Deadly Monopolies: New Book Explores How Patenting Genes Has Made Us Less Healthy

from the stop-the-scourge dept

A few yeas ago, David Koepsell, came out with the excellent book, Who Owns You?, with the subtitle, "The corporate gold rush to patent your genes." It looks like there's now a new book out exploring the same subject, by medical ethicist Harriet Washington. The book is called Deadly Monopolies, subtitled: "The shocking corporate takeover of life itself--and the consequences for your health and our medical future." A mouthful in the subtitle, but it would seem these two books belong next to each other on the bookshelf.

NPR has an excellent overview of this new book, highlighting the key point: that patenting genes is making us less healthy:

Restrictive patents on genes prevent competition that can keep the medical cost of treatment down, says Washington. In addition to genes, she also points to tissue samples, which are also being patented — sometimes without patients' detailed knowledge and consent. Washington details one landmark case in California in which medically valuable tissue samples from a patient's spleen were patented by a physician overseeing his treatment for hairy-cell leukemia. The physician then established a laboratory to determine whether tissue samples could be used to create various drugs without informing the patient.

"[The patient] was told that he had to come to [the physician's] lab for tests ... in the name of vigilance to treat his cancer and keep him healthy," says Washington.

The patient, a man named John Moore, was never told that his discarded body parts could be used in other ways. He sued his doctor and the University of California, where the procedure took place, for lying to him about his tissue — and because he did not want to be the subject of a patent. The case went all the way to the California Supreme Court, where Moore lost. In the decision, the court noted that Moore had no right to any share of the profits obtained from anything developed from his discarded body parts.

And, of course, the book pins many of the problems on a familiar culprit that we've spoken about many times before here: the Bayh-Dole Act, which pushed Universities to start locking up research, rather than sharing it with the world:

But since the 1980s, researchers at universities and the pharmaceutical industry have become collaborators in ways that they weren't before, says Washington. The 1980 Bayh-Dole Act gave universities and small businesses control of their intellectual property — which allowed them to sell their patents.

"Before the 1980s ... most researchers worked within a university culture which encouraged free discourse without necessarily a potential product in mind," she says. "It encouraged collaboration and data-sharing, and the values held by medical researchers were values of academic excellence, medical achievement, altruism ... these were the motivations. Now that the patent is based upon the value of exclusivity, the corporation discouraged very strongly and prohibited data sharing. ... This culture of the corporation has overtaken the medical research culture."

We've been reporting on this stuff for years, and it's good to see it getting more publicity through books like this. Unfortunately, it seems unlikely to change in any significant way in the near future... unless, perhaps, the Supreme Court actually comes through and wipes out gene patents.

Filed Under: gene patents, harriet washington, patents

Appeals Court Says Genes Are Patentable, Because They're 'Separate' From Your DNA

from the chop-off-a-finger-and-patent-it dept

Well, this is unfortunate. We were quite happy with US district court judge Robert Sweet last year for making it clear that isolated genes are not patentable material in the Myriad Genetics case. This was one of those annoying patent situations where so many people had just assumed that genes were patentable for decades, without a single court testing that theory out. So industries were built up around the idea that genes could be patented. Thankfully, Sweet didn't let that bother him in pointing out that gene patents "are directed to a law of nature and were therefore improperly granted."

Of course, as expected, Myriad appealed, and even the Justice Department weighed in, saying genes shouldn't be patentable. However, the results of the appeal are in... and the Federal Circuit appeals court (CAFC) has reversed the lower court and said that patenting genes is just fine. The reasoning is bordering on ridiculous. The court effectively states that because isolated genes are isolated rather than a part of the full DNA strand, they are not "found in nature."

It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form--as distinctive chemical molecules--from DNAs in the human body, i.e., native DNA. Native DNA exists in the body as one of forty-six large, contiguous DNA molecules. Each DNA molecule is itself an integral part of a larger structural complex, a chromosome. In each chromosome, the DNA molecule is packaged around histone proteins into a structure called chromatin, which in turn is packaged into the chromosomal structure....

Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.

Later, it reiterates that separating out these genes make them somehow "different" and not a part of nature:

In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

Basically, they seem to be arguing that because a severed finger is not attached to a hand, the finger is not naturally occurring, and, thus, is patentable. Think about that. The dissenting judge in this ruling used a slightly less gruesome analogy, saying that the majority was basically saying that while a tree occurs in nature, snapping a leaf off the tree makes that leaf patentable.

The one good thing about the ruling is that it still rejects parts of Myriad's patents, but for other reasons, not because they're unpatentable parts of nature. The dissenting opinion from Judge Bryson (starting on page 88 of the ruling) is well worth reading. It starts out by attacking the problem with common sense, saying that if you were to ask someone if genes should be patented, they would answer, "Of course not. Patents are for inventions. A human gene is not an invention." But then Bryson goes on to discuss the more specific points raised by Myriad. First, he points out that Myriad didn't even really "invent" the key parts here:

At the outset, it is important to identify the inventive contribution underlying Myriad’s patents. Myriad was not the first to map a BRCA gene to its chromosomal location. That discovery was made by a team of researchers led by Dr. Mary-Claire King.... And Myriad did not invent a new method of nucleotide sequencing. Instead, it applied known sequencing techniques to identify the nucleotide order of the BRCA genes. Myriad’s discovery of those sequences entailed difficult work, and the identified sequences have had important applications in the fight against breast cancer. But the discovery of the sequences is an unprotectable fact, just like Dr. King’s discovery of the chromosomal location of the BRCA1 gene.

From there, Judge Bryson points out that an isolated gene clearly is a part of nature, and thus unpatentable:

Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature. While the process of extraction is no doubt difficult, and may itself be patentable, the isolated genes are not materially different from the native genes. In this respect, the genes are analogous to the “new mineral discovered in the earth,” or the “new plant found in the wild” that the Supreme Court referred to in Chakrabarty. It may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant. But that does not make those naturally occurring items the products of invention.

The same is true for human genes.

This case is far from over. It seems likely that CAFC will quickly be asked to rehear the case en banc (with the full slate of judges in the court, rather than just a panel of three), and after that it will likely go to the Supreme Court. Still, it's unfortunate that CAFC went this way, and hopefully a later ruling rejects this momentary lapse of reason.

In the meantime, it'll be important to pay close attention to what happens in the "sister" case to this one, Prometheus Laboratories v. Mayo Collaborative Services, in which there's a question of whether or not diagnostic tests can be patentable. In that case, like this one, CAFC said diagnostic tests are patentable, and that case has now moved on to the Supreme Court, which will likely hear the case in the fall. That may be a precursor to the final result in this case.

Filed Under: brca1, brca2, cafc, dna, gene patents, patents
Companies: aclu, myriad genetics

Can Genes Be Patented? Appeals Court Will Weigh In Soon

from the and-we-wait dept

It's been just over a year since a district court judge surprised much of the world by saying that you could not patent genes. This was a huge, and very smart ruling, but it certainly upset those who had been patenting genes (or making money off of those patenting genes) for many years. They insisted that this simply couldn't be true at all, and tried to hide behind claims that they weren't really patenting genes at all, but merely the process to separate out the genes. To hear them talk about it, the judge's initial ruling was so far out of left field that the appeals court couldn't possibly uphold it. Well, we'll soon find out. The case against Myriad Genetics and its patenting of the BRCA1 and BRCA2 genes has finally been heard by the Appeals Court, and we're waiting to see if they recognize the absurdity of patenting genes... or if they figure out some way to twist the law (which only allows patents on things made by humans...) into keeping gene patents around. Of course, whoever wins, this case will be appealed to the Supreme Court, who very well may want to weigh in. What's really sad is that a big part of the argument by those who want the lower court ruling overturned is that it will "upset" an entire industry. The real problem, of course, is that an entire industry was built up around these highly questionable patents in the first place.

