Challenging the Constitutionality of Gene Patents: Ass’n for Medical Pathology v. USPTO

Association for Medical Pathology & ACLU v. USPTO & Myriad, 09-cv-4515 (S.D.N.Y. 2009)

Earlier this year, a group of organizations and individuals filed suit against the USPTO, Myriad, and individual directors of the University of Utah Research Foundation (ex parte Young action) demanding that the breast cancer gene patents (BRCA1 & BRCA2) be found invalid or unenforceable and that the PTO’s policies and practices with respect to genetic patents be declared unconstitutional. The federal lawsuit argues (1) that the genes are not patentable because they are “products of nature” and (2) that the patentee’s use of patent rights to limit scientific research on the genes violates constitutional First Amendment protections. The defendants moved to dismiss based on various standing and jurisdictional issues. In an 85 page opinion, Southern District of New York Judge Robert Sweet has denied all of the defendants’ motions to dismiss.

Judge Sweet recognized this case as important:

This action is unique in the identity of the parties, the scope and significance of the issues presented, and the consequence of the remedy sought. . . . The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific innovation in biomedical research.

Jurisdiction & Standing to Sue the USPTO: The court found that the overarching statutory scheme of the Patent Act did not preempt the court’s jurisdiction over the PTO in this case since the Patent Act does not “provide a remedy for persons who complain about the constitutionality of patents issued by the USPTO and/or the policies and practices of the USPTO. . . . The novel circumstances presented by this action against the USPTO, the absence of any remedy provided in the Patent Act, and the important constitutional rights the Plaintiffs seek to vindicate establish subject matter jurisdiction over Plaintiffs’ claim against the USPTO.”

The court also found that the plaintiffs have standing to sue the USPTO for their Constitutional grievances; declaratory judgment jurisdiction over Myriad and the Directors, and personal jurisdiction over the Directors as representatives of the State of Utah.

In the final few pages, Judge Sweet outlined plaintiffs’ case against the USPTO:

In this case, the Plaintiffs have pled sufficient factual allegations to satisfy the standard set forth in Iqbal. The Complaint alleges the existence of a specific, written policy for the patenting of genes and the parameters of the policy. . . . The Complaint further alleges that the information encoded in the BRCA1/2 genetic sequences, rather than being the result of an inventive process, exists in nature. . . . Based on these factual allegations, the Plaintiffs assert that the patents-in-suit grant Myriad ownership rights over products of nature, laws of nature, natural phenomena, abstract ideas, and basic human knowledge and thought in violation of the First Amendment’s protections over freedom of thought. In addition, the Plaintiffs assert that Myriad’s ownership of correlations between certain BRCAl/2 mutations and an increased risk of breast and/or ovarian cancer has inhibited further research on BRCA1/2 as well as genes that interact with BRCA1/2. As a result, the patents-in-suit are alleged to violate Article I, section 8, clause 8 of the Constitution which directs Congress to “promote the Progress of Science and useful Arts . . . .”

The facts alleged in the Complaint are plausible, specific, and form a sufficient basis for Plaintiff’s legal arguments. Consequently, the pleading requirements as set forth in Iqbal are satisfied.

The next decision in the case is expected in January based on the Plaintiffs’ motions for summary judgment.

MTD decision.pdf

88 thoughts on “Challenging the Constitutionality of Gene Patents: Ass’n for Medical Pathology v. USPTO

  1. Malcolm, I once only half joked that with the election of the great narcissist, that one would have to move to China to escape communism.

    That said, government funding during WWII and during the space race did bring a number of significant advances that may not have occurred so rapidly without its support. The government should support basic research, but even the government knows that giving private companies the patents on government research is the best way to bring new technology and products to market.

  2. “China has benefitted by being hostile to capitalism and, as anyone will tell you, so has the United States. Open your eyes, Ned.”

    Sure, but look what happened to the Mayans.

  3. Hans you do understand me correctly although I take issue with the last sentence. Patents can provide incentives for anything. So can sex with attractive people, or fear of death. That doesn’t mean that using such incentives is necessary or wise for accomplishing any desired goal.

    Ned: ” Do you really believe China would benefit by being hostile to capitalism?”

    China has benefitted by being hostile to capitalism and, as anyone will tell you, so has the United States. Open your eyes, Ned.

  4. Ned:

    I don’t recall Malcolm saying that patents weren’t important. He’s just mocking those who think that patents are a panacea. And he’s right, particularly when you’re talking about patenting the results of basic research. You know, stuff like causes, functions, and correlations. The notion that patents provide any, and I mean ANY, kind of incentive for basic research is absurd.

  5. Malcolm, OK, name me all the great drug and biotech advances coming out of any country that bans such patents or provides compulsory licenses? I am thinking, for example, of India — who are very hostile to such patents.

    Poverty and backwardness correlate well with a lack of protection of intellectual property generally.

    MM, do you know what happens when government gets involved in regulating economic activity? Shortages and surpluses of all kinds. When the commies took over the French revolution, they imposed price controls on bread and coal. What happened? You guessed it. No bread and coal. They had to sent out foraging parties to confiscate supplies at the point of a bayonet to keep the people of Paris warm and fed. Each day every citizen had to get in line at 4 in the morning, as supplies usually ran out by 8. The rich got fed. How? They bribed their way to the front of the line, that is how.

