Print 21 comment(s) - last by BRB29.. on Jun 17 at 2:49 PM

  (Source: Mashable)
Full genes are not patentable, but court rules that "abridged" non-naturally occurring genes can be patented

In a unanimous 9-0 decision [PDF], the Supreme Court of the United States drew a significant line regarding what can and cannot be patented when it comes to genes.

I. Naturally Occurring DNA -- Not Patentable

The decision boils down to this: full human genes -- stretches of deoxyribonucleic acid (DNA) with a mixture of sequences that code (carry the blueprints to a protein) and non-coding sequences (sequences that do not directly correspond to amino acids in a protein) -- are not patentable.  However, if you remove those non-coding sequences and produce an "abridged" genome with only the coding sequences (so called cDNA) that is patentable -- except in cases where it is short enough to be indistinguishable from naturally occurring DNA.

The justification for allowing cDNA patents is because it does not occur naturally in humans.  In nature, the "abridged" sequences are produced as messenger ribonucleic acid (mRNA), not DNA.  However, mRNA is generally not very useful in gene testing as it is much more fragile than DNA, hence researchers typically use synthetic DNA production methods (such as using special viruses and/or protein-based isolation) to create abridged copies of the gene in stable DNA (cDNA).

[Image Source: Mashable]

Writes Justice Antonin Scalia:

As we have recognized before, patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.” (quoting Mayo v. Prometheus, at 23)
cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. Petitioners concede that cDNA differs from natural DNA in that “the non-coding regions have been removed.” Brief for Petitioners 49. They nevertheless argue that cDNA is not patent eligible because “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” Id., at 51. That may be so, but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

In other words, most, but not all of cDNA is patentable.  (On average 95 percent of a genome is non-coding [source], so cDNA is much easier to analyze than raw duplicates.)

II. Breast Cancer Fight Highlights Broader Ethical/Legal Conflict

The SCOTUS's decision to take up the issue was prompted by a lawsuit brought by the Association for Molecular Pathology, the Public Patent Foundation (PUBPAT), and the American Civil Liberties Union (ACLU) against Myriad Genetics, Inc. (MYGN) and the University of Utah Research Foundation (Association for Molecular Pathology v. Myriad Genetics).

The case focused on patents on BRCA1 and BRCA2 genes -- naturally occurring genes which, when mutated, play a critical role in the development of breast cancer.  BRCA1 and BRCA2 are sometimes called "Jewish genes" as these mutations are most commonly found in people of Ashkenazi Jewish descent -- including actress Angelina Jolie, who opted to have a preventive double-mastectomy when she tested positive.  Mutations are also found at lower rates in people of European (BRCA1 and BRCA2), Pakistani (BRCA1 and BRCA2), African (BRCA1), and Native American (BRCA1) descent.

BRCA Genes
The BRCA1 and BRCA2 genes play a critical role to breast-cancer.

Myriad -- along with the University of Utah -- was the first to identify and extract the genes and their mutant varieties.  They proceeded to file a number of patents on the full genes, their mutant varieties, and on abridged (cDNA) versions of the normal/mutant genes.  They then developed tests that women could have to determine their breast cancer risk.

Critics complained that Myriad was using its patents to stifle breast cancer research at various clinics/universities.  They also complained that the company's patents on the genes were keeping the cost of testing high, leading to unnecessary breast cancer deaths.

Myriad and the University of Utah, however, argued that they invested the money to track down the gene and now should reap the rewards.

Ultimately the issue became much broader than the specific violation in the case, as over 20 percent of the (unaltered) human genome was patented as of this year.

III. Both Sides Claim Victory

Under the Supreme Court ruling most of these patents will go away.  Justice Scalia says that Myriad's arguments for allowing the patenting of naturally occurring DNA were invalid, as the DNA was not chemically altered.  He writes:

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focuson the genetic information encoded in the BRCA1 and BRCA2 genes. 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 (such as claims 1 and 2 of the ’282 patent) 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 withthe information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

The verdict ultimately is somewhat of a draw for opponents of gene patenting (some universities, civil liberties groups, government labs, and private clinics) and proponents of gene patenting (other universities, private biotech firms).

