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  (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).

DNA
[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.
[Image Source: AU-KBC RESEARCH CENTRE]

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.

BRCA 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





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