    Chavez the enlightened has similarly regulated the prices of food in Venezuela. What happened? You guessed it.

    Examples multiply. State direction always fails. As in the Soviet Union or Nazi Germany, you get a lot of guns, but little butter.

    In contrast, private investment always works to bring high quality low cost products to the people. The patent systems of England, the United States, Germany and Japan have a lot to do with their respective prosperity.

    China has caught on and is moving rapid to bring free enterprise and IP protection to China. Do you really believe China would benefit by being hostile to capitalism?

  6. “”How about if you discover a bacterium that is able to ‘eat’ oil and realize that you can use it for that purpose outside its natural environment? This has been patentend without any discussion on ethics or 101.”

    Difficult to assess what the problem is, if any, without seeing the claims.

  7. Ned: “Where, pray tell, does the money come to run the lab, etc., etc., etc.”

    They’re called “government grants” Ned.

    Speaking of which, folks are going to see more money like that soon in the form of Federal government aid to the states which will be necessary to prevent unemployment from rising. Remember that wingnut fantasy of private corporations stepping up to save the world because government was the worst thing ever? You know, Ronnie Reagan’s wet dream?

    It was a pile of b.s., sort of like the idea that if we don’t grant patents on everything under the sun that innovation will cease and the world will stop turning.

  8. “Imagine the technical progress that would have take place in the Roman Empire had they had a patent system? It boggles the mind.”

    Apparently it already has.

    Incidentally, recent archaeological research reveals that the Mayans launched a comprehensive patent regime in about 825 AD. However, the legislation was repealed a short time later amidst controversy over genetically modified chico zapotes. The civilization collapsed a few decades later.

  9. If this turns into an attack on the whole doctrine of claiming “isolated and/or purified” in any claim for any chemical previously existing in nature [typically buried along with millions of others in plants or animals], could it not have far wider patent law concerns? [Notwithstanding the fact that many such patents also have various method, product-by-process, and “new use” claims that could survive.]

  10. Agent G said: “One fundamental question here appears to be the notion that there is no motivation to perform research, if there is no private profit incentive on the results of that research.”

    Where, pray tell, does the money come to run the lab, etc., etc., etc.

    It is thinking like this that is so lame brained as to be unfathomable. I can hardly believe that any poster on a blog dedicated to patents such as this has no clue.

    Do people such as these have any sense of history? Why did England and then the United States take off technically, way ahead of everyone else? Why did Germany so closely follow? Why did Japan turn into the technical juggernaut it is? And why are countries that have been here for hundreds and hundreds of years show no technical progress at all despite having great universities?

    Got a clue yet?

    Imagine the technical progress that would have take place in the Roman Empire had they had a patent system? It boggles the mind.

  11. No one goes into science to get rich. However, many go into engineering to either make money as an engineer or to build a better mousetrap.

  12. “How about if you discover a bacterium that is able to ‘eat’ oil and realize that you can use it for that purpose outside its natural environment? This has been patentend without any discussion on ethics or 101.”

    (1) I thought that bacterium was engineered and not found in nature. To the extent it was found in nature then

    (2) I would say claims to using the bacterium to clean up oil spills after discovering this property would be patentable. Just like using knowledge of a gene sequence should be patentable. However, the bacterium itself to the extent it was not created by man (whether re-created in a lab or not) should not be patentable either. Even if it gets past 101, it should never get past 102 as it is not novel.

  13. There are sufficient ‘products of nature’ that should be (or already have been deemed) patentable. How about if you discover a bacterium that is able to ‘eat’ oil and realize that you can use it for that purpose outside its natural environment? This has been patentend without any discussion on ethics or 101.
    Several other examples in that area are readily available.
    Also in the area of chemical compounds (like drugs) that are avialble in nature (e.g. taxol, ergotamine and many, many other plant-derived chemicals) the inventions comprise nothing else than finding the compound, isolating it and finding a use for it.
    I do not see a basic difference between patenting of genes (and other compounds of the human or animal body, such as proteins) and patenting of chemical compounds that can be found in nature.

    Unfortunately, there are no equivalents in the electrical or mechanical arts where the same argument could be made. Possibly closest would be the finding of a new sort of subatomic alement (the newquark). If you would be able to isolate this ‘compound’ and find a use for it, I would say that you should be able to patent it.

  14. “Can it cut a PVC pipe in half and still chop a tomato like this?”

    Probably. Obsidian is exceedingly sharp; it’s being used for modern surgical applications.

  15. “There would be no polio vaccine, and there would be no space travel,”

    I agree. Jonas Salk refused to patent the polio vaccine for profit because he want to have the vaccine distributed as quickly and widely as possible, and he believed that patenting would have hampered this. When Salk was asked who owned the patent on the vaccine, Salk replied, “There is no patent. Could you patent the sun?”

    On space travel, it was and pretty much is still funded by public money; hence, the public owns the IP.

    Genes and cellular machinery and components are products of nature, and no patent should issue thereon. Patents based on methods of using genes and cellular machinery and components seem to me to be fair game as proper subject matter.

    Furthermore, I know of very few scientists (I can only think of one off the top of my head) who went into science with the only motive of making a buck. If that’s you’re motive, forget the science and get a business degree.

