Vanda Pharmaceuticals recently filed a petition for writ of certiorari, asking the Supreme Court to review a May 2023 decision by the Federal Circuit that invalidated claims from four Vanda patents covering methods of treating Non-24-Hour Sleep-Wake Disorder (“Non-24”) using the drug tasimelteon (Hetlioz). Vanda Pharmaceuticals Inc., v. Teva Pharmaceuticals USA, Inc., 23-768 (Supreme Court). The district court held that all the asserted claims were invalid as obvious, and the Court of Appeals for the Federal Circuit affirmed this decision. Vanda.cert.petition
The main question now before the Supreme Court is whether obviousness requires a showing of “predictable” results, as suggested in KSR International Co. v. Teleflex, Inc., or if a “reasonable expectation of success” is sufficient. Although these two tests are close to one another, they have meaningful differences. Importantly, the court’s obvious-to-try approach would invalidate truly innovative and unpredictable results so long as the pathway to get there was reasonable. The patentee here argues that the courts should not find any solutions solutions obvious unless those solutions were themselves reasonably predictable from the prior art. With this background, the patentee raised the following question to the Court:
Whether obviousness requires a showing of “predictable” results, as this Court held in KSR, or a mere “reasonable expectation of success,” as the Federal Circuit has held both before and after KSR?
The Supreme Court addressed the obviousness standard most recently in KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). In KSR, the Court explained that “a combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. KSR‘s language is built on longstanding precedent that an invention cannot be considered obvious if, at the time it was made, it would not have been “perfectly plain” or “immediately recognizable” to one skilled in the art.
- Dow Chemical Co. v. Halliburton Oil Well Cementing Co., 324 U.S. 320 (1945) (not obvious if not “perfectly plain to an expert”).
- De Forest Radio Co. v. General Electric Co., 283 U.S. 664 (1931) (not obvious unless results would have been “immediately recognized” by one skilled in the art).
- Textile Machine Works v. Louis Hirsch Textile Machines Inc., 302 US 490 (1938) (obvious only when “plainly indicated” or “plainly foreshadowed” by the prior art).
According to Vanda, the Federal Circuit’s “reasonable expectation of success” test improperly renders innovations obvious that, while representing advancements in pharmaceutical science, were still unpredictable breakthroughs at the time achieved. Vanda criticizes the Federal Circuit for clinging to its own expectation-of-success obviousness test as a “subsidiary requirement” that it treats as effectively overriding the controlling Supreme Court precedents.
In Vanda’s view, reasonable expectation of success sets a lower obviousness standard than predictability. This comes to a key point particularly in the ‘unpredictable arts’ of pharmaceutical and biotech research where extensive experimentation is almost always required to determine whether a particular idea will succeed. Because experimentation is necessary for any true discovery, the fact that some folks are conducting similar experiments provides us with information about whether the result is obvious-to-try, but the question here is what it says about the ultimate results. Although in a different context, the issues presented here are similar in nature the Supreme Court’s discussion in Amgen, where a “research assignment” was insufficient disclosure to teach the full scope of the resulting invention.
The inventions here involved fairly narrow differences, and the Federal Circuit concluded that a PHOSITA would have seen a reasonable expectation of success. But, as you can see, the court’s key with all of this is reliance on KSR‘s flexible approach and expanded use of the reasonable expectation of success standard. Lets look for a moment at the particular obviousness contentions:
- Administering without food: Some of the claims required administering the drug without food. Although it was not obvious whether this drug would work better with or without food, the Federal Circuit concluded that there was a motivation to try and a reasonable expectation of success here since FDA guidance recommended food studies, and there are just two potential options (with or without food). There result here is close to a per-se obviousness ruling while the patentee argues that the fact that particular result was unknown and unpredictable at the time.
