Controversial U.S. bill would lift Supreme Court ban on patenting human genes
sciencemag.org
sciencemag.org
Logically, if they exist by default and we are making observations about them, then how do we get to patent/own the very idea of them? An absurd parallel would be Charles Darwin patenting a giant tortoise - an entity that exists in nature - upon his discovery and requiring a license fee each time a natural history museum displayed one.
But that's one side of the story; what's the argument for the bill? Is there a logical reason why the patent system should be expanded to include entities you observe in nature?
I am sure the above can be formulated with more precision and panache, but as far as I can tell, I'm not sure what the equivalent set of ideas are for the people arguing for this bill. The best that I can come up with is an appeal to utility (i.e. it would incentivize X, Y or Z). However that's not a strong enough argument - what's the "steel man" that's missing from this conversation?
"But then why would those companies finance the research to identify and understand genes ???"
Yes, the answer to that takes about 10 seconds (less if you're aware of the concept of gene therapy), but that's mostly all they have to go from.
It already has.
The argument for is that another monopolistic Monsanto is potentially created with sufficient coffers to keep politicians who support this bill in a lot of money for a long time.
The idea is to find man-made process involving something unpatentable and patent that process. The pharmaceutical industry is doing it regularly. And I would say it is the patent system working as intended. Others can still do research on that flower and you get rewarded for your discovery.
These two articles discuss some of the thoughts about why the BRCA patents were considered valid by a number of legal experts:
https://www.nytimes.com/roomfordebate/2013/06/06/can-the-hum...
> But Myriad’s patents don’t cover genes in their naturally occurring, unisolated form, just as the aspirin patent did not cover chewable bark. Rather, the BRCA1 and BRCA2 patents claim the genes as isolated, purified and used in a scientific or medical context.
> Thus, Myriad’s patents cover the same “composition of matter” that these patents have always covered, and which built the modern pharmaceutical industry in the early 20th century.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3979127/
It's at least not as simple as saying that these patents are just patenting the genetic sequence and anyone who even looks at them is violating patent law and that somehow others own the genes in our body.
You said:
> They enforced it against anyone else who wanted to test for mutations in the gene.
Anyone could be tested for mutations in the gene (in fact, 23andMe tested for those specific SNPs and you could see it in your raw data). What Myriad patented and enforced was using this in a specific medical context, as I understand it specifically a medical diagnostic test. Here is the BRCA1 patent: https://www.google.com/patents/US5747282
This is the abstract:
> The present invention relates generally to the field of human genetics. Specifically, the present invention relates to methods and materials used to isolate and detect a human breast and ovarian cancer predisposing gene (BRCA1), some mutant alleles of which cause susceptibility to cancer, in particular breast and ovarian cancer. More specifically, the invention relates to germline mutations in the BRCA1 gene and their use in the diagnosis of predisposition to breast and ovarian cancer. The present invention further relates to somatic mutations in the BRCA1 gene in human breast and ovarian cancer and their use in the diagnosis and prognosis of human breast and ovarian cancer. Additionally, the invention relates to somatic mutations in the BRCA1 gene in other human cancers and their use in the diagnosis and prognosis of human cancers. The invention also relates to the therapy of human cancers which have a mutation in the BRCA1 gene, including gene therapy, protein replacement therapy and protein mimetics. The invention further relates to the screening of drugs for cancer therapy. Finally, the invention relates to the screening of the BRCA1 gene for mutations, which are useful for diagnosing the predisposition to breast and ovarian cancer.
Here is the insulin patent: https://patents.google.com/patent/US1469994
And here is the adrenaline patent: https://patents.google.com/patent/US730176
These are both things naturally occurring in the body.
Profit. Pharma and biotech corporations fund political campaigns, and in exchange they want laws that allow them to extract more profit. That's pretty much how the political process works.
The question is, will it be really faster in the average case? The dumpster fire in software patents is that they often cover what anyone would, and often did, discover independently relatively quickly when first facing the problem.
As Joel Spolsky has put it:
>The number of actually novel, non-obvious inventions in the software industry that maybe, in some universe, deserve a government-granted monopoly is, perhaps, two.
>The other 40,000-odd software patents issued every year are mostly garbage that any working programmer could “invent” three times before breakfast. Most issued software patents aren’t “inventions” as most people understand that word. They’re just things that any first-year student learning Java should be able to do as a homework assignment in two hours.
I have no idea what would be the case in genetic biotech.
