4 Ways The Supreme Court Gene Patent Decision Will Change Medicine

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On Thursday, the Supreme Court ruled that companies cannot patent isolated human genes that are naturally occurring.

The decision defeats the Salt Lake City company, Myriad Genetics Inc. who had previously been granted patents on the BRCA1 and BRCA2 genes that put women at a greater risk for breast and ovarian cancer—a topic that gained more attention when actress Angelina Jolie revealed she underwent a double mastectomy after discovering she carried the genes.

According to the court’s decision written by Justice Clarence Thomas, Myriad did not create anything new when it comes to the BRCA genes, since they are a product of nature; therefore patenting them is illegal.

(MORE: Genetic Test Can Predict Most Aggressive Cases of Prostate Cancer)

However, Myriad did have a partial victory. The Supreme Court also ruled that synthetically-created DNA (known as cDNA) is patentable since it is not naturally occurring. In a statement about the ruling, Myriad wrote that the company has, “more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.”

Many individuals from the medical community are rejoicing. “[The decision] is brilliant, I am so happy about it,” says Dr. Cy Stein, department chair of medical oncology & therapeutics research at City of Hope, a cancer research hospital in Duarte, California. “Right now in 2013, this is not going to affect too many people immediately, but going forward into the future, this is big.”

Here are the reasons the decision is monumental:

1. There will be competition in BRCA testing: “Physicians will not be compelled to use the Myriad test exclusively,” says Dr. Stein. “This may help control prices, and will allow BRCA to be incorporated in a panel of genes that physicians may want to evaluate and test patients for. This cannot be done now.” Stein says that currently City of Hope cannot test its patients for BRCA in-house since it is under patent. Instead, they have to send out for testing. Now, Myriad still has a patent on the BRCA test, but if others develop new ways, there will be more screening opportunities.

2. Product development will speed up: The decision removes the threat of endless litigation if a product–for instance a screening method–is developed by one company that uses a gene patented by another.

“It’s actually chilling to think about what would’ve happened had this gone the other way,” says Dr. Stein. “Can you imagine if you had to go through this for every gene? You wouldn’t get anywhere. All of the genomics research that has been done would wind up in court. It would never be resolved.”

3. Biotech firms will have more freedom to innovate: Now, biotech firms will have greater freedom to operate. Potential competitive products cannot easily be quashed, the flow of research in all sectors–academic, industrial and clinical–will continue unimpeded. “Biotech investors can have confidence that products that are or will be in development will not taken over by larger corporations,” says Dr. Stein.

Daniela Hernandez, a writer for Wired, writes:

Although the patent incentive for discovering new genes is gone, the first person to isolate new sequences still has the best chance to build potentially lucrative applications, like novel medications, chemicals or biofuels, that can be patented. Already, scientists are at work trying to devise DNA-based programming code and biologics, for example.

4. There will be more personalized therapies that rely on gene sequences: According to Dr. Stein, most therapeutics in the foreseeable future are going to come from innovations in gene structure, gene function, or possibly silencing of messenger RNA (which is related to both).

“Many of our therapies will become more personal and more targeted. This seems to be the wave of the future, and would not be possible if each and every gene was patented by a different entity,” he says.

6 comments
punkakes13
punkakes13

gene patent is one of the most unhuman things ive aknowlegded.. when in terms of law .. good its not efective anymore..


mkb
mkb

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xanderpico
xanderpico

I agree with the decision regarding naturally occurring DNA sequences, and this is very important for basic research (and for biotech) to establish this properly. These are the "basic tools of scientific and technological work" and their potential utility is obvious enough to clearly define them as unpatentable. 

However, I disagree with decision regarding cDNA. (1) They focus heavily on the point that the introns have been removed, but that step DOES occur naturally, routinely. (2) Then they make the distinction between the representation of exon-only genes in RNA vs DNA, claiming the latter is unnatural. But in their own footnote, they accurately point out that this is not always the case and natural cDNA is made by viruses. They falsely rely on it being "rare" and not relevant to biology. It is in fact a critical process in evolution  (e.g., syncytins) that is still an active area of research. (3) Even if it never happened in nature, the distinction between RNA and DNA copies of the same naturally occurring sequence is arbitrary, like transcribing a text from one font to another. 

The argument for the unpatentability of naturally occurring molecules is stronger than expressed in this decision. The clear place to draw the line is with novel synthetic sequences, novel chemistry and non-obvious uses. 

janeerosen14
janeerosen14

My concern is that the new Court decision regarding genes being considered entities of nature ....will have a detrimental affect on research, discovery and patenting of natural products (compounds produced in nature for example from plants, bee hives, bacteria etc.) that have potent activity against disease.   If a natural product with activity against a human disease is isolated, the isolation process can be patented but not the structure of the compound as nature creates it.   If we are fortunate and if the natural compound can be derivatized without compromising its medicinal activity it might be a go...but so many natural products will lose activity if changed in any way.  So many natural products have great potential as future drugs....but without patent protection the incentive for biotech companies, academia and big pharma  to invest in the research, development and clinical trials will wane....and so much will be lost.  Not sure how this can be balanced in the end against the new decision in the Myriad case with regard to the issue of now not being able to patent genes....as they are considered products of nature. 

punkakes13
punkakes13

@janeerosen14 a product can be patent, just the natural and pure compose that not, because its naturall form nature, not man kind.. its not something man produced, therefore its not his, just cause he found it first 

and the gene case it is because we cant touch it, see it with human eyes, which it needs knowlegde, etc, only some can find those..structures and kind of matter that exist in the world.. but therefore, it is still universl to all of us, and cant be patent

just a product that comes from it.. or something..