Deciding whether human genes should be patented

Disclosure: This coverage is more of a blog style post. This week we highlight an ongoing topic in the scientific realm that I think is interesting and important from a researcher’s point of view, solely. It does not explore the commercial perspective, simply because the company—Myriad Genetics—did not respond to my email request for comment.

The scoop

A couple weeks ago, the Supreme Court added a case to its docket to review the future patenting of human genes.

One of Rasul Chaudhry's students demonstrates the use of stem cells in one of Oakland University's research labs. The patenting of breast cancer genes would be detrimental to the emerging field of stem cell research, Chaudhry said, because "There are many genes with overlapping pathways and functions. Patenting one gene would have a large effect on many different areas of research."

Myriad Genetics, Inc. is a Utah-based genetics company holding several gene patents.

On Nov. 30, the Court added a case that will challenge the patenting of genes used to determine hereditary breast and ovarian cancer risk in patients.

Researchers and physicians are challenging Myriad Genetics, Inc.’s notion that these gene products do not occur in nature.

Myriad Genetics did not respond in my efforts to discuss their latest case. But I set out to find how the patenting of human genes affects the future of medicine and science. Two local researchers weigh in on this ongoing topic.

(Please find the full court case proposal here. Find and follow the ongoing issue via The New York Times. Here is a link to the original article stating the Supreme Court’s decision to add the case.)

Local fervor

Introducing: Sofia Merajver, M.D. Ph.D., and Rasul Chaudhry, Ph.D.

Sofia Merajver is the director of the University of Michigan Breast and Ovarian Cancer Risk Evaluation Clinic at the University of Michigan Comprehensive Cancer Center. Merajver shares her thoughts on gene patenting and how it impacts the lives of her patients.

Rasul Chaudhry is a professor of molecular biology at Oakland University and is the co-director of the OU-William Beaumont Institute for Stem Cell and Regenerative Medicine. Chaudhry offers his expertise on the topic and how patenting of genetic material affects the future of his stem cell research.

Q: What do you think of gene patenting?

R.C: Gene patenting is not conducive to the free availability of naturally occurring genetic material and the collaborate nature of the scientific field needed for advancements and finding cures for the diseases such as breast cancers.

I think that gene patenting is detrimental to scientists and patients by limiting access to the patient’s genetic information. It also impedes the technological progress to develop affordable and reliable genetic testing.

In addition, no one should be able to patent a ‘fact of nature’, and I do not think that the act of DNA isolation, comparison or sequencing are innovative techniques worthy of a patent.

S.M: The history of gene patenting with regards to breast cancer is a very sad one. It has hampered research and has had many deleterious consequences.

It has inappropriately kept the price of the (breast cancer genetic screening) test very high. The standard methods of sequencing these genes were reduced in price by 1,000-fold but the price of the test only continues to increase. This is of course due to lack of competition. So the patenting eliminated competition unfairly for the patients and the public.

Q: When did the process of gene patenting really gain momentum?

S.M: The genes were (first) cloned in 1994 and 1995. And I believe the patents were issued in the late 90s.

So it’s been15 years or longer that they’ve been under patent and it has hampered research, it has deterred research and also hampered innovation because other companies have been discouraged from trying to find innovative ways to do it cheaper. And it has basically eliminated competition.

Q: How are genes used to study breast and ovarian cancer?

R.C: Mutations in several genes including TP53, PTEN, STK11/LKB1, CDH1, CHEK2, ATM, MLH1, MSH2, BRCA1 and BRCA2 have been linked with breast cancer.

However, the majority of hereditary breast cancers are related to BRCA1 and BRCA2 mutations, two genes recently patented by Myriad Genetics, Inc. Not all women with harmful BRCA1 or BRCA2 gene mutations will develop cancer; as such there is a need to determine the relationship between genetic and environmental factors.

Researchers study different mutations in these genes in the lab with the use of cDNA* from mRNA* used in the process of DNA replication to form new cells), genetically modified cell lines and mouse models. If researchers cannot use patented gene sequences, advancement in breast cancer research and therapies will be restricted.

*Side note: cDNA is known as complimentary DNA, synthesized from a template strand of mRNA and is used to clone genes. mRNA is known as messenger RNA, which are a group of molecules that play a specific role in DNA replication, identifying particular gene expression.

Q: Why is this significant?

