# data[].attributes.headline
PRO - Australian Federal Court Approves Gene Patents

# data[].attributes.subject
PRO - Australian Federal Court Approves Gene Patents

# data[].attributes.attachment_link.readable_text
The case was brought on behalf of cancer survivor Yvonne D'Arcy. DAN PELED/AAP

A Federal Court decision to allow gene patents could open the way for existing patents to be enforced more strongly in Australia, according to an expert in intellectual property.

Biotechnology companies will be permitted to hold patents on genes in Australia after a decision by the full bench of the Federal Court. The ruling upholds a Federal Court decision in February, 2013, which was under appeal.

The court found companies can hold patents in Australia over isolated biological material, in this instance, fragments of DNA that are defined as BRCA1 gene mutations, said adjunct professor of law at Murdoch University Luigi Palombi.

The BRCA1 and BRCA2 gene mutations predispose women with a familial history to developing breast and ovarian cancer.

It's unclear what impact the decision will have in Australia because the patents have not been strongly enforced here. Melbourne-based Genetic Technologies, which holds the local licenses for the patents, has faced a public backlash when it has tried to enforce the patents.

Genetic Technologies and Myriad Genetics have previously said the patents were a gift to the Australian people.

Associate Professor Clara Gaff, who formerly worked as a counsellor for people with or concerns about hereditary cancer said that people who provide genetic testing and patients are likely to be concerned if this means that testing becomes more expensive and unavailable to them in the way that's currently available.

"People see genes as essential human characteristic rather than something that's invented and that's maybe where some of the subtleties come in," she said. "People may have different views on that depending on what their perspective is."

"So researchers could see the benefits of patenting to enable them to be innovative and to enable funding for experimentation, while patients who want tests and don't want to have any restrictions around that, have fears that patenting might limit that."

Professor Palombi noted that the research exemption for the patent was so narrow that only pure research was permitted.

"Patients who want tests might fear patenting would restrict their access," Associate Professor Gaff said. "But to date, in Australia, that doesn't appear to have been the case."

Professor Palombi was less positive about the prospects for a broader impact in Australia.

"The patent claims in question are to pieces of DNA that exist in the human body and the court has said that material is patentable simply because it's been extracted from the human body," he said.

"What that means is that anyone who comes along and reproduces that biological material, no matter how they do it, or anyone who wants to use that material in some other way, even if it's in a gene therapy, can't do it without the permission of Myriad Genetics."

"We know Myriad hasn't been terribly useful in giving permission. That's why the case started in the United States in the first place, because over there women are paying over US$4,000 to have their genes tested," he added.

Professor Palombi said the decision was based on a case from the 1950s between the National Development Research Corporation and the Commissioner of Patents that been evoked repeatedly and has meant anything that has had a human hand on it is patentable subject matter in Australia.

"If you apply black letter law and you apply a very extreme interpretation of a near 60-year-old decision that had nothing to do with biotechnology, that's what we've got," he said.

In June 2013, the US Supreme Court ruled against gene patents in a similar case that involved the same company. Myriad Genetics owns the patents to the BRCA1 and BRCA2 gene mutations and fought the case through the US court system for years until finally losing it at the Supreme Court.

The Australian case only involved the BRCA1 gene mutation, and the court heard the case over a year ago. In its decision, the bench was critical of the final US decision noting a preference for the decision that was overturned by the Supreme Court.

"It's unprecedented to have a court of this kind actually do that to the Supreme Court," said Professor Palombi. "I don't know of any other decision in the English-speaking world where this has happened."

Lawyers at Maurice Blackburn who brought the case on behalf of a cancer survivor Yvonne D'Arcy told Fairfax media "the only way to overturn the decision would be if the firm was granted leave to appeal to the High Court.

# data[].attributes.attachment_link.title
Australian federal court upholds gene patents

# data[].attributes.attachment_link.description
A Federal Court decision to allow gene patents could open the way for existing patents to be enforced more strongly in Australia, according to an expert in intellectual property. Biotechnology companies will be permitted to hold patents on genes in Australia after a decision by the full bench of the Federal Court.

