Therasense Inc. (now Abbott) v. Becton, Dickinson and Co. (Fed. Cir. 2010)
The Federal Circuit has granted Abbott’s request for an en banc rehearing on the issue of inequitable conduct.
The rehearing will focus on six questions of law:
- Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?
- If so, how? In particular, should the standard be tied directly to fraud or unclean hands? See Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944), overruled on other grounds by Standard Oil Co. v. United States, 429 U.S. 17 (1976); Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933). If so, what is the appropriate standard for fraud or unclean hands?
- What is the proper standard for materiality? What role should the United States Patent and Trademark Office’s rules play in defining materiality? Should a finding of materiality require that but for the alleged misconduct, one or more claims would not have issued?
- Under what circumstances is it proper to infer intent from materiality? See Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc).
- Should the balancing inquiry (balancing materiality and intent) be abandoned?
- Whether the standards for materiality and intent in other federal agency contexts or at common law shed light on the appropriate standards to be applied in the patent context.
Abbott’s en banc brief is due in 45 days from today. The response is due within 30 days of service of Abbot’s brief. Briefs of amici curiae will be entertained and may be filed without leave of court. Under Fed. R. App. Proc. 29, the amicus curiae brief must be filed within 7–days of the filing of the principle brief of the party being supported. If the amicus curiae does not support either party then the brief must be field within 7–days of the petitioner’s principal brief.
Comment: The correct answers to these questions depend upon the purposes of the inequitable conduct doctrine. Namely, is the doctrine intended to the behavior of patent prosecutors is is it intended to catch perpetrators. The major empirical issue is that the doctrine pushes patent prosecutors to over-compensate in ways that potentially harm the system and certainly raise the costs of patent protection.
“I have repeatedly re-defined my terms, miscited statutes, abused case law and disregarded those portions of rules that were inconvenient to my position.”
There Ned – fixed your statement for ya.
“I have tried in these arguments to carefully limit the discussion
Translation: I have tried to ignore the valid point that ping keeps rubbing in my face because I have no argument against it. I have even, quite disingenuously tried to label it as spuriously self-evident.
“even here. I see nothing from you except self congratulatory jactitation”
Hey, most of the slam dunks were by IANAE, they were team congratulatory jactitations mind you. And the “see nothing” is because you have chosen not to see – I have quoted the text of the rule (I don’t need more than that).
Perhaps Ned is thinking of the rule as it used to be in England. If claim 1 is bad, the patent is bad.
You need the court to permit you to amend claim 1 to make it valid, and catch the infringer? Well then, you need equitable clean hands, to get your amendment admitted.
Except that England had to dismount from that high horse, to fit in with the amended European Patent Convention. Mainland Europe, you see, doesn’t “get” equity.
There is an extremely good reason, at the EPO, to have a darned good set of dependent claims, from the outset. But that’s another story.
Of course, they do have the concept that if one claim is invalid, all claims are unenforceable. This DOES tend to keep one honest and to actually try to get the closest art before the examiner as a matter of self interest.
In what parts of Abroad do they have this rule that if one claim is invalid the others are unenforceable? Pretty sure Europe and Canada (two member states of Abroad) don’t do that. If that were the rule anywhere in the world, why would you ever file a dependent claim in that jurisdiction?
Also, what would this rule have to do with not disclosing art that one has no duty to disclose? Once you’re aware of the art, just claim around it with smug satisfaction as you keep trying to justify doing in the US.
IANAE, haven’t you noticed that there is no duty of disclosure abroad? Of course, they do have the concept that if one claim is invalid, all claims are unenforceable. This DOES tend to keep one honest and to actually try to get the closest art before the examiner as a matter of self interest.
Not so, ping. I have repeatedly defined my terms, cited statutes, case law and rules, even here. I see nothing from you except self congratulatory jactitation. There is not a sentence or paragarph that you do not boast of your purported triumph over me or with whomever you are present jousting.
It would be a pleasure if you could come off your high horse of delusional self fame and actually demonstrate some actual knowledge of the law.
“Let me see if you actually know what you are talking about.”
Excuse me Ned, but you be the one needing to show you know what you are talking about. You seem to hang around the foul line instead of playing the game.
IANAE, you seem to mix intent and materiality.
Intent and materiality are the same thing when the question is whether the art is material to your belief.
Of course the two are separate when the question is whether the reference is inconsistent with a particular argument or whether the reference makes out a prima facie case, but belief is 100% intent. You either believe it or you don’t. A reference is material to your belief if you think it is.
