U.S. Patent and Trademark Office building

Laws and Facts of Patent Eligibility and Medical Diagnostics

This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.

By Jacob S. Sherkow

For this year’s Health Law Year in P/Review, I’ll be talking about § 101, that most enigmatic of laws from the patent statute. Like many other areas of intellectual property, patent law has a threshold subject matter inquiry embodied in statute—this is § 101—which reads, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” But because any “competent draftsman” of patent applications could claim an invention as, say, “a process” rather merely an idea, courts have, almost since the statute’s first enactment in 1790, ignored the language of the text entirely. You should too. Instead, it has for almost all of its history, been interpreted in the following manner: “Anything under the sun made by man” is patentable subject matter, save “abstract ideas” or “natural laws, phenomena, or products.” Sure: defining what is a “natural” law is tough, but it’s not a phrase so devoid of application as to make it nonsense. (Unless you’re a complexity theorist.)

But this reinterpretation leaves a fundamental procedural question unanswered: is the judicial inquiry into whether something is a “natural law” a question of fact or law? (Or a mix of the two?) The answer is important because it affects how appellate courts need—or need not to—defer to lower courts’ findings on the matter in litigation. If fact, the U.S. Court of Appeals for the Federal Circuit, could only overturn the factual bases of such decisions for lacking “substantial evidence”—a pretty high bar. If purely a question of law, the Federal Circuit could revisit courts’ determination of the issues entirely once presented with them on appeal. Given that district courts, in the wake of a 2014 Supreme Court decision about patentable subject matter, Alice Corp. v. CLS Bank International, have been particularly unfriendly to patents reviewed under § 101, the outcome of much patent litigation—especially those concerning medical diagnostics and biotechnologies—rests on this procedural nut. The Supreme Court is now slated to decide whether to hear a case precisely on these issues. The petition, HP Inc. v. Berkheimer, is, at the time of this writing, still waiting—eleven months late—for the views of the Solicitor General.

I have long thought that the inquiry is fundamentally factual in nature. A “natural law,” for example, ultimately depends on what scientists on the ground think is a “natural law;” divorcing the inquiry from the actual experience of people working in the field threatens to turn judges into philosophers of science. (Heaven forfend!) Naturally, the law should be that natural laws are in fact facts. And while the “abstractness” inquiry may seem closer to what judges do on a day to day basis, with respect to a claimed invention, it still depends on what’s an application versus an idea in the field. I, for example, may personally think that all software is, in some sense, abstract (thanks, Mark Lemley). But practitioners are correct to demonstrate that some pieces of code were concrete innovations that have changed the world (for good, and in some cases, for ill).

Resolving this question will likely have much to say about how future patent cases for health care diagnostics get litigated, from PGD aneuploidy testing to dose alteration regimes to sequencing technologies, and whether lower courts’ findings will ultimately be preserved by the Federal Circuit or revisited again on appeal—a procedural issue 229 years in the making. Here’s to figuring that out next year!

The Petrie-Flom Center Staff

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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