Showing posts with label Law. Show all posts
Showing posts with label Law. Show all posts

Thursday, June 13, 2013

Free Genes - SCOTUS strikes down Myriad

The SCOUTUS blog is reporting the Supreme Court has struck down Myriad Genetic's patent claim on two human genes - BRCA1 and BRCA2.

The decision is being called  a compromise by some news sources but the crux of the ruling is this...
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.
I am sure the lawyers for Myriad are scrambling to write new patents with slightly different wording to emphasize "cDNA" (which the court struggles with defining; in some instances they call it complimentary DNA in others composite DNA). However, it will be difficult overcome the following language in the present decision.
If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

Justice Clarence Thomas wrote the ruling and there is a one paragraph opinion by Justice Scalia partially affirming the ruling.

Read the entire ruling here. (It is only 18 pages long)

This decision sets the "product-of-nature" precedent for the patent eligibility of all naturally occurring human genes. As I currently work as a biochemist in a plant biology lab I am curious to see if this applies to plant genes.

It is not clear whether cDNA copied from naturally occurring templates (human DNA) is patentable or just synthetic cDNA.

I will update this post as I learn more about the Supreme Court's ruling.

Friday, May 31, 2013

We the Genes!


We the Genes of the United Cells, in order to form a more perfect Union, establish equilibrium, insure homeostasis, provide for the common immunity, promote the general Welfare, and secure Liberty to ourselves and our Posterity, do ordain and establish this Constitution for the United Status of Life. 

In the coming month the United States Supreme Court will likely rule on whether a private company can hold a patent on a human gene.  The company in this case (Myriad  Genetics) has spent a substantial amount of money and time figuring out that mutations in the BRCA1 and BRCA2 genes are associated with an increased risk of developing early-onset breast and ovarian cancer.  Because of this investment the company feels entitled to hold a monopoly on testing and reporting this information to patients who ask their doctor to be screened.  Recall Angelina Jolie's double-mastectomy headlines in recent weeks.

The company feels it has the right to be the only one to read a particular page in a book handed down to a woman by her mother and father.  This book of genes is called the genome. The human genome like the genomes of all other living things has been copied, proof-read, edited, re-drafted and copied again and again countless times over earth's rich and chaotic history. The current edition of your genome is without question a product of nature.

PCR happens.
Using a routine process in basic scientific research called the polymerase chain reaction (PCR) the company can isolate the BRCA1 and BRCA2 genes.  Once the genes are isolated from a blood sample they can be read by any of the well established methods for DNA sequencing.  Neither the method for isolating the genes, nor the method for sequencing the genes are at issue in this case. The patents associated with these decades-old processes have long since run out.  No, The object in question in this case are the BRAC1 and BRCA2 genes themselves. 

Can a company own exclusive rights to read your genes?

I say no. We ought to have the right to pursue any path we like to uncover the information we were each born with. Whether that path be through Myriad genetics, the Harvard-based personal genome project, or sending your blood samples to whoever has access to a PCR machine. Trust me, they are pretty darn common. We should have access to the secrets inside our own cells.

I think there is a fundamental misunderstanding among the justices in this case. The misunderstanding is that in cases of genetic testing the "product" is not necessarily any physical thing but rather naturally occurring INFORMATION.

A technical work-around attorneys representing Myriad Genetics are trying to use is that coding, composite, complimentary DNA (cDNA) is not present in nature and can be patented because it is only produced by scientists. cDNA conveys the sequence information of messenger RNA produced by nature. Though the cDNA itself can be construed as product of human tinkering, the information cDNA holds is not. The information therein is an impression of nature, like a plaster-cast of a wolf-print in the mud, or the ink-blot of a small mouthed bass.  The key piece of information the attorneys for Myriad Genetics leave out is that the cDNA is not used directly but only to gather information from nature.

The patient dos not need or care to have the amplified DNA prepared from their blood sample, the patient wants to know some information so they can make an informed decision about how best to proceed with preventive health measures like a mastectomy or hysterectomy.  Genetic information is a product of nature and is therefore off-limits according to a century of court precedent.

What incentives will researchers have to make discoveries?

While listening to the Oral Arguments in the case between the Association for Molecular Pathology v. Myriad Genetics I am struck at what little credit is given to the motivation propelling scientific discovery.  It seemed to me that the Justices kept asking questions with a particular concern for maintaining a clear market incentive for big genetic discoveries.

It was almost as if the justices were under the impression that market forces are the main drivers of scientific discovery.  This may be a matter of opinion but I do not think Charles Darwin, Jonas Salk, or Carl Woese were in it for the money.

