by Dennis Crouch
Par Pharma v. TWI Pharma (Fed. Cir. 2014)
In a strong opinion, the Federal Circuit has overturned a lower court summary judgment that Par’s megestrol formulation patent claims are obvious. (U.S. Patent No. 7,101,576). The case is interesting because it further solidifies the appellate court’s stance that functional claim limitations should be given their full weight and merit even when serving as the point-of-novelty of the invention.
As with many drug-related patents, Par’s claims include limitations regarding the effect of the drug. Here, the real benefit of Par’s formulation is that it is equally effective if administered in both a “fed” and “fasted” state. During prosecution (and in response to an obviousness rejection), par added the follow food-effect limitation: “wherein after a single administration … there is no substantial difference in the Cmax of megestrol when the formulation is administered to the subject in a fed versus a fasted state.” The remainder of the claim involves a series of specific dosages and particle size limitations to be used in the drug administration.
At trial, the district found the claims obvious based upon a combination of prior art references. Notably, the prior art was not shown to teach the food-effect limitation. However, the district court determined that the wherein clause deserved no weight in the obviousness analysis because it was simply describing a result inherent to the formulation.
On appeal, the Federal Circuit has vacated that finding — noting that the district court “incorrectly applied our law on inherency in the context of obviousness.”
Inherency: The traditional approach to inherency is with reference to the prior art — even when not expressly disclosed by the prior art, a feature will be deemed inherent to the prior art if “the natural result flowing from the operation as taught would result in the performance of the questioned function.” Hansgirg v. Kemmer, 102 F.2d 212, 214 (C.C.P.A. 1939). In the obviousness-combination context, the question is whether the non-disclosed limitation is the natural result of the combination of reference. In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981) (“[M]ere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art.”). The Federal Circuit here writes “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.”
Of importance, however, the “natural flow” must be proven with clear and convincing evidence and may not be established by probabilities or possibilities or expectation.
In reviewing the evidence presented in this case, the appellate panel found that the challenger had failed to present sufficient evidence of inherency. In particular, althought the evidence presented showed that the combination would improve the food-effect, there was no evidence presented that the food effect was substantially eliminated as required by the claims.
While it may be true that a reduction in particle size [as disclosed in the prior art] naturally results in some improvement in the food effect, the district court failed to conclude that the reduction in particle size naturally results in “no substantial difference” in the food effect.
On remand, the district court will likely consider further evidence with regard to inherency.
The case here also ties-in with Mayo v. Prometheus. Following that decision, the claimed food-effect as a result of the particular administration would be seen as an unpatentable law of nature. The question then is whether that claimed function can serve as the point of novelty sufficient to overcome the prior art.
woah, apparently not pleased with district court here: “The district court’s broad diktats regarding the effect of particle size on bioavailability and food effect are not commensurate with the actual limitations at issue. “
I think that the holding here is entirely consistent with prior case law, but the rule used to decide it is not. The CCPA explicitly rejected “flow naturally from” for inherency in obviousness cases in In re Henderson, 348 F.2d 550, 553 (C.C.P.A. 1965).
I think that it is important to understand that there are three different lines of law for inherency: (1) anticipation by inherency; (2) obviousness by inherency over a single reference; and (3) obviousness by inherency over a combination of references. (See Bradford Duft & Eric Mirabel, Principles of Inherency, 540 J. PAT. OFF. SOC’Y 539, 548 (1995)). The legal standard for each is different. I notice that 1.1.1.2.1 above is rather confusingly citing anticipation cases, which are one of the three, and not one that is relevant to the present case.
The rule for cases like this one (obviousness by inherency over multiple references) has always been that the results achieved from combining the references had to be expected at the time of invention for obviousness to be established. (See, Henderson, supra). The holding in this case is consistent with the Henderson rule, but the instructions for remand are not. I notice that Par never cited Henderson in their briefs. Hopefully, they will correct this omission if they need to return to the CAFC after remand.