# data[].attributes.headline
NEUTRAL - The Human Genome Should be Patented (Debate Arguments)

# data[].attributes.subject
NEUTRAL - The Human Genome Should be Patented (Debate Arguments)

# data[].attributes.attachment_link.readable_text
"A second objection to patenting genes is that DNA is a product of nature, not human ingenuity. The Council for Responsible Genetics, a Cambridge, Mass.-based organization of scientists, public health advocates, and consumers, takes this view. They have an online petition that states: "The plants, animals, and microorganisms comprising life on Earth are part of the natural world into which we are all born. The conversion of these species, their molecules, or parts into corporate property through patent monopolies is counter to the interests of the peoples of this country and of the world. No individual, institution, or corporation ... should be able to hold patents on organs, cells, genes, or proteins, whether naturally occurring, genetically altered, or otherwise modified."" -[[http://www.columbia.edu/cu/21stC/issue-3.1/lewis.html]] Genes are not invented but found, patenting a discovery is the legal equivalent to 'finders keepers, losers weepers' finding something is not the same as having the right to exploit it and sell it freely.

Point of information: Actually the answer the question is "No you cannot", even when land ownership is disputed. The story of the man who inadvertently caused the California gold rush exemplifies this point: " Sutter attempted to keep the discovery a secret and ordered his men not to breathe a word of it until he could obtain official title to the mineral rights in Coloma. This land belonged to the Culluma Indians and had not been included in the 48,000-acre grant he received from Mexican Governor Alvarado a decade earlier. But who was going to complain if he used it for his mill? After all, the entire California territory was in the process of being ceded to the United States, so ownership was, well, unsettled at best.
Unfortunately for Sutter, he was not able to keep the hoards of miners off the land around the mill, nor did he become its lawful owner, and the discovery of gold turned out to be his ruin. His valley settlement was all but deserted with the onslaught of the Gold Rush, except for squatters on his land. There was no one left to tend the Fort's businesses, livestock, or crops. The last years of Sutter's life were spent at the nation's capitol trying in vain to convince Congress to compensate him for his losses brought on by the California Gold Rush. He died a poor man in Pennsylvania."-[[http://www.comspark.com/chronicles/golddisc.htm]]

Firstly a patient (the owner of the land being dug up for genes) should give consent before having genes extracted from his/her body. (The current U.S legislation does not require this)
Secondly the patient should be informed of the monies to be obtained for the sale, study and development of what is extracted from his/her body.
Patenting genes removes a patient's right to know, to not be owned in part or whole and the right to object to being exploited.

# data[].attributes.attachment_link.title
The human genome should be patented - DebateWise

# data[].attributes.attachment_link.description
"A second objection to patenting genes is that DNA is a product of nature, not human ingenuity. The Council for Responsible Genetics, a Cambridge, Mass.-based organization of scientists, public health advocates, and consumers, takes this view. They have an online petition that states: "The plants, animals, and microorganisms comprising life on Earth are part of the natural world into which we are all born.

# data[].attributes.headline
NEUTRAL - Intellectual Property and Genomics

# data[].attributes.subject
NEUTRAL - Intellectual Property and Genomics

# data[].attributes.attachment_link.provider_name
National Human Genome Research Institute (NHGRI)

# data[].attributes.attachment_link.readable_text
Intellectual Property and Genomics

Overview

Whether or not genes can be patented has been debated since the inception of the Human Genome Project. At the heart of the debate have been questions about whether discovery of a gene is sufficient to claim an invention and whether gene patents encourage or stifle research and the clinical use of genomics. In a landmark decision in June 2013, the Supreme Court determined that DNA in its natural form cannot be patented.

Background

The earliest genetic patents were issued in 1982, following the U.S. Supreme Court case of Diamond vs. Chakrabarty, which opened the door to patenting biotechnology discoveries. Since then, the core of the debate over gene patents has been whether or not the discovery of a gene or sequence of DNA rises to the level of invention required by Title 35 of the United States Code [gpo.gov], which lays out the criteria that must be satisfied for a patent to be granted. According to the Code, a patent may only be granted on "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." Laws of nature, natural phenomena, and abstract ideas cannot be patented. Even if this first hurdle is passed, the invention must be novel; the existence of 'prior art' shows that someone else invented it first, of course. Also, the invention cannot be obvious to "a person having ordinary skill in the art to which said subject matter pertains."

