Chapter 21

Οη the Ethical Foundation of Proprietary Rights:

COVID-I_θ, Public Health, and the Limits of Ρατεητs
ßη the European Context

Enrico Bonadio and Andrea Baldini

ι. Introduction

Ιη mid-March 2020, ΝυηΖßα ναΙΙßηß - α journalist working for α local newspaper ßη Brescia,
α city ßη northern ltaly - got ßη touch with Cristian Fracassi, engineer and chief execuτive of
Isinnova, α 3D printing start-up.l The hospital ßη Brescia, which would sadly become famous
as one of the European epicentres of the pandemic, saw α spike ßη hospiτal admissions due το
COVID-19 infections ßη that period. The number of patients needing intensive care skyrockeτed
to 250 ßη just α few days, and the hospital was running out of respirator valves, wiτh τhε
offlcial supplier unable to meet the sudden demand. The valve, originally produced by υΚ
manufacturing company Intersurgical which owns patent rights protecting such α τechnology,
allows ICU patients to be connected to breathing machines. The design enables α maximum
eight hours of use, therefore requiring frequent replacement.
Ιη collaboration with engineer Alessandro Romaioli, Isinnova reverse-engineered τhe
valve, after Intersurgical apparently refused to share the schematics of the producτ.2 The release
of the 3D printed version of the reverse-engineered valves started immediaτely afτer τhε flrsτ
positive trial. Time was ßη effect of the essence: many were already dying as α consequence
of COVID-19 complications, with α death toll at that moment of 45,000 lives3 (ατ τhε τime of

1Zoe Kleinman, 'Coronavirus: 3D Prinιers Save Hospital with Valves', BBC l{elvs, 16 March 2020.
2
Jay Peters, 'Volunteers Produce 3D-Printed Valves for Life-Saving Coronavirus Treatments', The Verge, 17 March 2020.
3
Gianfranco Alicandro, Giuseppe Remuzzi, and Carlo La Vecchia, ºtαΙγ's First Wave of the COVID-19 Pandemic Has
Ended: Νο Excess Moπality ßη Μαγ, 2020', 396 The Lanceτ Ι0253, 12 Sepτember 2020, available ατ: < e27_28, hττps://
dol,org/10. 1016/S0140-6736(20)31865-1 >.
 Ραττ ΙΙI. HEALTH (AND RISK) REGULATION Co\,ΙD

writing, the death toll ßη ltaly has exceeded 108,000). "We're trying to save lives," Fracassi \\-ßιh '-:._ :
replied during αη interview with BBC /{ews, which was insirumental ßη bringing this case ßητο death of :ια].,,, ,

the media spotlight for having highlighτed α potential patent and public health issue. virus appea: ::
Ιη effect, early reports of the news suggested that Intersurgical was ready to go το cουττ, drugs or Ιß:ε-.,.'
threatening to sue Isinnova for patent infringement. Amidst public outcry, Charles Bellm for resιricι:,::.-,
- managing director of the υΚ company - later issued α statement claiming that his group had crisis? The ,].-
never considered α lawsuit. "[W]e were contacted at the end of last week for manufacτuring perhaps ßυ ,:-,
details of α valve accessory," Bellm said, "but could not supply these due to medical ΙΡ protecι":* :

manufacturing regulations, we have categorically not threatened to sue anyone involved".a personal ει: -

not offer sι_,: :

2. Patent Protection ßη Europe and the Ethics of Pandemic Litigation by τhε CO\ -)
major con:-_,:-.
The ltalian case was οηΙγ one among the many similar controversies ßη intelleciual propeny
Ιοòκdοτιτ :.,,;
(ΙΡ) protection thai emerged internationally.S How things actually unfolded ßη this story (and
of uniιr,. τò:, _..
other similar ones) is somewhat irrelevant here: what is important is α more general question
about the ethics of ΙΡ that the story raises, If Intersurgical had decided tο sue Isinnova, such
3. The Rele
α legal move would have been perfectly legal: but would have that been α morally jusτiflable
action? And, by bringing this doubt into the legal domain, should European laws accept or Afιel .__,
ignore claims of ΙΡ infringement ßη extreme circumstances such as α pandemic? α compuls::,
It should be noted as α preliminary matter that patents are strongly protected ßη Europe. Merck ßη ]_,-
The European Patent Convention (EPC), which is not αη Ευ instrument,G provides α solid legal manufacι*:. .
framework for the granting of European patents. Pharmaceutical companies from αΙΙ over τhε health cris=s,
world regularly obtain European patents to protect α wide range of new medicines - which Court gra::.:
they use to recoup the (often huge) investments necessary to develop them. Patent proτection contains ,:,. :
is therefore key to the pharmaceutical industry, also ßη Europe. This also clearly emerges from German Fε:.:
the recent European Parliament Resolution 'The EU's Public Health Strategy Post-COVID-19' The *:.:-'
of 10 July 2020,? While the Resolution calls οη the Commission and the Member Sτaτes το bv Shion,:=,
allow maximum sharing of COVID-19 health technology-related knowledge, ΙΡ and data to Disπicι C: _:
the beneflt of αΙΙ countries and citizens (Paragraph 6), οη the other hand it also reminds us unsucces s: -,
that the Ευ must keep α robust European ΙΡ regime το incenτivise research, developmenτ, and uslng τα_:ε=:.
manufacturing, to make sure that Europe remains α world leader ßη innovation (Paragraph 23).

