Therasense v. BD: En Banc Support from Law Professors

Guest post by Christian Mammen. Mammen is a Resident Scholar at UC Hastings. He also maintains an IP litigation and strategy practice. (He was also my boss when I was a summer associate at the Heller Ehrman law firm.)

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On March 8, 2010, I submitted an amicus brief (click here for a copy) on behalf of a group of nine law professors (Professors Cotter, Dolak, Gallagher, Ghosh, Hricik, Risch, Sarnoff, Takenaka and myself) in support of en banc review of inequitable conduct in Therasense, Inc. et al. v. Becton, Dickinson & Co. et al. The panel decision in Therasense affirmed the District Court’s finding of inequitable conduct. The inequitable conduct finding related to a failure to disclose to the USPTO statements that had been made to the European Patent Office. The majority decision drew a lengthy dissent from Judge Linn.

The law professors’ amicus brief argues that en banc review is appropriate because of the ongoing inconsistency in Federal Circuit precedents concerning inequitable conduct. In particular, the brief focuses on two specific issues: (1) the legal standard for intent and (2) the proper test of materiality.

Legal Standard for Intent: First, the applicable legal standard for the intent element continues to be uncertain. Although some expected that the 2008 Star Scientific decision (Star Scientific , Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008)) would prompt a widespread adoption of its single-most-reasonable-inference test for proving intent via circumstantial evidence, that has not been the case. In Therasense, the majority deferred to the District Court’s five findings on the intent issue, without addressing their legal sufficiency. Two of the five findings pertained solely to the materiality of the nondisclosed information; however, Star Scientific holds that “materiality does not presume intent.” One finding of the five was merely that the individuals knew the information and did not disclose it; again, this is not the standard for intent under Star Scientific. And the last two findings were that the individuals’ testimony should be rejected as not credible; these findings failed to address the single-most-reasonable-inference test set forth in Star Scientific.

In addition, the majority decision (and the underlying District Court opinion) implicate the “should have known” test for intent that has often appeared in the Federal Circuit’s precedents. The law professors’ amicus brief argued that there should be an en banc rehearing because there is a conflict between the Kingsdown-Star Scientific line of cases, on the one hand, which disfavor the “gross negligence” test—and by implication the associated “should have known” test—and the Brasseler-Ferring line of cases, on the other hand, which endorse the “should have known” test.

Objective Materiality: Second, since the 2006 Digital Control ruling (Digital Control v. Charles Mach. Works, 437 F.3d 1309 (Fed. Cir. 2006)), it had appeared that the Federal Circuit would steadfastly apply the older “reasonable examiner” test for materiality, rather than the newer and more objective test adopted by the PTO in the 1992 revision to 37 CFR 1.56 (“Rule 56″). However, in Therasense, the majority applied the 1992 version of Rule 56 as the test for materiality. This arguably creates a split in precedent that provides a basis for en banc reconsideration of the proper test for materiality.

Will this be the case in which the Federal Circuit takes inequitable conduct en banc? It is difficult to predict. Over the past five years, the Federal Circuit has declined en banc petitions in a number of prominent and controversial inequitable conduct cases. It can, however, be confidently asserted that, in the twenty-two years since the Federal Circuit convened en banc in Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988), the Federal Circuit has accumulated an impressive tally of inconsistent and contradictory panel decisions that cry out for en banc review.

47 thoughts on “Therasense v. BD: En Banc Support from Law Professors

  1. On the materiality prong, Digital Control held that any standard of materiality could be used. It’s just that the reasonable examiner standard is the broadest in most cases. So no split there.

  2. For example, we could argue with some force that the doctrine of unclean hands is a doctrine originating in England, but the English court do not impose on applicants draconian disclosure requirements.

    The difference would appear to be that the UK Patent Office doesn’t have a sign saying “please wash hands”.

  3. Why do we need a statutory fix? This can be fixed by the courts alone once it is recognized that the patent office has no substantive rule making authority.

    Furthermore, recognizing the harm the mere presence of Rule 56 has caused the US patent system, the PTO should simply repeal the rule. The doctrine of unclean hand could then operate normally and not be bound by Rule 56 and its interpretation by the patent office.

    For example, we could argue with some force that the doctrine of unclean hands is a doctrine originating in England, but the English court do not impose on applicants draconian disclosure requirements. Rather, it appears, that unclean hands requires a showing of a willful intent to obtain an invalid patent claim that was, in fact, successful. The showing of unclean hands in obtaining an invalid claim could then be used to withhold relief from related claims and related patents regardless of their validity as the Supreme Court did in Keystone Driller.

