By Dennis Crouch
Wyeth v. Abbot Labs (Fed. Cir. 2013)
In a unanimous opinion, the Federal Circuit has affirmed a summary judgment holding that Wyeth’s patents are invalid as lacking enablement under 35 U.S.C. 112. Wyeth’s patents cover the use of rapamycin antibiotic to treat and prevent restenosis following arterial balloon catheterization. See U.S. Patent Nos. 5,516,781 and 5,563,146. The claimed invention is simple and basically says, administer an “antirestenosis effective amount of rapamycin.” Claim 1 of the ‘781 patent reads as follows:
1. A method of treating restenosis in a mammal resulting from said mammal undergoing a percutaneous transluminal coronary angioplasty procedure which comprises administering an antirestenosis effective amount of rapamycin to said mammal orally, parenterally, intravascularly, intranasally, intrabronchially, transdermally, rectally, or via a vascular stent impregnated with rapamycin.
One requirement of patent law is that the patent application (at the time of its filing) must sufficiently enable a person skilled in the relevant art to make and use the full scope of the claimed invention without undue experimentation. This “enablement requirement” is codified in Section 112(a) of the Patent Act (Formerly known as Section 112¶1).
Here, it is the “full scope” requirement that kills the patent. In particular, Wyeth requested and received a broad construction of the claim term rapamycin to in a way that includes a large number of molecules that are structurally analogous to one another. However, the specification only discloses a single species along with a number of assays that could be useful to ascertain whether potential compounds exhibit the requisite effect.
In the appeal, the Federal Circuit aligned itself to the rule that broad claim scope requires broad disclosure. Here, the court noted that the rapamycin definition includes “tens of thousands” of candidate molecules and the specification “is silent about how to structurally modify sirolimus.
Undue experimentation: For its part, Wyeth argued that a lab tech with the usual skill and little creativity could systematically work through the various potential candidates to find which ones actually work. Citing to Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360–61 (Fed. Cir. 1998), Wyeth argued that a large pile of merely routine experimentation does rise to the level of impermissible undue experimentation.
The Federal Circuit disagreed – finding that the trial-and-error process of tens-of-thousands of candidates moves the project well into the range of undue experimentation.
[T]here is no genuine dispute that it would be necessary to first synthesize and then screen each candidate compound using the assays disclosed in the specification to determine whether it has immunosuppressive and antirestenotic effects. There is no evidence in the record that any particular substitutions outside of the macrocyclic ring are preferable. Indeed, a Wyeth scientist confirmed the unpredictability of the art and the ensuing need to assay each candidate by testifying that, “until you test [compounds], you really can’t tell whether they work or not [i.e., have antirestenotic effects].” J.A. 6929. In sum, there is no genuine dispute that practicing the full scope of the claims would require synthesizing and screening each of at least tens of thousands of compounds. . . .
Even putting the challenges of synthesis aside, one of ordinary skill would need to assay each of at least tens of thousands of candidates. Wyeth’s expert conceded that it would take technicians weeks to complete each of these assays. The specification offers no guidance or predictions about particular substitutions that might preserve the immunosuppressive and antirestenotic effects observed in sirolimus. The resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. We thus hold that there is no genuine dispute that practicing the full scope of the claims, measured at the filing date, required undue experimentation.
The take-away legal points here are (1) broad claims must do more to satisfy the enablement requirement than narrow claims; and (2) when excessive, routine non-creative efforts to recreate the invention can constitute undue experimentation.
The case is also interesting because it comes at a time where policymakers are looking to tighten the requirements of Section 112. As it did during the debate over the AIA, the Federal Circuit appears poised to make its mark on the current debate over patent scope and clarity.
I do indeed grant you the sovereign difference.
As we both know, the Federal Rules of Civil Procedure are very nearly as good as civil procedure in Scotland.
Hopefully I will be at the AIPLA Annual Meeting again this year and would be glad to join any readers also at the meeting in a drink. The products of Mr Jack Daniels, as I recall, have some merit, as does the beer of Sam Adams, although the family connection with the original brewer has been lost.
You are a wise man – even as we disagree. I bet a couple of pints shared between us would make a splendid evening.
“which is subtly but importantly different.”
I grant you the subtle and important difference as long as you grant me (again) the difference in law that inures to each sovereign.
(we’ve been down this path before my friend)
Sadly Calvin is almost unknown in the UK so I had to look him up.
But now I have I know that comments on Patently-O are like Calvinball – never the same rules twice. It occurs to me that much US litigation seems just like that!
I should have realised that you had the Chef America case in mind but have a feeling that it was not a biscuit that was involved. It ended up as carbon nevertheless.
