Aventis v. Amphastar Pharmaceuticals and Teva (Fed. Cir. 2008)
Summary: The CAFC affirmed a ruling that the Lovenox patents – owned by Aventis – are unenforceable due to a failure to submit important experimental information during prosecution. In dissent, Judge Rader could not find clear and convincing evidence of intent to deceive the PTO.
Inequitable Conduct: The Aventis patents are directed toward a heparin based drug used to help prevent blood clots. The specification includes a particular set of experimental examples that show an increased half-life of the claimed admixture. During prosecution, the applicant used those examples along with additional data to prove that its drug was inherently different from a prior art drug.
Aventis did not report to the PTO that its experiments showing an increased half-life of the claimed admixture used a different dosage than those testing the prior art drug. In a non-precedential 2006 opinion, the CAFC found the withheld information was material to prosecution — especially because Aventis argued that the benefit of the longer half-life was a potentially lower dosage. [non-prec decision].
By itself, a material omission does not render a patent unenforceable. Rather, a defendant must also show that the patentee acted with intent to deceive the patent office. The district court found intent through circumstantial evidence, and the CAFC affirmed after failing to find any clear error in the way that the district court interpreted the facts.
Dissent: In a strongly worded dissent, Judge Rader argued that inequitable conduct should only be found in “extreme cases of fraud and deception.” In particular, Judge Rader has seen that the intent requirement has lost its import as the court increasingly allows intent to be inferred from loose circumstantial evidence.
“More recently, however, the judicial process has too often emphasized materiality almost to the exclusion of any analysis of the lofty intent requirement for inequitable conduct. Merging intent and materiality at levels far below the Kingsdown rule has revived the inequitable conduct tactic.”
Here, Judge Rader argues that there is also compelling evidence that Aventis did not intend to deceive the patent examiner. For instance, Judge Rader noted that that Aventis actually “submitted all of the underlying data to the patent office with [its] second declaration on June 9, 1994.” Furthermore, focusing on the Aventis scientist who submitted the half-life studies, Judge Rader noted that his stellar reputation should also sway the court:
“I find it difficult to fathom that a scientist of Dr. Uzan’s caliber and reputation would engage in such deception. As the district court points out, Dr. Uzan has had a magnificent fifty year career with Aventis, has published over 350 scientific articles and has received numerous prestigious awards including the Galien Research Prize, France’s highest award for drug discovery. This world-class scientist would hardly risk his reputation and tarnish his brilliant career for a single example in the prosecution of a patent for an invention in which he was not even involved.”.
Result: The direct narrow result of this case is that patent applicants should clearly state experimental differences when comparing a claimed compound or method with the prior art. More broadly, this decision creates yet another reason for applicants to favor short & clean prosecution. It also emphasizes the importance of using a patent attorney or agent that truly understands the science behind each submission.
GP:”Awe shucks, you remember me?”
Somebody: Yes. We remember you. We remember that you announced that you were so busy it was going to prevent you from posting for a while. Yet you keep posting.
Holy cow man! Even I don’t remember posting that!
“You don’t even state that my conclusions are wrong…”
If it’s a bad argument, the conclusion is irrelevant. I thought you said you knew how to argue?
“Awe shucks, you remember me?”
Yes. We remember you. We remember that you announced that you were so busy it was going to prevent you from posting for a while.
Yet you keep posting.
BigGuy: “In other words, “to heck with any real analysis, let’s just jump to a conclusion that squares with my pre-determined worldview.””
As I stated, I am a practising chemist, not an attorney, but that certainly doesn’t mean that I don’t know how to argue or recognize a bad arguement. I certainly was not jumping to any conclusions, but was basing them only on what I had read in this blog, assuming that DC is able to accurately sumarize the aspects of the case. Your criticism is hardly unique as I’m sure that I could pick through the CAFC’s opinions to find support for my conclusions (as well as the opposite conclusions too given that there was dissent). Your rebuttal did nothing to advance the discussion. You don’t even state that my conclusions are wrong, but just nitpick that I took the wrong process to get there, something that I had already noted in my initial disclaimer.
The “Polluter Pays” principle is a fine one. If most of the IC defences are without merit, they are a form of pollution of the patent litigation system. So, how about making the polluter pay, in a quantum determined by the court, in an award of costs against the polluter?
