Myriad Genetics Refuses To Accept That People Have A Right To Access Their Own DNA Sequences

from the just-because-it's-your-genome,-don't-think-you-own-it dept

One of the biggest victories on the patent front was when the US Supreme Court finally ruled that naturally-occurring DNA cannot be patented. The company involved in this case, Myriad Genetics, didn't give up at this point, but tried to claim that despite this ruling, its patents on genetic testing were still valid. Fortunately, the courts disagreed, and struck down those patents too.

However, as we noted at the time, there's another issue that remains unresolved, which concerns the huge database of DNA that Myriad Genetics has built up over years of sequencing the BRCA1 and BRCA2 genes that have variants linked to cancer. Because of Myriad's unwillingness to provide that important data to the people whose DNA was sequenced, the American Civil Liberties Union (ACLU) has decided to take action:

On May 19, 2016, the ACLU filed a complaint pursuant to the Health Insurance Portability and Accountability Act ("HIPAA") with the U.S. Department of Health & Human Services ("HHS") on behalf of four patients against Myriad Genetics, a genetic testing laboratory based in Utah. The complaint was filed by patients who have experienced cancer, including breast and bladder cancers, or who are members of families with substantial histories of cancer.

All of the patients received genetic testing from Myriad Genetics in order to determine their hereditary risk for various forms of cancer and to guide treatment decisions. They later asked for all of their genetic information, not just the results, but Myriad refused to provide it. As the ACLU explains:

The patients want full access to their genetic information because they know that the understanding of genes and their variants is constantly evolving, and they want to be able to proactively monitor their own cancer risk and that of their family members as scientific knowledge and clinical interpretation of genomic information advances. Most importantly, the patients, many of whom have uncommon genetic variants, are concerned that Myriad controls much of the data about BRCA1 and BRCA2 genetic variants in a proprietary database. This impedes the ability of researchers to better understand whether these variants are connected with various types of cancer. The patients want to have the option of sharing their data with the broader research community.

The last point is key. Myriad is sitting on a wealth of information that might well lead to new treatments and even cures for the many cancers involved. Instead, it is asserting its proprietorial right over DNA that comes from other people. That's particularly egregious since the scientists who first sequenced DNA on a large scale were pioneers in data sharing. As early as 1996, laboratories taking part in the Human Genome Project not only agreed to share their data, but to do so immediately, and with no restrictions. Myriad Genetics' action is totally at odds with the ethos of sharing that lies at the heart of genomics.

As a blog post on the ACLU site notes, on the eve of the HIPAA complaint being filed, Myriad suddenly agreed to provide the information requested, but only on a "voluntary" basis. That is, it refused to recognize the broader rights of patients to their own genetic information. However, the ACLU believes that the law is straightforward here:

Patients are guaranteed access to their health information -- including their genetic data -- under HIPAA. In 2014, the U.S. Department of Health and Human Services amended the HIPAA regulations to make clear that all laboratories, which were previously exempted, are subject to this obligation. And earlier this year, HHS released guidance stating that with respect to genetic testing, patients have a right to access "not only the laboratory test reports but also the underlying information generated as part of the test," including "the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test."

Let's hope this case leads to yet another defeat for Myriad, and establishes once and for all that DNA sequences belong to the people from whom they were obtained. That way they will be free to make data available to researchers for the benefit of everyone, not just for a few companies like Myriad Genetics.

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Filed Under: dna, gene patents, hipaa, patents
Companies: aclu, myriad genetics

Australia Finally Rejects Gene Patents

from the big-win dept

Back in 2013, in a hugely important decision, the US Supreme Court rejected the idea of gene patents, in particular the patents held by Myriad Genetics for the BRCA1 and BRCA2 genes (that are genetic warning signs for breast cancer). A parallel case was happening down in Australia, where an Australian court went the other way last year, ruling that genes could be patented. As we noted, the case could still be appealed to the Australian High Court. And now... the High Court has finally rejected gene patents.

The High Court held that an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer, was not a "patentable invention"...

Specifically, the court rejected the argument that isolating the gene represented a "manner of manufacture" as required by the law to be patentable.

The Court unanimously allowed the appeal, holding that the invention claimed did not fall within the concept of a manner of manufacture. The Court held that, having regard to the relevant factors, an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture. While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed. A plurality of the Court considered that to attribute patentability to the invention as claimed would involve an extension of the concept of a manner of manufacture which was not appropriate for judicial determination.

