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Human Genes Are ‘Products of Nature’? Isn’t This A No-Brainer???!!!

In a landmark case today, the United States Supreme Court held that human genes are “products of nature,” and cannot be patented. I don’t know about you – but to me this seems like common sense.

However, like all things in life, the complexities are in the details. For instance, the Court also determined that composite DNA (cDNA) which is synthetically created is entitled to patent protection. So what does all of this mean? And what is cDNA?

Let’s look at what we know:

·Mutations in either BRCA 1 or 2 genes predispose a person to certain cancers including breast and ovarian cancer.

·These gene mutations can be passed down from generation to generation, from either the mother or the father’s side.

·With a genetic mutation in BRCA 1 or 2, a woman is five times more likely to develop breast cancer than a woman in the general population.

·Most important, we know that women diagnosed with breast cancer under the age of 40 are more likely to have these genetic mutations. They are therefore frequently referred for genetic counseling and testing.

If you haven’t been following the Supreme Court case, here it is in a nutshell: Myriad Genetics is the company that discovered the location and sequence of the BRCA 1 and 2 genes and developed a test to determine if a person has a mutation of either of those genes. (Side note: this is the test Angelina Jolie used that received so much media attention recently). Because Myriad held and enforced the patents on BRCA 1 and 2 genes, it was the ONLY company that could conduct testing for mutations.These tests cost upwards of $3,000. So if you wanted to be tested for the mutation and didn’t want Myriad to do the testing or if you wanted a second opinion … it was not possible! Myriad was the only company allowed to do the testing.

In court, Myriad argued that the company’s discovery of the location of BRCA 1 and 2, as well as its ability to extract those genes for testing, entitled it to a patent on BRCA 1 and 2. The Supreme Court has now rejected those claims. The Court stated, “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

The Court did find that, “the lab technician unquestionably creates something new when cDNA is made.” It therefore, can be patented. What is not clear (to me) from the Court’s decision is the role of cDNA in Myriad’s testing and whether its finding that cDNA can be patented affects Myriad’s exclusive claims to BRCA 1 and 2 testing.

As I see it, opening the door to healthy competition which could lower the cost of genetic testing and make it appropriately accessible to more young women would be a great outcome; allowing other companies to perform BRCA testing could allow people to obtain a second opinion – something that was not previously possible because of patenting; and this decision could aid breast cancer researchers by providing greater access to information related to BRCA 1 and 2.

Regardless, the Supreme Court’s decision that human genes cannot be patented is an important one. It establishes precedent that no company owns the rights to BRCA 1, BRCA 2, or any other human gene – and that is important for all of us.

However, it remains to be seen how the Supreme Court’s decision will alter current practice. Young Survival Coalition is hopeful it means that Myriad and other companies will continue to invest in technology and testing that helps us to better understand the origin of and/or risk of developing cancer that would ultimately improve patient outcomes.

I guess the question that needs to be asked is – could this decision discourage companies from investing in other gene mutation identification and/or tests that we don’t even know about yet? I don’t know the answer – but I think the question is an important one to ask.

While many people are applauding the Supreme Court today, I am giving them more of a pat on the back. To me, not allowing the patenting of human genes seems like a no-brainer. In the end, patients need to be the number one focus of our medical community, not profits.

I have to admit I cane2€™t understand their desicion to limit themselves in this way, as those presenting this document are very well aware of functional RNAs, unless perhaps it is the line of reasoning that they are interested in presenting, not if their line of reasoning covers all molecules that might be considered.IANAL, but my guess is that they wanted to side-step the what is a gene question by limiting themselves somewhat, hence the With qualifications not relevant here . The case is specific to BRCA1 and BRCA2, so the judge only has to rule on them. I don’t know how far this would go to setting a precedent, but if the judge makes a distinction between altered and unaltered DNA in his ruling, then I guess it would be pretty clear that functional RNAs would be included (as well, possibly, as non-coding DNA).

Let’s face it the decision is good AND bad.Myriad Genetics has adevncad the field greatly and expanded our knowledge and has saved lives.If this decision hampers investigations into other heritable diseases then the decision is a poor one.

We have a daughter that, in all likelihood, is still here because of genetic testing. I share your concern over the need for proper incentives to encourage continuing research into the the role of genetic structure in cancer. It would seem that a more appropriate incentive than patent protection would be a legislated, limited time protection similar to the structure in place for prescription drugs.

I have a friend in PT who is a manager. He had a discussion about an employee with a manager above him. They had been learning a new technique, kind of chiropractic in nature but extremely effective. The company wanted to lay off the employee in question because he was too good at his job. He was able to get people happy, recovered quicker then anyone else and as such the number of visits they could bill for his patients were lower.

For me, this story perfectly captures all that is wrong in medicine.

The socio-economic aspect of human health is a serious problem that most people including me until recently are unaware of.

I view most of the decision by the supreme court a step in the right direction. Medicine should not be patentable or for profit.

Research, medicine, should be driven by helping people alone and not greed.

I work for a company that supports open source software. Computer software is written in various programming languages, i.e. code. Open source software is code/software anyone can use. It’s pubic so anyone can access the source code, change it do whatever they want. It’s played with by the masses so more bugs are found and fixed. Developers exist around the world and the focus is on the code, not the product or the money. What cool thing can we do today? People have found that many heads combined are better than one.

I had the privilege of hearing Karen Sandler of the Gnome Foundation speak. Karen, has a heart condition and needed a pacemaker. Her immediate questions upon hearing this news was about the code running on the pacemaker. She quickly learned it was owned by one vendor and despite efforts, they weren’t going to let her see it for herself. Since then she has worked extensively to make sure that the code running on any medical device has code open to the community, secure – someone walking by her can’t access her device and trigger a fatal shock. It’s not locked down to a specific vendor so if the company goes out of business, she is out of luck. Her pacemaker is obsolete and unsupported. She’d have to get a new one. Here is link to a version of her story. [1]

We have a daughter that, in all lolikiheod, is still here because of genetic testing. I share your concern over the need for proper incentives to encourage continuing research into the the role of genetic structure in cancer. It would seem that a more appropriate incentive than patent protection would be a legislated, limited time protection similar to the structure in place for prescription drugs. See you in Philadelphia in September.