Now, if all that is required is that the reference be closer than other references or in some way might be relevant to patentablity, then I really have no way of telling “objectively” whether I can safely withhold the reference EVEN IF I affirmatively believe that my claims are patentable over the reference.
You can’t safely withhold the reference. Why are you even asking? Why does it even cross your mind to attempt to withhold the closest prior art you have? If you affirmatively believe your claims are patentable over the reference, that’s all the more reason to disclose the reference rather than splitting hairs about your technical duty to disclose. Equity doesn’t stand for technicalities. Never has.
If you withhold closer art and disclose more remote art, that strongly suggests to me that something dubious was going on. Granted, I’m not a judge, but why would you ever put yourself in a situation where a judge would be shown that you made that sort of decision?
IANAE, you seem to mix intent and materiality. This is one of the issues that has to be resolved in this en banc case.
Intent to not disclose may be deliberate, in the words of Linn, but this cannot be enough unless one has some knowledge of the materiality of the referenced not disclosed. So, if I intend not to disclose a reference at a time that I believe my claims are patentable over, and my belief is in fact confirmed, then their should be no IC.
Now, if all that is required is that the reference be closer than other references or in some way might be relevant to patentablity, then I really have no way of telling “objectively” whether I can safely withhold the reference EVEN IF I affirmatively believe that my claims are patentable over the reference.
IANAE, this latter standard is no standard at all. It gives free rein to defense counsel to conduct fishing expeditions to find anything not disclosed and to manufacture an IC case out of whole cloth. We in the patent bar recognized the problem and argued successfully with the PTO for a change. They listened and amended Rule 56 accordingly.
But the Federal Circuit still has not caught up. It is time they did.
If THAT statement is in fact true, and is confirmed to be true in court, there can be no fraud on the PTO.
“Fraud” is such an ugly word. Let’s focus on inequitable conduct instead.
I assume you threw in the “and is confirmed to be true in court” in support of your earlier argument that valid claims are not subject to inequitable conduct for non-disclosure.
Except that the statement is one of belief, not of fact. The statement is therefore doubtfully true if you have close art you have not disclosed, regardless of its objective materiality.
The mere fact that you didn’t disclose close art casts doubt on your belief, because you knew you had to disclose it, and you wouldn’t have had a problem with disclosing it if you were as confident about patentability as you let on in the declaration.
Exactly my point, IANAE. If THAT statement is in fact true, and is confirmed to be true in court, there can be no fraud on the PTO.
the “or” section is relates to arguments actually made regarding patentability. Now, if the features in the non disclosed art and the argument are unrelated, only the first part of the “or” pertains.
So as long as you don’t make some careless statement on the record to the effect that you believe the named inventor(s) to be the original and first inventor(s) of the subject matter which is claimed and for which a patent is sought, you’re pretty much in the clear?
Ping, the “or” section is relates to arguments actually made regarding patentability. Now, if the features in the non disclosed art and the argument are unrelated, only the first part of the “or” pertains.
Ping, OK, then, tell me requirements of a “written description of the invention.” Let me see if you actually know what you are talking about. Then we can discuss some real cases to test your knowledge.
Ned, buddy – I do understand that you are attempting to create legal effect in order to support your position, but you are yet again making up law.
The world of IMHO-Ned law might be a well-run and organized world. In fact, it might be a nice place to visit. Buts you gotta come back to reality.
Dont be conflating WD, which is statutory with having a prior art section, which is plainly not (if you think it is, then show me where the “must” is and/or explain why 37 CFR leaves out that lil’ ‘ol item). Show me the part of WD that says you MUST have a prior art section.
And I oh so do love your answer to anon.
And “leaving out” the exact thing I keep telling you about AND accusing me of missing something spuriously self-evident is just WAY too chicken-sh_t of a way of saying that I have been right all along. Ya see, I keeps telliin ya that the “or” applies and yous responds “Huh?”
My turn to Slam Dunk all over Ned.
ping, you really do not understand, I believe, the written description requirement. It requires you to distinguish, in the specification, old from new. In deciding Ariad, the Feds relied on Eaton, a Supreme Court case, that long ago laid out this requirement.
It would not take too much more to suggest that this requirement really means that one must distinguish the old as known to the applicant at the time of filing, pretty much the same thing as best mode. No search required.
But, if this section is misleading in any way, then WHAMO, we get pretty much what you guys have been advocating.
Anon, I am aware of the “or.” I have tried in these arguments to carefully limit the discussion a situation where the “or” did not apply. I believe AVID is such a situation.
As I said, AVID would be a good case to take en banc as well.
He pointed out that the Feds have yet to address the substance of the 1992 change in Rule 56.
