Ripper Patent Rulling In Oz

The Australian Supreme Court just completely slapped down gene patents, which, with a bit of common sense, should be an end to that particular abomination in IP land:

Australia's highest court has ruled unanimously that a version of a gene that is linked to an increased risk for breast cancer cannot be patented. The case was brought by 69-year-old pensioner from Queensland, Yvonne D'Arcy, who had taken the US company Myriad Genetics to court over its patent for mutations in the BRCA1 gene that increase the probability of breast and ovarian cancer developing, as The Sydney Morning Herald reports. Although she lost twice in the lower courts, the High Court of Australia allowed her appeal, ruling that a gene was not a "patentable invention."

The court based its reasoning (PDF) on the fact that, although an isolated gene such as BRCA1 was "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." Since the information stored in the DNA as a sequence of nucleotides was a product of nature, it did not require human action to bring it into existence, and therefore could not be patented.

Although that seems a sensible ruling, the pharmaceutical and biotechnology industry has been fighting against this self-evident logic for years. The view that genes could be patented suffered a major defeat in 2013, when the US Supreme Court struck down Myriad Genetics' patents on the genes BRCA1 and the similar BRCA2. The industry was hoping that a win in Australia could keep alive the idea that genes could be owned by a company in the form of a patent monopoly. The victory by D'Arcy now makes it highly likely that other judges around the world will take the view that genes cannot be patented.

………

Striking down gene patents in Australia, as in the US, clears the path for new entrants to the gene testing market, which is likely to drive down prices. It could also spur more biomedical innovation by allowing researchers freedom to investigate previously patented genes and develop new therapies, without fearing potential lawsuits.

If the judgement is followed by courts in other jurisdictions, and the whole idea of gene patents is rejected, the number of people whose lives could be saved will be correspondingly greater.

It has been patently^* clear for decades that isolating genes is a process of discovery, and not invention, and hence they should not be covered by patents.

The biotech industry's counter-argument has always been, "But we want our money!:

In a statement, Myriad also expresses its disappointment with the ruling. "The High Court's decision comes at a critical time when we're entering the golden era of personalized medicine," it says, as GenomeWeb reports. "In order for personalized medicine to become a reality, strong patent protection is essential because it provides the research-based companies like Myriad with an incentive to continue to invest in R&D."

(emphasis mine)

Basically, they are arguing that if we won't allow them to patent their discoveries, they will take their marbles and go home.

There are two things wrong with this:

• Patents are for inventions, not discoveries.
• Allowing for rent seeking through patents makes it more likely that genetic products will will be released without adequate testing, because the potential profits are so huge.

And that is ignoring the fact that it is taxpayer funded research that have led to these discoveries.

^*Pun not intended.

SCOTUS Strikes Down Human Gene Patents

In yet another smack down to the increasingly patent crazy United States Court of Appeals for the Federal Circuit (Patent Court), the Supreme Court has ruled that the contents of the human genome are a discovery, not an invention, and so they cannot be patented:

Pronouncing what may seem like a patent truism, the Supreme Court ruled unanimously on Thursday that biotech researchers have to create something to get monopoly protection to study and apply the phenomenon. Because Myriad Genetics, Inc., “did not create anything,” the Court struck down its patent on isolating human genes from the bloodstream, unchanged from their natural form. Because Myriad did create a synthetic form of the genes, however, that could be eligible for a patent, the Court concluded.

The decision was a major blow to a company that believed it had a right to be the sole user and analyst of two human genes, mutations in which show a high risk, for women found to have them in their blood, of breast and ovarian cancer. But the ruling will give medical and scientific researchers, and family doctors, greater opportunity to help women patients discover their potential vulnerability to those types of cancer.

………

The scientific and legal key to the Court’s denial of patent protection to isolated, natural forms of DNA were these sentences: “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.”

