It’s About Time

A patent may be invalid for several reasons. It may be non-novel under 35 U.C.S. § 102. The patent may be obvious to one of skill in the art, § 103. Perhaps the patent does not enable one of skill in the art to practice the invention, is indefinite, or lacks a “written description”—all grounds for invalidity under § 112.

Then there is § 101, subject-matter eligibility. This requirement for validity is different than the requirements listed above. Section 101 renders unpatentable natural laws, naturally occurring phenomena, and abstract ideas. The Supreme Court’s decision in Mayo v. Prometheus Labs, however, suggests that the content of § 101 that is truly distinct from sections 102, 103, and 112, lies in examining what I’ll call a given claim’s “future breadth”: the broadness of its scope compared to future, unknown applications. Future breadth differs from ordinary claim breadth, which is the broadness of a claim’s scope as compared to the prior art or an allegedly infringing devices.

Prometheus Labs applied § 101 to invalidate two patents that claimed methods for optimizing the therapeutic efficiency of a drug by administering the drug, measuring its metabolites, and comparing the measurements to a newly discovered concentration range in order to determine whether the drug dose should be increased or decreased. The Court held that the patents effectively  claimed a natural process, i.e. the correlation between metabolite levels and drug effectiveness.

The Court’s analysis under § 101 borrows heavily from invalidity principles under the patent laws, namely sections 102, 103, and 112. This raises the question whether and how much substantive legal content § 101 has that is distinct from the other sections.

Let’s start with something that sounds unique to § 101:

If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.”

(Slip op. at 8-9.)

So far, so good. Law of nature + “apply the law” = invalid patent. But because all patent claims rely in part on some law of nature the meaningful inquiry lies in determining whether the non-Law of nature portions of the claim are the equivalent of directing the reader to apply a law of nature. In this inquiry, § 101 begins sound more like sections 102, 103, and 112.

In determining that Prometheus Labs’s patents effectively recite “apply this natural law,” the Court turned away from § 101 and relied on doctrines from other areas of patent law. After disposing of the claim’s directive to administer the drug, and the natural law itself (the “wherein” clause), the Court turns to something that sounds like an anticipation or obviousness inquiry under § 102. In explaining why the “determining” step of the claim does not add enough “additional features” showing “that the process is more than a drafting effort” the Court writes (slip op. at 10):

[M]ethods for determining metabolite levels were well known in the art…. Thus this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field.

So, now the rule for § 101 is as follows: Law of nature + steps known (or obvious) in the art = invalid patent.

The Court’s criticism of Prometheus Labs’ patent also suggests written-description or enablement (§ 112) problems: “[T]he claim simply tells doctors to: (1) measure (somehow) the current level of the relevant metabolite….” As characterized, that limitation could read on later-arising blood-metabolite techniques not adequately described in the patent. (See slip op. at 16-17, discussing this concern.)

The Government suggested that the invalidity inquiry be left entirely to sections other than § 101. The Court rejects this, and holds that § 101 has content distinct from those sections, sometimes. But what is that content, and what’s the motivating concern?

The answer may be found in a “temporal” approach to invalidity. In a sense, sections 102 and 103 examine what the state of the art was at the time the claimed invention was invented—the past. Section 112’s prohibition on indefiniteness can be seen as motivated by a present concern that a person is unable to avoid infringing the patent because its claims are indefinite. Finally, Section 101 can be viewed as being concerned with future breadth, i.e. the risk that patents’ claims are broad enough to capture future general applications of a natural law or process that they must be held invalid.

Posted on April 25, 2012, in Invalidity, Patent and tagged , . Bookmark the permalink. Comments Off on It’s About Time.

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