  4. 2. If a reference is cited by one patent office it must be disclosed to the other patent offices or the patents are invalid period.

    — even if the failure to do so was an oversight, Alan?

    — even if an equally pertinent reference was already of record in the other patent offices?

    Yep. Because once this rule is in force no patent attorney would ever dare not review the files for what was said to other patent offices when preparing a response. There would be no excuse for “oversight” or “equally pertinent reference”.

  5. 6, I believe you’re a USPTO examiner? Are you one of the ones that complains about the huge number of references that applicants dump on you, which are often probably not very relevant?

    If so, I sympathise. I can understand that it makes your job harder.

    However, there is a reason why applicants send them to you. The defence attorneys in the case I referenced were fishing for any slightest suggestion that I might have missed sending the examiner something, no matter how irrelevant. Had they found one, they would have gone to town, dressing it up to make it appear far more relevant than it really was.

    And if I’d tried to help the examiner by saying which references were most relevant and why, then they’d have gone to town on that too, trying to make out that I was misleading him.

    Believe me, I’d like to help you and make your life easier. It’s what I do for EPO examiners, for example. If I know of a better reference than the one they are using, I’ll send it in and explain it. If I don’t know of any better reference, I won’t bog them down with piles of less relevant stuff. This helps them do a good job, and it therefore helps me get strong European patents.

    But in the USA, trying to help the examiner is just not safe. I’d like to cooperate with you and help you do a good job, but as the law stands I can’t. Tell your Congressman that the law on IC is a mess and needs sorting out.

  6. IPman, I hear that fraud is one of the deeper lvls of he ck. God will know even if the other attorneys do not.

    Have fun sleeping.

  7. The defendant’s attorneys should also explain upfront in their pleadings why they believe the the alleged omission or inconsistent statement was made with intent to mislead or deceive. And not just an inference that there must have been such an intent because the reference was so material. The pleadings should cite genuine evidence of intent, perhaps based on something that has come out during discovery.

    On the occasion that I personally was alleged to have committed IC, the defendant’s attorneys conducted a fishing expedition for a long period of time, before eventually they quietly dropped the issue. They never did have a shred of evidence, but just hoped that something would come out of the woodwork if they shook it hard enough.

    OK, you can say that I and my client prevailed on the IC issue in the end, but it was a huge strain and waste of resources. Pure litigation tactics, and one of the things that is wrong with the US litigation system.

  8. I think that it should be OK to allege IC PROVIDED THAT:

    1. The defendant’s attorneys MUST explain WHY the alleged omission or inconsistent statement is not cumulative to EACH OF THE information, including the patent specification, already cited; and

    2. If they fail, they would be subject to SEVERE consequences (after all, it is a violation of ethical rules to charge another attorney with IC without proper basis therefor.)

  9. Ned, is that it? All of it? I’m a bit disappointed. But never mind. Let’s drop it, shall we? We’re not really progressing, are we?

  10. Max, it has to do with claim construction in US courts. Individual terms are construed. These are part of claim elements, which together form the claim.

    Ned

  11. 2. If a reference is cited by one patent office it must be disclosed to the other patent offices or the patents are invalid period.

    — even if the failure to do so was an oversight, Alan?

    — even if an equally pertinent reference was already of record in the other patent offices?

  12. Ned, I’m a patent attorney. But I’m not a programmer, an EE or a biotech PhD. I don’t understand these “claim elements” you are going on about. If I don’t, neither will a jury member, no matter what the particle size of your granules. We both understand the very simple concept of “evidence-based” medicine, but a grasp of what this philosophy means in practice is way beyond the appreciation of most jury members, I suspect.

  13. Max, you got it. Small, easily digestible pieces. Rather that ask for a result that requires five to ten sequential logic steps, break it down. Ask the questions individually, in the proper sequence.

    Don’t ask does x reference anticipate claim 1. Ask instead about whether the x reference has the claim elements in dispute, element by element, with, of course, the proper construction of the claim element concerned given with the question.

  14. ping, I’m guessing that “granularity” in:

    “With enough granularity, juries can do a good job”

    means something like “condensing the entire information content of the brain of the PHOSITA into palatable, easily digested, bite-sized chunks”.