Excellent post Greg – thanks for the info!
Very nice summary, Greg, thank you.
This standard for obviousness by inherency over a combination of references — that the inherent feature be known or obvious at the time of invention — is crucial for preserving the ability to rebut a prima facie case of obviousness with evidence of unexpected results.
“The case here also ties-in with Mayo v. Prometheus. Following that decision, the claimed food-effect as a result of the particular administration would be seen as an unpatentable law of nature.”
I respectfully disagree. This case does not merit a 101 analysis.
If we follow the proposed reasoning for conducting a 101 analysis of the Bar claims as related to the “law of nature” exclusion, then all methods of treatment would be considered invalid, because efficacy (the improvement) is the result of natural processes occurring in a body, and those natural processes are the results of the laws of nature in action. In fact, all composition claims claiming any improved property would also be invalid, because those improved properties would necessarily derive from the natural properties of the components of the composition and those natural properties are the results of the laws of nature in action. In other words, even though biological and chemical processes and compositions and their properties and interactions are governed by laws of nature, they are not themselves laws of nature.
We have to be careful not to over read the requirements of the 101 statute and on top of that misapply the unfortunately related current poor jurisprudence on point.
The Par claims include tangible steps, provide tangible results and do not recite any “law of nature”. They meet the 101 requirements for subject matter eligibility.
I hear you loud and clear Rick.
One analogy to what you are saying is my ‘big box of electrons, protons, and neutrons.”
It is the exact same logic, simply applied to where that logic takes you.
And like the lack of actual limits to the Court’s “Gist/Abstract” sword, it is not up to practitioners to try to come up with some post facto limits to the judicial activism.
Stomp on the gas peddle of what the Justices have done. There is NO more expeditious path to showing why that logic used is f@tally defective.
Dennis, on 101, if the food effect is the only novelty in the claim, you might have a real 101 case. But the claimed compound was not known, and the food effect itself was apparently an unexpected result.
One of the reasons I find this case confusing is that the Feds agreed with the district court that the food effect was not substantial and could not overcome the other reasons to make the new compound obvious. This whole discussion seems inconsistent with its requirement to show all claim limitations because the only difference between the obvious to try compound and the prior art was the claimed food effect.
One scratches one’s head.
A food effect is not a law of nature. It is the indirect product of laws of nature in action. The food effect is the product of the biological and chemical processes occurring within the body, and those processes are governed by laws of nature.
Consider the difference between gravity and an object falling due to gravity. We cannot claim gravity alone; however, we can claim methods requiring an object in motion (falling). For example, consider the following prophetic claim.
“A method of preparing sand comprising repeatedly dropping a steel hammer onto a silicate glass substrate, thereby breaking the substrate to form the sand.”
The “dropping” is the necessary result of gravity, and the “breaking” is the necessary result of the differences in properties between the hard steel hammer and the brittle silicate glass when the two collide with sufficient momentum to overcome the attractive intermolecular forces holding the molecules of silica together.
Even though the prophetic claim above requires gravity and the glass will necessarily break due to the differences in natural properties between steel and silicate glass, the claim is nonetheless subject matter eligible, albeit unpatentable for lack of novelty. The claim should still be subject matter eligible even if it read as follows:
“A method of preparing sand comprising repeatedly dropping a steel hammer ‘under the force of gravity’ onto a silicate glass substrate, thereby breaking the substrate to form the sand.”
Even though the claim recites gravity and the method relies upon gravity, the claim does not cover solely gravity. It provides a tangible result and includes a tangible step.
The current jurisprudence on 101 analysis is the problem. For some reason, the Courts are unable to accept the straightforward requirements of the statute, which can be summarized as follows: an invention is subject matter eligible if it is tangible, includes a tangible step, or provides a tangible result. An abstract idea is not tangible. A claim that specifies only a law of nature is specifically excluded. A law of nature in and of itself is not tangible, because a law is merely an expression of observed results. (For example, weight is the result of the existence of gravitational forces and weightlessness is the result of lack of gravitational forces. In either case, the law expressing those gravitational forces does not change.)
