Bayer Schering Pharma AG v. Barr Laboratories, Inc. (Fed. Cir. 2009)

Common Sense, Perhaps, But Whose?

    By Kevin E. Noonan --

The Supreme Court in KSR International Co. v. Teleflex Inc. established a standard (such as it is) of "common sense" in evaluating whether an invention is obvious.  If the Court had been careful to follow the statute, it might have stressed more carefully that the answer to the question "whose common sense" must be the person of ordinary skill in the art.  Perhaps it was the contempt they obviously felt for the invention at issue -- an electronic controller for adjusting the position of a gas pedal in a vehicle -- but as a consequence of the KSR decision the "common sense" at issue is all too frequently a lay judge's view of what would be obvious.

This is what happened at the District Court in Bayer's suit against Barr for filing an ANDA on Bayer's Yasmin® contraceptive.  Bayer's patent-in-suit, U.S. Patent No. 6,787,531, claims a pharmaceutical composition of an oral contraceptive comprising a combination of drospirenone and ethinylestradiol.  Claim 1 of the '531 patent is representative of the claimed formulation:

1.  A pharmaceutical composition comprising from about 2 mg to about 4 mg of micronized drospirenone particles, about 0.01 mg to about 0.05 mg of 17-alpha-ethinylestradiol, and one or more pharmaceutically acceptable carriers, the composition being in an oral dose form exposed to the gastric environment upon dissolution, and the composition being effective for oral contraception in a human female.

This combination as an oral contraceptive was not new; the formulation was.  Bayer found that, despite the fact that drospirenone was known to be acid labile and to isomerize into an inactive form under acidic conditions (such as those encountered in the stomach), the combination could be advantageously formulated using micronized drospirenone (which increased absorbsion of the drug but was expected to also increase the rate of isomerization) and by not coating the drospirenone with an enteric coating (the conventional way of protecting an acid-labile compound from stomach acid in oral drug formulations).  Barr's position was that the use of micronization to improve drug absorbsion and the use of enteric coatings to protect acid-labile drugs were "routinely considered" by drug formulators in making drugs for oral administration, and that Bayer's claims were thus obvious.

Bayer introduced testimony relating to how the invention was made, specifically relating to the surprising findings that formulating the drug in ways that should have increased isomerization (micronizing the acid-labile drospirenone and dispensing with the enteric coating) in fact had the opposite effect.  According to this testimony, the reason for this paradoxical result is that the micronized drug was absorbed more rapidly than it isomerized in vivo, and enteric coatings made the effectiveness of the drug more variable; it was uncontested that the drug had to be 99% effective to be useful as a contraceptive.  This testimony (supported by documentary evidence) established that Bayer scientists had originally prepared formulations that were unmicronized and enterically-coated, and that they were successful only when they changed direction and prepared the formulation that was the subject of the '531 patent.  In short, the entirety of Bayer's evidence from the scientists that developed the formulation was that the results were surprising and unexpected, circumstances that traditionally have been sufficient to overcome a prima facie obviousness determination.

The District Court Judge, the Honorable Peter Sheridan, disregarded this evidence on the grounds that it was not reasonable to him that Bayer's scientists would have changed direction as abruptly as they purportedly did in their formulation work.  Moreover, the Court relied on a prior art treatise not particularly directed to oral contraceptives (Aulton, 1988, Pharmaceutics: The Science of Dosage Form Design) and a number of scientific journal articles relating to in vitro and in vivo acid-lability of spirenone (not drospirenone but a related compound), in deciding that the invention would have been obvious.  In addition, the Court cited three studies (including both in vitro and in vivo arms) with the related drug spirenone that purported to show the absence of spirenone isomers in blood samples from experimental animals or human volunteers administered tableted spirenone.  In vitro studies on drospirenone, on the other hand, showed that 80% of the drug had isomerized in a 0.1N HCl solution at room temperature.  The Court found that spirenone and drospirenone were related "as close[ly] as fraternal twins" and thus imputed the behavior of spirenone to drospirenone despite the evidence that they differed at least in their in vitro properties.

