Endo v. Actavis (Fed. Cir. 2019)
Obviousness is a tough issue to appeal because its flexible fact-heavy analysis lends itself to giving deference to the fact-finder. This is a case-in-point.
Endo is the exclusive licensee of Mallinckrodt’s U.S. Patent 8,871,779 covering a form of the opioid oxymorphone. Claim 1 is directed to a highly pure form of “oxymorphone” with “less than 0.001% of 14-hydroxymorphinone.”
Actavis argued that the claims were invalid as obvious. However, following a bench trial the Delaware district court sided with the patentee — holding that the claims had not been proven invalid with clear and convincing evidence.
The district court did make a major legal mistake — holding that confidential communications between the FDA and oxymorphone producers (including the patentee) were not prior art. In the communications, the FDA “mandated that opioid
manufacturers reduce ABUK impurities in oxycodone and oxymorphone to below 0.001%” — the exact result claimed by Mallinckrodt. On appeal, the Federal Circuit found the communications prior art under pre-AIA § 102(f) (“A person shall be entitled to a patent unless (f) he did not himself invent the subject matter sought to be patented.”). Note that 102(f) was eliminated by the AIA and so this type of confidential communication will likely not be counted as prior art in future cases.
On appeal, the Federal Circuit held that the FDA communication – despite being prior art – did not show that the claims were obvious. Although the communications expressly set out the low-impurity goal and was the motivational force for the research, it did not set out the solution created by the patentee.
The majority opinion was penned by Judge Wallach and joined by Judge Clevenger. Judge Stoll wrote in dissent — arguing that the error was not harmless. In particular, the FDA mandate actually expressly discloses every limitation found in claim 1, “yet, the district court determined that this mandate did not disclose ‘anything substantive relevant to obviousness.'”
While we owe deference to a district court’s factual findings, such deference is not due where the trial court applies the incorrect standard to arrive at those findings. I would vacate the district court’s decision and remand for a proper analysis under the correct legal standards.
According to the dissent, the FDA statement would have provided substantial motivation to combine prior art references that worked toward the proffered solution.
= = = = =
102(f) what have we lost: Inventor is given secret information that leads to creation of the invention. That information is a 102(f) reference under pre-AIA law and can also be used to as part of an obviousness argument. Post-AIA, the provision was wholly eliminated except that the law still supports a narrow action for complete derivation.
” A hydrochloride salt of oxymorphone comprising less than 0.001% of 14-hydroxymorphinone.”
Two questions about these claims.
1) “Comprising” is open ended, so there seems to be an issue with “comprising less than…” If I have $100.50 in my pocket, my pocket “comprises less than $1”, because it comprises $.50 (in addition to another $100, which is fine, because comprising is open ended).
2) It doesnt claim a pharmaceutical composition or a pill, only a salt. Even a salt that is contaminated on a macro-scale will contain certain quantities that are pure. In other words, if I take prior art, I will be able to find a few molecules of the salt that contain less than .001% impurity. Seems like this would raise issues.
A few thoughts in response:
1) Inherency cannot be proven by probabilities or possibilities. Endo Pharma v. CustoPharm, 894 F.3d 1374, 1381 (Fed. Cir. 2018). In other words, it is not enough—if one hopes to show a claim to be inherently anticipated or obvious over inherent disclosures—to be able to show that a prior art composition had a statistical likelihood assymptotically approaching 100% of containing the property in question. Other than such a statistical argument, however, I do not know how one might hope to establish that “this impure, prior art composition contained pockets of material that rose to the claimed purity levels.” That is as much as to say, this sort of argument cannot “cut the mustard” for invalidating the claims over the prior art.