While that was not disputed, because the legal controversy focused rather on what Myriad claimed it did to locate and then isolate the forms of genetic DNA, those agreed-upon factors were enough to convince the Court that “Myriad did not create anything.” As Justice Thomas commented further: “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry.”

I think that one of the reasons that this was a unanimous ruling was that it was a very narrow ruling, hence the caveats about their explicitly saying nothing about synthesized genetic material.

Still, it is a good ruling, and yet another much needed bitch slap to the Patent Court.

Crap

A federal appeals court has overturned a lower court ruling and ruled that patents of genes are legal:

A federal appeals court affirmed the right of Myriad Genetics to patent two genes linked to breast cancer, overturning a lower court ruling that threatened a key element of the biotech business.

The U.S. Court of Appeals for the Federal Circuit in a ruling on Friday backed Myriad's right to patent two "isolated" human genes -- BRCA1 and BRCA2 -- that account for most inherited forms of breast and ovarian cancers.

………

The appeals court said the genes isolated by the company can be patented because Myriad is testing for distinctive chemical forms of the genes, and not as they appear naturally in the body.

One member of the three-judge appellate panel dissented, saying that despite Myriad's process of isolating a human gene it still could not be patented.

………

The appeals court also said that Myriad's method for screening potential therapies was patentable.

The judges did, however, agree with the district court that Myriad's method of analyzing DNA sequences did not involve sufficient transformation, and thus could not be patented

I'm not surprised. This is the Court of Appeals for the Federal Circuit, a body that was created specifically to rule on patents, and they, under the "when all you have is a hammer, everything looks like a nail" theory, are insanely pro patent.

How insanely pro patent? They are assuming patently false facts to justify their ruling:

Bruce Wexler, a patent expert at the law firm Paul Hastings, said the ruling means the appeals court has recognized that DNA takes on a different molecular structure when it is isolated and removed from the body.

"That is a very significant result that is very important to the biotech industry," Wexler said.

This is scientific bullsh%$. DNA is DNA is DNA is DNA, whether in vivo or in vitro.

Here's hoping that the Supreme Court or the full appeals court (unlikely, see my hammer nail argument), and it gets slapped down.

SCOTUS has issued a number of "what are you smoking?" rebukes of the Court of Appeals for the Federal Circuit regarding patents over the past few years, so there is some hope, but such a ruling would be highly disruptive to the industry, and the Roberts court has been very pro-industry, so I think that it is a small one.

Background here.

Court Case Against the Patenting of Genes Progresses

I originally wrote about this in May, and my position then is what it is now, that you patent inventions, not discoveries, and that the counter argument, "discovering is hard work," is a load of crap.

The case law is clear that, "a product of nature is unpatentable unless it is sufficiently different to become a patentable 'composition of matter.'"

In any case, the litigation, put forward by a number of civil liberties and scientific organizations, is now making arguments before the judge:

Federal court hearings continued Tuesday on a lawsuit that could transform biotechnology in the United States by eliminating gene patents.

The case hinges around the claims of Utah-based Myriad Genetics on BRCA1 and BRCA2, a pair of genes closely linked to breast and ovarian cancer. Myriad “owns” the genes, and says its patents make it possible to profit on diagnostic tests. The company argues that if you remove the patents, the tests — indeed, commercial biotechnology as we know it — will vanish.

Myriad is, from the perspective of an engineer, not a patent attorney, dammit,^* full of crap.

Their tests for the gene are still protected, it's just that alternative, and better test methods for the gene that they discovered will be able to compete.

Fundamentally, IP law is about the public good, as it says in the Constitution, "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries," [where "discoveries" means "invention", hence the reference to "inventors", it gets complex],

My guess is that if Myriad had been a bit less hard assed about their patents, they have absolutely refused to license to anyone for any purpose, this case would probably have never come up.

As it stands now, they are literally killing people, and this makes them a thoroughly unsympathetic defendant.

I can't imagine this not ending up at the Supreme Court though.