- 20 mg dose to “entrain patients”: An ongoing clinical trial was testing the 20 mg dose, but had not yet shown it to be effective to entrain patients as required by the claims. The court saw the ongoing clinical trial as evidence supporting a reasonable expectation of success as to the result of the trial, while the patentee argued that it offered only hope, not a predictable solution. See OSI Pharms v. Apotex (Fed. Cir. 2019) (clinical trial provides only hope, not expectation of success).
- Avoiding Co-administration with CYP enzyme inhibitors: A similar drug (ramelton) had shown problems with co-administration with these CYP enzyme inhibitors, creating a reasonable expectation that tasimelteon would also show similar results. On this point, the testimony was that PHOSITA would not have “ruled out an interaction.” Here, the patentee argued that the weak evidence here would fail under a predictability test.
The Supreme Court has not addressed obviousness standards since its 2007 decision in KSR. If the Court grants review, this case offers an opportunity to resolve both new and longstanding divergence in Federal Circuit obviousness decisions.
Although obviousness has long been the central feature of patent prosecution, it has seen a tremendous resurgence in US patent law over the past decade. This is primarily driven by the AIA trials (mainly inter partes review) that rely upon the lower standard offered by KSR. PTAB decisions and the frequency of Federal Circuit obviousness decisions appear to be bleeding over into other arenas — especially Hatch-Waxman infringement litigation that is generally decided by a judge rather than a jury.
Vanda is represented in the Supreme Court petition Paul Hughes team at McDermott Will & Emery that includes Sarah Hogarth, Christopher Bruno, April Weisbruch, and Grace Wallach. Teva’s opposition brief is due in mid-February. Although Teva has not yet filed an appearance at the Supreme Court, I expect that JC Rozendaal from Sterne Kessler will represent Teva before the court along with his team that includes Byron Pickard, Deirdre Wells, William Milliken, and Sasha Rao. At the rehearing stage, Teva argued repeatedly that Vanda was mischaracterizing the Federal Circuit’s decision; not engaging with the panel’s actual analysis; and attempting to re-argue the facts. Welcome to election season.
Federal Circuit’s Sleepy Obviousness Decision and Vanda’s En Banc Rehearing Petition
I express no opinion whether the facts accurately describe the issue here, but the statement of law is correct. The Supreme Court routinely applies predictability as the standard because a predictable result adds nothing to the store of knowledge and therefore does not advance the art. All of the “old” (pre 52) “invention” cases distinguish an outcome that is the result of the combination from an outcome that is the result of the mere aggregation of individual pieces. Often they use the term “synergy.” (see, e.g. Reckendorfer v. Faber as a good summary)
Later cases carry forward the notion in terms of if the result is consistent with what the art would have expected. A&P Tea, Sakraida, Anderson’s Blackrock.
I don’t buy the notion that “predictability” is a higher standard than “reasonable expectation of success” (although I can see how a pharma attorney might think that) and I don’t even think they are talking about the same things. But I do agree that obviousness requires all three of (1) a motivation to make a change (although this often falls under the kind of routine experimentation that is discussed in KSR), (2) the ability to make the change (i.e. enablement of the change) and (3) the results to be consistent with expectations (i.e. “predictability”). “Reasonable expectation of success” derives from a discussion of the second element, while “predictable results” derives from the third.
Much discussion is always had on a motivation, but the whole point of KSR was to undercut the reliance on textual motivations or suggestions. That’s why KSR provides so many exemplary rationales based upon enablement and predictability. Granted I am in software (an exceedingly predictable space), but in my experience 90% of cases can be dealt with simply by looking through the specification to see if there is any technical teaching (there almost never is, especially not one consistent with the breadth of the claimed functional scope) and then rephrasing one of the two sentences in the following paragraph:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.
Results are always predictable in software. Enablement is largely settled by the specification and claim scope. Presumably the opposite occurs in the less predictable arts, where nonobviousness is easier to find and the patentability turns upon proper enablement and possession of the full scope claimed.
Regardless, I view the issue as already decided – It seems to be settled law that unexpected results is a successful retort to routine optimization/experimentation. If reasonable expectation of success was sufficient for obviousness, routine optimization/experimentation would be unassailable.
