Cuento internacional sobre patentes genéticas: entre la incertidumbre médica y jurídica
| Autor | Agnieszka A. Machnicka |
| Cargo | Lecturer at the Faculty of Public Management, Law and Safety, The Hague University of Applied Sciences (The Netherlands) |
| Páginas | 117-159 |
Doctrina / Articles
International Tale on Gene Patents
– between Medical and Legal
Uncertainties
Cuento internacional sobre patentes genéticas: entre
la incertidumbre médica y jurídica
Agnieszka A. Machnicka
Lecturer at the Faculty of Public Management, Law and Safety, The Hague
University of Applied Sciences (The Netherlands)
DOI: 10.14679/2032
Sumario / Summary: 1. Introduction. 2. Genes as a (non–)discovery? 2.1. Discovery
vs. invention. 2.2. The evolution of the notion of ‘discovery’. 3. Myriad Genetics and
its patent litigation chronicle. 3.1. The U.S. patents. 3.2. After the battle scenery.
3.3. Behind the “BRCA 1/2 gene” patent. 3.4. Myriad Genetics’ patents in Australian
courts. 3.5. The European Patent Office. 4. Further developments involving gene
patents. 4.1. Myriad Genetics against Ambry Genetics – litigation over the BRCA gene
testing. 4.2. The USPTO Guidelines amended. 4.3. The unbearable persistence of
(the) monopoly. 4.4. Further perspectives on gene patents. 5. Cumulative innovation
and gene related inventions. 6. Conclusions.
Resumen / Abstract: This work is inspired by the international litigation chronicle
of Myriad Genetics that remains of topical importance in the judicial and academic
discourse regardless of the time that passed since. It discusses approaches of various
jurisdictions to the problem of gene patenting as well as patenting of genetic
diagnostic testing. The article takes under scrutiny the judgments rendered in the
U.S., Australia as well as the decisions by the European Patent Office and places
them into interdisciplinary background of genetic science. The issue is significant,
both theoretically and practically. Notwithstanding the expiration of patents that
constituted the subject matter of the Myriad’s various lawsuits, the problem still
remains currently relevant. Firstly, because the judgments in individual cases did
not answer all the questions, but – in some way – only prepared a path for future
decisions. Secondly, it is on account of new scientific breakthroughs in the area
of human genetics. Consequently, the domain of genetic diagnostics is under
Rev Der Gen H Núm. 57/2022: 117-159
AGNIESZKA A. MACHNICKA
118 Rev Der Gen H Núm. 57/2022
continuous development and in the future may continue to reveal new scientific
discoveries and (possibly) inventions. The lack of uniform and transparent rules in
this field, and well-defined boundaries for potential monopolies constantly brings not
only uncertainty for medical practitioners and scientists, but also real disadvantages
for the patients.
Esta obra se inspira en la crónica del litigio internacional de Myriad Genetics, que
sigue siendo de actualidad en el discurso judicial y académico a pesar del tiempo
transcurrido desde entonces. En él se examinan los enfoques de diversas jurisdicciones
sobre el problema de las patentes de genes, así como de las patentes de pruebas de
diagnóstico genético. El artículo examina las sentencias dictadas en Estados Unidos
y Australia, así como las decisiones de la Oficina Europea de Patentes, y las sitúa en
el contexto interdisciplinario de la ciencia genética. La cuestión es importante, tanto
desde el punto de vista teórico como práctico. A pesar de la expiración de las patentes
que constituyeron el objeto de los diversos pleitos de Myriad, el problema sigue
siendo de actualidad. En primer lugar, porque las sentencias dictadas en los casos
individuales no respondieron a todas las preguntas, sino que –en cierto modo– sólo
prepararon el camino para futuras decisiones. En segundo lugar, debido a los nuevos
avances científicos en el ámbito de la genética humana. En consecuencia, el ámbito
del diagnóstico genético está en continuo desarrollo y en el futuro puede seguir
revelando nuevos descubrimientos científicos y (posiblemente) invenciones. La falta
de normas uniformes y transparentes en este ámbito y de límites bien definidos para
los monopolios potenciales no sólo genera constantemente incertidumbre para los
médicos y científicos, sino también desventajas reales para los pacientes.
Palabras clave / Keywords:
Patent law; Gene Patents; Genetic Medical Methods; BRCA1 and BRCA2 Genes;
Myriad Genetics.
Derecho de patentes; Patentes de genes; Métodos médicos genéticos; Genes BRCA1
y BRCA2; Myriad Genetics.