^*I LOVE IT when I get to go all Doctor McCoy!!!

ACLU Challenges Gene Patent

The ACLU is arguing that Myriad Genetics' holding a patent on two genes associated with various forms of cancer, BRCA1 and BRCA2, is not a legal use of the patent process.

I got some training in engineering schools on patents, and it was always made clear to us, by our non-lawyer professors, that a patent was for an invention, not a discovery, and it seems to me that these genes are the latter, not the former, but I'm an engineer, not a lawyer, dammit!^*

Among other things, they are arguing not just that the patent should not have been granted, and I agree with that, because at its core IP is an infringement on every one's rights in order to, "To promote the Progress of Science and useful Arts," as it says int he constitution, and it is clear that by patenting a gene, they are not doing this.

Additionally, the ACLU is saying that the way that Myriad is violating the first amendment:

As the A.C.L.U. explored the restrictions on competition that companies like Myriad had put in place — blocking alternatives to the patented tests, and even the practice of interpreting or comparing gene sequences that involved those genes — the restrictions started to look like not just a question of patent law, Mr. Hansen said, but of the First Amendment’s guarantee of free speech as well.

I'm not sure if that would fly, since, after all, IP has at its core the restrictions of the rights of everyone for a perceived public benefit.

As to the reason as to why the patent examiners approved it?

The decision to allow gene patents was controversial from the start; patents are normally not granted for products of nature or laws of nature. The companies successfully argued that they had done something that made the genes more than nature’s work: they had isolated and purified the DNA, and thus had patented something they had created — even though it corresponded to the sequence of an actual gene.

This is bullsh%$. They are arguing that they can patent a discovery, because it's hard work.

Here's hoping that they win, because the current patent regime in the US is hamstringing economic development and innovation in our society, which is the exact opposite of its intended purpose.

^*I LOVE IT when I get to go all Doctor McCoy!!!

Court Rules Gene Patents Illegal

It is generally true that bad people push the law until it breaks, and the folks at Myriad Genetics are a truly nasty bit of work.

Basically, they discovered the genes BRCA1 and BRCA2, which predispose one to breast cancer, and had received a patent on the genes, and offered a not particularly good and very expensive test for the genes, and using their government granted monopoly, they were prohibiting any and all competing tests or research on better tests for these genes.

The judge has now ruled that the genes are a discovery, and not an invention, which makes them non-patentable, except, perhaps in Germany.^*

The VC's are wringing their hands, because patent protection helps with their pump and dump schemes, but development has been continuing apace on genes that are not covered by these patents:

Some biotechnology investors and executives say that lack of patent protection for DNA could diminish investment and remove incentives to develop tests. That could slow the move toward so-called personalized medicine, in which genetic tests are used to determine which drugs are best for which patients.

James P. Evans, a professor of genetics at the University of North Carolina, said that would not necessarily be the case. There is thriving competition in areas like testing for mutations that cause cystic fibrosis or Huntington’s disease, even though no company has exclusivity.

“It’s quite demonstrable that in the diagnostic area, one does not need gene patents in order to see robust development of these tests,” he said.

Note that this does not prohibit patenting the tests, it just prohibits patenting the genes.

This is a good ruling: the patenting of genes, or for that matter the patents of hedging techniques, as is the case in Bilski, which the Supreme Court will heard arguments for in November.

IP law is, at its core, public interest law (it's in the constitution), and patents on business methods, species, and genes, do not serve the public interest

Earlier posts on the subject.

^*This is what got us that Mercedes ad where they say that they have a patent on crumple zones, but "Never enforced the Patent". They never enforced the patent, because it is not recognized anywhere else in the world.^†
†I believe Germany changed their patent laws at some point in the 1970s.^‡
‡I offer the caveat that these comments in the footnotes regarding the Mercedes patent are recollections of a conversation over a decade ago vague 20+ year old memories though, so YMMV, though a Google search does have people who recall the ad.

