This post is co-authored by Antoinette F. Konski and Jacqueline D. Wright Bonilla
The U.S. Supreme Court entertained oral argument today in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The case is being closely monitored by the pharmaceutical and biotechnology industry, and in particular those in the industry that patent diagnostic methods and companion diagnostics. At its core, the case addresses whether certain patent claims directed to diagnostic methods or methods of optimizing therapeutic efficacy for treatment recite patent eligible subject matter under 35 U.S.C. § 101.
The Oral Argument
Mayo in its brief [Mayo Merit Brief] and response [Mayo Reply Brief] presented the issue as to whether the claims at issue effectively preempt the use of naturally occurring correlations. Specifically:
“Whether 35 U.S.C. Section 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the patent effectively preempts use of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve ‘transformations’ of body chemistry.”
Petitioner Mayo Collaborative Services (“Mayo”) presented first arguing, consistent with its framing of the issue, that the patents harm patients because they broadly preempt the use by a physician and others of a physical phenomenon. Patients are harmed because the patents prevent others like Mayo from offering a better metabolite test that more accurately reflects the correlation. Justices Sotomayor, Kennedy and Scalia questioned Mayo regarding the exact scope of the preclusion – the claimed ranges within the patent claims and whether the test could be offered by Mayo and other clinics without a recommendation to the treating physician as to how and whether to use this information. Justice Scalia also noted that any medical patent relies on natural processes – “I mean, even if you invent a new drug, what that new drug does is – natural. It affects the – human physiognomy in a certain natural way.” Transcript at 9.
Not surprisingly in light of his statements in his dissenting opinion in LabCorp, Justice Breyer took the lead in questioning Mayo’s assertion that the patents here attempt to claim a law of nature. In this regard, Justice Breyer wanted to know how much one must include in a claim so that it recites an application of a natural phenomenon (patent eligible), rather than the natural phenomenon itself (patent ineligible). Mayo argued that under Bilski and Flook, the addition of a “conventional” step is insufficient. The claim must recited something that narrows the application of the correlation so that the claim does not preempt any use of the correlation. Also, according to Mayo, under Bilski, a conventional (non-novel) step plus a natural phenomenon is patent ineligible.
The discussion turned to what claim language would satisfy Mayo. Several justices asked how Mayo would come out if the claims had not recited open-ended ranges (i.e., greater than or less than certain metabolite amounts). Mayo responded that doctors need freedom to make choices, freedom to judge for themselves, but then seemed to suggest that perhaps the claims could be specific enough to be patent eligible if the claims recited both specific non-opened ended ranges and treatment steps based on the natural correlations.
The U.S. Government’s View
The U.S. Government argued as amicus curiae for the perspective of the United States and the U.S. Patent and Trademark Office. The Government argued in favor of patent eligibility here. The Government argued that the issue of whether an invention should be patented should not be so strongly tied to the issue of patent-eligibility but rather answered by the criteria of novelty and non-obviousness (not at issue in this case). Justice Breyer questioned whether the Government’s position is that everything that is not a product or process of nature should be patented as long as it is novel and non-obvious. The Government advised that all questions of patentability are addressed at the same time by the Patent Office when an application is examined and therefore, the issues of novelty and non-obviousness should limit unduly broad patents. The danger of addressing the issue differently, the Government noted, is that “you’re going to call into question lots and lots, thousands in fact, of medical use patents where the patent is: Administer a therapeutically effective dosage of this drug in order to treat this disease.” Transcript, page 33.
Prometheus in its brief [Respondent Promotheus Labs brief] presented the issue as to whether concrete claims for improving treatment are patent-eligible. Specifically:
“Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient’s dosages of synthetic thiopurines are patentable processes under 35 U.S.C. § 101.”
During oral argument, Prometheus began by clarifying the scope of the claims at issue, and in particular the claimed ranges of the toxicity levels. Justice Alito began the questioning, focusing up front on what is and is not a patent on a law of nature, such as inducing photosynthesis by use of artificial light. The underlying process, Prometheus explained, is not patentable but the use of the light would be.