Let’s assume something like the following numbers:
>95% of litigated patent cases include allegations of inequitable conduct
< 1% of litigated patent cases include a finding of inequitable conduct (These numbers are total guesses on my part. If anyone has real statistics, that would be most helpful. It would be interesting if the real numbers were greatly different from these guesses.) Of course there's going to be "different planets" viewpoints if there is a yawning chasm between allegations of IC and findings of IC. The prosecutor bar sees a situation where practitioner ethics is unjustifiably smeared as a matter of routine litigation strategy, while the defense bar sees a situation where only a small fraction of IC is actually caught in litigation (e.g., if the number of IC patents is more like 5-10% of patents in litigation, which would not be too surprising). It's not easy to see how to fix this situation. The obvious compromise is to sanction frivolous allegations of IC in combination with making real IC easier to prove. However, "frivolous" vs. "real" isn't going to be settled any time soon. It may be better to eliminate the IC defense entirely, if there is no sensible way to reform it.
Somebody wrote: “GP, or Gideon, or Gideon Pope, whatever he’s calling himself these days, needs to go back on his lithium.”
Awe shucks, you remember me?
Reminds me of that fantastic line from Pirates of the Caribbean . . .
“You are the worst [patent attorney] of whom I have ever heard.”
GP: “Yes, but you have heard of me.”
Anyone have statistical info on Fed Cir “inequitable conduct” rulings since Kingsdown?
GP, or Gideon, or Gideon Pope, whatever he’s calling himself these days, needs to go back on his lithium.
GP: The question is whether intent should be an element of inequitable conduct, or whether we should just ignore intent and let it travel along with materiality.
You describe situations where intent is clear, and then lambast people that would defend those who deceive with intent. I haven’t seen anyone here defend those who deceive with intent, so your rant is entirely inapplicable. But tell us how you really feel about it.
“Patent attorneys who lambaste the ridiculously low IC standard that we have today are just self-centered j@ckasses playing an inside game.”
I think most practitioners complain about the standard for finding intent in court and not about what kind of behavior is inequitable. In cases where we all agree about intent, I doubt many of us would disagree on what the result should be. But we probably disagree widely on what we believe happened in this case.
I don’t really have any heartburn with people who believe that the Dr did withhold with intent, but I don’t think the aspersions cast on those who believe otherwise are warranted.
IC – another law/equity anomaly unique to patent law. What other jurisprudence allows a finding of ‘intent’ -mens rea – without a jury. Since, according to CAFC, this is pure equity relief – RADER is correct to delineate – on the case by case basis – a high standard for what is after all the extraordinary remedy of equitable relief.
“I didn’t read anything but Dennis’ (EK6,MM) review, so I may have missed something… And what you have is a clear case of people trying very hard to obtain a patent inequitably.”
“I have not had time to read either opinion or the patent, just the summary provided by DC and the comments … the applicant has received a patent without giving up anything of importance i.e., they are keeping the advancement as a trade secret.”
In other words, “to heck with any real analysis, let’s just jump to a conclusion that squares with my pre-determined worldview.”
If something were left out of the disclosure, the proper thing to do would be to invalidate the patent under 35 USC 112. That’s not what happened here. What’s alleged here is that information contradicting an argument to get the claims allowed was withheld.
Assuming that the patent could not be invalidated based on that omitted data, I think intent should play a role.
Marvin, somehow you managed to miss or distort every point made in my comment. Congratulations!
I didn’t read anything but Dennis’ (EK6,MM) review, so I may have missed something.
But assuming that DC’s review is faithful, then it’s really simple . . .
Any stooge who managed an “A” in chemistry 101 could figure out that omitting a difference in dosage in an example, with the claimed invention having a larger dosage, and then pointing to the example and arguing that the effectiveness of the claimed invention compared to some prior agent is superior and could lead to lower dosages in practice is . . .
flatly misleading.
So now you take a competent PhD or three, a competent patent attorney or two, and you give them a couple of years of prosecution to repeatedly reinforce the error that they originally made, and?
And what you have is a clear case of people trying very hard to obtain a patent inequitably.
As a practitioner, I’d like to add that I’m embarrassed that so many members of the patent bar believe that the correct standard for inequitable conduct should be only when an inventor or practitioner is caught breaking into the PTO – these self-serving m0r0ns are no better than the cop unions that have the “cooling off rule” whereby after any shooting or other incident in which a citizen is killed or injured, the cops who did the damage or killing can’t be interviewed for several hours and, in fact, are left together.
I despise inside games.
Patent attorneys who lambaste the ridiculously low IC standard that we have today are just self-centered j@ckasses playing an inside game.
They submitted selective information.
They left out a critical comparative element.
They argued, repeatedly, a point of patentability that would have been directly refuted by the omitted element.
They got the patent issued.
Inequitable conduct.
We need to raise the bar, not lower it.
I’m not an attorney, but a practising chemist, so you are forewarned about the following. Additionally, I have not had time to read either opinion or the patent, just the summary provided by DC and the comments – (my bad, I know), but it seems here that if something this relevant was left out of the publication, it would be impossible for a PHOSITA to see what the improvement was over the current art AND that it would be impossible to duplicate such an improvement. Lacking these critical teachings, the applicant has received a patent without giving up anything of importance i.e., they are keeping the advancement as a trade secret.
