The Possible Impact of Legal Globalization on the ECJ Decision on Human Embryonic Stem Cell Patents and its Implications

• Author: Amy Lai
• Position: PhD Candidate, Allard School of Law, University of British Columbia.
• Pages: 261-274

The Possible Impact of Legal Globalization on

the ECJ Decision on Human Embryonic Stem

Cell Patents and its Implications

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I. Introduction: From Br ¨ustle to ISCC

On December 18, 2014, the Grand Chamber of the Court of Justice of the

European Union (ECJ) lifted part of its more general 2011 ban on obtaining

patents for human embryonic stem cells (hESCs), by ruling in International

Stem Cell Corporation v. Comptroller General of Patents, Designs and Trade

Marks (ISCC) that hESCs made from unfertilized eggs can be patented.

1

In

this landmark case, the ECJ held that the moral exclusion of industrial and

commercial uses of “human embryos” in Article 6(2)(c) in Directive 98/44/

EC on the legal protection of biotechnological inventions, or the Biotech

Directive, does not cover “parthenotes,” the unfertilized human eggs

produced by parthenogenesis.

2

This case arose when the United Kingdom’s Intellectual Property Office

(UKIPO) refused to grant two national patents to International Stem Cell

Corporation (ISCC), a California-based publicly traded biotech company.

The UKIPO stated that these two patents growing out of parthenogenesis

fell within the definition of the term “human embryo” adopted by the Grand

Chamber in Br ¨ustle v. Greenpeace.

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ISCC appealed, arguing that Br ¨ustle did

not apply because mammalian parthenotes can never develop to term due to

a lack of paternal DNA.

4

ISCC cited specific language in Br ¨ustle that

determines what might constitute a human embryo: “capable of

* PhD Candidate, Allard School of Law, University of British Columbia.

1. Case C-364/13, Int’l Stem Cell Corp. v. Comptroller Gen. of Patents, Designs, and Trade

Marks, EU:C:2014:2451 (Dec. 18, 2014).

2. Id. “Parthenogenesis” is a term describing the reproduction from an ovum without

fertilization, a normal process in some invertebrates and lower plants.

3. “The first patent, GB0621068.6, entitled ‘Parthenogenetic activation of oocytes for the

production of human embryonic stem cells,’ covered both the methods for producing

pluripotent human stem cell lines from parthenogenetically-activated oocytes and the stem cell

lines. The second application GB0621069.4, entitled ‘Synthetic cornea from retinal stem cells,’

included claims to methods and ‘product-by-process.’” Aurora Plomer, Case C-364/13 –

Patentability of Embryonic Stem Cells and Parthenotes: Inherently Uncertain?, E

UTOPIA

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(Dec.

19, 2014), https://eutopialaw.com/2014/12/19/case-c-36413-patentability-of-embryonic-stem-

cells-and-parthenotes-inherently-uncertain/.

4. Id. More specifically, ISCC argued that the parthenogenetically-activated oocytes are

incapable of initiating the process of development of a human being due to the phenomenon of

genomic imprinting. Id. Confronted with research suggesting that these hurdles could be

successfully overcome by genetic engineering, ISCC amended the claims by introducing the

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