EISAI v. DR. REDDY’S LABORATORY and TEVA PHARMACEUTICALS (Fed. Cir. 2008)
Eisai’s blockbuster ulcer drug AcipHex boasts over $1 billion in annual worldwide sales. The company holds a patent covering the active ingredient – rabeprazole – and its salts. Dr. Reddy’s and Teva each filed ANDAs and Eisai filed suit to block generic entry.
Eisai won a summary judgment decision that the patent is infringed and enforceable. The appeal focuses on obviousness and inequitable conduct.
Obviousness of Chemical Compounds: Structural similarity is the touchstone of the obviousness inquiry for patents claiming a novel chemical compound. A looming question for pharmaceutical companies, however, is how the Supreme Court’s decision in KSR v. Teleflex will impact chemical patents.
In KSR, the Supreme Court eased a defendant’s pathway for invalidating a patent as obviousness. KSR’s focus, however was on inventions created by combining known elements. Here, the individual components of Eisai’s claimed compound were all known. However, the Eisai decision cabins-in KSR’s importance by showing that the assumptions found in KSR often do not apply to chemical compound cases.
“The Supreme Court’s analysis in KSR thus relies on several assumptions about the prior art landscape. First, KSR assumes a starting reference point or points in the art, prior to the time of invention, from which a skilled artisan might identify a problem and pursue potential solutions. Second, KSR presupposes that the record up to the time of invention would give some reasons, available within the knowledge of one of skill in the art, to make particular modifications to achieve the claimed compound. Third, the Supreme Court’s analysis in KSR presumes that the record before the time of invention would supply some reasons for narrowing the prior art universe to a “finite number of identified, predictable solutions.” In Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008), this court further explained that this “easily traversed, small and finite number of alternatives . . . might support an inference of obviousness.” To the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these “identified, predictable solutions” may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.”
Thus, in chemical compound cases, “a prima facie case for obviousness for a chemical compound still, in general, begins with the reasoned identification of a [prior art] lead compound.” Obviousness can then based on structural similarity along with some “motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound.” Although the motivation to modify the prior art can come from many different fields, some motivation is needed. In chemical cases, this motivation may be proved by showing a ‘sufficiently close relationship’ between the prior art and claimed compound that would ‘create an expectation . . . that the new compound will have similar properties to the old.’ (internal quotation marks removed). In other words, an obvious substitution would be ‘predictable.’
In this case, the lead compound – Lansoprazole – is quite similar to the claimed compound Rabeprazole. The difference is only found in a trifluroethoxy substituent at the 4–position (see figure) versus a methoxypropoxy substituent. Although structurally similar, the CAFC could not find any motivation to substitute the active groups. In particular, the court noted that it would not make sense to drop trifluroethoxy from the prior art — since it is that substituent that activated Lansoprazole.
“The record, however, shows no discernible reason for a skilled artisan to begin with lansoprazole only to drop the very feature, the fluorinated substituent, that gave this advantageous property.”
Nonobviousness affirmed.
A High Bar for Inequitable Conduct: As usual, Judge Rader took a hard stance against inequitable conduct. He writes:
“Inequitable conduct in prosecuting a patent application before the United States Patent & Trademark Office may take the form of an affirmative misrepresentation of material fact, a failure to disclose material information, or the submission of false material information, but in every case this false or misleading material communication or failure to communicate must be coupled with an intent to deceive. Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1378 (Fed. Cir. 2008). Materiality, defined as “what a reasonable examiner would have considered important in deciding whether to allow a patent application,” and intent are both questions of fact, and require proof by clear and convincing evidence. Id. To satisfy the “intent” prong for unenforceability, “the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive.” Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc) (citing Norton v. Curtiss, 433 F.2d 779 (CCPA 1970)). Gross negligence is not sufficient. Id. This is a high bar.”
This opinion along with Judge Rader’s recent dissent in the Aventis case may show a growing split within the court on the issue of inequitable conduct.
Notes:
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I updated this report to add a squishy word: “often.” The modified sentence now reads: “However, the Eisai decision cabins-in KSR’s importance by showing that the assumptions found in KSR often do not apply to chemical compound cases.”
Mr. Crouch:
How come this post isn’t categorized in either “chemical” or “obviousness”? I think it would be useful to keep the categories comprehensive.
