[pp.int.general] Criminal patents

[Daniel Riaño]

Sorry, I thought it was available to all (I am not a subscriber),
especially after reading the advice to link the page. I copy & paste the
full article, warnings and all. It's worth reading:


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> March 26, 2013 6:53 pm
> Science: Custodians of the code
>
> By Stephanie Kirchgaessner
> Scientists and biotechnology companies are locked in a debate over the
> ethics of genetic patents
> DNA
>
> Joanna Hershey’s gut told her the news would be bad when she decided to
> undergo genetic testing to see if she was at high risk of breast cancer.
> Her grandmother had died of the disease. Her mother and two aunts had
> fought and survived it.
>
> When the results came back, her fears were confirmed.
>
> But she had a plan: relentless vigilance until the first possible sign of
> disease, at which point, she says, she will opt for a double mastectomy,
> even if such radical surgery is not immediately required.
>
> “One sign of it, and they’re gone,” she says.
>
> For now, the 31-year-old lawyer is participating in a screening programme
> for high-risk women at Memorial Sloan Kettering in New York, where she has
> either a mammogram or an MRI every six months.
>
> “The only reason I’m in that programme is because I got the genetic
> testing done,” she says. “It has been drilled into my head that early
> detection is the key to surviving.”
>
> Advancements in the scientific understanding of human genetics, and new
> tests such as the one that revealed Ms Hershey’s risk, are offering
> patients life-saving information – as well as groundbreaking medical
> treatments – to fight disease and live longer lives.
>
> But for scores of scientists, doctors, and women’s health advocates, there
> is another side to the story, one that raises profound legal and even moral
> questions that will come before the US Supreme Court on April 15.
>
> The gene mutations Ms Hershey shares with other women in her family are
> patented by Mark Skolnick, the scientist from the University of Utah who
> first isolated and sequenced them. That means that only one company, Myriad
> Genetics, which was co-founded by Mr Skolnick, has the exclusive right in
> the US to perform clinical tests or research on these genes, known as BRCA1
> and BRCA2.
> Myriad model falls apart outside the US
>
> Myriad Genetics’ monopoly over the US market has been controversial but
> undoubtedly successful. The company is expected to generate total revenue
> of up to $565m this fiscal year on the back of its testing services. Its
> model has not worked as well around the world, however, reflecting stark
> differences in how gene patents are seen in other markets.
>
> Myriad approached the international market much as it did the US. It
> sought patent rights internationally, then pursued licensee relationships
> in every country or region in which it wished to market its test for the
> BRCA genes. The BRCA gene test identifies mutations that make women more
> susceptible to breast cancer. It also insisted initially on performing the
> primary genetic test at its facilities in Utah.
> Continue reading
>
> For the past 19 years, Myriad’s patents have raised questions about
> whether any single entity should control the rights to DNA and whether an
> individual – or company – that discovers a particular gene should be
> granted the same privileges and protections that Thomas Edison once sought
> for his lightbulb.
>
> A legal challenge against Myriad by the American Civil Liberties Union, an
> activist group known for its defence of free speech, is forcing the high
> court to confront this question: can genes be patented?
>
> The case could have sweeping implications for the $83bn biotechnology
> industry, which has argued that a whole range of patents that encourage
> private investment in start-ups could be at stake.
>
> Legal scholars are closely watching the patent case, too. There is a
> suspicion – feared by some, celebrated by others – that the court is
> drawing important new distinctions about what constitutes an invention
> (which is patent-eligible) and what is simply a discovery of a naturally
> occurring phenomenon (which may not be patent-eligible, even if it
> represents cutting-edge science). In the age of genetics, when a gene found
> in a human is identical to one found in a fly, knowing the difference is
> more complex than it seems.
>
> “The court appears to be narrowing the boundaries of patentable subject
> matter in a field that has long taken for granted the availability of
> patent protection,” says Rebecca Eisenberg, a professor at the University
> of Michigan Law School.
>
> While the immediate focus is on the Supreme Court, European challenges to
> gene patents are also becoming important test cases.
