by Dennis Crouch
Spectrum Pharma and the University of Strathclyde v. Sandoz Inc. (Fed. Cir. 2015)
In this case the Federal Circuit shoots down two fairly silly arguments, but not without first giving them full credence and consideration. Although the patentee lost here, the Federal Circuit appears to agree with the patentee that its less-pure compound could have been patentable over a purer version identified in the prior art even though the added impurities provided no benefit, functionality, or synergy — PHOSITA simply would not have been motivated to make the less-pure version.
Background: The ANDA lawsuit here centers around Strathclyde’s patent (licensed to Spectrum) covering the the drug Fusilev aka l-leucovorin and Sandoz’s related generic drug application. The drug leucovorin was found to be effective at treating iron deficiency that can occur with 5-FU cancer treatment. Later, researchers discovered that it was actually one isomer of leucovorin (6S) that was effective and the other isomer (6R) was just along for the ride. The patentee here substantially purified the 6S isomer and attempted to patent it as part of a therapeutic composition. Claim 1 requires “a mixture of (6S) and (6R) diastereoisomers and consists of at least 92% by weight of the (6S) diastereoisomer, the balance of said compound consisting of the (6R) diastereoisomer.” It turns out that years earlier a researcher had manufactured a pure form of the 6S isomers and the 50/50 mixture of 6S/6R isomers was known as well. By the time of the invention in question here it was also known that the 6S isomer was the effective one. Later studies proved that the substantially pure form was clinically no better than the 50/50 mixture having the same effective amount of the 6S isomer.
Obviousness:
A patent claim is invalid as obvious if an alleged infringer proves that the differences between the claims and the prior art are such that “the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a) (2006) (pre-AIA). Obviousness is ultimately a conclusion of law premised on underlying findings of fact, including the scope and content of the prior art, the differences between the claimed invention and the prior art, and the level of ordinary skill in the pertinent art. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007); Graham v. John Deere Co., 383 U.S. 1 (1966). “The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact.” Alza Corp. v. Mylan Labs., 464 F.3d 1286 (Fed. Cir. 2006). In addition to common knowledge or teachings in the prior art itself, a “design need or market pressure or other motivation” may provide a suggestion or motivation to combine prior art elements in the manner claimed. Rolls Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010);
Here, the patented mixture could be made by simply mixing the known pure 6S isomer with the 50/50 mixture so as to reach the claimed 92% ratio. The patentee argued that there would have been no motivation to combine these references — going from a pure substance to a less-pure substance. The Federal Circuit sees merit in that argument:
[I]f the pure material is known, no reason has been shown why one would want to have an impure material. Although one may not be motivated to obtain an impure material and, in effect, it therefore can be argued to have been nonobvious—which is Spectrum’s position here, that the 92–95% pure material was nonobvious over the known pure material.
The Federal Circuit ultimately rejected that argument “despite its superficial appeal” by looking at the patent from the starting point of a 50/50 mixture – and finding that there would have been a motivation to improve its purity. The court also noted that the new mixture offered no “unexpected advantages over the prior art pure material, the less-than-pure material, and any others of similar concentration.” In essence, this case is can be seen as very much parallel to KSR – where a combination of two known elements, with each element being used as expected, is unlikely to be patentable absent some unexpected results or synergy.
Objective Post-Invention Evidence Showing Obviousness: Of interest, the Federal Circuit approved of two additional bits of evidence that occurred post-invention that helped prove obviousness. The first was evidence that several other researchers were able to obtain the 92% isomer concentration shortly after the patentee obtained its results — that appears have provided some evidence of obviousness. Secondly, the court relied upon post-invention studies showing no benefit of the pure drug to negate any synergy argument.