2) It is axiomatic to patent law that “claims are construed the same way for validity as for infringement.” In re Cuozzo Speed Tech., 793 F.3d 1268, 1286 (Fed. Cir. 2015). Imagine that Endo were to try to enforce these claims against someone with a high-ABUK content stock of prior art oxymorphone, arguing that “each vial contains pockets that answer to our purity limitations.” Endo would be laughed out of court in the first instance, and then whallopped with Rule 11 sanctions in the second instance. The same should happen, except in reverse, if anyone should try to defend against Endo’s claims by arguing invalidity in view of inherent anticipation.
i would not argue inherency. i would go obtain the prior art product and via chemical analysis show there were at least some crystals in the prior art that met the desired purity. those crystals were offered for sale and/or in public use, ergo invalidity.
[I] would go obtain the prior art product…
Do you have a time machine? The product that existed before the critical date does not exist any longer. Instead, what exists is whatever results from allowing that pre-filing product to age. Oxymorphone is not like granite. It changes with time.
greg, as a thought experiment, imagine I sell a bottle. The bottle has equal weight red pills and blue pills inside. The blue pills are 100% oxymorphone with no impurities. The red pills are 100% 14-hydroxymorphinone.
Do I get around infringement because the total contents of the bottle does not infringe the claim since the total contents of the bottle taken together has more than 0.001% 14-hydroxy? Even though the blue pills alone would infringe?
Okay, what if they are in two separate bottles, but the two bottles come together in a cardboard box? Infringement or not? You see where I am going with this…
Once again, a few more thoughts:
1) On further reflection, I can agree that Endo would have done better to draft its claim “… comprising
lessno more than than 0.001% of 14-hydroxymorphinone.” You are right that they have opened themselves up to an unnecessary risk of a judge giving them too literal a claim construction, in a manner that would have made the claim to read on the prior art.2) Still and all, I dare say that everyone knows what the claim is supposed to mean, and it is hardly a travesty of injustice if the court gives the claim the construction that was intended, rather than a more woodenly literal construction, so long as that more generous construction is applied both to validity and infringement.
3) As for your hypo, once again, I take your point, but I think that you are trying to do philosophy instead of law here. Your thought experiment is a variation on Zeno’s paradox. Suppose that I tried to argue that an accused murderer could not have stabbed the victim as the prosecutor alleges, because stabbing requires motion, and Zeno’s paradox proves that motion is impossible? Do you think that I would get my client off with that argument? I think it much more likely that I would lose my law license for making such an argument in a real court during a real trial.
In addition to Greg’s comments, I would point out that your understanding of the term “comprising” seems to require some updating.
In the use of the term coupled with “less than” you cannot arrive at the attempted meaning in your point 1).
That’s just not how the term works. The amount of money in your pocket is the “critical item,” and you cannot parse that critical item to separate amounts and then try to say that one separate amount can be taken as not including the other separate amount. It is a logical error to sate that your pocket comprises less than $1 just because you want to create an artificial distinction between the full dollar amount and a second group of less than a full dollar amount.
In your 2) example, there is also error in that you do not get to take any “given amount,” and then attempt to parse that amount into two different groups (here based on micro/macro distinction) and say, well this micro quality would be pure. That is not what the term “comprising” means in the context of patent law.
anon,
lets talk logic… if i have $100 in my wallet, does my wallet “comprise” $.50?
if yes, is $0.50 less than $1?
if my wallet comprises 50 cents, and 50 cents is less than one dollar, then my wallet “comprises less than $1”..
problem is logically it doesnt make sense to use open transition for limiting amounts.
the flaw is using open transition..
The flaw is in your attempted use of a term that does not fit the meaning as that term is to be used in the legal context.
Any cites to the “critical item” doctrine, in the legal context? Or is that just how you feel?
“Critical item” doctrine goes by the name: context.
That you ask for a cite to such only shows that you don’t understand that.
Perhaps you are a first year. Perhaps you are self taught. Either way, you simply are not recognizing how the term “comprising” is used in patent law.
Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948)
See link to mpep.uspto.gov
Also note that your examples attempt to take a named essential element and “play games” with that element.
Not if you only have $100 bill in your wallet. You never had $0.50!
Sorry xtian, but if you have a $100 bill you DO have $0.50.