  16. One fundamental question here appears to be the notion that there is no motivation to perform research, if there is no private profit incentive on the results of that research. If we have devolved to such a sorry state, such that our economic system cannot accommodate science and research for a common public interest, then we have a very sad future ahead of us. There would be no polio vaccine, and there would be no space travel, if that had been the case with past generations. On gene patenting, I think we need to reevaluate our relationship to nature, research, and profits.

  17. “Mommy, how come nobody likes that “Mooney” guy? Oh wait, I think I know…”

    Yes, but don’t be afraid, Little Johnny. Go back to your clubhouse and work on your computerized method for recommending brands of bubble gum before some other genius invents it first.

  18. “That seems more like a software per se rejection than a “bilski” rejection.”

    Agreed, but the dozens of them I’ve seen in the last year were apparently inspired by Bilski. Before that, these only showed up occasionally, with regards to Beauregard claims (written by my predecessors – I hardly ever write them). The brilliant idea to apply these rejections to circuit claims is a post-Bilski phenomenon.

    Granted, none of these rejections have been maintained for very long (I only recall writing one appeal brief on this point), but it’s all a colossal waste of time and money. Frankly, my suspicion is that most of these rejections aren’t even believed by the examiners who write them, but are instead the result of instructions from an SPE to the effect of “Find some way to reject the claims.” I can’t prove it, of course, but I’m willing to give most of the front-line examiners the benefit of the doubt.

  19. That seems more like a software per se rejection than a “bilski” rejection.

    Sure that’s a bad rejection.

    But boy o boy, that claim looks ripe for a Benson based rejection. But maybe it wouldn’t apply, I’m not seeing the whole claim.

  20. “Historically I simply have to disagree. What with all the court cases constantly coming out. Benson, Flook, etc. etc.”

    You’re free to disagree. But keep in mind that these cases involve judicially created exceptions to statutory subject matter. They’re called that for a reason.

    “I would have to see those apparatus claims in order to have an opinion.”

    All of them? I’m not going to share my clients’ claims with you, but I can give you an example rejection. It’s been disguised, but the syntax and illogic are typical. These rejections have died off a little recently, but I was receiving several of these a week earlier this year. For the sake of argument, please accept my contention that these claims are of the form: 1. A whatchamacallit circuit … comprising a processing circuit configured to perform operation A, operation B (based on the results of A), and operation C (based on the results of B)… Now, what am I supposed to make of this rejection:

    “Claims 1-10 detail a whatchamacallit circuit. All of the limitations cited are capable of being software structures (see specification: wherein the “whatchamacallit circuit may comprise software-based logic for performing these computations” may be implemented in software); and therefore the claims are software per se.”

  21. BigGuy: “And yes, “you could sit on it” would be a substantial, credible utility for a sawn log, just as “you could pick your teeth with it” is for a toothpick. Both are substantially more credible than “I don’t know what it is, but I’m sure somebody would love to study it.”

    I agree with the last statement but — dare I say it? — you’re in strawman/non-sequitur mode. 101 utility, just like everything else in patent law, isn’t examined in a vacuum.

    Nutritional supplements for dog food are patentable and isolated sequence tags (to use a classic example of a composition failing 101) could certainly be used for as nutritional supplements for dog food. The problem is that the use is not a credible, substantial utility.

    A tiny piece of wood could also be used as a convenient perch for your pet fly or food for your pet termite. I submit that such a use is not credible and not substantial.

    I’m assuming, by the way, that 6’s “sawn log” is not just any sawn log but a *novel* sawn log, i.e., it is claimed just as the novel BRCA1 sequences are claimed, with sufficient specificity to remove it from the prior art (I somehow understood it as being the stump remaining after the tree was cut down). For example, the stump would be claimed with numerous limitations relating to its bark, the angle of the cut relative to vertical and relative to the ground, any irregularities in its surface, etc., just as the nucleotide sequences are expressly listed in the EST claims.

    Anyway, feel free to disagree with the conclusion (I’m not entirely convinced myself!). But recognize that 101 utility is not quite the slam dunk you think it is. Like everything else, there are nuances. Consider the analysis if the well-claimed stump is two feet tall but only 1 1/2 inches in diameter. Is “sitting on it” a credible, substantial utility (assume there isn’t a lubricious coating)?

  22. “I don’t think that has ever been Congress’ intent.”

    Historically I simply have to disagree. What with all the court cases constantly coming out. Benson, Flook, etc. etc.

    Plus, it seems to me, a gene itself (which is a natural occuring thing) having been separated from a mass of tissue being claimed simply as the gene separate from anything kind of preempts all uses of the gene itself ala Benson. I mean, doesn’t it? That could be somewhat of a problem.

    “The same goes for for the thousands of “Bilski” rejections in the last year that the patent corps has improperly applied to apparatus claims.”

    I would have to see those apparatus claims in order to have an opinion.

    In any case, you’re probably right about a log section.

  23. Jules, I’m not suggesting anything per se. It is just that if millions of dollars are spend to isolate genes that have specific utility and there be no possibility of protection against freeloaders, I think that only idiots would make the investment.

    Do you get my drift?