The District Court explained its reasoning as follows:

The prior art states the in vitro studies are unreliable unless they are correlated to in vivo testing (Aulton, McGilveray).  Unlike Nickisch, a person of ordinary skill in the art would conduct such testing.  Decisions about drug dose form are then made based upon the in vitro/in vivo testing.  That is, the decision whether to micronize and/or enteric coat comes second.  In this case, Bayer argues that the person of ordinary skill in the art would reverse this process ("put the cart before the horse").  This does not make sense.  Justice Kennedy in KSR observed that in analyzing an obviousness defense, the court must use its common sense.  KSR, 127 S. Ct. at 1732.  In this instance, Bayer's alleged exception to the in vitro/in vivo correlation rule (that it does not apply to acid sensitive drugs) does not ring true.  A person of ordinary skill in the art must precisely know and verify the characteristics and chemical reactions of a drug in order to evaluate its therapeutic value in humans.  To follow McGinity's alleged exception for acid-sensitive drugs can only lead to sketchy, imprecise formulation results and an increased risk of injury to users.

The Federal Circuit affirmed, in a decision by Judge Mayer joined by Judge Friedman; Judge Newman dissented.  The majority based its decision on the portion of the KSR opinion regarding when an invention that is obvious to try is also obvious:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

As these principles have been explicated by the Federal Circuit (most recently in In re Kubin), the proper analysis is to be found in In re O'Farrell, and moreover the two O'Farrell scenarios constitute the only way that something that is obvious to try is not also obvious:

First, an invention would not have been obvious to try when the inventor would have had to try all possibilities in a field unreduced by direction of the prior art.  When "what would have been 'obvious to try' would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful" an invention would not have been obvious.  O'Farrell, 853 F.2d at 903.  This is another way to express the KSR prong requiring the field of search to be among a "finite number of identified" solutions.  550 U.S. at 421; see also Procter & Gamble, 566 F.3d at 996; Kubin, 561 F.3d at 1359.  It is also consistent with our interpretation that KSR requires the number of options to be "small or easily traversed."  Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008).

Second, an invention is not obvious to try where vague prior art does not guide an inventor toward a particular solution.  A finding of obviousness would not obtain where "what was 'obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it."  O'Farrell, 853 F.2d at 903.  This expresses the same idea as the KSR requirement that the identified solutions be "predictable."  550 U.S. at 421; see also Procter & Gamble, 566 F.3d at 996-97; Kubin, 561 F.3d at 1359-60.

Here, the majority analyzed the facts as found by the District Court to arrive at this application of the O'Farrell tests:

At this point, a person having ordinary skill in the art has reached a crossroads where he must choose between two known options:  delivery of micronized drospirenone by a normal pill following the spirorenone analogy in the Krause series, or delivery of drospirenone by an enteric-coated pill following the Nickisch teaching that the drug needs to be protected from the stomach.  This is a finite number of identified, predictable solutions.  See KSR, 550 U.S. at 421.  The prior art would have funneled the formulator toward these two options; he would not have been required to try all possibilities in a field unreduced by the prior art, thus avoiding the first pitfall of O'Farrell, 853 F.2d at 903.  Additionally, the prior art was not vague in pointing toward a general approach or area of exploration, but rather guided the formulator precisely to the use of either a normal pill or an enteric-coated pill, thus avoiding the second pitfall of O'Farrell.  Id.  Because the selection of micronized drospirenone in a normal pill led to the result anticipated by the Krause series, the invention would have been obvious.  See KSR, 550 U.S. at 421.

This is not on its face an unreasonable assessment of the prior art.  However, like the District Court, it ignores, indeed it disregards, the affirmative evidence of what did happen in favor of the majority's reconstruction of what could have happened.  While this might be an acceptable analytic method in the absence of the kind of evidence asserted by Bayer, in this case it results in the substitution of the Court's "common sense" for the facts.

