Don’t Let Experts Testify as to Obviousness

“The expert in a patent case can testify to the underlying facts in support of an opinion, just as experts in other types of cases can testify to underlying facts. An expert may talk about what is or is not disclosed in the prior art, for example, or how words are used in the technical area, or how a device operates. But the expert may not go the extra step and say that a claimed invention is obvious.”

When obviousness of a patent claim is at issue, some experts may opine along these lines: “Therefore, the subject matter of claim 1 would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art.”

Whether such is common practice or not, testimony of this sort ought not to be allowed. Such testimony should be objected to and stricken as irrelevant. In cases involving a jury, a motion in limine ought to be used to prevent such testimony from coming before a jury.

The Roles of Experts

Experts are fact witnesses that are, like all fact and other witnesses, allowed to testify to what they saw, what they heard, and what they did. Unlike other witnesses, however, expert witnesses are further allowed to express opinions within the fields of their expertise. Experts’ expertise comes from having specialized knowledge, education, training, or experience.

Regardless of their fields, experts’ expertise does not extend to questions of law. No witness, not even an expert, can render a legal opinion.

This principle of evidence finds application throughout the law. There are numerous civil and criminal cases in which experts were allowed to opine about the significance of various facts but were not allowed to opine that there was a legal violation, for example, or that a legal standard was satisfied. Fed. R. Evid. 702 treats experts as witnesses allowed to give opinions within their areas of expertise. Opinions about the law, however, are not specifically allowed by this rule. Although Fed. R. Evid. 704(a) says “An opinion is not objectionable just because it embraces an ultimate issue,” this does not mean that testimony about an ultimate issue of law is permitted.

There is some case authority permitting experts to testify on “ultimate” issues that involve legal standards. The touchstone for admissibility, however, is whether the testimony is helpful to the decision-maker, whether it be judge or jury. See the Notes of Advisory Committee to Fed. R. Evid. 704.

There are numerous reasons for disallowing expert testimony on legal issues.

1.   Expert Testimony Is Unnecessary.

Before any judicial or quasi-judicial tribunal, the law is presented to the legal decision-maker not from the witness stand but from counsel table. Briefs, motions, oral arguments, proposed jury instructions, and other advocacy vehicles are available for helping the judge identify and evaluate a legal issue. Admitting sworn testimony on a legal issue of American law is unnecessary.

2.   Many Experts Are Not Legal Experts, Anyway.

Many experts have no legal training at all, so testifying to a legal issue is beyond the range of the expert’s expertise.

3.   The Legal Decision-Maker Has A Monopoly as To the Law.

Questions of law are to be determined only by a tribunal, such as an appellate court, or a trial court, or the Patent Trial and Appeal Board. The tribunal, and only the tribunal, is empowered to address legal issues.

In a district courtroom, for example, the only person in the room empowered to determine legal questions is the person who sits on the bench.

Advocates cannot say what the law is. Advocates may argue as to what rules ought to apply or whether the law requires something or whether a legal standard is met, or whether a particular outcome ought to be reached; but their arguments are in no way binding upon the legal decision-maker.

A jury cannot say what the law is. In a jury trial, the jury must follow the law as instructed by the judge, and typically jurors take an oath or affirmation to follow the judge’s instructions.

An expert cannot say what the law is. If an expert were to testify to a legal question before a jury, then there would be a risk that the expert would misstate the law or otherwise interfere with the judge’s instructions. There is an unavoidable prospect for confusion where an expert espouses one standard and the judge instructs on another.

The prospect for confusion is not limited to jury trials. Even in the case of a bench trial, expert testimony about a legal question could lead to confusion or misapprehension of the proper legal standards. The same prospect for confusion also exists in a hearing before an agency.

It is sometimes said that the problem with expert opinions reciting legal conclusions is that they infringe upon the function of the jury. Actually, the problem with expert opinions on issues of law is even more basic than that.

Such opinions are, quite simply, not relevant.