Infringement by Importation: A second set of claims included a limitation that the composition was provided in “a quantity at least sufficient to provide multiple doses of said mixture of (6S) and (6R) diastereoisomers in an amount of 2000 mg per dose.” Although Sandoz was planning to sell drug in single-use vials of ~200 mg per dose, the patentee argued that Sandoz did plan to import the drug in larger shipments and, at that importation would be infringing. The Federal Circuit rejected that argument – finding that the ANDA infringement inquiry under 271(e)(2) “focuses on a comparison of the asserted patent claims against the ANDA product that is likely to be sold following FDA approval.” Thus, the fact that Sandoz plans bulk-imports does not create liability.
On this front, it seems that the Federal Circuit may have left open the possibility that Sandoz imports may still infringe under 271(a) once the generic maker begins imports.
Doctrine of Equivalents: The patentee had argued for infringement under the DOE even though it had narrowed the very amount element during prosecution. Its argument was that the amendment should not count as narrowing because other claims in the patent were still broader. That argument fell on deaf ears:
[B]y claim amendments and distinguishing statements on the prior art during prosecution, Spectrum is now estopped from invoking the doctrine of equivalents to prove infringement. When submitting an amendment with the application claims that eventually issued as claims 5–9, the applicants asserted that the newly added claims “include specific limitations as to quantities of materials,” and distinguished the prior art by pointing to the “quantities of these specific mixtures specified in the claims.” Those claims were also added following an office action rejecting the previous original claims as obvious in view of Rees. The applicants again explicitly highlighted the significance of the dosage limitation during an appeal to the Board, their brief stating that the claims “require a minimum of four grams,” the “quantity limitations set forth in the claims” which “define an aspect of the invention that is of great practical significance.” The applicants unequivocally argued that Rees, which allegedly only produced experimental quantities, “do[es] not teach, suggest, or otherwise render obvious the claimed compositions in the quantity specified” in the application claims that became claims 5–9. Those statements are clear and unmistakable expressions of the applicants’ intent to surrender coverage of quantities of the compound in lower doses.
Thus, Sandoz wins here on all fronts.
This is the quintessence of KSR. I had an applicant argue that there was “no motivation” to make the invention ( that they claimed mind you) because it would have made the invention worse. So pretty much the same.
I threw a “substitution of known elements to obtain predictable results” at them and they shut up.
“ ( that they claimed mind you) ”
The quintessence of hindsight…?
😉
You always feel you have to /golfclap when they actually get it right. As I’ve said previously it is a mistake to think about “motivation” when the correct thought is “predictability.” The art knew what a 50/50 would do, the art knew what a pure 100% would do, and unless something in between behaves unpredictably (i.e. generates “unexpected results”) it will also be obvious.
While there are certainly motivations (MM gives the basic one – dilution saves money) you could have NO motivation and it would still be obvious, because a motivation for combination is only ONE mechanism by which a rationale for obviousness is shown. Granted its the most common one, but by no means is it the only one.
If you take off all your clothes and jump in the ocean at the north pole, the result is predictable. Same thing if you were to remove your suit while walking on the moon – predictable result. That renders it obvious. The fact that it would be difficult or impossible to find a motivation for doing it is irrelevant.
There are so many brilliant inventions that “combine known elements” in nonobvious ways to solve significant problems.
Once a patent runs on a machine the machine has passed to the public. Aggregating a bunch of machines that use their known purposes isn’t any more patentable than trying to repatent them individually. Either an art doesn’t know about a structure, or the art knows of the structure but it is behaving differently than would be expected – those are your only ways of patenting something. Telling an art what it already knows, even if you do it a lot, is not patentable.
RG: If you take off all your clothes and jump in the ocean at the north pole, the result is predictable. Same thing if you were to remove your suit while walking on the moon – predictable result.
What if I leave my tie on and dye my eyebrows green?
Sure I cool off. That’s predictable. But what about the extra laughs from those who are “in” on the joke? You couldn’t predict that. Amusement is useful (reduces stress). Can I haz patent now?
If it became publicly known that the courts was now authorizing patents on worse ways of accomplishing things, de-invention so to speak, the patent system would take another disastrous public relations hit.
