Moral and ethical questions for patenting genetic material

The use of embryonic stem cells to develop medical treatments is a controversial topic. Michael Factor and Moshe Tritel look at the situation in Israel.

Embryonic stem cells are extracted from a blastocyt—a fertilised human ovule that is four or five days old. These stem cells can develop into different kinds of cells and are the subject of research that promises novel treatments, cures and even the prevention of diseases. However, the process of extracting the cells kills the embryo. This raises fundamental moral issues.

The Israel Patent Law 1967 does not discuss ordre public or morality. All technologies are patentable under the law, except for Section 7, which excludes from patentable subject matter:

• Methods of therapeutic treatment on the human body, and

• New varieties of plants or animals, except microbiological organisms not derived from nature.

The law is intended to prevent the restriction of access to medical treatments.

In order to allow pharmaceutical companies the possibility of realising a profit as a necessary incentive for product development, appropriate language has been developed to enable drugs to be patented and the law to be bypassed.

There is currently no basis in the Israel Patent Law to prevent patents for embryonic stem cell research.

The Israel Patent Office has at least 68 patent records relating to embryonic stem cell research. Some of these are for issued patents. Applicants include Israeli hospitals and university technology transfer companies.

With regards to the moral and ethical positions regarding stem cell research, I would prefer Israel to take the lead on this issue. We should have our own voice on such topics and our own intellectual traditions to draw on. I think this argument can be extended to the issue of patents for gene sequences as well.

Israel is a world leader in non-conventional pregnancies. The health funds provide support for couples to have expensive fertility treatments when they already have one baby. Blastocyts are the embryos resulting from human ovules that are fertilised in a petri dish or test tube. Such treatments provide more embryos than can sensibly be implanted.

Therefore, blastocyts are the by-products of medically assisted procreation; which like natural procreation, with its production of ova and generation of millions of sperm cells, is a wasteful system at best.

"There is broad consensus among Rabbis and Talmudic scholars that embryonic research is acceptable."

Perhaps surprisingly, there is broad consensus amongst Rabbis and Talmudic scholars that embryonic research is acceptable. Unlike the Christian tradition, which sees life from the moment of conception, in Jewish Law, an embryo is not considered viable until 40 days after conception, which coincides with the beginning of tissue formation.

Before his death, in a much publicised visit to Israel, Christopher Reeves, the actor who once played Superman and, then following an accident, became a paraplegic, met with Israel’s president. He saw embryonic stem cell research as the only chance for people like him to walk again, and came to acknowledge and support the research being done in Israel.

Should there be legislation?

Regardless of one’s position on the religious, ethical, philosophical and moral issues, the patent playing field is not the correct place to restrict areas of scientific research.

A more interesting question is: should there be legislation governing embryonic research and, if so, what form should it take? I think the topic should be widely and publically debated by ethicists, scientists, philosophers, politicians and religious leaders.

Patenting gene sequences

A related and also controversial issue concerns the patenting of gene sequences. Here, there are fundamental patenting questions as to whether there is novelty, utility and inventive step. There is also a question whether, as a matter of policy, it is correct to grant a patent monopoly for something so fundamental.

The issue has recently become urgent. US Federal Judge Robert Sweet (Manhattan) has summarily dismissed patents for two human genes associated with hereditary breast and ovarian cancer, ruling that gene sequences are not patentable subject matter.

The lawsuit was brought by the American Civil Liberties Union to challenge patents held by Myriad Genetics and the University of Utah Research Foundation on grounds that genes are “products of nature” and cannot be patented.

The lawsuit, which concerns patents for the BRCA1 and BRCA2 genes, was filed on behalf of women’s health groups, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. The wider issue is patents for genes in general. It should be noted that the issue is not genetic engineering, but rather patenting scientific discoveries. Though not automatically disqualifying other gene patents, this ruling does threaten their validity. It is expected to be appealed, and it is noted that the US Supreme Court has never ruled on the patentability of gene sequences.

Last year, Melbourne-based Genetic Technologies threatened to sue hospitals and laboratories testing for mutations after it bought patents from Myriad in the US. This has triggered an Australian government-supported parliamentary inquiry headed by Liberal Senator Bill Heffernan.

“It asks the fundamental question: who owns your body? I mean do we want our bodies to be converted into a tradable instrument that gets traded around the planet,” Senator Heffernan said.

In general, for something to be patentable, it must be novel, inventive, useful and man-made. The human genome is presumably man-made in the sense that fingernail clippings, urine and hair are. But gene sequences are really more a scientific discovery than an invention. Mapping gene sequences is not novel and inventive in the traditional sense.

However, there are strong economic arguments that without a financial incentive of the type that a patent provides (a limited monopoly), the private sector would not invest in gene research.“We don’t think people should have a monopoly just because they have discovered a gene,” says Professor Ian Olver of the Cancer Council of Australia.

The European Court of Justice has also been asked to clarify through interpretation of Directive 98/44 whether a DNA sequence is entitled to patent protection as a compound as such, or only under circumstances where the DNA performs its function.

Israel patents for gene sequences

In October 2008, in Circular M.N. 64, the Israel commissioner of patents and trademarks ruled that gene sequences can be patented in Israel.

In a decision considering the no less controversial, but less emotionally charged issue of patenting business methods, the commissioner interpreted the law to exclude business method patents. He argued that software is covered by copyright law, so legislators have effectively made it not patentable. In his explanation, he clarified the basis for his conviction that the Israel Patent Office and Israel Patent Law should be aligned with the law and patent offices of other developed nations, such as Japan, Europe and the US.

This position is admirable as far as commercial/ ethical policy is concerned, and covers business methods and software. A small country like Israel should have patent laws that are similar to those of other countries. Indeed, the TRIPS agreement under the World Trade Organization has done a lot to align patent laws worldwide.

However, in regard to morally and ethically charged matters such as stem cell research,which raises fundamental questions about what is life and who should be allowed to own the building blocks of life, Israel has its own historical, ethical and religious traditions and philosophy. It is more important for Israel to be true to these traditions than to conform to the norms of other countries.

In fact, the Knesset actively decided not to include ordre public considerations when Section 7 was drafted. The Knesset rejected the UK patent law and the draft European patent law. Over the years, IP legislation committees have proposed amendments that were not implemented. Perhaps the current state of affairs regarding embryonic stem cell research and gene patents is not merely an example of poorly drafted law, but is actually the result of policy.

Dr. Michael Factor is a partner at JMB, Fa©tor & Co. He can be contacted at: mfactor@israelpatents. co.il

Dr. Moshe Tritel, PhD, is a patent attorney and head of biotechnology at JMB, Fa©tor & Co. He can be contacted at: mtritel@israel-patents.co.il