That's a fairly complex way of saying you can't patent genes. It's always nice to see a little more common sense enter the patent system.

Filed Under: australia, brca1, dna, gene patents, patents
Companies: myriad genetics

Myriad Genetics Finally Gives Up Its Gene Patent Fight... Just As The Patent Office Opens The Doors Up To More Gene Patents

from the some-good,-some-bad dept

For many years, we've been covering the story of Myriad Genetics, the biotech company that has a test for the BRCA1 and BRCA2 genes (often an indicator of a higher risk for breast cancer). The company argued that because of its patent on those genes, no one else could test for those genes. Back in 2013, the Supreme Court did the right thing and finally rejected the concept of gene patents, despite years of the USPTO granting such patents. As the court noted, allowing gene patents created a perverse situation in which a single company could have the exclusive right to isolate a person's own genes -- and that's just not right.

But Myriad Genetics did not give up easily. Just a month after the Supreme Court ruling it sued a bunch of competitors over a different set of gene patents, insisting that the Supreme Court had really only struck down the two in question. Those lawsuits did not go well, as Myriad lost again and again. At this point, it's only choice was to go back to the Supreme Court, where it was obviously going to get a pretty big smackdown -- so Myriad has now admitted that it will not pursue an appeal effectively ending this latest round of cases (after costing those other testing centers tons of money to defend themselves).

As the ACLU notes, this news is great, but there's also some bad news. Just as Myriad is finally coming to terms with what the Supreme Court actually said a year and a half ago, the US Patent and Trademark is quietly opening the door back up to gene patents:

In response to severe criticism by industry groups, patentholders, and patent attorneys, the Patent Office issued new guidance in December that watered down the standard for determining whether something is an unpatentable product of nature. It said that differences in structure or function could allow companies to patent things based in nature. Under this test, if a surgeon removed a kidney from one's body in order to transplant it, the surgeon could argue that she should be able to patent it because it no longer has the same structure as in the body since its blood vessels were cut. The kidney, of course, would be intended to function just as it has prior to being removed in the body that receives it.

The Supreme Court has long rejected this view. For example, in 1931 the court said that a fruit treated with a preservative in its rind could not be patented, because while it has a different structure, its uses are still the same – to be eaten. The applicant could have sought a patent on a new preservative it developed, but not on the fruit itself.

In other words, the ugly head of gene patents may be about to come back alive, despite the Supreme Court killing it off a couple years ago. However, there's still a chance the USPTO will reconsider:

The public has an opportunity to weigh in on this latest guidance. The Patent Office is seeking comments until March 16. In its next revision of the guidance, the Patent Office must require differences in both structure and function when assessing patent applications. Otherwise, the public will bear the consequences when another company, like Myriad, wields its exclusive rights on nature to stall medical and scientific advancement.

Filed Under: cafc, gene patents, patents, supreme court, uspto
Companies: myriad genetics

Myriad Loses Again: Patents On Genetic Testing Ruled Invalid

from the now-go-forth-and-innovate dept

Back in 2013, the Supreme Court struck down patents that Myriad Genetics had obtained on naturally-occuring DNA sequences linked to breast cancer. As a result of that judgment, other companies started offering diagnostic tests based on the genes in question. Myriad claimed that despite losing patents on the DNA, its patents on tests based on that DNA were still valid, and took legal action to stop others from offering similar services. As we reported earlier this year, a federal district court judge refused to grant Myriad a preliminary injunction against one of those new entrants, and now the genetic testing patents have been ruled invalid, as Bloomberg reports:

Myriad Genetics Inc. (MYGN) can't block competitors' DNA tests to determine risk for breast and ovarian cancer after a U.S. appeals court said three patents on the tests never should have been issued.

The patents cover products of nature and ideas that aren't eligible for legal protection, the U.S. Court of Appeals for the Federal Circuit said in an opinion posted today on the court's docket. The court upheld a trial judge's decision to allow the competing tests, including those made by Ambry Genetics Corp., to remain on the market.

That's great news for women who can now choose freely from among a range of diagnostic options, often at prices substantially less than comparable testing offered by Myriad. It means that Myriad's monopoly on data derived from those tests has been broken: thanks to its patents, it has created the world's largest database of mutations in breast cancer genes. Most importantly, perhaps, it opens up the field of gene-based diagnostic testing to allow new entrants to experiment and innovate more freely. That, rather than granting monopolies to a few companies, is far more likely to lead to new medical breakthroughs, products and services.

