Just over three weeks ago the United States Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, which sent much of the patent world into a whirlwind. In that decision the Supreme Court unanimously found that the claims at issue did not exhibit patent eligible subject matter because the additional steps that were added to the underlying law of nature were well known in the industry. A curious ruling for many reasons, and one that will have to be digested over many years as the United States Patent and Trademark Office and the Federal Circuit struggle to figure out how Diamond v. Diehr remains good law (it was not overruled) and remains consistent with a ruling that seems completely inapposite.
To continue to provide a variety of perspectives on this landmark ruling what follows is the reactions of those in the industry. Without further ado…
A dissection of most any patent claim will reveal, at some level, a law or a product of nature. The holding in Prometheus does not hinge on whether a naked “law of nature,” e.g., gravity, is patent-eligible–clearly it is not. Rather, the question we will be grappling with in the coming years is: what additional elements must be included in the claim to render the claim sufficiently “unconventional” or “inventive” so as to confer patent-eligibility? The claims in Prometheus, included steps in addition to the “law of nature” that were determined by the Federal Circuit to be transformative. The Supreme Court, however, concluded that the steps were insufficiently “unconventional” to confer patent eligibility. In contrast, the Court distinguished a patent-eligible “law of nature” claim in the landmark 1981 Supreme Court case Diamond v. Diehr as “add[ing] to the [law of nature] something that in terms of the patent law’s objectives had significance–they transformed the process into an inventive application of the formula.” (Prometheus. at p. 12).
The Court provides us with little guidance as to how much must be added to the “law of nature” to confer the requisite “significance.” At the outset one can compare the elements of the claim in Diehr with the elements of the claim in Parker v. Flook to derive some broad boundaries of the universe of patent-eligible subject matter. From this comparison comes a suggestion that specific and tangible “post-solution activity,” e.g., opening a mold at the appropriate time determined through use of the Arrhenius equation in the Diehr claim. In contrast, the “post solution activity” in the claim at issue in Flook, setting new alarm-limit values in response to the results of a mathematical algorithm, was determined to be insufficient. But is “post-solution activity” always required? The answer is unclear. Perhaps if the “pre-solution activity” rises above being “conventional or obvious,” “post-solution activity” will not be required.
Prometheus stands for the proposition that a naked “law of nature,” even a newly-discovered novel and non-obvious “law of nature,” will not be eligible for a patent. On the other hand, a claim reciting a “law of nature” will be patent-eligible if the remaining elements or combination of elements in the claim are patentable. The Court rejects the suggestion of the United States as Amicus Curiae (and many other commentators) that the other provisions of the patent statute (e.g., novelty, nonobviousness, and meeting the enablement and written description requirements) are better suited to screen out unpatentable subject matter. (Prometheus at p. 21). But on some level, aside from the “law of nature,” isn’t this exactly what the Court has done?
The most frustrating aspect of this decision was the Court’s the importing of a section §§102/103 analysis into a §101 analysis. In essence, the Court said that the method does not involve the hand of man (§101) because the primarily elements of the method are things that man has done many times before (§§102/103). Instead, the proper analysis should have been that urged by Judge Rader and the USPTO-first examine compliance with §101, then move on to §102, §103 and §112. However, the court has very clearly spoken, and has left little for patent practitioners to grasp on to. While we can apparently still argue that the steps used in a diagnostic are not conventional, in most situations this will be extremely difficult.
An open question is whether this reasoning will be applied in other contexts, such as composition claims. If the Supreme Court eventually hears the Myriad case, perhaps it will apply a similar reasoning: the isolated DNA does not involve the hand of man (§101) because it was obtained primarily by steps that man has done many times before (§§102/103). One can even imagine a similar analysis where the claimed composition is a conventional vector including a DNA sequence, rather than just the isolated DNA sequence.
Another open question is the effect of this ruling on the diagnostics industry and health care in general. This decision is good news for doctors, patients and insurance companies in the short term. But in the long term? It is hard to say whether, with the reward of patent protection possibly no longer available, life sciences companies will continue to innovate in diagnostics and personalized medicine. Sure, there are other ways to incentivize invention, such as through government prizes or regulatory exclusivity. But while the patent system is by no means perfect, it is the most transparent and equitable system for government to promote development of technologies which make the world a better place. With Prometheus, the best innovation incentive system ever known took a significant hit.
