Bundesgerichtshof refers human stem cell patent case to ECJ

In a dispute between the acclaimed German scientist and inventor Oliver Brüstle and Greenpeace about the patentability of Brüstle's German patent DE 19756864, the Bundesgerichtshof has last Thursday decided to refer to the ECJ questions regarding the interpretation of art. 6 of Directive 98/44/EC on the legal protection of biotechnological inventions.

Greenpeace had filed for nullity of Brüstle's patent asserting that it was against public moral ("sittendwidrig"). The patent claims the use of certain cells for the treatment of neural deficiencies such as Parkinson or multiple sklerosis. Originally, the stem cells were derived from blastocysts (whether that's an embryo is the issue), but, as Oliver Brüstle points out, they have long been cultivated outside the human body. Greenpeace argues that this is irrelevant: at the beginning of the chain was a human embryo, and an embryo had to be killed to harvest the cells. It was against art 2 of the German Patent Act, which corresponds to art. 6 Directive 98/44/EC , to grant patents for uses of human embryos for commercial or industrial purposes. Art. 6 Directive 98/44 reads:

1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

The German Patent Court (Bundespatentgericht) partially revoked Brüstle's patent in 2006. Greenpeace argues that human life starts with the fusion of sperm and ovum, and blastocysts are embryos in the sense of the law. Brüstle counters that in the UK, France, Spain, Sweden and Denmark the term "embryo" is only used for fertilized eggs 14 days after fertilization. The patent claims the use of stem cell lines which were harvested from blastocysts 4-5 days after fertilization, and therefore before the blastocyst can be rightfully called an embryo. In a less legal vein, Brüstle likes to point out that his research is largely funded by the German government - the same government that now says the results of the state-funded research are against public morale...

The ECJ will now have to rule on the interpretation of "human embryo" in the sense of art. 6 Directive 98/44/EC. Is a stem cell derived from a blastocyst which has lost its ability to develop into a human still an embryo? If so, is a blastocyst a human embryo? If so, is purely therapeutic use of stem cells a "commercial or industrial purpose" in the sense of art. 6?

The stakes are high - the ruling could make or break a lot of biotech applications claiming the use of human stem cells.

If all this sounds vaguely familiar to IPKat readers - well, it is; the EPO's Enlarged Board of Appeal last November ruled on a similar question and revoked a patent describing a method for obtaining embryonic stem cell cultures from primates, including humans, filed by the Wisconsin Alumni Research Foundation (WARF) in 1995, because it involved the destruction of human embryos (G 2/06); IPKat post here.

UK patent practice on human embryos post-WARF

The Intellectual Property Office in the UK issued a notice earlier this month on inventions involving human embryonic stem cells. The text runs as follows:

"Advances in stem cell technology raise questions about the patentability of:

* stem cells which have been isolated from human embryos, and
* processes involving these cells.

Uncertainty about what can be patented in this field may arise because the Patents Act 1977, as amended to implement Directive 98/44/EC on the legal protection of biotechnological inventions, does not directly address the patentability of human embryonic stem cells.

This Notice sets out the Intellectual Property Office’s general practice on the patentability of inventions involving such stem cells, although each case will be treated on its own merits in the light of all the relevant circumstances. Moreover, the Office's practice is subject to any future guidance from the UK courts.

This Notice supersedes a previous Notice of the same title issued in April 2003. It reflects an update in the Office's practice to take account of the recent WARF decision [briefly noted by the IPKat here] from the European Patent Office Enlarged Board of Appeal (EBoA), which has addressed the patentabilty of human embryonic stem cell cultures. The EBoA held as unpatentable those products (namely, human embryonic stem cell cultures) which at the filing date of the patent application in question could only be obtained from a method which involved the destruction of human embryos. However, the EBoA concluded that the decision “is not concerned with the patentability in general of inventions relating to human stem cells or human stem cell cultures.”

The Office has reconsidered its practice in this area in light of this decision.

(i) Processes for obtaining stem cells from human embryos

According to Paragraph 3(d) of Schedule A2 to the Patents Act 1977 uses of human embryos for industrial or commercial purposes are not patentable inventions. On this basis, the Office will not grant patents for processes of obtaining stem cells from human embryos.

(ii) Human totipotent cells

Human totipotent cells have the potential to develop into an entire human body. In view of this potential, such cells are not patentable because the human body at the various stages of its formation and development is excluded from patentability by Paragraph 3(a) of Schedule A2 to the Patents Act 1977. The Office will therefore not grant patents for human totipotent cells.

(iii) Human embryonic pluripotent stem cells

Human embryonic pluripotent stem cells, which arise from further division of totipotent cells, do not have the potential to develop into an entire human body, and can be grown in culture and the cell lines stored in cell banks. Although there is some opposition in the United Kingdom to research involving embryonic stem cells, a number of reports from influential UK political, medical and scientific bodies [1] in recent years have emphasised the enormous potential of stem cell research, including embryonic stem cell research, to deliver new treatments for a wide range of serious diseases. This indicates that on balance the commercial exploitation of inventions concerning human embryonic pluripotent stem cells would not be contrary to public policy or morality in the United Kingdom. Thus, the Office will continue to grant patents for inventions involving such cells provided they satisfy the normal requirements for patentability and provided that, at the filing or priority date, the invention could be obtained by means other than the destruction of human embryos".

The IPKat, who thanks his friend Sophie Maughan for spotting this, notes that nothing in the foregoing text affects the patentability of embryonic stem cells belonging to fictional cats.

More on human embryonic stem cells here
How to make good porridge here

EPO hears WARF arguments

Yesterday the European Patent Office (EPO) heard oral submissions on the application of Wisconsin Alumni Research Foundation (WARF) for a European patent that relates to human embryonic stem cells. All in all, some 126 submissions were received from interested parties, including the United Kingdom Intellectual Patent Office (UK-IPO) -- which observes that there is no consensus within European Patent Convention Contracting States concerning the public policy issues which WARF’s application raises.

The IPKat has received a press statement from Scotland-based IP practice Shepherd and Wedderburn, which endorses the UK-IPO’s position that it is for Contracting States and not the EPO to determine acts which they consider to be immoral. Says the statement:

"The issues raised by bioscience are within the margin of appreciation of Contracting States. It is unfair to WARF that the moral acceptability of its purported innovation will be decided upon by the EPO, based on its perception of what may be acceptable across the breadth of Contracting States".

The firm predicts that the EPO is likely to move cautiously [the IPKat says, that's no surprise if you consider its movements over the past 30 years], concerned not to be seen as pushing potentially unwanted technical innovation on to the more conservative Contracting States. This caution, concerning issues of public policy which ought rightly to be decided at Contracting State level, may have unintended consequences. The firm's conclusion is that the imposition of moral criteria upon patent application decisions in the stem cells field may well drive investment from Europe to jurisdictions where patent criteria will be decided upon solely on the basis of merit [the IPKat has never understood why this should make any difference: wherever the R&D cash is spent, the results will be either patentable or non-patentable in the same markets -- and even the absence of patent protection has never stopped people commercialising their products if they see a profit ahead. Can someone assist him?].

The IPKat awaits further developments with bated breath.