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Obviousness Is an Issue of Law

Obviousness is an issue of law. E.g., In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1373 (Fed. Cir. 2016). As a matter of principles of evidence, experts are not allowed to testify as to issues of law. There is no exception to this principle in patent law. Accordingly, an expert ought not to be allowed to express an opinion as to whether something is obvious or not.

To be sure, the expert in a patent case can testify to the underlying facts in support of an opinion, just as experts in other types of cases can testify to underlying facts. An expert may talk about what is or is not disclosed in the prior art, for example, or how words are used in the technical area, or how a device operates. But the expert may not go the extra step and say that a claimed invention is obvious. To do so would be to express an opinion on a legal issue.

The Millennium Case

The case of Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356 (Fed. Cir. 2017), shows that expert testimony on obviousness is irrelevant. The Millennium case also demonstrates the pitfalls of what happens when expert testimony improperly strays into such legal questions. (The Millennium case is also notable for its discussion of inherency as it relates to obviousness.)

The Millennium case involved a pharmaceutical patent that had been challenged in district court as obvious, and the district court invalidated the claims in question on obviousness grounds.

The Federal Circuit determined there was a legal error in the district court’s determination. Without going into the highly technical details of what was missing, there was no evidence supporting motivation to make the claimed invention, nor any indication in the prior art that the invention could be made.

In short, the prior art had at least one evidentiary “gap” in it, and the gap was fatal to a determination of obviousness, as a matter of law.

And yet, there was considerable testimony in the record that the compound was indeed “obvious.” In particular, expert testimony had been admitted——from not one but from several experts——that the compound was obvious in view of the prior art.

The district court gave the expert testimony considerable weight and agreed that the compound was obvious.

On appeal, the Federal Circuit had this to say about the experts’ testimony: “None of the experts presented by the many defendants stated that they were aware of prior art to fill any of the gaps in teaching or suggestion of the [patented] product——although they variously opined that this long-sought discovery was obvious.”

Arguments were made by counsel that the prior art did show those things that were thought to be missing. Arguments of counsel are not evidence, of course; and when pressed, the experts themselves were unable to identify where the references disclosed those missing things.

In the end, the Federal Circuit gave these expert opinions on the issue of obviousness no weight or deference at all. The opinions made no difference in the outcome.

The expert opinions on the issue of obviousness were, quite simply, irrelevant.

What Does the Millennium Case Mean?

The Millennium case highlights the evidentiary significance of expert testimony in several respects.

1.   Expert Testimony Is Not Prior Art.

At the risk of venturing into tautology, only prior art is prior art. Experts cannot in general pass off their present-day opinions as time-of-filing (or time-of-invention) prior art.

2.   Expert Opinions May Not Fill in Evidentiary Gaps.

Of course, the prior art that forms the bases for an expert’s opinions is prior art and is always fair game for a challenge. In the Millennium case, the prior art was challenged, and there were gaps to be found in it. It was clear error for the district court to conclude that there was obviousness, with such gaps present in the evidence. The experts opined that, in spite of the gaps, there was obviousness anyway. The Federal Circuit determined that this expert testimony did not matter one bit, effectively saying that expert testimony cannot fill in gaps in the prior art.

In other contexts, the Federal Circuit has recognized the principle that technical expertise is not a substitute for prior art evidence. See, e.g., In re Lee, 277 F.3d 1338, 1344-45 (Fed. Cir. 2002) (agency expertise is not evidence, and cannot serve as a substitute for evidence). The Millennium case suggests that a similar principle applies to expertise of outside experts as well, and that this principle applies in adversarial proceedings.

3.   The Potential for Confusion Is Quite Real.

Expert testimony about obviousness could lead to confusion or misapprehension of the proper legal standards, and in the Millennium case, that very thing seems to have happened.

Indeed, the expert testimony apparently had a profound effect upon the district court. The district court’s written decision made special note of one of the experts, Dr. Repta, who opined how a person of ordinary skill in the art “would have found the claims obvious based on the art described.” The judge was explicit in his reliance upon this expert: “The court finds that the testimony of Dr. Repta is persuasive and supported by the evidence.”

