Re-moralising the Patent System Guidance on the patentability of stem cells still needed

(IPRinfo 4/2010)

Amina Agovic
LLD Cand. at IPR University Center, Helsinki University

Morality is a complex issue for the intellectual property in general, but its application to biotechnological, including stem cell (SC) inventions is specifically challenging.

Few issues divide researchers, patent community and public more than patenting human embryonic stem cells (hESC)s. Key issues surrounding hESC inventions revolve around the question of ’how to patent SC inventions’. This in turn raises an issue of how to interpret a morality provision found in patent law.

Patent Law is a Distinctive Species of Law
Patent law is a distinctive species of law from many aspects but especially due to its authentic ability to take ethics and morality into account in a patent examining process. The TRIPs Agreement (Art 27.2) prescribes a scope for dealing with ethical concerns in patent law. The European Patent Convention (EPC) Article 53(a) (hereinafter ’morality clause’) clearly states that, ’European patents shall not be granted in respect of a) inventions the publication or exploitation of which would be contrary to ’ordre public’ or morality…’.

Supporters of patentability of SCs point to the SC therapies and medical advances, while opponents point to the ’tinkering with nature’. Furthermore, grant of exclusive monopoly rights over morally contentious inventions becomes particularly troublesome in SC areas because there may be some inventions that no one should ’own’ or be encouraged by governments to invent. Especially, since for most of the SC technology inventions, standard patentability requirements are not and have not proved too difficult to fulfil.

EPO’s Failure to explain Morality leads to Confusion
In 1998, the EU enacted the ”Biotech Directive” (Directive 98/44/EC on the legal protection of biotechnological inventions, (1998) OJ L 213). The EPO, although not obliged, has taken the Directive provisions into account and transposed them into the EPC. This included the morality clause, and almost instantly storm clouds rolled in.

European Patent Office’s (EPO) failure to articulate and elaborate on the notion of morality clause as such has led to precarious and disconcerting results within the scientific, legal and economic circles. Unsurprisingly, the SC patent debate continues with little to none consensus. Although the EPO case law deems ethics embedded in the patent law, it is unclear and confusing how the patent office and patent examiners are meant to deal with hESC inventions.

No National Concepts of Morality in Europe
Lack of national concepts of morality and the fact that those that do exist are not uniformed across the EPC countries wreaked all sorts of havoc at the EPO. Decisions such as the Edinburgh patent (European Patent No EP 695351) made it clear that the EPO will not base its decision on national principles of morality. Instead, the EPO suggests that patent decisions be based on international and European law. Such language only adds to the confusion of patent morality.

Thus far, the European Parliament refuses to engage in the discourse over finer points of patent law, ethics and hESCs, but absent clear guidelines on hESC research, scientists and patent attorneys are left determining the limits of patent eligibility by describing the subject matter in their patent applications.

On the other hand, the EPO’s latest s.c. WARF decision (2008) fails to clarify the matter. It may even act as a disincentive to investment in new life science technologies. ’High’ expectations are now pinned on the Brüstle patent questions forwarded to the European Court of Justice (ECJ) in Spring 2010.

WARF’s Application on Stem Cell Monopoly
WARF patent application, EP-A 0770125 (in 1996) claimed a monopoly for a cell culture comprising primate embryonic stem cells which are capable of proliferating in vitro for over one year and so forth. At the time of filing, it is described in the application that such invention could be prepared exclusively by a method which necessitates the destruction of human embryos from which the said products are derived, if the said method is not part of the claims. The scope of protection did not extend to methods of isolating stem cells from primate embryos, or to cells as they exist in the human body, rather to cells in a culture produced by a technical process.

The Examining Division (ED) at the EPO rejected the application invoking Article 53(a) EPC and Rule 23d(c) EPC as grounds for dismissal. The ED held that patentability exclusion under Rule 23d(c) to ’uses of human embryos for industrial and commercial purposes’ is not directly related only to the scope of the monopoly claims but also to concerned inventions, thus including all aspects that made the claimed subject-matter available to the public.

It was concluded that Rule 23d(c) excludes from patentability products whose isolation necessitates the direct and unavoidable use of a human embryo. This decision goes further than that of Edinburgh Patent case and raises the bar possibly to non-patentability of useful products isolated from cultured hESCs if their production involves direct and unavoidable use of an embryo.

EBA rejected WARF appeal
The Enlarged Board of Appeal’s (EBA, the Supreme Court of the EPO) decision on 25 Nov 2008 demonstrated EPO’s lack of will to tackle key questions concerning patent protection available to stem cell research in Europe. EPO asserted its established policy that it will not grant a patent if the invention relies exclusively on a method which necessitates the destruction of a human embryo from which the said products are derived.

WARF further confirms that this ban stands ’even if the said method is not part of the claims’. The EBA stated that, ’what needs to be looked at is not just the explicit wording of the claims but the technical teaching of the application as a whole as to how the invention is to be performed’. It further added that, ’to restrict the application of Rule 28(c) … to what an applicant chooses explicitly to put in his claim would have the undesirable consequence of making avoidance of the patenting prohibition merely a matter of clever and skilful drafting of such claim.’

The EBA asserts that the WARF decision does not concern the general question of human SC patentability. In addition, the EBA rejected the request for a preliminary ruling on the matter by the ECJ due to lack of any legal and institutional link between the EPO and the EU.