  24. Just as a follow up, from a post by Karl Enevold, PhD, over at IPWatchdog…

    “I have a major complaint with your statement ” Isolated and altered DNA does not naturally occur. Methods for detecting, screening and identifying do not naturally occur. Diagnostic methods and screening techniques are carried out by people”. With >300,000 SNP’s clearly identified by researchers and 10,000,000 thought to exist in the human genome, we are talking about DNA sequences that are known to exist naturally and technologies known to exist previously. Obviousness rules should have been utilized to invalidate these claims. Breast cancer and altered Brac sequences are naturally occuring in the human population and have been with us for 1000’s of years and not discovered in 2009, 1999, 1989, or even 1979. Molecular biology and specifically nucleic acid hybridization technologies, as well as sequencing technologies owe their existence to academic researchers from the 1970’s and maybe the 1980’s with the development of PCR; all supported by public funding.”

    link to ipwatchdog.com

  25. Ned: “given that the methodologies for finding the genes associated with a given physical phenomena are known, but expensive, would he search be conducted at all if the people spending the money on the research could not protect it from third party free riders?”

    I’m not quite clear on where this fits into granting a patent. Are you suggesting that such claims could be rejected under 103, but with evidence of secondary considerations, might be granted a patent?

    “Would the search be conducted at all?”

    I don’t know for sure. Has breast cancer been around since the beginning of human history?

  26. “You’ve stretched and perverted the words manufacture and process etc. so far that they no longer really have much meaning. I’m not sure if a court should allow that.”

    Actually, I just used the rather straightforward definition for manufacture out of Merriam-Webster. I think the real stretching and perverting is being done by those who are trying to convert 101 into a substantial filter. I don’t think that has ever been Congress’ intent. I don’t have any real problem with the judicial exceptions, and I understand the concerns over processes that are no more than human interactions or mental steps, but a suggestion that a human-manufactured log doesn’t even pass the 101 hurdle is silly, and a waste of time. The same goes for for the thousands of “Bilski” rejections in the last year that the patent corps has improperly applied to apparatus claims.

    “I’m not sure ‘you could sit on it’ is a credible, substantial utility for 101 purposes.”

    At least outside the biotech/chemistry area (not my field), where people apparently routinely create things that they don’t have the foggiest idea of what they’re good for, the utility prong of Section 101 simply isn’t that important. Attempting to turn it into a substantial filtering mechanism would raise far more issues than it would solve. Again, a red herring and a waste of time.

    And yes, “you could sit on it” would be a substantial, credible utility for a sawn log, just as “you could pick your teeth with it” is for a toothpick. Both are substantially more credible than “I don’t know what it is, but I’m sure somebody would love to study it.”

    In my humble opinion, that is.

  27. Terry Cole posted: “One suspects that a ruling in favour of patents on genes will not be honoured overseas (TRIPS provides for an ‘Ordre Publique’ exception). Where will this leave a BRCA patent?”

    You should know terry that the equivalent European BRCA patents have been granted – and met opposition. As a matter of fact both patent legal and ‘ordre public’ arguments were used in the opposition, but the European patent office has denied any merit in the ‘ordre public’ arguments. Nevertheless, especially the first BRCA patent has been limited to an extreme extent, basically having the result that this technology is now freely usable in Europe. Anyone wanting a read of the opposition and appeal following it should read the original decision:

  28. “Is Grok the caveman’s obsidian knife patentable?”

    Can it cut a PVC pipe in half and still chop a tomato like this?

  29. “It’s really not that complicated. If “the portion generated from a log immediately after a 2 ft in diameter tree is cut down” was produced by hand or machine, it’s a manufacture, and meets 101.”

    Could also be a 101 utility issue there. I’m not sure “you could sit on it” is a credible, substantial utility for 101 purposes.

  30. “You’ve conflated the issue by picking an example with serious 102/103 problems, but it’s still a product of human industry.”

    That’s not really conflating issues because I am setting aside the 102/103 issues for the moment.

    “Is Grok the caveman’s obsidian knife patentable? Or is it just a raw material that he chipped off a lava bed? ”

    Another great example. Same thing.

    Is Joe the researcher’s gene patentable? Or is it just a raw material that he separated from a mass of tissue?

  31. “Furthermore, let us assume I’m a clever enough drafter to somehow be claiming specifically the portion generated from a log immediately after a 2 ft in diameter tree is cut down. Patentable subject matter still?”

    Assuming that doesn’t read on a tree that fell over naturally, why not? You’ve conflated the issue by picking an example with serious 102/103 problems, but it’s still a product of human industry.

    Is Grok the caveman’s obsidian knife patentable? Or is it just a raw material that he chipped off a lava bed?

  32. Alright that’s one for patentable subject matter.

    Concerning your definition though Big, I might would say that this is the “raw materials” from which “manufactures” are later made. And I think that, were we in court, I could probably get expert testimony from a lumberjack or sawmill operator to show my side. Really all the process is doing is “harvesting” materials because we can’t move whole trees around very easily.

    Analogously one could say that genes are the raw materials rather than a manufacture.

    I believe you guys might be in for more of a fight on this gene issues than you think. You’ve stretched and perverted the words manufacture and process etc. so far that they no longer really have much meaning. I’m not sure if a court should allow that.

    In any case, one for. Who else?

  33. “Patentable subject matter still?”

