In re Efthymiopoulos (Fed. Cir. 2016)
In a split opinion, the Federal Circuit has affirmed the PTAB’s determination of obviousness. Biota’s patent claims influenza treatment through oral inhalation of zanamivir while the prior art teaches the identical treatment by nasal inhalation. A second prior art reference also suggests that similar compound can be taken via “inhalation” (without the nasal or oral modifier). On appeal, the Federal Circuit affirmed that the general inhalation disclosure “is reasonably understood to disclose inhalation by either the nose alone, mouth alone, or both.”
Judge Newman writes in dissent:
The PTAB and now this court rule that it was obvious to administer this drug by oral inhalation, although there is no reference, no prior art, no suggestion, proposing that this mode of application might succeed, or that it should be tried. There was evidence of skepticism even as oral inhalation was evaluated. There was no contrary evidence. The evidence on which the Board and now this court rely is the evidence in the patent application itself, describing oral inhalation, its benefits, and its effectiveness. Upon learning this information from this inventor’s disclosure, the Board found that it was obvious, and my colleagues agree that it is obvious to them.
In its brief, the PTO wrote:
Efthymiopoulos seeks to capture as his exclusive property right a particular (but not particularly new) way of delivering an old compound to treat a well-known disease. Specifically, Efthymiopoulos claims a method for treating influenza, an infectious disease of the respiratory tract caused by influenza (flu) viruses, by administering zanamivir, a compound known in the prior art as an inhibitor of influenza virus production, by inhalation of zanamivir through the mouth alone. Efthymiopoulos contends that his contribution to the art is the route of inhalation – treating influenza solely by oral inhalation.
But the evidence of record shows that oral inhalation would have been obvious. Specifically, as of the effective filing date, skilled artisans understood inhalation to mean oral, nasal, or both. The prior art was replete with available oral inhaler devices for use with well-known micronized dry powder formulations. Skilled artisans also knew that oral inhalation delivers more drug to the lungs and that nasal inhalation delivers more drug to the nasal cavity. Skilled artisans further knew that some strains of influenza infect the lungs, and that young children are more susceptible to lung infections.
The case here is an example of the difficulty with the flexible obviousness analysis — it allows for well supported arguments on both sides.
I have had a quick look at the Decision and the Dissent and the wrapper of EP-B-764023 which I take to be the EPO family member. Decisive seems to be how successful is a drug administration regimen that is exclusively oral, compared with effectiveness when administered nasally.
I am left puzzled by what the proprietor means by a drug administration regimen which is “effective”. Can anybody help?
I mean, suppose we are prior to the date of the claim, and you the PHOSITA have a patient with pneumonia and needing this medication. Now, for some reason (which we do not need to go into) nasal delivery is not possible. Would you i) try oral delivery, or ii) give up and throw away the drug dispenser unused?
If you were to try oral delivery, would that be because you assess as greater than zero the chances that it will have some useful “effect” against the disease?
Judge Newman tells us the claimed subject matter is inventive because on the relevant date oral administration would not have been “obvious to try”. Why was that? Because, the judge tells us, nowhere in the prior art was there any teaching that oral administration “would have a reasonable likelihood of success”. What does she mean, here, by “success”? As effective as nasal? More effective than nasal? Effective enough to help the patient in his/her fight against the disease?
See post 12.
This may be more of a “procedural matter” than a purely factual one.
You set me thinking.
If you were to claim”…..through the left nostril alone” and I argue to Judge Newman that your claim is obvious, would she uphold your patent because I had failed to provide her with evidence of prior art suggestions to adopt this administration route?
Yup! Totally non-obvious lacking a specific teaching!
There is a real albeit subtle difference here Ben.
As I indicated, this may have more to do with the procedural aspects than with the factual aspects (per se), and is certainly not indicative of any larger “truth” as to any type of end result of someone else (easily) following the proper procedural path to obtain the legal decision of the claim being found obvious.