In the case of gene patents, critics have pointed out that such patents fail to meet most or all of these criteria. Firstly, genes are naturally occurring, and while much intellectual effort may have gone into discovering them within the DNA sequence, discovery is not the same as invention. Secondly, with the completion of the Human Genome Project in 2003 all of the human gene sequences were in the public domain and, therefore, prior art. Finally, many argued that discovering the location of a gene never rose above the bar for being non-obvious; certainly by the late 1990s the practice was common place. Despite the criticism, DNA patenting has proven to be a very active area. Although it is difficult to determine a precise number, some estimates assert that a fifth of the human genome is subject to patent claims.

Patents are issued to encourage innovation, and provide protection to allow those investing in an innovation the opportunity to maximize the profit from their investment. Patents issued for genetic technologies such as new methods of DNA sequencing are no different and their issuance has been extremely valuable to those developing products based on genetic discoveries. However, when patents limit the use of basic genetic information, they threaten to inhibit or unduly constrain biomedical research, and the translation of research discoveries to clinical applications.

Indeed, one of the early principles agreed upon by leaders of the Human Genome Project was that the DNA sequence generated should be freely available to the public. This principle was codified in the 1997 Bermuda Principles, which set forth the expectation that all DNA sequence information should be released into publicly available databases within 24 hours of being generated. This policy of open access to the genome has been a core ethos of genomics ever since.

Over the years that this debate has occurred, there have been concerns that large numbers of patents associated with the human genome would limit the integration of genomic medicine into health care because of either restrictive patents or prohibitive costs. Diagnostic tests on patented genes cannot be invented around, as is possible with other patents. This is because the actual DNA sequence to be tested is claimed in the patent, not the method of analyzing the gene to determine its sequence, and so only the patent holder, or their licensees, have the rights to sequence that DNA during the patent's life.

In addition, so-called "patent thickets," where multiple patent holders stake their claims across the genome, could have the potential to inhibit the translation of genetic discoveries into health care benefits. Patent thickets have occurred in other technological domains when multiple patent holders have related claims; for example in consumer electronics or standards for digital video and music.

In April 2010 the Secretary's Advisory Committee on Genetics, Health and Society published a report,Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests [oba.od.nih.gov]. Resting on the underlying assumption that patents on human genes were acceptable, the report recommended that diagnostic (but not therapeutic) genetic tests, be exempted from patent infringement, along with a research use exemption. Exempting diagnostic patents from infringement while still recognizing that diagnostic gene patents could exist was greeted with controversy at the time, especially considering that the case studies that accompanied the report showed mixed evidence of harm to patients as a result of gene patents.

NHGRI and Patent Policy

The debate about gene patents was already a hot topic at the time of the early Congressional deliberations about the U.S. involvement in the Human Genome Project. Discussions on The Hill about the potential effects of gene patents resulted in a statutory mandate [gpo.gov] to the National Human Genome Research Institute (NHGRI) to research "legal issues regarding patents" as part of the then center's research into the ethical, social, and legal implications of human genome research.

Indeed, such were the concerns over the patenting of human genes that, in 2001, NIH Director Harold Varmus, and NHGRI Director Francis Collins wrote to the U.S. Trademark and Patent Office (USPTO) urging them to implement stricter criteria for biotechnology patents. USPTO raised their bar for issuing such patents, with new guidelines stating that identification of a gene's sequence alone is not patentable, but that a gene isolated from its natural state may be patentable if the applicants can demonstrate "specific, substantial and credible utility" for the discovery. See: United States Patent and Trademark Office Utility Examination Guidelines [uspto.gov] (2001).

How patent holders license the gene patents they have been issued has also been a critical component of the ethical discussions about genetic intellectual property. A patent that is widely or, in some cases, even freely licensed does not pose the same types of impediments to the implementation of genomic medicine as a patent that is exclusively licensed. To explore the range of issues implicated in consideration of genetic intellectual property practices, NHGRI, in partnership with other NIH institutes, commissioned the 2005 National Academies reportReaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health [nap.edu].

NHGRI worked extensively with the NIH Office of Technology Transfer to develop Best Practice Guidelines for the Licensing of Genomic Inventions [gpo.gov], published in 2005. The institute, in partnership with other organizations, has worked actively on these issues in an effort to maintain a level of access to basic genomic data able to achieve maximum public benefit through freedom to operate for researchers and care providers.