    6, go read the definition of “manufacture”: link to merriam-webster.com . It’s really not that complicated. If “the portion generated from a log immediately after a 2 ft in diameter tree is cut down” was produced by hand or machine, it’s a manufacture, and meets 101. It might be anticipated by the well known activities of beavers, but that’s another matter.

  34. john, given that the methodologies for finding the genes associated with a given physical phenomena are known, but expensive, would he search be conducted at all if the people spending the money on the research could not protect it from third party free riders?

  35. I appreciate your attempts to help me out not6. However, my claim covers many things that are not toothpicks, just as it does things that are toothpicks, does that affect the analysis? Furthermore, let us assume I’m a clever enough drafter to somehow be claiming specifically the portion generated from a log immediately after a 2 ft in diameter tree is cut down. Patentable subject matter still?

  36. I’d like to point out that challenges to the unconstitutionality of laws under Article I, Section 8, Clause 8 (the IP clause) get rational basis review. See Eldred v. Ashcroft, where a challenge to the 1998 Sonny Bono Copyright Term Extension Act (CTEA)was defeated.

    Good luck with that claim!

  37. Patents on gene’s, on lab-created or purified genes do not in any way advance the art or lead to new studies. Identifying functions of particular genes do, but they are found in nature and therefore should not be 101 subject matter.

    (1) The methods of isolating or recreating genes should certainly be patentable assuming they are novel and nonobvious.

    (2) Using the genes or mdifications thereof should be patentable.

    I am not sure this judge’s decision is particularly good, but I do not understand how anyone can believethat patent claims to actual gene’s should be patentable.

  38. I have little understanding of patent law, but I am involved in genetic research. The first step of any genetic test, or almost all research, and some potential future treatments, on a gene is to make a purified copy of the region or gene. Doing this is both obvious at trivial beyond belief. (under a single £/$ a go in materials, goggle PCR, and yes it is illegal on patented genes without permission)

    Finding genes responsible for diseases is expensive but not at all novel, take a large number of people and use a set and standard methodology to link propensity towards diseases to regions using genetic “makers” which can be tested, then find genes in the area. Once you have done this tests for gene variants are also trivial, and could be made up by first year undergraduates.

    the only difficult step is the size of study needed thousands of people or more, but this is expensive not novel, in fact the methodology is entirely standard and quite old.

    Once someone has patented a gene product they are capable of, stopping any and all research or charging any amount of money legal within patent law for any genetic test or research at all, even if the test or gene turn out not to be linked to the original gene.

    several genes have been patented due to being in regions linked to cancer by such studies, but have later turned out to be false leads, the patents still stand and could affect anyone else who makes a treatment based on that gene.

  39. 6,

    While I don’t know how the claim would fare now, look at U.S. Patent 1,654,230, for example, a patent to a toothpick made from wood. (Presumably a separate and cut out piece from a log, as you require). There are quite a few toothpick patents out there, and probably many more patents drawn to other wooden implements.

    The toothpick is essentially an particular “isolated and purified” form of wood.

  40. “One suspects that a ruling in favour of patents on genes will not be honoured overseas”

    With a few exceptions, US Patents have no effect overseas anyways. What difference would a ruling upholding a US patent have overseas?

  41. Your anger is mis-directed, Christian. The history of patent law is replete with examples of inventions that would have made their inventors a lot of money, if they had been patented. It’s no wonder that patent attorneys push the envelope and it’s not fair to blame them when they do this.

    Me, I get upset about those politicians and judges who are not competent to define the patentability envelope. If the Rules are unclear, the Game turns into a farce.

    Are you with me on that?

  42. This is crazy. I’m a patent lawyer and I need to feed my family. If I can’t patent any crazy crap I demand, who will feed my children and pay for my golf club memberships? Come on judge, please show some integrity and get with the system.

    Yours

    Everythievinglawyer LLC

  43. I am still wondering, and perhaps someone told me the answer, but I have forgotten, is the following claim patentable under 101?

    A separate and cut out portion of a log.

    Does that pass 101?

  44. Kevin R. – Absolutely for patents the equivalent situation would be a 102 issue. But if I understand the Golan v Gonzalez holding correctly, the broader ratio decidendi is that the first amendment can trump IP rights where traditionally no such rights existed.

    If patenting a natural property such as human genetics is arguably changing the traditional contours of intellectual property, I reckon it would be vulnerable. But hey, I’m not the judge.

  45. “I struggle to apply Golan’s reasoning to gene patents. If the isolated sequence was ever in the public domain before patenting, then it would be a 102 issue, right? Can you help me to understand what I am missing?”

    Perhaps there is a privacy issue here. Can someone prevent me from isolating or sequencing a gene from my own body, using old techniques?

    Seems wrong, somehow.

  46. One suspects that a ruling in favour of patents on genes will not be honoured overseas (TRIPS provides for an ‘Ordre Publique’ exception). Where will this leave a BRCA patent?

  47. Terry Cole – I think that you’re right that Golan stands for the general proposition that under some circumstances, the First Amendment will limit congressional attempts at regulation under its IP clause powers. Thank you for bringing that to my attention. However, I read that case to stand for the proposition that you can’t let people rely on something being in the public domain, and then take it away again using the IP clause. I struggle to apply Golan’s reasoning to gene patents. If the isolated sequence was ever in the public domain before patenting, then it would be a 102 issue, right? Can you help me to understand what I am missing?