Judge Newman's dissent focused on this error (emphasis added):

I do not share their view that it would have been obvious to do that which was indisputably unobvious to the experienced formulation scientists whose assignment was to formulate the known product drospirenone.  The evidence showed, without contradiction, that it was known that micronized drospirenone rapidly degraded at the acidity of stomach acid.  The evidence showed, without contradiction, that the Bayer scientists working in this field believed that the product required an enteric coating in order to prevent degradation in the stomach, upon ingestion as an oral contraceptive.  Yet my colleagues, employing their own expertise, hold that since the scientists working in this field turned out to be mistaken, it would have been obvious that it was not necessary to take steps to prevent acid degradation.  The court discounts the testimony of the scientists themselves, ignores the knowledge concerning this product and its instability in acid, ignores the textbook teachings, and finds that this unlikely process obviously should have been tried.  That is not the law of obviousness.

Unfortunately, it is what the law of obviousness has become.  Judge Newman also pointed out that even KSR requires a reasonable expectation of success, whereas what the majority thought would be obvious was actually an experiment that the prior art taught should fail:

The law does not hold it "obvious to try" experiments that contravene conventional knowledge, and that are not deemed reasonably likely to succeed.  . . .  The Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) explained that the standard for "obvious to try" is whether there was a "reasonable expectation of success" at the time.  It was undisputed that there was not.

                                            * * *

The district court stated that micronization was a "viable" option, and that although success was "uncertain," the invention was obvious to try.  However, "viability" is not the standard.  "Viability" implies that the experiment may or may not succeed.  What the law requires is not guesswork, not dumb luck, but a reasonable degree of predictability of success.  My colleagues depart from the statutory standard, in ruling that persons of ordinary skill would have conducted experiments that were expected to fail.

                                                      * * *

The exercise of judicial expertise to override the clear evidence of how persons of skill in this field actually behaved, is inappropriate.

Judge Newman is too polite to say it, but decisions such as these are not only contrary to the statute, but are a form of judicial tyranny, where the law is what the court says it is (despite undisputed evidence to the contrary and a statutory standard for assessing such evidence).  The Supreme Court's KSR decision let loose this avenue for judges rather than scientists having the common sense that matters in deciding obviousness.  While a judge's judgment may be sufficient or even necessary in some circumstances, obviousness has a statutory basis and requirements for satisfying the statute.  Judges substituting their common sense for the common sense of the person of ordinary skill in the art is not a result required by the KSR decision but it has certainly been encouraged by the Federal Circuit's jurisprudence since KSR.  Only a return to a faithful interpretation of the statute and the exercise of the Federal Circuit's expertise in applying patent law to the scientific facts can reverse this current trend.  It cannot happen too soon.

Bayer Schering Pharma AG v. Barr Laboratories, Inc. (Fed. Cir. 2009)
Panel: Circuit Judges Newman, Frieman, and Mayer
Opinion by Circuit Judge Mayer; dissenting opinion by Circuit Judge Newman

Comments

[Dan Feigelson]

Thanks, Kevin. "Judicial tyranny" is right. I'm sure you enjoy as much as I do explaining to clients that determining non-obviousness in the USA is a crapshoot that comes down to who's on your panel at the CAFC.

(You'd think the CAFC would have learned by now that when Newman dissents in a chemical case, it means the majority got it wrong. Even pre-KSR, Mayer got it wrong in Pfizer v Apotex; whereas post-KSR Newman still got it right in Sanofi v Apotex. But no, apparently many or most of the judges prefer to muck things up with decisions like this one.)

[6]

Kev kev kev.

[6]

Man, what a monumental post. Here is the thing Kev. They submitted testimony that the results they found in their experiment were unexpected. However, if we look to page 7 of the decision there was art available to the omniscient poshita which suggested that it it shouldn't have been unexpected, at worse it should have been 50/50 because the references tell a person of ordinary skill that really they need to go and find out if their specific species behaves in x way or not. So, no unexpected results.

Furthermore, there is a teaching away in so far as the general knowledge/textbook suggested that z would happen in their experiment if they ran it. However, the teachings on page 7 suggest that such may very well not be the case with this genus of compounds and that if you want to know if it is the case then you need to go find out for yourself. Thus, the teaching away isn't solid either.

Other than that, it is a straightforward obviousness analysis.

In short, page 7. Read it and the references it involves and then get back to us. Ok?

"the affirmative evidence of what did happen in favor of the majority's reconstruction of what could have happened. "

Look kev, it isn't what "could have happened" it is what would have happened. Or, in some rare cases, what would have been likely to have happened. Take your pick of terms, but it isn't the same as "could have happened".