Of course, the other way of tossing this invention is to say it fails straight 101 – it simply is not a utility distinction. You can’t take something useful (6S) and combine it with varying amounts of something useless (6R) and expect to be awarded different UTILITY patents. It’s a design choice.
The “invention” in this application (the disclosure of knowledge that 6R is useless) is not really a patentable disclosure in light of the admittance that the art previously was using 6S/6R compounds.
Utility distinction?
Huh?
Random, you have got to be kidding here. The word in 101 that applies is not “utility,” but “improvement.
If there are cases that go off on “utility distinction” I would be amazed. Truly amazed.
What in the world?
If there are cases that go off on “utility distinction” I would be amazed. Truly amazed.
Of course there are, Ned. Why is it that a book with new, non-obvious words isn’t patentable over a blank book? Same thing with a cd that has non-functional information on it.
You can’t take something that differs from the prior art only by a distinction the law doesn’t recognize and call them different. The prior art used a 6S compound to treat something. This art uses a 6S compound to treat the same thing. The fact that there are additional non-utilitarian claimed items in there is irrelevant.
I’m saying that just like you can’t take a piece of paper and change an ornamental design on it and call it a “new and improved” paper, you can’t take a 6S compound and change an ornamental design and call it a new and improved 6S compound. There is no utility in the change from the preexisting.
Random, 101 requires utility, not a utility distinction.
101 further requires new or improved. A product of nature is not new.
But if something is less good than before? How can this pass 101’s requirement of improvement?
From a prior art point of view, we have known and used before. The distinction over the prior art must not be obvious. That is like “knowledge.” But a functional improvement? That really is a requirement of 101 — and used to be a requirement of the law prior to 103’s adoption. KSR simply restored, in my view, the concept of improvement — and stuck it in 103, when really, it is a 101 concept.
How can this pass 101’s requirement of improvement?
The argument would be that “improvement” is merely an alternative point of entry. “New” (but not necessarily improved) is the other alternative.
I think the issue both you and RG are raising can be addressed under 103 (under certain circumstances; under certain other cirumstances 101 may be more appropriate). Consider a patented surgical process. Can I obtain a patent on a “new process” merely be adding some trivial detail that doesn’t improve the process, e.g., “wherein someone in the operating room wears a purple hat”? I think the correct analysis is that the “new” process is obvious in view of the prior art that teaches (1) the recited surgical process and (2) the recited wearing of a hat. As RG has already pointed out, the issue is predictability: does the hat add something unexpected to the process? The question isn’t really whether one skilled in the art would be “motivated” specifically to wear a purple hat in an operating room. It’s a question of what the heck is the purpose of the hat in the claim other than avoiding anticipation.
MM, a distinction without a difference.
But such a distinction can be non obvious as all get out. I am thinking of a claim to a player piano playing a particular song or where the piano is made of a particular kind of wood that does not enhance its utility at all. If the only issue is obviousness, the claims issue.
103 does not ask the right question to get to the result we know is right.
KSR restored the idea that there had to be a functional improvement, and more than just that, it had to be unexpected. But it there is no functional improvement, why do we even have to get to whether the difference is unexpected?
I can see how Rich tried to handcuff the law into asking only one question, and that was about obviousness. This could and did lead to the patenting of a lot of stuff that made no functional difference to the underlying subject matter, but did in fact monopolize business methods and the like. The man, think, knew exactly what he was about.
But back to the issue at had, what is the Legal basis for a distinction without a difference? Do we even have to reach 103? Isn’t this really a 101 issue?
I am thinking of a claim to a player piano playing a particular song or where the piano is made of a particular kind of wood that does not enhance its utility at all. If the only issue is obviousness, the claims issue.