That depends on the facts established below, does it not?
Well, what if the reasoning goes, oral administration does not work because it cannot reach the sinuses and as long as there is infection in the sinuses, the infection in the lungs will be re-established almost immediately after the orally administered dosage dissipates? Moreover, the sinus colony may receive a reduced exposure to the medicine only sufficient to kill off the weakest members of the infecting colony, thereby selecting for drug resistant bugs.
Mightn’t it be non-obvious to do oral administration in that scenario?
As Malcolm pointed out, the issue here is very factually intensive (he even added “b0ring”).
As I pointed out, Newman’s dissent seems more on the procedural aspects that those same (b0ring) extensive factual predicates were not stepped through adequately enough in this case and by the Office or PTAB below.
She disagrees with the Majority who seems to take a “maybe the below did not do what they needed to do, but we’ll just fill in the blanks and -wink- and say ‘good enough’ hand wave.”
Regardless of any view of the claims themselves, Newman’s focus appears to be on the Means used to get to the Ends (and merely saying the Ends are good – or even inevitable – is simply not enough for our system of law).
In that view, she is correct. See eBay.
merely saying the Ends are good – or even inevitable – is simply not enough for our system of law
People who pretend to be born yesterday in service of a Kafka-esque game are miserable excuses for human beings. And, yes, that applies to Judge Newman’s dissent in this case.
And please try to get off your high horse, “anon.” You only care about “means” when your peculiar interests are being served. We all know that. We’ve seen it. You’re a hypocrite of unbelievable proportions. Stop the inane preaching.
The proper Means are NEVER “Kafka-esque games” Malcolm.
Quite the opposite.
And the rest of your post of mindless and off point ad hominem shows what exactly…?
“And please try to get off your high horse, “anon.” You only care about “means” when your peculiar interests are being served. We all know that”
First – it is disingenuous to accuse me of riding a high horse when I have the correct grasp of the law and you do not. the only horse I ride here is the one you provide by taking the incorrect course.
Second – it is duplicitous to accuse me of using an “Ends justify the Means” approach when I have done no such thing. Do more than just lay out an empty accusation. Do not cloak your L I E in a banal “we all” – your sockpuppets do not count in your prevarications here. You merely employ the very thing that you accuse me of in the immediate instance.
If you look to my comment at 10, I suggest that the claim itself is anticipated by your hypothetical if any doctor, in fact, used the product off-label in the manner you describe.
I understand that this is an ex partes case, but there is no reason to pursue this case as in any real suit the defendant can win the case with a simple affidavit from a doctor.
‘A method for transporting a human being to jupiter by chemical rocket’ is clearly non-obvious as the prior art only discloses transporting humans to the moon, and there is a paid schill who said that people were skeptical about using chemical rockets to get to jupiter.
That’s lovely Ben.
But if in the case below, that “paid shill” was not rebutted, and his testimony is taken as fact, can the reviewing court simply chose to ig nore that fact because it wants to and with only a hand wave?
I think that you are learning the wrong lesson here (of being glib).
that “paid shill” was not rebutted
Secondary considerations absent invention are not patentable. They’re called secondary for a reason. You’re confusing insufficiency with chosen ig norance.
I am not confusing anything Ben.
Maybe you are confusing what it means to be an accepted fact.
Confused enough to refer to the wrong poster.
I just noticed that it wasnt you who posted the reply.
Big Whoop.
I am still not confused about anything that I have said, Ben.
As for Random – he is way off.
Your argument doesn’t rebut the weak (but extant) evidence of your confusion. Better get a paid shill.
Do you even know what the words you use mean, Ben?
I have no need of any rebuttal. There is no confusion in my statements.
YOU may be confused – but as evident here, that confusion more than likely merely comes from you not understanding the law under discussion.
Further, “getting a paid shill” means nothing in a discussion of law. Why would you even offer such advice?
You only demonstrate that you are truly c1ueless, Ben.
