The United States Supreme Court on December 7, 2011, heard oral argument in Prometheus Laboratories v. Mayo Collaborative Services, U.S. No. 10-1150, 12/7/2011, which addressed the issue, in general, of when natural phenomena becomes patentable under Section 101 of the Patent Act. Just last year, the Supreme Court in Bilski v. Kappos, 130 S.Ct. 3218 (2010), addressed the related issue of what constitutes an abstract idea under Section 101.
Prometheus Laboratories sued Mayo Medical Laboratories for infringing its patent on a diagnostic method for treating Crohn’s disease. The Federal Circuit in 2009 reversed a summary judgment that the claimed method is ineligible for patent protection under 35 U.S.C. Section 101, and Mayo sought Supreme Court review. The case was remanded to the Federal Circuit for reconsideration in light of the Supreme Court’s ruling in Bilski.
The Federal Circuit then held that claims reciting the application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and the method of calibrating proper dosage of drugs to treat autoimmune diseases are patentable. In particular, the claims state that a level less than 230 “indicates” a need to increase the medicine, and that a level greater than 400 “indicates” a need to decrease the medicine.
The Federal Circuit rejected Mayo’s assertion that the patent impermissibly claims natural phenomena and, thus, should be rejected under Section 101 of the Patent Act. According to the court, the claims “recite specific treatment steps, not just the correlations themselves. And the steps involve a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs and measuring specific metabolites. As such, and contrary to [defendant’s] assertions, the claims do not preempt all uses of the natural correlations; they utilize them in a series of specific steps.”
Supreme Court Oral Argument
At the Supreme Court, Petitioner first argued that patented method is not patent-eligible because “of its broad preemption of a physical phenomenon, which prevents others like Mayo Clinic from offering a better metabolite test with more accurate numbers.” Justice Sotomayor disagreed with this broad claim noting that petitioner could offer the test, “it just can’t recommend the dosage to the doctor.” Petitioner responded by asserting that a doctor who is aware of the claimed range infringes merely by drawing blood and that Petitioner “hasn’t been able to offer this competing test” for 7 years.
Justice Kennedy asked whether the method become patentable when there are more complicated monitoring steps even though it may preempt a “whole range of different choices.” Petitioner responded that the key is the specificity of the claims.
Justice Scalia did not agree with this approach suggesting that such a rule would be too difficult to apply and that a new drug that relies on “natural processes” would deny patentability. Petitioner responded that that the key is “specificity.”
Justice Breyer then suggested that if petitioner could explain his hypothetical, that a company could not obtain a patent for looking a person’s little finger to know if they needed more of a drug, then “he would have an understanding of where [Petitioner] was coming from.” Petitioner agreed with Justice Kennedy that the key is “how much you have to add” to the natural phenomena. Petitioner asserted that it must be more than adding “prior art to prior art.”
Petitioner also responded in a question from Justice Ginsburg that Section 101 of the Patent Act is crucial because Sections 102 (novelty) and 103 (obviousness) would not bar an applicant from obtaining a patent for E=mc2. Justice Kennedy then (to laughter) found that petitioner was “getting warmer” when he stated that it must be more than an “incidental step,” but Petitioner could not explain what has to be added, other than asserting that it must limit the natural phenomenon in some respect. According to the Petitioner, the problem is that the Prometheus patent does not recite any specific action that a doctor has to take after observing the natural correlation. It would be different, he said, if the patent had called for the doctor to make a specific “treatment protocol” which would allow Mayo Clinic “to come up with different numbers that it believes are more accurate and more helpful for patients . . . .” In closing, Petitioner again emphasized that the key is whether the patent preempts the entire field.
The U.S., appearing as amicus curiae, began by agreeing with both parties that a mental step may not be patented by tacking on an utterly conventional process for administering drugs and testing their effects. According to the government, patent eligibility, under Bilksi, is a threshold eligibility question, and the test is whether the claim recites a process. Chief Justice Roberts asked if a process that calls for placing wood on a grate and igniting it to obtain heat satisfies that test. The government replied that no patent would be awarded for that process because it does not meet the test for novelty under Section 102 and nonobviousness under Section 103. The government then suggested that as a “practical matter,” it does not make any difference because “the PTO examiner gets a patent application and answers every question, 101, 102, 103 and 112, and makes a decision about all of them.” The Chief Justice questioned this approach, noting that it does make a difference in litigation and questioned the advantage of putting off an analysis under Sections 102 and 103. Justice Kagan also took issue with the argument that dubious claims would be caught under Section 102, pointing out that there was “novelty here.” The government explained that the process is not novel, but the inferences drawn at the end may be novel. The government contended that there is value in awarding patents to such advances even with the excluding effects identified by Mayo. In response to a question from Justice Scalia, the government stated that the discovery of a new physical change to the body caused by an old drug could be patentable under the right circumstances.
Respondent began by arguing that Supreme Court precedent distinguished between things that exist in nature with the intervention of man and things that exist without the intervention of man. Thus, in response to a question from Justice Alito, Respondent suggested that a process to create photosynthesis with a lamp inside building could be patentable, but the underlying process is not patentable.
Justice Breyer then provided two examples illustrating the basic issue of what has to be added to a law of nature to satisfy the patent eligibility standard under Section 101. He also warned respondent that “if you put too little in the answer to that question, I believe I can take things like E=MC2 and make them patentable. And if you put too much in, you are going to wreck your own case.” Respondent replied that under the Court’s holding the natural phenomenon needs to be transformed by, for example, the use of a machine, so it’s no longer just a mere principle. To illustrate this understanding Respondent cited Samuel Morse’s invention of the telegraph, which he was able to patent, and his attempt to obtain a patent for the use of electricity to write at a distance, which was denied on the grounds that what was being claimed was at “such a high level of generality” that it would inhibit future innovation. In other words, the issue is whether the claim is written at such a high level of generality that it inhabits future innovation.
Respondent argued that the patent in question is unlike the Morse case in that the patent here is directed to the use of a specific class of drugs to produce a particular effect to be measured. Justice Kagan pointed out that the process is not a treatment protocol but rather a way to generate certain facts “that exist in the world.” As expected, Respondent disagreed with this description and explained that the claims involve a number of steps.
The Chief Justice then pointed out that respondent when pressed on patentability under section 101, seems to rely on Sections 102 and 103. Respondent explained that issues of novelty and nonobviousness are governed by well-established rules, and that using Section 101 to reject patents where the issue is really novelty and nonobviousness would overlook those important rules. The respondent explained that under Section 101 there are two primary things to be explored: “[I]t has to be a process in the physical world, a hands-on process. And it can’t be so broad that it preempts all follow-on innovation.”
On rebuttal, petitioner argued that if Mayo determined that the patent treatment parameters were wrong, Mayo should not be precluded from challenging the patent by the threat of a “treble damages” lawsuit, and that respondent’s suggestion that the patent could be challenged under the utility prong of Section 101 is not a solution. Petitioner argued that it is important that the Court maintain the robust test for patentability that has existed for 150 years. Petitioner concluded by asserting that the patent is simply too broad and it precludes anyone in the country from proving that the patent treatment numbers are wrong.