If the “particular song” or “particular kind of wood” does not enhance its utility then the claim is, at a minimum, obvious over “a player piano playing a song.” It is probably anticipated by “a player piano playing a song” too. And if the Applicant admits that the art knew of “a player piano playing a song” then the claim must be attempting to claim non-utility things (either a useless particular song or a useless particular type of wood) and there you don’t even pass 101.
Random, you are using “obvious” in a meaningless way. If something is unknown and unknowable in any predictable way based on known information, it is not obvious.
The particular song is entirely original cannot be knowable.
I do not see how it is proper to find a claim to the combination of an old player piano and a new song unpatentable based on obviousness unless one simply excludes and gives no weight to the new song.
But the basis for such exclusion must lie either in 101 or in 112.
Random, you are using “obvious” in a meaningless way. If something is unknown and unknowable in any predictable way based on known information, it is not obvious. The particular song is entirely original cannot be knowable.
You’re bifurcating the claim. The question is Is the system obvious? The particular song, when placed in the player piano, behaves like any other song would. Are the particular notes played different? Sure. Is the playing of particular notes a distinction within the useful arts? No. From a patent standpoint it is no different than a player piano with any other music.
I do not see how it is proper to find a claim to the combination of an old player piano and a new song unpatentable based on obviousness unless one simply excludes and gives no weight to the new song.
But the basis for such exclusion must lie either in 101 or in 112.
Well sure you can 112b and force the applicant to remove the player piano from the claim leaving only the particular song. You can also use 101 to show that the claim is actually only directed toward the particular song and reject it in that fashion. But from a 103 standpoint you can reject it because the distinction is not a patent distinction – the particular music has no relationship to the utility. That’s hardly a new concept, the office rejects non-functional descriptive material on a daily basis.
Random, 101 requires utility, not a utility distinction.
Suppose A invents the book. The book fall into conventional use. B then goes to the patent office and says “I didn’t invent this book, nor is this book new, but I want to patent it.” Certainly B fails 102, but does B pass 101 scrutiny? I think this is a pretty easy “No” as he’s not purporting to have something new or improved or some advancement of the art.
Now suppose instead B colors his book cover blue. B then goes to the office and says “I didn’t invent this book, but I made it a pretty new color and I want to patent it.” Now I suppose there are three ways to look at this –
1) The blue book is obvious over the prior art of a book
2) The blue book is anticipated by the prior art of a book because the coloring to make it blue (which has no inventive or utilitarian value, it is nonfunctional descriptive material) is not given patentable weight, and consequently a book anticipates a book.
3) There is no invention at all because the invention is the non-useful act that “a book can be painted blue.”
I’d submit to you that if the applicant knows that 6R is useless, and is distinguishing his invention by the amount of 6R there is, we have a (3) situation. You’re letting non-inventive aspects control the utility question when the question has to be if the novelty impacts utility.
If I build a machine and the machine doesn’t work (and therefore has no utility) but the machine comprises a known screw, would you say I have utility because the known screw has utility? That’s not the novelty of the invention. The question is what did this guy do? He varied the amount of a useless substance in a mixture. That lacks utility. The fact that some component of the system had known utility on its own (absent the combination you’re claiming) doesn’t mean that your invention has utility. If that were the case nothing would ever lack utility because everything in the world can be used to do something!
Random, while varying something useless does not change the utility of the claimed subject matter, it remains useful. There simply is no improvement.
We do not disagree on the result, here. What I do not understand is why you are struggling to reinvent “improvement” when “improvement” is already in the statute.
Random, while varying something useless does not change the utility of the claimed subject matter, it remains useful.
But HIS INVENTION is not useful. THE PREVIOUS INVENTION was useful. It’s the same reason that a processor didn’t save Alice’s claims Ned. You’re confusing the fact that something is in the claim with it being his invention.
