You may die because of a gene patent that should never have been granted. The owner of that patent owns the gene that exists in your body. It’s private property. Well, according to the late Michael Crichton anyway. Good golly, that sounds frightening.
What should and should not be patentable has been the subject of debate – and legal disputes – for a long time. A particularly hot topic in recent years has been the propriety of gene patenting. For those interested in a thoughtful debate on this subject, alarmist op-eds like Crichton’s leave much to be desired. Rest assured that no one has or ever will own your genes. Gene patents cover copies of genes in an isolated form that does not occur naturally. The fear that Jude Law will knock down your door one day demanding royalties (or else!) because your kidney is “using” a patented gene is utter nonsense.
Generally speaking, things such as natural phenomena, laws of nature and abstract ideas cannot be patented. Thus, one cannot obtain a patent on gold, lightening or the theory of relativity. On the other hand, “anything under the sun that is made by man” is patent eligible, including microorganisms modified by the introduction of naturally occurring DNA sequences. Between these poles is a grayish area wherein lies the question of whether a naturally occurring compound or molecule that would otherwise be unpatentable becomes patent eligible once it is isolated or purified through human intervention.
It has been generally considered settled law that isolation or purification of bio-molecules is sufficient to render them patent eligible. The USPTO clearly adheres to this view (although given some of the inventions it allows, that gov’t agency’s view is certainly not above reproach), and it’s well-founded. For example, Louis Pasteur had patents on yeasts for making beer and wine. Before the advent of modern genetic research, the only way to make antibiotics was to isolate the microorganism that made the drug, which resulted in patents on antibiotics like lincomycin. Taxol, an anti-cancer drug produced naturally in the bark of the yew tree, is another example of a patentable natural product. More than 80 years ago, the only “treatment” for certain types of anemia was eating a pound of raw liver per day. Researchers worked for decades trying to identify and purify the component in liver that made the treatment effective after the discovery was first made (which resulted in a Nobel Prize). Finally, Merck succeeded in identifying and isolating that component – vitamin B12 – and obtained a patent on it. In an infringement suit, the defendant argued that vitamin B12 was a “natural substance” and therefore unpatentable. The appellate court disagreed, finding that Merck’s purified B12 was superior to natural B12 since patients no longer had to chow down a pound of yummy liver every day.
Against this backdrop comes Association for Molecular Pathology, et al. v. USPTO, et. al. In this case, various medical organizations, researchers and public interest groups, together with the ACLU filed a lawsuit against the USPTO, Myriad Genetics and the University of Utah seeking to have patents relating to isolated DNA molecules that encode naturally occurring proteins which are potentially useful in identifying a genetic predisposition to breast cancer declared not only invalid, but unconstitutional.
As a threshold matter, 88-year old Judge Robert Sweet broke new ground in jurisdictional jurisprudence by allowing members of the public with no reasonable apprehension of being sued for infringement to challenge a patent’s validity and the USPTO’s interpretation of substantive patent law. Feeling his oats, Judge Sweet then penned an even more controversial 156-page opinion on Monday holding that isolated DNA is not patentable subject matter:
The claims-in-suit directed to “isolated DNA” containing human BRCA1/2 gene sequences reflect the USPTO’s practice of granting patents on DNA sequences so long as those sequences are claimed in the form of “isolated DNA.” This practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character. Many, however, including scientists in the field of molecular biology and genomics, have considered this practice a “lawyer’s trick” that circumvents the prohibitions on the direct patenting of DNA in our bodies but which, in practice, reaches the same result. The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.
Why is this controversial? Well, for one thing, the USPTO and the courts have until now uniformly held the position that genes are just chemicals regardless of the “biological information” they contain, and isolated genes are not products of nature because they are chemically different than genes in their native state. Now a court has said that genes are more than just chemicals. Vitalism has become a principal of patent law, at least to one trial judge. Secondly, this exception for DNA carved out by Judge Sweet, if upheld, will essentially invalidate many thousands of gene patents, and potentially other biotech patents as well.
However, that is no small “if.” The Court of Appeals for the Federal Circuit, which hears all appeals in patent cases, is made up largely of patent savvy judges and is generally viewed as a patent-friendly venue (or at the very least, it is not patent-hostile). As such, it is not likely to pull the rug out from under investors who have believed for the last 30 years that these sorts of inventions are patentable and have pumped a huge amount of resources into the biotechnology sector as a result. Moreover, the CAFC is not shy about torching trial judges that make flippant characterizations of patent law, such as the notion that the well-established practice of isolating or purifying naturally occurring molecules is some kind of patent “lawyer’s trick.” Further, Judge Sweet has left many patent lawyers scratching their heads at his (mis)reading of several precedents en route to arriving at his decision. The CAFC may very well weigh in on that, too.
Judge Sweet mercifully stopped short of holding the entire patent system unconstitutional, dismissing claims that no one but the ACLU could bring – that gene patents violate the First and Fourteenth Amendment, and that gene patents actually impede the advancement of science and medicine in violation of the Patent and Copyright Clause. The First and Fourteenth Amendment claims are cutting edge, to put it charitably. The claim that patents impede rather than promote progress is pretty wild as well, although it’s an argument that has gained modest traction due to a vocal anti-patent community. It’s an argument that also happens to run counter to the great weight of empirical evidence.
Prediction: This decision gets reversed on appeal and the Supreme Court denies cert.
Regardless of what happens, the gene patenting debate has a limited shelf life anyway. The human genome has been mapped and most gene sequences were published prior to 2000. All gene patent applications filed at that time will expire in 2020 (the vast majority without being put to any practical use), and any publicly disclosed genes that weren’t filed on by 2000 are barred from patenting by statute.
