Saturday, September 06, 2014 1:33:10 AM
Australian Full Federal Court Upholds Myriad Gene Patent
[SCOTUS] "Justices, 9-0, Bar Patenting Human Genes"
So the present Australian position is inapposite the SCOTUS decision.
by Shawn Sullivan Posted on September 5, 2014
Today, in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115 .. http://sullivanlaw.net/cases/2014FCAFC0115.pdf, the Full Court of the Federal Court of Australia upheld the validity of Myriad Genetics’s Australian patent on methods and materials relating to the human gene known as BRCA1.
THE BRCA1 GENE. Certain mutant alleles of the BRCA1 gene cause a predisposition to breast and ovarian cancer. Among other things, Myriad’s patent affords Myriad exclusive rights over a molecular diagnostic test that it developed to detect the presence of the BRCA1 gene and thereby to indicate whether an individual has an increased susceptibility to cancer.
ISOLATED DNA. Claim 1 of the Myriad patent applies to “isolated” nucleic acid sequences corresponding to the relevant BRCA1 DNA mutations and polymorphisms. An “isolated” DNA sequence is one that has been removed from its normal cellular environment. Isolation is typically performed by cell lysis–bursting of the cell membrane or the nuclear membrane in order to release the DNA and RNA from inside–followed by chemical treatment to separate proteins from nucleic acids, centrifugation, and the application of enzymes to break down RNA and leave only purified DNA. The isolation process does not alter the sequence of nucleic acids; each strand contains both the protein-encoding “exons” and the non-coding “introns” as they existed in the cell prior to isolation. In this respect, DNA that has been isolated by extraction from a cell differs from synthetically-produced cDNA, which contains only exons and whose exact sequences are not found in nature.
ARGUMENTS AGAINST VALIDITY OF THE PATENT. The Myriad patent’s opponents, cancer survivor Yvonne D’Arcy and the group Cancer Voices Australia, contended that isolated nucleic acid is not materially different from cellular nucleic acid and that naturally occurring DNA and RNA, even in isolated form, are products of nature that cannot form the bases of a valid patent. The Full Court rejected this reasoning. In particular, the Full Court found inapposite a 2013 decision of the U.S. Supreme Court, which invalidated certain claims of a closely related U.S. patent owned by Myriad on the ground that isolated nucleic acid is a “product of nature” and thus is not patentable subject matter under U.S. patent law. See US Supreme Ct: Naturally Occurring DNA is Unpatentable Product of Nature .. http://sullivanlaw.net/us-supreme-ct-naturally-occurring-dna-is-unpatentable-product-of-nature/, SullivanLawNet (13 June 2013).. http://sullivanlaw.net/us-supreme-ct-naturally-occurring-dna-is-unpatentable-product-of-nature/.
AN “ARTIFICIALLY CREATED STATE OF AFFAIRS.” Observing that the Australian patent legislation differs from the U.S. Patent Act, the Australian court opined that it is unhelpful under the Australian legal regime to employ terms such as “the work of nature” or “the laws of nature” as a basis for denying a patent. “In Australia,” the court observed, “there is no statutory or jurisprudential limitation of patentability to exclude ‘products of nature.’” Instead, the court explained, the patentability analysis “should focus on differences in structure and function effected by the intervention of man and not on the similarities.” According to the Full Court, the key inquiry “is whether it consists of an artificially created state of affairs, not whether it produces or fails to produce an artificial effect.” The court concluded that the isolated nucleotide sequences claimed by Myriad did constitute such a state of affairs and as such were patentable. It wrote:
---
The isolated nucleic acid … has resulted in an artificially created state of affairs for economic benefit. The claimed
product is properly the subject of letters patent. The claim is to an invention within the meaning of s 18(1) of the Act.
---
http://sullivanlaw.net/australian-full-federal-court-upholds-myriad-gene-patent/
===
Australian federal court upholds gene patents
5 September 2014, 4.46pm AEST
IMAGE
The case was brought on behalf of cancer survivor Yvonne D'Arcy. DA
Reema Rattan
Health + Medicine Editor at The Conversation
Interviewed
Luigi Palombi - Adjunct Professor at Murdoch University
Clara Gaff - Program Leader, Melbourne Genomics Health Alliance at Walter and Eliza Hall Institute
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 .. https://theconversation.com/gene-patenting-australian-court-rules-brca1-patent-is-legal-12240, 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 .. http://blog.patentology.com.au/2010/09/myriad-offers-brca-gene-patent-as-gift.html .. 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 .. http://www.theage.com.au/national/mutation-of-breast-cancer-gene-can-be-patented-says-federal-court-20140905-10ckfp.html .. “the only way to overturn the decision would be if the firm was granted leave to appeal to the High Court.
http://theconversation.com/australian-federal-court-upholds-gene-patents-31350
[SCOTUS] "Justices, 9-0, Bar Patenting Human Genes"
So the present Australian position is inapposite the SCOTUS decision.
by Shawn Sullivan Posted on September 5, 2014
Today, in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115 .. http://sullivanlaw.net/cases/2014FCAFC0115.pdf, the Full Court of the Federal Court of Australia upheld the validity of Myriad Genetics’s Australian patent on methods and materials relating to the human gene known as BRCA1.