  15. Ned,

    I read your comment very slowly. But I’m having a little trouble with it. What do you mean by enough granularity? What makes the granularity enough? Do you mean granularity in the sense of “consisting of or appearing to consist of granules”? Or perhaps you mean that the enough is “finely detailed”? Thanks in advance for any clarification that you can provide.

    Cranky is the bomb!

  16. MaxDrei, you’d be surprised just how much a skilled patent judge can help determine the right result. He does claim construction, controls evidence and argument, and issue jury instructions. When the evidence is undisputed, he can issue summary judgments. When it is one sided, he can overrule contrary verdict.

    Patent issues can be broken down into small pieces where the jury can fully understand them. With enough granularity, juries can do a good job, and their verdicts can be analyzed to see if they followed the law.

    But, as I said, the infringer bar seems to want to avoid expert courts in favor less expert courts, which is understandable, for that will allow its attorneys room to roam, so to speak.

  17. Urkel, hike up those suspenders – the plague is not where the IC was found, it is where the IC is pled.

    My data indicate that, …there has been significant year-to-year growth in the percentage of cases in which IC is pled. See my article for the specific numbers.

    Chris, I am just too lazy to go looking. Why don’t you just post the numbers here?

  18. “The patent owner prevailed on the inequitable conduct issue in 46 of the 60 cases”

    So, 14 cases where inequitable conduct was found? Some “plague”.

  19. Ned, how much help can these expert judges deliver to a jury, stuck with the impossible task of understanding the evidence on which the finding of the facts depends? Isn’t this what is driving the craving to have the PTO settle the facts relating to validity, before ever the dispute arrives in court?

    Suppose one patent in every hundred that issues ever gets involved in an infringement action. Why have the PTO exhaustively determine validity, on every claim in all the other 99 issued patents. Is that a sensible use of precious resources?

    And if that’s not sensible, what then is to be done, to husband those precious resources more economically?

  20. MaxDrei, we have district courts in the US that expedite patent cases and whose judges are expert in patent law. The big companies do everything in their power to avoid these courts in favor of other courts that go slower, much slower, and whose judges are generally unfamiliar with patent law.

    So, don’t hold your breath. The last thing the infringement bar wants is a patent court with skilled patent judges and expedited procedures.

  21. NAL, I regret that my meaning failed to make its way across to you. I had thought that my:

    “…how does the American court decide competently (at first instance, where the facts are all found….”

    was clear enough to reveal that I was talking about fact-finding in the court, rather than at the PTO. I had thought that “the first instance” in this context meant “the instance where the litigation starts, the one before the appeal instance”. Doesn’t it? I’m confused.

  22. “How about reforming the way you do first instance patent actions?”

    MaxDrei,

    I believe what you are referring to is the execution of its duties by the Office.

    I agree with you.

    However, such reform in execution does not need legislative reform. The Office has the tools it needs in the law as it stands. The Office needs but to fix its own internal workings.

    When the definition of the problem resolves to having too many customers, the Duellist mindset perpetrates its penchant perversion.

  23. Dear All, your two contributors patent litigation the English way proceed on the basis that the judge is competent (in all senses of the word). Having then read Ned, what I’m thinking is that litigating a patent in the USA can never get anywhere near the English way. The judge hasn’t got a technical degree, hasn’t spent the previous 20 years as an advocate competing with other technically qualified barristers for commissions to argue patent validity cases, for clients who MUST be successful (whether asserting the patent or destroying it) by any means the law allows.

    Such people, when they get elevated to the bench, are in no mood for hanky-panky, and have the clout to deal with it when they detect it.

    Whereas, in the USA, it’s responsibility shared, between judgee and jury. Two stools anybody; falling between, anybody?

    And another thing. When the issue is one so abstruse that only two professors of chemistry can argue it satisfactorily, how does the American court decide competently (at first instance, where the facts are all found) which of them has “the better view” of those facts?

    So, Ned, I’m not at all sure it’s fair to lay the blame at the doors of the USPTO, or the Federal Circuit, or SCOTUS. How about reforming the way you do first instance patent actions?

  24. Paul Cole 1. Clearly, English law is where the US law ought to be. Where we go wrong is by allowing the USPTO to make rules about a “duty of disclosure” and then having the courts actually enforce those rules via equity. The rules then have the force of law.