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Filed Under: brca1, brca2, dna, dna patents, gene patents, genetic testing, patents
Companies: myriad genetics

Australian Court Disagrees With US: Claim Genes Are Totally Patentable

from the sucks-to-be-DownUnder dept

Last year, the Supreme Court made an important ruling in the Myriad Genetics case, effectively saying that genes aren't patentable, even if you can separate them out from the rest of a strand of DNA. Myriad Genetics had isolated two key genes related to breast cancer, BRCA1 and BRCA2 and argued that only it could test for those genes, because of its patent. The Supreme Court soundly rejected that, noting that you cannot patent something in nature, and clearly Myriad did not "make" the genes. Unfortunately, as we'd noted just a few months earlier, a court in Australia had come to the opposite conclusion, saying that Myriad Genetics had legitimate patents on BRCA1 and BRCA2. That case was appealed, and there was some hope that after the US's ruling, higher courts in Australia might see the light. Not yet apparently. An appeals court has agreed that genes are patentable Down Under, which means that such important genetic tests there are likely to be much more expensive and limited.

You can read the full ruling here if you'd like. The case can still be appealed to the Australian High Court, so perhaps it will take the same trajectory as in the US, where it needed the Supreme Court to finally point out the absolute insanity of patenting genes. Though, frankly, if Australia does keeps genes patentable, it might make for an interesting natural experiment to see how much innovation and research happens in both places -- one with, and one without, patents.

Filed Under: australia, brca1, brca2, breast cancer, dna, genes, patents
Companies: myriad genetics

Myriad Genetics Loses Again: Court Refuses To Grant Preliminary Injunction Against Rival Genetic Testing Company

from the battling-cancer dept

In June last year we reported on a major ruling from the Supreme Court, which effectively said that you can't patent genes. That ripped a huge hole in Myriad Genetics' monopoly on testing for the BRCA1 and BRCA2 genes that are linked to breast cancer, but that didn't stop it suing some of the new entrants to this market. In particular, it asked a federal judge in Utah to order one of them, Ambry Genetics, to stop providing its gene testing service for those genes. The American Civil Liberties Union filed an amicus brief opposing Myriad's motion, together with a number of other organizations. Here's the latest development in the case:

Yesterday, a federal district court judge in Utah rejected Myriad's motion. Judge Shelby found that Myriad had failed to establish that it was likely to win its lawsuit against Ambry, because there are substantial questions about whether Myriad's patent claims improperly monopolize products of nature, laws of nature, and abstract ideas.

While Myriad's lawsuits can proceed -- for now -- patients continue to have the right to choose other BRCA genetic testing providers. They can obtain a second opinion before making life-changing medical decisions. And they can decide which laboratory will have their data.

That last point is important. As the ACLU explains:

Myriad has used its patents over the genes to create the largest database in the world about BRCA genetic mutations and their medical significance and refuses to share that information with the scientific community.

That underlines another huge problem with gene patents: they allow monopoly-holders to lock up key medical information that could have been used by researchers around the world to advance knowledge and come up with new treatments. Far from accelerating innovation, as apologists for patents like to claim, they throw huge roadblocks in its way. It's yet another reason why the Supreme Court's decision to strike down gene patents should be celebrated.

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Filed Under: brca, brca1, brca2, dna, gene patents, genetic testing, injunction, patents
Companies: ambry, myriad genetics

US Court Rules Again That Natural Phenomena Cannot Be Patented, Casting Further Doubt On Gene Patents

from the keep-'em-coming dept

Back in June, Mike wrote about the important Myriad Genetics judgment from the Supreme Court, which said that naturally-occuring genetic material could not be patented. However, because of some hedging from the judges, there were concerns about how much this would block gene patents in practice. Last week we had an indication that the impact is indeed likely to be significant, as VentureBeat reports:

a District Court judge in California upheld the landmark [SCOTUS] ruling, and struck down a patent held by a San Diego-based diagnostics company called Sequenom. Sequenom offers a non-invasive genetic test for Down's Syndrome, which pregnant women can take as early as 10 weeks.