The Federal Circuit’s Millennium opinion, however, demonstrates that the experts did not understand the proper legal standards, because they concluded that the claimed invention could still be obvious in spite of fatal gaps in the prior art evidence. This was not a factual error; it was a legal error. The experts had testified that obviousness was present, when as a matter of law, it was not present; and the district court made a reversible error by adopting those experts’ conclusions.

Notably, the law of the Third Circuit, in which the Millennium case was tried, held that no witness may testify to a legal conclusion. E.g., Berckeley Inv. Grp., Ltd. v. Colkitt, 455 F.3d 195, 217 (3d Cir. 2006) (“an expert witness is prohibited from rendering a legal opinion”). The district court allowed the testimony anyway (possibly over no objection) and made a legal error by relying upon it.

4.   Expert Opinions About Obviousness Carry No Weight.

In the Millennium case, expert opinions as to what “obvious” means, or what is or is not obvious, carried no weight.

Irrelevant Evidence Is to Be Excluded.

Under the Federal Rules of Evidence, irrelevant evidence is not permitted and may not be relied upon as a basis for a conclusion. Expert opinion as to obviousness, being irrelevant and therefore improper, ought to be excluded from an evidentiary record made in a courtroom.

Expert opinion on obviousness also ought to be excluded from quasi-judicial proceedings before the USPTO, such as cases of inter partes review. It is true that the agency’s rules of evidence are not identical to those of the federal courts; but it does not follow that the agency is bound by no rules of evidence at all.

In a case before the agency, irrelevant subject matter must be excluded. The Administrative Procedure Act, 5 U.S.C. § 556(d), addresses that evidentiary rule: “the agency as a matter of policy shall provide for the exclusion of irrelevant, immaterial, or unduly repetitious evidence.”

If experts are known habitually to opine on legal questions of obviousness, it may be time for that practice to come to an end.

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16 comments so far.

  • [Avatar for Anon]
    Anon
    July 31, 2019 07:23 am

    It is an interesting view to posit that you have three types of cases: purely factual, purely legal, and then the spectrum of cases that are a mix of factual and legal.

    However, I think for the mechanism under discussion that it is LESS helpful to focus on the fact that the last group occurs over a spectrum than it would to recognize that for ANY item in the spectrum, there remains some point that MUST exist that differentiates from a purely factual basis.

    The entire spectrum could have been reduced to a much cleaner (dare I say brightline?) Rule for the mechanism to identify that differentiating point between the factual and legal.

    The court arrives as a somewhat parallel end, but its reasoning evades clarity and invites a “spectrum” of uncertainty by focusing on the spectrum of factual/legal combinations and basically throwing up its hands and saying “case by case” — and doing so without an affirmative clarification.

    The cleaner reasoning would align with my views: no matter what the particular case facts may present, the issue could be viewed in light of the law at point and that law at point will have a fixed differential between the facts and law at hand. A known a priori fixed differential. Focusing on that a priori known would provide clarity of reasoning for all parties involved, regardless of the spectrum of the third type.

  • [Avatar for Dmitry Karshtedt]
    Dmitry Karshtedt
    July 29, 2019 02:09 pm

    Precisely – if we are going to talk about credentials, Judge Sleet has seen a number of patent cases in his day and he’s unlikely to confuse colloquial obviousness and legal obviousness at the time of filing. There is no evidence from his opinion that he did – if anything, he faithfully followed precedent. Experts are allowed to testify to their knowledge of the art and the testimony doesn’t need to be grounded in a specific reference to indicate a teaching (see KSR). A teaching can come from market pressures, design need, or what would have been common sense in the art at the time of filing, all matters within an expert’s purview. In any event, perhaps a jury might have been confused, but this was a bench trial. Maybe a better example is needed to illustrate the prejudice point. (As an aside, it is sort of interesting that Bill Lee, who I think tried this case for the plaintiff and is not a bad lawyer, did not make any evidentiary objections to the use of the word “obvious” so far as I can tell, though he made numerous other objections.)

