Ariad v. Eli Lilly (08-1248.pdf, Fed. Cir. 2009) (Judge Moore; Concurring opinion by Judge Linn)
Ariad sued Lilly for infringing its patent that claims a method of reducing NF-κB (“en eff kappa be”) activity. The listed inventors of the patent include, inter alia, two Nobel Laureates, and the original assignees include Harvard, MIT, and the Whitehead Institute. A jury found that both Evista and Xigris infringe, and the judge denied Lilly’s JMOL motion on invalidity. The resulting judgment was for $65 million in past damages and an ongoing royalty of 2.3% of sales.
On appeal, the Federal Circuit reversed the lower court’s decision – finding the asserted claims invalid for lack of written description. The written description requirement is intended to ensure that the inventors “disclose the technologic knowledge upon which the patent is based [and] demonstrate that the patentee was in possession of the invention that is claimed.” (Quoting Capon). Consequently, the disclosure in the patent document “must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed” and was in “possession” of the invention at the time of filing including “all elements and limitations.” In other words, Ariad “must describe some way of performing the claimed methods.” The actual level of disclosure depends upon several factors such as the extent of prior art, maturity of the science, and the “predictability of the aspects at issue.”
Here, it was clear that the invention was “extraordinarily creative” in a highly unpredictable field with little prior art available. Ariad’s expert even testified that the invention necessitated the development of a new vocabulary. All these factors indicate that the written description bar will be set high.
Here, Ariad’s description was scant on real examples
The ’516 patent discloses no working or even prophetic examples of methods that reduce NF-κB activity, and no completed syntheses of any of the molecules prophesized to be capable of reducing NF-κB activity.
Without specific examples, Ariad attempted to show that its description was sufficient by bolstering the skill of a PHOSITA. Unfortunately for the Patentee, the Jury found an early effective filing date and much of Ariad’s evidence showed skill in the art after that 1989 date.
Because written description is determined as of the filing date—April 21, 1989 in this case—evidence of what one of ordinary skill in the art knew in 1990 or 1991 cannot provide substantial evidence to the jury that the asserted claims were supported by adequate written description.
Although important, these small date issues probably made no difference because the description was so lacking and the prior art so sparse.
The state of the art at the time of filing was primitive and uncertain, leaving Ariad with an insufficient supply of prior art knowledge with which to fill the gaping holes in its disclosure.
“We therefore conclude that the jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description, and thus hold the asserted claims invalid.”
Caveat Vindicor: In its conclusion, the court noted that this result likely turned on clam construction. If Ariad had agreed to a narrower construction in litigation or narrower claim language during prosecution, then the written description requirement might have been satisfied. Of course, if it had pursued that strategy, infringement would have likely been lost.
Although Judge Linn concurred in the opinion, he wrote separately to remind readers of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.
Notes:
- Pioneering inventions are less likely to be found obvious or anticipated. However, one problematic result highlighted by this decision is that those pioneer patents are more likely to be trapped by the formalities of the patent system.
Confused, to me, as of now, the case doesn’t invite any such question. Help me. Are you saying no more than that, if the claim is invalid, there can never be any “infringement” of it? If so, that’s trite, no? Or are you perhaps saying that any inadequacy whatsoever in the “written description” is like “inequitable conduct” in that, once established, it kills the entire patent and every single one of the claims in it so there’s no need even to begin to analyse the scope of any particular asserted claim of the patent?
This case invites the question, if there was an inadequate written description, how could Eli Lilly have infringed in the first place?
“Because someone somewhere has decided that is what the industry needs”
Malcolm hanging with his buddy 6 again.
No, it was decided that that was what the law said.
Good point on the contrast with software though Malcolm. The power of PHOSITA is a double edged sword. It can cut you with 102/103 as well as slice away with 112 so much, eliminating the need to include exacting (actual) code that many may think is required. Personally, I think many patents concerned with software still fail 112 even given the near-omniscient PHOSITA, so I must stifle my gag-reflex and admit that I would be in agreement with Malcolm when considering many patents as “bad”. I just won’t descend to the level of thinking that it doesn’t matter which portion of law makes them bad, and that the distinction is not important. It is important whether 101, 102, 103 or 112 is the point of the sword. To say otherwise seems incomprehensible to those who practice in the field of law.
Alan McDonald wrote:
“I could never understand how any DNA sequence patent could be allowed after the first one.
One the steps for identifying a sequence was invented, isn’t all the rest just applying that basic knowledge. If I’m right, then this CAFC decision makes complete sense. If I’m wrong, where am I wrong?”