I’d find it more persuasive if he pointed out that the Feds had ruled on the matter. Especially since this “plague” is pleaded in every single case. You’d think a rule change almost 20 years ago would have come up in discussion by now.
I see a whole lot of overlap between the old rule (substantially likely a reasonable examiner would consider it important) and the new rule (establishes a prima facie case in combination, or inconsistent with applicant’s arguments). It all comes down to what is relevant enough that it should be shown to the examiner before you get your patent. Would a reasonable examiner not fashion material art into a prima facie case? Would a reasonable examiner not want to see art that casts doubt on your argument?
Besides which, this is an equity issue, so the courts will always tend to rule against the person who did something shady, regardless of changes to specific wording.
It’s sad that people are quibbling about imagined nuanced exceptions to the rule, rather than simply disclosing the art they know is relevant and taking the patent scope they’re legitimately entitled to have.
Ned Heller,
Thank you for the link. While The Hon. Gerald J. Mossinghoff has an apparent advantage in pedigree over Ping, I think that if you are depending on that article to base your understanding of Rule 1.56, Ping has a better case of what the rule stands for.
Specifically, from the second page, Mossinghoff states “The Federal Circuit has not yet ruled upon the significance of the change from the ‘important to a reasonable examiner’ standard to the ‘prima facie case of unpatentability’ standard.” This makes for a nice soundbyte, but it is not a fully accurate reading of the Rule.
Ping correctly points out that there is an “or” in the section (actually there is more than one) that defines materiality and either (1) which contains the prima facie reference, or (2) which does not, can be used to define materiality. IANAE correctly and subtly notes this as well.
You may want to reconsider your ardent position on this matter.
“This obligation to discuss the art in the background section might be akin to an obligation to disclose the best mode.”
More worhtless IMHO-Ned Law.
Ned, the best mode is a statutory requirement.
A background section is not even required.
Try to understand the difference between “must” and “should”.
More reds, greens and blues, please.
And it’s ok that you kowtow to IANAE, since in a way, that is bowing to me too.
IANAE, I think we understand each other’s positions quite well. I now ask you to read Mossinghoff’s piece linked above, but relinked here. He pointed out that the Feds have yet to address the substance of the 1992 change in Rule 56. Clearly, Feds in AVID continued to recite the revoked 1977 standard of materiality and did not discuss the new Rule 56. Obviously, one of the reasons they are taking the issue of IC en banc is to actually determine what the duty of disclosure us under the 1992 version of the rule.
At the same time, they need to take AVID en banc as well.
link to oblon.com
If one actually complies faithfully with this duty, there should be no art that needs to be disclosed.
Really? You honestly believe that?
So what’s the point of IDS practice at all? Is it solely for applicants who know they’re filing invalid claims?
I am arguing that if the jury has actually found the claims valid over the non disclosed reference, this should preclude a finding of IC solely for non disclosure — based on Dairy Queen.
That argument has the same problem. Material and invalidating are not the same thing. Material is a lower standard. There are material references that do not invalidate, and therefore a valid patent may still have material references that must be disclosed.
Remember how OJ was acquitted in the criminal trial but found liable in the civil trial? Different evidentiary standards give different results even if they depend on the same facts. The results are not inconsistent, it’s simply that there was enough evidence to reach one conclusion but not the other.
Why bother with the second trial? Because the jury in the first trial was never asked whether on a balance of probabilities OJ killed what’s-her-name and what’s-his-name. Nor should the question have been asked, because the result in the criminal trial did not depend on the answer.
“increasingly demonstrating your inability to reason to even think that IANAE has made a slam dunk here”
Must be a matching set thingy to the spuriously self-evident or somethin.
I love how haughty Ned gets when he loses arguments, don’t you Sarah?
“Your reading of Rule 56 is not tenable.”
Try actually reading it yourself Ned. You keep on missing the points.
“was assumed”
Well, we know the dangers of “ass-u-me”, don’t we?
“contemplating… was advised”
Damm that’s compelling… NOT
“advised by someone”
Oh I know – advised by Kappos Cat – Puuurfect.
“one of the ways”
Another Slam Dunk – yep, Ned’s still standing at the foul line.
Regarding Keystone Driller, clearly you are right that in that case a prior finding of invalidity was not required, just the independent opinion of a third party that the prior use was invalidating.
But, there is a subtle difference that I am arguing. I am arguing that if the jury has actually found the claims valid over the non disclosed reference, this should preclude a finding of IC solely for non disclosure — based on Dairy Queen. There are common issues of law and fact involved in the determination of materiality both for validity and patentability purposes. The court cannot constitutionally decide these differently.
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