    It also may be that the case was given away in oral argument – I’ve certainly seen this happen more than a few times – but that’s not Judge Sleet’s fault, nor the fault of the word “obvious.”

    The law/fact distinction is an interesting one – some think that the Federal Circuit has turned 103 into a mostly factual inquiry. This cert petition, among others, deals with it.

    https://www.supremecourt.gov/DocketPDF/17/17-1707/51222/20180625142910887_Nichia%20Corporation%20v.%20Everlight%20Electronics%20Petition.pdf

  • [Avatar for Daniel Hanson]
    Daniel Hanson
    July 29, 2019 01:14 pm

    First off, thanks, everyone, for your thoughtful comments.

    1. Obviousness is a legal question. The Millennium case and dozens of other Federal Circuit cases are authority for this point.
    2. Experts cannot testify to legal questions. This is a widely recognized principle of evidence, although each circuit has it own case authority.

    From these two premises follows the syllogistic conclusion that experts cannot testify as to obviousness. We could just stop there and call it a day. But the Millennium case illustrates what can happen if experts testify to matters of underlying fact—which is permissible—and then go the extra step to opine a legal conclusion.

    If the obviousness mentioned in the expert’s opinion is not a legal opinion, then the expert testimony is still improper under rule 403 (as well as other rules of evidence), because it is confusing and prejudicial. Obviousness in the conventional vernacular and legal obviousness under patent law may use the same word, but they most certainly are not synonymous concepts.

    Now, there is no question that the trial judge in Millennium made a lot of findings of fact. During oral argument of the case, the Federal Circuit seemed to explicitly acknowledge as much. But the fact-finding must be grounded in the prior art, and the Federal Circuit determined that some critical aspects were not so grounded. When counsel was asked flat-out where certain facts appeared in the prior art, and counsel could not cite chapter and verse from the prior art, the defendants-appellees’ case was in really serious trouble.

    Now, as to whether my essay puts forth a distinction without a difference, there are two things to consider:

    1. Your friendly neighborhood federal judge may not see many patent cases, but that judge probably sees a lot of other types of cases. In a securities fraud case, would that judge permit an expert witness to testify that, in the opinion of the expert, a party’s conduct constituted fraud? Would that judge permit an expert witness in a criminal case to testify that, in the opinion of the expert, an accused person’s actions were a crime? In a negligence case, would that judge permit an expert witness to testify that, in the opinion of the expert, a particular person was negligent? If not, then an argument can be made that experts in patent cases involving obviousness ought to play by the same rules. And that leads to the second point:
    2. The true test of whether it makes a difference may be to give it a try. File a trial brief and motion in limine saying that experts’ opinions on legal questions are out of bounds (and be sure to direct your own expert witnesses to avoid legal conclusions). Challenge an expert affidavit in an IPR in which the expert repeatedly opines on legal questions. Move to strike testimony that crosses the line, or otherwise move that it be allowed no weight at all. If you then prevail on any of these motions, observe and decide for yourself and see whether it makes a difference.

  • [Avatar for Anon]
    Anon
    July 29, 2019 07:14 am

    This all seems to beg the question of whether or not the item really is a question of law.

    If, as proposed here by more than one commentator, there is no difference (merely a meaningless distinction), and IF the presence of facts alone is dispositive, THEN the end item cannot be an actual question of law, now can it?

    Even if one wants to dwell in a mixed question of law and fact domain, there must still be some portion of law which must provide a material difference from factual matters.

    The question posed then from a slightly different angle: WHAT is that material difference that makes this NOT merely a factual matter?

  • [Avatar for Dmitry Karshtedt]
    Dmitry Karshtedt
    July 29, 2019 12:02 am

    In tort cases, experts are sometimes precluded from testifying on questions of fault because fault concepts wall within the jury’s ordinary experience and having an expert speak to it gives the issue faulty a veneer of technical quality, leading the jury to defer to experts unduly. See, e.g., Gabus v. Harvey, 678 P.2d 253 (Okla. 1984). I don’t think this rationale applies in patent cases.