No English court would have come out with such a fatuous interpretation of the claims because the standard over here is not “what do the words mean?” but “what would a skilled reader understand was meant by the words?” which is subtly but importantly different. The judgment of Lord Hoffmann in the Kirin-Amgen case contains the relevant explanation and is worth reading. The question I have is : How did Chef America annoy the courts to such a degree that they would issue a judgment like that?
suffice to say, that INANE is looking for more Calvinball face sp1kes…
Paul,
I was off on the temperature, but 358 F.3d 1371
How do you take your coffee, then?
That would have been a perfect time for the old “the way I take my women” joke, but I’m not sure I can improve on “by mouth”.
Suffice it to say, then, that he clearly doesn’t take it decaf.
Can you explain the reference to biscuit at 550 degrees?
If you want to take your coffee by mouth, then you better explicitly ask for it that way.
Or do you like biscuits at 550 degrees?
(and the laugh from MaxDrei is the laugh of a f001)
LOL
Jim, I offer you three reasons why EPO Examiners will not countenance “about” or “substantially” whereas the USPTO will.
1. Under the EPC, lack of clarity is not in itself a ground of invalidity. Petitioners for revocation of an issued Claim are powerless to object, so the EPO feels obliged itself to scrutinise the clarity issue thoroughly, before the thing even gets to issue.
2. The patent issues for up to 40 countries, in only two of which is the national language English. If the claim is going to be litigated in translation, well, thinks the EPO, the English of the grant document had better be clear to start with.
3. Under the EPC, the Protocol on the Interpretation of Article 69 (scope of protection) makes it mandatory on infringement judges to find for the claim a meaning that simultaneously delivers legal certainty for the public with a scope of protection for the Inventor that is “fair”. The Protocol is Europe’s “Doctrine of Equivalents”. Under the Protocol, weasel words in the claim like “about” or “substantially” are rendered truly superfluous.
When drafting, you could include an explicit “substantially” in front of every substantive feature. When I was taught to draft, it was explained to me that the court will read them in anyway, as implicit, so you gain nothing by including it explicit, but you do lose clarity. And that was long before the EPO had come into existence.
How do you take your coffee, then?
When drafting claims, one has a choice between using “about”, and omitting it in the hope that the Doctrine of Equivalents will extend protection beyond the literal scope of your claim. European examiners give you no such choice, and will strike the word from the claims. Contrast US practice, where we’re taught to stretch and scrabble for the broadest possible claims during prosecution. The reasoning, as explained to me by more than one grizzled veteran, is that the outcome of litigation is wildly unpredictable – although I’ve never quite understood why the scope given to “about” in litigation is not equally unpredictable.
The practice is so much the norm today, that you have to worry about a court holding that a patentee who chooses not to use “about” has chosen to disclaim equivalents.
Completely disagree Paul.
Have a biscuit cooked at 550 degrees and think about it.
When asked how I take my coffee, I usually reply: “By mouth”. I do not think that the parenteral or intravascular route is practical. Nor do I think that hot coffee would be pleasant intranasally, intrabronchially,or rectally. It does not penetrate skin so the transdermal route is not feasible. I may need a caffeine-impregnated vascular stent, but thanks to say not yet.
If you de-clutter the claim from buzz-words and pointless generality (we do not carry out these procedures on cats or cows), you get the following:
1. A method of treating restenosis in a person
undergoing a percutaneous transluminal coronary angioplasty procedure which comprises administering rapamycin to said person.
2. The method of claim 1, wherein the rapamycin is administered via an intravascular stent.
The remaining verbiage could be administered intrarectally to the author of the patent.
However, the key issue is the meaning of the word “rapamycin”. At the relevant time it clearly and unequivocally meant sirolimus because that was the only known compound in the series. There was no lack of clarity, merely an attempted stretched meaning which was the endeavour of “an astute trial lawyer” (US v Adams) and not what a skilled reader would have understood when the specification was first drafted.
Also, the claim is terribly poorly written.
I admit that I haven’t yet read the opinion, but from the write-up above it seems lacking in clarity and precision. I will read it soon.
The least the court could do would be to articulate definitive criteria that enable a reasonable determination of the undue/routine experimentation issue…BEFORE the issue lands in litigation.
Does the court in fact do this?
It seems like that same old arrogant, non-rigorous “smell test” that is often used by those not willing, or not able, to put a reasonable amount of work into something. The excerpt evidences no real reasoning, just a conclusory “The resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation.”
