by Dennis Crouch
Guandong Alison Hi-Tech Co. v. International Trade Commission and Aspen Aerogels, Inc. (Fed. Cir. 2019)
The USITC issued a limited exclusion order prohibiting Alison from importing certain aerogel composite products used for insulation. U.S. Patent 7,078,359. On appeal, the defendant argued that the claimed “lofty” structure was indefinite.
The Patent Act requires that the patent include claims “particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” 35 U.S.C. 112(b) (formerly 112 ¶ 2). The Federal Circuit has long interpreted this provision as creating an “indefiniteness requirement.” In its most recent pronouncement on the issue, the Supreme Court held that claims must “be precise enough to afford clear notice of what is claimed.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 909 (2014) (holding that patent claims must “inform those skilled in the art about the scope of the invention with reasonable certainty.”) A claim that is indefinite is also invalid and unenforceable.
On appeal, the Federal Circuit agreed with the defendant that “lofty” batting is a term of degree whose boundary is not fully clear. However, it is clear enough for patent law work. In a particular, the court defined “lofty” batting is batting that “shows the properties of of bulk and some resilience.” The specification further explains that “bulk” refers to air between the fibers, and “sufficient resilience” occurs where the batting can be compressed and then substantially spring back to its original bulk. The court also noted that the specification includes more than 20 different examples (some from the prior art) of “lofty” batting that can be used to understand the scope of the term.
In sum, the written description of the ’359 patent provides sufficient detail to inform a person of ordinary skill in the art about the meaning of “lofty . . . batting.”
How lofty is “lofty” Alison asks, “Alison seeks a level of numerical precision beyond that required when using a term of degree” rather “some modicum of uncertainty” is permitted. Quoting Nautilus.
Enforcement Action Affirmed.
As I have often written, we have concepts of day and night, even though we cannot identify the nanosecond when the one turns into another.
Come to think of it, the nanosecond differs as between Minneapolis and Houston. Patent examiners engage in an unending hunt for spurious precision. Who can say precisely how many ml of water has to be present in each balloon of a Bunch of Balloons before they are sufficiently full?
Paul,
You alight upon a conceptual framework — one in which it would be pertinent to add: breadth is not indefiniteness.
Also worth noting that there is NO such “requirement” of — only an optional claim format of — “objective physical structure” (let alone distinguishing by such).
Guandong Alison was the only precedential decision today, but an almost-as-important non-prec came down today in Ino Therapeutics. This is an important addendum to the Vanda line of cases. I think that Judge Newman’s dissent was more convincing than the Chief’s majority opinion, and of course the whole thing is not yet precedent. Still and all, if this line of thinking catches on, it will constitute a really important exception to the Vanda basis for §101 eligibility.
Ino Therapeutics case claim: don’t give the admittedly conventional NO [laughing gas] treatment to those patents that have a specified heart defect. Is it really that surprising that this is held unpatentable?
Is it really that surprising that this is held unpatentable?
Candidly, it is hard to say, Paul. I can look at this case two ways, and the degree of surprise depends on which way.
Viewed from one perspective, it has long been the case that one invents a drug, one patents the drug, one later determines that the drug works better in certain demographic or biomarker groups, and one separately patents applications of that later discovery. The majority alludes to this sort of patent at footnote 5 of the opinion, and acknowledges that this sort of discovery has historically been regarded as patentable. Nevertheless, the majority seems to suggest that such claims have historically been considered patentable merely because no one had ever thought to challenge these sorts of claims on §101 grounds. If that is the upshot of this case, then that is a surprising conclusion.
The other way of looking at this case, however, is that it featured a highly unusual claim phrasing, in which one does not actually infringe unless one withholds treatment from a patient population. I have never seen a claim phrased like that, with good reason. This would have been a hard claim to prove infringement, even if it had not suffered an invalidity problem. In other words, one (fairly unalarming) way of looking at this case is that the outcome was a function of the poor claim drafting, and so long as the rest of us do not use that (highly unusual) claim structure, there will be no problem.
I am not sure (yet) which of those two readings is the better one. Presumably part of the reason why this was a non-prec opinion is because the highly unusual claim format would have made it hard to apply (or at least too easy to distinguish) this opinion in future cases. If, however, it should turn out that discoveries about non-responding patient populations are to be regarded as unpatentable in future (unless one can also invent a new dosing regimen to apply to those non-responders) that is going to be a significant development in the law, with important implications for allocation of R&D capital.
Greg, don’t you think your paragraph 3 is confusing legitimate, traditional unobvious “new use” claims with this kind of “SAME use, but don’t give it to those it’s bad for” claim?