In any event, thank you for generating this conversation.
Depends what you mean, Dude, by “get on fine”. There are plenty of parties in mainland Europe who are aggrieved about cheats having prospered, in civil law jurisdictions, up to now. My belief is that common law jurisdictions have powerful tools that can winkle out evidence that is beyond the reach of civil law jurisdictions. Mind you, with the EU Enforcement Directive just now introduced, all over mainland Europe, where the tempering effects of 700 hundred years of English legal equity are absent, and with that well-known tendency of a pendulum to swing over-centre, who knows what’s in store for us, when patents get litigated in Europe next year and the year after.
Dude
My own view is that “letters patent” should mean what it says and that a granted patent should be taken at face value, as it would be understood by the PHOSITA. Validity, construction and enforceability should depend first and foremost on the teaching provided by the patent as published and as compared to the relevant prior art. Inequitable conduct and other prosecution issues should rarely be relevant unless particularly egregious. That’s pretty much how it works in Europe (or the UK at least), where the only serious prosecution issue is usually the question of added subject matter; i.e. was the content of the application materially increased after filing, to the benefit of the patentee and the detriment of others.
Sorry to come so late to the discussion.
MaxDrei & Eurodisnae: I would be interested to have your comments about inequitable conduct before the patent office as a general matter. Europe seems to get on just fine without the kind of disclosure duty operative in the US.
Hope that Mooney sycophant gig works out for you Max. Maybe you two can go on the road, you know, the one that is paved with good intentions.
Sorry Eurodisna. With “the” molecule, I expressed myself somewhat infelicitously. The OTP is to make a compound that is a “mere alternative”. But, in writing this answer, I may have answered my own question for, even if it is to be no more than a mere alternative, it still has to exhibit pharmaceutical activity, and that’s not obvious. Forgive us, other readers, for this somewhat abstruse discussion between two non-chemists about chemical obviousness at the EPO. My championing of PSA was qualified by a doubt whether it fits snugly with chemistry. I’m coming round though. Bad news for readers who weary of my enthusiasm for PSA.
Max, I’m no chemist either, but given a claim that defines a new molecule, I can’t see how a valid OTP would be simply “how to make” the molecule, which must rely on hindsight with knowledge of the invention. For it to be obvious, there would have to be some obvious reason for wanting to make it, starting from the closest prior art.
Thanks Comment. Makes sense that the PTO motivation can differ from the subjective motivation of the inventor. You write “for pharmaceutical compounds”. So, if I look upon it as if “pharmaceutical” is automatically read into the claim directed to “Molecule X”, that is, implicit in the claim, would that be one way to understand motivation and its relationship to obviousness?
Posted by: MaxDrei | Jul 30, 2008 at 07:18 AM
–They should be claiming “Anti-ulcer drug, namely molecule X” but instead (successfully) claim “Molecule X and thereby win a monopoly even when molecule X is used as an auto fuel additive. Doesn’t seem right to me. You? —
Here in the US, the obviousness question is, what is the motivation to make the particular molecule being claimed? “For the sake of making a new molecule” is not motivation to the Federal Circuit. The USPTO’s obviousness rejection can use a different motivation than the applicant. It’s just that for pharmaceutical compounds, the motivation is almost always for some known therapeutic effect (see upthread for why).
Thanks Eurodisnae. Can you go a step further namely:
KSR=PSA=Absolute protection of substances = QED.
What I am driving at is the PSA “objective technical problem” and how it relates to claims directed to “Molecule X”.
Seems to me (non-chemist) that, for such a claim, the OTP is to make a new molecule. Easy to solve.
Seems to me, however, that the OTP which Judge Rader and chemists before the EPO invoke is the very different one, of making an efficaceous anti-ulcer drug. Much harder, of course and far less obvious.
And so it comes to pass, that chemists have their cake, and eat it too. They should be claiming “Anti-ulcer drug, namely molecule X” but instead (successfully) claim “Molecule X and thereby win a monopoly even when molecule X is used as an auto fuel additive. Doesn’t seem right to me. You?