Wow, what a great declaration. It’s clear for the parties, but is effectively totally useless for anybody else, or for patent law in general. It tells us nothing more than we already know, which is insufficient to make prospective determinations of undue experimentation.
Once again, the CAFC misses an opportunity to do some broader good in patent law.
I haven’t been paying much attention to recent opinions for a while, but it is disappointing to see that during my absence, nothing seems to have changed.
Now that was funny, Davy.
Maybe the patentee was hoisted on his own canard.
that must hurt
Paul, I must admit, I am not sure what you are saying. You say, the patent discloses and claims rapamycin. But the court said that only one species of rapamycin was disclosed, sirolimus. It is a product of nature produced, according to the spec., produced by Stremtomyces hygroscopicus.
The construction of the term rapamycin was “a compound containing a macrocyclic triene ring structure produced by Streptomyces hygroscopicus.”
But, I think that is what was disclosed. Its name is sirolimus.
Why is the claim construction broader than the disclosure?
Am I missing something here?
Ned, is this essentially what the case stands for, that is, one cannot claim a genius when disclosing only a species in the non-predictable arts.
LOL – nice misrepresentation Malcolm.
Tell me again about ‘configured to’ is structural language and the controlling law regarding the exceptions to the printed matter doctrine as well as squaring Prometheus with the precedent case most on point…
What? Can’t hear you.
What?
(and that’s note even noting that you STILL don’t have the nuts to admit the plain FACT that I was right and you were wrong in the Myriad case.
LOL
Malcolm has the urge to misstate my profession AND accuse me of that which he does.
LOL
Shocked (not)
let’s compare the number of agendas that each has torched with volunteered admissions,
“Let’s compare the number of planets that each has decimated with the power of our minds alone!”
“Let’s compare the number of fights each has won using only his bare fists against ten sailors!”
“My brother can beat up your brother!”
Rinse. Repeat.
Which two justices had their robes hemmed?
LOL.
That’s not even funny, INANE.
referred to the present Supreme Court as Eight-and-Three-Fifths Black Robes.
Which two justices had their robes hemmed? Only anon knows, and he’s not telling.
Leopold – yet again you misrepresent what I post, implying my post ‘brings it up again’ something that it clearly never brought up in the first place.
A shameless deceitful trick – and one you share with the one for whom you wear your cheerleader outfit.
C’est La Vie.
I’m a little surprised that you bring it up again, but go ahead, Honest Abe, explain once more what you meant when you referred to the present Supreme Court as Eight-and-Three-Fifths Black Robes.
“desire for patent reform”
I see what you and Malcolm have in common: deliberate misrepresentation of what other people post.
It is not the desire for patent reform that was the target of the comment and you know it.
Just like you purposefully misrepresented the Robes comment. You do realize that such deceit is unethical, right?
I am a professional bull fighter – figuratively, of course.
O’le !
LOL – let’s compare the number of agendas that each has torched with volunteered admissions, shall we?
Then tell me (if you can find the nuts), who was right in the Myriaddecision?
Then tell me how the Supremes (and various other entities) came to have the same ‘troubles’ as I?
Sorry, what was that? I did not hear any answers from you… Can you speak up?
LOL
Nice prevarication Malcolm.
Would any of those words be the subject of the discussion? Clearly not, as you were able to type them. Just guessing? Not likely.
And yet, Leopold, finds no difficulty (at all) with such purposefull deceit.
Sure, it is not at the level of the N word and that separate type of fallout, but it is a more pernicious type of problem, and indicates an equally awful – if not more awful – character defect, especially for one in the legal field.
And yet, Leopold, who supposedly runs a multi-million dollar law firm, cannot see the character defect (but loves to hand on my every word).
Hmmmmmm. What planet in which far-off galaxy do you run this multmillion dollar law firm?
Malcolm’s cavaliar attitude – as opposed to any remorse or even second thoughts as to his use of – to using the N word
“Nattering nabob”? “Narcissist”? “Nutcase”? “Nutjob”? Or are we talking about the dreaded “Noodlehead”?
I’m just guessing at the context here.
The problem for the patentees was that nobody knew what the alternative compounds were and there was no basis for sound prediction. The patentees described and claimed rapamycin because that what was all that was known at the time.
Please advise, with the utmost respect, what this has to do with an invention in the chemical arts.
Much patent practice in the chemical arts can be characterized as the hunt for spurious precision. Not everything can neatly defined by a precise number or range. Please let me know, to the nearest second, whn day will end tomorrow and night will begin.
A huge problem is that Rader and his collegues are so ignorant that all you have to do is to add a generic flowchart and they think you are a world-class genius with a spectacularly complex invention.
