Today, staff from Senators Tillis and Coons will sit in a room with a group of stakeholders—primarily patent lawyers and lawyers from the pharmaceutical industry—and discuss their recently released draft for a § 101 bill.
That draft bill reflects little of the careful input that has been provided to the Senators over the course of the past five months, including hundreds of pages of data and suggestions explaining the concerns that the proposed legislation creates.
Instead, they’ve produced a bill that would eliminate hundreds of years of case law and replace it with untested, unclear language that will fail to provide crucial protections against vague, abusive patents. At the same time, the draft legislation would create completely new uncertainties about what is and is not patentable—the exact opposite of the predictability that Senator Tillis claims to want to promote.
It’s not a very long bill, so let’s go through it all, section by section.
“Useful” – § 100
The draft bill adds a new definition in § 100. Going forward, “useful” would be defined as “any invention or discovery that provides specific and practical utility in any field of technology through human intervention.”
Let’s start with “specific and practical utility.” Turns out, that’s more or less the existing standard for “useful”—and that standard is almost meaningless. Outside of cold fusion and perpetual motion machines, rejections for lack of utility are extremely unusual. So we’ve already seen that half of this change is effectively meaningless.
Next up, we have “in any field of technology.” What is a field of technology? Does it exclude anything? Or does it mean anything that someone says is an area of technology, including business methods or financial systems? Is a method of filming a yoga class an area of technology? It’s a yoga class, but also a method of creating a film. Ultimately, it’s completely unclear what’s in and out—and the only way we’ll find out is by running the language through the courts, the exact approach that Senators Coons and Tillis claim to want to avoid. (In fact, as we’ll see later, they want to avoid judicially-created exceptions so badly that they’ve explicitly barred them in a later provision. Given that, it’s unclear whether “field of technology” will actually limit anything at all.)
Finally, we have “through human intervention.” This seems likely intended to bar claims to naturally occurring phenomena and laws of nature, so that we won’t get patents on DNA inside a person or on the law of gravity. But trivial additions of technology will make those naturally occurring products or laws of nature patentable, so we’ll wind up with patents like “a specific strand of human DNA when examined by conventional DNA testing” (i.e., the Myriad case) or “making an object fall using the law of gravity by human action providing an initial impetus moving the object.” It doesn’t carry the weight the drafters might have wanted.
“The Invention as a Whole” – § 101
Now we get to what is claimed to be the purpose of this bill—addressing section 101.
But § 101’s text remains nearly unchanged. The word “new” is eliminated from “new and useful” as a claimed attempt to clarify that § 101 shouldn’t address novelty. And then a second section is added, explaining that “eligibility under [§ 101] shall be determined only while considering the claimed invention as a whole, without discounting or disregarding any claim limitation.”
As one of my comments to the drafters explained, this fundamentally misunderstands the way in which courts have applied § 101 and risks enabling a new range of patents. The Supreme Court ably explained this in its Flook decision, stating “[e]ven though a phenomenon of nature or mathematical formula may be well known, an inventive application of the principle may be patented. Conversely, the discovery of such a phenomenon cannot support a patent unless there is some other inventive concept in its application.” To do otherwise permits the patenting of laws of nature and other types of discovery that patent law was never intended to permit to be patented.
So, again, the changes being made here suggest that drafters—intentionally or otherwise—are perfectly willing to allow patents on laws of nature so long as conventional technology is appended in some way.
It should not escape anyone’s notice—least of all those Senators currently working on legislation intended to reduce drug prices—that the people who have pushed hardest for making laws of nature combined with conventional techniques patentable are biotech companies who want to patent medical diagnostics and methods of treatment. There were several Supreme Court cases about this type of patent. If this bill had been in place, the Myriad breast cancer patent would have stood up, as would the Mayo patent on a diagnostic test.
“Functional Claim Elements” – § 112
In an apparent attempt to provide a sop to people who’ve been critical of changing § 101, there’s a minor change included to § 112. There are a number of problems with the existing § 112, many of which could be significantly improved with simple changes.
This change is not one of those meaningful improvements. Instead, it simply codifies the Federal Circuit’s recent Williamson case, stating that any “claim element expressed as a specified function without the recital of structure, material, or acts in support thereof shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.”
While the change would remove any suggestion that the magic words “means for” are meaningful, it simply isn’t a significant change. It would do absolutely nothing to combat abstract and overbroad patents that current case law doesn’t already do.
That’s it for text intended to be part of the U.S. Code. But there are a few additional bits of statutory text intended to guide interpretation by the courts. Let’s start with the most ridiculous one.
“No implicit or other judicially created exceptions to subject matter eligibility, including ‘abstract ideas,’ ‘laws of nature,’ or ‘natural phenomena,’ shall be used to determine patent eligibility under section 101, and all cases establishing or interpreting those exceptions to eligibility are hereby abrogated.”
In one short paragraph, hundreds of years of case law are swept away.
O’Reilly v. Morse, holding that Morse couldn’t patent using electromagnetism to communicate? Gone. (And since Morse’s claim was for “marking or printing intelligible characters at any distances”, it would be eligible under this law.)
Gottschalk v. Benson, preventing an applicant from claiming converting between two forms of decimal? Gone. And that claim would be eligible as well.
Myriad, barring patenting a breast cancer gene? Gone. And guess what—claims to isolated DNA would become eligible (after all, the isolation is a human intervention), so that patent’s back in too.
And it’s not just the classical eligibility cases that this throws into question. The entire doctrine of obviousness-type double patenting—a doctrine which prevents patent owners from obtaining patents with longer terms on obvious variations of their own technology—is potentially eliminated. That doctrine is a judicially-created eligibility doctrine—exactly what this text eliminates. And that means that problems like over-patenting and patent thicketing will become more concerning, especially given that now the additional patents will be eligible for longer terms than the original patent. Given the potential financial benefit of even a single additional year of patentability on a blockbuster drug or a key semiconductor patent, the elimination of this provision will result in less innovation and higher prices to consumers in all areas of technology.
And as mentioned, by stating that judicial exceptions and implicit exceptions will not be permitted, it’s unclear that courts will even be allowed to interpret the language that the drafters seem to think will limit patents to technological arts.
It doesn’t end there, of course.
“The provisions of section 101 shall be construed in favor of eligibility.”
Unsatisfied with wiping out existing case law and doing their best to prevent judges from interpreting new statutory text, the drafters decided to put their fingers on the scale and say that in any close case, let’s tip the scales towards patentability. Instead of permitting patent examiners and judges to assess the facts of each specific patent on its own merits, the drafters would rather grant more patents—despite the potential chilling effects on other innovators threatened by the kind of marginal patents this would most affect.
There’s one last section, but to be honest, it’s completely unnecessary for it to be part of the law. Unsatisfied with wiping out existing case law and barring judges from developing new case law, the drafters decided to call out particular areas of the case law they just eliminated that they dislike. Some are provisions that hold no basis in legal theory, like barring any consideration of what is routine and conventional in the § 101 inquiry—even though § 112 inquiries like enablement and written description incorporate elements of what was well-known in order to determine if the patent applicant has complied with § 112. And some are simply incoherent, like barring consideration of the manner in which the invention was made as if their own text didn’t require considering whether the invention involves human intervention or not.
Staff drafting this bill received a tremendous amount of feedback. It’s unfortunate that little to none of the critical input appears to be reflected in their draft legislation.