A unanimous Supreme Court invalidated a patent on a diagnostic method for helping doctors safely administer thiopurine (TP) drugs that are used to treat autoimmune diseases such as Crohn’s disease and ulcerative colitis. Prometheus Laboratories (Prometheus) found that a certain compound 6TG could be administered with the TP drug and the level of 6TG in the blood measured with a specific level indicating more TP is needed and another specific level indicating less TP is needed. This was important to have enough TP to be effective but not so much as to be unsafe, as excessive dosage was potentially lethal, but had yet to be achieved because different people tolerated different amounts and different people required different doses to be effective. Prometheus solved that riddle with this invention. Specifically claim 1 of the patent directed to a method of optimizing treatment of an immune-mediated gastrointestinal disorder had 2 steps, first administering a dose of certain medicine containing 6TG, second measuring the level of 6TG in the blood, and 2 wherein clauses, first that 230 pmol/ 800,000,000 red blood cells (“units”) indicated a need to increase TP dosage and second that 400 units indicated to decrease TP dosage. Prometheus licensed manufacture of a diagnostic kit based on the patent. That Prometheus invented this was not in doubt. Mayo Clinic wanted to use the patented method without paying Prometheus so began selling kits and challenged the patent on the basis that it was an unpatentable as claiming a law of nature. That Prometheus discovered this alleged “law of nature” was not in dispute. That they spent lots of money inventing it was not in doubt. That it was valuable was not in doubt. That it was a major advance in TP treatment methodology was not in dispute. Yet, the trial court nevertheless agreed with Mayo that it impermissably claimed a law of nature and was invalid. However, on appeal the Federal Circuit (twice) held it patentable. The Supreme Court reversed, and went unanimously for Mayo, declaring the patent invalid as claiming a law of nature.
Was it correct or a travesty of justice?
The reviews have been mixed, with Patently-O, law.com and biotech blogs publishing posts suggesting the Supreme Court blew it as the claim was really to a diagnostic method not a law of nature, and may invalidate all diagnostic method patents and medical treatments patents and will reduce the incentive to develop such treatments and thus slow the progress of medical science.
On the other hand, the anti-patent lobby is rejoicing, saying this is good because such patents lock up life-saving medical treatments and make medical care much more expensive and this will encourage development of new treatments utilizing the methods declared unpatentable.
It’s a hard case with both sides having good points. We join those concluding the Supreme Court blew it. The founding fathers already decided oppositely when they created the patent system, and the first patent was to a method that merely claimed a law of nature, that heating soda ash a second time would give a higher purity of potash. The founding fathers were Deists and individualists who believed in a natural rights theory of property, namely that property comes naturally as the fruit of labor and not from a King or Church, and that intellectual property rights are the rightful fruit of original creative intellectual labor and serve as a just reward for the effort of inventors. They also believed that exclusive manufacturing and sales rights belong rightly to the person(s) who invented the thing being made or sold, because when invented it was solely in the mind of that person unknown to the world and thus actually in the inventor’s exclusive control, i.e. his or her “intellectual property”. To encourage inventors to give their inventions, their “intellectual property” to the public, James Madison proposed that the Government grant patents to the first and true inventor rather than, as King George did, to some special friend or rich patron of the King/Government who really did not exert the effort to create the item being patented. Thomas Jefferson opposed the issuance of patents at all, contending that the system would be corrupted by Government and patents end up going to the big, wealthy and powerful and thus used by Government and the wealthy to oppress the people. The compromise was that patents would go to inventors after reasonable examination to assure that it was the true and first inventor that got the patent and no one else such as a friend of Government. This approach has served the US well for 222 years since 1790, but will be ditched next March pursuant to the Anti-Inventor Act of 2011 (officially misnamed the America Invents Act and commonly called “Patent Reform”) in favor a system where the first and true inventor does not get the patent but rather the first one to file at the US Pat. & TM Office claiming to be an inventor. The first and true inventor loses out unless he or she has proof of derivation by the one who filed, but such proof is in the possession of the one who derived and thus challenges will be ineffective and pointless.
That means the fat cats will get the patents and the real inventors will lose, which gets us close to what Jefferson predicted.
Mayo v Prometheus brings us yet another step closer to abandoning the patent system envisioned by the founders, as it prevents the patent reward going to the inventor and instead allowing big pharma to steal the invention without rewarding the inventor. When Prometheus came up with its discovery, it chose to file a patent disclosure giving the invention to the public in return for the limited period of exclusivity provided by the patent system. Prometheus viewed the incentive of the patent system as worth disclosing its invention rather than keeping it secret. Jefferson likely agreed with Madison on setting up a patent system because he agreed with Madison that otherwise inventors might go to their graves with their invention and the public thus be deprived of the invention, but that a patent system as we have it would not only reward the creative effort of the inventor to encourage them to invent but would also reward the inventor for disclosing his invention. Mayo v Prometheus tells the inventor of a diagnostic method to keep it secret to keep possession of it rather than lose it by disclosing it, and Mayo v Promethius does this by preventing the patenting of the method.
It is hoped that this erroneous and counterproductive interpretation of the patent system will be overruled by Congress in new legislation. It is also hoped, but not likely, that the best Congress money can buy will go back to first to invent so the vision of Madison and Jefferson can be kept alive for the benefit of America as the technical leader of the world. Unwittingly, the Supreme Court is killing our technical edge, as did Congress with the Anti-Inventor Act of 2011
The natural rights theory on which the patent system was founded is now under attack. Anti-patent activists claim patents retard rather than promote the progress of science. Small inventors correctly contend that patents are a great and necessary equalizer that do not depend on how big, rich or powerful you are, and which should reward their risk-taking so as to encourage them to risk inventing as they develop the majority of new products. In effect the patent system requires the inventor to give the invention to the public in return for an exclusive lease to the invention for about 17 years (20 from filing, less about 3 years of red tape at the US Pat & TM Off). This is so because at the end of that time the invention becomes public domain, free for everyone and anyone to use. That exclusive lease, that patent, can be very valuable to the inventor if the invention is very valuable. And, the invention thus given to the public can be very valuable forever, as those whose lives are saved by the lowered cholesterol from use of atorvastin calcium (Lipitor) which just came off patent this year can attest.
Here, the Supreme Court misses the point that the patent system is intended to encourage inventors to give their invention to the public and to reward their risk taking in making the research discoveries that leads to such discoveries as the safe way to administer this valuable medical treatment. Safe administration of TP had alluded researchers until this invention was made. Would Prometheus have invested the money to invent this if it knew Mayo could reap where it did not sow and take the invention for free? Arguably not. How many future diagnostic methods will now go to the grave with their inventor as a result of this? How many future diagnostic methods will be missed due to lack of incentive to invest in R&D to develop them? We will never know, but really it is our loss, and it is one that the founding fathers sought to prevent 222 years ago only to have the Supreme Court unanimously kill the goose that laid the golden eggs in diagnostic medical methods.