aJay Peters, 'Volunteers Produce 3D-Printed Valves for Life-Saving Coronavirus Treatlnents', cit.
5For α discussion of international
ραtεηι controversies durlng the pandemic, see for instance Enrico Bonadio and
Andrea Baldlni, 'COVID-19, Patents and the Never-Ending Tension between Proprietary Rights and the Protection
of Public Health', 11 European Journal of Risk Regularion 2, ρρ. 390-95, avaiiable at < https://doi.or!I0.1017l
err.2020.24 >.
6
European Patent Convention (Convenτion οη τhe Grant of European Patenιs) of 5 October 1973 as revised by τhe Acτ
revising AIticle 63 EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000. The EPC has been
signed by 3Β Contracιing States, including countries which are not Ευ Member States.
7
European Parliament Resolution 2020/2691(RSP) 'The EU's Public Health Sιrategy PoscCOVID-19' of 10 July 2020
[Ρ9_ΤΑ(2020)0205].

234
 COVID-1g, PUBLIC HEALTH, AND ΤΗΕ LIMITS OF PATENTS ΙΝ ΤΗΕ EUROPEAN CONTEXT

Lives." Fracassi With that being said, one could argue that behaviours seemingly disregarding τhε imminenτ
g ιhis case into death of many individuals as well as the concrete possibiliτy of furτher spreading of α dangerous
§ι.ιe. virus appear morally disputable. Patents, one mαγ very well add, should ηοτ make access το
ιοιο Court,
qO
drugs or life-saving technologies more difficult, especially during α pandemic. Should we allow
Char]es Bellm for restrictions of circulation of knowledge and iτs ουτcοmε το increase profiτs ßη τimes of α healτh
ι fus group had crisis? The COVID-Iθ pandemic has taught us many τhings, bυτ when looking ατ ρατεητ iaws,
π,anufaCturing perhaps its most important lesson has to do wßτh τhε eτhical jusτificaτion of ΙΡ. Ρυτ ßη α nuτshell,
trc το medical ΙΡ protection cannot be fully or effectively vindicaτed by egoisτic τheories.θ Ιη oτher words,
invorved".a personal gain - broadly understood both as existential self-realisaτiong or economic ρτοfiτ10 - does
ηοt offer solid moral ground to justify ΙΡ ßη extreme and urgent situations such as those produced
by the COVID-Iθ crisis. And egoistic takes οη ΙΡ justifications clearly show τheir Ιßmßτò when
major conflicts between individual and societal well-being emerge. The many mοητhs of global
ÝòααΙ ρτορεΓtγ
lockdown have been α poιverful reminder of α simple truth αbουτ humans: we are α communiτy
ιhis sιory (and
of unity, whose collective well-being also makes individual self-satisfacτion possible.
ιηεταΙ question
Isinrιoι.a, such
3. The Relevance of Collective Well-being: should patent rules be relaxed?
rallι- j usτiflable
Ια\ξS accept or After αΙΙ, collective well-being was taken ßηtο consideraτion by τhε German judiciary when
α compulsory licence over α patent owned by the Japanese company Shionogi was granτed το
red ßη Europe. Merck ßη 2017. While controversial, compulsory licences allow eligible drugmakers το legally
lεs α solid iegal manufacture and sell generic versions of patented drugs during ηατßοηαΙ emergencies, public
rm αΙΙ over the health crises, or ßη other insiances of extreme need. Iη thaτ case τhe German Federal Ρατeητ
Ecines - which CouΠ granted Merck the compulsory licence to continue selling τhe ΗΙν drug Isenτress, which
[εflι prOteCtion contains the patented active ingredient raltegravir.11 The decision ,was also conflrmed by τhe
r eιcerges from German Federal Supreme Court shortly after.12
τι{ΟνΙD-19' The grant of the compulsory licence was preceded by α paτenτ infringemenτ claim broughτ
mber Sτaτes το by Shionogi (oιvner of the European patent over τhε ralτegravir) αgαßηsτ Merck before τhe
Ρ ald data to District Court of Duesseldorf ßη 201513 after licence ηεgοτßατßοηs beτrveen τhe pariies were
bo reminds us unsuccessful. The Japanese company sought, inter αΙßα, αη injunction ρτενεητßηg Merck from
i.elop:nent, and using raltegravir ßη their drugs. The court stayed the suit pending the opposiτion proceedings
?aragraph 23).

