By Michael Borella --
Republican Senator Thom Tillis of North Carolina has released a new proposal to reform the text of 35 U.S.C. § 101. The Senator's last effort in doing so died on the vine in 2019, purportedly due to stakeholders being too far apart in their visions of what patent eligibility should be all about.
But with growing concern regarding China possibly eclipsing the U.S. in R&D of emerging technologies, there is a renewed impetus to fix at least some of the ambiguities introduced by the Supreme Court in Alice Corp. v. CLS Bank Int'l and Mayo Collaborative Services v. Prometheus Laboratories, Inc. Those decisions, which came down in 2014 and 2012, respectively, led to the current state of affairs in which diagnostic methods are effectively unpatentable and software patents can be invalidated based on fuzzy, conclusory reasoning.
The Proposal
§ 101. Patent eligibility
(a) IN GENERAL.—Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in section (b) and to the further conditions and requirements of this title.
(b) ELIGIBILITY EXCLUSIONS.—
(1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such:
(A) A mathematical formula, apart from a useful invention or discovery.
(B) A process that—
(i) is a non-technological economic, financial, business, social, cultural, or artistic process;
(ii) is a mental process performed solely in the human mind; or
(iii) occurs in nature wholly independent of, and prior to, any human activity.
(C) An unmodified human gene, as that gene exists in the human body.
(D) An unmodified natural material, as that material exists in nature.
(2) CONDITIONS.—
(A) CERTAIN PROCESSES.—Notwithstanding paragraph (1)(B)(i), a person may obtain a patent for a claimed invention that is a process described in such provision if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing, the steps of the process that the machine or manufacture perform.
(B) HUMAN GENES AND NATURAL MATERIALS.—For the purposes of subparagraphs (C) and (D) of paragraph (1), a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery, shall not be considered to be unmodified.
(c) ELIGIBILITY.—
(1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined—
(A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and
(B) without regard to—
(i) the manner in which the claimed invention was made;
(ii) whether a claim element is known, conventional, routine, or naturally occurring;
(iii) the state of the applicable art, as of the date on which the claimed invention is invented; or
(iv) any other consideration in section 102, 103, or 112.
(2) INFRINGEMENT ACTION.—
(A) IN GENERAL.—In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact.
(B) LIMITED DISCOVERY.—With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph.
This text is a mouthful, having over an order of magnitude more words than the 36 of the current section. So let's break it down.
The Exclusions
Section (b)(1) states that mathematical formulas, mental processes, and naturally occurring processes are not eligible for patenting. But there are limits the scope of these exclusions. Specifically, mathematical formulas that are an element of a useful invention or discovery presumably would not doom the entire invention. Likewise, mental processes as notions of abstract thought are not patentable, but a mental process implemented on a computer ostensibly could qualify. Similarly, naturally occurring processes outside of the human experience are not patentable while human-made processes involving some aspects of natural processes could also qualify.
Along the same lines, unmodified natural material and unmodified human genes are not patent eligible, though such material "that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery" could qualify. This provision appears to codify and expand upon the holding of Association for Molecular Pathology v. Myriad Genetics, Inc.
But things get sticky in Section (b)(i)(B)(i), which states that a "non-technological economic, financial, business, social, cultural, or artistic process" would also be an exclusion. The problem with this language is that these terms are not defined and potentially quite broad. Alice, as interpreted by the Federal Circuit, provides an exception for "methods of organizing human activity." This current exclusion is a gotcha for patentees. As someone who has spent too many hours arguing with patent examiners over whether inventions implemented solely on computers are "organizing human activity," I can only imagine how the courts and the USPTO might misuse the exclusion of Section (b)(i)(B)(i).
Moreover, Section (b)(2)(A) does little to rein in the scope of this exclusion. The language "if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing, the steps of the process that the machine or manufacture perform" suggests that a machine or manufacture must "integrate" the process . . . into what exactly? The proposal is silent.
Eligibility Procedure
Section (c)(1) addresses what should and should not be considered while carrying out the eligibility inquiry. Notably, one must take into account "the claimed invention as a whole and without discounting or disregarding any claim element." This is a welcome provision, as there is a long track record of judges and patent examiners conveniently ignoring claim elements on their way to declaring claims ineligible.
Further, one must not consider "whether a claim element is known, conventional, routine, or naturally occurring . . . the state of the applicable art, as of the date on which the claimed invention is invented [or] any other consideration in section 102, 103, or 112." This is also a welcome provision, as it overrules the problematic prong two of Alice while bringing back the more logical pre-Mayo separation between §§ 101, 102, 103, and 112 of the statute.
One point is unclear, however, in that Section (c)(1)(B)(ii) tells us that eligibility shall be determined without regard to whether a claim element is naturally occurring. On the other hand, Section (b)(1)(D), excludes naturally occurring inventions from patentability. One possible interpretation of these sections is that individual claim elements being naturally occurring does not impact the eligibility analysis unless the entire invention (i.e., all elements) is naturally occurring.
Litigation
Section (c)(2) codifies the "quick kill" under § 101 (the main reason why some parties will tell you that Alice is just fine) by stating that a court "at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section." Thus, invalidation of patents during the pleading stage would still be possible, but only "when there are no genuine issues of material fact." To this latter point, "the court may consider limited discovery relevant only to the eligibility" of the claims when ruling on such a motion.
Conclusion
In sum, Senator Tillis' proposed revisions to § 101 seem to be two steps forward and one step back. It is an attempt to find a middle ground between varying stakeholder concerns by overruling some aspects of the Supreme Court's recent eligibility jurisprudence and codifying other aspects. It is unlikely that any one stakeholder will be entirely satisfied with this proposal, but as a starting point we could do much worse.