Not a great tactic to take when trying to hold a legal conversation with anyone, let alone with me.
Ben –
Notfanuttin, but it would not be obvious to transport a human to Jupiter by chemical rocket.
It took 3 days to get to the moon by chemical rocket. The moon is about 238,900 miles away.
On a good day, and good days are not very common, Jupiter is 1527 times further away (365,000,000 miles). So, it would take 4,583 days, or about 12.5 years to get to Jupiter by chemical rocket, and that assumes you could make a rocket big enough to carry enough groceries to last a guy 12. 5 years. Oh, and that’s just for a one way trip. The groceries would have to last over 25 years if ya wanted to get her home again.
I read Newman’s dissent not so much as “THIS claim” must be non-obvious, but more in the way of the eBay directive of “don’t hand wave the analysis”-and-the-Office-and-the-majority-did-just-that.
Yes, it would be exceptionally easy to make the case (even perhaps b0ringly so), but if you don’t actually make that case, you shouldn’t expect to end up at the Ends you want “just because.”
Clearly this is not in the record but an interesting thought I had is that this patent may also be anticipated under 102 by off-label use of zanamivir by doctors in the intervening years.
It is actually one of the cases where the PHOSITA may have less incentive to try the alternative methods of administration than laypeople or doctors who know that people don’t like having crap up their noses. So a doctor might recommend oral instead without even really thinking about it.
Also not to start too much of a firestorm here but the non-obviousness argument ultimately hinges on the fact that:
It was undisputed that, at the time of this invention, it was believed that the influenza virus infected primarily the upper respiratory tract, that is, the nasal passages.
Someone want to explain how this claim isn’t barred under 101 for the same reason that the “fetal DNA is located in a previously unknown place” natural phoenomina case was? It’s a conventional treatment for a disease that the art was mistaken about the location of. It’s even less inventive, because there was no change at all from the previous act save moving the location. At least the DNA case had an additional test step (albeit a conventional test) to ferret out the DNA.
RG: Someone want to explain how this claim isn’t barred under 101 for the same reason that the “fetal DNA is located in a previously unknown place” natural phoenomina case was? It’s a conventional treatment for a disease that the art was mistaken about the location of.
For starters, remember that Sequenom’s claims didn’t treat anybody for anything. The claims recited a method for detecting a detectable molecule using conventional molecule detection technology. Information-gathering technologies (as well as information storage, processing and disseminating technologies) are treated differently by our patent system, for great reasons.
It’s even less inventive
I’m not sure about that.
In any event, the claim here was properly deemed obvious following a straightforward application of the law. Note that the right result was reached here at the initial stage of examination, and similarly deficient pharma claims to these are deemed obvious all the time, and yet somehow there isn’t an army of trained m0nkeys flying around the Internets complaining that “nothing is patentable” and nobody is going to develop better drug delivery methods because “Prost is senile.”
Please wake me up when a claim to a method of treating a headache with aspirin “wherein the headache is caused by watching a scrolling advertisement requesting a political donation” sails through the PTO and is asserted against 200 defendants in East Texas. Then we’ll know we have a 101 problem.
For starters, remember that Sequenom’s claims didn’t treat anybody for anything. The claims recited a method for detecting a detectable molecule using conventional molecule detection technology. Information-gathering technologies (as well as information storage, processing and disseminating technologies) are treated differently by our patent system, for great reasons.
Does that matter though? Mayo *did* treat people and it was insignificant post-solution activity because the treatment was conventional. The inventiveness of this claim can’t come in the treating, because they’re not suggesting that they discovered the treating aspect. The only argument is that the method of delivery is new, but the method of delivery flows directly from the natural fact.
All methods of delivery flow from “natural facts.”
(there is a reflection of the rather undefined notion of “directed to” or the leading edge of the sword in “Gisting” that can be seen in Random’s words)
Mayo *did* treat people and it was insignificant post-solution activity because the treatment was conventional.
