Tuesday, December 13, 2011

The End of Embryonic Stem Cell Research in Europe? The European Court of Justice Decision, Case C-34/10, October 18, 2011

The European Court of Justice (“ECJ”) ruled in the case Brüstle v. Greenpeace (Case C-34/10) brought up by Greenpeace seeking annulment of the German patent – Patent No. DE19756864C1 – held by Mr. Brüstle concerning isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects. The main focus of the decision is the interpretation of Article 6(2)(c) of Directive 98/44/EC (1998 OJL (L213) 13-18) of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

The German Federal Patent Court (Bundespatentgericht, “BPatG”) ruled on December 5, 2006, Case 3 Ni 42/04, on the basis of Paragraph 22(1) German Patent Protection Act (“PatG”) in conjunction with Paragraph 21 Subsection 1 Point 1 PatG in conjunction with Paragraph 2 Subsection 2 Point 3 PatG, that the patent at issue is invalid in so far as it covers precursor cells obtained from human embryonic stem cells and processes for the production of those precursor cells. The court held that the patent also violates the German Embryonic Protection Act (“ESchG”), which prohibits research with human embryos. Mr. Brüstle appealed against the judgment to the German Federal Court of Justice (Bundesgerichtshof, “BGH”), December 17, 2009, Case Xa ZR 58/07.

In accordance with the guiding principles of European Union Law, the national law of the Member States must be interpreted in terms of the rules and regulations set by the European Union; the court held that the outcome of the application for the annulment of the patent de-pends on the interpretation of Article 6 of the Directive, which is implemented in the PatG as well as the ESchG. Thus, the BGH referred specific questions to the ECJ and requested a preliminary ruling regarding:

1. the interpretation of the term “human embryos” in Article 6(2)(c) of the Directive;
2. the interpretation of the expression “uses of human embryos for industrial or commercial purposes” and the question if this especially includes the use for the purposes of scientific research;
3. and if an invention is unpatentable even if the use of human embryos does not form part of the technical teaching claimed with the patent, but whose production necessi-tates the prior destruction of human embryos. See, in detail: Bundesgerichtshof [BGH] [German Federal Court of Justice], December 17, 2009, Case Xa ZR 58/07; ECJ, October 18, 2011, Case C-34/10, para. 23.

The Concept of Human Embryo

Because the Directive lacks a definition of the term “embryo” and after considering the preamble and the scope of the directive, the court ruled:
"any human ovum after fertilisation, any nonfertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any nonfertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute[s] a human embryo" (Case C-34/10, para. 53);

"stem cells obtained from a human embryo at the blastocyst stage, […] whether they are capable of commencing the process of development of a human being, […] are included within the concept of human embryo” (Case C-34/10, para. 37).

Human Embryos for Scientific Research

The Directive is limited to the patentability of biotechnological inventions; it does not regulate the use of human embryos in the context of scientific research directly. Considering Recital 14 of the Directive, the court ruled:
"[the] use of human embryos for industrial or commercial purposes' within the meaning of Article 6(2)(c) of the Directive also covers use for purposes of scientific research" and are not patentable;

"only use[s] for therapeutic or diagnostic purposes which [are] applied to the human embryo and are useful to it [are] patentable". (Case C-34/10, para. 46)

Inventions Based on the Destruction of Human Embryos

Taking into account that a human embryo is destroyed when a stem cell is removed during the blastocyst stage, for example, in the production of neural precursor cells (Case C-34/10, para. 48), the court held that when the destruction occurs at a stage long before the implementation of the invention it is irrelevant (Case C-34/10, para. 49). Therefore, the court ruled:
"an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos" (Case C-34/10, para. 49);

"the fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is, in that regard, irrelevant" (Case C-34/10, para. 49).