The Courts and Gene Patents

In 2009, the questions regarding gene patents finally went to court when the Association of Molecular Pathologists, the American Civil Liberties Union, and a coalition of other groups, filed a lawsuit against Myriad Genetics, the USPTO, and the University of Utah Research Foundation. The suit challenged the constitutionality and validity of the BRCA1 and BRCA2 gene patents. Myriad Genetics had been particularly active in enforcing their exclusive license to these breast cancer genes, sending cease and desist letters to other labs and even researchers it felt were infringing its intellectual property. Critics of the company also pointed to the test's high price and the fact that it created a health disparity between those who could afford to be tested and those who could not.

The case was first heard in the United States District Court for the Southern District of New York and in March 2010, District Judge Robert Sweet ruled in favor of the plaintiffs [graphics8.nytimes.com] and against Myriad Genetics, finding that the BRCA1 and BRCA2 genes were products of nature and therefore not patentable material. Judge Sweet's ruling made the important point that it is the information encoded in a gene, and not just the molecular structure, that makes them valuable to the patent holder. Since the raw information encoded in a gene is a product of nature, Judge Sweet asserted that it was not patentable under section 101 of Title 35 of the U.S. Code.

Myriad and the other defendants appealed Judge Sweet's decision, and so the lawsuit over gene patents moved on to the Court of Appeals for the Federal Circuit. This court affirmed part of Judge Sweet's ruling but the ruling on Myriad's claims to the isolated genes [cafc.uscourts.gov] were reversed in a 2-1 ruling (in favor of allowing Myriad to hold the patents). Writing the opinion, Judge Alan Lourie rejected Judge Sweet's argument about the information content of a gene, and focused on the fact that isolating a gene broke the covalent bonds between the molecules within the DNA, thereby creating a new substance. Judge Kimberly Moore concurred in part with Judge Lourie, also finding Myriad's claims to the isolated BRCA genes patent-eligible, not because they were new substances but because USPTO had been granting such patents since the 1980s, and she believed that throwing them out would be too disruptive to the biotech industry.

The plaintiffs appealed this decision to the U.S. Supreme Court, but following their 2012 ruling in another diagnostic patent case [supremecourt.gov], the Supreme Court returned it to the Federal Circuit for reexamination. upon reexamination, the Federal Circuit arrived at the same decision as in their first ruling, upholding Myriad's core claim on the isolated gene sequence information. The case again was appealed to the Supreme Court, who heard oral arguments [supremecourt.gov] on the question of whether isolated human genes are patent-eligible subject matter in April 2013.

On June 13 th 2013, the Supreme Court published their ruling [supremecourt.gov] in the case, unanimously finding that isolated but otherwise unmodified genes were products of nature and therefore not patent eligible subject matter. However, the court did find that cDNA, synthetic DNA molecules that contain only the exons of a gene, do involve an inventive step, and thus remain patent eligible. The opinion, written by Justice Clarence Thomas, agreed with Judge Sweet's 2010 argument that the information content of a gene was as important as its chemical structure.

The court's opinion also agreed with a friend of the court brief, filed by the U.S. Department of Justice on behalf of the federal government when the case was before the Federal Circuit in 2011 (and again in a modified form when the case went before the Supreme Court in 2013). In this brief, the government took the position that isolated, but otherwise unmodified DNA should not be patent eligible, but that cDNA should be patent eligible. NIH and NHGRI are very pleased with the Supreme Court's ruling in this case, and the removal of serious potential roadblocks that could impede the widespread adoption of genomic medicine.

Additional Resources
Last Updated: October 23, 2017

# data[].attributes.attachment_link.description
Overview Whether or not genes can be patented has been debated since the inception of the Human Genome Project. At the heart of the debate have been questions about whether discovery of a gene is sufficient to claim an invention and whether gene patents encourage or stifle research and the clinical use of genomics.

# data[].attributes.attachment_link.description
Patent gives exclusive rights to the inventor for a period of time granted by state or national government in trade for public disclosure of their novel inventions.