“The Supreme Court’s analysis in KSR thus relies on several assumptions about the prior art landscape. First, KSR assumes a starting reference point or points in the art, prior to the time of invention, from which a skilled artisan might identify a problem and pursue potential solutions. Second, KSR presupposes that the record up to the time of invention would give some reasons, available within the knowledge of one of skill in the art, to make particular modifications to achieve the claimed compound. Third, the Supreme Court’s analysis in KSR presumes that the record before the time of invention would supply some reasons for narrowing the prior art universe to a “finite number of identified, predictable solutions.” In Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008), this court further explained that this “easily traversed, small and finite number of alternatives . . . might support an inference of obviousness.” To the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these “identified, predictable solutions” may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.”
and
“Obviousness can then based on structural similarity along with some “motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound.” Although the motivation to modify the prior art can come from many different fields, some motivation is needed.”
and
““The record, however, shows no discernible reason for a skilled artisan to begin with lansoprazole only to drop the very feature, the fluorinated substituent, that gave this advantageous property.”
Ergo, KSR = PSA, QED?
Reading that last little offering, I felt compelled to consult Webster’s, on the meaning of a word that came immediately to mind, namely “subversive”. Until I read your posting, Chaon, I had thought it a dirty word. Now (compliment) I no longer think that. Been spending time with your mouth open, have you? At least long enough for some tricky patent lawyer to put swear words into it?
As someone who has filed ridiculously broad claims to the PTO along with sworn statements that those claims describe inventions that are, to the best of my knowledge, new, I find MM’s comments disturbing because they remind me that we’re not fooling anyone.
You know, for this patent practitioner, looking in on the zoo, from a viewpoint outside the fence, the Mooney contributions consistently make a good deal more sense than those of certain other contributers. Just thought I would get that off my chest, even though many would say I’m impertinent, and that it’s none of my business. But it is my business, and I do hope that Mooney goes on contributing, so I can continue to learn, from the ensuing outcry.
Get real Mooney. The point is, Rader is trying to discourage the longstanding and tiresome practice of raising IC at every patent trial. Rader as much as said so in the opinion. You strut around like you’ve got something going on, yet you don’t have a clue about the fundamental reality of the ugly history of IC.
By the way, Pollyanna wants her satin panties back.
“I think you are naive in the extreme about the motives of U.S. District judges, who ARE busy and typically technically semi-literate at best.”
But the fact is that findings of inequitable conduct are still very rare so judges seem to be doing just fine controlling their insidious desires to dispose of cases.
Compare that with the ridiculously broad claims that are routinely presented by applicants to the PTO (and readily identified by anyone perusing the database), along with sworn statements that those claims describe inventions that are, to the best of the inventor’s knowledge, new.
I think that Rader doesn’t like IC because he doesn’t like the stink that rises out of it and taints the entire enterprise. He really wants to believe that the vast majority of patents are filed simply to protect the inventor’s wonderful invention. Maybe that was the case at some point and maybe it will be the case again. But it seems to many of us who have been in the trenches for at least the past decade that patent speculation and trolling became a business in itself, where the ends justify the means.
To raise the bar on IC, to hold one’s nose and look away, merely encourages bad behavior because it decreases the chances that an applicant will be caught and applicant’s take that fact into account.
On the other hand, it seems very unlikely that a genuine (heh) inventor will forgo filing an application merely because he/she is worried about being wrongly accused of IC and losing the patent.
I can not think of a single instance of IC being found where I felt certain that an innocent person got screwed by the system. Is there some shocking fact pattern out there that I missed? Every time I read a case where IC is found it seems to me that the decision was reasonably well grounded.
“Um, no? Have you checked the dockets of US District Court judges lately? They are busy. Perhaps you encountered the concept of “judicial economy” in law school. It’s an important concept. Your argument against judges finding IC is no more compelling than an argument against judges finding a lack of subject matter jurisdiction. If a judge can dispose of a case quickly, he/she should do so. Next in line!”
For someone who voices such cynicism about the motives of most patent practitioners (and nearly every patent except the ones you prosecuted), I think you are naive in the extreme about the motives of U.S. District judges, who ARE busy and typically technically semi-literate at best. I think Aventis was wrongly decided and, YES, disturbing. IC is (or at least ought to be) tantamount to fraud and should be a disfavored cause of action, not a convenient shortcut so the judge can bail out of the office Friday afternoon and play golf.