    The duty imposed by the Supreme Court to the PTO is not one of disclosure, but one of candor. The inquiry should always be did we tell the truth. We should apply general principles of equity at all times in these inquiries.

    What we need for the Federal Circuit to do is make a clean break from Rule 56 and declare, once and for all, that the USPTO cannot legislate substantive law.

  25. It is sometimes good to sort out the ratio decidendi of a case.

    What went wrong for the patentee in Therasense is inconsistent statements. One of them, possibly, was what we folk in England call pork pies. In the US, it may be, but I don’t know, that on the basis of the pork pies, a patent was obtained. The vice was not failing to disclose documents in a European file. It was making inconsistent statements and getting caught. The fact that the inconsistent statement turned up in the prosecution history of another European application is irrelevant – it does not matter where it tuned up but instead what matters is that there was an inconsistent statement which indicates that representations made to the USPTO were false.

    What would happen in an English trial? One way or another the inconsistent statement would be put to the patentee’s witnesses in cross-examination. If the pork pie was sufficiently serious as to undermine the basis of the patent, then the patent would be revoked. If it was not that serious, and there was a good invention after all, then the patent would probably be maintained.But telling pork pies to get a patent runs the risk that the judge will get angry, and if he can then find a pretext to hold the patent invalid, he may do so. It is doubtful whether the character and attitudes of judges differ that much from place to place in those countries which have a good legal system.

    On the whole, though this seems something which you folk in the US need to sort out. So the initiative is welcome

  26. Just Visiting: “Actually, what the ROW does not have is a rule 56 like duty of disclosure, so that mere failure to submit a reference or information cannot count as fraud.

    Quite right.

    But few jurisdictions tolerate deceit. I suspect that none of those jurisdictions would tolerate the submission of declaration full of lies in order to get a patent.”

    I wouldn’t be so sure.

    Here’s my prediction about what would happen if such a case was litigated in the English Patents Court.

    1. The court would form its own independent view on whether the patent was valid or invalid.

    2. If the same lies were advanced in court, the patentee would likely be found out and there might be a question about perjury. To that extent, the court definitely wouldn’t tolerate deceipt.

    3. Err… but otherwise, that’s it.

    Would the court take any notice of what happened in the US application? No, that’s irrelevant.

    Would it take any notice of the arguments advanced to the EPO during the application process? No, there is a long tradition in the English courts of ignoring the prosecution history when deciding the validity of a patent. They judge the patent as it stands, in the light of how the skilled person would construe it as written, and against whatever prior art the defendant raises in the case in suit.

    If the court finds the patent invalid, then it may permit the patentee to amend it, narrowing it to cure the invalidity. That’s at the discretion of the court.

    At one time, discretion to amend would typically have been refused if the court felt the patentee didn’t have clean hands or should have made the amendment earlier. So I suppose that misbehaviour in the EPO could have been brought up at that stage, with the result that the invalidity would be incurable.

    However, that practice was changed by the Patents Act 2004. Now the English court is to have regard to the principles adopted under the EPC when considering amendments. The EPC has no requirement for clean hands before permitting amendment.

    So if there were lies or misrepresentation during the prosecution (in the US or the EPO) then I suppose that the only problem for the patentee would be if he called the same witness in the court action. Any contradictory statements would no doubt be brought out in cross-examination in an effort to weaken his credibility.

  27. Just Visiting writes:

    “But few jurisdictions tolerate deceit. I suspect that none of those jurisdictions would tolerate the submission of declaration full of lies in order to get a patent.”

    Just, what do you think might actually happen, in any one of those jurisdictions, when their reserves of tolerance are exhausted? Has it happened yet, anywhere? EG and others will be interested to know.

  28. Very interesting discussion. I’d like to weigh in on a couple of issues that have been raised.

    1. On whether there is a “plague” and what the data shows, I have made some effort to quantify the prevalence of inequitable conduct at both the pleading stage and the Federal Circuit ruling stage. My results are set forth in my recent article, published in the Berkeley Tech. LJ. My data indicate that, although the ratio of patent cases filed to CAFC rulings of inequitable conduct has remained pretty low and constant, there has been significant year-to-year growth in the percentage of cases in which IC is pled. See my article for the specific numbers.

    2. Caesar, thanks for the suggestion about using footnotes in briefs. I’m curious to hear the basis for your suggestion against using them. Byran Garner, who has written a lot on legal writing style, advocates the format used in this brief. I’ve experimented with it in appellate briefs over the past several years and have come around to Garner’s viewpoint.