Justice Breyer again tried to focus on a test to determine what needs to be added to a natural phenomenon to make it a patentable process. As stated by Justice Breyer, “if you put too little in the answer to that question, I believe I can take things that like E = mc2 and make them patentable. And if you put too much in, you are going to wreck your own case.” Transcript at 40.
Prometheus answered by replying in terms of the Bilski, machine or transformation test and that with the use of machine or a transformation, the test is more clearly satisfied. The more difficult issue is that when the claims, as a practical matter, may preempt an abstract idea in such a way that the patent would greatly suppress follow-on inventions. Prometheus used as an example, the patenting of the process for vulcanizing rubber, which Firesone patented many years ago, to cure rubber into using it and that there have been subsequent improvement patents to that initial invention.
Justice Kagan asked why Prometheus did not claim the relationship between a certain treatment at a certain number, and then for another number, using another treatment, because “that clearly would have been patentable. Everybody agrees with that.” Transcript at 46.
Prometheus answered that all the claims have three steps because you have “an administering step which clearly carries its own benefits with it. It’s not novel, but it’s certainly a process step that in and of itself could be a process. We couple that with determining – you determine the amount of metabolites and in the next step gives the doctor valuable information in order to decide what to do next.” Transcript at 46. Prometheus’ counsel further noted that requiring in a claim that a doctor increase or decrease a dosage based a specific determined range is not useful because that’s not how doctors practice medicine. Transcript at 47. Depending of the specifics of a particular patient, a doctor may choose to go outside the stated ranges, especially if numbers are close.
Prometheus also answered Justice’s Breyer’s inquiry on patents that do identify and develop useful information, even if they have a mental step on the end, such as the identification of biomarkers or measuring the biomarkers to allow which of 10 particular drugs is going to work for that particular patient. Thus, Prometheus argued, the methods that end with a mental step that produce information should be patent-eligible.
Prometheus also explained to the Court that the patent claims do not prohibit anyone from developing better numbers that will help the medical profession. If, for example, the numbers for toxicity are wrong, the utility section of the patent statute would prevent the application from issuing as a patent or would invalidate the claim if issued.
Mayo addressed the issue of whether a low hurdle for patent-eligibility would protect patients. Mayo argued that Section 101 of the patent statute has, for over 150 years, protected the public domain. According to Mayo, to reduce it to a dead letter would be contrary to the Court’s precedence and harmful to the medical community. Mayo also emphasized that the process is a natural process because the metabolites come from the liver, not a test tube.
The Goldilocks Rule
Like Goldilocks, the Justices seemed to struggle with the right test for what should or should not be patent-eligible. As Justice Breyer asks, when does a claim recite enough so that corresponds to an application of a natural phenomenon (patent eligible), rather than the natural phenomenon itself (patent ineligible)? An answer, Justice Breyer admitted during oral argument, was absent from his dissenting opinion LabCorp, which Mayo relies upon so heavily. Justice Breyer did not provide much insight during oral arguments either, but he carefully questioned parties about their views.
When thinking about the answer, one may want to consider the following: Too high of a standard and a lack of exclusive rights for a period of time to recoup research and development costs could chill investment and development of new therapies and diagnostics. Too low a standard and the industry runs the risk of broad patent claims that preempt future research and development. Only a test that is “just right” can find the right balance between fostering or inhibiting innovation and providing benefit to the public.
In a written opinion in this case, the Court may lay out a better test of when a claim corresponds to an application of a natural phenomenon, rather than the natural phenomenon itself. It will be important for the Court to provide some clarity, one way or another, especially as relating to diagnostic method claims. Uncertainty in the law is far worse than no clear outcome or test at all, especially for a relatively new industry like personalized medicine. The thoughtful questions by so many Justices during oral argument indicate that the Court may try to provide some clarity.