"whereas what the majority thought would be obvious was actually an experiment that the prior art taught should fail"

Um no, the prior art taught 2 things. It taught that 1 it was likely to fail and 2 if you don't want to be an rtard then you will do your own experiment to find out if it fails or not. Somewhat astonishingly, the scientists took the second path. And they even managed to do it whilst not even knowing of the 2nd path because they didn't have those references. AMAZING! But not amazing for omniscient Poshita.

[Kevin E. Noonan]

Dear Dan:

There are plenty of instances where the court would have been right in its analysis. For example, I think the Pfizer v. Apotex case was properly decided because of what was claimed - the formulation per se, rather than methods for formulating. I think this because the unexpected results in the Pfizer case all related to the advantages in manufacturing, which weren't compelling for formulation claims.

Here, my dissatisfaction stems from the court substituting its "common sense" for what happened on the ground at the time. Everything looks easy and obvious in hindsight, and that's something we have to live with in view of KSR. But we shouldn't have to live with the evidence being ignored when there is evidence.

Thanks for the comment.

[Kevin E. Noonan]

Dear 6:

Not quite. The person of ordinary skill is not omniscient - she can't predict the future, or predict that an experiment assumed by the prior art to fail will actually succeed. So when we get an unexpected result that is pretty much solid evidence that an invention wasn't as obvious as it may look in hindsight.

It is precisely those instances where the art is not clear where it is important to consider all the evidence and not employ ex post facto "it would have been" analysis. Which is what both the district court and the CAFC did.

One of the biggest misreadings of the Supreme Court's "finite number of identified, predictable solutions" language is applying it to situations where the two outcomes are success or failure. Because those will always be the only two outcomes that matter.

And remember, the PTO granted these claims.

Thanks for the comment.

[Paul Cole]

If you look at Graham v John Deere which KSR acknowledges is the leading authiruty on invnetive step you will find that there are certain preparations for making the decision, but thereafter a decision is taken according to the evidence. If the evidence is that a step was not obvious to try,and is uncontradicted, then the court must decide accordingly. A failure of due process here, if Judge Newman's assessment is correct on the facts.

[6]

Omniscient with respect to knowledge of the prior art Kev. Come on, stay with me here. Did I just now join this online chat group today?

"So when we get an unexpected result that is pretty much solid evidence that an invention wasn't as obvious as it may look in hindsight."

When did we get an unexpected result Kev? The scientists got a result that was unexpected to them. It wasn't necessarily unexpected to POSHITA who had more knowledge of the publications than the scientists did thanks to his art omniscience.

That's the whole point of those teachings on page 7 Kev. That the result wasn't as unexpected as the "textbook" made it out to be.

Look, I'm not even saying that I personally would have gone the way the DC did. But you can't just side with Newman without alledging clear error somewhere. And the point at which the DC's case must be attacked is the stuff on page 7. She doesn't allege clear error there, or clear error with the legal determination of obviousness based thereon. She just alleges "this isn't how it is supposed to work!" and reiterates the undisputed facts while leaving out some other facts yadda yadda.

As an aside, I'd like to see how Newman comes to grips with the stuff on page 7. Just what does she think that it suggests to poshita? You notice that she leaves this particular hole wide open in her analysis that supposedly is considering all the facts. By which she means all the facts that lead to an uncontested unexpected result/teaching away.

Sorry, but you can't have an unexpected result when the prior art specifically tells you that it is a toss up and you need to go run the experiment to find out. Even if the conventional wisdom tells you on the other hand that it will probably not work. You have more specific information telling you that you really need to go find out because it really can't be predicted. Aka 50/50. 50/50 is not unexpected.

"It is precisely those instances where the art is not clear where it is important to consider all the evidence and not employ ex post facto "it would have been" analysis. Which is what both the district court and the CAFC did."

Imma have to disagree. "It would have been" (reasonably) expected is precisely the right analysis to employ since the applicant is asseting that it "would have been" unexpected. They're all just assertions. Both of them have some evidence on either side. The judge sorted it out. Maybe he was wrong. But he wasn't clearly wrong.