The problem with patenting a gene is that it is not a “technology”. In the case of the BRCA1/2 gene in question, there is absolutely nothing they can do with the gene itself that will bring profit or stimulate innovation. The way they make profit off of it is by making a test that detects it. So by patenting it, they are monopolizing the market around that gene, and preventing others from competing by making a better test, or to look for other actions of that gene.
As a medical pre-professional, my concerns are that in the case of patenting a gene, 1) you did not create anything, 2) there is unknown variation among the human population with regards to every gene (how do you patent ambiguity) 3) even with strict standards requiring you to demonstrate that you know of an effect of that sequence of DNA, thus classifying it as a gene, a patent gives you an ownership of it that far exceeds the true knowledge you have of its functioning and interacting with the body. The idea that you can patent it because “it is not in the same form it is in the body” is ludicrous because each genes are not static. They do not have one “form”.
Perceptually, I think of it like language, which is a very common analogy. Each base of DNA is a letter. No one is going to let you patent any letter that you don’t specifically create (and people DO create, modify, and patent their own nucleotides). A gene is a phrase, as functional arrangement of letters. Again, you can’t copyright any ordinary phrase, but you can do it to a unique slogan, and even then you wouldn’t get in trouble for using it casually. If you wanted to make up your own brand new language or a new way of printing or an ebook reader, by all means – have at it. But don’t go stamping logo your on “Let’s eat, mom!”
The quoting of 6 articles is impressive, but hollow. On inspecting them I found:
The NIH article you quote concludes, “Whether this swing of the pendulum will help, hurt or have no effect on innovation and the progress of science remains an open question.” Not exactly damning, but far from supportive, either.
The Social Science Research Network article (what information is provided in the abstract) does not relate to the issue of progress, but rather to gene ownership and current legal disputes involving genetic patents.
The article headed by John Walsh of U. of Chicago, as well as the genomedicine article conclude that patents do not hinder research because people ignore them. The implication is that if at some point in the future patent holders became more stringent in enforcing their patents, it could have a negative effect on “progress”
Your strongest support comes from the Project on Science and Intellectual Property in the Public Interest, funded by the AAAS, dealing with the issue of intellectual property (IP) in general.
Most of the investigations above also look into whether people had to stop research due to patents (which 99% of the time they did not, because they ignored them). What they did not ask, and which would be very hard to find out, is how often researchers could not even begin a project because they did not have access to IP.
Well now I Must say, this is truly a very fascinating & important Guestpost (and Comment). Congrats & thanks, Joe Mama & seth.revels. (Not that I think this issue rivals College Basketball in significance or anythinglikethat but still, it’s Good. 😉 (Any chance we might read a further expert opinion from oldtime commenter Dr Mike Wiser ~ y’know, Matt’s Brother Mike ~ on the matter?)
Yes but does this mean that when the CERN/LHC boys finally Find ~ or, re-Create ~ the Higgs Boson, they can’t Patent it? Sniff 🙁
Seth,
I’m not sure how you’re defining “technology,” but if you mean it has to be something “that will bring profit or stimulate innovation,” those are not requirements for securing a patent. 95-99% of all patents are not commercialized. Moreover, the whole purpose of a patent is precisely to provide the inventor a temporary monopoly on that invention. In the case of gene patents, the invention is the isolation of the coding sequence (mRNA) used to produce the protein by splicing out all the “junk” DNA introns that don’t encode the protein and then converting it to cDNA, which is what is cloned, sequenced and patented. The cDNA that is the basis for gene patenting does not exist prior to being synthesized in a lab by a scientist. You probably recognize that that is not an easy thing to do. You may also recognize that most of the companies in this high risk area where most of the products fail are small companies like Myriad. If there is no way for investors in these companies to get a return on their investment, then investment disappears, along with many of the drugs and diagnostics techniques that the biotech industry has developed over the last quarter century. And in many cases gene patents protect not just genetic testing, but actual medicines and therapeutics, which often require billions in investment to develop.
Despite the temporary monopoly provided by patents, it’s simply not true that gene patents prevent researchers from “look[ing] for other actions of that gene.” For example, hundreds of researchers have written thousands of papers on their work with BRCA genes, some as recently as last year. Now, could Myriad have sued all these researchers? Yes. Why didn’t they? Because spending millions of dollars to litigate an infringement suit against researchers who don’t compete anywhere in the marketplace and who haven’t commercialized any product or service that you can obtain any damages on is a profoundly stupid way to go about enforcing your patent. I’ll grant you that essentially ignoring infringement may sound like a funny way to go about defending the merits of gene patenting, but the reality is that it’s commercial use of the isolated DNA that is sought to be precluded, not research use. The chances that “at some point in the future patent holders became more stringent in enforcing their patents” by suing scientists in large enough numbers to have any chilling effect on research are zero (at least as long as businesses continue to operate as businesses).
The NIH article you quote concludes, “Whether this swing of the pendulum will help, hurt or have no effect on innovation and the progress of science remains an open question.” Not exactly damning, but far from supportive, either.
The full conclusion is actually quite supportive:
Oops, looks like I used one too many blockquotes 🙂
Joe Mama – have you taken out a patent on this seemingly troll-proof post ? (And, yes, stipulated that the post is clearly neither leprechaun- nor clurichaun-proof) …
Patent law gives the patent owner 20 or 14 years (depending on type) until anyway may use it. Given that these genes have been around much longer than that shouldn’t the patents be public domain now anyway 🙂
Yes but does this mean that when the CERN/LHC boys finally Find ~ or, re-Create ~ the Higgs Boson, they can’t Patent it? Sniff 🙁
Well, U.S. Patent No. 3,156,523 covers element 95 (americium) and U.S. Patent No. 3,161,462 covers element 96 (curium).
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