Not sure what you’re driving at. It was Prometheus’ claims that were at issue. The first step of detection of metabolite levels was old in the art and the second (and final step) only required a “new understanding” of what the data meant. There wasn’t a new treatment protocol described by the claims at issue, nor was any new treatment required for infringement.
The only argument is that the method of delivery is new,
In fact, they’re arguing that their “new” delivery method results in a transformation of matter that was nobody expected. Their problem is that this transformation of matter was expected and the delivery method was suggested in the art.
In fact, they’re arguing that their “new” delivery method results in a transformation of matter that was nobody expected.
But that “unexpectedness” is due solely to a discovery about a natural phoenomina.
To use an example we used in that fetal DNA case – Everyone knows how to drill for oil. If we allowed for a patent on “drilling for oil at location X” purely because nobody knew there was oil under the ground at position X, we would essentially be patenting the natural phoenomina discovery that “there is oil in this location” because the drilling steps are entirely conventional. I believe you agreed with me that that claim would be ineligible.
This is the same thing, it’s just that instead of “the public did not know there was oil at location X” instead we’re saying “the public did not know that influenza was present in the lower respiratory tract.” The remaining steps – administering a dose of a drug to the affected location, is conventional. Given that the solution preexisted and the discovery of the “problem” is not a discovery about a man-made machine but a fact of nature, aren’t we allowing for a patent on a natural thing.
If the spec said “The public didn’t know that influenza affected the lower respiratory tract, therefore I claim any treating of influenza in the lower respiratory tract” you would have no problem calling this a 101, right? So why does it change when there is a wherein clause that limits the treatment to a conventional treatment – “I claim treating influenza in the lower respiratory tract, wherein the treatment is known treatment drug X and the treatment delivery method is a known method of getting a drug to that location Y” aren’t you just appending insignificant conventional action and knowledge onto the ineligible discovery?
aren’t we allowing for a patent on a natural thing.
No patent was allowed here.
You do understand why that’s important, right?
No patent was allowed here.
That’s not what we’re discussing. Whether the facts also support a 103 is not the same test as to whether it is a 101. I’m asking you to distinguish it from the fetal DNA and the oil drilling hypothetical, because I don’t see a distinction.
Random,
You are correct – welcome to the moving goalposts of Malcolm land.
But you did not answer his question of “You do understand why that’s important, right?“
No patent was allowed here.
That’s not what we’re discussing.
It’s absolutely what we’re discussing. We’re discussing how facts about the world and facts about conventional detection methods relate to determinations of eligibility and obviousness. In this case, the claims were correctly deemed obvious.
Note that the fetal DNA detection methods can even be distinguished from the oil drilling methods, although the result (ineligibility) is the same. Finding an old disease in a “new location” and using conventional methods to treat that disease are more like the simple oil drilling hypo, for sure. But these latter two scenarios can also be distinguished depending on the specific facts, e.g., perhaps there are reasons to expect that the conventional method would not work at the particular location.
If the spec said
Ultimately it doesn’t matter at all “what the spec says” (patent-adverse admissions excepted). What matters are the facts.
If your hypothetical is that you discover the non-obvious fact that influenza is in the hair and you claim “Treating flu in the hair by applying anti-flu drugs to the hair”, then I agree with you that the claim should be ineligible. Note that there is still plenty of room for patentability, however, and note also that this analysis doesn’t mean that “no treatment methods are eligible.”
1) Who ever invents of DISCOVERS….may obtain a patent therefor.
2) There is nothing to DISCOVER but laws of nature and natural phenomenons.
3) We do allow claims to drill a location X. Either through a lease or via filing a prospecting claim. See Treasure of the Sierra Madre. link to imdb.com
4) “It’s even less inventive, because there was no change at all from the previous act save moving the location.”
Yeah, no change at all except for the change that allowed the treatment to work. Surely THAT sort of change is not the sort of progress in the sciences that we want patents to promote.
sigh…..
