Clearing the CRISPR patent landscape: Towards a solution for South Africa

• Author: Naidoo, M.
• DOI: https://doi.org/10.47348/SALJ/v139/i2a6
• Published date: 15 May 2022
• Date: 15 May 2022
• Citation: (2022) 139 SALJ 365
• Pages: 365-406

365

https ://doi.org /10.4734 8/SALJ /v139/i2a6

CLEARING THE CRISPR PATENT

LANDSCAPE: TOWARDS A SOLUTION

FOR SOUTH AFRICA*

MESH ANDR EN NAIDOO†

Doctoral Fellow, University of KwaZulu-Natal

DONRICH W THALDAR‡

Associate Professor, University of KwaZulu-Natal

Patenting activity regarding new CR ISPR (Clustered Regularly Interspaced Short

Palindromic Rep eats) genome editing tec hnology has mushroomed to create a vast

and complex pate nt landscape. However, because o f South Africa’s current depositor y

patent system, the South African C RISPR patent landscape cont ains foundational

patents with ove rlapping claims, as highlight ed by the ongoing litigation in the United

States betwee n the Broad Institut e and the University of California. B oth these

parties were g ranted four patents in South Afric a. Also, the South Afr ican landscape

may contain multipl e low-quality pa tents that have the potential to obstr uct scientic

research in South Af rica. The solution in the South Af rican cont ext is threefold, but

requires that the Intellectual Property Polic y of South Afri ca: Phase I must rst b e

operationalise d to: (a) prioritise CR ISPR patent applications for for mal examination

and substantive search and examination; ( b) provide sucient resources for e xtra-

curial patent opposition proceedings regarding all CR ISPR patent applications and

granted patents; and (c) crea te certaint y by developing an obviousness standard with

well-dened parameters. Although CRISPR is not yet advan ced enough to fall

within the class of life-saving technologies in the shor t-term, CR ISPR may become

critical in th e treatment and eradi cation of priority diseases su ch as HIV/AIDS and

tuberculosis. Ac cordingly, prioritising CRISPR-relat ed patent applications serve s the

public interest in a ccess to healthcare. By using (a), (b) and (c) in tande m, a triple

layer of mechani sms will counte r the problems of overlapping cla ims and of low-

quality patents, and hence remove these potential obstr uctions to CR ISPR research

in South Africa.

Access to hea lthcare – CR ISPR – genome edit ing – patent ing – public

interest

* This ar ticle is ba sed on research done for the rst author’s LLM under the

supervi sion of the second author and the co-supervision of Professor Ju lian

Kinderlerer. The authors w ish to acknowled ge the suppor t of the Nationa l

Research Found ation (Grant 116275) and the University of KwaZu lu-Natal

(African Health Research Fl agship Grant). The authors a lso wis h to thank

Julian K inderlerer and Yousuf Vawda for their helpfu l comments on this ar ticle.

The authors bea r responsibility for all remaining errors.

† LLB LLM (KwaZulu- Natal). https://orcid.org/0000-0002-8547-0380.

‡ BLC LLB MPPS ( Pret) PhD (Cape Town) PGDip (Oxon). h t tps :// or c i d .

org/0000-0002-7346-3490.

(2022) 139 SALJ 365

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366 (2022) 139 THE S OUTH AFRICAN L AW JOURNA L

https ://doi.org /10.4734 8/SALJ /v139/i2a6

I IN TRODUC TION

Genome editi ng has grown enormousl y, predomina ntly since the develop-

ment of the CRISPR-Cas9 system, which th rust the eld of biotech-

nology (‘biotech ’) into the public view.1 This revolutionar y technology

provides, in compa rison to current res earch tools, a reasonably quick , easy,

precise, and inexpensive method2 of targeting and editing speci c genetic

sequences.3 CR ISPR-Cas9 has the potentia l to promote scientic rese arch,

enhance biotech, a nd aid in the diagnos is and treatment of human d isease.4

As such, CRISPR-Cas9 and its variants, generally referred to collectively

as CRISPR, have been the subject of numerous patent applications,

primarily in the United States (‘US’) and Europe, by va rious institutions.

The CRISPR patent landscape ha s, however, been dominated by

ongoing litigation on the tech nology’s foundational patents, which has

left the globa l ownership and licensing position unclear. In this ar ticle, we

demonstrate that contemporary patenti ng activity has created a complex

1 Genome editing r efers to ‘the del iberate a lteration of a sele cted DNA

sequence in a liv ing cell’ in order to ch ange a gene’s func tion. Nueld Cou ncil

on Bioethics G enome Editing and Human Reprod uction: Social and Ethical I ssues Short

Guide (2018) 3; Neil Kirby ‘Gene editin g and South African law’ (2016) 16(3)

Without Prejudi ce 17.