Sorry – just don’t believe you.
I’ll get over it. But I answered your question, while you ignored mine. So what do you do?
Leopold,
Sorry – just don’t believe you.
Too convenient for you to ignore the propensity that is plainly obvious.
But perhaps you should just pay a little more attention to what you do decide to respond to and what you decide to not respond to (for example, onthis very thread, Malcolm’s cavaliar attitude – as opposed to any remorse or even second thoughts as to his use of – to using the N word; funny how that slipped by you).
WAKE UP.
LB: … please point me to the place in the “archive” where I can find this alleged transgression of MM’s. If it’s appropriate, I’ll be more than happy to condemn it. Something tells me you won’t, though.
anon: LOL – pick a thread – any thread.
Yeah, that’s what I thought.
HOWEVER, you do seem to read every one of my comments.
Yeah, right, like there is time enough in the day for that.
What is it that you consider to be ‘your work?’
I run a multi-million-dollar law firm. What do you do?
“where I can find this alleged transgression of MM’s. If it’s appropriate, I’ll be more than happy to condemn it. Something tells me you won’t, though.”
LOL – pick a thread – any thread.
But please, pick the thread with your eyes open.
Perhaps find the thread wherein you first told me to ‘justshutup.’ As I recall, I quite nicely outlined exactly why you were aiming at the wrong person.
As to “never claimed to read every single comment” – that’s nice. No one ever said that you did.
HOWEVER, you do seem to read every one of my comments.
Hmmmmm.
What is it that you consider to be ‘your work?’
I’m not at all sure why you find any absence of comments from me “alarming,” but please point me to the place in the “archive” where I can find this alleged transgression of MM’s. If it’s appropriate, I’ll be more than happy to condemn it. Something tells me you won’t, though.
I might point out, by the way, that I’ve never claimed to read every single comment on this site, nor have I taken on (or desire) the responsibility of pointing out every use of inappropriate or offensive language here. Some of us have work to do.
good point
“Why would I? You’re the only one who gives a sh-t ”
Obviously the blindfolded archer in the cheerleader outfit wanting others to have ‘perspective’ gives a sh-t.
And yet, Leopold’s absence of comments regarding Malcolm and Malcolm’s lack of perspective (and self-awareness, let alone the hypocrisy) is alarmingly absent.
That like (exactly like) Leopold telling the wrong people to “justshutup.”
Whew, you are not denying it (LOL).
And yet, you don’t see the hypocrisy.
And neither does your archer friend with the blindfold and the cheerleader outfit.
C’est La Vie.
Are you now denying that you are one of two people who used the N word on this blog, Malcolm?
No, I’m laughing at a pathetic s0ci0path blogtroll who thinks he’s “got something on me.”
LOL
Are you now denying that you are one of two people who used the N word on this blog, Malcolm?
Let’s be clear, you know, like use the English as a first language skill of yours not for obfuscation (as typical) but for clarity.
LOL – and yet, for all of your claims that I have troubles, you are the one actually having the troubles.
Love that accuse-others-of-that-which-you-are/do rhetorical tool you use.
/off sarcasm.
Cheering on one of only two people to EVER use the N word on this blog. Bravo.
Weirdest. Blogtroll. Ever.
What he said was to single out business methods and software.
I think that’s because “clarity” is, in fact, a bigger problem in those art units than in biotech where the terminology used is typically the established terminology in the field. Business and software prosecutors, as we’ve seen here for years, seem to have a greater tendency to use obfuscatory jargon to create the illusion of an invention where none exists. It’s understandable why they might choose to do that.
It’s also not “patent big0try” to point this out. That reminds me of another great phrase for you guys to use. You should start referring to efforts to minimize computer-implemented j–k patents as a “high tech lynching.” That’s got a lot of pizzazz, too. Run with it!
For someone to claim ‘mastery’ of English
I never claimed mastery of English. I only asserted that you seem to have difficulty with both reading comprehension and expressing yourself clearly. Combined with your path0l0gical ly ing habit, it gets you into some trouble occasionally. Like ten times a day, on average.
“That diminishes the magic.”
LOL
From Malcolm’s world of Opposite Reality…
Wrong Leopold, you did not go back into the archives far enough.
But love the RAH RAH Malcolm that you (once again) are doing.
Cheering on one of only two people to EVER use the N word on this blog. Bravo.
What he said was to single out business methods and software.
For someone to claim ‘mastery’ of English as a first language and ‘superior’ reading comprehension skills, you seem to have a lot of trouble with the basics.
Oh, the meaning of the “meme” is clear enough. You’re suggesting a moral equivalence between a desire for patent reform and a hatred for certain ethnic or racial groups. Get some perspective, anon.