The fact that a distinguished scientist was involved is even more compelling: I would hold him to a higher standard (i.e., he should know better that something was missing) than a novice who can’t tell the difference between an Erlenmeyer flask from a Dewar flask.
I would submit that had this occurred in a submission to a technical journal, a full retracion would be likely, and/or a guaranty that all future submissions would be scruitnized in full detail, assuming that the referees hadn’t rejected it as being of dubious validity.
Personally, I don’t see that intent should have anything to do with it. Society is trading a patent for the teachings. No teachings, no patent.
Just the naive ramblings of a PHOSITA.
Another reason Judge Moore should never have been appointed to the bench. I was one of her GMU students, and most of my classmates were amazed and appaled that she was appointed. She has no practical experience – how can she know what’s intentional and what’s just typical in the life of a patent attorney when she hasn’t practiced? Her opinions unfortunately drip with this kind of isolated intellectual/theoretical decisionmaking. Granted, she didn’t write this decision, but you can tell he had some influence in it.
I think the evidence strongly suggests that the Dr’s omission was at most negligent. Negligence shouldn’t be enough to make the patent unenforceable. However, the arguments that in the alternative the omission was not material might seem to undercut any argument regarding lack of intent, and the Federal Circuit had already ruled on that issue.
I think Rader was right concerning the finding of intent simply by finding materiality creates bad decisions. I don’t think Rader did a good job of making that point.
Malcolm “our country down the rathole where it presently resides”
I can’t imagine a more succinct way of summarizing your outlook on various issues.
This outlook in turn leads to the logic that if you have nothing to lose, there will be no barrier to committing fraud. As if being caught or possible repercussions are the only concerns. Ever here of integrity?
Your outlook also leads to the notion that being a “really smart scientist” means gaming the system to maximize your personal wealth – not advancing science.
Finally, if we are going to equate inequitable conduct with criminal behavior, shouldn’t we also import the “beyond a reasonable doubt” standard. Does anyone think that the behavior here meets that standard?
As is well known, the CAFC applies a much higher (stricter) standard for anything said in any EX parte affidavit or declaration used to obtain allowance of a patent (which it treats as an “affirmative representation”) than the CAFC typically treats merely unitentionally not citing a piece of alleged prior art. So declarations of any kind should be avoided whenever possible, which I think is part of what Prof. Crouch means by striving for a “short and clean file history. ” Unfortunately, that can be very difficult in certain arts. The [repeat] lesson in this decision is that what is NOT said in a declaration can ALSO be treated as part of an affirmative missrepresentation. Yet few patent application prosecutors o[ther than a few interference litigation experts] have experience in INTER partes [professonally challenged] affidavit preparation, or have them reviewed by such practioners before filing them. A patent application of sufficiently high value should be.
Wasn’t me: good point, but see p. 11 of the opinion: “this court did not accept the explanation that the half-life data were dose independent because the evidence clearly suggested otherwise.” Hmmmm.
I’ve just glanced at it, but doesn’t the result also follow from the “abuse of discretion” standard? So the Fed Cir should be congratulated for giving some weight to the fact-finding of the lower court, right?
“Though imo the penalty should be on the order of the amount the attempted extortion was to be for.”
As one of those greedy bloodsucking attorneys, I’d have to support that. Just figuring out that amount should take up about half my billables. It’s already expensive just to figure out how much existing and practiced patents are worth.
Hmmm, so you think that there would be higher standards invoked? Deal. Only the worst of the bad ones get it, but they get it good. Heck, just making it a felony with a penalty of 10$ would be enough to keep most goody goody white collars from doing this. Hard to get a good job with a felony on your record I hear.
Though imo the penalty should be on the order of the amount the attempted extortion was to be for.
“Malcolm: The reputation is material to deriving intent. You look at what he had to gain and lose”
Yes. As I said, the answer is that he had absolutely nothing to lose when he filed his carefully written declaration because nobody really gives a hoot about the bit players in these inequitable conduct cases. And who knows what he had to gain? If he was promised anything in exchange for the declaration, he isn’t likely to bring THAT up at a patent trial where — using your own logic — he has nothing to gain and everything to lose.
By the way, a really smart scientist doesn’t write or sign declarations for other people’s patent applications. A really smart scientist waits for a litigator to call him or her up to testify as an expert in a bitterly fought patent trial. That’s where the $$$ is and those previously filed declarations for one’s buddy’s application can end up biting one in the behind or, worse, preventing one from being hired by the trial team.
E6K:
You wish this were criminal, which would invoke high standards, a jury, etc. and suddenly all of your “bad guys” walk.