Useful contribution. I wonder, have you anything useful to say on the first of the three elements namely motivation to combine, in the context of the notion that enjoys currency at the EPO, that the question is not what the objective and legally fictitious skilled person who knows all the prior art “could” have done but, rather, what that person “would” have done.
I mean, when you know what the invention is, and have searched through the prior art universe in the luxury of that knowledge, combining the disclosures of prior publications D1 and D2 very often looks with the benefit of hindsight like an obvious thing to do. But was it at the time? Is it what the skilled person “would have done” or is it merely only something they “could” have done, if they were in the right frame of mind.
Is it what the skilled person “would have done” or is it merely only something they “could” have done, if they were in the right frame of mind.
“I know I could do X to achieve the result but I would prefer to do Y” only has a difference if you assume that both X and Y options are equally available over the full breadth of the claim, but rarely are claims written that require that to be the case. I struggle to think of any situation where I had both X and Y available and yet I could not fashion some reason to use the inferior one. Rarely are both X and Y equally available, rarely is Y superior to X in every conceivable fashion, and rarely does the use of Y not degrade Y. I suppose that if hypothetically one was presented with such a case, there might be a question under non-US law (based on what you told me), but I have difficulty imagining such a claim being written for such a X/Y fact pattern being true, and if it was I have difficulty imaging what the harm would be if someone got the answer wrong. If there truly is no reason to use X when Y is present, and the claim only covers situations where X is used when both X and Y are available, I am not sure what harm there is over giving/denying a monopoly to the illogical choice of action.
But those situations don’t exist. You “would” use the inferior option you “could” take for at least the reason that you likely encounter scenarios when the superior option is not present. I think steak is a universally better meal than sandwiches, but I sometimes eat sandwiches because I can’t afford steak for every meal.
I do appreciate your efforts to explain, Random, but what they do is to reveal the gulf which separates the obviousness analysis at the EPO from the one at the USPTO.
The “could/would test”, so familiar and meaningful for patent practitioners in Europe as a way to free the TSM obviousness enquiry from the taint of hindsight knowledge of what the invention is, and to render the enquiry objective rather than subjective, is beyond the comprehension of those patent professionals in the USA who don’t routinely act for clients petitioning the EPO for the grant of patents.
That’s valuable education for me, helpful every time I have to brief clients in the USA.
MaxDrei – you might want to reconsider your conclusion at 6.1.1.1 as Random does NOT represent “patent professionals in the USA.”
Any “gulf” then is more referential to Random’s twisted views as an Examiner.
The caveat of “unless” means that your overbroad assertion as to universality of “predictability” is false.
The Venn diagram of the words simply are not the complete overlap that you would have it
The caveat of “unless” means that your overbroad assertion as to universality of “predictability” is false.
I do not assert that predictability is sufficient for obviousness, I merely assert that it is necessary for obviousness. The question of this case is if obviousness requires a showing that the results were predictable. The answer is yes.
You need to work on your basic set theory,
Predictability has nothing to do with obviousness
Hmmmm. That does not sound quite right. What does Bard have to say about it?
“Predictable” and “obvious” are not perfect synonyms, but they have significant overlap and can be used interchangeably in many contexts.
Here’s a breakdown of their differences and similarities:
Similarities:
Both words imply that something is easy to foresee or guess because it lacks novelty or complexity. They can be used to describe events, situations, or ideas that are readily apparent or lacking in surprise. In some contexts, they can be used negatively to suggest that something is unoriginal, boring, or lacking in depth.
Differences:
Predictable emphasizes the aspect of being able to anticipate something based on past experience or established patterns. It implies a reliance on known information or rules to make a prediction. Obvious emphasizes the clarity or ease of understanding something. It suggests that the information or situation is readily apparent to anyone without requiring special effort or knowledge.
Conclusion: while “predictable” and “obvious” share some common ground, they have subtle differences in their connotations.
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A mere difference in connotation seems like a slim reed to me…..