8
For αη instrucive survey of philosophical justiflcatlons of intellecιual ριορεΓτγ, see Adam Moore and Ken Himma,
τkc Bonadio and ºntellectual Property', ßη The Sιanford Encyclopedia of Philosophy, Ed. Edward Ν. Zalta, Winter 2018 (Meτaphysics
δd *e Protection Research Lab, Stanford UnlveIsity, 2Ο18), available at < https://plato.stanford.edu/archives/win2O1B/enτries/
: dc:,cι9110.1017/ intellecιual-propeπy/ >.
9
Georg Withelm Friedrich Hegel, EΙements of the Phllosophy of Right, Ed, Allen Wood, Cambridge: Cambridge
ιeι:sed by ýe Act University Press, 1991.
τbΕ EPC has been 10
John Locke, The Second Treatise of Government, Ed. Peter Leslett, Cambridge: Cambridge Universiτy Press, 198Β.
11
Decision of the German Federal Patent Court of 11 July 2017; Χ ΖΒ 2Ι17, GRUR 2017, 1017,
Ι,9- ο: ,0 July 2020 12
Judgment of the German Federal Supreme Court of 21 November 2017; 3 Li 6/16, GRUR 2018, Β03.
13
Landgericht Dýsseldorf (4c Ο 48l15).
 C ο \,ΙΙ
Part ΙΙI. HEALTH (AND RISK) REGULATIoN

against Shionogi's European Ρατεητ iniτiated by Merck before the European Patent Offlce,la Ιοgeτhετ \1 ,-_-,

oppo5es ýe :Ξ
Ιη τhε meanτime, Merck applied for τhe grant of α compulsory licence before the German
Federal Ρατεητ Cουττ, As Shionogi objecτed το τhε claim brought forward, Merck requested medical prc,:-
νοßυηιαΓ\,Ι::Ξ]
τhε Courτ το gταητ τhe compulsory licence by ιναγ of α preliminary order. The request was
unpreCedeΓ_::,:
lodged ρυτsυαητ το Secτion Β5 of τhε German Patent Act. This provision allows compulsory
licences το be granτed as αη inτerim measure where the applicant is able to furnish evidence uncenainιies ;

τhατ τhε prerequisiτes for granτing α compulsory licence as outlined within Section 24(1)-(6)
rethink of *ε
of τhε Ρατεητ Acτ are given and τhατ αη urgenτ public interest ßη granting the licence exists.
Recen: :
α further pc_,:
Ιη τhis specific case, τhε licence was granted because the health of many people was at risk,
including τhατ of ρτεgηαητ women, infanτs, young kids as well as newly infected and long-term
As αη ουιιι:
justified the compulsory licence, independeni,i
ρατßεητò.15 Ιη parτicular, ßτ was held τhατ τhe public interest
one tO be α;::
also τaking ßητο αccουητ τhε effecτs τhατ αη injunction against Merck would have created for
ΗΙν patients, The German Federal Supreme Court's release clarifled as follows: BioNTech α::
ßΒ earh-deι-s
'The Federal Court also shares τhe assessment of the Federal Patent Couft that α public interest
exPOrιS ιΟ :e
ßη the granting of α compulsory licence is credible. Ιt is true that not every ΗΙν or AIDS
groupS Stop the ρα::,
ρατßεητ is required το be τreaτed wiτh ralτegravir ατ αηγ time. There are, however, patient
ýατ needed ralτegravir το mαßηταßη τhe safety and quality of treatment, These include, ßη interesιs.
particular, infanτs, childτen under 12, plegnant women, people who need prophylactic
treatment because of τhe risk of infecτion, and patients rvho are already treated with Iseniress 4. Conclus
and who are threaτened rviτh significanτ side effects and interactions lvhen sιvitching ßο another
drug'.16
Ιη eýßι*
ýat could òα;
This German case is cετταßηΙγ εχcερτßοηαl. There are ηο (recent) reported decisions ßη
r-yith α more :,.
Europe where compulsory licences of pharmaceutical patents have been granted. Yet, this
While recog:.
example shows us someτhing ßmροτταητ: the public need to access important life-saving τιßý:ι
those
medicines may ßη some specific circumstances override the private interests of patent owners ßη
altruistic cc::
resτricτing such access (indeed, as ρατεητò constitute monopolies, their owners are usually able
from offeι:-:
το charge higher prices for τheir paτenτed products and thus restrict availability). The collective
indiyiduals. Ι
good τhus may supersede τhe financial inτerests of speciflc companies, Also, it seems that
exercise ο:
,,,

