T**********e
发帖数: 29576 | 1 人类基因不能专利， 但是cDNA可以专利。这个决定很让人奇怪。
A victory for genes
Nature Medicine (2013)
he decision has been a long time in coming—so long that Myriad's patents
were due to expire in less than three years. And the 15-year delay has
surely not aided patients who frequently benefit from healthy competition in
the biotech sector or from research on BRCA genes. Yet the decision brings
relief to those of us who reject the idea that an individual or corporation
can own—even for a limited time—human genes and thereby control their use.
In 1994, Mark Skolnick, a future founder of Myriad Genetics, along with
several other research groups, cloned BRCA1, followed swiftly by BRCA2.
Myriad Genetics was founded that same year, and the company filed patents
for the two genes in 1994 and 1995. Mutations in the genes are associated
with increased susceptibility to breast and ovarian cancers, and Myriad has
successfully translated this information into genetic testing kits. Moreover
, by claiming intellectual property rights on these genes, they have
precluded other companies and university-based diagnostic labs from
commercializing competing tests, effectively establishing a monopoly on BRCA
testing.
But in 2009, the American Civil Liberties Union and the Public Patent
Foundation filed a lawsuit against Myriad Genetics, the US Patent and
Trademark Office and others, stating that patenting BRCA1 and BRCA2 was
unconstitutional. After several rounds in lower courts, with alternating
decisions in favor of and against the motion, the Supreme Court agreed in
November 2012 to hear the case (Association for Molecular Pathology et al. v
. Myriad Genetics, Inc., et al.).
In siding with the plaintiffs in this case, the Court's decision rests on
the interpretation of a section of the US Code governing patent law that has
remained virtually unchanged since 1793. According to the Code, “any new
or useful process, machine, manufacture or composition of matter, or any new
and useful improvement thereof” can be patented. Although not explicitly
stated, the wording has been interpreted to mean that naturally occurring
phenomena are not new or invented and therefore are not inherently
patentable. In writing the Court's opinion, Justice Clarence Thomas stated,
“Myriad did not create or alter any of the genetic information encoded in
the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed
in nature before Myriad found them. Nor did Myriad create or alter the
genetic structure of DNA . . . . We . . . hold that genes and the
information they encode are not patent eligible . . . simply because they
have been isolated from the surrounding genetic material.” http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf.
Although clearly concluding that naturally occurring genes (isolated or not)
are not patentable, the Court nevertheless indicated that cDNA is patent
eligible, a decision that has led to at least one commentary questioning the
scientific basis of that decision http://www.bloomberg.com/news/2013-06-13/the-supreme-court-s-bad-science-on-gene-patents.html/. Granted, cDNA is not naturally occurring and, if made from mRNA, is an altered form of the intact gene, as it excludes introns. But the sequence of cDNA is dictated by the sequence of its template mRNA or DNA. Given that the Court concluded that Myriad did not alter the genetic information of the isolated BRCA genes, and if cDNA does not alter the information encoded by the cellular mRNA (or DNA), shouldn't the same decision on patent eligibility apply to cDNA?
Nevertheless, companies seeking to develop genetic tests of BRCA genes do
not seem perturbed that the cDNA might be patent protected. There are many
ways in which a genetic sequence can be analyzed, and therefore a patent
claim on a cDNA can be easily sidestepped. Moreover, new technology and
cheaper genomic sequencing may eventually obviate the need to employ cDNA in
gene testing. Interestingly, the Court's decision stated that not all cDNAs
would be patent eligible, as those originally derived from DNA without
introns might not be. That qualification could specifically affect patents
on bacterial or viral cDNAs, which would extend the decision's reach.
Thus, the full impact of the Court's ruling has yet to be felt. A recent
analysis published in Nature Biotechnology concluded that about 8,000
patents involving genes—and, of these, 3,500 involving human genes—would
probably be invalidated by the Court's decision (Nat. Biotechnol. 31, 404–
410, 2013). However, the number of US patent applications involving human
genes has declined since its peak in 1999, and in 2001 the US Patent Office
revised its examination guidelines to more explicitly require evidence of
utility of an isolated gene in a patent application, thereby limiting the
ability for someone to receive a patent on gene sequence alone. So, although
the patent landscape will now be indelibly altered by this ruling, the
effect on research and development could be modest.
Yet some pundits argue that invalidating patents on human genes will harm
the biotech industry and reduce the incentive to develop new diagnostic
tests, whereas others (including industry insiders) feel that enabling
competition will result in more research and development, more tests on the
market and lower prices for consumers. Myriad itself issued a statement
saying that their patent claims that were not challenged in the lawsuit
remained valid (or at least patent eligible) and protect the intellectual
property underlying their BRCA gene test—and ultimately their business
model. With this ruling, the US Supreme Court has achieved an unusual
situation—a win for science, for patients and for industry. Long may it
last. | c*********y
发帖数: 3348 | 2 Myriad不是上个月的案子吗, 不是用 Nature Products 否定了， 而CD
NA 由于自然界不存在， 应该是允许的。
不过 the Supreme Court 案子也是葫芦官乱判葫芦案， 给的理由都是忽悠人的。 |
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