Anyway, thanks for the well wishes on the bar exam. I just finished the first day. Grueling and worse than I anticipated, but I have to remember the pass rate in Maryland has been running around 70-75%.
BTW, I mostly enjoy your comments and even those of your archenemies on this board. I don’t want to fall into any ad-hominem attacks, so please don’t take it that way.
Regards.
“Don’t you find it a little disturbing that U.S. District Judges find it convenient and tempting to sidestep all the complications of claim construction and Markman hearings, and subject oneself to probably a 50% reversal rate on appeal, when it’s so much easier to “decide” the case on the basis of inequitable conduct?”
Um, no? Have you checked the dockets of US District Court judges lately? They are busy. Perhaps you encountered the concept of “judicial economy” in law school. It’s an important concept. Your argument against judges finding IC is no more compelling than an argument against judges finding a lack of subject matter jurisdiction. If a judge can dispose of a case quickly, he/she should do so. Next in line!
Good luck with the bar exam.
“It works so well that the Posita would not want to modify it” How well would that be then? Is that how American inventors usually think? Just about lanzoprazole, or about everything current? The auto industry perhaps.
Ignore the first comment above. I had it all backwards as to who was claiming what.
The lead compound analysis is a crock. So, lansoprazole is the starting point because it has desirable traits. OK, fine, lansoprazole it is. But, it works so well that the POSITA would not want to modify it! So if you choose the “best” molecule as a starting point, no motivation to modify, but you can’t pick a lesser molecule because why would one want to use an inferior starting point? Wait…what?
Perspective of a practicing chemist: I’m surprised that Eisai’s original Markush claims didn’t go broader to cover this moiety.
It wouldn’t be overly challenging to look at Markush claims from multiple patents and establish both trends in the coverage and the broadest coverage. In this case, the moiety in question is providing water solubility. Woudn’t such an analysis be a way to define the knowledge of what then is obvious?
As far as obviousness in the area of chemical compounds, I think Luke’s comment speaks to the point. I would add that the obviousness question here should turn on the number of possible substituents (known in the prior art? suggested in the prior art?) of roughly comparable molecular weight and lipophilicity, or possibly other desirable properties. It’s not strightforward to define the problem precisely, I suspect, but my guess is in this case the courts got it right, and there was no obviousness here.
As far as obviousness generally, I was initially sympathetic to the views expressed by the 24 or 26 or whatever law professors who argued against the TSM test, but in hindsight (pun intended), I’m starting to think the “cure” in KSR is worse than the disease. Aside from the bizarro ruling in KSR itself, affirming a summary judgment of obviousness (pretending that such a question is legal rather than factual), I agree with MaxDrei who has expressed elsewhere on this board that the U.S. lacks any meaningful standard for determining obviousness. And don’t tell me about the Graham factors–they are superficial and hopelessly vague, and don’t address the hindsight problem.
I for one agree with Judge Rader, so I guess that puts me somewhere out in the tall grass. (By way of disclosure, I’m just a neophyte, in fact I have to sit for the bar exam today and tomorrow.)
Anyhow, I think it worth quoting from Judge Rader’s dissent in Aventis after remand, filed May 14, 2008, reported at 525 F.3d 1334 (case linked):
Although designed to facilitate USPTO examination, inequitable conduct has taken on a new life as a litigation tactic. The allegation of inequitable conduct opens new avenues of discovery; impugns the integrity of patentee, its counsel, and the patent itself; excludes the prosecuting attorney from trial participation (other than as a witness); and even offers the trial court a way to dispose of a case without the rigors of claim construction and other complex patent doctrines. This court has even observed a number of cases, such as this one, that arrive on appeal solely on the basis of inequitable conduct where the trial court has apparently elected to try this issue in advance of the issues of infringement and validity.
525 F.3d at 1349-50 (citations omitted).
Don’t you find it a little disturbing that U.S. District Judges find it convenient and tempting to sidestep all the complications of claim construction and Markman hearings, and subject oneself to probably a 50% reversal rate on appeal, when it’s so much easier to “decide” the case on the basis of inequitable conduct? I think IC is a sort of scorched earth/atomic bomb litigation tactic that should be reserved for truly exceptional cases, just like willful infringement has in the past been overused by patentees, but more recently has been reined in. See, e.g., Knorr-Bremse.
