Supreme Court strikes down diagnostic method claims as non-patent-eligible subject matter
| March 20, 2012
Mayo Collaborative Services v. Prometheus Laboratories
March 20, 2012
Supreme Court, 9-0, opinion by Justice Breyer
Summary
Although we typically cover the CAFC in this blog, today we will be visiting the Supreme Court. The Supreme Court unanimously ruled that the diagnostic method claims in this highly-anticipated case were invalid as failing to comply with 35 U.S.C. §101. In short, the Court ruled that a claim reciting a diagnostic method (which is inherently based upon a law of nature) that applies only conventional, known steps is invalid.
Details
The claimed invention concerns optimization of dosage of a drug used to treat disorders such as Crohn’s disease. It was previously known that high levels of a drug metabolite called 6-thioguanine (6-TG) could cause harmful side effects, wheres low levels of 6-TG were indicative of non-effectiveness of the drug. However, as followers of this case will remember, Prometheus discovered the specific levels of 6-TG which form guideposts for dosing by a doctor, and was granted a patent on this. A representative claim is as follows:
1. 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 in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 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 subsequently administered to said subject.
An additional claim omits the “administering” step. The Federal Circuit previously held that both claims were patentable, since the “administering” and “determining” steps were transformative, citing the machine-or-transformation test of Bilski. The Federal Circuit held that even if the “wherein” clauses recited a mental step or a law of nature, this was insufficient to render the claims as a whole unpatentable.
The Supreme Court has now strongly rejected this analysis, distancing itself from the machine-or-transformation test of Bilski. The Supreme Court recognized that laws of nature are not patent eligible and that applications of laws of nature might be patent eligible. However, the Supreme Court framed the patent eligibility analysis as: How much needs to be added to a law of nature to make it patent eligible? The Court clearly stated that a “drafting effort” by patent attorneys is not sufficient.
With respect to the “administering” step, the Supreme Court acknowledged the hand of man by stating that “it takes a human action (administration of a thiopurine drug) to trigger the manifestation” of the law of nature. However, they dismissed the “administering” step as insignificant, since it instructed a doctor to give a known drug to a pre-existing group of patients who receive the drug in question anyway.
With respect to the “determining” step, the Court stated that this informs doctors to determine the level of the metabolite by any laboratory process. The Court also held that this step was insignificant, since the manners in which the metabolite levels are determined are conventional and well known.
As to the “wherein” clauses, the Court stated that they only inform a practitioner about a law of nature (the range in which the drug can be effective and non-toxic). No active step is required in the “wherein” clauses.
Overall, the Court stated that the conventional “administering” and “determining” steps were not sufficient to make the law of nature (recited in the “wherein” clauses) patent-eligible. Rather, the “administering” and “determining” steps were regarded as mere insignificant data gathering or “pre-solution activity,” citing to In re Diehr. In particular, the Court states that
the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Put another way, the Federal Circuit viewed these claims as reciting a transformative process at their core, with a law of nature or mental step added on. Meanwhile, the Supreme Court viewed the same claims as reciting a law of nature at their core, with conventional (although potentially physically transformative) steps added on.
Comparison to Precedent
In supporting their conclusion, the Supreme Court cites to Diehr and Flook, and conclude that this case lies squarely between the patent-eligible claims of Diehr and the unpatentable claims of Flook. In the Court’s view, both of these cases involved claims which have at their core a law of nature. However, they distinguish between the two because in Diehr, the steps used to apply the law of nature were non-conventional, and in Flook, the steps used to apply the law of nature were conventional. Meanwhile, the Court concludes that the claims in question are “no stronger than” the unpatentable claims in Flook. Additionally, the opinion cites Neilson v. Harford, a UK patent case from 1841, as well as 2010’s In re Bilski and 1972’s Gottschalk v. Benson. The Court concludes that in each of these cases, the method claims did little more than instruct a user to simply apply a law of nature, abstract idea or law of nature.
The Supreme Court also provided some commentary on the Bilski machine or transformation test. In 2008, the Federal Circuit established a test that if a method involved a particular machine, or included transformation of an article to a different state or thing, such a method complied with §101. However, in 2010, the Supreme Court rejected the exclusivity of this test stating that this was “an important and useful clue” to patent eligibilty. The implication was that if a claim passed the machine-or-transformation test, it was patent-eligible, but there could theoretically be some claims which fail the machine-or-transformation test but are still patent-eligible. However, in this instance, the Supreme Court states that this test from Bilski was never meant to trump the law of nature exclusion. As such, it seems that a claim which passes the machine-or-transformation test can nevertheless be non-patent eligible.