Here let me put it like this – the fact that the office fails to correctly police 112b so that the claim only contains what the applicant considers to be their invention does not mean that 101 suddenly goes away. Your guy did not invent the player piano, nor does his particular music behave differently (i.e. cause a non-obvious combination) than any other music. The office shouldn’t have allowed the player piano to be in the claim. The invention is directed toward particular music, which is non-statutory and non-useful. The fact that the office doesn’t push the player piano out of the claim (as it would if Applicant also claimed the building the piano was in) doesn’t suddenly make it the invention of the Applicant.
If it became publicly known that the courts was now authorizing patents on worse ways of accomplishing things, de-invention so to speak, the patent system would take another disastrous public relations hit.
Imagine the patent on the slow car, the medicine that almost worked, the rifle that shot, but did not hit.
What a joke that we should even consider exposing the patent system to such ridicule.
the rifle that shot, but did not hit.
But think of all the saved lives! 😉
MM, reminds me of the artillery shells manufactured by Schindler at the end of WWII.
Depending on the method of creating the more-pure stereoisomer, 92% could be much more cost-effective chemically. Not all methodologies of obtaining single stereoisomers result in near-100% yields. The Federal Circuit has more-or-less ruled that picking methods of generating stereoisomers from the prior art is non-obvious: Plavix was non-obvious when a French company used Pasteur’s method (1859). The motivation could have genuinely been financial, but more likely it was to use any trick to get another Orange Book patent.
The Federal Circuit has more-or-less ruled that picking methods of generating stereoisomers from the prior art is non-obvious: Plavix was non-obvious when a French company used Pasteur’s method (1859)
That was one of the worst decisions the CAFC ever published. Newman, right?
Dennis
I guess I don’t agree that making something “worse” in all instances is not a viable path to patentability, particularly where the “worse” thing is considered otherwise unusable by an industry for the same purpose. While not in the same field, I did some work for a telecommunications company back in the mid-late 90s, who wanted to make a “worse” version of Amati’s famous ADSL Standard T.1413 protocol modem. Why “worse”? Because to implement the full standard using an ASIC was hundreds/thousands of dollars. My guys figured out a way to make a 1/10 speed version that cost 1/10 the cost; that way, it could be incorporated directly into a PC. Note it was still “compatible” but was a “worse” version of the standard. This work was heavily patented and eventually became part of the G.lite standard, which was a “light” version of the full standard.
So I submit that sometimes “worse” can indeed be “better” for other reasons.
Sure, I agree with this.
JNG, reduced cost to manufacture the same thing might be an improvement, but I am not so sure that the same can be said where the reason for the reduction in cost is a reduction in utility.
Nevertheless, the ultimate test is “unexpected results.” If reducing capability was known to reduce cost, and I submit, this has been know forever, there is nothing unexpected.
This argument is backward – you give no detail about the changes made and only discuss the results as if the end drives the means rather than vice-versa.
The question is: Are the changes that your guys made known or not? If it was obvious, the fact that it was “worse” wouldn’t have made it patentable (and indeed you’re giving a motivation – 10% of the cost). If it wasn’t obvious, the fact that it is only 10% of the speed is irrelevant as well – it’s still patentable. It simply has no bearing on the issue.
Here let me make it clear cut – one way you could create a system that is 1/10th the speed is to write a command that waits 9 seconds for every second of processing it does. That system is obvious, despite the fact it is worse (10% the speed) and has EVEN LESS motivation than your system (since it is still 100% of the cost). It’s obvious because a command to wait for 9 out of every 10 seconds is known and the result is predictable. The fact that no rational person would have a reason to intentionally slow down their processing is irrelevant.
Immediately following the end of the above quote from this case: “..Rolls Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010);” the Court continued with “accord KSR, 550 U.S. at 420.”
I find it strange that the Fed. Cir. would cite legal authority in that order? [Or in some other cases only cite their own cases and not even mention a controlling Sup. Ct. case at all.] As for the mere statement of “accord” if KSR is not the controlling authority on 103 in general, and “common knowledge OR teachings in the prior art” in particular, what is?