    It is true that experts cannot testify to pure questions of law, like duty. I’m not sure about mixed questions of law and fact, but as another commenter suggested that may be a distinction without a difference. If an expert says “undue experimentation” without mentioning the magic word “enablement,” I’m not sure that’s really a material distinction as far as the tribunal is concerned. Likewise, if an expert says there’s motivation and and there’s reasonable expectation of success (if this is supported by facts, not just say-so), I’m not sure if saying that the claims would have been obvious adds very much because these are the factual sub-elements of obviousness.

    I don’t think the testimony in Millennium could have been prejudicial because, even though the expert may have used the word “obvious,” he properly testified to motivation and reasonable expectation of success and supported this testimony by evidence. It looks like the trial judge (and this was a bench trial) understood the difference because he recited at length the relevant prior art disclosures and actual evidence proffered by the experts, not just bare statements of obviousness (some of which I reproduced above), and explained how these facts bear on the ultimate legal question of obviousness. (Regardless, it doesn’t seem like the plaintiff made any evidentiary objections, which is a waiver. Since evidentiary challenges were not preserved, the appellate panel would be without authority to revisit those evidentiary issues, and accept what happened at trial as a given.)

    As to the gaps, let’s maybe leave the judges’ credentials aside for the moment (while Judge Newman is amazing, I think every judge on the Federal Circuit is capable of handling a chemistry case) and just look at what the actual asserted gaps are, one by one.

    “The first group shows that lyophilization is a known technique to prepare pharmaceutical formulations, although no reference shows lyophilization of bortezomib.” –> This is not much of a gap because, if a reference taught lyophilizing bortezomib specifically, it would have been anticipatory. For similar reasons, the Federal Circuit’s requirement that the defendant had to point to a teaching that called out a specific reference (Asano) to establish motivation was rejected in KSR. It was enough to show that similar pedals were being equipped with digital sensors at the pivot point.

    “The second group shows that mannitol is a known inert bulking agent, although no reference shows mannitol as a bulking agent for bortezomib.” –> Again, that would have been anticipatory. There was evidence that lyophilization and bulking with mannitol could have been accomplished with other compounds that could form esters, and that these were common techniques.

    “The third group starts from the Adams Patent that states that boronic acids can form esters, although mannitol is not included in the ester-forming alcohols mentioned in the Adams Patent.” Here’s where the experts filled the gap by explaining that mannitol is a commonly used ester-forming alcohol. (From the testimony: “There is a vast literature out there showing that boronic acids form esters with sugar in aqueous solutions. And there are also a number of them which actually show the boronic acids, both alkyl and aryl, forming mannitol esters. So that’s not surprising.” Bortezomib, by the way, is a boronic acid, or as the expert noted: “Or, as I stated just previously, bortezomib is a boronic acid. Therefore, other boronic acids do and there is no reason not to anticipate — not to expect that boronic acid would form a boronic acid ester.”)

    Anything else in the opinion? “Nor does the Adams Patent teach or suggest that the esters provide a solution to the problems of instability and insolubility of bortezomib.” Perhaps, but again teachings in the art say that esterification can improve stability and solubility of similar compounds and expert testimony notes that a PHOSITA would have applied these teachings to bortezomib.

    The opinion then states: “None of these references, alone or in combination, suggests or teaches that the solution to the problems of creating an efficacious formulation of bortezomib lay in freeze-drying bortezomib with mannitol to form an ester having the necessary properties for stability, storage, and treatment.” This is an awfully narrow way to define a problem. Compare the Federal Circuit in KSR: “[T]he district court was required to make specific findings as to a suggestion or motivation to attach an electronic control to the support bracket of the Asano assembly. . .. The court did not explain how suffering from the problem addressed by the ‘595 patent would have specifically motivated one skilled in the art to attach an electronic control to the support bracket of the Asano assembly.” KSR, the Supreme Court version, allows knowledge of solutions to similar problems to be a source of motivation. And that seems like a reasonable thing for experts to testify to.