Sequenom plans to appeal the decision to the Federal Circuit Court of Appeals. It was highly unexpected, and has caused shockwaves of disbelief in the scientific community. The judge, Susan Illston of the United States District Court in Northern California, ruled against Sequenom after a summary judgement, citing the Supreme Court case "Association for Molecular Pathology v. Myriad Genetics, Inc., 12-398."

In both cases, the judge ruled that a "natural phenomenon" could not be patented.

As Science magazine explained in its report on the case:

If this decision stands, "I don’t see how you can maintain a genetic diagnostic claim anymore," says Christopher Holman, a molecular biologist and professor of law at the University of Missouri, Kansas City.

However, that does not mean that biotech is now an area that will be abandoned by investors. As the VentureBeat story notes:

Bryan Roberts, a health-focused investment partner at Venrock, predicts that "real innovation will be patentable and rewarded" while patents on natural phenomena will not. Roberts is a leading investor in Ariosa Diagnostics, the San Jose, Calif. based company that filed suit against Sequenom in 2011.

That connection means that Roberts may be biased in his view of this particular case, but his broader analysis of the ruling's impact remains true:

The ruling "raises the bar to rely on intellectual property as a business defense," said Roberts. "It will drive prices down [and support] the product that is both high quality and efficiently priced."

What makes this latest judgement (embedded below) particularly welcome is that it joins the Myriad Genetics decision, and an earlier SCOTUS ruling that struck down a patent on basic medical diagnostics, to form part of a growing body of US case law that brings some much-needed sanity to the world of gene patents.

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Filed Under: biotech, dna, gene patents, patents
Companies: ariosa diagnostics, myriad genetics, sequenom

Nobel Prize Winning Economist: Intellectual Property Reinforces Inequality, Hurts The Economy

from the say-that-again dept

Nobel prize winning economist Joseph Stiglitz, who has spoken out before about how intellectual property hurts innovation and makes globalization problematic, has written a fantastic op-ed for the NY Times about how intellectual property increases inequality and how that can lead to much greater harm for the economy.

Much of his article is about the Myriad Genetics case, in which the Supreme Court recently struck down gene patents. Stiglitz points out how this is a good thing, and uses the Myriad case to show how patents in particular can do tremendous damage. He talks about why the Supreme Court ruling was important, but notes there's much more to be done. Of course, since he doesn't mention it, I'm guessing that the piece was either written before Myriad thumbed its nose at the ruling by filing a bunch of new patent lawsuits about the new competitors that have sprung up in its wake, or Stiglitz wasn't yet aware of that fact. Either way, the fact that this is how Myriad has responded really only makes his argument that much stronger.

Most of the article focuses on the history of Myriad, how it's basically putting lives in danger and disproportionately harming the poor, who can't afford $4,000 for a simple test. But, the really interesting part is in the last third of the piece, where he digs a little deeper into how this kind of "inequality" actually has a tremendous cost on the economy that is rarely taken into account. In part, this is based on the fact that patents allow for companies to just try to seek a larger part of the existing pie, taking away the incentives to create larger pies -- which is where real innovation and economic growth occur.

Some of the most iniquitous aspects of inequality creation within our economic system are a result of “rent-seeking”: profits, and inequality, generated by manipulating social or political conditions to get a larger share of the economic pie, rather than increasing the size of that pie. And the most iniquitous aspect of this wealth appropriation arises when the wealth that goes to the top comes at the expense of the bottom. Myriad’s efforts satisfied both these conditions: the profits the company gained from charging for its test added nothing to the size and dynamism of the economy, and simultaneously decreased the welfare of those who could not afford it.

While all of the insured contributed to Myriad’s profits — premiums had to go up to offset its fees, and millions of uninsured middle-income Americans who had to pay Myriad’s monopoly prices were on the hook for even more if they chose to get the test — it was the uninsured at the bottom who paid the highest price. With the test unaffordable, they faced a higher risk of early death.

And, while you can argue that the poor always have it tougher, and if they can't afford the test, that's an unfortunate part of life, Stiglitz has a detailed response to that as well. The question is not just whether or not the Myriad tests for BRCA1 and BRCA2 are helpful in their own right, but what would have happened in the absence of the current situation. And Stiglitz argues, compellingly, that Myriad has actually made things much worse. Without such patents, it's likely that the same genes would have been discovered anyway and we'd have more, better and cheaper genetic testing for a much wider selection of the population.