Yes, there is ample evidence that you do not appreciate the legal effects of words.
Say, “Laa Vee.”
The legal effect of “predictable” is not what’s obvious in your comment, as usual.
As usual, you try to be witty and
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Why in the world would you even A S S ume that my comment is attempting to provide some type of obviousness for the legal effect of “predictable?”
Clearly, my direct comment was merely observing YOUR lack of legal understanding.
Too clever by half is still zero given your state of cleverness.
If you hadn’t been excreting the same forms for scores of years, I would just assume a (badly) trained AI was generating your constant
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Yet again marty, YOUR lack of ability to understand law does NOT make my posts to be “G1bber1sh.”
I have instructed you MANY times to ask very specific questions of your own patent attorney.
Funny, how YOU never seem able to do that.
Q. How delusional do you have to be to think I would spend fees to ask in ane questions cooked up by an anonymous & obviously unbalanced Internet rando?
A. Very
The money you would “lose” in those fees would VASTLY be made up in your increased awareness of the law.
Just think of all the time you would save from typing the nonsense that you do in this blog.
Part of the problem is that CAFC does not do an enablement type inquiry for obviousness. In general, they just ask whether the references on their face are pointing toward the invention.
Whether or not it’s predictable or reasonable to try various options depends on the difficulty of “trying”. Does it take years and millions of dollars to “try” something that we think has a coin flip chance of working ex ante? Or does it a person or two a weekend to try a handful of different alternatives? In the latter case, a “finite number of predictable choices” could reasonably be 50-100 alternatives even if the chance of success of any given one is low, ~10% or so.
RES came about because there are many bio inventions where the prior art plainly points toward the invention, but the chance of it actually working is considered low. Obviousness is not appropriate in that circumstance because there is a good chance the invention would not have been pursued but for the patent incentive.
I am not sure that this, “art of the problem is that CAFC does not do an enablement type inquiry for obviousness.” is quite right.
Given multiple past discussions on the use of (or impropriety of attempted use of) science fiction, one COULD postulate that the proper application of the Graham Factors is in fact the type of “enablement type inquiry” that you speak of.
Part of the problem is that CAFC does not do an enablement type inquiry for obviousness. In general, they just ask whether the references on their face are pointing toward the invention.
I’d argue that RES IS the CAFC doing an enablement type inquiry for obviousness. It’s just that being motivated and enabled to make a change is not sufficient to make a claim nonobvious. The change must also generate expected results.
You forgot that caveat as to “unexpected.”
“It’s just that being motivated and enabled to make a change is not sufficient to make a claim nonobvious. The change must also generate expected results.”
Nope.
It’s incredible how bad you are at this.
“An ongoing clinical trial was testing the 20 mg dose, but had not yet shown it to be effective to entrain patients as required by the claims. The court saw the ongoing clinical trial as evidence supporting a reasonable expectation of success as to the result of the trial, while the patentee argued that it offered only hope, not a predictable solution.”
Ok, we are going from “obvious-to-try” to a “reasonable expectation of success” to “try-it-and-hope-that-it-works”.
Soooo
This recalls my prior stated position regarding the ‘TOO EARLY” filing of many Big Pharma applications, given that claims are not actually possessed at time of filing – and the sheer number of items that represent claims that
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FDA testing:
“while the patentee argued that it offered only hope, not a predictable solution.””
One is not allowed to file ‘on hope,’ as possession is required AT the time of filing.
And this goes to my prior position that pharma is the only discipline where it is required to makes its inventions public (the clinical trial) which forces the the patent filing.
anon’s solution is to render the pre-clinical trial patent filing invalid. I proffer another solution is to remove the regulatory requirement of public disclosure of clinical trials.
what’s the best course of action? who knows..
And this goes to my rebuttal to your comment that REGARDLESS of any other Federal agency, the patent law does NOT provide an exception for possession at time of filing.
My “solution” is ONLY for consistency with the law as written.