The way that this usually works is that you invent diptophograthil, you find it is useful for treating incontinence, and you claim “a molecule according to formula I…” and “a method of treating incontinence, the method comprising administering a molecule according to formula I… .” Then, 5, 10, whatever years later, you discover that patients with the gleK type 4 allele do not respond to diptophograthil, but that patients with types 1, 2, and 3 alleles do. At that point, you write a claim along the lines “a method for treating incontinence in a patient in need thereof, the method comprising: (1) determining that the patient carries a type 1 gleK allele, a type 2 gleK allele, or a type 3 gleK allele; and (2) administering to the patient a pharmaceutically acceptable dose of diptophograthil.”
The thing that the patentee did here that I have only rarely seen before was to go beyond steps #1 & #2 above, and add method steps of (3) determining that another patient carries a type 4 allele and (4) not administering diptophograthil to that type 4 patient. If the patentee had omitted those steps #3 & #4, however, then the claim would have been identical in all material respects to a wide assortment of claims that have historically been regarded as enforceable. This claim is useful (for treating incontinence), novel (in that no one had been running the GleK allele test as part of the diptophograthil treatment protocol before), and nonobvious (because the benefit of running the test was not apparent to the ordinary physician before the inventors’ discovery).
Moreover, these claims (without the do-not-administer step) should be enforceable. Diptophograthil (a purely imaginary drug, whose properties I am merely making up for purposes of this hypo) has undesirable side effects (like most drugs). If a patient will not benefit from diptophograthil, there is no reason to subject him or her to the discomfort and expense of diptophograthil treatment. We should want pharma companies to invest the R&D capital necessary to make these sorts of discoveries, and therefore should want them to be able to internalize the gains that flow from successfully making such discoveries. It would be a policy-suboptimal outcome to say that such claims are §101-ineligible.
“We should want pharma companies to invest the R&D capital necessary to make these sorts of discoveries, and therefore should want them to be able to internalize the gains that flow from successfully making such discoveries.”
I don’t think anyone would disagree that we want to incentivize these discoveries, but the question is whether the patent system is the correct venue to accomplish this.
As a practical matter, you haven’t discovered a new drug, nor a new test. And this just incentivized going through combinations of old drugs and old tests. By giving pharma companies an easier avenue to make money (continue to cash in on existing drugs), you’re actively disincentivizing searching for new ones.
[Y]ou’re actively disincentivizing searching for new ones.
Er, no. “Actively disincentivizing” would be if we taxed them $1 billion per new drug they bring to market, or awarded 20 years of exclusivity for new uses of old drugs, but only 10 years of exclusivity for new drugs.
The regime I describe above actively incentivizes both new discoveries about existing drugs and the discovery of new drugs. In any event, I do not know that we should regard one sort of discovery (discoveries of improved uses of existing drugs vs. discoveries of new drugs) as better or more worthy. It is impossible to know ex ante whether patients will benefit more from the one or the other, so policy makers should be agnostic as to which gets allocated the scarce R&D capital.
Okay, fine, “passively disincentivizing.”
Also “improved use of existing drugs” is disingenuous to describe your example, which is exactly the same use of an existing drug, but with the recognition that it doesn’t work for a certain subpopulation.
The reality is this is a complex issue at the intersection of the FDA and the USPTO. In the context of the system we have, these types of patents tend to focus on finding ways of keeping the same, previously discovered drugs under patent protection for the same thing they were originally discovered to treat.
I find it fascinating that you advance a free-market-esque reasoning (policy makers should be agnostic!) for something that is a government-granted monopoly, and also the subject of regulatory approval by an entirely different agency.
“[I]mproved use of existing drugs” is disingenuous to describe your example, which is exactly the same use of an existing drug, but with the recognition that it doesn’t work for a certain subpopulation.
Fair enough. I do not mean to quibble over terminology. What I am describing is a situation in which the state of the art gives rise to a lot of unnecessary suffering among patients, and the inventor comes along and makes a discovery that reduces some of that suffering. That seems to me an “improvement” in the quality of care by anyone’s lights, and how exactly one cares to characterize that improvement is a matter of small import.
I find it fascinating that you advance a free-market-esque reasoning (policy makers should be agnostic!) for something that is a government-granted monopoly, and also the subject of regulatory approval by an entirely different agency.
Many people find my remarks fascinating, so you are not alone in this.