Filed Under: brca1, brca2, gene patents, patents
Companies: aclu, myriad genetics

USPTO Not At All Happy About Justice Department Saying Genes Shouldn't Be Patentable

from the internal-rift dept

Last week, the Justice Department surprised a ton of people by filing an amicus brief saying that isolated genes should not be patentable. The NY Times has an article quoting a bunch of outraged patent attorneys, who are worried about their own jobs more than anything else, but also has some tidbits suggesting that the Patent and Trademark Office is not at all happy either, despite the fact that they're both part of the same administration. We noted in our original post that there must have been quite the political battle, and as will often happen, the losers appear to be griping. The USPTO has said that, even though the very same administration it's a part of says isolated genes shouldn't be patentable, it will continue to grant such patents until a court tells them not to (which, er, is what the district court did). The article also quotes a lawyer who spoke with USPTO director David Kappos, and noted that Kappos "seemed chagrined" at the situation. That seems like a polite way of saying that the USPTO is pissed off.

Filed Under: gene patents, patents, politics
Companies: justice department, uspto

Surprise: Justice Department Says Isolated Genes Should Not Be Patentable

from the didn't-see-that-coming dept

Well here's a surprise. In the appeal of the ruling from earlier this year that genes are not patentable, the Justice Department has decided to weigh in with an amicus brief, changing the government's longstanding position on gene patents. The government's official position is now that isolated genes should not be patentable, though it does suggest that "manipulated" DNA could be patentable. They basically make the argument that merely isolating a gene isn't an invention, which makes perfect sense. What's interesting is that the Justice Department's position appears to disagree with the USPTO's stated position until now. There must have been a hell of a political fight within the administration to get this through... Anyway, the full filing is after the jump.

Filed Under: gene patents, justice department, patents

Myriad Appeals, Says Gene Patents Should Be Allowed

from the but-of-course dept

This will come as no surprise to anyone, but Myriad Genetics has officially appealed the ruling that invalidated gene patents. As you may recall, earlier this year, a court noted that genes are unpatentable, noting that they "are directed to a law of nature and were therefore improperly granted."

Myriad is appealing on two points. First, it's claiming that the people who sued have no standing, because there's no controversy since the company hadn't taken any action against the plaintiffs. That seems like a pretty weak argument, given that Myriad had made it clear that it would enforce its patents against anyone else who tried to do research or genetic testing on the specific BRCA1/2 genes. Second, Myriad is claiming that the patents are valid, because it connected not just the gene (which is unpatentable), but the isolated gene combined with the information that this mutation predicts breat and ovarian cancer (also, unpatentable by itself). Basically, Myriad is suggesting that tying two unpatentable things together make this patentable. That makes little sense, and hopefully the appeals court sees through it as quickly as the district court did.

Filed Under: brca1, brca2, gene patents, patents, standing
Companies: myriad genetics

Myriad Offers To Give Up Its Infamous Gene Patent In Australia

from the but-why? dept

We've been covering the legal fight over the patenting of genes for quite some time, and there's been an interesting (if odd) development, concerning the BRCA patents, held by Myriad Genetics, that have been the key patents in the legal battle. Back in March, a district court judge famously held that genes were unpatentable, and said that the BRCA patents (covering genes related to breast cancer) were invalid. A few months later, it was interesting to see a very similar case filed in Australia, also against Myrida and over BRCA patents.

However, as Glyn Moody alerts us, there's been a slightly surprising development down in Australia, as Myriad has offered to surrender the patent to the people of Australia. Specifically, Myriad sent a letter, stating:

"Myriad wishes to gift Australian Patent No 686004 [the '004 Patent] to the people of Australia."