Not if you want to be pedantic, you may have to change your phrasing to indicate the actual forms of currency with a paper bill and metal coins….
You are being pedantic.
Even so, you would need to change what your write to be a certain item of paper money and a certain item(s) of metal money.
Otherwise you are as wrong as ksmith.
Anon, re (2) above:
As a thought experiment, imagine I sell a bottle with pills. The bottle has equal weight red pills and blue pills inside. The blue pills are 100% oxymorphone with no impurities. The red pills are 100% 14-hydroxymorphinone.
Do I get around infringement because the total contents of the bottle does not infringe the claim since the total contents of the bottle taken together has more than 0.001% 14-hydroxy? Even though the blue pills alone would infringe?
Okay, what if each pill is packaged in two separate bottles, but the two bottles come together in a cardboard box? Is sale of the cardboard box infringement or not? You see where I am going with this…
Your “pill” hypo has the same logical flaw.
You only show that you can be consistently wrong.
Not impressive.
you didnt answer– does sale of the bottle in the pill hypo infringe or not? i cant be wrong because i only asked you a question, i didnr answer it. infringe or not?
I need not answer a flawed hypothetical. That’s the point of pointing out that the hypothetical is flawed.
“The amount of money in your pocket is the “critical item,” and you cannot parse that critical item to separate amounts and then try to say that one separate amount can be taken as not including the other separate amount. ”
See Gillette vs Energizer — Four blades can be read as “a group of three blades” plus an extra blade, and therefore read on a claim “A razor comprising a group of three blades.” Seems like they “parsed the critical item (blades) into separate amounts (a group of three, plus one more). Oddly, they seem to have totally skipped discussion of the well-understood “critical item” doctrine that you just invented.
Your case does not go against what I said.
Your case includes rather than “does not include.”
You misapply that case to my words and prove nothing.
To have Gillette support your view the Court there would have had to have allowed a four blade item be considered to be merely groups and four single blades and not found as they did.
I provided the other answer above – feel free to withdraw your snark.
…or simply slink away in quiet disgrace, your semi-philosophic (but empty of law and fact) musings reft asunder.
I don’t follow what’s eating at Stoll. The FDA said, “Gee, wouldn’t it be nice if we had a physical composition that had the certain physical properties”, without explaining how to make the composition. So the FDA document is a non-enabling disclosure, and therefore doesn’t anticipate. And the trial court determined that combinations of prior art documents didn’t make it obvious how to make that desired composition. So why shouldn’t the patentee be able to claim the composition?
“Although Weiss discloses a method
of purifying oxymorphone ABUK through catalytic hydro-
genation, it does not provide key reaction conditions, see
J.A. 2295–98; see also J.A. 3456 (stating, by Endo’s expert,
that Weiss “omits[, inter alia,] . . . the time that the hydro-
genation reaction is run[,] . . . the amount and composition
of the . . . catalyst[,] . . . precisely what catalyst [is]
us[ed,] . . . [and] the pressure of the hydrogen gas,” each of
which can “affect the effectiveness of the hydrogenation
procedure”)”
What sort of mentally challenged PHOSITA do you chemistry guys deal with that this would pose any sort of barrier for? A lab tech with no college degree and 5 years of gravimetry experience?
All I can say is that, back when I used to work at the bench, I would say to myself “it should take me about three weeks to work out these assays conditions,” and then 8 months later I would finally report to lab meeting with that I had figured out the critical obstacle that was making the trials fail, and now I could finally begin the real experiment for which I had undertaken the assay optimization project in the first place. In other words, just because it sounds like an easy set of parameters to optimize does not mean that it will be an easy set of parameters to optimize. As one of my thesis committee members used to quip, “that is why they call it ‘research.'”
“In other words, just because it sounds like an easy set of parameters to optimize does not mean that it will be an easy set of parameters to optimize.”
That’s fair, though I wouldn’t be saying anything if instead the quote went along the lines of ‘Endo’s expert explained that one of ordinary skill in the art couldn’t resolve the appropriate reaction conditions’. Lacking such indicators, is it appropriate to assume the apparently simple is difficult?