Paul, I note Hughes is on the panel and he was on the panel I argued to last month. Hughes consistently seemed vastly more interested in Federal Circuit authority than Supreme Court authority even on the very same point.
One can see this in the recent case on laches where a bare majority of the court stuck to their case law rather than junk it in face of clearly contrary Supreme Court authority.
One does begin to wonder about this court.
Take the whole colloquy we had about Lockwood. They knew from Judge Nies’s dissent to en banc that Lockwood and Patlex were mutually inconsistent. But rather than consider that Patlex was wrongly decided, they seem to suggest that they would hold that Lockwood was wrongly decided, and would hold that there was no right to a jury trial for for validity – even though Patlex had no support in Supreme Court jurisprudence while Lockwood clearly was consistent with Supreme Court jurisprudence.
“…a combination of two known elements, with each element being used as expected, is unlikely to be patentable absent some unexpected results or synergy.”
I have to think this is overstated and hopefully won’t be applied as sweepingly as it sounds. There are so many brilliant inventions that “combine known elements” in nonobvious ways to solve significant problems.
Maybe it really hinges upon what “used as expected” means, and to what extent being paired with something “unexpected” can count.
Ken: I have to think this is overstated and hopefully won’t be applied as sweepingly as it sounds.
Read the statement carefully, Ken. It’s a simple fact that you should get used (or that you should’ve gotten used to a long time ago).
And here is the key quote from the Supreme Court in KSR:
“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. “
Straight out of Hotchkiss v. Greenwood.
Thanks Dennis – I take some comfort in the “according to known methods” part, as that at least leaves some room to argue that a given combination required some ingenuity in the way it was approached.
Ken, it IS interesting, is it not, that the Supreme Court has affirmatively restored Hotchkiss even though Judge Rich tried to get rid of it in crafting 103 the way he did?
Ned – yes and I don’t really have a problem with the articulation in Hotchkiss, and perhaps not even KSR, but at some point it slides so far that I can actually sympathize with what Judge Rich was trying to do.
Well, Ken, Hotchkiss and 103 seem to address two separate issues:
1. Whether in point of fact there is an improvement; and
2. Whether, if there is an improvement, it nevertheless was unexpected to one of ordinary skill.
There is room for both in the law and both should be required, I think. The problem with Rich’s view of things was that he wanted only 2, thereby never looking at 1. This is why the Feds seriously consider whether something worse could be non obvious. Of course it could.
DC: the Federal Circuit appears to agree with the patentee that its less-pure compound could have been patentable over a purer version identified in the prior art even though the added impurities provided no benefit, functionality, or synergy — PHOSITA simply would not have been motivated to make the less-pure version.
One reasonable “motivation” — and this applies across the board — is that diluting the pure compound means that you use less of it, thereby reducing costs and increasing profit. That’s a practice that’s older than the hills and the Federal Circuit should know better.
I agree that your motivation statement could provide a prima facie case of obviousness, shifting the burden to Applicant at the Office. That’s why I have few first-action allowances. If there is any reason, even a stretch like some may consider your motivation (diluting to save cost), I will make the 103, have the Applicant go on record rebutting the reason, then allow (if Applicant can reasonably overcome my proposed reasoning).
(That’s why attorneys should spend more time writing coherent and sound responses to Office Actions, rather than just complaining that the Office was wrong. Sometimes the Office knows its reasoning isn’t great, but it isn’t wrong, and it beats the “no response” received from some Applicants.)
If there is any reason, even a stretch like some may consider your motivation (diluting to save cost)
This isn’t a “stretch.” Not even close.
Another reasonable motivation is to avoid the prior art in order to get a patent that can then protect your investment. But that seems to take us to the same result: not patentable.
A dilution solely to avoid prior art shouldn’t be grounds to argue nonobviousness.
A dilution solely to avoid prior art shouldn’t be grounds to argue nonobviousness.
I’m curious as to whether this has ever been tested in court.
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