    Finally, there’s this in Millennium: “Dr. Repta’s testimony that dissociation of boronic esters would be ‘virtually instantaneous’ was contradicted on cross-examination, and is not supported by the Adams Patent, which does not discuss the dissociation or stability of the esters.” It is generally up to the trial court to resolve contradictory testimony and decide who to credit, not up to the appellate panel.

    It should not be a shock to the readers of this blog that the Federal Circuit, while an outstanding court with excellent judges, sometimes gets things wrong. I think it did here, especially given the case’s deferential posture (and it is well-established law that motivation and reasonable expectation of success are questions of fact). Any gaps were created by an extremely narrow statement of the problem, in tension with KSR. In any case, I don’t see any a priori reason to assume that the Federal Circuit is correct on an issue and the district court is not, at least not without an analysis of both opinions that I tried to get into here. I’m also not seeing exactly how the trial judge was misled.

  • [Avatar for Daniel Hanson]
    Daniel Hanson
    July 28, 2019 09:46 pm

    DK @ 6 & 10 –

    In a negligence or fault case, an expert witness may not opine that there was or was not “fault,” and counsel may not ask for such an opinion. The reason is that the elements of “fault” are established by law and are to be set out in the jury instructions. The expert has no business saying anything from the stand that may contradict the judge’s instructions. Similarly, the expert is not permitted to testify to subordinate issues of fault, if those issues are issues of law. An expert may not, for example, offer an opinion as to whether a person had a duty of care, or what the scope of that duty would be. Those are legal questions to be addressed by the judge, and an expert is not allowed to testify in a manner that may contradict the judge.

    Experts can testify to a lot of things related to fault, of course. But on issues of law, their testimony is impermissible.

    So it should be with obviousness.

    So, is it objectionable to ask, “In December of 1997, in short, why would one of ordinary skill in the art have found it obvious to freeze-dry bortezomib with mannitol?” Yes, that is objectionable, and the objection may go like this: “Objection: this question calls for an improper opinion and conclusion, particularly upon the issue of obviousness, which is legal question and a legal issue upon which this witness is not qualified to answer, and furthermore the question calls for testimony that is not relevant.” Objecting trial counsel could have set the stage for such an objection by a motion in limine and a trial brief, which sets out the reasons why such questions and testimony would be improper. There may be other grounds for objection as well, such as undue prejudice and lack of proper foundation and so on.

    The witness’s answer likewise is objectionable: “So as I see it, all of the elements there are expected. They are obvious.” The objection could be: “Objection, and I move to strike the final two sentences in the witness’s answer. Whether a thing is obvious or not is a legal question, about which the witness is not qualified to answer, and the witness’s testimony on this point would be irrelevant. Moreover, I object to and move to strike the cited portion of the witness’s answer because the witness flatly mis-states the law, saying in effect that if all of the elements of a claim are expected, then the claim must be obvious. That is not the law.”

    A similar objection and motion to strike would be urged in response to the assertion on cross: “So any POSA worth his salt would have come to this conclusion: This is obvious.” This is not a proper opinion, it is not within the witness’s field of expertise, it is not relevant, it is a mis-statement of the law, and (not to put too fine a point on it) it also is not responsive to the question that was asked.

    Whether such testimony would be prejudicial or not depends upon a number of factors, such as whether the fact-finder is a judge or a jury, whether the judge instructs the jury to disregard improper testimony, and the context in which the testimony is proffered. In the Millennium case, the expert testimony was actually harmful, in that the testimony apparently persuaded the judge to overlook fatal gaps in the evidence and to find obviousness where it was not present.