For example the ACLU viewed the ruling as a win in its commentary, writing:

By invalidating these patents, the Court lifted a major barrier to progress in further understanding how we can better treat and prevent diseases. And in fact, the decision will help, not hinder, the biotechnology industry. Most of the industry is focused on using genes as a starting point to create new tools, tests, and therapeutics.
We celebrate the Court's ruling as a victory for civil liberties, scientific freedom, patients, and the future of personalized medicine. It also demonstrates the power of creating alliances and fighting for the public interest. The ACLU and the Public Patent Foundation filed the case four years ago on behalf of twenty plaintiffs, including organizations representing over 150,000 medical professionals, geneticists, breast cancer and women's health advocacy groups, and patients. Few thought we had a chance against the decades-long Patent Office practice as well as the entrenched industry position. But litigation can be a strong tool in producing change, never more than when diverse communities come together. Here, the medical, scientific, and patient communities united, and were soon joined by many others, eventually including the U.S. government. We honor the contributions everyone made to our success today.

But Salt Lake City, Utah-based Myriad Genetics also views the ruling as victory.  It points out that it only had 5 claims on isolated, naturally-occurring DNA which are now invalid, while the cDNA ruling protects "more than 500 valid and enforceable claims in 24 different patents" related to the company's BRACAnalysis breast-cancer test.

The ruling leaves the IP protection of Myriad's BRACAnalysis breast cancer test mostly intact.
[Image Source: Bloomberg]

Its CEO and President, Peter D. Meldrum, remarks, "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."

IV. Looking Forward

Myriad stock has been up 8 to 9 percent since the news broke, allowing it to approach record highs of 2009.

For research institutions and Myriad's would-be gene testing rivals the news is mixed.  Much of the fundamental research on a gene does not rely on abridged versions of the DNA (in fact a great deal of research looks at the role non-coding DNA has in controlling transcription).  Further, gene testing firms and universities may be able to come up with less abridged forms of the DNA (than the patented versions) or create tests that can work on a series of naturally-occurring shorter coding sequences (that aren't patched together into a single coding sequence as cDNA).

Myriad protester
Myriad's critics can take comfort in the fact that its patents will eventually expire.
[Image Source: Business Insider]

Additionally, it's important to consider that patents in the U.S. have a term limit of 20 years (from the filing date).  The first Myriad BRCA1 patent (U.S. Patent No. 5,693,473.) was filed in 1995; that means that Myriad's exclusivity rights to the cDNA will begin to dissolve in just two years.  Other patents were granted as recently as May 2013 -- e.g. U.S. Patent No. 8,440,442 -- and won't expire until around 2030.

Sources: SCOTUS [PDF], Myriad, ACLU

Comments     Threshold

This article is over a month old, voting and posting comments is disabled

By Ammohunt on 6/13/2013 2:20:15 PM , Rating: 3
I am going to patent the genes that control blue eyes. Then troll the patent.

RE: So
By theapparition on 6/13/2013 3:23:44 PM , Rating: 5
I'm on the lookout for blue eyed, busty female DNA all the time.

I'm OK with you patenting that, but only if you can remove crazy from there.

RE: So
By chimto on 6/13/2013 8:34:59 PM , Rating: 5
If someone could remove the crazy from female DNA then that would be patentable as it is not a naturally occurring phenomenon.

RE: So
By BRB29 on 6/14/2013 10:35:10 AM , Rating: 2
is there a part in the DNA that allows women to be more attracted to the kitchen?

RE: So
By Ammohunt on 6/14/2013 2:41:37 PM , Rating: 2
Oh! thanks! i need to add the pie making gene to my patent portfolio.

RE: So
By Jeffk464 on 6/15/2013 11:56:39 AM , Rating: 2
I'm guessing laziness is tied into genes, so probably.

RE: So
By shaaaaawn on 6/17/2013 2:44:27 PM , Rating: 2
I think you're referencing the elusive Y chromosome

RE: So
By BRB29 on 6/17/2013 2:49:34 PM , Rating: 2
I thought XY makes a boy.

RE: So
By rs2 on 6/16/2013 9:42:26 PM , Rating: 2
No, that's too traditional and boring.

Better to find the red hair, green eyes, and proportional build DNA. Still remove the crazy, though.

RE: So
By GatoRat on 6/15/2013 5:11:52 PM , Rating: 2
Can you read?

RE: So
By Ammohunt on 6/17/2013 12:48:56 PM , Rating: 2
Can you? *Test below

Gofa ahk yoor selph.

Let the land grab begin
By DT_Reader on 6/13/2013 2:45:22 PM , Rating: 2
The race is now on to isolate every possible strand of cDNA and patent it, then leave it to someone else to later discover if it's of any value.

RE: Let the land grab begin
By DrizztVD on 6/13/2013 4:04:03 PM , Rating: 2
The race is now on to isolate every possible strand of cDNA and patent it, then leave it to someone else to later discover if it's of any value.

