What, if anything, does Mayo v. Prometheus mean for Software Patents?

Recently, the Supreme Court decided Mayo Collaborative Services (“Mayo”) v. Prometheus Laboratories, Inc. (“Prometheus”). Although it does not involve software patents, the decision clarifies the proper place of the Machine-or-Transformation test in section 101 analysis, discusses abstract principles of nature, and rejects a recent suggestion by the Federal Circuit to invalidate a claim under Section 101 only after it first passes muster under Sections 102, 103 and 112.

At issue here are two patents—U. S. Patent No. 6,355,623 (’623 patent) and U. S. Patent No. 6,680,302(’302 patent)—which, cover “processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high.” Id. at 3. Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10–1150, slip op. at 5 (Mar. 20, 2012). “The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects.” Id. at 3.

Claim 1 of the ’623 Patent is illustrative:
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.
’623 patent, col. 20, ll. 10–20, 2 App. 16.

Prometheus “is the sole and exclusive licensee of the ’623 and ’302 patents.” Id. at 6. “It sells diagnostic tests that embody the processes the patents describe.” Id. This dispute arose when Mayo stopped using the Prometheus test and “announced that it intended to begin using and selling its own test.” Id. The District Court found for Mayo, noting that although its test did infringe Prometheus’s patents, the patents were invalid as they claimed natural laws. Id. at 6–7. On Appeal, the Court of Appeals for the Federal Circuit reversed, noting that the invention met the machine-or-transformation test because the steps in the claims “involve the transformation of the human body or of blood taken from the body.” Id. at 7.

Upon review, the Supreme Court rejected the Federal Circuit’s analysis and held that the patents were invalid. Id. at 24. On the one hand, this decision can be read quite narrowly. The Court does say it is not persuaded that there is a relevant transformation here and, accordingly, the machine-or-transformation test fails. Id. at 19. There is, however, a lot more to this decision than a mere disagreement as to how the machine-or-transformation test applies to Prometheus’s claimed invention. The Court also says that “the ‘machine-or-transformation’ test is an ‘important and useful clue’ to patentability,” but it does not “trump[] the ‘law of nature’ exclusion.” The Court further explained, “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Id.at 2. The question then becomes “whether the claimed processes have transformed these unpatentable natural laws into patent eligible applications of those laws.” Id. at 3.

Ultimately, we are left with little guidance from the Court. It is quite clear that analysis under Section 101 is here to stay. It also clear that the machine-or-transformation is now a useful clue rather than a test. But a new test was not provided. Only time will tell how the courts, the USPTO, and practitioners apply this decision.

Machine-or-Transformation is not always enough.
With a bit of sleight of hand, the Court cites Bilski v. Kappos for the proposition that the machine-or-transformation test “is not a definitive test of patent eligibility, but only an important and useful clue.” Id. at 7. It is helpful to look back at Bilski to spot the sleight of hand. “This Court’s precedents establish that the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101. The machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible ‘process.’” Bilski v. Kappos, 130 S. Ct. 3218, 3227 (2010). Bilski never said that the machine-or-transformation was insufficient to determine whether a process was patent-eligible. Instead, it said that there might also be other ways to identify a patent-eligible process. After Mayo, the machine-or-transformation test is not really a test at all. Rather, it is, as the Court says, a useful clue.

The transformation branch of the machine-or-transformation test now seems less than dispositive. This suggests that software patents should, when possible, include claims that tie the invention to a machine. Claims that are tied to a machine are often more difficult to draft broadly than a process claim, so include both. More importantly, claims directed to software inventions should be described, as much as possible, in terms of actual electronic circuits that are programmed to carry out a series of electronic operations. The more detail provided at the electronic circuit level, the better.

Applying an abstract principal of nature is not enough.
It has long been understood that a principle of nature cannot be patented. See Mayo, at 1. The Court also explains that “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.’” Id. at 3. To cover patent-eligible subject matter, the claim must contain an “‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Id. This again suggests that narrow claims are more likely to withstand judicial scrutiny. At times, the Court discusses algorithms in the same breath as principles of nature – as though algorithms are all laws of nature floating in the ether awaiting discovery. Claims tied to a machine do not ensure that the “invention” therein recited is patent-eligible, but could improve the odds that the claimed invention will be viewed as a Seciton 101 compliant “machine.”

Section 101 is not going away.
The Court also weighed in on the ongoing debate in the Federal Circuit on the judicial morass of section 101, which we have discussed previously. In rejecting a proposal offered by the United States as Amicus Curiae, the Court said that relying on Sections 102, 103, and 112 in place of Section 101 would be inconsistent with prior case law. Id. at 20–22. Further, this approach would “creat[e] significantly greater legal uncertainty.” Id. at 21. The Court did acknowledge that there at times may be overlap between Section 101 analysis and the other sections of the patent act. Id. But it also noted that the other sections are unequipped to deal with laws of nature. Id. It seems that Section 101 analysis and uncertainty is here to stay.

One Response to “What, if anything, does Mayo v. Prometheus mean for Software Patents?”

  1. Janal Kalis says:

    A recent district court invalidated software claims to an expert system using the Prometheus decision. The court held that a computer providing treatment options based upon software instructions and data was no different from what a doctor does. It will be interesting to see what the CAFC does with this, if the case is appealed. More information about the case can be found here:

    http://holmansbiotechipblog.blogspot.com/2012/04/computer-implemented-method-for-guiding.html