1. Introduction
The issue of patentability of genes and genetic medical methods is not
new and has been tackled extensively by the doctrine from a legal as well
as ethical perspectives.1 Nevertheless, the problem is no closer to being
1 See: H.T. GREELY, ‘Legal, Ethical and Social Issues in Human Genome Research’ (1998) 27
Annu. Rev. Anthropol. 473-502; J.J. DOLL, ‘The Patenting of DNA’ (1998) Science, Vol. 280,
pp. 689-690; M.A. HELLER & R.S. EISENBERG, ‘Can Patents Deter Innovation? The Anticommons
in Biomedical Research’ (1998) Science, Vol. 280, pp. 698-701; B. ALBERTS & A. KLUG, ‘The
Human Genome Itself Must Be Freely Available to All Humankind’, (2000) 404 Nature
325; S. STERCKX (ed.), Biotechnology, Patents and Morality, 2nd ed., Routledge, 2021; D.B.
RESNIK, ‘DNA Patents and Human Dignity’ (2001) 29(2) Journal of Law, Medicine & Ethics
152-165; D.J. KEVLES & A. BERKOWITZ, ‘The Gene Patenting Controversy: A Convergence
of Law, Economic Interests, and Ethics’ (2001) 67 Brook. L. Rev. 233; J. BURLEY & J. HARRIS
(eds.), A Companion to Genetics, Blackwell Publishing, 2004; M.A. BAGLEY, ‘Patent First,
Ask Questions Later: Morality and Biotechnology in Patent Law’ (2003) 45 Wm & Mary
L. Rev. 469; Idem, ‘A Global Controversy: The Role of Morality in Biotechnology Patent
119
INTERNATIONAL TALE ON GENE PATENTS – BETWEEN MEDICAL AND LEGAL UNCERTAINTIES
Rev Der Gen H Núm. 57/2022
resolved. To the contrary, the jurisprudential developments only prove its
continuously open ended status. The present contribution is inspired by
lawsuits concerning patents of one specifi c patent holder, namely Myriad
Genetics, and its international litigation story. Although a few years have
passed since the famous rulings were given by the highest judicial authorities
in the U.S. and Australia, it would not be correct to say that clarity was
achieved in the regulation of this specifi c domain. Therefore, it seems useful
to look at these judgments again from a certain distance and in a wider
perspective that includes scientifi c as well as societal sides. One of the goals
of this contribution is to compare the arguments, reasons and analysis given
by different jurisdictions in response to the same problem, namely the pa-
tentability of genes and genetic methods. The discrepancies between various
approaches refl ect strong impediments in reaching an ultimate response to
this long-lasting issue of vital societal signifi cance. Another objective of the
analysis is to scrutinize judicial developments that came after the Myriad
lawsuits2 and to consider the societal impact of patenting in the area of
genetic diagnostic methods.
The issue discussed involves two interrelated problems. One is about
the patentability of DNA sequences as such. Another touches upon the
patentability of medical methods that involve DNA sequences. While the te-
chniques used to extract, isolate or purify the DNA sequence could potentially
be patent eligible (if novel and non-obvious), patenting of DNA or medical
methods that involve DNA pose major legal uncertainties. Consequently, the
analysis revolves around these two questions.
It is worthy of note that legal and regulatory aspects of genetic innova-
tions and of their use for medical purposes are constantly newly shaped, as
shown – for example – by recent discoveries of genes responsible for severe
symptoms of COVID-19 in certain patients.3 Further studies revealed, on
Law’, in: P.K. YU (ed.), Intellectual Property and Information Wealth: Issues and Practices
in the Digital Age, Vol. 2, Praeger, 2007, at 317; G. DUTFIELD & U. SUTHERSANEN, ‘DNA Music:
Intellectual Property and the Law of Unintended Consequences’ (2005) 18(1) Science
Studies, pp. 5-29.
2 E.g. Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117,
1135-36, 126USPQ2d 1266, 1281 (Fed. Cir. 2018).
3 E.g.: Kristina Dobrind et al., ‘Common Genetic Variation in Humans Impacts in
vitro Susceptibility to SARS-CoV-2 Infection’, bioRxiv 20 September 2020 (doi: https://
doi.org/10.1101/2020.09.20.300574); Erola Pairo-Castineira, Sara Clohisey, Lucija
Klaric,et al.‘Genetic Mechanisms of Critical Illness in Covid-19’ (2021) Nature 591, pp.
92-98(https://doi.org/10.1038/s41586-020-03065-y); Ben Guarino, ‘Scientists Pinpoint
Genes Common Among People with Severe Conoravirus Infections’, The Washington
Post, Science, 14 December 2020.
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