For more from Chirnomas please see Supreme Court Strikes Down Diagnostic Method Claims.
For better or worse, medicine is a business. Long gone are the days of the general practitioner’s little black bag and a doctor arriving at your child’s bedside. Oh, perhaps there are towns and villages where healers are satisfied by kind wishes, baskets of produce, a quilt, or simply a promise to pay. But doctors have families, mortgages, tuition payments (and yes, even some greens’ fees) to pay. Similarly, clinics and hospitals must make their loan payments or risk foreclosure. Bank managers are unlikely to accept the potential of a future house call or gall bladder surgery in lieu of payment on their debt. Wholesale delivery of medical services cannot be maintained if practitioners’ rewards are denied.
The more we push through Hamlet’s “thousand natural shocks that flesh is heir to” the greater the need for more efficient diagnoses and treatments. Mayo v. Prometheus highlights these needs but the Court’s finding belies means of fulfilling them. In denying patentees’ short-term reward for their medical efforts, they continue to reject that medical technologists require economic return. Altruistic motives aside, navigating the valley of death that lies between research and applications that benefit society requires resource concentration that has been most efficiently applied through the IP system.
In patents, the name of the game is the claim. In Prometheus, the Court impugned the claims as in-artfully drafted and insufficient to evidence the hand-of-man (so long held as the gold standard of patent eligibility). The researchers efforts at defining clinical benchmarks has been denied economic reward for the limited time promised by the Founders. In nullifying the first step in clinical application of medical discoveries, the Court denies the economic realities of modern medicine. Nine persons in need of medical attention seem to have set back access to efficient treatment at the very moment that we face a crisis in providing even basic remedies.
We are surprised and disappointed in the Court’s decision, which disregarded the considered judgment of the Executive Branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods.
While we are still analyzing the opinion, we are concerned that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement. While the opinion’s lack of guidance may limit its practical impact, we are troubled that the Court’s opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.
BIO will work with the Administration and the U.S. Patent and Trademark Office to ensure that the future application of this opinion does not irrationally restrict the ability of innovators to protect inventions that lead to cures, medical breakthroughs, and other technologies that make our lives and our environment cleaner, safer and healthier.
My input on the Prometheus case is based on the logical implications of the Court’s ruling and my suggestion as to how 101 could be approached. I will leave the nuanced interpretations and paths forward to brilliant attorneys such as Eric Guttag and Gene Quinn.
Logically, the Supreme Court is saying that known steps or elements in combination with a law of nature (technically, this case involved natural phenomenon, not a law of nature as pointed out by Robert Sachs) is not patent eligible. First, every invention ever made involves steps (elements) that were known individually before the invention plus laws of nature. You cannot create something out of nothing. Section 112 means that you have to be able to describe your invention in terms known to those skilled in the art. Thus the Supreme Court’s holding means that any invention that satisfies 112 is unpatentable under 101. The only inventions that will satisfy 101 are those that violate laws of nature or involve creating
something out of nothing. The question in 101 is whether a claim covers an invention.
Anything that man creates to solve an objective problem (non-objective creations are the subject of aesthetics/copyrights) is an invention. If a device/service is not found in nature separate from man, then it satisfies 101.
The Prometheus claims are a method of treating Crohn’s disease (auto-immune diseases). There is no method of treating Crohn’s disease in nature, other than letting the disease take its natural course. Here, Prometheus’ claims require a patient to take a drug and test a patient’s metabolites. This is done by man for the objective purpose of treating auto-immune disease. This is clearly within 101.
For more from Halling please see Supreme Court ‘Only Black Magic Patent Eligible’.
For our continuing coverage of this case please also see:
- Killing Industry: The Supreme Court Blows Mayo v. Prometheus
- Prometheus – What are We to Make of All This?
- Eviscerating Patent-Eligibility of Drug Testing Methods
- A Matter of Patent Law Despotism
- Selective Precedent Amnesia
From other blogs:
- What Should We Do? (or Can These Claims Be Saved?) (Patent Docs – Kevin Noonan)
- The Impact of Mayo v. Prometheus (Patently O – Dennis Crouch)
- Myriad, Prometheus and life science patents: The End of Days? (Medical Devices Daily – Mark McCarty)