If the courts want clarity, finally, the CAFC should also consider ruling that relative terminology, like “about” or “substantially” or “optionally” are per se invalid. With the ability to precisely claim numbers or ranges, why need words like “about” or “substantially” when the applicant can precisely claim numbers or ranges.
Come now, MM – you should understand the meme.
Or are you mad that I am putting it to a better use?
Another patent big0t.
What. The. F?
This case also appears to represent a possible approach to “best mode” disclosure — leave it out at your peril, because if it’s left out then it might not be covered even with an apparently otherwise “broad” claim…
Thank you Paul F. Morgan for confirming my post of 2:10 PM.
Another patent big0t.
Dennis, I respectfully suggest that the title here is a bit misleading. This is not really about patent “clairity,” which is indeed a real problem, but one of ambiguity. Especially in the many patent suits and threats these days on broad internet and/or business method patent claims with spec-undefined claim terms that take too long to get Markman clairification.
Also query if the Court may be more inclined to set a somewhat higher 112 bar (than even for other “unpredictable arts” claims) for a generic claim covering several hundred medically untested species where the claim is in the form of a claim to a “medically effective amount” of a drug [as here] with spec support for only a single species with that efficacy?
Ned,
Your canard of point of novelty and dissection tendencies are peeking through.
Not in the same way. The problem with generic or functional expressions in the predictable arts is that they cover all possible equivalents and according to the Supreme Court in O’Reilly v. Morse retard the progress of the useful arts rather than promote.
If one gets into the muck and tries to determine whether the full scope of the claim is enabled in the predictable arts, one seems to miss the point.
Yes, but not paragraphs 3-6.
In other words, Paul, the patentee was hoisted by his own petard?
test
A little more investigation throws more light on what happened here.
A brief scan of the 781 specification gives a strong impression that when the specification was drafted in 1992 what was intended to be covered was the single compound sirolimus, which was the only compound in the series known at the time and was an investigational compound, FDA approval only having been obtained in 1999. It is difficult to see how the meaning can be extended to cover a genus of compounds which at the time that the specification was drafted were not known to exist.
The so-called rapalogs were a later discovery and on brief investigation appear to have been altogether unknown at the time when the patent specification was drafted. They are equivalents in the sense that they have the same mode of action and binding sites. On the Festo criteria they were unforeseeable equivalents, and the most logical basis for a finding of infringement (if any) was the US doctrine of equivalents. The rapalogs have advantages e.g. increased water solubility making them suitable for injection so that the court in dealing with an equivalents claim would have to conduct a balancing exercise between the need to reward the pioneering inventor and the need not to inhibit further (and in this case beneficial) downstream research.
There may also have been an argument that over-strict construction was inappropriate and that the rapalogs are rapamycin with minor differences which do not affect its function. Such arguments have not fared well, even where they have been advanced, in the pharmaceutical field, which is one reason why Myriad, to a chemical practitioner, seems such an outlier.
Rapamycin is the old name for the compound sirolimus. The claim in my opinion meant what it said on the tin, and arguments that it had a generic meaning (other than by invoking the doctrine of equivalents) were never likely to lead to a good outcome.
Was Morse around back in the 1950’s?
Was 112 around back in the 1950’s?
Because we’re talking about scope of enablement and not plain vanilla lack of enablement. There’s nothing preventing the claim discussed above from being obvious, too, if any one of those 10000 rapamycin compounds was already known to have a positive effect for antirestenosis.
EG, Agreed. It seems hornbook law that one cannot claim a genius when disclosing only a species in the non-predictable arts.
The broader claim is not eligible because of Morse. See Lemley.
Morse was a 112 case?
LOL
The patent claimed a method for treating or preventing restenosis based on a large class of compounds (rapacymin) but described only one such compound (sirolimus) in that broad class. The non-enablement ruling here is a “no brainer,” on par with the University of Rochester case involving Celebrex.
The broader claim is not eligible because of Morse. See Lemley.
Dennis, one edit needed to insert the text in bold: Wyeth argued that a large pile of merely routine experimentation does not rise to the level of impermissible undue experimentation.
Subtle change in the meaning. 😉
Does this opinion relate to the predictable arts as well as the unpredictable ones?
Head, I like MM’s take on this: The synergy was not described in the specification, was supported by post filing tests that were tailored, the tailoring was not disclosed to the PTO, but was brought out during trial.
The takeaway for me is that if one is trying to claim a species in a genus, one better disclose in the specification something unexpected, some synergy that was larger than could reasonably be expected.