-And once they try to make money off it, sue them for royalties. Oh, the beauty of it...

RE: Let the land grab begin
By tayb on 6/14/2013 11:47:57 AM , Rating: 2
cDNA stands for created DNA. It is not possible to patent every possible cDNA because it is inherently infinite. Not only that but the law does not specifically allow cDNA to be patented. cDNA still has to meet the rest of the patent criteria. And if it does meet that criteria it will face legal challenges there as well.

Basically, this is a strong ruling against gene patenting. The genes that help identify breast cancer are no longer patentable. The test to check for likelihood of breast cancer is no longer monopolized which means all women will now be able to get a test they should ALL be getting.

RE: Let the land grab begin
By Jeffk464 on 6/15/2013 12:08:49 PM , Rating: 2
Yup, that's what I heard. This decision is suppose to open up research and lower the price of treatment.

RE: Let the land grab begin
By Jaybus on 6/17/2013 11:52:09 AM , Rating: 2
I agree, however it is not infinite. The only cDNA of any use is the cDNA that is essentially a copy of a mRNA that exists in humans or stock animals. Any other random cDNA is most likely completely useless, but also has the potential to induce cancer in the same way HPV and other viruses do. Nobody is going to patent random cDNA, only cDNA that copies human mRNA.

This is why cDNA patents should not be allowed either. It's too huge a burden on already swamped patent offices, and not just in the US. They should be able to patent any unique and better METHODS of making cDNA copies of mRNA, but not the molecule itself. Its like discovering that diamond makes a good abrasive, and rather than getting a patent on "using diamond as an abrasive", they get a patent on the carbon atom. Its ridiculous.

More fun for the lawyers
By bug77 on 6/14/2013 6:28:39 AM , Rating: 2
Since things in nature have the habit of mutating, good luck distinguishing what is naturally occurring and what isn't.

RE: More fun for the lawyers
By haukionkannel on 6/14/2013 7:12:32 AM , Rating: 2
Good point! Olmost seems like layers did make money to themselves with this new law... There will definitely be a infinite numbers of lawsuits because of this!

By sleepeeg3 on 6/14/2013 1:56:19 AM , Rating: 3
For those who have never take a molecular biology class:
*gDNA (genomic DNA) is in every cell in your body.
*gDNA is transcribed into mRNA (messenger RNA).
*mRNA can be isolated from your cells and an enzyme called reverse transcriptase can be used to create a cDNA construct (complementary DNA). This is a double strand copy of the mRNA that your body naturally produces. The judges deemed this patentable.

In sequencing, a section of gDNA is directly isolated, multiplied using PCR and sequenced. cDNA is never created. Since the SCOTUS ruled only cDNA can be patented, patents on gDNA are void.

The press release put out by Myriad is a smokescreen and claims a victory - this was a victory for the people. You own your own genes (believe it or not). The Supreme Court just made it legal. Companies are already launching their own testing on BRCA1/BRCA2 and other formerly patented genes.

gDNA is not patentable. This is what occurs in nature and can be sequenced by anyone with the brain, machines and money to do so. It opens up the market to a wide variety of competitors, which will bring down the cost and eventually make whole exome screening (the entire protein coding sequence of your cells) an inexpensive, one time fee. You will know whether you carry an allele for BRCA1 or some other genetic disease with high penetrance.

Why cDNA was determined to be patentable is beyond me, but hopefully will be overturned in a future decision. However, this should not affect the vast majority of biotechnology companies/institutions.

By Stuka on 6/13/2013 8:51:38 PM , Rating: 2
This article could really use an Orphan Black reference.

My vague understanding of genetics leads me to understand this precedent as paving the way so one could patent an entire organism based off it's "compressed" cDNA structure... just add water, err, non-coding DNA and voila, Ms. Jennifer, the first lab grown human, the sole property of the University of Utah.

Myriad Genetics = bad
By Belard on 6/14/2013 3:25:17 PM , Rating: 2
Myriad Genetics or any company has NO rights to our DNA. Everyone has them. Glad the court actually got something right, finally.

We are still entering new territory... there could be patents on making adjustments to DNA for making better babies (Think Gattca).

"When an individual makes a copy of a song for himself, I suppose we can say he stole a song." -- Sony BMG attorney Jennifer Pariser

Copyright 2016 DailyTech LLC. - RSS Feed | Advertise | About Us | Ethics | FAQ | Terms, Conditions & Privacy Information | Kristopher Kubicki