  48. ” I agree with your analysis of the claims. They cover isolated genes, mutations, and how to detect mutations. Isolated genes do no occur in nature, but are the product of man.”

    Ned,

    Thanks for seeing this as I do. What’s even worse is that the judge’s opinion mischaracterizes what these patents cover in the first 2 pages by adopting the characterization in the Complaint. For example, page 1 of the opinion says “the identified patent claims” “cover two human genes know as BRCA1 and BRCA2.” That’s simply not an accurate characterization of the claims covering the “isolated” genes. No wonder this opinion is so screwed up.

  49. Kevin R; it’s not a foolish idea to observe that the first amendment (say), which does not contain language explicitly repealing the IP clause of the constitution, leaves it undisturbed.

    That’s a fair summary of legal doctrine till quite recently. Your copyright analogy is particularly apposite, because it was a recent copyright case – Golan v Gonzales – which for the first time asserted that the first amendment can trump the IP clause. (Works which had been in the public domain were legislated back in by Congress).

    Where Congress has altered “has altered the traditional contours of copyright protection in a manner that implicates plaintiffs’ right to free expression”, copyright is vulnerable. I suspect gene patents will prove similarly vulnerable, especially in view of the widespread prohibition, even under TRIPS, of patents on medical treatment.

    One suspects that a ruling

  50. “I am not so sure you are right that the 11th amendment is limited to actions at law. Here is the 11th Amendment. It included actions in equity, which is the nature of an action to invalidate a patent.”

    Ned,

    I stand corrected. But the Ex parte Young doctrine still applies to allow unlawful actions by state officials to be enjoined (including authorizing actions infringing patents). The doctrine works by essentially “stripping” the offending official of sovereign immunity because of the unlawful activity. That’s why you see suits under the Ex parte Young doctrine against a named individual (not the state). Hope that makes sense.

  51. EG: I agree with your analysis of the claims. They cover isolated genes, mutations, and how to detect mutations. Isolated genes do no occur in nature, but are the product of man.

    Also, it appears that Myriad had guaranteed no to pursue anyone conducting pure research. They only intended to pursue commercial competitors.

    Most of the individual complainants only complain of lack of resources to get a test from Myriad. The test is available for a charge. As others have noted, Myriad competitors will also charge. There is no free lunch.

    The ACLU exists in a delusional world without property rights, where inventions appear from thin air, like fruit on the trees, and are the common resource of all mankind.

    I recall, somewhere, where these ideas were first written down. Robespierre? Marx? Something like that.

  52. EG: I am not so sure you are right that the 11th amendment is limited to actions at law. Here is the 11th Amendment. It included actions in equity, which is the nature of an action to invalidate a patent.

    “The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.”

  53. “Interestingly, the opinion doesn’t even address the sufficiency of the Complaint regarding the 35 USC 101 challenge of these gene patents as covering a “product of nature.” That’s the only challenge in this Complaint that might have any merit at all to move forward to develop the factual support.”

    Having now reviewed the patents involved, let me correct this statement I made earlier: there is no basis under 35 USC 101 for challenging these patents either. The claims are to isolated genetic material or methods for identifying/screening/detecting. In other words, the patentee isn’t simply claiming a “product of nature” (the claimed isolated genetic material doesn’t exist in nature).

    To put it bluntly, the plaintiff’s allegations that these patents cover “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought” are utterly groundless and complete rhetorical nonsense. As far as I’m concerned,this suit is a complete waste of judicial resources. I can only hope whichever appellate court (e.g., Federal Circuit) gets the appeal trounces this judge’s opinion and this suit.

  54. “Bootstrapping at its finest. The suit against the patent owners is for a declaration that the patents are invalid under 101. All they ever did is apply for and obtain a patent.”

    Ned,

    Let me be clear that I was only pointing out that the 11th Amendment doesn’t apply to suits that don’t involve actions for monetary damages against the states. If you look at my post at the beginning, I’m completely nauseated by the thought that this suit has gotten this far on nothing but an absurd and frivolous argument that getting gene patents is unconstitutional. This suit is but one of many reasons why I’m anti-ACLU (a hyprocritical, “two-faced” and “forked-tongue” organization if there ever was one).

  55. A quote for some other people:

    “In response to the questions about whether the hourly addition will be phased out, that rumor is false. Once the package is implemented, even if future changes are made to it, including termination of the entire package, I have committed that examiners will receive a net increase of at least one hour in time over their FY09 expectancies.”

  56. An aside for Noise:

    “There were several questions about a quote from a recent interview I gave that cited the administration’s opposition to the “sovereign function” language in the current patent reform legislation. I am opposed to the “sovereign function” language because it would block the US from participating in worksharing initiatives with overseas patent offices. I believe these initiatives have real promise, and do not support language in the legislation that could be misinterpreted to limit our ability to pursue work-sharing. Note however that worksharing should not be confused with taking examination responsibility and decision-making away from US examiners. Worksharing does not take examination responsibility or decision-making away from US examiners; it provides US examiners with another tool, like all the other tools we use, to enable our examiners to do the best possible job in examining applications having foreign counterparts.”