On a more serious note, I am not sure that there is much to say in response to this. Part of the genius of the patent system as a mechanism for incentivizing innovation is that it overcomes the Hayekian knowledge problem that plagues “prizes” as a government innovation incentive. It seems totally counterproductive to try to reintroduce through the backdoor (“we should prefer new drugs over old drugs”) the same knowledge problem that patents overcome, by saying that we will only award patents to the sorts of innovation that some central planner (who cannot have all the relevant data when making these plans) deems to be the “right” sort of innovation.
To illustrate the point, consider a firm facing a choice about where to deploy R&D capital. They could use the capital to fund a drug discovery program to find a drug to treat Lapinson’s disease (of which the world only has ~1000 patients), or they could invest the funds in further research on an existing drug that they already have in development to treat lymphoma. As it happens, the existing drug only works in patients who have the B* allele (approximately 20,000 lymphoma patients in the U.S. alone have the B* allele). For other patients, the drug will show no effect. The company developing this drug does not yet know about its correlation with allele B*.
If the company devotes the funds to the Lapinson’s project, they will discover a drug that improves the lives of ~800 patients total (the other 200 live in countries with such poorly functioning health care systems that they die before they are ever diagnosed, drug or no drug).
If the company devotes the funds to the lymphoma drug project, they will be able to get FDA clearance for a drug that will improve the lives of ~500,000 patients worldwide. Absent the work on the lymphoma project, the company will not realize that the drug only works in B* allele patients, and therefore they will sponsor phase III trials enrolling patients with the B+ and B- alleles. The result will be that no significant effect over placebo will be detected in the total patient population. The FDA will not approve this drug for any patients, and it will be resigned to the scrap heap.
Which is the better outcome? Surely we can all agree after-the-fact that the lymphoma drug is the worthier use of the scarce R&D capital, but no one can know that before the research is undertaken. Therefore, we should not want the patent laws to sway, ex ante, the decision of how to allocate this capital. Better to take a policy agnostic stance ex ante, and simply let the market reward the firms that make the best allocation of capital, and punish those who make less productive allocations.
Okay, fine, “passively disincentivizing.”
The active/passive was not the inaccurate part of your 4.1.1.1.1.1. The inaccurate part was the incentivizing/disincentivizing misapprehension.
The patent laws as they are presently constituted incentivize both the discovery of new drugs, and the discovery of improved ways of using those drugs. The idea that the patent laws “disincentivize” drug discovery unless they positively exclude other fields of R&D is bizarre. Do you worry that the awarding of patents for new agrichemicals “disincentivizes” drug discovery?
the majority seems to suggest that such claims have historically been considered patentable merely because no one had ever thought to challenge these sorts of claims on §101 grounds. If that is the upshot of this case, then that is a surprising conclusion.
I guess it depends on how much time you spend thinking about this stuff, and the level to which you’ve been Stockholmed like so many other patent attorneys out there.
Evergreening strategies like the one you describe have always had these issues. The claims are often written poorly and they often include within their scope the odd “act” of “doing nothing”. And that’s always been a problem.
Here’s a news flash for you, Greg: the more time you spend thinking about this stuff, the more you will discover that the system has been supporting some seriously flawed patent claims that don’t stand up to close scrutiny. The only things that keep those claims alive is (1) the hand clapping of the patent bar and the desire to “look the other way” (because, golly, all those wonderful pharma companies can’t be engaged in an ongoing giant PTO-facilitated scam that rips off the public … or can they); and (2) the fact that most patent attorneys lack the writing skill necessary to raise the issues in a winning fashion (because overcoming (1) demands that defendants put their absolute best foot forward)?
LOL — comment at 4.1.1.2 shouldn’t have ended with a question mark
“and the level to which you’ve been Stockholmed like so many other patent attorneys out there.”
That’s called cognitive dissonance ON YOUR PART.
if this line of thinking catches on
It already is “catching on” because “this line of thinking” has been discussed and advocated for, by me, in the comments section of this blog, for about ten years now. Regularly. Consistently.
And why was it advocated for?
Because it makes sense and because the opposite “line of thinking” leads to absurd results that will offend ordinary people who aren’t invested in patenting for the sake of patenting.
Wake up and pay attention. “Deciding not to administer a chemical to a child” when that decision is based on logic and non-patentable facts should not be the kind of act that will cause somebody to be dragged into Federal Court and have their life ruined forever. Why is that controversial? What part of that is difficult to accept?
Just to clarify: I didn’t mean to imply in my comment at 4.2 that it’s my advocation that is responsible for the “catching on.” Hardly! My point is that neither the issue nor its appropriate resolution is new. It was recognized a long time ago.