However, APPLICATION of (processes employing) abstract ideas or laws of nature are (should be) subject matter eligible as long as they provide a tangible result. A claim that is subject matter eligible must specify more than an abstract idea or law of nature, and it must possess or provide something tangible.
It is only after meeting the bar for subject matter eligibility that claims should be analyzed under the other statutes for patentability.
Unfortunately, the Courts have developed a mutated form of subject matter eligibility analysis that involves first a 102/103 analysis and second a 101 analysis. They improperly dissect a claim to identify the “novel” (102) limitation and then ask the question if that limitation is subject matter eligible (101). Subject matter eligibility should be analyzed on a whole claim basis, just as we due under proper 102 and 103 analyses. The Courts’ own jurisprudence provides precedence for a “whole claim” analysis. Yet, they throw the precedent out the window when it comes to 101.
Please see my comments in response to the USPTO’s Guidance for Determining Subject Matter Eligibility of Claims reciting or Involving Laws of Nature (link to uspto.gov).
As an aside, the Courts’ jurisprudence in Alice regarding subject matter eligibility is also incorrect. The simple act of requiring that a claimed abstract idea (business method) exist in a tangible object (computer) should be sufficient to render the claimed invention subject matter eligible under 101. That is not to say that it is patentable, i.e. it is still obvious to include business methods on computers.
Rick, so if a claim mixes the statutory and the non statutory, you would find that it passes 101, but would hold it unpatentable under 102/103 because the statutory part is old or obvious?
I suggest this is actually the preferred approach as it is the approach we use with printed matter, a doctrinal form of analysis that first began with Hotel Security.
Provided the claim as a whole (not just the “statutory” part) is indeed anticipated or obvious, then yes it would be unpatentable under 102/103 rather than 101. Once a claim contains a statutory element, the claim as a whole is subject matter eligible regardless of the existence of “non-statutory” element(s) in the claim. Keep in mind the potential interaction between statutory and non-statutory limitations in a claim. The claim as whole is then properly analyzed for patentability under the remaining statutes.
I think such an approach is well aligned with the statutes and most other jurisprudence, except, of course, for the incorrect 101 decisions these past few years. I fully believe 101 was included in the statutes as a simple litmus test, threshold or gateway so that only creations or discoveries that are in someway tangible (as discussed above) could be “patented”.
The proper analysis mentioned above would not require evermore complicated jurisprudence, judicial exception(s) or provisory statutory language. Frankly, the authors of the Patent Statutes were visionary.
As an aside, it is perplexing to me that industry and counsel haven’t been more vehement about and effective at arguing this approach of analysis before the Court. I wonder what it would take to get the Courts back in line. I believe the Court would ultimately have to admit the flaws of the recent 101 decisions if they could be made to understand and uniformly apply two basics concepts: tangibility and analysis-of-claimed-invention-as-a-whole.
I hear you again Rick, but if you expect the Supreme Court to relinquish its power addiction to inject its own policy views through the wax nose of 101, you are sadly mistaken. See Prometheus (the Court jealously guarding its own ‘implicit writings’ no matter what Congress actually said – the no dead letters comment)
No. I think that the only way to remove the addict is for Congress to explicitly remove appellate review from the Supreme Court (and yes, this type of action does have constitutional authority and would not result in a violation of the judicial review holding of Marbury).
While certain pundits have scoffed at the idea (it would not be easy to undertake, given our shoddy Congress), the same pundits have failed to address the legal propriety of such a move.
I’m a big believer that one who creates a problem is responsible for fixing it.
Maybe we can provide opportunities for cogent discussion by making on point presentations and hosting public forums at the next few IP conferences and/or perhaps by making one or more on point presentations before some authoritative committee(s) of the USPTO. We might hopefully get some Fed. Cir. judges or Sup. Ct. justices to attend.