several secτors of socieτy and poliτicians ßη Europe are pushing the argument that the current
principle οΙ "
COVID-19 global emergency jusτifies τhε relaxation of patent and other ΙΡ rights over medical
τechnologies useful το f,ghτ τhe virus.17 Ιτ will cerτainly be difficult to soften the traditionally ]3
TR1PS ,\ò::,::
pro-IP sτance adopτed by τhε European Commission and ßη general by Ευ Insiitutions. Indeed, ΕsιαbΙßòh-:.:,,
Ιηιemα::::l _

]9
Ατιη Dana;. -
Ια
The paιent was subsequenτly revoked by τΙιe εΙü noard of eppeals ßη 2017 - ΕΡΟ, Technical Board of Appeal 3.3.01,
Τ 1150/15, decision of October 11, 2017 _ Merck & Co., Inc. ν. SHIONOGI & CO., LTD.
r''Coι,id: Ε- ::
r3
Clrrisτof Hohne, 'Compulsory Licences ßη Germany: Α ΤοοΙ for Licensing Negotiations?', Europ ean Phormaceutical
]: 'Ευ r αcι_:. .
Revielv, Β March 2019, available αι < hιτps://www.europeanpharmaceutica]review.com/aricle/B4768/compulsory-
2]
Ιη eýýca ::..:
licenses-in-germany-a-too1-f orJicensing-negotiations/ >. Ierminc_:;l
16The τταηslατßοη has been τaken from α blogposτ by Andrew Goldman, 'German Federal Supreme Court Affirms ιheory' οι ,?
producιs *;":.
Compulsory License οη ΗΙν Drug', published ßη τhe Knowledge Ecology International (ΚΕΙ) website οη 13 July
2017, available at < wl.vw.keionline,org/23403 >. -' lom G, f 1::
r7
Ashleigh Furlong and Sarah Anne Aarup, ¸υτορe hinτs at patent grab from Big Pharma', Politico,3 February 2021. Sl,mpos:*;:,,