>
> This story begins in 1994. A race was under way to sequence cancer-causing
> mutations on a gene whose association with cancer had been discovered four
> years earlier by a geneticist named Mary-Claire King, then at the
> University of California, Berkeley.
>
> Mr Skolnick won that race when he uncovered the BRCA1 sequence and later
> tied another group of researchers, led by Michael Stratton at the UK
> Institute of Cancer Research, to clone and sequence another set of
> mutations on the BRCA2 gene. A person carrying mutations for those genes
> has up to an 87 per cent risk of breast cancer.
>
> Myriad Genetics’ new patents allowed it to become the only company in the
> US that could offer genetic testing for those mutations – even though some
> of its early research was helped by government funding. It also received
> funding from the drugmaker Eli Lilly.
>
> It has long been held in patent law that a product or law of nature – like
> an element on the periodic table – cannot be patented. Nor can abstract
> ideas. But the decision by the US Patent and Trademark office to grant the
> BRCA patents in 1997 was based on earlier court decisions that found that
> patents on naturally occurring substances were allowed if – like a modified
> bacterium that was the subject of a landmark 1980 case – it had “markedly
> different characteristics” than any found in nature.
>
> The question of whether isolated DNA molecules such as Myriad’s BRCA genes
> are indeed found in nature is at the heart of the challenge against the
> company’s patents.
>
> “What the ACLU is trying to do is say that they are a product of nature.
> And our response is that this has not been the standard for 30 years,” says
> Rick Marsh, Myriad’s lawyer. The isolated fragments of DNA in question, he
> says, are only in existence because of the “handiwork of man”.
>
> Some of the world’s most renowned scientists have weighed in on this
> question in briefs to the court, including Eric Lander, the genome pioneer.
>
> Prof Lander took issue with a lower-court ruling that found that while a
> whole genome was not patentable because it was found in nature, that DNA
> fragments were patentable, because they were not found in nature. “It is
> well accepted in the scientific community that chromosomes are constantly
> being broken up into DNA fragments by natural biological processes ...
> these DNA fragments are ubiquitous in the human body,” he wrote, adding
> that the BRCA genes were “unambiguously” products of nature.
>
> What worries many in the biotech industry is that this case could reach
> far beyond Myriad if its patents are invalidated.
>
> “The legal reasoning in this case transfers directly to others.
> Scientifically, there’s no distinction. It is just DNA, whether it is found
> in a bacterial body or human body. There is no law or science that would
> allow the Supreme Court to say ‘we are just going to strike down patents in
> human DNA’,” says Hans Sauer, a lawyer at the Biotechnology Industry
> Organization, a trade group.
>
> The BRCA genes in the human body are probably identical to the ones found
> in a chimp, Mr Sauer notes.
>
> The implications also reach beyond the medical applications of genetics.
> Companies that own patents for DNA sequences of sugar cane and all sorts of
> innovations are growing nervous, incredulous that what Mr Sauer calls the
> “marketplace behaviour by a single diagnostic company” could draw them in
> to a legal storm.
>
> But the ACLU says these concerns have been overblown, because they are not
> challenging the merits of patents on DNA that has in any way been
> transformed or altered, which is what often happens with genes used in
> therapies or for new functions.
>
> Mr Lander agrees, saying that a narrowly crafted decision by the court
> that explicitly gave patent protection only to non-natural DNA molecules –
> as opposed to naturally occurring genomic DNA – would foster scientific
> progress by guaranteeing unfettered access to study a “remarkable product
> of nature”: the human genome.
>
> But this case is about more than science. It is about the way Myriad
> exercised its patent rights to the detriment – the company’s critics allege
> – of medical advances.
>
> In 1999, a scientist at the University of Pennsylvania named Arupa Ganguly
> was issued a cease-and-desist order from Myriad after she developed an
> alternative test to screen patients for the BRCA genes. “I could not
> believe that an academic lab was being prohibited from doing a test that
> was going to have so many implications,” she says. “We were cheaper and
> using a different technique.”
>
> Myriad acknowledges it has blocked others from performing diagnostic tests
> for patients but insists that it has never obstructed research. Mr Marsh
> says Myriad abides by the unwritten rule that companies never enforce their
> patents against researchers. At the same time, however – and this is a sore
> point for scientists – Myriad has never explicitly assured those
> researchers that it would not claim in the future that they had infringed
> Myriad’s patent rights.