This is, certainly, an odd turn of events, and no one's quite sure why. Some have suggested that it's to help with the US case by avoiding another ruling against such patents in Australia -- but as the article notes, that makes little sense. The patent systems are different in the US and Australia and have little, if any, impact on one another. My guess (and it's a guess) is that Myriad realized that this one particular patent is weak, and doesn't want it to be a part of any lawsuit that could impact its other patents or the wider ability to patent genes, and is thus offering it up to get it out of the lawsuit. That's an admittedly cynical take, but I'm having trouble coming up with other possibilities that make sense. Perhaps any readers more familiar with the Australian patent system can fill us in on why they think this is happening.

Filed Under: australia, brca, gene patents
Companies: myriad

After US Victory, Breast Cancer Patients Take The Anti-Gene Patent Fight To Australia

from the don't-patent-our-DNA dept

As you hopefully remember, a few months back, a US court ruled that gene patents were not valid, after specifically dealing with a challenge, brought by the ACLU and some cancer patients, about a patent held by Myriad Genetics on the process of identifying BRCA1 and BRCA2, two genes that indicate susceptibility to breast cancer. While there will still likely be years of appeals before this gets anywhere in the US, it looks like a very similar fight is about to start down in Australia. Glyn Moody points us to the news that a similar lawsuit has been filed down under.

The difference here may be that, in Australia, Myriad worked out a deal with a local company, and that company has "gifted" the patent to various healthcare institutions for no royalty, meaning that the fact pattern is a bit different (in the US, if you wanted the test, you had to go to Myriad... or... Myriad). Of course, last year we had mentioned that Australian politicians were already discussing the possibility of outlawing gene patents -- so, potentially the regulatory process could make the judicial process here moot.

Filed Under: australia, gene patents
Companies: myriad genetics

Judge: Gene Patents Are Invalid

from the huge-news dept

In a huge ruling, U.S. District Judge Robert Sweet has said that gene patents are invalid. As you may recall, last May, the ACLU was the first to finally challenge whether or not genes could be patented. There was a lot of back and forth over the case, with many saying that a ruling against gene patents would throw a wrench into the business plans of many companies, because so many biotech/medical companies have been relying on the idea that gene patents must be valid for so long. But just because many companies relied on a mistaken understanding of patent law, doesn't mean that it should be allowed to continue. The judge made the point clear when it came to gene patents, saying that they:

"are directed to a law of nature and were therefore improperly granted."

The case was brought against Myriad Genetics, who will surely appeal, so this is nowhere close to over. But it involved a test for breast cancer, that Myriad basically had a monopoly over -- and the claim was that this not only made it more difficult for women to get tested, but it also greatly discouraged other research in the field. In part, this was because the patents that Myriad held were incredibly broad.

Patents, of course, are not supposed to be granted on things found in in nature -- and it's hard to argue against the idea that genes are found in nature. Supporters of gene patents often claim that they're not really gene patents, but a patent on identifying the gene, which is a nice semantic game that the judge clearly saw through. This is a huge step forward for encouraging more real research into genetic testing, rather than locking up important information.

Filed Under: brca1, gene patents, genes, invalid, nature, patents
Companies: aclu, myriad genetics

How Monsanto Used Gene Patents To Corner The Market In Seeds

from the you-can't-eat-without-eating-Monsanto dept

Dark Helmet points us to the news of an Associated Press investigation into how Monsanto basically cornered the market in seeds by using gene patents and coercive licensing agreements that basically make it impossible to grow certain products without having to first reach a restrictive agreement with Monsanto. And they did this all in about a dozen years. Gene patents are already troubling enough, and reading this report on how Monsanto used its gene patents to basically wipe out all competition is quite telling in exactly how patents can be used to significantly harm a market. Of course, beyond the ridiculousness of gene patents, this situation has been made worse by the recent Supreme Court decision that said that Monsanto could put an end user license agreement on seeds, such that even if you collected seeds from your own harvest to replant them, you could be found guilty of infringing on Monsanto's patents. The investigation here details how Monsanto basically has completely cornered the market, even limiting publicly funded research into certain seeds. And, of course, now the company is raising prices on various seeds when many farmers have little in the way of other options.

Filed Under: gene patents, patents, seeds
Companies: monsanto