hazardous work
(ILO 2006, 6)
.
¶ Worldwide,
diseases related to poverty
, including communicable, maternal, perinatal, and
nutritionrelated diseases,
comprise over 50 percent of
the burden of
disease in low
-
income countries,
nearly
ten
times the
ir
relative
burden in developed countries
(WHO 2006b, 3). If the developed world had its proportional share of poverty
-
related
deaths (onethird of all deaths), severe poverty would kill some 16,000 Americans and 26,000 citizens of the European Union ea
ch w
eek.¶
The cycle of
mutually reinforcing poverty and disease besetting low income countries
, and particularly the poorer
communities in these countries, could be broken by signifi cantly reducing severe poverty. But it is also possible to make su
bstantial p
rogress against the global burden of
disease more directly by improving health care in developing countries.¶
Poverty does not merely render
poor
people more
vulnerable to disease, but also makes it less likely that they can obtain medical treatment
for th
e
diseases they contract. This is
because
in poor countries medical care is rarely available for free, and
poor people are
typically
unable to buy
either
the care needed by
themselves or
their families
or the insurance policies that would guarantee them su
ch care. The price of health care in
poor countries therefore also plays a crucial role in explaining the catastrophic health situation among the global poor.
For these reasons, I urge an affirmative ballot.
Enter your thoughts here
Folder history
Folder history
0
0