THE BRCA1 GENE. Certain mutant alleles of the BRCA1 gene cause a predisposition to breast and ovarian cancer. Among other things, Myriad’s patent affords Myriad exclusive rights over a molecular diagnostic test that it developed to detect the presence of the BRCA1 gene and thereby to indicate whether an individual has an increased susceptibility to cancer.
ISOLATED DNA. Claim 1 of the Myriad patent applies to “isolated” nucleic acid sequences corresponding to the relevant BRCA1 DNA mutations and polymorphisms. An “isolated” DNA sequence is one that has been removed from its normal cellular environment. Isolation is typically performed by cell lysis–bursting of the cell membrane or the nuclear membrane in order to release the DNA and RNA from inside–followed by chemical treatment to separate proteins from nucleic acids, centrifugation, and the application of enzymes to break down RNA and leave only purified DNA. The isolation process does not alter the sequence of nucleic acids; each strand contains both the protein-encoding “exons” and the non-coding “introns” as they existed in the cell prior to isolation. In this respect, DNA that has been isolated by extraction from a cell differs from synthetically-produced cDNA, which contains only exons and whose exact sequences are not found in nature.
ARGUMENTS AGAINST VALIDITY OF THE PATENT. The Myriad patent’s opponents, cancer survivor Yvonne D’Arcy and the group Cancer Voices Australia, contended that isolated nucleic acid is not materially different from cellular nucleic acid and that naturally occurring DNA and RNA, even in isolated form, are products of nature that cannot form the bases of a valid patent. The Full Court rejected this reasoning. In particular, the Full Court found inapposite a 2013 decision of the U.S. Supreme Court, which invalidated certain claims of a closely related U.S. patent owned by Myriad on the ground that isolated nucleic acid is a “product of nature” and thus is not patentable subject matter under U.S. patent law. See US Supreme Ct: Naturally Occurring DNA is Unpatentable Product of Nature .. http://sullivanlaw.net/us-supreme-ct-naturally-occurring-dna-is-unpatentable-product-of-nature/, SullivanLawNet (13 June 2013).. http://sullivanlaw.net/us-supreme-ct-naturally-occurring-dna-is-unpatentable-product-of-nature/.
AN “ARTIFICIALLY CREATED STATE OF AFFAIRS.” Observing that the Australian patent legislation differs from the U.S. Patent Act, the Australian court opined that it is unhelpful under the Australian legal regime to employ terms such as “the work of nature” or “the laws of nature” as a basis for denying a patent. “In Australia,” the court observed, “there is no statutory or jurisprudential limitation of patentability to exclude ‘products of nature.’” Instead, the court explained, the patentability analysis “should focus on differences in structure and function effected by the intervention of man and not on the similarities.” According to the Full Court, the key inquiry “is whether it consists of an artificially created state of affairs, not whether it produces or fails to produce an artificial effect.” The court concluded that the isolated nucleotide sequences claimed by Myriad did constitute such a state of affairs and as such were patentable. It wrote:
---
The isolated nucleic acid … has resulted in an artificially created state of affairs for economic benefit. The claimed
product is properly the subject of letters patent. The claim is to an invention within the meaning of s 18(1) of the Act.
---
http://sullivanlaw.net/australian-full-federal-court-upholds-myriad-gene-patent/
===
Australian federal court upholds gene patents
5 September 2014, 4.46pm AEST
IMAGE
The case was brought on behalf of cancer survivor Yvonne D'Arcy. DA
Reema Rattan
Health + Medicine Editor at The Conversation
Interviewed
Luigi Palombi - Adjunct Professor at Murdoch University
Clara Gaff - Program Leader, Melbourne Genomics Health Alliance at Walter and Eliza Hall Institute
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 .. https://theconversation.com/gene-patenting-australian-court-rules-brca1-patent-is-legal-12240, 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 .. http://blog.patentology.com.au/2010/09/myriad-offers-brca-gene-patent-as-gift.html .. 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 .. http://www.theage.com.au/national/mutation-of-breast-cancer-gene-can-be-patented-says-federal-court-20140905-10ckfp.html .. “the only way to overturn the decision would be if the firm was granted leave to appeal to the High Court.
http://theconversation.com/australian-federal-court-upholds-gene-patents-31350
It was Plato who said, “He, O men, is the wisest, who like Socrates, knows that his wisdom is in truth worth nothing”
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