This recent decision may do more to impede the progress of embryonic stem cell research in Europe than any inherent limits in the state of science itself. The court used a very broad definition of the term “embryo” without using any scientific reference points. With its definition of “embryo” the court included nearly all possible stages in the development. Although, the court recognized that non-fertilized ova are incapable of developing into a human being, it nonetheless placed them on the same level as an embryo. The implications of this decision are widespread in Europe; the decision is binding and cannot be appealed. It remains to be seen how the German courts and legislature, as well as those of the other Member States will react and comply.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

Friday, November 11, 2011

The Next Ethical Problem in Translational Science: Crossing the "Policy Valley of Death". Eric M. Meslin, PhD. Nov. 14th, 2011

Join us Monday, November 14th at 3:00 p.m. for a presentation by Eric M. Meslin, The Next Ethical Problem in Translational Science: Crossing the "Policy Valley of Death". Location: Indiana University Center for Bioethics, 410 West 10th Street, Suite 3100, Indianapolis, IN.

This presentation will make the case that there are two gaps to be bridged in successful translational science, one between "the bench and the bedside" and another between the "lab and legislature." Without a sturdy bridge from the lab to the legislature, advances in translational science could be lost to the "policy valley of death."

Wednesday, August 24, 2011

Two Approaches to Cancer Studies

Two studies related to the prevention and treatment of cancer will commence in the US and the UK, respectively. The pilot phase of the Stratified Medicine Programme led by Cancer Research UK with support from the public, private, and charitable sectors seeks to provide the first nationwide genetic testing program for cancer patients. Collection and analysis of 9000 samples will be tested for a range of mutations in order to create targeted approaches to cancer treatment for six common cancers: breast, bowel, lung, ovarian, prostate, and melanoma. Existing patients derive the benefit of the targeted tests while researchers generate more data in order to understand underlying genetic factors.

Although the program is in its infancy, one must also ask if access to such personalized treatment is feasible on a national scale. Are such diagnostic techniques and treatments en masse reasonable or attainable? Theoretically, it should be possible to integrate such practice with a reasonable cost savings to the UK National Health Service. According to Harpal Kumar, CEO of Cancer Research UK, targeting medications to specific populations would drive costs down.

"The problem at the moment is that it takes $1bn to get a drug to market and 15 years or more. That is the justification for the pharmaceutical industry charging high prices… If on the other hand by the time you get to phase 2 you know exactly which patients it is going to work on, you only put those patients through and instead of 10% you get an 80% response rate… You get a licence on the basis of the data and don't have to go to phase 3 [a trial involving thousands of people]. That saves vast sums of money and years of development. What that does to the business model is it means you can justify charging lower prices because it cost a lot less in the first place." The Guardian, 22 August 2011
A second concern would be the privacy of patients' health data. According to Cancer Research UK patient, treatment, and outcome data will be provided in a "pseudonymised electronic format." Although research can be conducted without identifying information, the genetic information derived from such tests is, in effect, personally identifying, so can it ever be truly be considered anonymous?

In contrast to the UK study, a longitudinal US study (Cancer Prevention Study-3) sponsored by the American Cancer Society (ACS) will follow 300K people with no personal history of cancer for twenty years in order to understand lifestyle, environmental, and genetic factors that cause or prevent cancer. Unlike the UK study, the ACS study seeks to prevent cancer rather than treat it. The study will collect blood samples, waist measurements, and surveys from study participants. Research subjects derive no direct benefits from the study compared to the UK study; however, ethically speaking the study's website cites specific measures indicated to ensure privacy:
• label your data with a unique identification number when it is collected
• store your blood sample, survey data, and other study materials separately from all personal identifying information (like your name, address, and social security number)
• limit access to any identifying information to authorized study personnel only
• keep study documents in a locked, limited access research storage room
• have all staff sign confidentiality forms and undergo training in research ethics
• have all Volunteers sign confidentiality forms
• not share results with your family, your doctor, your employer, any insurance company, or other third parties and we will keep your records private to the extent allowed by law
--Jimmy P. Daruwala


References

Cookson, Clive. Genetic test promises cancer gains. The Financial Times, Retrieved 23 August 2011.

Boseley, Sarah. Cancer research in 'golden era,' says charity chief. The Guardian, Retrieved 22 August 2011.

Cancer Research UK. Cancer Research UK Stratified Medicine Programme Calls: Frequently Asked Questions, Retrieved 23 August 2011.

American Cancer Society. Cancer Prevention Study 3, Retrieved 24 August 2011.

American Cancer Society. Confidentiality and Ethics CPS-3. Retrieved 24 August 2011.