Is there a problem OUTSIDE of patent law that THEN needs to be addressed?
Perhaps.
That does not change the necessary application of consistent patent law – and the necessary result that ANY Pharma patent application violating that law
IS
invalid.
You (at least) DO engage on the merits (as opposed to a lot of my detractors) and offer a solution.
Kudos.
Let’s offer another: Rather than remove from public disclosure (which – given the level of out-of-the-sunlight shenanigans ALREADY in the Pharma world – is just not a good idea), let’s instead state that THAT type of public disclosure cannot be deemed prior art for a bona fide patent filing once possession IS obtained.
I strongly object to the framework proposed by Vanda. Science is inherently predictable. Invention is when humans discover and apply fundamental (predictable) principles. Predictability has nothing to do with obviousness. The analysis for obviousness should be TSM (teaching, suggestion, motivation) in the absence of objective indicia of non-obviousness.
Josh, I thought that, in the USA, TSM had already been tried (I mean: given a thorough work-out) but had been found wanting, unfit for purpose.
Not so in the EPO of course. There, it was installed from the get go, in the late 1970’s, and since then has gone from strength to strength to become, these days, more or less unassailable. What is your experience of it there, I wonder.
Max, TSM, as it was originally applied was deemed too narrow and incomplete. KSR v Teleflex (SCOTUS) said that while TSM was useful (and still a good methodology), that was not the only reason to combine references when making an obviousness argument. That case summarized and expanded upon several additional reasons to combine references and that is where the “reasonable expectation of success” and “predictable results” paradigm came from.
DVan,
You’ve been here long enough to know that MaxDrei really does not care about any US Jurisprudence, but just looks for opportunities to vulture his EPO-Uber-Alles shilling.
Very helpful, thanks. It leaves me wondering what is the key difference between the TSM methodology found wanting by SCOTUS in KSR and the TSM methodology applied in 1000+ decisions per year in EPO post-grant oppositions. Perhaps that notions of predictable results and various “expectations of success” are an integral part of the TSM enquiry at the EPO but incompatible with TSM jurisprudence in the USA.
Or perhaps because EPO-TSM methodology works under civil law but not under English law, evidence assessment and fact-finding being done so differently in the two rival legal systems. Come on, Josh Malone, tell us, won’t you, how, in KSR, SCOTUS got TSM wrong.
I call B$ on your assertion of “leaves me wondering”
The pile of horse carcasses next to the Well of Wisdom simply shows that your main purpose is nothing more than shilling for the EPO Uber Alles position.
In plain words, this is a request to remove “obvious to try.”
I am reminded of Yoda: “Do or do not. There is no try.”
But didn’t Yoda, in a much later movie say, “the greatest teacher failure is.”
Seems like “trying” necessarily precedes any type of “doing.”
I would most heartily disagree, as you mistake an earlier doing as ‘trying.’
That is not the lesson of Yoda.
In plain words, this is a request to remove “obvious to try.”
No its not. The question is a request to confirm that obvious to try requires the generation of predictable results. Whether or not the facts fit that question is another issue.
Obvious to try does indeed require predictable results. The line in KSR is
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.
If the inventors use a species in genus A to get result B, the claim is obvious to try when the art had a reasonable basis to believe that some characteristic in genus A could be used to result in B. When the art did not recognize the characteristic was result-effective there are not a “finite number of identified” solutions (i.e. you wouldn’t think to look at genus A) and OTT does not apply. When the results are not predictable (i.e. they think genus A could get result X, not result B) then the solution is not “predictable” and it does not “lead to the anticipated success” and OTT does not apply because there is surprise in achieving B rather than C.
If the rule was otherwise you couldn’t use unexpected, critical results to overcome a routine optimization of a range. It’s always nonobvious to surprise the art with an result different from what was expected.
Yes, yes it is.
Your error is in not understanding the limitations of your understanding.
See above and the lack of complete overlap due to important caveats.
Once understanding achieve, you do, Yoda correct is, see you will.
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