# data[].attributes.headline
PRO - Debunking the Myth: Your Genes are Patented

# data[].attributes.subject
PRO - Debunking the Myth: Your Genes are Patented

# data[].attributes.attachment_link.readable_text
MYTH: YOUR GENES ARE PATENTED. FACTS: IT IS NOT POSSIBLE TO PATENT YOUR GENES
The term "gene patent" is a misnomer, because genes as they exist in the body cannot be patented. Because a naturally-occurring gene - even a newly-discovered one - cannot be patented, patents don't provide ownership rights over our genes, and nobody can infringe a patent by having a certain gene, or by passing it on to their children.
If genes aren't patentable, what is?
Natural genes are not eligible for patenting, but artificial preparations of DNA molecules are, because they have new qualities that distinguish them from natural genes. Like other chemicals that are derived from nature (such as antibiotics or natural dyes), preparations of DNA molecules are patentable because they have been transformed through human intervention into something that is so different from the natural state as to qualify as new, useful, and man-made. This transformation begins with the purification and isolation of the natural DNA. But isolating and purifying is not enough. The resulting DNA preparation must have new qualities, advantages, and technical applications that allow it to be used in important new ways that are not possible with the natural gene, making it different not just in degree, but in kind. For these reasons, every nation in the developed world recognizes the patentability of such inventions.
How is a patented DNA preparation different from a natural gene?
Patented DNA preparations contain isolated DNA molecules that are stripped of everything that is necessary for the normal operation of a gene in its natural state. Such purified DNA molecules also are often reconfigured in ways that eliminate large parts of the genetic sequence of the natural gene, giving rise to DNA molecules that do not exist in nature. Such DNA molecules can be used in ways that are simply not possible with the natural gene - for example, to conduct gene transfer experiments, to make DNA vaccines, or to produce therapeutic proteins in large scale cell culture.
What else is required to make a DNA molecule patentable?
It is impermissible to patent a DNA molecule, even if isolated and purified, unless the scientist establishes the detailed biological function of the gene from which it was derived and identifies a credible, specific and substantial utility for it. Identifying a gene's biological role and establishing a credible, specific and substantial use for the claimed DNA molecule are often harder than identifying the new gene itself, and certainly meets the standard thresholds for inventiveness. Furthermore, in every case, the inventor has to satisfy the "novelty" and "unobviousness" requirements under which the claimed DNA must be new and distinct from all preexisting scientific knowledge. Finally, the patent application must contain a detailed scientific disclosure that enables other scientists to replicate the invention.

Overall, identifying, deriving, characterizing and describing a DNA sequence in this way requires the same level of human ingenuity as synthesizing a new chemical, composing a new metal alloy, or other human creations that are commonly deemed patentable.

For more information see: Gene Patent Myths on BIO.org.
This post was authored by Hans Sauer, Ph.D., J.D. Deputy General Counsel for Intellectual Property at BIO and Adjunct Professor of Law, Georgetown Law. Related Posts:
Filed under: Patently BIOtech, ACLU, AMP v. Myriad Genetics, AMP v. USPTO, DNA patent requirements, DNA patents, Gene Patents, gene patents pros and cons, isolated DNA patents, Myriad, patenting life, patenting people

# data[].attributes.attachment_link.title
Debunking the Myth: Your Genes are Patented

# data[].attributes.attachment_link.description
MYTH: YOUR GENES ARE PATENTED. FACTS: IT IS NOT POSSIBLE TO PATENT YOUR GENES The term "gene patent" is a misnomer, because genes as they exist in the body cannot be patented.