Well, the first place to start is with the realization that a “sequence patent” is patent to an *isolated* compound. Just identifying a sequence is only part of the story. You then have to isolate it. OK, that may be trivial in some cases (especially now) but not for others. 50 years ago people though DNA only ever came in small chunks, because all the isolation methods known that were used in preparing samples for identification unknowingly chopped it up.
Then you have to realize that identifying a sequence is not (always, even now) trivial, even if the sample hasn’t been significantly chopped up or otherwise damaged. There is no “one way” as you assume in your question. Just look at all the patents that have experienced problems because the sequence identified in the patent was *not* the true sequence as revealed many years later by subsequent work.
Cheers, Luke
“Here, it was clear that the invention was “extraordinarily creative” in a highly unpredictable field with little prior art available. Ariad’s expert even testified that the invention necessitated the development of a new vocabulary. All these factors indicate that the written description bar will be set high. Here, Ariad’s description was scant on real examples”
Contrast with most software patenting: not particularly creative and in a totally predictable field. And yet crap claims reciting nothing but functional fluff are issued by the hundreds every month.
Why? Because someone somewhere has decided that is what the industry needs. Will that someone please stand up? Oh, excuse me. The coma. I forgot.
Some opinion on the matter from one of the most knowledgeable biochemistry bloggers around:
link to pipeline.corante.com
Good quote: “Back in 2002, Ariad was issued an extremely broad patent on the uses of agents that affected the NF-kappaB pathway. And since it’s basically impossible to talk about inflammation without talking about NF-kB at some point, the company believed that it had the legal means to claim that many other companies were infringing their intellectual property … I found it potentially catastrophic that one could lay claim to fundamental biochemical pathways and then assert that this naturally gave you a piece of the action for any compound that affected them.”
Did Ariad just argue for the wrong priority date? What prior art would have prevented them from prevailing had Ariad conceded the 1991 priority date?
Understand that I do NOT work in the biotech field.
I could never understand how any DNA sequence patent could be allowed after the first one.
One the steps for identifying a sequence was invented, isn’t all the rest just applying that basic knowledge. If I’m right, then this CAFC decision makes complete sense. If I’m wrong, where am I wrong?
Max,
U.S. design patents feel like an illegitimate stepchild of the Trademark Cases, wherein the Supreme Court threw out the first Trademark Act for lack of Constitutional authority under the Patent & Copyright Clause. It was about 100 years, iirc, before Congress came up with the Lanham Act under the Commerce Clause. During the interim, industrialists wanted *something* federal to protect the “look and feel” and “identity” of their products.
Federal trademarks under the Lanham Act now cover the “identity” of products. Design patents still protect the “look and feel” gap between copyright creative works and utility-patented functional inventions.
For some reason, some applicants still try to protect design patent-type interests through trademark registrations … maybe cause trademarks endure indefinitely, while design patents expire at 14 years and pre-empt all other protections.
Agreed, trademarks and utility patents are different beasts. But how about “design patents”? At least in Europe, the borderline between the subject matter of a mark and that of a design is indistinct. In what sense is a “design”, when applied to a product, a discovery or a writing, while a “logo” applied to a product isn’t? How does the English litmus test “capricious addition Y/N” grab you?
Max:
Trademarks are different, IMHO. They are not a “writing” or “discovery” in the strictest sense. They are merely an indicator or where something came from (or at least supposed to be), and if there is no “something”, then why maintain a source indicator for it?
So what about trademarks, and the need to use them or see the marks expunged from the Register? As the English judge said, marks on the Register, but not in use, are “Abandoned vessels, clogging up the shipping lanes of trade”. This is why annuities, to maintain patents in force, are invariably on an ascending ramp, no?
I thought the claims were not supposed to be limited by the Disclosure.
Maybe they should just get rid of the Disclosure and put the entire invention in the Claims.
Or they should get of the Claims and put the entire invention in the Disclosure.
Then they should amend the Constitution to say,
“To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors THE EXCLUSIVE RIGHT TO THEIR RESPECTIVE WRITINGS AND DISCOVERIES (except for Non-Practicing Entities;”
Speaking of which, if a book is out-of-print, isn’t the copyright-holder a Non-Practicing Entity?
Dear extension,
Re: “The grant of a [patent] right does not require the reciever to exercise the full scope of the right.”