The rest, then, is the standard argument for patents and copyright: it takes money and time to investigate this and create a product that is useful. That investment makes no sense if the product can easily be reverse engineered on day one. Even if you could protect the knowledge through some sort of obfuscation, the public is better served by granting you a patent, because the latter is time-limited and the forced publication of your knowledge helps to build on and critically assess the product you are selling.
I generally don’t quite get the distinction b/w “invention” and “discovery”. I guess the idea is there is a limited amount of knowledge to “discover”, but inventions are theoretically unlimited? I’d love to hear from someone who is pro-patent for one category but not the other, preferably with real examples and not “what if you patent gravity?”
The bill replaces that with a “product of human intervention” test: https://www.jdsupra.com/legalnews/legislators-propose-patent.... The end goal is similar, but in theory it’s easier to define what inventions are the product of human intervention, versus ones that are naturally occurring.
More discussion here: https://www.jdsupra.com/legalnews/legislators-propose-patent...
Incentive - I'm not sure why you dismiss this, as it is an important part of the justification for intellectual property laws in general. Lincoln said "The patent system added the fuel of interest to the fire of genius," a quote that is carved into the stone of the Dept. of Commerce building in DC.
Constitution - Article 1 Section 8 says "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." Identifying a gene and its function would seem to qualify as a discovery.
Social - A key feature of patents that is often overlooked is that they are public records. The idea of a patent is not just to secure a temporary monopoly, but to use that temporary monopoly as compensation for public disclosure of a trade secret. The patent expires and then the idea is public knowledge and free to use. This is in contrast to ideas and information that might be kept secret and never divulged to the public.
Philosophical - Is math discovered or invented? There is not universal agreement on this. Likewise, what about something like a vaccine, which is simply a special preparation of naturally occurring materials that trigger your naturally occurring immune system? Which part was invented, and which part discovered? Ultimately it's arguable that humans are naturally occurring phenomena, and all of our works are simply re-arrangements of materials and energies that are themselves naturally occurring. If the distinction between discovering and inventing is up for debate, it follows that related laws are too.
I don't actually believe that genes should be patentable, but I do believe in being able to articulate opposing arguments for consideration.
How can we compete with China if we don't <have a surveillance state>/<edit embryos with CRISPR>/<patent everything possible>/<eliminate all protections for laborers>?
Much like Europe has with the US, there is an argument to be made that we should just let them have their piece of the world and return to living happy, normal lives that are less stressed and more focused on being good to one another.
They have nothing to do with China.
Russia
Japan
Asia in general
Terrorists
Immigrants
They don't always result in the same choices, but the instincts are similar.
I'm not sure how to quantify that, but let me see if I can say this. I don't hate my neighbor because they're different from me, but I will say that it is human nature to be tribalistic.
So generally I don't think that there is anything to reconcile there.
but this would mean we'd have to actually produce things again..
EDIT: Ok that was argumentative, but really children do not have a choice to be thrown into this world, and to think that there is someone who knows better about how this should be done is the absolute highest hubris.
Ummm, have you seen Gattaca? Let me spoil it for you: it doesn't end well. Every reasonable scientist working in CRISPR is against editing the human germline. Here is a good piece on it:
https://www.nature.com/news/don-t-edit-the-human-germ-line-1...
Also note, why do you assume that "we" would be in control? Suppose a government took control of your genome? Or a private company? Given the expense there is almost no way it would be democratic.
"We" will be in control because embryos cannot be edited without a process that is essentially IVF. If governments are going to force this on women, we have bigger problems to deal with. It will be as straightforward as a couples using the technology to select for and against certain straightforward traits.
In the world of Gattaca we see that only a few religious nut jobs inflict natural conception on their children. They are called god-born because they are the product of religious extremists. Genetic engineering is common and accessible to all classes. For example portable genetic testing services so ubiquitous that they are available at company party.
As viewers, we should take away what I means to choose to cripple another human permanently. You should think long and hard about winning Jesus points for a second life by consigning a real person with the same ability to feel and dream to Hell in this life.
Argument from fiction doesn't work, because the evidence is fictional.
I don't understand precisely how "reasonable" is defined here. It's a subjectively loaded notion as it is, and I feel compelled to express a lot of skepticism toward any claim of "every reasonable person is of the position I'm currently taking".
Gene work prior to life; yet another term with much debate; is not the real issue, it is what happens to the life that comes of it. What are the rights we will apply to a person or animal that was modified by gene edits? Animals are pretty much a wash as society only distinguishes between pets and livestock within certain societies.