The tone of the Justices' questions regarding market-incentives and scientific discovery reminded me of a conversation on the recent Freakonomics podcast in which the hosts Stephen Dubner and Steve Levitt have the following exchange.
DUBNER: Since fighting cancer is big business, what’s the incentive to find a cure?  
LEVITT: So I would say the incentive for a cancer cure is not really a market incentive, it’s a being a hero kind of incentive. That there are so many doctors out there, researchers, medical researchers who if they could be the one who was forever remembered as the one who prevented cancer, who got rid of cancer, they would do anything to do that. So I think there are really strong incentives out there. And they aren’t exactly market incentives, although I think that person would be quite rich anyway...
I think the "being a hero kind of incentive" is the kind of incentive that pushes the world into a progressively safer more peaceful context. A context where human life-span lengthens and justice systems move away from a punitive to a rehabilitative mode. It is my opinion that knowing as much as we can about our bodies and specifically our genes will allow us to attain an unprecedented state of self-awareness, health and social responsibility.

Wednesday, May 1, 2013

Five-year-old boy shoots and kills his little sister

On a little country road on the banks of the Cumberland River in southern Kentucky a five-year-old boy accidentally shot and killed his two-year-old sister on Tuesday April 30th, 2013.

The gun was his. He owned it legally. Given to him as a gift "the cricket" is a .22-caliber rifle marketed as "My First Rifle."

This may have been an accident but it certainly should make us stop and think.

When does nostalgia for a bygone era start to cause real problems?

How about when kids start dying!

As if Sandy Hook, Aurora, Columbine, and the hundreds of massacres yet to come were not enough. We have to watch as stories like this one come to pass.

Holding onto the ideals of frontier justice, machismo self-reliance, and the delusion that a well-regulated militia stands a chance against the nuclear arsenal of the Federal government make no sense.

If the "pen is mightier" then get one out and write a real letter on real paper, stick in a real envelope and send it to your congress persons telling them this is the last time you want to read a news story like this.

When is enough enough?

 

Tuesday, July 10, 2012

Center for Inquiry - VIDEO

The use of video in the free-thought community is growing rapidly and I love it. Seeing video of bloggers I regularly read makes them more real. In the following video Chris Mooney hosts the Center for Inquiry's radio show Point of Inquiry. The video was recorded in Amherst, New York and focuses on maintaining a separation of church and state.


Tuesday, April 24, 2012

Animals feel. Common sense. Right?

An interview with Bernard E. Rollin University distinguished professor of Philosophy at Colorado State University and University Bioethicist in residence.

Retaining a thick Brooklyn accent Bernie (as he is known by his students) is a force to be reckoned with.  A proud weightlifter and connoisseur of Harley Davidson motorcycles, you might not peg him as a Columbia-educated University distinguished professor.  My first encounter with this giant of animal welfare came as he guest-lectured a bioethics class I was taking in the fall of 2006.  His plea for students to embrace logic, critical thinking, and practice “weight-lifting with your mind” was imprinted on us with his use of punctuating profanity as he lectured.  He is what you would consider a “Rock Star” professor on par with Temple Grandin in reputation among students.

Sunday, March 1, 2009

Freedom to Write in Stone


USA Today has announced that humanists are happy about the recent supreme court decision regarding free speech. I consider myself a humanist yet I am not so happy about it.

The supreme court in essence ruled that a city government can decide which religious monuments to allow in public places. The issue at the center of this case began when a small religious group in Pleasant Grove, Utah known as the Summum church requested that the city display a three foot granite slab outlining its core principles, the "Seven Aphorisms" next to a monument listing the Ten Commandments that has stood on this public park since it was donated by eagle scouts in 1971. I have posted about this case before and you can find all the quarks surrounding this religion described in detail here.

The problem with the supreme court decision is that it allows city governments to choose which religions are allowed to mark up public places. In my mind when one religion is allowed to display their beliefs carved in stone then that automatically makes the surrounding space a public forum and therefore any person or peaceably assembled group of people have the right to place their words in that public forum as well.

As I said before...

"In the case of the Summon religion and their granite slab I feel like the only fair thing to do is tell the city of Pleasant Grove to either remove all religious writings from the public land or allow those tasteful and aesthetically pleasing views of other religions to be erected as monuments of equal size and equal real estate value. The city still has the right to refuse in this instance but has to be an equal opportunity censor."

What do you think?

Tuesday, February 17, 2009

ARRA signed at Museum of Nature and Science

Today the American Recovery and Reinvestment Act is signed at the museum of nature and science in Denver. Appropriate it is that this recently blue state host such a moment. The text of the ARRA is available here for your pursuing pleasure and is overwhelming in its breadth and depth. It addresses the economic downturn with the following list of priorities. I have no memory of a single piece of legislation attempting to fund so many programs simultaneously.

(1) To preserve and create jobs and promote economic recovery.
(2) To assist those most impacted by the recession.
(3) To provide investments needed to increase economic efficiency by spurring technological advances in science and health.
(4) To invest in transportation, environmental protection, and other infrastructure that will provide long-term economic benefits.
(5) To stabilize State and local government budgets, in order to minimize and avoid reductions in essential services and counterproductive state and local tax increases.

With start-up companies like AVA Solar making their home in the sun-soaked state it is no wonder the road to renewal begins in the mile high city. To read more about what the stimulus bill actually does for jump starting clean energy, environmental projects, and scientific research click here. This article clearly breaks down the planned $60 billion set aside for green initiatives within ARRA into understandable bits.