Precisely what sort of analysis are you supposed to invoke during times of unexpected results/teachings away? You say consider all the evidence, but that is what the court did. He weighed it, and guess what? His measurement came out a certain way, and it wasn't a clearly erroneous way.

"One of the biggest misreadings of the Supreme Court's "finite number of identified, predictable solutions" language is applying it to situations where the two outcomes are success or failure. Because those will always be the only two outcomes that matter."

I kinda agree with you, but I kinda don't. I especially don't like the way you use two embodiments called "success" and "failure" because that is a word game trap. We're talking about two real world objects or methods that involve structures or steps. Not "success" or "failure".

In any event, I don't really use obvious to try. This case doesn't need to reach out to obvious to try, even though the judges do. There is plenty of motivation to make the combination, old school TSM knocks it out.

Bottom line, I disagree with your line of reasoning, but I don't necessarily agree with the DC's being all that great either. However, he is the judge.

[Noise above Law]

"because it really can't be predicted."

6, you do love bringing the rope.

[Kevin E. Noonan]

Dear 6:

It is hard to be as pithy as Noise, so I won't try. I will say that his comment is the point: the Supreme Court says the result needs to be predictable. And what is predictable can't be "maybe it will work, and maybe it won't" - those are always the choices. What is required is that the skilled worker would have not expected the invention to work, and if it works unexpectedly it isn't obvious.

The larger point, whether this invention is obvious or not, is that neither court addressed the uncontroverted evidence that it was surprising and unexpected that the invention worked. Now, Barr had every opportunity to refute that evidence, and they didn't. Seems to me that for an impartial judge would be enough.

I'm no more in favor of giving patents when there isn't an invention as you are - it's like trying to teach a donkey to count (except that it annoys everyone not just the donkey). But if we want obviousness to be anything more than "seems obvious (in hindsight) to ME," then we need to follow the statute and give weight to evidence of unexpected results. If the court had done that, I would have posted on something else today.

But I appreciate your perspective "in the trenches," and thanks for the comment.

[Keep It Real]

"One of the biggest misreadings of the Supreme Court's "finite number of identified, predictable solutions" language is applying it to situations where the two outcomes are success or failure. Because those will always be the only two outcomes that matter."

Except that's not what happened here. Here, there were two possibilities for a "new" formulation of this old drug. While one was allegedly more likely to result in success, both could reasonably be expected to work. It's not as if the "teaching away" here was some sort of ancient lore that nobody questioned until the "geniuses" at Bayer decided that it was worth a try.

"the Supreme Court says the result needs to be predictable. And what is predictable can't be "maybe it will work, and maybe it won't" - those are always the choices."

Again, this is misrepresenting the majority's analysis. The point is that there were two standard options for formulating the "new" composition. It doesn't matter what Bayer's scientists "believed" was more likely to "work" based on their selective (and self-serving) reading of the literature. All that matters is that there were two industry-recognized options.

If you take your strident position to the limit, you open the door for a per se finding of non-obviousness anytime a choice between two "unpredictable" elements is made by the patentee. Yes, either one or both or neither will work. But the "inventor" is going to attempt to patent the better working example, or both, regardless. The point of KSR is to put the lid on the patenting of these sorts of trivial "improvements" that are nothing but mere tinkering with the obvious elements. The issuance of such patents does not reward "innovation" but, rather, rewards mechanical mindless tinkering and, more harmfully, raises the costs for everyone of obvious modifications of old inventions.

"neither court addressed the uncontroverted evidence that it was surprising and unexpected that the invention worked"

Perhaps the fact that the inventors expressed surprise was uncontroverted because the fact was not particularly persuasive to anyone, seeing as how self-serving the inventors' testimony was. A truly unexpected result would be an improvement in drug efficacy that surpassed that typically achieved by micronization. Even then, maybe not enough in this case to justify a patent.

Newman: "What the law requires is not guesswork, not dumb luck"

That is an incorrect statement of the law, at least when there's a very small number of choices. KSR made that quite clear.

[Kevin E. Noonan]

Dear Keep:

But that is the point - this isn't a merely trivial manipulation, since there are advantages to this formulation of the combination that are not found in the prior art.