EBA’s Clever Reasoning avoids Discussion on Morality
By carefully and cleverly articulating the wording text of the decision, the EBA successfully avoided a discussion on morality and patents and thereby, postponed the patent morality issue for another few years. This continuing struggle between the patent monopoly and morality seems to suggest a troubled and almost slippery slope approach taken by the EPO. While some were pleased with the WARF ruling which affirms the EPO’s ’backward looking’ approach to hESC patent applications, many were disillusioned.

This ’backward looking’ approach allows the patent examiners to continue to look at the prehistory and the origins of stem cells in order to rule on patentability of an invention. This indicates that so long as a destruction of a human embryo is implicated, patent is unlikely to be granted. Bavarian Justice Minister Beate Merk called the WARF decision an ’ethical victory’, while Greenpeace said, ’without public interference, such patents would long be accepted’.

The Aftershocks of WARF
That the WARF rejection is not without its immediate repercussions despite the EPO calling it a one off SC decision, becomes evident by looking closely at the UK Intellectual Property Office (UK IPO). Shortly after the WARF decision, the UK IPO altered its patenting practice placing it in line with the EPO’s position on patenting hESCs. This supersedes the UK IPO’s previous practice notice and may signal a significant shift in patenting policy.

Prior to the WARF decision, the UK was one of the few EU countries flexible on patenting hESCs. How this impacts the otherwise fairly flexible British patent policy on hESCs remains to be seen. In addition, the pending Brüstle appeal of a German patent before the German Federal Supreme Court (BGH) with questions forwarded to the ECJ will provide for an interesting decision and, likely, one of the first insights into the repercussion of the WARF ruling for national patents.

Will Brüstle case clarify patentability of hESCs?
Oliver Brüstle of the University of Bonn obtained a German patent claiming a method of converting embryonic stem cells (ESC) into nerve cells that could potentially be used to treat neurological trauma and disease. The patent claims described neural precursor cells derived from ESCs and methods for producing the neural precursor cells. There was no mention of the use of embryos for producing the ESCs. Nevertheless, in 2004, Greenpeace filed an opposition to the patent issued.

The German Federal Patent Court revoked Brüstle’s patent claims which referred to embryo derived hESCs and cell lines. Brüstle then appealed to the Bundesgerichtshof (BGH). He argued that ’the patented methodology, based on already available ESC lines, does not destroy any embryos’. Interestingly, Brüstle’s research on human embryo-derived ESC lines was legal, which at the time did not provide adequate reasons to ban his research results from being patented. The Brüstle appeal was postponed in view of the then pending WARF appeal.

Give the circumstances of WARF appeal, the BGH is now referring a number of crucial questions to the ECJ for a preliminary ruling (Case C-34/10, lodged by BGH in January 2010).

The ECJ is asked to rule on the interpretation of ’human embryo’ in the sense of Article 6 of the Biotech Directive. The first question concerns the meaning of the term ’human embryos’ and what it includes under Art. 6(2)(c). Secondly, the BGH asks about the meaning of the expression ’uses of human embryos for industrial or commercial purposes’ and whether such includes any commercial exploitation within the meaning of Art. 6(1), especially use for the purposes of scientific research. The third question queries the patentability of technical teaching under Art. 6(2)(c) even if the use of human embryos does not form part of the technical teaching claimed, but is a necessary precondition for the application of that teaching.

The ECJ is expected to deliver its decision within 1-2 years. What the ECJ decides may break or make not only SC patent applications, but the progress of the life sciences as an industry in Europe.

No Progress on Biotech Directive
Despite the fact that the Biotech Directive has been in force for over 10 years, the EPO is yet to deny a patent for being immoral. Nevertheless, EPO’s hesitance to rely on the morality clause as a legitimate criterion in examining ethically contentious applications has all but indisputably slowed the patenting procedure of hESCs. To date, EPO rulings indicate a clear lack of any substantive definition of what constitutes morality or ethics within the European context and lack of procedural guidance on interpreting the morality clause.

The result is the never ending debate on patenting hESCs. Meanwhile, patent examiner and the EPO face complex issues of patent morality and no tools provided in dealing with hESC innovation.

WARF patent disputes
The Wisconsin Alumni Research Foundation (WARF) patents (Primate embryonic stem cells) have been subject to proceedings before the US Patent and Trademark Office (USPTO) and the EPO. They are based on the research carried out in the late 1990s on the derivation of human embryonic stem (hES) cell lines.

WARF’s European patent application EP-A 0770125 was filed at EPO in 1996 and refused by EPO’s Examining Division (ED) on 13 July 2004. WARF appealed to the Technical Board of Appeal, which in its Interlocutory decision of 7 April 2006 referred four questions to the Enlarged Board of Appeals EBA. WARF had requested that the referred points be further referred to the European Court of Justice for a preliminary ruling, but the EBA refused.

EBA ruled on 28 November 2008 (Case G 0002/06) that claims to inventions requiring the destruction of human embryos at the time of filing the application are not allowed. WARF’s invention fell within the prohibition of Rule 28(c) EPC.

Edinburgh:
Edinburgh University Patent, European Patent EP 0695351 was granted to the University of Edinburgh on 8 December, 1999. After a lengthy opposition/appeal procedures the owner withdrew its appeal on 20 November 2007. The patent remained in force in an amended form.

Brüstle:
German Patent DE 1975864 C1, European patent application EP-B-1040185
Greenpeace v Oliver Brüstle: German Federal Patent Court, 5.12.2006 (3 Ni 42/04); appeal before the German Federal Supreme Court (BGH). Request for a preliminary ruling of ECJ lodged on 21 January 2010. Case C-34/10, published in Official Journal of the EU, C 100/19 of 17.4.2010.