I imagine some of our (practitioners on the Patently-O blog) clients would support such efforts given the incredible rate at which patents are being invalidated and claims are being rejected under 101 these days. Millions to billions of dollars down the drain… It would seem worth the effort.
What I find difficult about this kind of functional limitation being used to uphold a claim’s validity, is how do you put the shoe on the other foot? In other words, lets say I accept that this limitation is enough to overcome some set of prior art, how is a person able to practice the obvious invention? Because the public does have a right to practice that which is in the public domain.
Alex: What I find difficult about this kind of functional limitation being used to uphold a claim’s validity, is how do you put the shoe on the other foot? In other words, lets say I accept that this limitation is enough to overcome some set of prior art, how is a person able to practice the obvious invention?
That is one of the critical questions, Alex.
The formulation was obvious and administering that formula to people in need of the formula, some of whom may be fed or fasted, is also obvious. So that subject matter is properly in the public domain.
At least it should be were it not for illogical decisions like this one that remove treatments from the public domain because some previously undescribed “result” got stuck in.
Ah well. It’s only sick people that have to pay more as a result of decisions like this. And they probably deserve to be sick. If only I weren’t a bleeding heart liberal I could understand the awesome fairness here.
The formulation was obvious and administering that formula to people in need of the formula, some of whom may be fed or fasted, is also obvious.
Wait a second, I think you are skipping to quickly to your conclusion. Both parties conceded that all structural limitations were known in the art, and that there was a motivation to combine the cited references. That is not the same thing, however, as to say that the result was “obvious.” The courts have long held, however, that the discovery of an unexpected result for a chemical composition can show that something that we might have initially considered obvious is not so obvious as we might first have thought.
That is exactly what we have here. Sure these elements (megestrol acetate at 400 mg/day, particle size less than 2 µm) were sitting around in the art. Sure there was a reason why one might have micromilled megestrol acetate down to <2µm particles. But you cannot stop there. You have to consider whether one of ordinary skill at the time of invention would have expected that so doing would relieve the food effect associated with megestrol. Given that it was well established by the district court that no one was even aware of the existence of a food effect at the time of invention, it is impossible that one of ordinary skill would have expected the micromilling to relieve the food effect.
Therefore, the composition is not obvious. You cannot just skip past these unexpected results when assessing obviousness.
Greg, there is something amiss here. If compound X is obvious to try, being “known” variant of an existing compound with every expectation that it would be successful in the known effect, the issue is whether the discovery of some unexpected property render that compound non obvious?
I would say definitely not. The patent should be limited to the “use” of the property.
This is like Myriad, where the BRCA was not claimable per se, but the property that it caused cancer could be used in a diagnostic process.
I would say the discovery of an unexpected property of an otherwise obvious compound to be a problem in the law.
[T]he issue is whether the discovery of some unexpected property render that compound non obvious?
Yes, I agree. That is the issue.
I would say definitely not.
Do you mean this as an expression of your understanding of what the law is, or as an expression of your preference as to what the law should be? If the latter, fair enough.
If the former, however, I have to disagree. Consider, for example, In re Papesch, 315 F.2d 381, 386-87 (C.C.P.A. 1963)
In other words, it is possible to have a situation in which a challenger has built an otherwise adequate case for the obviousness of a claim, but the challenger still loses because the properties of the claimed compound/composition possess an advantageous property that would not have been expected in the art at the time of invention. That is true even if there are advantageous properties to the compound/composition that would have been expected and would have motivated the ordinary artisan to combine the cited references. Henderson, 348 F.2d at 555.
Greg, thanks — and AFAIK, CCPA cases are en banc and controlling until overturned by en banc Fed. Cir. cases.
I still view it from the point of view that the discovery of the unexpected property was just that, unexpected. A serendipity.
Let us consider the following. The inventor is trying to determine the best combination of two drugs to cure toenail fungus. During this investigation, the range of selected combinations is known. The one that best cures toenail fungus, however, unexpectedly also cures male baldness.