>
> The ACLU contends that Myriad’s patents have limited the availability of
> genetic tests. Sandra Park, a lawyer for the ACLU, says a test developed by
> the University of Washington that looks at 20 genes that are correlated
> with breast and ovarian cancer excludes the BRCA genes, so patients who
> want a full diagnosis would have to undergo a separate genetic test from
> Myriad.
>
> Myriad criticises the ACLU tactics, saying that its case was cherry-picked
> by the ACLU because of the emotional reaction people have to breast cancer.
> “If we had patent claims on isolated DNA for toe fungus, then they would
> not have brought this case against us. They wanted to hit a public nerve,”
> says Mr Marsh.
>
> . . .
>
> Robert Cook-Deegan, a research professor of genome ethics, law and policy
> at Duke University, is a man staking out the middle ground. Both sides, he
> says, have exaggerated the harms and the benefits of gene patents.
>
> Yes, patents have encouraged private investment in biotech. But the
> benefits have been marginal. And yes, Myriad’s control of the BRCA patents
> has delayed some clinical research. However, given the thousands of
> research papers that have been published on the genes, it does not appear
> to have done real harm. The frequently cited high cost of Myriad’s test
> (about $3,300) is more of a reflection of the US healthcare system than it
> is of Myriad’s monopoly.
>
> But there have been real-life harms from Myriad’s patents, he says, and
> here is one example. There are a small number of patients – about 3 per
> cent – who are tested for the BRCA mutations but do not get the clear-cut
> results that Ms Hershey did.
>
> For patients who are told they have a “variant of unknown significance”,
> there are few options, because Myriad does not perform all the kinds of
> further testing that can be needed, Dr Cook-Deegan says. There are labs
> that do perform those tests, but they do so quietly, in a “world of
> shadows”, because they are infringing Myriad’s patents and could be liable.
> Patients must “know the right doctors” to get the answers they need.
>
> “It is not just a patent law case. It is a lawsuit about who gets to
> decide questions about healthcare and whether patent law trumps all other
> things that people care about,” he says.
>
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>

2013/3/27 Anouk Neeteson <jakobsheep at gmail.com>:
> For those without access to the previous link, this is what it is about :
>
http://www.bloomberg.com/news/2013-02-14/myriad-genetics-wins-australian-bid-to-patent-human-genes-1-.html
>
>
http://www.aclu.org/free-speech-technology-and-liberty-womens-rights/association-molecular-pathology-v-myriad-genetics
>
> latest news :
>
http://www.patentdocs.org/2013/03/is-lack-of-preemption-the-key-for-the-supreme-court-to-decide-in-myriads-favor.html
>
> On Mar 27, 2013 9:44 a.m., "Daniel Riaño" <danielrr2 at gmail.com> wrote:
>>
>> Mark Skolnick (Myriad Genetics) is coming back into court once again
>> to defend his company's exclusive rights over clinical tests and
>> scientific research over two mutated genes of human DNA (BRCA1 and
>> BRCA2), responsible of some form of breast cancer. This time it is the
>> American Civil Liberties Union who is raising the vital question of
>> whether is it possible to patent molecules found in nature
>> (specifically in our bodies). The case against Myriad Genetics and its
>> partners will be held at the US Supreme Court on April 15. Mark
>> Skolnick and friends will presumably start one new jeremiad about the
>> need to defend the right to patent genes in order to foster scientific
>> innovation in the face of the fact that (aside the point that their
>> research was aided by public founds as well) their copyrights are
>> making clinical testing and research expensive, thus pulling apart
>> patients from a cure (and from their money)
>>
>>
>>
http://www.ft.com/intl/cms/s/0/6e93c6fa-9180-11e2-b839-00144feabdc0.html?ftcamp=crm/email/2013327/nbe/Analysis/product#axzz2Oj1Ov4U6
>> ____________________________________________________
>> Pirate Parties International - General Talk
>> pp.international.general at lists.pirateweb.net
>> http://lists.pirateweb.net/mailman/listinfo/pp.international.general
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