  29. Based on Keystone Driller, those who seek equity must come into court with clean hands. The case involved the intentional suppression of prior invention to courts, with an observation that the prior invention was also not disclosed to the USPTO.

    The original rule 56 noted the duty of candor and good faith — from Keystone Driller. Then the rule imposed a disclosure requirement.

    Over the years, the disclosure requirement has overtaken us — so much so that we have forgotten the original purpose for the requirement, and have extended the duty of disclosure without regard to the underlying rational for rule 56.

    In the present case, if the statements made to the USPTO were literally correct; the holding amounts to a finding that a US patent is unenforceable because of misstatements made to foreign patent office. On its face, this is nonsense.

    We have lost our way. Think, people, think.

  30. If I am reading the patent statistics from patstats.org of the University of Houston Law Center correctly then:

    For cases in which there was a decision in 2008: 93 patents were alleged unenforceable due to inequitable conduct. The patent owner prevailed on the inequitable conduct issue in 46 of the 60 cases (where some cases addressed multiple patents).

    For cases in which there was a decision in 2009: 38 patents were alleged unenforceable due to inequitable conduct. The alleged infringer prevailed on the inequitable conduct issue in six of the 34 cases (again where some cases addressed multiple patents).

  31. “that would “harmonize” us with the ROW which has no such “plague.”

    Actually, what the ROW does not have is a rule 56 like duty of disclosure, so that mere failure to submit a reference or information cannot count as fraud.

    But few jurisdictions tolerate deceit. I suspect that none of those jurisdictions would tolerate the submission of declaration full of lies in order to get a patent.

    I’m not convinced that Therasense case involved a declaration full of lies submitted with the intent to deceive the office. But that said, anytime your own patent (even a foreign one) is being used as a reference, IC alarm bells out to go off every time you make statements characterizing that patent. Perhaps the lesson here is to be extra careful in those situations.

  32. One note about the amicus. Next time try not to use footnotes. It’s not a law review article. And if you don’t think it makes a difference, you haven’t been a judge or a clerk.

  33. MM,

    A very civil response and debate. I too apologize for my snippty comment. IC is a real “hot button” with me. Let’s leave it at that and move forward. Peace.

  34. EG You’ve obviously never been accused of IC, otherwise you wouldn’t say what you said. (Or may be you would anyway.)

    My earlier comment was too ornery. I apologize, EG. But your comment was inane.

    You are correct that I’ve never been accused of IC but it’s hardly “obvious” based on my comments. It’s “obvious” because the number of prosecutors accused of IC is small.

    I could turn the tables and state that “It’s obvious that anyone who goes on and on about how terrible IC is has probably been acccused of IC.” That’s probably far more accurate.

    At some point, after you’ve prosecuted enough patents, the odds increase that a patent you’ve secured will be held up to scrutiny and something “fishy” will be found (but the odds are still very small, unless you’ve been consistently sloppy). I would not be shocked if it happened to me at some point. Why would I be surprised? I’ve been on both sides of patent litigation. It’s bloodsport. All sorts of accusations get thrown around and most of them don’t stick, including some that should. Why would I let it bother me?

    We just have to do our very best to keep your nosse clean without being silly about it.

  35. “You have issues, EG. Work on them.”

    MM,

    I already have but you obviously like living in your “Alice in Wonderland” world of patent practice. That you won’t even address the reality of the “plague” that IC is speaks volumes.

  36. You’ve obviously never been accused of IC, otherwise you wouldn’t say what you said. (Or may be you would anyway.)

    I stopped reading your comment at that point.

    You have issues, EG. Work on them.

  37. If, as implied in your last paragraph, you believe the plague is actualy the decorum of patent practicioners, then I bet more than one person on this board may take offense to such a broad, sweeping accusation of the profession.

    I didn’t make a “broad, sweeping accusation of the profession.” Look, there are large numbers of prosecutors out there. Given the stakes involved in obtaining patents (period), the temptation to play “fast and loose” before the PTO is necessarily going to be irresistable to many practitioners. Not just one or two but hundreds, at least. This is not a “smear”. It’s just reality. It’s the reality that you and I live in. Human nature and all that.

    The idea that patent prosecutors and their clients are somehow the most honest people on earth is laughably absurd.

    The plague is the repeated assertion of IC by those that have no other basis for invalidity other than stretching the limits of the multiple standards of IC.