The main substantive problem with the proposal is use of unclear terminology and a lack of recognition of how broadly courts and the USPTO have viewed the exclusions to patent eligibility in the past (and how the courts have expanded the exclusions over the years since Alice). If these issues could be buttoned up, this legislation has the potential to be a modest course correction for American innovation.
" I can only imagine how the courts and the USPTO might misuse the exclusion of Section (b)(i)(B)(i)."
Two points:
(1) If this bill were to become law, I envision much of the case law about "technological" inventions from the CBM era living on to inform the implementation of this new provision.
(2) I agree that there will be a lot of initial confusion over this section's reach until it has been litigated for a few years. If the statute were clearly to elimination Mayo and Myriad while only partially repealing Alice, that would still be progress. Not perfect, but better than the status quo (as you say, "two steps forward and one step back").
Posted by: Greg DeLassus | August 03, 2022 at 01:37 PM
One needs only to familiarize oneself with the EPO case law on what is and what is not "technical" to appreciate how challenging this distinction is to operate fairly and predictably, in a myriad of marginal cases. But if you want to confine the grant of patents (each one having any commercial value being a real restraint of trade) to non-obvious contributions to the useful arts, what is the alternative?
Posted by: MaxDrei | August 04, 2022 at 11:11 AM
The buzz I am receiving is that this a (possibly purposeful) Trojan Horse against software patents.
This is far more than one step back (to carry the analogy provided by Mr. DeLassus).
Posted by: skeptical | August 04, 2022 at 12:00 PM
MaxDrei,
How in any real world sense would EPO case law inform the US Jurisprudence on contributions to the Useful Arts?
Posted by: skeptical | August 04, 2022 at 02:50 PM
I have a question. What counts as "integrating"?
I appreciate that it has to be "something more" than "merely storing and executing, the steps of the process that the machine or manufacture perform" but that don't impress me much. What else are computers doing, other than storing and executing?
In other words, how effective a filter on eligibility will "integrate" prove to be in practice? Who's to say? Is "integrate" any more than a wave of the hand, an "I know it when I see it" criterion?
Posted by: MaxDrei | August 05, 2022 at 04:05 AM
MaxDrei,
That is a great question. If left unanswered, it is likely that the courts will fall back on their Alice-based reasoning (or lack thereof).
Mike
Posted by: Michael Borella | August 05, 2022 at 10:32 AM
How many people here remember the briefing for In re Bilski en banc? Anyone who has a question about what is meant by "integrating" should go read those briefs that argued for the machine or transformation test. That is what (b)(2)(A) is doing---codifying the machine or transformation test.
Posted by: Greg DeLassus | August 05, 2022 at 10:57 AM
I disagree that this is codifying the machine or transformation test - and I seriously doubt that any court would find as such.
Posted by: skeptical | August 05, 2022 at 12:19 PM
I should rather say that (b)(2)(A) codifies the "machine" prong of the machine or transformation test. For better or worse, I do not see an effort here to codify the "transformation" prong.
Posted by: Greg DeLassus | August 05, 2022 at 01:33 PM
Again, I disagree that this is codifying even the machine prong.
Tillis DOES advance some language "in regards to" machine action, but this in no way resembles how the courts have attempted to write any type of 'machine' legislation.
Perhaps Mr. DeLassus should abstain from discussing technology (and law related to such) that he clearly does not understand.
Posted by: skeptical | August 06, 2022 at 07:52 AM
"Section (b)(i)(B)(i)... states that a 'non-technological economic, financial, business, social, cultural, or artistic process' would also be an exclusion. The problem with this language is that these terms are not defined and potentially quite broad."
May I suggest that this is less problematic than it appears at first sight. Firstly, it seems to me that this provision is essentially harmless relative to the status quo. That is to say, I cannot think of a single claim that has been successfully asserted post-Bilski that would not pass even a capacious construction of this prohibition. The courts are already excluding claims on basically this basis, so putting it formally into the statute will really not affect any real world outcomes.
Secondly, I am not sure that “technological” is as “undefined” as some imagine. “Congress is presumed to be aware of an administrative or judicial interpretation of a statute and to adopt that interpretation when it… adopts a new law incorporating sections of a prior law… That presumption is particularly appropriate [w]here… Congress exhibited both a detailed knowledge of the… judicial interpretation and a willingness to depart from those provisions regarded as undesirable or inappropriate… .” Lorillard v. Pons, 434 U.S. 575, 580 (1978). In other words, insofar as courts have interpreted “technological” in the patent context, Congress can be presumed to incorporate those interpretations when Congress uses the word “technological” in a statutory revision without providing additional definition.
As it happens, the CAFC has had several occasions* to interpret “technological” in the context of the CBM statutes. This word already has the beginnings of a common law definition, and (like most common law terms) that definition will become ever more clearly focused as case law builds up. The canvas here is less blank than folks suppose.
(*) HTTPS://SCHOLAR.GOOGLE.COM/SCHOLAR?HL=EN&AS_SDT=1FFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFE0000000000000004000001FFFFFFECFFF87FE3FFFFFFF00000000000000000004&SCIODT=1FFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFE0000000000000004000001FFFFFFECFFF87FE3FFFFFFF00000000000000000004&CITES=14570700292112568579&SCIPSC=1&Q=%22TECHNOLOGICAL%22&BTNG=
Posted by: Greg DeLassus | August 09, 2022 at 01:54 PM
The Status Quo IS a problem (and one being sought to be rectified), so a statement like, "it seems to me that this provision is essentially harmless relative to the status quo" is CLEARLY a non-starter.
Please stop posting on this topic that you clearly do not understand, Mr. DeLassus.
Your "push" is easily seen as a Big Pharma bias, and "divide and conquer" IS in fact very bad for you too.
Posted by: skeptical | August 09, 2022 at 07:34 PM