Assume for the sake of this argument, the compound that cures toenail fungus is obvious because it was within the known range and obvious to try.
Now, if one allows the discoverer to claim the compound that also best cures toenail fungus just because it cures male baldness, the monopoly would not coincide with the discovery. I would think the claims should be limited to the use of the obvious compound for the unexpectedly discovered use.
Alex, public domain? This is a case about obviousness, not anticipation. They are not the same thing.
What is the distinction you see here? Maybe (probably) I’m being oversimplistic here, but:
If a patent claim is anticipated by a reference, that anticipating subject matter is still removed from the public domain until someone shows by clear and convincing evidence that the claim is anticipated.
If a patent claim is obvious over a combination of references, the subject matter suggested by the references is still removed from the public domain until someone shows by clear and convincing evidence that the claim is obvious.
Don’t invalid claims remove subject matter from the public domain in the same way for both obviousness and anticipation?
“If a patent claim is obvious over a combination of references, the subject matter suggested by the references is still removed from the public domain until someone shows by clear and convincing evidence that the claim is obvious.”
I still do not get just how something that is new can “be” in the public domain. We are not using our words carefully here.
If we see a train moving at high speed toward a brick wall, we know that it is going to crash. But until it crashes, it is not in fact in the state of having been crashed.
If I had to elaborate (I doubt I should for anyone who does patent law): “The public has a right to practice that which is in the public domain, and obvious derivations thereof.”
From a policy perspective, I think this is the most important part of the decision:
Further, in Santarus, we correctly identified that “an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations.” 694 F.3d at 1354; see also id. (“To hold otherwise would allow any formulation— no matter how obvious—to become patentable merely by testing and claiming an inherent property.”).
Santarus is important. The issue I have with this CAFC opinion is that the panel drove a truck through the logic underlying the Santurus’ holding in the very next sentence following the passage you quoted, on page 16:
Importantly, though, neither party [in the Santurus case] disputed that the blood serum concentrations claimed in Santarus were expected
Absent evidence of teaching away, why should it matter that a previously undescribed “effect”of an otherwise obvious method was “expected” or not?
Let’s consider a simple hypothetical.
Prior art reference A teaches drug X for treating baldness (drug is going off patent). Prior art reference B teaches that the potency of certain classes of drugs (of which X is a member) is improved when it is suspended in mineral oil. Therefore, treating bald people with X suspended in mineral oil is obvious.
Applicant discovers that administering X suspended in mineral oil to the scalp leads to “substantially unchanged” FSQ serum values in a “significant” number of patients (that’s “important” because lower FSQ values correlate with a 2-4% lowered risk of Blatfrak’s Syndrome in bald people). So applicant appends this result to its otherwise obvious claim. The claim is granted.
Now the generic company can no longer market the otherwise obvious generic product because at least some patients are going to experience “the new result”. The defendant — not the patentee — has the burden of proving by clear and convincing evidence that the “new” result “necessarily flows” from the otherwise obvious method recited in the claim.
What is being “promoted” by this scenario, other than keeping drug prices as high as possible for as long as possible?
“What is being “promoted” by this scenario, other than keeping drug prices as high as possible for as long as possible?”
The patent lawlyer job market?
Hmmm.
Ridicule on lawyers (who know the law) — ok
Jokes on tech people pretending to know the law — not so much.
One way streets…
Here’s what I think ought to happen at the PTO for this hypothetical application:
Examiner receives amendment with the appended functional limitation. Examiner effectively maintains the rejection but appends a statement of this sort: “Once POSITA combines X with mineral oil as suggested by reference B, they will have achieved the same composition as the Applicant’s composition. Thus the composition suggested by A and B would have the same properties as the Applicant’s composition, including the same [serum values etc.].” Then the boilerplate citations to In re Best, In re Spada, etc.