    Kappos

  57. Posted by: EG | Nov 03, 2009 at 09:01 AM:

    “I thought states had 11th Amendment immunity from suits in US District Courts.”

    Ned,

    Only against suits for recovery of monetary damages. Suits against state officials to enjoin them from unlawful activity (i.e., unconstitutional activities or in violation of federal statute) may proceed under the doctrine of Ex parte Young. See Pennington Seed v Produce Exchange case cited at 76 of the opinion.”

    Bootstrapping at its finest. The suit against the patent owners is for a declaration that the patents are invalid under 101. All they ever did is apply for and obtain a patent.

    If states are generally immune from being sued for patent infringement, they should similarly be immune from suits for patent invalidity unless they actually sue someone. I fail to see how one can remove the immunity simply by saying that the subject matter of the patents is not patentable under Supreme Court precedent.

    The alleged unconstitutionality is the policy of the USPTO in granting gene patents. Resolving that question will result is very broad damage to many issued gene patents. I would suggest that every owner of gene patents has an interest in the outcome of this action and should be able to intervene as a class.

  58. “”87 year old Judge Sweet”

    Sounds like a man that knows exactly what he is talking about.
    ———

    Word. To the extent that certain of the BRCA1 claims may have 101 issues (e.g., issues similar to those in the Prometheus v Mayo case) they may indeed present First Amendment issues relating to freedom of thought. It is clear, however, that not all of the claims objected to by the plaintiffs have 101 problems.

  59. Disclaimer:

    My knowledge of “all things genetic” lies some where between “nil” and “much less than nil”.

    Nonetheless, the import of this case does seem to transcend much more than just so-called “gene patents”.

  60. 87 year old Judge Sweet has handled many controversal cases and taken strong positions. E.g., He has “…expressed strong opposition to the United States War on Drugs, saying the drug war is “expensive, ineffective and harmful” and that only “gangs and cartels benefit from current drug laws”. In an interview with PBS, he said that the mandatory minimum sentence for drug offenses violates due process and separation of powers.”

    link to en.wikipedia.org

  61. Snarky – I hear you. I should have developed my position a bit more… I don’t think it is about which controls but whether one limits the other. The First Amendment was adopted with knowledge of the IP clause in the Constitution. Since the FA does not explicitly limit the IP clause, and since they left the IP clause in there, one could argue that the second in time was not intended to limit the first. To compare it to the 18th and 21st Amendments, see the first line of the 21st Amendment: “The eighteenth article of amendment to the Constitution of the United States is hereby repealed.” The second in time explicitly limits (repeals) the first.

    To think of it another way, consider copyright law. There may be very good First Amendment reasons why I should be able to photocopy some book and give the copies out to all my friends. But First Amendment aside (and not considering a fair use defense), it would be infringement all the same.

  62. I am curious what others may think about the prospect of an interlocutory appeal order being issued by the trial court.

    The allegations in the complaint that the trial court has held are sufficiently pleaded for the case to proceed are certainly matters of significant national and international importance, and the trial court’s footnote of “chips and carburators” notwhithstanding, the complaint does appear to have application to far more than simply genetic testing. It seems to put on trial the constitutionality, inter alia, of Title 35, 37 CFR and the MPEP.

    There has been much spirited discussion within academic circles concerning the metes and bounds of Article 1, Section 8, Clause 8 as implemented in Title 35. It will be most interesting to see how even those academics who argue for more narrowly defining patent law and its associated rights weigh in on this matter (as I expect they will certainly do to chalk up one more published article).

    Again, I am curious about how others may view the case. I assume this is a matter the defendants would like to present to the CAFC just as quickly as possible, and I likewise assume this is something the plaintiffs would like to avoid at all costs.

  63. “On First Amendment: Please see Article I, Section 8, Clause 8 – which all came before the Amendments.”

    That would make the First Amendment controlling. Its the laws passed later that we follow. Please see the Eighteenth and Twenty-First Amendment for a good example.

  64. The idea that the BRCA1 patent has inhibited research is laughable. Get on Pub Med and see how many papers have BRCA1 in the title or abstract.

  65. “On Policy: How about not using federal courts as a political soapbox?”

    Good luck with that. ;)

    While this baby step is a PR “victory” for the plaintiffs, I still have no doubt that they will fail miserably in their attempts to rid the world of allegedly evil so-called “gene patents” under current law.

    Whether they will eventually succeed in changing the statute to ban “gene patents” is another story. As long as Big Pharma or Universities see profit in these patents, however, these activists aren’t going to get very far, at least not with their present set of arguments and data.

  66. “Don’t they understand that this will lead to LESS gene testing as noone will commercialize these things!

    Also, the unpatented tests for other genes cost just as much as Myriad’s patented tests for the BRCA genes!”

    Your second sentence shows the problem with your argument in the first: companies HAVE commercialized unpatented genetic tests, so it is not true that the patent incentive is needed to bring these tests to market. Genetic diagnostics are not like drugs that require expensive FDA approval.

  67. Whaaaat?
    On 101: Isolated and/or purified.
    On First Amendment: Please see Article I, Section 8, Clause 8 – which all came before the Amendments.
    On Policy: How about not using federal courts as a political soapbox?

    Unbelievable….