So how do we address people born of this work? Are groups going to demand that certain work is never done? Just look at current news around the world for some points of contention. People are always point towards issues which they assume cannot be disputed, deadly birth defects or handicaps that prevent a self fulfilling life. However what if, provided it can be done, if groups decide to limit the number of births of one sex? Or say, should it ever be provable, if homosexuality is genetic, would we disallow removing the combination? A dictatorship that decides to create a modified race of brain addled fighting men?
Then consider all the effects on competitive areas, from sports to education. Would engineered humans be afforded the same consideration or locked out?
It is actually not directed to gene patents specifically, but totally overhauls section 101 of the patent act, which addresses what kinds of inventions can be patented. The part that draws concern is the following:
> No implicit or other judicially created exceptions to subject matter eligibility, including “abstract ideas,” “laws of nature,” or “natural phenomena,” shall be used to determine patent eligibility under section 101, and all cases establishing or interpreting those exceptions to eligibility are hereby abrogated.
Those judicially creates exceptions have been used to preclude patenting of genes, algorithms, etc. On the other hand, the law offsets that somewhat by beefing up the utility requirement:
> The term “useful” means any invention or discovery that provides specific and practical utility in any field of technology through human intervention.
That totally new requirement will be construed by courts, but seems to be directed to limiting the effect of the previous paragraph.
In the land of pure speculation, I think gene patents will still be invalid under this new section 101, because the invention must arise through “human intervention.” The bigger effect will probably be on software patents, where the “abstract idea” exception is heavily used, but where the “human intervention” test will certainly always be satisfied.
For a body of text like that, isn't copyright the more appropriate IP construct?
A patent might be valid if it referred to a particular process for synthesizing that gene in the form of a DNA molecule.
Patent law is a bit nonsensical, IMO. It doesn't handle the real world well.
I think it's why decisions about things like the copyrightability of APIs have been so complicated; the law has still never deeply grappled with the question of how to harmonize the several deeply different legal regimes that "executable expressions" can be affected by. What is the set-intersection of patents and copyrights? That's a really thorny question if you sit down and try to take it seriously.
I've heard anecdotally that that's why there's so many cooking blogs that bloviate endlessly about how the recipe will look when it's done and what it made them feel when they ate it first and maybe just a bit of history about the region where it's from before finally almost-begrudgingly consenting to share the recipe, because that's all copyrightable content that can't be legally stolen, whereas if they just posted a bare recipe, anybody could walk off with it.
https://www.tillis.senate.gov/services/files/E8ED2188-DC15-4...
Relevant quote: "No implicit or other judicially created exceptions to subject matter eligibility, including “abstract ideas,” “laws of nature,” or “natural phenomena,” shall be used to determine patent eligibility under section 101, and all cases establishing or interpreting those exceptions to eligibility are hereby abrogated."
If the court is interpreting a law passed by the legislature, the legislature is free to change the law. In effect, they would be saying "no, you misunderstood us--the law should be interpreted this way and we're revising it so that's clearer." Sometimes the bill drafters are very explicit about this, including a statement in the preamble to the bill or in the legislative history that the bill is being drafted for the specific purpose of overriding X decision.
(Tracking this is challenging--see this article for a good discussion https://www.repository.law.indiana.edu/cgi/viewcontent.cgi?a...)
On the other hand, if a court finds that a law is unconstitutional, that means that the legislature does not have the authority to pass the law to begin with. A constitutional limitation can't be overridden by statute.
In this case, the Patent Act is a law passed by Congress and can be changed by Congress within the limits of its constitutional authority.
In the United States, the legislature most certainly has the authority to modify the Constitution and has done so on several occasions.
(State constitutions vary in how they can be amended.)
No other authority has to approve before the change goes into effect, and the Supreme Court will go along with such changes even if they change court precedent unless the law violates the constitutional restrictions on Congress. Most proposed laws don't, including the one we're discussing here.
By contrast, for a federal constitutional amendment, even if every single US Senator and every single member of the House of Representatives votes yes (note that the President is not involved in this process), if the states take no action, no amendment happens.
Very different.
Not necessarily. If a law is found to be unconstitutional, that might only mean that some provisions exceed Congress's authority. They can always modify the law, and amend it in order get around the unconstitutional aspects. Not all constitutionality decisions are as black-and-white as that.
In these cases, though, (and I'm not a lawyer!) the existing decisions are on weaker grouns. The court held that nothing in the constitution or the legal charter of the USPTO gave it the power to allow protection for things like gene, software or business method patents. So trying to regulate them was beyond the powers granted to the government by itself.