Yup, you got that right, but the rest is, to use a judicial term, gobbledygook. Nuts. It makes no sense whatsoever, because:
Congressional empowerment, of a particular “power” specified by the Framers, is a different story – it would require a formal Amendment to reduce that specified power.
Re: “(C)”
No comment.
Dear extension,
Re: “The grant of a right does not require the reciever to exercise the full scope of the right.”
Yup, you got that right, but the rest is, to use a judicial term, gobbledygook. Nuts. It makes no sense whatsoever.
A grant of a right to exclude includes the grant of lesser rights, such as the right to damage for trespass. The grant of a right does not require the reciever to exercise the full scope of the right.
(i.e. just because someone is hiting you and you have a right to self defence doesn’t mean you have to fight back, you could also use an included right of hudling in a ball).
So… congress has the constitutional authority to prevent patent infringement with manadatory permanent injunctions. But they don’t have a constitutional obligation to do so. They can choose to exercise only a portion of that authority, such as to require damages.
Hi Lionel,
Re: “’THE EXCLUSIVE RIGHT TO THEIR RESPECTIVE WRITINGS AND DISCOVERIES’ does not equal the right to an injunction.’”
I agree. I never said otherwise. In fact, the word “injunction” never appears in the Constitution even once.
What the Framers explicitly said, however, was that an inventor could stop anyone else from using his invention, at the inventor’s discretion, i.e., “the exclusive Right”, period (except for the itemized Constitutional exceptions). An injunction is not the only way to fulfill the Constitution’s mandate. Any other interpretation of the patent clause is to condone compulsory licensing, and, let’s face it, that’s ridiculous.
Re:
“ebay did not end the threat of an injunction, it just raised the bar for getting one to a fair level.”
Given what the Framers explicitly said, with all due respect, to say the least, I believe your further comment is moot.
JAOI,
“Without the treat of injunction, infringers are far less inclined to take a license.”
E-bay did not end the threat of an injunction, it just raised the bar for getting one to a fair level. If someone rips of your invention, you are still going to get an injunction.
“THE EXCLUSIVE RIGHT TO THEIR RESPECTIVE WRITINGS AND DISCOVERIES” does not equal the right to an injunction.
“I wonder if Judge Linn concurs with my opinion – that the USSC eBay decision is constitutionally unlawful – most IP scholars do.”
Source?
Its been a fun day on Patently-O, and I didn’t get redacted once. Cheers to all, and to all a good night. God bless everyone.
See, I told No. 6 hasn’t his wits about him.
“The USSC eBay decision makes it harder for ordinary inventors to license their wares. ”
I’m pretty sure you could probably license your “wares” (lol) for 1$ per lifetime all inclusive license at any point in time, to anyone and that hardly sounds “hard” to me, or “harder” than trying to get several thousand dollars from a company under the old injunctive relief regime. I’m going to have to conclude that a denial of injunctive relief has never made it harder to license your wares.
Time for cocktails, oar is it cocktales.
Whatever, it is that time, so my idle curiosity can maybe invent something.
Hey Boss, please make that fairy tales. Trolls have tails. Malcolm has fairy tales. And No. 6 hasn’t his wits about him; he’s lost his marbles and doesn’t play with a full deck, nor does he have all his oars in the water. Other than that, they are fine people. No offense,
Hi Leo,
It is almost that time in Bermuda.
Re: “I’m probably going to regret asking, but could you kindly identify one or two of these IP scholars that concur with your opinion that eBay is constitutionally unlawful?”
Answer:
I’ll go out on a limb and guess that Professor Crouch, Kevin E. Noonan, Esq., Spencer Hosie, Esq., Ronald S. Katz, Esq. & Shawn G. Hansen, Esq. would concur.
I thought I came up with a good answer. What do you think? All parties I named have written articles condemning comedians like Malcolm and others who don’t know dick about practicing patent law and can’t stop telling fairy tails about imaginary trolls.
“You fed the troll. See what happened?”
Hey, if Professor Crouch, Kevin E. Noonan, Esq., Spencer Hosie, Esq., Ronald S. Katz, Esq. & Shawn G. Hansen, Esq., Denny Crane, and Alan Shore all agree with JAOI, then who am I to argue?
Sure Boss:
Hi-five Six,
The USSC eBay decision makes it harder for ordinary inventors to license their wares. Boy, you are dense, or r u Just a retarded dickhead?, or r u pulling our chains?
Leo: “I’m probably going to regret asking”
You fed the troll. See what happened?
Will somebody explain to No. 6 why eBay aggrieves all independent inventors?
“:Hi five No. 6,
Without the treat of injunction, infringers are far less inclined to take a license.”