I take your point, but I would note that the portion that you are quoting is the “see also” quote. They cite another portion of the Joint Appendix (from which, for whatever reason, they do not quote) as the main evidence for the assertion that Weiss was not enabling. I do not know how to look up that Joint Appendix citation, but I am content to take it on faith that if the panel considered that evidence sufficient to support the assertion, that it is sufficient.
Motivation to combine is not saying which methods to combine or even pointing at all how to do it. From what I can see in this article what the FDA did is akin to saying “wouldn’t it be nice if Cars got 60 miles to the gallon”. In no way should this make a specific method of making cars meet this standard obvious – that’s just silly.
The larger 102(f) philosophical argument not going to engage in except to say that given how the Supreme Court has expanded obviousness to almost ridiculous levels especially in the biochemical arts – hard for me to care much about the loss.
But then I like and believe in patents as good things.
“In no way should this make a specific method of making cars meet this standard obvious – that’s just silly.”
Just FYI: they didn’t claim “a specific way”.
1. A hydrochloride salt of oxymorphone comprising
less than 0.001% of 14-hydroxymorphinone.
A composition claim NEED NOT claim a specific way.
See post 2.1.1.1.
Put your “anti” in check there Ben.
I am not suggesting they do. I was solely pointing out that contrary to Cole’s implication, these claims do not recite anything analogous to “a specific method of making cars meet this standard”.
And you quite miss the point that a mere government edict (mandate) rises to be proper prior art FOR a composition claim — regardless of DC’s musings.
And you wonder how it is that you are known as the same person that consistently upvoted Malcolm back in the day?
Declaring your conception of “the point” to distract from your kneejerk reaction is cute but ineffective.
Except you DO miss the point here – consistently and consistently in a manner of being anti-patent.
And that is NOT “cute” AND ineffective.
Comparing our relative positions, mine is clearly quite better.
I hear you DC.
I have noted previously that MANY examiners improperly apply “motivation to combine” as being merely “motivation.”
This mere “motivation” is then “supported” with a plain quote to the benefit as listed in the secondary reference alone, with the rather mindless “it is always a motivation to combine anything of benefit with anything else.”
This is likely a “policy” laz1ness.
DC what the FDA did is akin to saying “wouldn’t it be nice if Cars got 60 miles to the gallon”. In no way should this make a specific method of making cars meet this standard obvious – that’s just silly.
Depends on the rest of the prior art. The existence of an FDA standard is certainly a motivation to create something that meets that standard. The FDA thinks so, anyway.
Not sure how 102(f) even comes in to play in this case. Even if the FDA communication was prior art, how does it prove, either by itself or in combination with any of the other references, that the inventors didn’t invent the claimed subject matter? By clear and convincing evidence? Or even by a preponderance?
102f was the section a party argued that it should be considered prior art under I would presume. For some reason the fed circ. seems to have agreed that it should be considered prior art under that section.
If it is considered to be prior art under 102f then it does its proving job (or lack thereof) just like any other prior art reference does, but the facts found and then the graham factors.
but = by
6,
See my post below at 1.1, then turn to the appeal case at page 15 (footnote 9). The write-up here does not focus on the distinguishing point of enablement that better informs the context of the case.
A distinction to keep in mind is that the appeal court here is talking about the mere consideration of the FDA communication as a potential blocking item of prior art (and NOT that it IS a blocking item of prior art) in its pointing of error at the court below.
Bottom line is that the lower court made an error in its determination that the confidential FDA missive could not be considered, but the lower court did NOT make an error in its determination that the confidential FDA missive WOULD NOT BE a blocking item of prior art (on the basis of sufficiency).
Footnote 12 is rather interesting, calling out the dissent for inserting a policy decision in place of actually applying the controlling law on the legal issue of obviousness – with a “wide-open” type of quote to 101 (see also my post at 2.1.1.1).