Then the burden shifts to the Applicant to establish why this may not necessarily be so – for instance, perhaps they could show how one could make a composition of X in mineral oil according to the prior art references’ suggestion that would not produce such serum values.
RH,
Are you doing this by taking official notice of the facts that you are advancing?
By “facts,” are you referring to the compositions being the same? If so, then this would need to be established by comparing what’s in the application with what the prior art suggests.
CAFC: “Importantly, though, neither party [in the Santurus case] disputed that the blood serum concentrations claimed in Santarus were expected”
MM: Absent evidence of teaching away, why should it matter that a previously undescribed “effect”of an otherwise obvious method was “expected” or not?
I think what the court was getting at here was that in Santarus, the blood serum concentrations were considered by both parties to be a consequence of the formulation. That is, had one of the parties set forth evidence that the blood serum concentrations could be a result of something other than merely the formulation, then it would have been established that one would not necessarily achieve the same concentration merely by making the same formulation. So, if we had reason to expect that the blood serum concentrations could be a result of something other than merely the formulation, then we wouldn’t think that the blood serum concentrations would be an inherent characteristic of the formulation.
Is prior art reference B an improvement patent?
(If so, there is an excellent albeit often overlooked quote from KSR that fits)
If so, there is an excellent albeit often overlooked quote from KSR that fits
Ooooh lookie it’s another one of those awesome guessing games where “anon” has some point to make but just can’t find the words.
Oh, I have the words at the ready.
You haven’t answered the question yet though.
This reading thing too much for you? Dialogue is more strenuous than monologuing…
Correct ruling. The fact that it is invalid under 112 and 101 is irrelevant for the 103 analysis. The district court can’t save defendants by applying the correct argument to the wrong requirement.
Dennis: The case is interesting because it further solidifies the appellate court’s stance that functional claim limitations should be given their full weight and merit even when serving as the point-of-novelty of the invention.
That’s an interesting take on this interesting case. I had just finished reading it when I saw this write-up. I think it was wrongly decided.
The CAFC needs to start to think a bit more deeply about its own jurisprudence with respect to both inherency, obviousness and “functional claiming” (of which this claim is certainly a class) before they open this door any wider. It’s a recipe for disaster.
Here’s the claim:
A method of increasing the body mass in a human patient suffering from anorexia, cachexia, or loss of body mass, comprising administering to the human patient a megestrol formulation, wherein:
(a) the megestrol acetate formulation is [details omitted]
… the administration is once daily;
wherein after a single administration in a human subject of the formulation there is no substantial difference in the Cmax of megestrol when the formulation is administered to the subject in a fed versus a fasted state…
Anyone who sees a claim like this and sees the issue being addressed by the CAFC will immediately know how and why that “wherein clause” ended up in the claim: it was inserted into the claim during prosecution after the claim was rejected as obvious (as noted by Dennis in his write-up). Indeed, both the district court and the panel here agree that both the formulation and its administration for the stated purpose here (increasing body mass in a patient in need of such an increase) was obvious in view of the prior art. All that was missing from the prior art was a definitive statement as to the underlying cause of the weight gain of patients treated with megestrol.
So what the applicant did was “discover” that in some patients application of the method yielded the result described by the “wherein” clause. The applicant didn’t test every patient on earth so they had (and we still have) no way of knowing whether the claimed discovery is some sort of “natural law” that “necessarily” occurs with every administration to every patient meeting the parameters of the “wherein” clause. (It’s important to pause here and recognize that (1) in any clinical study it’s inevitable that some previously undescribed “effect” is going to be present; and (2) the Federal Circuit has indicated that such “effects” can be discovered years after the filing date of the application and then used as evidence of non-obviousness, even when the “effects” are not recited in the claim).