Can we get to the part where you were aggrieved now? Telling me about the facts of enforcement don’t tell me how you were aggrieved by the ebay decision.
“Half the problems in properly examining a patent are that we’re picking up apps that don’t really flesh out the true scope of the claimed invention, but merely do so conceptually. Sure, it might be enough to skimp past WD, but how good of an examination do you think you’re going to get?”
Wait, are you claiming Examiners read the spec? I must say I haven’t seen much evidence of that.
Dennis: “Although Judge Linn concurred in the opinion, he wrote separately to remind readers of his belief that the written description requirement should be eliminated and enablement be allowed to do its job”
For what it’s worth, I tend to agree with Judge Linn. The distinction between written description and enablement is and was silly and unnecessary.
Dear Jim H.,
Yes, I’m angry about eBay – in fact I’m livid.
USSC Justices et al., Congressmen, Executive agency leaders – most seem to suck and not give a hoot about their Oaths of Office. Look at the mess we are in all because they do not abide the Constitution.
But, I’m not dismayed; I’m a happy camper – everyday is a blessing.
And, I’ve gotten three notices of allowance in the past year.
PTO Examiners are the best people in my book – they make the Supremes look like chumps.
JAOI,
“Hey, why do you think that?”
You raise eBay every chance you get. You’re bitter about eBay. Perhaps angry is better than bitter. As time passes, your bitterness festers as you stew in your juices of anger at the eBay decision.
Hello Jim H.,
Where have you been?; we missed your input.
Re: “bitterness”
Hey, why do you think that? Everybody who knows me thinks I’m a sweet guy, life of the party, especially after a Manhattan or two.
JOAI,
“And yes, I have been aggrieved.”
You don’t say……
By any chance to you have a picture of Robert Kearns (inventor of intermittent windshield wipers) hanging in your house as motivation for your bitterness:
link to en.wikipedia.org
Hi five No. 6,
Without the treat of injunction, infringers are far less inclined to take a license.
6:
Your next post just popped up. If you think he’s wrong, and you have all those refs, just put in the two paragraphs showing he’s wrong and cite your refs.
That’s gotta be easier and more fair to everyone involved than playing Larry Litigator with the MPEP rules for submitting evidence to the file.
Let the Board tell the Applicant that he can’t get his “evidence” in without a 1.132 from an expert saying that it exists…
But give the Board the ability to blow him away with the facts instead of wasting his money and everyone’s time filing an RCE, a 1.132 affidavit with app’x, etc.
6:
Is he wrong — i.e., is his description of the function of an “LCD screen” incorrect as of the filing date? In that case, call him out with a better reference — e.g., “LCD screens were not known in art at the time of filing to have the function of opening beer bottles. See, e.g., LCDs from A-Z, by Malcolm Mooney (2002 ed.).”
Or are you just pretending to understand the FRE (that don’t apply at the BPAI anyway) and costing the inventor/client money for no good reason?
“Are you suggesting no injunctions against infringement of a valid patent have been denied Plaintiffs since eBay? On what planet do you reside? And yes, I have been aggrieved.”
Having an injunction request denied and only raking in cash is being aggrieved? On what planet do you reside?
How were you aggrieved? If so, why have you not brought suit appealing to the SC?
“And when did the Fed. Rules. of Civ. Pro. enter into the BPAI appellate process?”
That is a good point. I’m not 100% certain about that. But if we’re not to use their “rules”, by which “rules” shall we consider evidence in cases? Shall they just be able to make a statement on the record (sans affidavit) and have it stand as “evidence” or “substantial evidence”? If so, could I not simply counter it with my own statement?
Weren’t those rules of evidence implemented back with the APA in Zurko?
“Only if you want to look like an a$s in front of the Board.”
I can live with that lol.
See, the thing is, in this case, the wiki just didn’t specify something clearly enough for him. Looking into the matter a bit deeper he will find that I am correct, and I have substantial evidence in the form of publications to back me up (I r examiner, its what we do lols?) but why should I assert substantial evidence against his hearsay? Hearsay, which, btw, also discloses what he alleges is missing, and he might would get hit with rule 11 for making this outrageous assertion in court.
“Should I disparage his reliance on the wiki as being hearsay and dismiss the argument out of hand for lols?”
Only if you want to look like an a$s in front of the Board.
6 – isn’t Wiki the epitome of the knowledge of a PHOSITA? And when did the Fed. Rules. of Civ. Pro. enter into the BPAI appellate process?