And even if this were trivial, a competitor could just make and market the combination formulated differently and then no problem. The point is that if the improvement is trivial (as, maybe, as in the Pfizer patent) then the art can go along, no harm no foul. But that isn't the case here in my view.

Unless you believe there is a moral component to patenting (the inventors didn't deserve the patent), then when an unexpected result is obtained on a new formulation it should be patentable. That isn't per se, it's the statute. The only basis the Supreme Court has for limiting the statute is if it exceeds Congressional power by not "promoting the progress," and on that score I trust the scientific evidence above the seat of the pants "obvious to me" opinion of a lay judge. That kind of finding by a judge may work for determining when something is pornographic but I don't think it works very well for obviousness.

Thanks for the comment.

[Keep It Real]

"Unless you believe there is a moral component to patenting (the inventors didn't deserve the patent), then when an unexpected result is obtained on a new formulation it should be patentable."

Well, no, it can't be that simple because (and we've all seen this trick attempted by myriad applicants and patentees) you can always find some property of your otherwise obvious formulation that wasn't "predictable" or "expected". You simply need to use your imagination, then you slap a "wherein said composition has this property" clause onto your claim. It has worked in the past to obtain a patent, and it will surely work in the future, as long as Examiners are human.

"That kind of finding by a judge may work for determining when something is pornographic but I don't think it works very well for obviousness."

I think it worked perfectly well here. The claimed variant formulation did not have sufficiently wonderful and unexpected results to merit a patent over the prior art, given the minute number of standard variations to choose from.

[Kevin E. Noonan]

Dear Keep:

We disagree - so be it. I think the lay judge should have deferred to the evidence (which was more than just finding some property and slapping a clause onto the claim - the claim at issue doesn't have such a clause). And it will work because examiners are required by the statute to consider evidence of non-obviousness (In re Sullivan for example).

This type of decision will occur in the future so long as lay judges think the common sense referenced in KSR should be theirs, no matter what the evidence. I think this is a bad idea, even if I totally agreed with you that the court got it right in this instance.

Thanks for the comment.

[Bob]

In the context of copyright law, our courts have stated that the law does not protect "sweat of the brow."

This opinion reaches the unremarkable conclusion that the same holds true for patent law. The relevant prior art would have led the objective skilled artisan to formulate the drug in one of two ways. Thus, both such formulations are obvious, as it requires no inventiveness to choose between two options.

But it is clear that this is not what the named inventors did. Instead, they ignored the relevant prior art, and took it upon themselves to reinvent the wheel. In the end, they arrived at exactly the place where the prior art would have led them (had they bothered to consult it and mentally digest it).

[MaxDrei]

I was hoping for some reaction to the "due process" comment from Paul Cole (August 10 at 11.11am). Hoping, because Paul is from Europe, and could have commented with authority on how Europe decides the issues of "obvious to try" and "unexpected result" by the use of evidence of fact, but chose to hold back, the better to tempt from other contributers to this thread insightful comments whether there was due process in this case, or not.

[Noise above Law]

MaxDrei,

I appreciate your post!

[Kevin E. Noonan]

Dear Bob:

My problem with your position is that it could render obvious (in hindsight) the kinds of inventions where the prior art thinkg was "That will NEVER work!" Because I think that is the point here - these inventors did two somethings that should not have worked - micronized a drug prone to isomerize to an inactive form in acidic media and did not include an enteric coating known in the art to protect acid-labile drugs - and got a drug that didn't isomerize and was absorbed efficiently enough to be 99% effective. And the uncontroverted evidence was that this result was surprising and unexpected.

I think innovation is fostered when the renegades who act contrary to the accepted wisdom are rewarded (when their inventions work), if only to encourage thinking outside the box.

Thanks for the comment.

[Kevin E. Noonan]

Dear Max:

Due process isn't an issue here, I think, because it doesn't cover an instance where you get the wrong results.

Here, the patentees received a patent examination from the PTO, obtained a patent, sued in district court and lost, and then appealed to the Federal Circuit and lost. They can file a petition for certiorari with the Supreme Court (an unlikely outcome), but at every stage they have received all the process due to them. So I think the only issue is whether the district court and the CAFC made a mistake. I think they did, but that doesn't make this a due process issue, at least in the U.S.