I credit SOME of the confusion here as a “gloss” against using terms sounding in function and the tendency to “jump” at a type of knee-j er k reaction against “result.” See my post at 2.1.1.2.1.
Does Moore’s law “prove” that every advancement in integrated circuits is obvious?
No. Not sure why you’re asking that either. But moore’s law could potentially assist in a 103 (shrinking down some parts from what is shown in a primary ref) I would think. If that sort of situation is present here in this case then that could happen. I’m not expert enough in the area to know if that situation is analogous at all.
Hey AAA JJ, and anon, I was just down at my local watering hole and the barmaid was moving chairs around near me at the bar for whatever reason. She scooted me on the chair over a bit, and then gave me a hug (unauthorized) from behind with her very voluptuous upper self pressing upon my back, and I would guess around her stomachish/pelvis on my bottom.
Question for you guys, how many years in the clink do you think she requires to not sexually assault (or harass even) mans? Is it worth the $$$?
AAA JJ,
Near as I can tell, Stoll had the Supreme Court Kool-Aid out and was reacting purely on a “policy” basis.
Somehow the claimed improved purity product (in Stoll’s mind) was the same non-pure product available in 1959 (although the date of the FDA mandate is not spelled out, I am pretty sure it did not go back to 1959).
She confused the date of the mandate as having a prohibitive effect on any innovation that would only later come about and meet the mandate.
I suppose we should move the date of any “actual” innovations related to landing on the moon back to JFK’s mandate…. (or simply declare that for policy reasons, such do not fall under the Patent Act).
OT, but an interesting Quinn blog article today reports “$5.3 billion of [brokered patent] market as sold [even though individual patent prices have dropped]. In 2017, we predicted that through 2018-Q3 we would observe at least $3.75 billion transacted; the market blew those numbers away. This is an extremely active market.”
If accurate, this leads to the important question of who is buying up all those increasing numbers of patents for those increasing billions of dollars? What % is by PAEs buying them to sue on? What % is defensive buying to not get sued, or to acquire counter-claim ammunition? Is there some other partial reason?
I can think of one “partial” reason:
Buy low.
As you say off topic and I would say a good thing. Just like with land an active patent market is a good thing.
I hear you here as well DC.
Quite in fact, there was an award winning (historical award) article over at Patent Docs awhile back that went into how our system was expressly created such that the patent property right was FULLY alienable – with direct intent for such.
Why isn’t this just evidence of 102 “in public use” prior art ? Was there no evidence that the manufactured in fact performed what was required by the mandate? The communication could be evidence of a public use.
Even if it is not “public use” (and I do not mean to say that it is not), I think that you could still make out that the FDA’s communication to the patentee was “otherwise available to the public” under §102(a)(1). It was a non-confidential disclosure (FDA did not swear Endo to secrecy) made before the filing date.
I agree with the majority here that the FDA communication’s status as prior art does not really determine the outcome. The claimed invention as a whole is still non-obvious, even in view of the FDA’s communication. But the invention does not become less obvious under the AIA, because the FDA’s communication is still prior art under the AIA.
? A 102(a) argument was made and lost at the D.C. re the FTC letter and not reversed by the Fed. Cir., expressly leaving only 102(f).
But I also wonder if there could have been better presented below and on appeal that not every drug company sent this letter by the FDA had entered into either an express or clear implied agreement of confidentiality? And/or the extent of that letter distribution, to those interested, being a 102(a) publication.
Lest there be any confusion of equivocation here, Paul, I was talking about AIA §102(a)(1), whereas I believe that you are talking about pre-AIA §102(a). I just want to make sure that 3rd party readers do not get confused between the pre-AIA and AIA section numbering.
How? The entire point of this article seems to be that it wouldn’t be and I can’t see how it would come in under the AIA since it is in no way available to the public. According to the article and the case this was a confidential communication – are you saying it was not?
