In light of the twelfth Annual Conference for Human Genetics, which took place in Montreal on the 14th of October, Le Devoirpublished an article entitled “À qui appartiennent nos gènes?”, or to whom do our genes belong? The article highlights the fact that 20% of the human genome is patented and quotes Professor Gold from McGill University as saying, “Il faut payer la compagnie pour travailler sur ces gènes. Est-ce ainsi que nous voulons considérer le corps humain?” (Translation: a company must be paid to work on our genes. Is it in this way that we want to consider the human body?)
In Canada, the issue of patenting genes has been recently addressed in two cases: Harvard College v. Canada and Monsanto Canada Inc. v. Schmeiser. Both of these cases deal with the patenting of life forms; the former establishes that humans and animals, or “higher life forms”, cannot be patented, whereas the latter establishes that engineered genes and cells are patentable, even when their intended use is insertion into life forms such as plants. Despite the ruling in these cases, the Canadian courts have not yet directly addressed the issue of patenting human genes that have not been genetically modified or engineered.
However the issue has recently arisen in the United States in the case of Association for Molecular Pathology v. United States Patent and Trademark Office, 2010, United States District Court: Southern District of New York. The plaintiffs pleaded that Myriad’s patents relating to the human Breast Cancer Susceptibility Genes 1 and 2 (BRCA1, and BRCA 2) should be revoked given that they were broad enough to reach BRCA1/2 DNA isolated from any human being. The judgement for the case was delivered by Judge Sweet in favour of the plaintiffs, although the case is currently under appeal.
The patents under question in this case allowed Myriad to protect unmodified portions of DNA corresponding to BRCA1/2 genes (BRCA1/2 DNA sequences). In other words, everyone has BRCA1/2 DNA sequences in their genome and through its patents Myriad claimed ownership over these portions of DNA.
The following question arises: should companies be allowed to own a specific gene sequence? Or in other words, should Myriad be allowed to own my BRCA1/2 DNA sequence even though I have never interacted with them? Of course, my gut reaction to this question is no. Why should I give up the rights to gaining knowledge about the state of my genome, and have to pay some company to be able to have access to this information? But upon further reflection, answering yes is not so outrageous.
When a particular DNA sequence is determined to be indicative of the risk of a disease state, gene testing is used in the patient to look for DNA sequences that deviate from the known normal risk- free DNA sequences, or for DNA sequences that match sequences that are known to be indicative of disease. These techniques “look” directly at the patient’s DNA to ascertain whether information which codes for the disease is present, such that the risk of the occurrence of the disease may be identified before the disease manifests itself. Gene testing techniques are therefore useless without the knowledge of what DNA sequences code for the disease. Patents that protect genes provide protection for DNA sequences that code for the disease, as well as sequences that code for the normal disease-free state. These sequences are not artificially modified.
The main objection to patenting gene sequences that have not been modified is precisely the fact that they have not been modified, and are therefore not new. United States Code Title 35 –Patents, s.101 Inventions Patentable states that:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title
Similarly, s.2 of the Canadian Patent Act states that:
Invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter;
Judge Sweet in the Myriad case maintains that gene sequences are not patentable because they do nothing but describe DNA, and given that DNA in itself is descriptive, the gene sequences are not “new”. The function of DNA is to direct the composition of proteins; it is a recipe. The protein produced will then result in the manifestation of disease. Therefore Judge Sweet maintains that that the function of DNA is to describe the manifestation of the disease, and an unmodified DNA sequence which is used to aid in the description of what the DNA under scrutiny describes, is not patentable. While this argument may be compelling, I do not agree with it.
The role of DNA is to dictate protein formation, however it is not the role of DNA to describe the risk of disease manifestation. The calculation of risk is a human construct; the risk is not ascertainable by simply “looking” at the DNA. As such, using DNA to express the risk of disease is a repurposing of DNA.
Looking at the DNA and describing its content is content is not useful, however understanding the meaning of the description is. There is a difference between simply saying that a gene responsible for breast and ovarian cancer exists, and saying that certain deviations from a standard form of the gene lead to ovarian and breast cancer. I believe that the latter is the basis of a diagnostic tool and should be patentable, whereas the former is a statement of fact and should not be patentable. These genes are not being patented to exploit their function as a protein recipe; they are being patented as baseline comparison standards. This purpose is evident in Myriad’s methods claims. The novelty does not lie in a new composition or manufacture, then, but in the repurposing of the DNA from a protein recipe to a means of diagnosis.
What is being rewarded through the patent is not an observation of the existence of a cancer gene, but rather the ability to be able to diagnose the possibility of cancer before it manifests itself. Viewed in this way, I believe that Myriad’s patents, and patents which aim to protect gene sequences, should be read in accordance with their. If the methods claims suggest that the gene sequences are to be used as comparison standards, then I believe that this is the aspect of the gene sequence that should be protected. In other words, I do not think it is appropriate for Myriad to enforce its patents against laboratories who are researching the gene sequence for a purpose other than using it as a comparison standard, but it is ok for them to hold exclusive rights to use a particular gene sequence as a comparison standard.
The field of biotechnology is evolving and makes use of tools that mimic cellular functions in order better understand the role played by each of the cellular components. One of these cellular components is DNA, a recipe for protein encoding. Being able to understand what the recipe means constitutes the basis of diagnostic tools that act as predictors. The value of this understanding lies in the ability to repurpose DNA from a simple recipe to a diagnostic tool. A diagnostic tool attaches meaning to the recipe which was not there otherwise. In this way, I believe that gene sequences that are used as comparison standards are new and useful improvements of the function of DNA, which, as found in nature and unmodified by the human mind, do not on their own act as a predictor of disease.
McGill Journal of Law and Health 