Thanks for the comment.

[PatentAttorney]

I agree with Keep It Real. When there are only two possibilities, and the prior art specifically states that one of these possibilities should work, the product obtained by using one of the possibilities doesn't merit patent protection, in my view. This is true even when the chosen route was less likely to work than the other route. This is perfectly consistent with the statute, as it nowhere states that "unexpected results" automatically lead to a finding of non-obviousness. The relevant question is whether or not the claimed formulation would have been obvious to a PHOSITA. When there are only two possibilities to make the formulation and the prior art states that one has to try both, the formulation is obvious.

Kevin's approach would lead to an unjust result of excluding from the public domain the formulation made by one of the only two possible methods, when it was known beforehand to try both of these methods. Such a result is inconsistent with a proper reading of the law, in my opinion.

[Kevin E. Noonan]

Dear Patent Attorney:

The problem with your analysis is that the two alternatives are "micronize or not micronize" and "enteric coat or not enteric coat" - which actually makes for 4 combinations not two. And while I agree that making choices per se does not confer patentability, making choices against the teachings of the prior art, that work at a 99% effectiveness level, should be patentable.

But disagreements are one of the reasons to blog.

Thanks for the comment.

[Keep It Real]

"And the uncontroverted evidence was that this result was surprising and unexpected"

In spite of the result, I suppose the take-home lesson here is for inventors to write "WOW I AM SO SURPRISED BY THIS AWESOME RESULT!" on every page of their notebook.

[6]

Sorry Kev, we're gonna have to agree to disagree on what KSR stated and on how nontrivial this combination in this thread was. If you were to take a genuine look at KSR you will find that it goes a bit beyond what you are saying.

If, after having taken a genuine look at KSR, you were to believe that KSR went too far then I would be inclined to agree with you in some respects. None the less, it went where you say it didn't.

As a final note, I don't understand how you are so blind as to see that there is evidence refuting that the unexpected result in this case should hold much weight. It is on page 7. You do yourself a disservice by ignoring it or not having noticed it for this long.

I grant you that if the teachings on page 7 did not exist then the secondary consideration would likely carry the day. And, furthermore, I might would have allowed the application even if I had all the evidence before me. But, this isn't about what someone would do, or what the correct determination was to have made. This is a case about whether or not there was clear error in the DC's judgement. He gets latitude. You cannot point to clear error, neither can Newman or anyone else, the case is properly affirmed.

[a new penny]

Two quick thoughts:

1) What happened to presumption of validity? This was a issued patent, was it not? Does that factor into the level of evidence (or argument) required by the Judge?

2) Does "teaching away" disappear, since teaching away means that you are teaching away from something, and wouldn't it be obvious to try everything, even the thing taught away from, since you can always selectively group the universe of choice to A) do it per the teaching and B) do it against the teaching?

[breadcrumbs]

6,

I posted an answer to your "page 7" pillar on The Patent Prosepctor at:

http://www.patenthawk.com/blog/2009/08/patent_contraceptive.html

Your house of logic is built on sand in this thread as well as on that comparable thread.

Are you betting that Kevin doesn't read that blog?

[Kevin E. Noonan]

Dear 6:

Lest any of our readers think we didn’t consider what the district court said (we reviewed it extensively at www.patentdocs.org/2008/03/bayer-schering.html), here is the CAFC’s abbreviated synopsis on “page 7:

Bayer claimed that its innovation was that the drospirenone could be micronized to increase its bioavailability, and that the micronized drospirenone would not need to be enteric coated for protection against the highly acidic gastric environment.

The district court ruled that these claims were invalid as obvious, and rejected Barr’s other theories. The court found that a person having ordinary skill in the art would have considered the Krause I, II, and III studies’ results that spirorenone though acid-sensitive would nevertheless absorb in vivo because drospirenone is closely related to spirorenone. It also found that while the Nickisch reference did teach that drospirenone isomerizes in vitro when exposed to acid simulating the human stomach, a person of ordinary skill would be aware of the study’s shortcomings, and would verify whether drospirenone absorbed or isomerized with precise in vivo and in vitro testing as suggested by the Robert Aulton treatise, Pharmaceutrics: The Science of Dosage Form Design (1988).