    Now that would be an interesting statistic: how often is IC the only defense raised in an infringement case?

    By the way, I guess I will be the first to note on this thread (someone has to do it in every IC thread), that a successful IC defence does not render the patent invald but rather unenforceable. An easy distinction to blur and I’ve done so myself on more occasions than I can count.

  38. “It’s not a plague or a scourge. It’s a defense in patent infringement and one that it is upheld very rarely because it is difficult and expensive to prove.”

    MM,

    You’ve obviously never been accused of IC, otherwise you wouldn’t say what you said. (Or may be you would anyway.) As one who has been deposed for alleged IC (that wasn’t proved), I can tell you it isn’t fun and is a “plague” and a “scourge.” Also, in the “bad old days,” just an allegation of IC in a patent suit would draw a threatening letter from the OED. Or doens’t your involvement patent practice go back that far?

    IC is simply a patent litigator’s “gravy train” and a patent prosecutor’s “nightmare.” So let’s harmonize with the ROW and get rid of IC, once and for all.

    Also, if we’re going to call this thing “inequitable conduct,” then why not impose an “equitable remedy” such as paying the attorney fees required to prove the IC, rather than the “draconian remedy” of complete unenforceability of a patent would otherwise be patentable on the merits? Again, what IC has become is vehicle for taking a patent down, not on the merits of whether the claimed invention is patentable, but how the patentee, inventors, etc., conducted themselves during patent prosecution which may have nothing to do with the merits. And unless there is also strict enforcement of FRCP 9, IC will continue to be alleged in over 80% of the patent infringment actions suits (as it has been in the past). That IC is “rarely upheld” as you allege does not address how costly it is to defend against an allegation of IC which is present in over 80% of the litigated cases, and which also “rarely” results in an “exceptonal case” finding under 35 USC 285 when not “upheld.”

    Alan,

    Per se rules like you suggest are also a really bad idea especially as the remedy you propose is again not “equitable” but simply “draconian.” In fact, these per se rules have all the mark of the “Alice in Wonderland” world of antitrust. Let’s face it, those who try to obtain patents aren’t usually the “bad guys” they’re painted to be when IC is alleged in a patent lawsuit. You’re proposed “per se rules” also don’t address whether the patent or at least certain claims in it wouldn’t have been obtained on the merits but for the alleged misconduct. Let’s make the validity of the patent stand (or fall) on the merits, not merely the alleged misconduct of those who obtained the patent

  39. Isn’t the real idea in Therasense about alleging a material fact in an affidavit (which was use as the basis of allowing a case) which is inconsistent with a factual position made to the EPO, the problem?

    Thersanse does not overrule the established principle that a party, as an advocate, can have legal positions which are inconsistent, especially between different countries.

    Isn’t it reasonable to conclude that it was the actual conduct of the attorney and the head researcher that caused the problem of IC in the first place?

    That is, even if Applicant cited the EPO actions to the Patent Office under 1.56, the court would have called BS because of the conduct of Abbott?
    Wouldn’t it have made more sense for the court to go into the evidence issues underlying the circumstances behind the inconsistent positions of fact (especially with the filing of an affidavit, which is a representation of fact), instead of whether or not the EPO prosecution was cited?

    Right result, wrong rationale.

  40. Isn’t the real idea in Therasense about alleging a material fact in an affidavit (which was use as the basis of allowing a case) which is inconsistent with a factual position made to the EPO, the problem?

    Doesn’t Thersanse also not overrule the established principle that a party, as an advocate can have legal positions which are inconsistent, especially between different countries?

    Also, isn’t it reasonable to conclude that it was the actual conduct of the attorney and the head researcher that caused the problem of IC in the first place.

    That is, even if the EPO action and arguments were cited to the Patent Office under 1.56, the court would have called BS because of the conduct of Abbott?

    Wouldn’t it have made more sense for the court to go into the evidenary issues underlying the circumstances behind the inconsistent positions of fact 9especially with the filing of an affidavit, which is a respentation of fact), instead of whether or not the EPO proseuction was cited?

  41. As usual, I’ll take the other side.

    Let’s have some per se rules.

    1. If you tell the PTO a reference says X and tell the EPO the reference says Y both patents are invalid period, unless the inconsistent positions are identified to both offices.

    2. If a reference is cited by one patent office it must be disclosed to the other patent offices or the patents are invalid period.