    Now, as to whether the Federal Circuit misconstrued the evidence, there are three observations. First, Judge Newman specifically pointed out that the “gaps” in the prior art, 862 F.3d at 1365, which the experts’ testimony could not fill. Second, Judge Newman has considerable education and experience in this field of technology, and is unlikely to be buffaloed by the technical subject matter. And third, as is evident from the oral argument, Judge Newman was not the only member of the court bothered by the gaps in the prior art. Judge O’Malley was concerned as well. Counsel for the defendants-appellees was specifically asked where certain facts appeared in the prior art, and counsel did not proffer a straight answer, opting instead to direct the Court to several pages of expert testimony in the appellate record; those pages did not answer the judges’ questions. In rebuttal, counsel for the plaintiff-appellant stressed that the issue is whether the legal requirements for obviousness are present, and argued (correctly) that expert conclusions “not tethered to any prior art at all” are not sufficient.

  • [Avatar for Dmitry Karshtedt]
    Dmitry Karshtedt
    July 27, 2019 03:49 pm

    Here’s the summation of Dr. Repta’s testimony in Millennium v. Sandoz, available at 2014 WL 11901015:

    On direct:

    *** Q . . . In December of 1997, in short, why would one of ordinary skill in the art have found it obvious to freeze-dry bortezomib with mannitol?

    A. Why? Because all the information was in the prior art to piece together that this would happen. The stability would be increased by forming an ester, the POSA would know that. The solubility would be increased. Not that solubility was an issue, really, in this case, but it would be increased because you would have a second species now — the apparent solubility would increase because you would have a second species, which would be the mannitol ester. And third, in the lyophilization, you had something which would rapidly — be expected to rapidly dissolve. So as I see it, all of the elements there are expected. They are obvious. ***

    On cross:

    *** Q. My question is, having not identified any subset of references, you also did not identify any specific motivation, reason, anything for combining a specific subset of these 53. Correct?

    A. I don’t think that is correct, unless I am misunderstanding your question, because the motivation would have been stabilize to get a product, to gain a boronic acid, that would have been lyophilization, lyophilization with mannitol would have been a way of stabilizing. So any POSA worth his salt would have come to this conclusion: This is obvious. ***

    Where’s the prejudicial error in allowing this kind of testimony?

  • [Avatar for Daniel Hanson]
    Daniel Hanson
    July 27, 2019 01:29 pm

    FB @ 7-

    I share your amusement, to a degree. The case of Innovention Toys, LLC v. MGA Entertainment, Inc., 637 F.3d 1314 (Fed. Cir. 2011), discusses a rather odd aspect of expert testimony with respect to section 103. “A determination of obviousness requires a factual finding of the level of ordinary skill in the art,” said the Federal Circuit, and if the “district court makes a determination that an invention would have been obvious to one having the lowest level of skill, i.e., a layperson,” then expert testimony would not be needed (and would arguably be largely irrelevant), because “what is obvious to a layperson is necessarily obvious to one with a higher level of skill in the field of the invention.”

    Of even greater intrigue is the converse to this proposition. If the invention can be understood by a layperson, and if the invention is NONobvious to a layperson, then expert testimony supporting obviousness ought to be largely irrelevant.

    And then there is the inherent amusement that comes about when experts testify to “common sense.” If you need a doctoral degree and twenty years of experience to understand what is going on, then that understanding isn’t really “common” sense, is it?

  • [Avatar for Daniel Hanson]
    Daniel Hanson
    July 27, 2019 01:27 pm

    AAA JJ @ 5-

    You are correct that a careful, prudent, and experienced expert can testify without resort to saying whether a thing is obvious or not. But many do not do so, though they ought to.

    If an expert is challenged every time the expert says something is obvious (or nonobvious), would it make a difference? I think it could.

    Consider an IPR petition supported by an expert affidavit that makes liberal use of the word “obvious” and its variations. If all of the assertions of obviousness in the affidavit are stricken or otherwise treated as irrelevant, it might gut the affidavit, and sink the IPR. That can make a difference.