Advocates of tough intellectual property rights say that this is simply the price we have to pay to get the innovation that, in the long run, will save lives. It’s a trade-off: the lives of a relatively few poor women today, versus the lives of many more women sometime in the future. But this claim is wrong in many ways. In this particular case, it is especially wrong, because the two genes would likely have been isolated (“discovered,” in Myriad’s terminology) soon anyway, as part of the global Human Genome Project. But it is wrong on other counts, as well. Genetic researchers have argued that the patent actually prevented the development of better tests, and so interfered with the advancement of science. All knowledge is based on prior knowledge, and by making prior knowledge less available, innovation is impeded. Myriad’s own discovery — like any in science — used technologies and ideas that were developed by others. Had that prior knowledge not been publicly available, Myriad could not have done what it did.

Further, on top of that, keeping more people alive to do more and contribute more to society, while not having to take on the costs of breast cancer, also has tremendous positive impacts on the economy, which are almost entirely ignored by most who view the situation through the single prism of "patents = incentive for innovation."

Indeed, one of the important insights of Robert W. Fogel, a Nobel Prize-winning economic historian who died last month, was that a synergy between improved health and technology accounts for a good part of the explosive economic growth since the 19th century. So it stands to reason that intellectual property regimes that create monopoly rents that impede access to health both create inequality and hamper growth more generally.

He further notes that supporters of strong patent laws have "overemphasized their role in promoting innovation," and that many of the greatest and most important innovations of the modern era were not driven because of the opportunity to patent them, or even to directly profit from them. As he notes, there are many, many other ways to pay for modern innovation without creating the burdensome negative impacts of today's intellectual property system, harming overall innovation while increasing inequality and increasing prices.

It's great to see such concepts make their way to the NY Times. Hopefully it leads more people to begin to recognize just how broken today's intellectual property systems are.

Filed Under: economics, gene patents, health, inequality, intellectual property, joseph stiglitz, patents
Companies: myriad genetics

Myriad Mocks Supreme Court's Ruling On Gene Patents; Sues New Competitors Doing Breast Cancer Tests

from the chutzpah dept

Remember how, just a month ago, the Supreme Court had struck down gene patents in the Myriad case? If you don't recall, Myriad claimed, effectively, to have patented the isolated BRCA1 and BRCA2 genes, which are indicators of a likelihood for developing breast cancer. As such, they blocked anyone else from doing tests to find those two genes, and charged a whopping $4,000 or so for anyone who wanted the test. The Supreme Court, thankfully, tossed out those claims, noting that Myriad "did not create or alter any of the genetic information" in those genes, and that if found valid, it would "give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes." That's obviously crazy, so it was good that the Supreme Court rejected those claims.

Immediately after that, a few competitors jumped into the space, offering BRCA1 and BRCA2 testing -- for significantly lower prices. And, Myriad wasted very little time in suing them all for patent infringement. Huh? The short version is that Myriad claims that the Supreme Court merely removed five total claims out of its patents, and it still has 515 remaining claims across 24 patents -- and these tests violate those:

As of the morning of June 13, 2013, Plaintiffs collectively had 24 patents containing 520 claims concerning two genes (BRCA1 and BRCA2), and methods of use and synthetic compositions of matter related thereto. On June 13, the Supreme Court of the United States ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible, thereby reducing the overall patent estate to 24 patents and 515 patent claims. This case involves none of those five rejected claims.

The filing goes on to suggest that the Supreme Court ruling really didn't mean very much at all. In many ways, this really does appear to be Myriad giving the middle finger to the Supreme Court. As Tim Lee notes, if Myriad's interpretation of the Supreme Court ruling is correct, then the Court's ruling is effectively meaningless, because Myriad (and anyone else) can effectively write patents for genes by just changing how they structure the patents:

The patent claims the Supreme Court invalidated last month were “composition of matter” claims, covering the chemical structure of the BRCA genes. But Myriad’s patents also have “method” claims covering processes for diagnosing breast cancer. And while these patents use different language than the composition-of-matter patents the high court invalidated, their practical effect on the genetic testing market could be very similar.

Consider Patent 6,951,721, one of the patents cited by Myriad in its lawsuit against competitor Ambry Genetics. It claims the concept of diagnosing breast cancer by “determining the nucleotide sequence of the BRCA1 gene” from a “female individual” and then checking for mutations at specific points on the gene. The patent isn’t limited to any particular technology for isolating or sequencing the patient’s BRCA1 gene. So while it’s not technically a patent on the BRCA1 gene, it might as well be.

