Patents and patients: the implications of the Prometheus v. Mayo Supreme Court decision
At the end of 2011, the medical diagnostic testing industry had a sense of comfort that patent claims directed to diagnostic methods were patent-eligible. Today, however, in light of recent Supreme Court activity, that sense of comfort has all but evaporated.
In March 2012, in a unanimous decision, the Supreme Court pronounced in Prometheus v. Mayo that a claim to a method of optimizing a particular therapy using specific steps is not eligible for patent protection. This decision arguably has crippled the validity of thousands of foundational patents that support the diagnostic methods industry and stunted the growth of the newly burgeoning personalized medicine sector of the medical industry. And, soon after the decision in Prometheus, the Supreme Court remanded a further diagnostic method case to the Federal Circuit to be decided in line with its pronouncements in Prometheus.
In arriving at the conclusion that methods of optimization of a therapeutic regimen are patent ineligible, the Supreme Court not only disagreed with Prometheus and the Federal Circuit, but also specifically disagreed with the position of the U.S. government. The government had urged the Court to decide in favor of patent eligibility for such methods. This would then afford the Patent Office opportunity to determine patentability using stringent application of the remaining sections of the patent statute (namely 35 USC §§102; 103; and 112). Despite the government’s pleadings, the Supreme Court opted to agree with Mayo, the doctors and the healthcare sector advocacy groups. In effect, the upshot of this decision is that it places in serious doubt the validity of diagnostic methods patents and significantly affects business decisions in the diagnostic and therapeutic methods industry.
The claim at issue in Prometheus recites:
“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
a. administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
b. determining the level of 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine in said subject, having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8×10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug susceptibility administered to said subject.”
The claim was held to be patent ineligible because it recites laws of nature—in this case the relationship between the concentrations of certain metabolites in the blood and the likelihood that a particular therapy will be ineffective or harmful—and such laws of nature are patent ineligible. However, the decision contains little guidance as to what diagnostic steps would be “significant” enough to convert a law of nature to a patent eligible application. This decision creates significant uncertainty and ample room for argument in litigation settings.
Nowhere in the Prometheus claim is there any mention of the practitioner of the method being a “doctor.” However, in a tone that is generally unfavorable to patentees in this industry, the entire decision repeatedly focused on upholding a doctor’s right to choose a therapy. This decision has profound and far-reaching consequences not only for the patents that have already been issued, but also for patent eligibility of new methods that combine therapy with diagnosis of a particular condition. These “theragnostic” applications are at the heart of personalized medicine, which allows the tailoring of therapy so that only people who will benefit from a particular drug are given that drug and the patient is not unnecessarily exposed to the unwanted side effects. The assessment of the risk of the side effects compared to the benefits can only occur if the practitioner (regardless of whether a doctor, nurse, or lab technician) performs the test. One must not overlook the fact that while the end user of the test may be that practitioner, the entities that are garnering the economic benefit of that testing are typically companies that supply the practitioner with the kits to perform it.
Thus, while there are many economic and policy-based arguments in this decision, those arguments have failed to recognize the impact of the decision on an entire sector of the biotechnology industry. In particular, the decision confounds the business plans of companies seeking to transform failed drugs into successful, more targeted therapies that are recognized through screening for biomarkers that are predictive of responsiveness of the patient to the drug. It is a valuable, significant, often patentable, insight to discover why a particular drug only works in a small fraction of the patient population. I would argue that this insight is not an insight into a law of nature. It is the discovery of the very nexus that allows the scientist to transform a failed or useless drug into a life-changing drug that enters the marketplace and benefits the lives of patients who often suffer from debilitating diseases.
How then is a diagnostic company incentivized to publicly disclose discoveries that lead to identification of useful therapies and the methods for performing diagnostic tests that will benefit the patient population? In Prometheus, the Supreme Court noted that “we must recognize the role of Congress in crafting more finely tailored rules where necessary. We need not determine here whether, for a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.” However, considering that patent reform took almost a decade to pass through Congress, it is unlikely that such Congressional intervention is imminent. Frankly, the Prometheus decision simply is one that decreases the protections available to the diagnostic methods industry as compared to all other industries. It is an unfair taking of rights that were previously available to a valuable economic sector of the biotechnology industry. The only two types of claims that the decision seems to condone are claims to “a new drug” or “a new way of using an existing drug.” It is feared that by taking away patent eligibility for diagnostic methods, this decision pushes companies toward trade secret practices for that subject matter. Such trade secret practice will not benefit the patient population at large as it will limit the knowledge base within the diagnostic company.
If the companies cannot get Congressional redress for diagnostic method claims, the recourse would seem to be a return to the Courts. In this regard, immediately after the decision in Prometheus, the Supreme Court granted certiorari [a decision to hear an appeal from a lower court] to Association of Molecular Pathology et al. v. Myriad Genetics (AMP v. Myriad), vacated the Federal Circuit decision, and remanded the case to the Federal Circuit for re-review in accordance with the high court’s decision in Prometheus v. Mayo.
The Federal Circuit had previously held Myriad’s gene claims to genes and methods of screening for cancer compounds patent eligible and patentable. Questions remained about the screening claims. On remand, based on Prometheus, there is a significant chance that the Federal Circuit will hold the diagnostic claims invalid as being patent ineligible. In order to avoid this devastating outcome, it is a reasonable prediction that there are likely to be numerous amicus [“friend of the court”] briefings in AMP v. Myriad in the hope that that decision could take the sting out of the Prometheus decision. That being said, it is also fair to say that regardless of which side prevails in AMP v. Myriad at the Federal Circuit, we are likely to see parties driving the case back to the Supreme Court.
While some commentators have indicated that the Prometheus decision is not too troubling and will be limited to its facts, the danger is that litigants will stretch its reach and courts will misapply the Prometheus decision as broadly requiring invalidation of any claim that recites a law of nature among its steps. Ultimately, all invention is on some level based on the practical application of natural discoveries. A broad application of Prometheus will result in much mischief in the field of personalized medicine. It can only be hoped that in deciding AMP v. Myriad the court will at least provide sufficient interpretation and guidance as to what would be a “significant” enough step to convert a law of nature to a patent eligible application.
Editor’s Note: Dr. Rasheed takes a strong advocacy position, analyzing a Supreme Court decision that held that patents cannot be granted for methods of optimization of a therapeutic regimen. It is not necessarily the opinion of the editors and publisher of Medical Laboratory Observer, but it is one that is very much worth considering and very relevant to the clinical laboratory. We would be interested in hearing from readers on either side of this issue. Did the Court rule correctly, or was it in error? How might the matter be further addressed, either by judicial or legislative action?
Nabeela Rasheed ([email protected]) is a shareholder at Chicago-based McAndrews, Held & Malloy. She has a PhD in biochemistry, and her practice concentrates on counseling, acquisition and enforcement of intellectual property rights for her firm’s biotechnology and pharmaceutical clients.
This column addresses compliance, regulatory, legal, certification, and additional concerns in the lab. Readers can submit questions to [email protected].