DC,
See the case at page 15 — again footnote 9 — (majority):
“However, we have stated that § 102(f)
“does not pertain only to public knowledge, but also applies
to private communications between the inventor and another
which may never become public.” OddzOn Prods.,
Inc. v. Just Toys, Inc., 122 F.3d 1396, 1401–02 (Fed. Cir.
1997).”
This is not even the most “egregious” type of “secret prior art” that exists.
How did they rationalize that private communications to and from the FDA were prior art?
NB. I didn’t take the time to read the opinion so fell free to call me out.
Did you take the time to read the quote to which you are responding?
I can’t see how it would come in under the AIA since it is in no way available to the public.
As used in the statute, the “public” is any “person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor.” In re Smith, 714 F.2d 1127, 1134 (Fed. Cir. 1983).
So, who is the “inventor” of this disclosure in question? The FDA disclosed this particular idea to Endo, not the other way around. While the FDA owes a duty of confidentiality to the applicant Endo, Endo owes no such duty to the FDA. Therefore, when FDA communicated this idea to Endo, it communicated it to “the public.”
The idea of this particular ABUK impurity level was “available to the public” because it was available to Endo, and Endo was (in this instance) “the public.”
Mere “idea of” — as a mandate — simply does not carry the weight that you are implying is there, Greg.
Why do you even bother?
The crux of the decision seems to be that even though the confidential FDA letter was held to be [only] 102(f) prior art* re this pre-AIA patent: “Even if the FDA communications provided a general motivation to the opioid industry to achieve a particular purity level, see Plantronics, 724 F.3d at 1354, we need not resolve whether it provided the legally-required motivation to combine because we conclude that a PHOSITA would not have a reasonable expectation of success based on the prior art, see Intelligent BioSys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (explaining that reasonable expectation of success and motivation to combine are “two different legal concepts”). … that “knowledge of the goal does not render its achievement obvious”).12”
Good point, but does not this ignore the apparent assertion in the dissent that “it’s achievement” is not being claimed, that is not recited anywhere in the claims?
*a very rare event in patent litigation.
Not sure I follow you Paul — it’s a composition claim having a certain desired state. How is this not “achievement of the government mandate?” If not achievement, wherein then the (necessary) utility?
Isn’t “a composition claim having a certain [pre-requested by others] desired state” claiming that result, not how to achieve that result, and preempting any and every other way of achieving that result?
Straight up composition claims do not reflect ANY certain “how to make” and ALWAYS “pre-empt” every other way of achieving the composition.
I do not see an issue here.
I claim “a hammer.” Are you telling me that my claim must also include how that hammer was made and that if the claim “pre-empts” all other manners of making hammers that I have a problem?
Isn’t “a composition claim having a certain [pre-requested by others] desired state” claiming that result, not how to achieve that result, and preempting any and every other way of achieving that result?
I think that you have gone too deep into the weeds of this opinion here, Paul, and you are making the whole thing more difficult than it needs to be.
“Less than 20 ppm ABUK” is a structural limitation, not a functional limitation. If the FDA had told the company that the composition needed to be “85% bioavailable” or “soluble in 90% EtOH at 67C” and the company had listed those properties in the claim, that would be claiming the result. So long as they confine themselves to reciting structural (rather than functional) limitations, however, they are claiming the solution, not the problem. The only question, then, is whether they have enabled the solution (which the patentee had in this case).
These are not Product-by-Process claims, so you run the very real risk of conflating (and getting wrong) optional claim formatting.
It seems like you’re saying (1) the composition was previously described and (2) the way to achieve that composition was not known, and therefore a claim to the composition without referencing how to get the combination is anticipated/obvious. But (2) means the disclosure was not enabling, so the previously described composition is actually not anticipated/obvious.
No Ben, that is NOT what the case is saying.
Description (which would be in the spec and not necessarily in the claim) was NOT “previously” there, and the case says nothing as to any purported lack of enablement for the claim that Stoll would deny.
“No Ben, that is NOT what the case is saying.”
Fortunantly, I was not saying anything about what “the case” was saying, or the description/enablement of the patent’s disclosure.