Of course, as you look over the details, it seems like Myriad is still going to be in trouble. Effectively, the claims it's relying on may appear to be more similar to a patent on the diagnostic process itself. But, that's a problem for Myriad, because in the big Prometheus Labs case, which the Supreme Court decided a year ago, and which it relied on in the Myriad case itself, medical diagnostics aren't patentable either.

It seems like Myriad is just trying to squeeze some more money out of these patents before it gets smacked down again. Of course, not everyone agrees. Dennis Crouch seems to think they have a "very strong case," while PubPat's outspoken Dan Ravicher feels otherwise:

PubPat director Dan Ravicher, e-mailing Ars from Beijing, described Myriad's new suits as a way to save face with Wall Street. He said the Supreme Court decision was a "total loss" for Myriad, and the synthetic cDNA they are focused on now is not needed for genetic testing. "I am confident they will lose these cases, too, so long as the defendants have the financial resources and institutional desire to fight," said Ravicher.

Of course, it's that last bit that's the challenge. Any such case will take years and millions of dollars. And, during that time some may just choose to settle, and if lower courts side with Myriad and issue injunctions it can be a big risk for the competitors in the space. The end result may work in Myriad's favor even if these cases are completely bogus: it's likely to scare away competitors, and keep the prices of its breast cancer gene tests very high, making it much more likely people will die. I do wonder how Myriad's execs look at themselves in the mirror. There is no reason for doing what they're doing other than to enrich themselves, while ensuring that more women will die from undetected breast cancer. Sickening.

While the FTC has claimed that it's going to go after patent trolls, this seems like another situation where they, along with the DOJ, should also look into Myriad. While it may not be a traditional "troll," there's certainly a strong argument to be made that the company is abusing patents in a manner this is likely to lead to much higher prices for consumers, especially following the Supreme Court rejecting the very premise that they're now relying on in these new lawsuits -- that no one but Myriad can offer tests for BRCA1 and BRCA2. One hopes that the FTC decides to expand its "investigations" into companies like Myriad.

Filed Under: brca1, brca2, breast cancer, cancer, gene patents, lawsuits, patents
Companies: myriad genetics

Supreme Court Strikes Down Gene Patents

from the good-news dept

Here's a bit of good news: the Supreme Court has effectively said you can't patent genes, though in typical Supreme Court fashion, it hedged a bit. Basically, they found that merely separating out naturally occurring DNA is not patentable, but that synthetically made "complementary DNA" or (cDNA) can be patentable. This case has been going on for quite some time, involving a company called Myriad Genetics, which isolated two genes, BRCA1 and BRCA2, where mutations indicate a high likelihood of developing breast cancer. Myriad then set up a very lucrative, extremely high priced set of tests to find those mutations and argued that others testing for those genes violated its patents -- because stopping breast cancer should be prohibitively expensive, apparently.

The unanimous ruling found that merely separating out naturally occurring genes cannot be patentable, because that would be ridiculous:

It is undisputed that 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. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.

And that doesn't make much sense under patent law:

Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes)by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.

Myriad's main argument was that it basically had to put a lot of work into finding and isolating the genes, but the court noted that "Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy [the conditions for patent eligibility]."

The court also rejects the idea that just because the US Patent Office regularly granted gene patents for years, it should be allowed to continue to do so. The court does say that complementary DNA, made by Myriad, can be patentable:

... 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...

The court also points out that you can still patent a form of a test for DNA, if that method is innovative, but you can't patent the underlying genetic structure if it's naturally occurring. However, Myriad's method was not new or innovative. As the court notes, it was "well understood by geneticists at the time."

On the whole this is a good ruling that will invalidate a large number of bogus gene patents. While patent extremists are complaining that this will destroy the biotech field, more reasonable minds are pointing out that it should have little effect. I'd argue that, if anything, it may drive greater efforts in biotech, since companies can now do more exploration on genes without fearing being sued by someone who discovered and isolated a particular gene first -- and this should also lead to significantly cheaper genetic testing, creating even more opportunities for biotech firms to innovate on top of widespread genetic testing.

Filed Under: biotech, dna, gene patents, isolated dna, patent eligible, patents, supreme court
Companies: myriad genetics