Posts like these may convince others that you are simply here to waste the applicant’s money and time. But I know better.
Hello No. 6,
Are you suggesting no injunctions against infringement of a valid patent have been denied Plaintiffs since eBay? On what planet do you reside? And yes, I have been aggrieved.
I have a question:
A certain case I have has an applicant appealing a decision and relying on wikipedia to establish the function of a device, for example, an LCD screen. Should I disparage his reliance on the wiki as being hearsay and dismiss the argument out of hand for lols?
“This patent is 106 pages long including the drawings. Without knowing the art, it is difficult to tell whether the bar for sufficient written description was set too high.”
The quality of the description is not dependent on length, that is what I was trying to get across upthread.
JAOI why haven’t you gotten the SC to overturn themselves yet? What are you waiting on? Your death? Oh wait, you mean that you haven’t been personally aggrieved by it yet? That’s strange because neither has anyone else to my knowledge.
Dear Mr. Daily,
Thank you for your concurring opinion.
May I add that the Constitution specifies that, “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors THE EXCLUSIVE RIGHT TO THEIR RESPECTIVE WRITINGS AND DISCOVERIES;” (emp. added)
Leopold:
As a specific example, Richard Klar argued in an article written after the grant of cert but before the decision in eBay that compulsory licensing is unconstitutional. 27 Whittier L. Rev. 985.
As others (e.g. Paul Schoenhard) have pointed out,though, the Constitution specifies only ‘the exclusive right’ not ‘the right to exclude.’ Thus, the right may be something else, such as the ‘exclusive right to profit’ or something similar. It is not entirely clear that the *Constitution* solely contemplates the right to exclude, although the Patent Act certainly does.
Hi Leo,
Re: “I’m probably going to regret asking, but could you kindly identify one or two of these IP scholars that concur with your opinion that eBay is constitutionally unlawful?”
I’ll go out on a limb and guess that Professor Crouch, Kevin E. Noonan, Esq., Spencer Hosie, Esq., Ronald S. Katz, Esq. & Shawn G. Hansen, Esq. would concur.
I’ll bet you thought I’d say Denny Crane and Alan Shore (¢¿$).
This patent is 106 pages long including the drawings. Without knowing the art, it is difficult to tell whether the bar for sufficient written description was set too high.
“I wonder if Judge Linn concurs with my opinion – that the USSC eBay decision is constitutionally unlawful – most IP scholars do.”
I’m probably going to regret asking, but could you kindly identify one or two of these IP scholars that concur with your opinon that eBay is constitutionally unlawful?
In his concurring opinion, Judge Linn wrote:
“(“[T]he claims made in the patent are the sole measure of the grant.”); see also Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052 (Fed. Cir. 2002) (en banc) (“Consistent with its scope definition and notice functions, the claim requirement presupposes that a patent applicant defines his invention in the claims, not in the specification. After all, the claims, not the specification, provide the measure of the patentee’s right to exclude.”). The court’s invention of a separate written description requirement has “create[d] confusion as to where the public and the courts should look to determine the scope of the patentee’s right to exclude,” University of Rochester, 375 F.3d at 1326, causing uncertainty “in how inventions are protected, in how the [Patent & Trademark Office] discharges its responsibilities, and in how business is conducted in emerging fields of law,” id. at 1327.”
I wonder if Judge Linn concurs with my opinion – that the USSC eBay decision is constitutionally unlawful – most IP scholars do. Judge Linn cites a case which predates the USSC’s eBay debacle.
“However, one problematic result highlighted by this decision is that those pioneer patents are more likely to be trapped by the formalities of the patent system. ”
Not if you give a fleshed out disclosure rather than a skimpy one. Seriously, you could probably have given this patent the needed elements to fulfill WD in the amount of words it takes to fill 2 pages, or less.
So don’t think I’m advocating bloating your spec needlessly. Put the important things in for god’s sake. Half the problems in properly examining a patent are that we’re picking up apps that don’t really flesh out the true scope of the claimed invention, but merely do so conceptually. Sure, it might be enough to skimp past WD, but how good of an examination do you think you’re going to get?
As I posted over at hawk, I don’t really concur with Linn on this one. Although it is a tough call, and one that can go either way.
Judge Moore strikes again!; her ego grows as we speak.
“In its conclusion, the court noted that this result likely turned on clam construction.”
Stop, you are making me hungry.
Seriously, 99.9% of us will not have to worry about this issue. Most things I see are combinations of known elements, and further arrangements of the same thing.
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