Les, “There is nothing to DISCOVER but laws of nature and natural phenomenon[].”
Agreed.
LE ROY ET AL. v. TATHAM ET AL., 55 US 156, 174-175 (1852)
link to scholar.google.com
I’m not sure what your point is here Ned.
You say you agree and then you paste in this contrary edict.
The edict is wrong, is my point.
Les, I agreed with what you said about discovery being of laws of phenomena of nature. But that does not mean you have a right to patent laws of nature or phenomena of nature just because you discover them. I posted the Supreme Court case that explained why. Patents are for inventions, not for discoveries.
Well…. if you ignore the Constitution and 35 USC 101…. whoever invents or DISCOVERS…
As well as ignore what Congress explicitly stated (35 USC 100)…
But since when is the scrivening of the Court “bound” by the explicit words of Congress… 😉
If only there was some sort of well-known machine that one could place into their mouth for the purpose of delivering an aerosol to the lungs, so that people wouldn’t make silly statements questioning whether the art might understand that “oral inhalation might succeed.” We could call it “an inverse exhaler machine.” I bet it would work great for asthma.
As anyone who has ever, you know, done anything strenuous can tell you, one can breathe both through their nose and their mouth. Is it the same thing in every case? No. Does it *suggest* that a nasal intake could lead to an oral intake? Of course it does. Does obvious-to-try apply to a two-option setup? Of course it does. You don’t have to know something will succeed for it to be obvious, you just have to be motivated to make the attempt. You don’t need an expert opinion on this – the town moe-ron could tell you its worth a try.
Also – lol at the suggestions that there lacks a reasonable likelihood of success or that it is unexpected results when a treatment for influenza is delivered to an area with influenza, it treats the influenza. The study applicants cited didn’t find a statistical difference in the results due to intake, and were directed to prevention rather than treatment anyway. Unexpected results could have saved this claim, but there weren’t any.
RG You don’t need an expert opinion on this – the town moe-ron could tell you its worth a try.
But the town patent attorney will gently take his super serious pipe from his mouth and ask you “Then why didn’t anybody try it before, hmmm? Now, check out these smoke rings.”
Unless the SCOTUS intervenes to address Patlex, the PTAB will forever be her legacy – no matter how many times she dissents.
How is the PTAB her legacy…?
She wrote Patlex.
PTAB…?
Let’s use the Socratic method here.
What administavtive mechanism was at issue in Patlex?
gotcha – you mean the transition from the courts into the executive branch based on “patents are not property” (even though Congress explicitly says otherwise)….
Have a feeling that that will not be her legacy – but I catch your drift.
anony, not only did she write Patlex, but her reasoning has been sustained.
Patent rights are public rights because they are created by statute.
I have read many a law review article that have concluded that that is exactly where the Supreme Court is on the public rights doctrine. The only exception to this general rule is where a legal remedy is provided for the newly created statutory right. That legal remedy is accorded a right to a trial by jury and the right to be heard in a court of law.*
What many in this conversation do not fully appreciate is that a action to revoke a patent is, in point of fact, a legal remedy (writ scire facias), and it was used at common law to revoke patents.
Thus, even if patents are public rights, the remedy to revoke a patent has a right to a trial by jury in a court of law.
*
Curtis v. Loether, 415 US 189, 193 (1974)
Ned – correct. The reasoning of Patlex cannot be limited to a single administrative tribunal. Newman created the Article I “slippery slope,” and the PTAB (and whatever comes next) is her legacy.
As for the statutory issue, the question is whether the statute displaces a traditional cause of action that existed at law, equity, or admiralty. If no, then an administrative claim (i.e. public right). If yes, then an Article III claim (i.e. private right).
If merely “at statute,” what would exist of Article III?
Hint: nothing.
That’s pretty scary – and I cannot see the Supreme Court taking that path (as that would remove even them from the loop).