R.C: Determination of the mutations in genes related to breast and ovarian cancers are needed for the diagnosis.  No company should have a monopoly on genetic testing, thereby limiting patient’s resources. Gene patenting restricts the use of patent genes and DNA sequences in the research community and clinicians for finding treatments or cures. It is also limits the progress in genomic comparison studies.

Q: How does gene patenting affect your patients?

S.M: I have a very strong opinion about that mostly because I’ve been struggling to help patients find out if they carry a gene and I know some patients have chosen to not find out in part because they are worried that they will make an investment of time and effort then they will be asked to discontinue their work.

Q: How does gene patenting prevent patients from obtaining a second medical opinion?

S.M: If (Myriad Genetics, Inc.) holds a patent, there are no other companies that spring up to do cheaper job or a better job so they have discouraged competition. So one only has to go by (Myriad Genetics, Inc.’s) opinion or interpretation of the test because there is nobody else doing the test.

But at the same time that the technology has been discovered everywhere for other reasons to sequence genes more economically and the cost has gone down while the cost of their test has gone up

So they have never adjusted to the fact that there have been innovations because they don’t need to innovate, because they held a patent, that’s the definition of a monopoly, it doesn’t help anyone, it’s just monopolistic

You want to encourage diversity and competition and patents were intended to do that but it didn’t have the intended effect in this case because you are patenting something that shouldn’t be patented

When you patent technology, then you are doing the right thing.

But when you patent something that exists in nature already, you are not patenting something that will encourage competition and investment to create jobs or anything. It just doesn’t have any good effects other than enrich one company.

Q: Why would the Court rule in favor of the genetic company?
R.C: The court could rule for the genetic company because the DNA they use for testing is cDNA derived from mRNA and thus considered the DNA (cDNA) not found in nature but is a process generally used to determine the function and sequence of a gene.  Gene patents are significant incentives to biotechnology companies to fund research for cancers and other diseases.

Q: Myriad Genetics, Inc. Argues that the genes in question are not naturally occurring because they are fortified with artificial additions not found in nature. What does this mean?

S.M: The genes are a natural product. The claim in the patent is that what they have patented is not something that exists in the body. (They argue) that in the body, genes are bound to proteins and so on.

And that’s total nonsense, because what they patented is the sequence. And of course the sequence exists in the body—that’s where they got it. They didn’t patent the method—an innovative method—which would be fine, nobody argues with that.

So by patenting the actual sequence, which is a natural product by nature and exists in all of us, then they actually hamper competition. They hamper innovation and they cost taxpayers and patient enormous amounts of money for what is very simple testing. So the patent has tremendous negative impact.

Q: How does gene patenting impact research?

S.M: I left the field completely. I stopped doing research in this field—I have a whole career in research—but I changed subjects because I wasn’t going to try to do research and be constantly caused by Myriad Genetics to seize and assist.

Because they took the attitude that if you were doing any sort of testing, even if it was not for profit, that you had to stop.

Q: Rasul Chaudhry, how would this affect your research with stem cells?

R.C: Stem cells are a good model to study developmental biology, disease processes and gene function as well as the origin of cancer.  Furthermore, stem cells have immense potential for drug discovery, regenerative medicine and cell therapy.  Gene patenting for breast cancer genes sets a dangerous precedent, and this would be particularly detrimental for the emerging field of stem cell research. There are many genes with overlapping pathways and functions, patenting one gene would have a large effect on many different areas of research.

Q: How is gene patenting viewed by other nations?

S.M: The American patent only hurts the American society. The rest of the world really finds it to be laughable that genes are patented in the United States. Europe doesn’t uphold the patent—ignores it completely—And they’ve done a lot more research. It is really quite amazing.

Interested in more?

For information about the Breast and Ovarian Risk Evaluation Clinic at the University of Michigan Comprehensive Cancer Center, visit http://www.cancer.med.umich.edu/prevention/brisk-clinic.shtml.

For information about the OU-WB Institute for Stem Cell and Regenerative Medicine, visit http://www.oakland.edu/iscrm.

About Jen Bucciarelli

Veggie lover and aspiring word chef, reporter Jen Bucciarelli covers all things health and medicine for Rochester Media and The Community Edge. She is always on the hunt for local experts who can help improve the lives of our readers. Send her a note at [email protected].

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