  68. This suit seems likely to proceed as a DJ action by the individuals claiming to be personally threatened with patent infringement against the patent owner. But as noted, the far more serious standing issues here are as to all the other plaintiffs and defendants, which, as noted, got very little consideration in this initial decision. Will, or can, those other defendants try to get out of this suit by a mandamus action, or otherwise?

  69. Perry, as you know, patents aren’t granted in perpetuity. The are granted for limited times. If you’re going to start arguing public policy, then look at the big picture: how many medicines, methods of treatment, and methods of diagnosis WON’T be developed if the people investing time/money in that developent can’t make a profit, for a limited time, off their investment (i.e. if they know their investment isn’t protected)? How many more improvements to the human condition *will* result from allowing patents on those improvements – especially knowing that the improvements will become public domain in 20 years? I think this is a no brainer.

    In any case, looks like the judge just gave the CAFC a way dispose of the inevitable appeal without even having to get into the merits – standing is a precondition for the court’s jurisdiction.

  70. Don’t they understand that this will lead to LESS gene testing as noone will commercialize these things!

    Also, the unpatented tests for other genes cost just as much as Myriad’s patented tests for the BRCA genes!

    This whole thing is insane and misguided.

  71. True, a naked 101 attack is outside the statutory scope of a reexamination, but the arguments by the plaintiffs here, and others, include arguments that could have been presented as a 103 attack based on prior scientific literature. E.g., [in the recent words of one of them]: “the non-inventiveness of cDNA .. since mRNA does the exact same thing in our bodies, and has done so since evolution began.” With an inter partes reexamination based on prior literature support for that argument [assuming it exists], they could have taken that issue to the Board and then to the CAFC, without this “end run” direct [alleged] constitutional attack, which suits are normally legally disfavored.

  72. “I thought states had 11th Amendment immunity from suits in US District Courts.”

    Ned,

    Only against suits for recovery of monetary damages. Suits against state officials to enjoin them from unlawful activity (i.e., unconstitutional activities or in violation of federal statute) may proceed under the doctrine of Ex parte Young. See Pennington Seed v Produce Exchange case cited at 76 of the opinion.

  73. Interesting constitutional question indeed. The US gov’t and several universities spent millions and perhaps more to isolate the genes that contribute to certain types of breast cancer. Once isolated and published, anyone can look for these genes using common techniques and appropriate for their own use the valuable research of the original discoverers. Obviously, such research should be protectible by patents, otherwise the failure to protect the investment would short circuit future research.

    But on the other side are the form of the claims. The patents appear to be of two types: on the genes themselves and on “test and infer.” What one does with the information is not specified except to say that it is important in making proper medical decisions.

    We have spent many pages here over the last few months arguing “test and infer” as an independent Section 101 problem. This controversy presents the issue in a new light that requires thought.

    But the patents on the genes themselves do present problems. The Supremes have often said that while one cannot patent a natural phenomenon, one can patent a useful application of such. The test for the gene seems to be the useful application; but patenting the gene itself seem to directly present a constitutional problem; the patenting of a naturally occurring phenomenon.

    I look forward to the discussion.

  74. Paul,
    I don’t know what good filing of a re-ex would do (re your comment about failure to exhaust administrative remedies). Filing a re-ex doesn’t go to the question of the PTO’s policy that, e.g., BRCA1 is patentable SM. (Not that I necessarily agree with plaintiff here).

  75. The patents under challenge are owned by a number of parties including the UURF, an arm of the University of Utah, the Government of the United States, the University of Pennsylvania, and two private entities in Canada. The suit named only two owners.

    I asked in another thread, just how this is possible constitutionally. An action against a patent is not in rem. How is it possible to declare a patent invalid without joining all owners?

    Additionally, two of the entities are states agencies. I thought states had 11th Amendment immunity from suits in US District Courts. The issue of waiver was not discussed in the opinion.

    More on the other issues next.

  76. Isn’t there a public policy argument here? I remember distinctly the very first case in my Contracts hornbook (thank you, Prof. Monroe Freedman), Shaheen v. Knight, where a fellow who had engaged a doctor to perform a vasectomy sued the doctor for breach of contract when his wife became pregnant. As I recall (it’s been 40 years since I read the case), despite the fact that there was a breach under traditional contract law, the court held that the fellow was not entitled to damages, since it was against public policy to award damages for the birth of a healthy baby. Similarly, isn’t there an argument that it’s against public policy to monopolize for profit a cure for cancer via a gene patent that would prevent the deaths of otherwise healthy people?

  77. Did these standing challenges as to the PTO include failure to exhaust administrative remedies by [not] filing a reexamination, and/or the failure to address the controlling statutory issue before making an alleged Constitutional challenge?

  78. With all due respect to the judge here, allowing the constitutional challenges to these gene patents to proceed is turning this case into a farce. The opinion spends most of its judicial energy on the standing and jurisdictional issues, but only a mere 4 pages on the constitutional challenges issue. It remains my opinion that the constitutional challenges to these gene patents are absurd and unsupportable on any set of facts.

    Interestingly, the opinion doesn’t even address the sufficiency of the Complaint regarding the 35 USC 101 challenge of these gene patents as covering a “product of nature.” That’s the only challenge in this Complaint that might have any merit at all to move forward to develop the factual support.

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