First, as we noted, the prior art teachings were not for drospirenone but for a related, but different, compound, spirenone. Second, while the court felt competent to criticize the Nickisch reference in hindsight, the skilled worker would be obliged to consider its teachings suggesting that spirenone and drospirenone had different properties. Finally, the Aulton treatise was a generic text that may have helped the court understand (incompletely) some of the considerations involved in drug formulations, but the point of an invention is that it isn’t something found in a textbook.

Putting all of that to one side, the point of my post isn’t whether the court was right or not – courts are allowed to make mistakes, and under different circumstances it would have been unfortunate for Bayer but of little other note. My point, which you haven’t (and I daresay can’t) refute, is that it is not sound policy for courts to substitute their intuition or “common sense,” in hindsight, in the face of affirmative and uncontradicted testimony that a result was surprising and unexpected. Particularly when the documentary and prior art evidence establish that the invention was not something the art would have expected to work. Otherwise, we preclude or at least inhibit inventions involving truly counterintuitive insights (or even experimental results) by applying hindsight to say “the skilled worker would have known it would work,” when the evidence is manifestly to the contrary.

Thanks for the post.

[Kevin E. Noonan]

Dear breadcrumbs:

I usually read Gary's blog, but it's been busy here.

But I did just now. Thanks for the heads-up.

[Kevin E. Noonan]

Dear Keep:

The difference between what these inventors did and what you suggest is that the facts supported their assertions. If it were so easy to show that the claim of unexpected results was illegitimate, Barr would have been able to have their expert provide countervailing evidence for the district court to cite. And if that had happened, I would have written a different post, because a district court judge is certainly justified in deciding credibility of experts who differ.

What I don't think the judge should do is substitute his "common sense" in the face of uncontroverted evidence - and if he disbelieved the Bayer inventors on credibility grounds, he should have/would have said so. He didn't.

Thanks for the post.

[6]

dng it kev, your site just ate my comment 3 times in a row.

Bottom line. I agree it isn't good policy. 103 isn't good policy. Bad policy flows directly from the bad statute.

This judge didn't substitute anything for anything. And certainly not common sense for evidence. He considered the entirety of the record. That is, he considered the evidence, and the "common sense" (although those two words do not appear to have come from the DC, but rather only from the USSC in this particular decision).

I would call what he considered the evidence and an objective analysis of the rest of the art from the point of view of a poshita. Perfectly legitimate to consider all of that.

Admittedly, the objective analysis in this case was quite poor, and that is why I wouldn't personally have used it. None the less, lay judge is lay judge. No clear error, that's how the cookie crumbles.

Don't be mad, but I've totally precluded "great counterintuitive insights" etc. I do so when a legitimate objective analysis of the rest of the art suggests that it actually wasn't all that counterintuitive. And you know what? I don't recall ever having heard any bs back about these types of rejections. Which is rather astounding I have to say, because you would expect there to be. And if the applicant came back and said, well, ok, maybe you're right but we still feel like it would have been counterintuitive because of xyz then I'd consider that too. But secondary considerations are just that. Secondary. Second class citizens in the world of 103.

[MaxDrei]

Ignorant question from Europe. In pharma, when judging obviousness, are unexpected results really (as 6 seems to be asserting) a secondary consideration?

I ask because, in Europe, they aren't.

Just curious.

[Kevin E. Noonan]

Dear Max:

6 is not an examiner in the chemical arts, which have traditionally been more unpredictable than the others and have traditionally relied on unexpected results for establishing non-obviousness.

I think there may be some confusion between unexpected results and the "secondary considerations" in Graham v. John Deere, since while something that is obvious may still have commercial success or satisfy a long-felt need, if the results were truly unexpected then they are more likely to be non-obvious as well.

Which has been the law until the distortions of the CAFC trying to satisfy KSR (unnecessarily, in my view). But remember, this is a 3-judge panel and since obviousness is very much reliant on the underlying facts, the next panel could decide the other way.

Thanks for the post.