    Consider a court case involving the validity of a patent, in which a ruling on a motion in limine forbids witnesses from saying whether anything is or is not obvious, and forbids counsel from asking about obviousness. Sure, lawyers and witnesses can talk about the underlying facts, but a jury will never hear any expert say that the invention would or would not have been obvious. Or, if there is an expert on the stand who insists on using the word, perhaps out of habit, objecting may cause the witness to lose credibility. These things can make a difference.

    Just as a reminder, it is not fair play for an expert to say that something is “obvious” in a conventional, rather than a legal, sense, because the two senses are quite different. See my essay, “Distinguishing Colloquial Obviousness and Legal Obviousness,” published on IPWatchdog on 31 May, 2019.

  • [Avatar for Fat Bastard]
    Fat Bastard
    July 24, 2019 05:02 pm

    It has always amused me in a morbid way that we use the ultra-skilled to testify to what the ordinarily skilled would do or have done. But when you think about it they are probably more competent to do it than the abjectly unskilled.

  • [Avatar for Dmitry Karshtedt]
    Dmitry Karshtedt
    July 24, 2019 03:34 pm

    As explained by the district court in Millennium, the defendant’s experts testified that a PHOSITA would be motivated to lyophilize bortezomib because such procedures were known to improve a compound’s stability and explained that lyophilization could often be successfully accomplished with mannitol, which is very well known agent that’s been used for this purpose with other molecules (think KSR and updating constant-ratio pedals with digital sensors when it was known that regular pedals can be updated with such sensors). I’m not sure why experts can’t testify on such matters. The patentee lyophilized bortezomib with mannitol and happened to make a mannitol ester, a product that the court found to be obvious based on the credibility of the expert testimony I summarized above (experts also testified that esterification can improve stability). Arguably it was the Federal Circuit that overreached by ignoring or discounting all this testimony.

  • [Avatar for AAA JJ]
    AAA JJ
    July 24, 2019 12:28 pm

    “..better to have the expert speak on how a person if ordinary skill would understand the art, whether she would have a reasonable expectation of success, and whether the secondary considerations would apply.”

    So if the expert testifies that: 1) all of the claimed features are in the prior art, 2) one of ordinary skill in the art would have an apparent reason with rational underpinning to modify/combine the prior art, 3) with a reasonable expectation of success, and 4) such modification/combination would result in the features as arranged in the claim, what’s the difference if the expert concludes the claim is obvious? All of 1)-4) are questions of fact. If all of facts 1)-4) are established, the claim is obvious.

    Sounds like a distinction without a difference to me.

  • [Avatar for Benny]
    Benny
    July 24, 2019 12:03 pm

    103 rejections are entirely subjective. I haven’t found any consistency in patent examination as to what is and what isn’t obvious. File an application for a knurled flange bracket, one examiner will cite a smooth straight bracket as prior art for obviousness, another will ignore a three quarter-knurled flange bracket as prior art. You might as well buy a lottery ticket where the prize is a patent.

  • [Avatar for Kevin Noonan]
    Kevin Noonan
    July 24, 2019 10:18 am

    I am always amazed when experts opine on obviousness per se. I can destroy their credibility and raise the impression that the lawyer drafted their report. So much easier and better to have the expert speak on how a person if ordinary skill would understand the art, whether she would have a reasonable expectation of success, and whether the secondary considerations would apply.

  • [Avatar for Night Writer]
    Night Writer
    July 24, 2019 08:59 am

    The biggest thing that is going on now is that the CAFC judges make their own private 103 rejections that are sometimes expressed as 101 rejections. The “judges” hire clerks with some technical training and have them write up an analysis as if it is by experts and then they hold the claims obvious or ineligible.

    The current state of the law is outrageous. As far as I can tell the average judge appointed by Obama on the CAFC does not even have the remotest idea what hindsight reasoning is.

  • [Avatar for Mark Martens]
    Mark Martens
    July 24, 2019 07:59 am

    Schopenhauer said
    “All truth goes through three stages:
    First, it is ridiculed.
    Second, it is violently opposed.
    Finally, it is accepted,…as obvious.”