  42. @ mooney

    The plague is the repeated assertion of IC by those that have no other basis for invalidity other than stretching the limits of the multiple standards of IC.

    If, as implied in your last paragraph, you believe the plague is actualy the decorum of patent practicioners, then I bet more than one person on this board may take offense to such a broad, sweeping accusation of the profession.

  43. EG If IC isn’t ditched, the next best alternative is to make the “intent” standard one of “deliberate misrepresentation” … of the alleged “material fact.” That would or should avoid what happened in Therasense

    There’s actually some far more effective that can be done which would avoid what happened in Therasense: if you find yourself having multiple meetings with your co-workers and/or client to discuss what to do about statements that were made before the EPO that are no longer helpful to you and are potentially harmful, please open the window and let some oxygen into the room. Then breathe deeply and make sure whoever is charge of prosecuting the US case makes a note to disclose the reference, whatever strategy is ultimately decided upon.

    It’s really that easy.

    As for McKesson, that was a much closer case than this one, it appears, and I believe was lost in part because the prosecutor (whose name everyone remembers — not) was an especially poor witness.

    Nothing else is going to remove this “plague” and scourge from the patent system.

    It’s not a plague or a scourge. It’s a defense in patent infringement and one that it is upheld very rarely because it is difficult and expensive to prove. The vast majority of instances of inequitable conduct before the PTO are never identified, and in the rare cases they are identified, there are no legal consequences for the perpetrator(s). I’ve asked the question hundreds of times but : where is the list of practitioners barred or suspended from prosecuting because of inequitable conduct before the PTO? If this plague is real, the list must be growing quite fast.

  44. I thank all the professors for their efforts to bring reasonableness into the entire concept of inequitable conduct.

  45. As I’ve said before I would be fine if the whole concept of inequitable conduct were completely ditched (but that would likely require legislative enactment as SCOTUS and the Federal Circuit are unwilling to do so by court decision); that would “harmonize” us with the ROW which has no such “plague.” The SCOTUS view of “uncompromising duty of candor and good faith” is unworkable, unrealistic, and illogical. As even admitted by the Federal Circuit in Digital Controls. there are at least 4 different standards for judging IC, none of which the Federal Circuit has been clear about as being “the standard” other than to say that USPTO’s Rule 56 standard isn’t it. IC remains a trap for the innocent and a litigation “money sink” that only litigators can love.

    If IC isn’t ditched, the next best alternative is to make the “intent” standard one of “deliberate misrepresentation” (I wouldn’t mind it requiring proof “beyond a reasonable doubt”) of the alleged “material fact.” That would or should avoid what happened in Therasense, as well as that “horror of horrors,” McKesson. And frankly, the Federal Circuit needs to “put up or shut up” about IC being a “plague” by strictly enforcing the “intent” and “materiality requirements, as well as liberally granting those accused falsely of IC attorneys’ fees under 35 USC 285. Nothing else is going to remove this “plague” and scourge from the patent system.

  46. CM Two of the five findings pertained solely to the materiality of the nondisclosed information; however, Star Scientific holds that “materiality does not presume intent.” One finding of the five was merely that the individuals knew the information and did not disclose it; again, this is not the standard for intent under Star Scientific. And the last two findings were that the individuals’ testimony should be rejected as not credible; these findings failed to address the single-most-reasonable-inference test set forth in Star Scientific.

    My understanding of the District Court and the appellate court’s reasoning was that the plaintiffs failed to provide a reasonable explanation for their failure to disclose to the Examiner their contradictory statements before the EPO. Among other facts, the Judge noted a substantial lack of credibility on the witness stand, based in part on their demeanor.

    I agree that Star Scientific is a troubling case but that’s because, when blindly applied, it could be used to excuse just about any deceptive behavior. A much better case for revisiting Star Scientific would be one in which, e.g., Judge Linn overturns a finding of inequitable conduct because the defendant failed to provide a signed statement from the applicant that he/she intended to deceive the PTO. At the (improper) extreme, that is what Star Scientific would appear to require for inequitable conduct to hold if virtually any post-hoc excuse for failing to disclose a reference trumps all other evidence showing deceptive intent.

    in Therasense, the majority applied the 1992 version of Rule 56 as the test for materiality.

    Presumably that is because both parties agreed that this was the proper test. I don’t see the dissent arguing that this test was improper. Does it make any difference which test for materiality was used in this case?

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