Malcolm: The reputation is material to deriving intent. You look at what he had to gain and lose; that is, if you’re even bothering to decide on intent. And most inequitable conduct doesn’t come out because most patents are never litigated so nobody looks that closely at them.
What’s funny is that the higher dose is probably not even material. Unless the dose is high enough to overwhelm the bodies capacity to metabolize the drug, the dosage doesn’t change the half-life of the medication. I don’t know the dosages or reaction rates at issue, but if it turns out the dosage difference was immaterial then they probably should have ensured that their patent litigator also understood the technology.
I think we should bring back public floggings for such transgressions. Or put a merciless, dogged policeman on the tail of the bread thief to hound him perpetually.
In all seriousness, although the emphasis in the previous few comments seems to focus on the reputation aspect of the dissent. To me more telling is the fact noted by Judge Rader that Aventis actually “submitted all of the underlying data to the patent office with [its] second declaration on June 9, 1994.”
It seems pretty clear that they were not “trying to pull a fast one” over on the PTO. Any (mis)information was corrected. Thus, the PTO actually had all of the necessary information before the patent was granted (independent of whether or not the information originally was omitted accidentally or purposefully).
As an an everyday joe locked up in an institution, I don’t care Malcolm. Frankly I never understood why there wasn’t stiffer penalties for things like this. I mean seriously, you can go to jail for stealing bread, how is attempting to extort thousands or millions of dollars from a corp any less bad?
As a patent prosecutor, I care, Malcolm.
Well, I agree with Paul Cole that the majority and dissent are on different planets. Judge Rader is apparently from the planet where elites with fancy credentials are somehow deemed morally superior to all those non-professionals who never published anything in a “real” magazine. That makes me sad because it is that attitude more than any other that led our country down the rathole where it presently resides.
Seriously, this parargraph is priceless in its silliness: “I find it difficult to fathom that a scientist of Dr. Uzan’s caliber and reputation would engage in such deception. …Dr. Uzan has had a magnificent fifty year career with Aventis, has published over 350 scientific articles and has received numerous prestigious awards including the Galien Research Prize, France’s highest award for drug discovery. This world-class scientist would hardly risk his reputation and tarnish his brilliant career for a single example in the prosecution of a patent for an invention in which he was not even involved.”
Five words: patent holder William French Anderson.
The fact is that a finding of inequitable conduct is still exceedingly rare, in spite of the fact that I (and many other attorneys I know) routinely find extraordinarly smelly declarations and clear examples of ball-hiding in patent prosecution histories where the prestigious “prize-winning” inventors, declarants or reputable prosecutors should know better.
Is Dr. Uzan going to prison? What does Dr. Uzan lose? Nothing. His reputation isn’t tarnished by this because (news flash for Judge Rader) most inventors and declarants do not lose much sleep over “inequitable conduct”. In their minds, that’s something that the lawyers will “take care of.” Shareholders might care, but for reasons that have nothing to do with the inequitable conduct. After all, the smart shareholders made their money after the patent issued then bailed out before the patent went up in flames. And the attorney covers his/her behind with an email to the client saying “I’m persuaded but I can’t promise you that a court will be.” Or something like that.
Remember HOFFMANN-LA ROCHE, INC. v. PROMEGA CORPORATION? What happened to the scientists “implicated” in that fiasco? Were they fired? Prohibited from filing declarations before the PTO? Or other patent applications?
In fact, nobody really cares. What people care about is whether more money was made while the patent was in force than was spent to acquire or prosecute the patent. That’s all.
CAFC 1
Bad guys: A billion
Oh well, making progress I suppose.
“This world-class scientist would hardly risk his reputation and tarnish his brilliant career for a single example in the prosecution of a patent for an invention in which he was not even involved.”.”
That part is probably true, I wonder if he did it more?
“More broadly, this decision creates yet another reason for applicants to favor short & clean prosecution.”
If only there were more such reasons.
As usual in this situation the majority opinion and the dissent live on different planets.
On the whole, though, properly designed experiments are preferable to questionable ones. The underlying message of Festo is that a patent has to be fit to place before a judge, and only those who have personal involvement in litigation fully comprehend the very high standards that this implies.
As usual in this situation the majority opinion and the dissent live on different planets.
On the whole, though, properly designed experiments are preferable to questionable ones. The underlying message of Festo is that a patent has to be fit to place before a judge, and only those who have personal involvement in litigation fully comprehend the very high standards that this implies.
Judge Rader’s dissent is right on the mark. Here’s seconding the hope that intent to deceive is put back into the inequitable conduct doctrine.
I really really hope that an actual intent to deceive is put back into the inequitable conduct law sometime during my career. I seriously doubt that any practicing patent attorney would have all of their patent held as enforceable under the current standard where intent to deceive seems to be assumed.
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