This case is a rare instance where I am totally unconvinced by Judge Newman. Usually, if she writes an opinion, I find myself nodding along saying “if only the rest of the CAFC were just like her…” Here, however, I really I cannot see what she is trying to defend. Even if Von Itzstein does not name mouth inhalation in the list of ways to administer zanamivir, surely the PHOSITA knows that patients have mouths and that they can inhale things through the mouths. Once one also knows from elsewhere in the record (the opinion does not give the precise citation) that “young children… [a]re more susceptible to lower respiratory tract infections from the virus,” and that “oral inhalation delivers more drugs to the lower respiratory tract…,” it seems to me that obviousness is the only logical outcome here.
Based on the facts as they are summarized in the opinion (and neither the majority or the dissent seem to disagree really on the facts), the PTAB clearly got this one right. Judge Newman’s dissent seems to me as nothing more than the occasional instance of “even Homer nods.”
Greg, I can agree with everything but the word “occasional” in your last line.
Judge Newman is now 89 years old – born on June 20, 1927. Not surprisingly, like many really old patent attorneys, she is not fond of all the new-fangled patent law from the Sup. Ct. and Congress.
Judge Newman is now 89 years old – born on June 20, 1927.
But totally not senile! Unlike, say, Judge Mayer (whose age-related dementia is perfectly evident, at least according to all the super serious armchair doctors over at the Junk Patent Luvvers Club).
Although I don’t agree with her in this case, may she go on forever! We need a Pauline Newman preservation society to keep her active indefinitely. And prior to her judicial appointment she had much relevant experience in our profession.
Amen!
Well, I really will insist on that “occasional.” This particular Newman opinion seems to me to sail wide of the mark, but it is very much the exception. Usually, she runs circles around her colleagues in terms of her clear, lucid, and accurate exposition of the law. Nor do I see any decline in the quality of her written work today compared to 10, 20, or even 30 years ago.
I will understand if she decides to take a well deserved retirement, but I certainly do not see any evidence that she needs to do so. If she qualifies as “senile,” we should all be so lucky to experience such “senility.”
Greg, I made no suggestion at all of any senility – merely that [in several prior opinions] she has expressed her dislikes for some new-fangled patent law, like the decisions of IPRs, as here. That may logically influence her enthusiasm for reversing them, as here.
It was MM that made the “senile” remark. Because he likes to put people down, particularly those with which he disagrees.
I made no suggestion at all of any senility
Fair enough. I still stand behind my earlier “occasional.”
Usually, she runs circles around her colleagues in terms of her clear, lucid, and accurate exposition of the law
The idea that Newman was some sort of goddess of legal clarity and logic crashed and burned around the time — pretty much at the peak of the bubble expansion — that she insisted we needed product-by-process claims to protect all those awesome “new” compositions that nobody could describe except by their manufacture. That’s when the cheerleading for Newman was revealed to be little more than just the usual cheerleading by the usual people for More Patents, All the Time, Easier to Enforce.
Heck, even Judge Rader managed to figure his way through that “controversy.”
Because anyone who does not agree with Malcolm is an obvious p00pyhead, duh.
(Translated from the Malcolm fretting)
“Judge Newman is now 89 years old”
Jesus. I thought she was 70’s. Love the old bird but its time for a long vaca before the reaper man comes.
Judge Stevens was great in Bilski at 89. Then he retired at 90.
Appears to be having a great retirement still at 96.
“Judge Stevens was great in Bilski”
You could not have picked a worse example, Owen.
Judge Newman has been especially friendly to pharmaceutical patents her entire career.
“Once one also knows from elsewhere in the record (the opinion does not give the precise citation) that “young children… [a]re more susceptible to lower respiratory tract infections from the virus,” and that “oral inhalation delivers more drugs to the lower respiratory tract…,” it seems to me that obviousness is the only logical outcome here.”
Yes this is true, but how good is mere ordinary skilled artisan (no factual finding here who that is that I saw) at putting that 2+2 together?