# data[].attributes.headline
Debatepedia: Pros and Cons of Gene Patents

# data[].attributes.subject
Debatepedia: Pros and Cons of Gene Patents

# data[].attributes.attachment_link.keywords[]
argument: gene patent monopolies impair research and development

# data[].attributes.attachment_link.keywords[]
argument: gene patenting invites malicious lawsuits from patent-holders

# data[].attributes.attachment_link.keywords[]
argument: gene patents allow others to use and profit-from invention

# data[].attributes.attachment_link.keywords[]
argument: gene patents are essential to future of biotech industry

# data[].attributes.attachment_link.keywords[]
argument: gene patents can harm patient care and pricing

# data[].attributes.attachment_link.keywords[]
argument: gene patents do not apply to natural genes

# data[].attributes.attachment_link.keywords[]
argument: gene patents do not give ownership over others' genes

# data[].attributes.attachment_link.keywords[]
argument: gene patents do not incentivize innovation

# data[].attributes.attachment_link.keywords[]
argument: gene patents do not offer monopoly power to inventors

# data[].attributes.attachment_link.keywords[]
argument: gene patents harm efforts to tailor medicine to individuals

# data[].attributes.headline
NEUTRAL - Wikipedia: What is a Gene Patent?

# data[].attributes.subject
NEUTRAL - Wikipedia: What is a Gene Patent?

# data[].attributes.attachment_link.description
A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time.

# data[].attributes.attachment_link.readable_text
A gene patent is a patent on a specific isolated gene sequence, a natural sequence that has been altered, the processes and methods for obtaining or using it, or a combination of any of these. In the United States, gene patents have only been granted to gene sequences that have known functions.

In 1980, the first patent for a living organism was filed, but was rejected by a patent examiner for the United States Patent and Trademark Office (USPTO). The patent was filed for a newly created bacterium that Ananda Chakrabarty, a microbiologist, had created for digesting crude oil in oil spills. Chakrabarty appealed, arguing that although the USPTO does not allow patents on living organisms, if it is "man-made", such as through genetic engineering, then such an organism is patentable. In a 5-4 ruling by the U.S. Supreme Court in the Diamond v. Chakrabarty trial, Chakrabarty was awarded a patent for the microorganism he created. Current patent law prohibits the patenting of laws of nature or natural phenomena. Although genes are certainly natural phenomena, some believe the act of isolating and studying them makes them patentable under the Chakrabarty ruling. Others disagree and don't believe gene sequences should be patentable. Although lower courts have heard cases involving gene patents (see below), the Supreme Court has yet to weigh in.

A recent high profile case that received extensive media coverage involved Myriad Genetics Inc., a biotechnology company, and their patents on two genes linked to ovarian and breast cancer, BRCA1 and BRCA2. In August 2012, Myriad won in U.S. federal appeals court when the court ruled in favor of upholding Myriad's patents. However, the company was denied their patent on methods "analyzing" and "comparing" DNA sequences. Myriad has a gene test, BRACAnalysis, which assesses BRCA alleles for their associated breast and ovarian cancer risk. Women who test positive have an 82 percent and 44 percent greater risk for breast and ovarian cancer, respectively, during their lifetime. The approximately 20 nonprofit groups, medical organizations, doctors and individuals who challenged Myriad's patents on the BRCA1 and BRCA2 genes fear that the appeals court's decision will have adverse affects on basic research and slow patient test results in the medical field. Supporters of gene patents claim that gene patents help encourage research and invention. In November 2012, the Supreme Court agreed to hear arguments about the BRCA patents, and a decision is expected in 2013.

Gene patents have been a hot topic of debate in recent years given the growth of the industry. Patents are currently held on 20 percent of the human genome by corporations and scientists, a number that continues to grow. As the number of patents grow, so does the number of those that challenge and support gene patenting.
Update
On April 15, 2013. The Supreme Court heard oral arguments about the patentability of genes, specifically the BRCA1/2 genes and the patents held by Myriad Genetics. During the approximately hour long session, the Justices asked a number of questions that offered insight into their line of thinking:

* How much modification must occur during the extraction process to make an otherwise natural product patent eligible?

* Does isolated DNA have a new function/use that is different from DNA inside the body?

* Will there be incentive for companies to invest in new discovery if they are not assured patent protection?

* Is cDNA materially different from genomic DNA?

* Is deciding where to "snip" DNA to isolate a gene considered an invention?

On June 13, 2013, the Supreme Court unanimously ruled that genes are not eligible for patenting. The majority opinion was written by Justice Clarence Thomas. "Myriad did not create anything," wrote Thomas. "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." However, the ruling also allows for the patenting of cDNA, a synthetic form of DNA that is created in the laboratory by making a DNA copy of an mRNA molecule that was previously isolated.

CLICK HERE for a case study addressing gene patents
CLICK HERE to learn about the pros and cons of patenting genes

REFERENCES

Cohn, Meredith. "Gene Patent Case Could Impact Patients, Research." The Baltimore Sun. The Baltimore Sun, 22 Sept. 2012. Web. 29 Oct. 2012. < http://articles.baltimoresun.com/2012-09-22/health/bs-hs-brca-patents-20120922_1_myriad-genetics-patents-brca>.