US Comes Out Against Patenting Genes

This is a big deal, and a case where a very bad actor forced their hand:

Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry.

The new position was declared in a friend-of-the-court brief filed by the Department of Justice late Friday in a case involving two human genes linked to breast and ovarian cancer.

“We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,” the brief said.

Basically, a company, Myriad Genetics, got a patent on breast cancer genes, it licenses government funded research which found the BRCA1 and BRCA2 genes, and has used this patent to prevent the development of better and cheaper tests, and their behavior was so egregious that the government felt compelled to act.

It's still up to the judge, but this is a good first step.

Genes have never been an invention, they have been a discovery, and discoveries are not supposed to be patentable.

Today in Bad Ideas

There are bills in the Senate Judiciary Committee that would restore patents for software and genes, because ……… a f%$# tonne of lobbyists and corrupt campaign contributions I guess?

I don't think that this Supreme Court has done much good, but their work in reining in excesses of our current IP regime is good.

The current regime is a license for parasite rent seekers.

It creates massive inequality and it destroys innovation when some patent troll can shake you down at a moment's notice:

The Senate Judiciary Committee is scheduled to consider two bills Thursday that would effectively nullify the Supreme Court's rulings against patents on broad software processes and human genes. Open source and Internet freedom advocates are mobilizing and pushing back.

The Patent Eligibility Restoration Act (or PERA, S. 2140), sponsored by Sens. Thom Tillis (R-NC) and Chris Coons (D-Del.), would amend US Code such that "all judicial exceptions to patent eligibility are eliminated." That would include the 2014 ruling in which the Supreme Court held, with Justice Clarence Thomas writing, that simply performing an existing process on a computer does not make it a new, patentable invention. "The relevant question is whether the claims here do more than simply instruct the practitioner to implement the abstract idea of intermediated settlement on a generic computer," Thomas wrote. "They do not."

Yeah, Clarence f%$#ing Thomas got this right. ¯\_(ツ)_/¯  

That case also drew on Bilski v. Kappos, a case in which a patent was proposed based solely on the concept of hedging against price fluctuations in commodity markets.

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Software and Internet advocates have taken notice. This week, the Linux Foundation, working with the Cloud Native Computing Foundation (CNCF), announced an expanded partnership with Unified Patents, intended to defend open source software against what it gamely calls "non-practicing entities" (NPEs), but most people would term patent trolls. "As the risk and volume of frivolous litigation against open source projects grows, the need to provide accessible protection from NPEs has become crucial," the Linux Foundation writes.

In interviews with The Register, leaders at CNCF and Unified Patents described patent trolls as actively chasing any widespread technology, aiming for settlements over the cost of trials. Nearly 98 percent of NPE claims are settled, according to Unified Patents, but NPE claims challenged at the US Patent and Trademark Appeals Board lose 67 percent of the time.

Challenging patent claims, however valid, could get tougher under the PREVAIL Act, the other bill being considered by the Senate Judiciary Committee this week. PREVAIL would, among other changes, limit patent challenge petitions to 14,000 words, hampering attempts to debunk complex patents. The Act would also eliminate clearance patents, which companies can use to clear any infringement claims prior to their own products' release.

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Another wrinkle in the PERA bill involves genetic patents. The Supreme Court ruled in June 2013 that pieces of DNA that occur naturally in the genomes of humans or other organisms cannot, themselves, be patented. Myriad Genetics had previously been granted patents on genes associated with breast and ovarian cancer, BRCA1 and BRCA2, which were targeted in a lawsuit led by the American Civil Liberties Union (ACLU). The resulting Supreme Court decision—this one also written by Thomas—found that information that naturally occurs in the human genome could not be the subject to a patent, even if the patent covered the process of isolating that information from the rest of the genome. As with broad software patents, PERA would seemingly allow for the patenting of isolated human genes and connections between those genes and diseases like cancer.

This is a horrendously bad idea. 

Shut it down