Dismissing the Government’s (and Judge Rader’s) viewpoint
Worthy of note is the Supreme Court’s rejection of the arguments by the U.S. Government. The Government argued that the claims at issue comply with §101, but may be invalid in view of §102, §103 and §112. It urged that many processes, such as igniting wood for heat, would be patent eligible in view of §101, since they involve the hand of man. However, processes like this could not actually be patented, since they would be anticipated by previous human activity. This is similar to the position of Judge Rader of the CAFC.
The Supreme Court misinterpreted the Government’s position as wanting to shift entirely the patent-eligibility analysis to §102. In particular, the Supreme Court states that §§102 and 103 are silent as to treating laws of nature as being part of the prior art, particularly with respect to newly discovered laws of nature (which the Court presumes would be novel). This commentary seems to ignore other tools which Examiners may have to regard a newly discovered law of nature of application thereof as known or obvious under §102 and §103, such as by inherency and/or Official Notice.
Policy Concerns
Finally, the Supreme Court acknowledges the policy arguments on both sides of this case, but states that they are reluctant to reach a conclusion that might “suit the needs of one field [but] produce unforeseen result in another.” The Court dodges the question of whether increased protection of diagnostics is desirable or not, and states that Congress is free to craft specific rules applicable to this field.
Driving Diagnostic Methods “underground”?
Not surprisingly, this decision is deeply disturbing to many patent practitioners as well as those in the diagnostics industry. Based on this decision, it would appear that an inventor seeking to maximize exclusivity of a diagnostic method which only applies conventional methods and reagents may wish to refrain from filing a patent application, and instead rely on trade secret protection. Although some aspects of such a diagnostic method could become public in the regulatory process, this might be the more prudent course of action. On the other hand, diagnostic processes which include a new method and/or a new reagent should be safe to make their process known to the public in the patent process. In view of this decision, it would not be surprising to see the diagnostic industry dramatically ramp up their lobbying efforts to encourage Congress to refine the patent and/or regulatory statutes to attempt to circumvent today’s Supreme Court decision.
Alternative claim drafting possibilities?
How could Prometheus have avoided this outcome? Although the Court at one point criticizes the generality of the claimed steps, it appears that even if the claims recited specific laboratory steps (e.g., blood extraction, centrifugation, metabolite analysis, etc.), this would not have made a difference. Presumably, even if these steps were specifically recited, this would not change the fact that they are conventional.
Alternatively, perhaps the claims could have recited an active step of “re-administering” the drug at different dosages based on the determination of the metabolite level. The Court might have viewed this as novel and not just insignificant post-solution activity, although it is questionable how they would interpret re-administration at the same dosage level as before.
Although such a “follow-up” step could be helpful in some contexts, it is of little comfort for those trying to claim diagnosis of a disease such as Alzheimer’s, since it is unclear what such a follow-up step would be. Even if the follow-up step is clear where disease treatment strategies are well known, the question of divided infringement would arise. What if the diagnosing clinic is entirely separate from a subsequent treating clinic? Note that we are awaiting the CAFC’s en banc decision regarding divided infringement in McKesson and Akamai.
Myriad and possible spill-over into other technical fields
What about the extended impact of this case? The first question on the minds of most is likely to be the Myriad Genetics case. The method claims in question in that case have already been invalidated, and in view of Prometheus, it is nearly inconceivable that these method claims would survive in any future analysis of such claims by the Supreme Court or the CAFC. As to the composition claims of Myriad, this decision is arguably limited to method claims, so it might not impact the analysis. However, in view of previous opinions and oral hearings on these issues, the distinction between composition and method claims could be viewed as a trivial distinction. In such as case, the reasoning here could “spill over” into the analysis of composition claims.
Additionally, as Bilski had a wide impact outside of the computer and software arts, this case could have a significant impact outside of life sciences. Those drafting method claims involving software and data processing may wish to revisit their claim drafting strategy to ensure that steps which supplement any mental process or calculation are not entirely conventional, and are not just insignificant data gathering or post-solution activity. It is unclear what establishes a difference between insignificant and significant activity, but a novel combination or ordering of steps may be helpful.
Tags: §101 > bilski > biotech > diagnostics > law of nature > patent eligible subject matter > Supreme Court