236
 COVID_lg, PUBLIC HEALTH, AND ΤΗΕ LIMITS ΟF PATENTS ΙΝ ΤΗΕ EUROPEAN CONTEXT

aent Offlce.la together with the US, υΚ, Switzerland and other industrialised ηατßοηs, τhε Ευ sτrongly
e the German opposes the temporary international waiver οη TRIPS obligationslB for α11 coronavirus-relaτed
rck requested medical products, including vaccines, proposed by India and South Africa,19 preferring insτead
Ρ rcquest was voluntary licensing of ΙΡ to promote equitable and global access το such producτs. γeτ, τhe
τ compulsory unprecedented health emergency that Europe is facing, with the death τοΙΙ sτill increasing and
nish eγidence uncertainties growing over whether new COVID-Iθ variants are more infecτious, may τrigger α
fon 2α(1)-(6) rethink of ihe current ΙΡ maximalist policy.
Ecence exists. Recent trade tensions between the Ευ υΚ
regarding exporting vaccines have added
and
le ι-as at risk, α further political layer to the complex relationship between public health and corporaτe profiτ.
ad long-term As αη outcome of what can be rightfully described as α scientif,c miracle, several vaccines
ιkon licence, independently produced by different pharmaceutical companies have become available. The Ιαòτ
ye creaιed for one to be approved by the Ευ writing is the AstraZeneca vaccine, following Pfizer-
at the time of
: BioNTech and Moderna.2o Ιη early February 2021, the European Commission backπacked οη
its early decision to αρρΙγ αη emergency provision included ßη the Βτεχßτ deal το block vaccine
κ inιeresι
or _\IDS exports to the IJK, at α Lime when Europe suffers from α shortage of the medicine τhατ could
Π gloups stop the pandemic.21 Here trade regulations seem tο be bent ßη order tο serye speciflc ροΙßτßòαΙ
duae. ßη interests.
ρhι ßαòιßò
ι Isεnress 4. Conclusion
D ano:irer
Ιη ethical theory altruistic forms of consequentialism offer α suitable philosophical framework
that could capture these exceptional cases that we discussed ßη this Chapter, τhus providing us
Ι deιisions ßη
rvith α more robust justification of ΙΡ that balances individual and collecιive needs and concerns.22
red. \eτ, τhis
While recognising the ethical relevance of egoistic demands, altruistic consequenτialism places
α liie-saving
those within α larger altruistic framework whose final horizon is societal υtßΙßτγ. Tradiιionally,
Επß orιτιers ßη
altruistic consequentialism has offered justiflcations based οη the collective gain ýατ follows
ι usuallγ able
from offering people incentive for innovation." Βγ rewarding the efforτs of cerτain ingenious
[he òοlΙeòτßνe
individuals, ΙΡ protection has been considered α powerful stimulus to creativiτy, τhe consisτenτ
ßt seeτls that
exercise of which appears to be instrumental ßη maximising social υtßΙßτγ, which is τhe key
fl ihe current
principle of altruistic consequentialism,
a,er nedical
ι Ε,αdßιßοηαΙΙγ
1sTRIPS Agreement οη Τ.ua.-n.Ιut.O Οrο.." of lntellectual Property Rights, Apr. 15, 1994, Marrakesh Agreemenτ
ιßιχτs. Ιndeed, Establishing the World Trade organization, Annex 1C, 1869 U.N.TS. 299, 33 LL.M. 1197 (1994). This World
Internationa] Organization treaty provides minimum standards of ΙΡ protection at global level.
19Αηη Danaya Usher, 'South Africa and India push for COVID-19 patents ban', The Loncòt,5 December 2020.
dΑ_::εα,3.3.01,
20
'Covid: Ευ approves Astrazeneca vaccine amid supply row', BBC l{ews, 29 January 2021.
ι ΡΙτ-τιòeυιßòα1 21
¸υ vaccine export row: Bloc backtracks οη controls for ΝΙ', BBC l{ews, 30 January 2021.
ΕΒ ε,:::::ulsory- 22
Ιη ethical theory altruistic consequentialism is usually called utilitarianism. Ιη this context, we ορτ for τhßò αΙτeτηατßνe
terminology ('altruistlc consequentialism') to avoid α potential ambiguity rvith what is known as τhe 'υτßΙßτατlαη
: Cσ_::: _\ffirms theory' of ΙΡ (i.e., ΙΡ rights represent αη encouragement from the State for the production of invenτions and culτural
futε ::: 13 July products useful to society).
23
Tom G. Palmer, ¸τε Patents and Cop5,τighιs Morally Justified - the Philosophy of Ρτορεττγ fughτs and ldeal Objecτs
Ι Fι*ι._.:τι, 2021 . Symposium οη Law and Philosophy', 73 Harvard Journal of Lαιυ & Public Policy 3, 1990, ρρ. ò17-66.
 Part ΙΙI. HEALTH (AND RISK) REGULATIoN

Βυτ convenτional alτruisτic consequentialism is inadequate insofar as it conceptualises

ßηηονατοτs ßη τerms of individual subjects, which could be either persons, instituiions, or
companies. And γετ, ατ α time where scientiflc cooperation is at one of its historic peaks, we
cannot fail to witness and acknowledge once again that the logic of discovery is of α distribuýve
kind: innovators are likely to be collective rather than individual subjects, and laws should flnd
ways to ρτοτεct τhε possibility of collaboration. This ßη turn seems at odds with commonsensical
takes οη ΙΒ buτ ßτ is ceιτainly α welcome implication of altruistic understandings of patents,
Balancing alτruistic and egoistic motives ßη innovation is certainly difflcult - and there is
ηο εχαcτ science to ihat. Prudence and tact are essential requirements of effective management
of ΙΡ ρτοτεòτßοη. EspeciaΙly when dealing ιvith public health emergencies of α global scale such
as τhe COVID-I9 pandemic, proflτ may very well have to bow to ethical or moral concerns.
There is ηο denying that ΙΡ laws ρΙαγ α generally signiflcant role ßη promoting research with
positive societal impact, but they are not flawless, and we should not exclude α need for reform
to meet τhese new challenges. The key is to Ιαγ out conditions for strengthening the mutual trust
that international public health cooperation requires.

Ρß

ΒΑΙ