Another way to put this is, despite the criticisms on this board and elsewhere about the presumption of validity, I think an infringement case should begin with a presumption that the patent is valid (arguably just by a preponderance standard, I think the statutory language would permit that although the case law would haver to be overturned), and that alleged infringers should not have easy access to the often unjustified windfall of IC. Like the infringer in Aventis. I fail to see how an infringer has “better equities” than a patentee who arguably did not intend to deceive the PTO, although certainly could have been more transparent in flagging pending related applications.
Pollyanna makes some good points
A key point in the obviousness determination of this case is that (p8) “the record contains no reasons a skilled artisan would have considered modification of lansoprazole by removing the lipophilicity-conferring fluorinated substituent as an identifiable, predictable solution”. I.e. why would you replace the very item that is (probably) responsible for activity?
However, there is a very good reason to so experiment – to see if you could improve the effect. If we look at the lead compound we see the substituent is a small but still quite lipohilic group, 3,3,3-trifluoroethoxy, due to the terminal trifluoromethoxy group. Replacing this with a methoxyethyl group as in the claimed compound could be expected to give quite similar properties in many cases. (But not, I would say, to the point of being legally obvious – I don’t think it would even be “obvious to try”) So there are cogent reasons why one might to the substitution envisaged.
But nothing like this sort of consideration seems to have entered into the trial record.
Cheers Luke
Malcolm makes some good points; but asks
“Of course, very narrow picture type claims are only valuable if the actual composition being protected is *the* only composition that has the desired properties. After all, why were those generic companies fighting over this in the first place? ;)”
Well, in the pharmaceutical field, it’s because the specific compound the generic manufacturers want to make is the one that has already passed the regulatory hurdles.
Making a variant of the active ingredient, as opposed to say a different adduct of it, or formulation, isn’t any good, since it will have to go through a whole new set of clinical trials, etc.
So they need to make the *exact* compound (by which I mean a specific core compound plus al its various salts, etc.) claimed for regulatory reasons.
Cheers, Luke
I do hope we are going to get some discussion of chemical obviousness on this thread, following a nil showing for the same case on the Prospector and the Barista blogs despite valiant efforts by those two to stimulate comment. Meanwhile, many thanks to Malcolm Mooney, the only commentator (so far) with anything intelligent to say on the subject. What I want to know is whether the USA handles the non-obviousness of claims to “Molecule X” any differently from the EPO. As to the adjective “genuine” (Malcolm, I laughed out loud) we all know of the perils of adjectives in claims. But adjectives are even more dangerous than that: they have the power severely to embarrass an eminent CAFC patents judge.
Stop talking to yourself Dennis.
“It’s obvious because I say it’s obvious.”
That’s the standard, if you can call it that.
Just Visiting, the explanation is that it’s possible for the district court to wave off a big stink based on some sweet talk, threats of being overturned on appeal, the importance of the patent, etc and be all-too-forgiving. Then when the CAFC reads the findings of fact they can say: we don’t care how important this patent is anybody who engages in X and Y and Z is guilty of inequitable conduct (as a per se matter).
Fine. As we know, this very rarely happens (raising the question: why is Rader so uptight about the alleged scourge?)
On the other hand, if the district court listens to the testimony of all the witnesses and sees how they behave in the courtroom and on the stand and gets the sense from the behavior of the attorneys that there is covering up going on left and right and reaches a conclusion, based on the entirety of the circumstances, that there was inequitable conduct, absent a glaring error the CAFC should let it ride. They weren’t there.
Mooney, I told you to stop talking about me. And stop calling me at work.
“Agreed. And for the same reason, finding no IC where the trial court did should be even more difficult.”
Could you explain why you believe this?
Just Visiting, the only one I’m aware of is Critikon.
I have a more extended comment on this pending review because it tripped the spam filter…
“While Rader has been an inequitable conduct dissenter, finding inequitable conduct where the trial court did not ought to be fairly difficult for the FC.”
Agreed. And for the same reason, finding no IC where the trial court did should be even more difficult.
Dennis: “This opinion along with Judge Rader’s recent dissent in the Aventis case may show a growing split within the court on the issue of inequitable conduct.”