So you fix that by writing a law spelling out more clearly what the USPTO is allowed to do.
The actual language in the constitution itself is very broad: "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". It's extremely hard to read a ban on gene patents in that, IMHO.
You are probably thinking of cases where the Supreme Court has found laws to be unconstitutional. In that case, the legislature has two options: change the law so it's constitutional (might not be possible if the fundamental aspects of the law was to found to be unconstitutional), or change the constitution to accommodate the law (hard because it requires a supermajority of state legislatures to pass it). Both options are available to the legislature and once either is done then the Supreme Court ruling is either no longer applicable (if the law was changed) or possibly completely invalidated (if the constitution was amended).
We have, as a society, shifted much of our research and development to the private sector. It should be no surprise that the private sector now seeks to recoup their expenditures by protecting them by whatever means necessary.
[0]https://www.supremecourt.gov/opinions/12pdf/11-796_c07d.pdf
Isn't that backwards? If they don't have comparable restrictions, why hamstrung American companies by making them respect patents that Chinese companies don't have to respect?
If you're curious about hearing a non-straw-man opinion about "gene" patents, I'd suggest this short article that discusses the BRCA patents and least describes what the patents were actually about. If you're really curious, there are longer more comprehensive sources than this opinion piece:
https://www.nytimes.com/roomfordebate/2013/06/06/can-the-hum...
> Of course, the patent system only protects new things. You cannot get a patent on the raw, untouched form of a molecule as it exists in nature.
> However, you can get a patent for identifying, isolating and purifying something that already exists in the world. For example, the inventor of aspirin at the turn of the 20th century isolated and synthesized the active ingredient in willow bark, which people had chewed for thousands of years to relieve pain and fever.
> The greatest confusion in the debate about the Myriad case stems from failing to understand this distinction. Unfortunately, the Supreme Court contributed to the confusion when it took the case to answer: “Are human genes patentable?” Patent experts scratched their heads, because the answer is undisputed: No, human genes in their naturally occurring form are not patentable.
> But Myriad’s patents don’t cover genes in their naturally occurring, unisolated form, just as the aspirin patent did not cover chewable bark. Rather, the BRCA1 and BRCA2 patents claim the genes as isolated, purified and used in a scientific or medical context.
The gene patents are "composition of matter" patents that apply the genes to particular contexts. I'm not going to argue about the appropriateness of those patents here (which would also seem to apply to the aspirin patent), but I do think it's important to understand what the actual debate is about.
For example, it's also almost certainly false that gene patents covered the entire genome (a response here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3979127/ ), and it's false that just because one component of a patent mentions a genetic sequence that all use and research of that genetic sequence is a violation of the patent (because the patents include more than just the gene sequence -- they are a specific application).
That means Congress can always just change the law.
The Supreme Court didn't say "gene patents are unconstitutional" they said "patents under this x,y,z regulation don't fit x,y,z part of the constitution being argued, we agree/disagree with the lower court". So Congress changes x,y,z regulation with a,b,c law to provide clarity, and it may create the same outcome as before, amongst other outcomes.
If the Supreme Court ruled against the merits of a specific law that Congress passed, then sure Congress could not make another law to overrule it (well it would be immediately stayed by the courts).
Here the Supreme Court ruled against an OUTCOME of a law that doesn't exist. They ruled against interpretations of a patchwork of nuanced regulations which never had any legislative guidance, which resulted in the aggrieved party not being able to enforce their gene patent alongside the patent examiners not approving any more of them.
Congress is now ending this mess by providing that missing legislative guidance.
+ Congress has the power to propose law. + The court has the 'checking' power to rule on the law. + Congress has the 'checking' power to change the law to invalidate that ruling. + The court has the 'checking' power to rule a law unconstitutional. + Congress has the 'checking' power to change the constitution to invalidate that ruling.
Congress always has the power to override the court.
They are proposing a law that directly addresses a Supreme Court interpretation of existing law.
Happens often, Supreme Court says law X doesn't mean Y and if you want it to mean that then rewrite it to say so.
When they rule on a matter of statutory interpretation, the bits of federal common law that still exist today, or other federal grounds for a decision that aren't about the Constitution, an Act of Congress is plenty sufficient to change that by eliminating or modifying the basis for the decision.
In reality, I don't think we're going to stop trade with China, I'm just saying I'd be okay with it and that surface-level concerns with such an idea are easily solvable.
We detached this subthread from https://news.ycombinator.com/item?id=20104483 and marked it off-topic.