Goh, Rachel. "Gene Patents: 2010 Update." Gene Patenting. N.p., 24 Feb. 2011. Web. 28 Oct. 2012. < http://genepatents.info/>.

Liptak, Adam. " Justices, 9-0, Bar Patenting Human Genes. The New York Time s. 13 June, 2013. <http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html>.

Maxmen, Amy. "The Great Gene-Patent Debate." Nature. Nature Publishing Group, 20 July 2012. Web. 28 Oct. 2012. < http://www.nature.com/news/the-great-gene-patent-debate-1.11044>.

Stempel, Jonathan. "Myriad Wins Gene Patent Ruling From US Appeals Court." Reuters. Thomas Reuters, 16 Aug. 2012. Web. 29 Oct. 2012. < http://www.reuters.com/article/2012/08/16/us-myriad-patent-idUSBRE87F12K20120816>.

# data[].attributes.attachment_link.description
Patenting Genes A gene patent is a patent on a specific isolated gene sequence, a natural sequence that has been altered, the processes and methods for obtaining or using it, or a combination of any of these. In the United States, gene patents have only been granted to gene sequences that have known functions.

# data[].attributes.headline
PRO - Living Things (All Rights Reserved)

# data[].attributes.subject
PRO - Living Things (All Rights Reserved)

# data[].attributes.headline
CON - Patents on Human Genes: A Patient's Perspective

# data[].attributes.subject
CON - Patents on Human Genes: A Patient's Perspective

# data[].attributes.attachment_link.description
Get the latest in biotechnology through daily news coverage as well as analysis, features, tutorials, webinars, podcasts, and blogs. Learn about the entire bioproduct life cycle from early-stage R&D, to applied research including omics, biomarkers, as well as diagnostics, to bioprocessing and commercialization.

# data[].attributes.headline
CON - Breast Cancer Gene Patent Case (Australia)

# data[].attributes.subject
CON - Breast Cancer Gene Patent Case (Australia)

# data[].attributes.attachment_link.title
Breast cancer gene patent case - Maurice Blackburn

# data[].attributes.attachment_link.description
http://www.mauriceblackburn.com.au This is an important legal case about the commercialisation of human genetic material. In an Australian first, in 2010 Maurice Blackburn began legal action against four biotech companies to challenge a patent over human genetic material - specifically mutations of a gene known as BRCA1.

# data[].attributes.attachment_link.description
Since the advent of genetic engineering, a lot of weird questions have cropped up, particularly with regard to what information a company can patent. Individual genes, as they are discovered, are now immediately patented and can be controlled by the company that owns the patent.

# data[].attributes.headline
NEUTRAL - 7 Takeaways From Supreme Court's Gene Patent Decision (US)

# data[].attributes.subject
NEUTRAL - 7 Takeaways From Supreme Court's Gene Patent Decision (US)

# data[].attributes.attachment_link.readable_text
The Supreme Court on Thursday issued a ruling that bans the patenting of naturally occurring genes but allows edited or artificially created DNA to be patented.
What does the decision mean for patients and the biotech industry? We talked to experts about some of the big takeaways:
1. Naturally occurring genes are no longer patentable.
The Court on Thursday sided with the American Civil Liberties Union (ACLU) and threw out patents held by Utah-based Myriad Genetics used in a popular but expensive breast and ovarian cancer test that detects mutations in the genes BRCA1 and BRCA2.

The test gained national attention after actress Angelina Jolie revealed that her decision to undergo a double mastectomy was the result of testing positive for one of the mutations.

This week's ruling, authored by Justice Clarence Thomas, states that naturally occurring DNA segments are not patentable.

"I think the major takeaway is that human genes as they exist in [cells] are unpatentable subject matters going forward," said Jacob Sherkow, a fellow at Stanford Law School's Center for Law and the Biosciences.

The ruling applies not only to BRCA1 and 2, but also to thousands of other patented genes associated with various diseases such as colon cancer, Alzheimer's disease, and muscular dystrophy.
2. Synthetic DNA is still fair game.
The Court tried to strike a balance in its ruling by banning some types of gene patents but not others.