That may true. If so, I think Rader is standing so far out in left field that the grass is up to his chest.
First we had that case a few weeks back where he expressed astonishment that a “highly respected scientist” would “risk his reputation” by becoming involved in a less-than-100%-honest effort to secure a patent. That struck me as shockingly naive, both in its pollyana view of patent applicants and in its ignorance of the actual effect of a solitary inequitable conduct finding on a perpetrator and his/her reputations (zilcho).
While not quite as bizarre, this case has its own bit of revisionist weirdness. Specifically, on page 12, we find this chestnut:
“Finally, the district court found that Teva’s theory that Eisai deliberately hid the ball from the Patent Office by separately filing the ’552 and ’013 prosecutions to be “implausibly risky,” given that such similar applications would usually be assigned to the
same examiner in the same art unit. Trial Order at 53”
Try to figure that logic out: separately filing applications and not disclosing the rejections from one application to the Examiner of another is not evidence of anything ***because it’s likely that you’d get caught and probably wouldn’t work anyway.***
Wha …?!?!?!? It’s like ignoring a receipt for rubber gloves as evidence of prior planning in a murder/disappearance case on the grounds that “every respectable murderer knows that you have to throw the receipt away.”
Anyway, Rader’s “issues” are bound to washed away by the rising tide because as folks get more desperate for patents and judges start to see the same “strategies” utilized again and again, we’re going to see more chicanery exposed, not less.
With respect to inequitable conduct, I cannot remember any recent cases where the FC has found inequitable conduct despite the trial court finding differntly. While Rader has been an inequitable conduct dissenter, finding inequitable conduct where the trial court did not ought to be fairly difficult for the FC.
Dennis: “However, the Eisai decision cabins-in KSR’s importance by showing that the assumptions found in KSR do not apply to chemical compound cases.”
Well, I wouldn’t go that far. I’d say that the CAFC merely recognized that the Supreme Court did not intend that KSR be applied in a moronic, thoughtless fashion. Let’s look closely at the key sentence in the excerpted passage from the decision:
“To the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these “identified, predictable solutions” may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.”
Here’s the take-home: (1)the chemical arts are sometimes predictable, but sometimes they are not predictable;
(2) If the particular chemical art at issue is unpredictable, this MAY make obviousness more difficult to prove.
There is nothing at all surprising or new here.
Perhaps there were a few chicken littles who wanted to believe (or wanted others to believe, so they could pretend to be standing up for something) that KSR was going to destroy the pharma and biotech industry because nobody would be able to patent a new composition ever again — OH MY GOD!!!!!!! Those chicken littles may find solace in this case but, in fact, this case changes absolutely nothing.
The real take home here is that a very narrow picture-type claim is more likely to survive an obviousness challenge than the sort of broad claim with functional language that is typically deemed to be more valuable by clients. Of course, very narrow picture type claims are only valuable if the actual composition being protected is *the* only composition that has the desired properties. After all, why were those generic companies fighting over this in the first place? 😉
In the case where a composition (i.e., a chemical compound or formula) is claimed more broadly, such that it encompasses a generic “off the shelf” solution to a problem (i.e., “a meltable blah blah comprising a lubricating agent,” “a cyrstalline blah blah comprising an acidic moiety”, “a non-scented blah blah comprising a divalent salt”) then KSR is still going to crush the claim nine times out of ten.
One bit of laziness in that excerpt that irritates me is that reference to “genuinely predictable.” The term “genuinely” in that context is not at all helpful. This afternoon’s weather is predictable (it won’t rain). Is it “genuinely predictable”? Adding glycerol will make a solution more viscous. Is that phenomenon “genuinely predictable”?
The CAFC has previously recognized that the issue of “genuine predictability” is a red herring. The question is: would one skilled in the art have a ****reasonable expectation**** that the compound *as claimed* would have a non-trivial use? Based on a cursory reading of this case, it seems to me that the answer was quite plainly “no,” even if you acknowledge (as required by law) that the expectation need not be close to certainty.
The truly confounding aspect of the obviousness analysis in the chemical context is that, depending on how the claim is drafted, the problem to be solved by the art does not need to bear any resemblance to the features and uses of the composition that are highlighted in the patentee’s (or applicant’s) specification.
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