That’s because the claims asserted by Prometheus against Mayo, even if interpreted more narrowly than Prometheus’ wished (i.e., interpreted such that the claim, in order to be infringed, required administration of a changed dose if the metabolic data met certain criteria), put the issue right under the spotlight.
And just to stir the pot a bit more, it’s an issue that affects not just claims relating medicine, but all claims that recite “if then” logical steps where one of the options is “do nothing.” Such claims are always problematic because, in part, turning the act of “doing nothing” into a liability (outside of professional negligence, anyway) is fraught with Constitutional issues (to say the least). Or at least that used to be the accepted wisdom among my mostly deceased libertarian friends (who were actual libertarians, not these fake glibertarian derpshirts who run around today).
To look at it from another perspective, a patentable claim protects new steps, leading to non-obvious transformations of matter. They don’t protect the act of deciding not to do anything because that’s what knowledge of facts compels you to do. Good grief, it should give us all pause that we even have to be discussing this.
Just to clarify, but it appears that the line of thinking that Greg is talking about as catching on is NOT the majority opinion (to which you appear to be addressing as ‘catching on’).
The moment the term “lofty” is relied on to get over some prior art that differs from the invention only in terms of its “loftiness” is the moment this claim goes up in a cloud of incredibly lofty black smoke.
This is a new one. My very first post on this thread has been swallowed by the filter. How strange.
Never mind, there it is, #1 below.
The term “f-a-t-a-l-l-y” will trigger the filter because it includes a word that describes Big Jeans’ head.
Your 0bsess10n is noted.
Sadly.
The “insolubly ambiguous” standard grew out of the need to interpret §112(b) in view of the §282(a) presumption of validity. Because it is supposed to require “clear and convincing” evidence to show that a patent claim is fatally unclear, it follows that so long as some meaning can be ascribed to the claim, it has not yet crossed the border into invalidity for lack of definiteness.
The downside of this rule is that it creates an incentive for the applicant to phrase the claim as vaguely as s/he can get away with. The Supreme Court (wrongly) tried to deal with this poor incentive by simply doing away with the “insolubly ambiguous” standard. This was really not the Court’s choice to make unless and until Congress amended the §282(a) presumption. The Nautilus decision is also really at odds with both i4i and Kimble.
The better way to have dealt with this problem is the same way that the common law treats ambiguous contract provisions. One does not throw out the contract as unenforceable. Rather, every time some live issue in the dispute over the instrument turns on an interpretation of an ambiguous phrase, one interprets the ambiguity in a manner that favors the one who did not draft the phrase in question (which in a patent dispute will always mean the alleged infringer).
That’s what happens when people (and within that group, attorneys especially, whom have ethical duties to not place any one branch of the government above the Constitution — including especially the Supreme Court of the Judicial Branch), turn a blind eye to the scrivening of the Court and their re-writing (as opposed to actual interpretation) of Statutory Law by way of legislating from the bench with Common Law law writing…
The court in Nautilus addressed your particular line of reasoning (see footnote #10) by noting (1) that indefiniteness was fundamentally a question of law rather than fact; and (2) section 282 expressly incorporates noncompliance with 112 as part of the invalidity defenses, suggesting that the presumption of validity is subject to the definiteness requirement, not the other way around.
Sure, but that argument makes the exception to swallow the rule. Section 282(b)(2) can be equally well (which is to say, not very well) described as incorporating the novelty and nonobviousness requirements. If “clear and convincing” is subject to novelty, nonobviousness, clarity, support, and enablement—rather than novelty, nonobviousness, clarity, support, and enablement being subject to “clear and convincing”—then what is even the point?
“ but that argument makes the exception to swallow the rule. ”
And you are surprised…?
The Supreme Court (wrongly) tried to deal with this poor incentive by simply doing away with the “insolubly ambiguous” standard.
Oh for cripesake. “Insolubly ambiguous” is not a “standard.” It’s 100% pure bulls–t. That test was doomed from the moment the CAFC first floated it out there. Good riddance.
Pick better fights, Greg.
“Because it is supposed to require “clear and convincing” evidence to show that a patent claim is fatally unclear, it follows that so long as some meaning can be ascribed to the claim, it has not yet crossed the border into invalidity for lack of definiteness.”
So pre-Nautilus, did you need clear and convincing evidence or merely a preponderance of evidence that a claim was “insolubly ambiguous”?
I am not sure that this point was ever litigated, Ben. Honestly, it is very easy to overstate the importance of the difference between “more likely than not” and “clear & convincing.” You can literally count on your fingers the number of CAFC cases in which this distinction is critical to the outcome.
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