SCOTUS: isolated, naturally occurring DNA segment can't be patented

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A naturally occurring DNA segment is not eligible for a patent simply because it has been isolated, the Supreme Court of the United States ruled June 13. DNA that is not a product of nature may be patent eligible, however.

The ruling came in Association for Molecular Pathology, et al. v. Myriad Genetics Inc., et al., 12-398, in which Myriad Genetics Inc. filed several patents after discovering the precise location and sequence of what are known as BRCA1 and BRCA2 genes. Mutations in these genes can significantly increase a person’s risk of developing breast and ovarian cancer.

Other organizations offered BRCA testing after Myriad discovered the genes, but the company asserted that testing infringed on its patents.

janis-mark-mug.jpg Janis

The United States Court of Appeals for the Federal Circuit held both isolated DNA and cDNA – which is an exons-only molecule that is created in a lab – are patent eligible. Two of the three judges on the panel held that the act of isolating DNA allows a company to obtain a patent.

The question in this case is whether Myriad’s discovery of the location and genetic sequences of the genes render it patentable under 35 U.S.C. Section 101. “In this case … 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 opinion states, delivered by Associate Justice Clarence Thomas. All of the justices joined, with Associate Justice Antonin Scalia joining in part.

“The court said that you can’t get a patent on a DNA sequence that has been isolated from its surrounding material because it’s a ‘product of nature,’ but you can potentially get a patent on a DNA sequence that has been altered in the lab,” explained Mark D. Janis, director of the Center for Intellectual Property Research at Indiana University Maurer School of Law.

Thomas noted what was not implicated by this decision. There are no method claims before the court; the processes used by Myriad to isolate the DNA were well understood and widely used. The case doesn’t involve patents on new applications of knowledge about these genes. And the court did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

“We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”

In a statement issued after the decision, Peter D. Meldrum, president and CEO of Myriad Genetics Inc. said, “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward. More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs.”

Janis believes the impact of the decision will be modest.

“There are many alternative ways to claim biotechnology inventions, and the court’s decision is directed only to one of those strategies,” he said. “In the long term, I think it will be viewed largely as a symbolic gesture by the court – a reminder that at least some subject matter does lie in the zone of ineligible products of nature. I do not think it will be regarded as a particularly memorable exposition of patent law principles.”•


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  1. If a class action suit or other manner of retribution is possible, count me in. I have email and voicemail from the man. He colluded with opposing counsel, I am certain. My case was damaged so severely it nearly lost me everything and I am still paying dearly.

  2. There's probably a lot of blame that can be cast around for Indiana Tech's abysmal bar passage rate this last February. The folks who decided that Indiana, a state with roughly 16,000 to 18,000 attorneys, needs a fifth law school need to question the motives that drove their support of this project. Others, who have been "strong supporters" of the law school, should likewise ask themselves why they believe this institution should be supported. Is it because it fills some real need in the state? Or is it, instead, nothing more than a resume builder for those who teach there part-time? And others who make excuses for the students' poor performance, especially those who offer nothing more than conspiracy theories to back up their claims--who are they helping? What evidence do they have to support their posturing? Ultimately, though, like most everything in life, whether one succeeds or fails is entirely within one's own hands. At least one student from Indiana Tech proved this when he/she took and passed the February bar. A second Indiana Tech student proved this when they took the bar in another state and passed. As for the remaining 9 who took the bar and didn't pass (apparently, one of the students successfully appealed his/her original score), it's now up to them (and nobody else) to ensure that they pass on their second attempt. These folks should feel no shame; many currently successful practicing attorneys failed the bar exam on their first try. These same attorneys picked themselves up, dusted themselves off, and got back to the rigorous study needed to ensure they would pass on their second go 'round. This is what the Indiana Tech students who didn't pass the first time need to do. Of course, none of this answers such questions as whether Indiana Tech should be accredited by the ABA, whether the school should keep its doors open, or, most importantly, whether it should have even opened its doors in the first place. Those who promoted the idea of a fifth law school in Indiana need to do a lot of soul-searching regarding their decisions. These same people should never be allowed, again, to have a say about the future of legal education in this state or anywhere else. Indiana already has four law schools. That's probably one more than it really needs. But it's more than enough.

  3. This man Steve Hubbard goes on any online post or forum he can find and tries to push his company. He said court reporters would be obsolete a few years ago, yet here we are. How does he have time to search out every single post about court reporters and even spy in private court reporting forums if his company is so successful???? Dude, get a life. And back to what this post was about, I agree that some national firms cause a huge problem.

  4. rensselaer imdiana is doing same thing to children from the judge to attorney and dfs staff they need to be investigated as well

  5. Sex offenders are victims twice, once when they are molested as kids, and again when they repeat the behavior, you never see money spent on helping them do you. That's why this circle continues