2 Altern ative gene editing te chniques, such as zinc  nger nucleases, have been

found to cost approx imately $5000 to order, and designing a sin gle customised

protein can cost over $1000. By contra st, CRISPR-Ca s9 can cost a s little a s

$30. Scienti sts can cr eate an RNA t emplate wit h free software and a DNA

kit at a cost of about $65. Brian Wang ‘D isruptive CRISPR gene ther apy is

150 times cheape r than zinc nger s and CRISPR is faster a nd more precise’ Next

Big Future 9 June 2015, available at http://nextbigfuture.com/2015/06/disruptive-crispr-

gene-therapy-is-150.html, accessed on 15 Febru ary 2021; Mark Shwart z ‘Target,

delete, repai r: CRISPR is a revolutionar y gene-editing to ol, but it’s not without

risk’ 2 018 Stanford Medicine, available at https://stanmed.stanford.edu/2018winter/

CRISPR-for-gene-editing-is-revolutionary-but-it-comes- with-risks.html, accessed on

15 Februar y 2021.

3 Catheri ne Jewell & Vijay Sha nkar Balak rishn an ‘The battle to own the

CRISPR-Cas9 g ene-edit ing tool ’ WIPO Magazine April 2 017, available

at https://www.w ipo. int/w ipo _m aga zin e/en/2017/02/ar tic le_ 00 05.h tml, accessed on

10 September 2019.

4 It is wor th noting some of the potenti al therapeutic benets of C RISPR

technology. CRISPR can be, and h as been, appl ied in numerou s industr ies.

The most sign icant of t hese are the me dical and healthca re elds, where

CRISPR can be utili sed in the tre atment and prevention of a varie ty of genetic

and infectious diseases, inc luding cystic brosi s, Huntin gton’s diseas e, muscular

dystrophy, sickle cell anaem ia, beta -thal assemi a, blind ness, certain ca ncers,

and HIV/AIDS. Furthermore, CRI SPR can be used i n diag nostics for d isease

detection. I bid; Clar a Rodríg uez Ferná ndez ‘7 dis eases CR ISPR technolog y

could cure’ Labiotech 23 July 2019, available at https://www.labiotech.eu/crispr/crispr-

technology-cure-disease/, accessed on 23 Janua ry 2020.

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CLEAR ING THE CRISPR PATEN T LANDSCAPE 367

https ://doi.org /10.4734 8/SALJ /v139/i2a6

landscape,5 resulting in u ncertainty as to how CR ISPR technology

can be util ised or resea rched further.6 We also investigate some of the

solutions posed by the Intellectual Propert y Policy of the Republic of

South Afr ica: Phase I7 (‘IP Polic y’) and discuss how best to operat ionalise:

(a) substantive search a nd examination (SSE) procedures; (b) heightened

standa rds of patentability; a nd (c) patent opposition proceedi ngs to combat

the increasingly complex patent landscape — while taking into account

the interests of various role players, and ensur ing that the public health

interests in this technology are ser ved.

II THE CRISPR PATENT DISPUTE

(a) Background leading up to the dispute

The patentin g of CRISPR has resulte d in litigation i n foreign jurisd ictions,

as two inst itutions have battled over sole rights to the technolog y.8

This dispute has brought t he perils associated with patents i n health-ba sed

research and innovation to the fore. The key foundational patent holders

for the CRISPR technolog y are Emmanuelle Charpentier from the

University of Vien na, Jennifer Doudna from the University of Califor nia

at Berkeley (‘UC’), and Feng Zha ng of the Broad Institute (‘Broad’).9

5 As the number of patents that a re grant ed increases, the patent claims

outlin ing the scope of protection wi ll narrow, decrease i n value, and become

more challenging to enforce. Timothé Cy nober ‘CRISPR : One patent to rule

them all ’ Labiotech 11 Februar y 2019, available at https://labiotech.eu/features/crispr-

patent-dispute-licensing/, accessed on 10 September 2019.

6 Thi s may impac t what the technology covers as well as the countries i n

which the patent applies. This is because patents are territor ial and a re requir ed

in each count ry where the i nvention is intend ed to be util ised. Joan ne van Har melen

‘Intellect ual property r ights and g enome editi ng: Navig ating the p atent thicket’

ENS Africa, available at http://biosafety.org.za/cms/modules/media/scripts/documents/

document.handler.php?media_les_id=1201, accessed on 15 September 2019;

Jacob S Sherkow ‘The CR ISPR patent landscape: Pa st, present, and fut ure’ (2018)

1 The CRISPR Journal 2.

7 Department of Trade and Indust ry ‘Intel lectua l Propert y Policy of the

Republic of South A frica: Phase 1’ GN 51 8 GG 41870 of 31 August 2018, avail-

able at https://www.gov.za/sites/default/les/gcis_document/201808/41870gen518_1.pdf,

accessed on 7 November 2020.

8 Althoug h CRISPR itsel f cannot be patented, Ca s9 is an enz yme found in

a natura l bacter ial proces s. What wa s sought to be pat ented were the metho ds,

engineer ed elements, and struct ures modied from their natu ral stat e to be used

for editin g the genomes of l iving mamma lian cel ls. Broad Com munications

‘For journa lists: Statement and background on t he CRISPR patent process’

16 January 2 020, availab le at https://www.broadinstitute.org/crispr/journal ists-stateme nt-

and-background-crispr-patent-process, acce ssed on 18 Januar y 2020; A FP ‘Broad

Institute wins gene-edit ing patent c ase’ Yah oo News 25 Ju ly 2014, available at

https://www.yahoo.com/news/broad-institute-wins-gene-editing-patent-case-015314896.

html, accessed on 14 December 2 020.

9 Jewell & Balak rishnan op cit note 3.

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