While companies can no longer patent genes with the same sequences found in cells, the decision allows edited forms of genes not found in nature-known as complementary DNA, or cDNA-to be patented.

cDNA is not useful for diagnostic tests, but it is crucial for producing protein-based drugs, explained Robert Cook-Deegan, a professor of genome ethics, law, and policy at Duke University's Institute for Genome Sciences and Policy.

"Those are the billion-dollar molecule patents," Cook-Deegan said. "Biotech companies care a great deal about cDNA patents, and it should be reassuring to them that those patents are still fine."

Hank Greely, a bioethicist and law professor at Stanford University, predicts

cDNA patents will become even more valuable as scientists move beyond merely exploiting naturally occurring proteins.

"In the longer run, as we move into an era of synthetic biology, where we start trying to improve upon nature, then I think [cDNA patents] will be important," Greely said.
3. Prices for testing genetic diseases are already falling.
Hours after the ruling was announced, other biotech companies announced competing tests for the BRCA1 and 2 genes. One company, DNATraits, said it will offer the test for $995-about one-third the cost of Myriad's test.

Cook-Deegan said he was surprised at how fast companies reacted to the Court ruling.

"At least one company thinks they can safely enter the market," he said, referring to DNATraits. "They think they can't get sued, and I think they're probably right."
4. It could get easier to sequence whole genomes.
The high court's ruling could help clear the way for companies that are developing whole genome sequencing technologies that determine an organism's entire DNA sequence at once, rather than one gene at a time.

"Because Myriad and other companies had patents directed to pieces of isolated genomic DNA, it was at least an open question whether whole genome sequencing would have infringed on those patents," Sherkow said.

"I don't think it resolves the issue definitively, but the Court's ruling opens the door for whole genome sequencing to proceed without the fear of being sued for patent infringement."
5. There are implications beyond human genes.
Arthur Caplan, a bioethicist at New York University, says the ruling will extend beyond companies that focus on human genes because it "applies to not just human genes, but also patents over plant, animal, and microbial genes.

"So I think there's going to be some upheaval in parts of the biotech world beyond just human [gene] companies."
6. Whether Myriad's secret patient database will be opened is unclear.
Cook-Deegan of Duke University called the Court's ruling "really sensible," but thinks that Myriad should be forced to publicize its database of results from women who have taken its tests over the years.

"Myriad has eight years of data that they have not shared publicly. I want to know what's going to happen to that data," Cook-Deegan said. "As far as I'm concerned, everyone who's done the tests anywhere in the world should have the rights to access that data because they were acquired under an illegal monopoly."

But Stanford's Sherkow thinks that's unlikely to happen. "The Court's decision does not implicate Myriad's database of clinical outcomes," he said. "Myriad can continue to keep those as trade secrets, and they don't have to disclose that information."
7. The ruling might not actually matter that much.
While the ACLU hailed the Court's decision as a major victory for "civil liberties, scientific freedom, patients, and the future of personalized medicine," Stanford's Greely argued that the ruling is relatively unimportant.

One reason is that the gene patents held by many companies were set to expire soon anyway-in the case of Myriad, in 2016. "They were going to disappear as a problem," Greely said.

Furthermore, the old gene patents don't affect many current tests that only look at small bits of a gene, as opposed to the entire gene.

"The new technologies for sequencing would probably not even infringe on the Myriad patents anyway because of the way the patents were written and how the new technologies actually do the testing," Greely said.

The Court's ruling also leaves other legal questions unanswered. For example, can naturally occurring proteins or molecules be patented?

The answer to that question would ultimately have a more significant impact on the biotech industry, Greely says, because many modern drugs start out as naturally occurring molecules.

# data[].attributes.attachment_link.title
7 Takeaways From Supreme Court's Gene Patent Decision

# data[].attributes.attachment_link.description
The Supreme Court on Thursday issued a ruling that bans the patenting of naturally occurring genes but allows edited or artificially created DNA to be patented. What does the decision mean for patients and the biotech industry? We talked to experts about some of the big takeaways: 1.

# data[].attributes.headline
CON - Gene Patents: 5 Things You Should Know (US)

# data[].attributes.subject
CON - Gene Patents: 5 Things You Should Know (US)

# data[].attributes.attachment_link.description
The debate over whether we can patent genes has come to a head with the US Supreme Court weighing in on two human genes linked to cancer. Laci has all the details on what you need to know about this colossal decision and the impact it could have on medicine.