Now comes the complete logical disconnect: although the claim is drafted in such a way that it would appear to any reasonable person that the “natural” effect of this otherwise obvious method (<–do not forget this fact!) is to cause the result recited in the wherein clause, apparently it's up to the defendant to prove "with clear and convincing evidence" that the "no substantial difference" is the "natural result". That proof, of course, will often require a boatload of money. I have no idea how this result makes any sense to anybody or what "progress" is promoted by such a rule, other than "progress" in keeping otherwise obvious drugs as expensive as possible for as long a time as possible.
The silver lining here is that the district court judge seems to written an excellent opinion dealing with the other aspects of the 103 analysis, and the CAFC panel appears to have recognized that. Most importantly, both the defendent, the judge and the panel relied on some crucial 103 case law that some practitioners are inclined to forget: the motivation to combine references in the prior art need not be the same as the motivation that inspired the application to make the invention (Alcon, 687 F.3d at 1369 “We have repeatedly held that the motivation to modify a
prior art reference to arrive at the claimed invention need not be the same motivation that the patentee had.”). We have explained that “that “[m]otivation to combine may be found in many different places and forms.” Allergan, Inc v. Sandoz, Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013); see also Alza, 464 F.3d at 1294 (stating that the motivation to combine does not have to be explicitly stated in the prior art, and can be supported by testimony of an expert witness regarding knowledge of a person of skill in the art at the time of invention), nor does the alternative motivation need to be "the best" of similar alternatives in the art (mere suitability is enough; See Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013); Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc., 713 F.3d 1369, 1376 (Fed. Cir. 2013).
The other silver lining, for the defendent anyway, is that eligibility and enablement issues also seem likely to be addressed on remand.
Apologies: second and third paragraph are in italics due to formatting error. Those are my comments, not Dennis’.
MM, I think there may be a difference between 102 and 103 here.
If a claimed compound was known, properties inherent in that compound cannot be used to distinguish the prior art. We all seem to agree on this.
However, if the claimed compound was unknown, it seems the court has held here that an unexpected property of a new compound might be enough to support patentability even in view of some known reason to make the new compound.
We had this discussion recently in connection with post invention discovery of unexpected results where the inventors at the time of invention had every reason to attempt to try to make the new composition and at that time expected success.
This truly confusing, because I really do not understand the Court’s reasoning. If the compound is obvious to try with expected success, why does later-discovered unexpected results matter at all?
But certainly it does matter if one actually claims that unexpected result, does it not?
“further solidifies the appellate court’s stance that functional claim limitations should be given their full weight and merit even when serving as the point-of-novelty of the invention.”
They didn’t cite Titanium Metals? Titanium Metals Corporation of America v. Banner, 227 USPQ 773 (Fed. Cir. 1985)
The claim:
1. A titanium base alloy consisting essentially by weight of about 0.6% to 0.9% nickel, 0.2% to 0.4% molybdenum, up to 0.2% maximum iron, balance titanium, said alloy being characterized by good corrosion resistance in hot brine environments.
The court there said that the feature of “alloy being characterized by good corrosion resistance in hot brine environments” is inherent to an alloy with those amounts of impurities, and the alloys were known.
I don’t see much difference between Titanium Metals and this case. True, this case concerns a method, but the feature they added appears to be a feature of the formulation and not of the method. Although I could be wrong here, having not read the patent.
the feature they added appears to be a feature of the formulation and not of the method
If I understand it correctly, that’s precisely the issue here. Certain formulations were at least obvious from the prior art. But, it wasn’t clear from the evidence that the food effect necessarily flowed from those particular formulations. So, the claims conceivably are limited to a non-obvious application of non-obvious variants of the known formulations. The door is still open for these claims to be found invalid, if the challenger can show that the food effect does flow from the prior art formulations.
That seems reasonable, Dan.
My new/old(?) friend basket might want to rest his name calling efforts long enough to note the timing here and my post on the Pater Reform thread concerning inherency.
Do you have a point to make other than this reference to some name-calling allegation that nobody cares about?
If so, try to make it. Ask someone to help you out if you’re having trouble.
The point is easy to see, Malcolm – my fan base of naysayers and name callers are engaged in pure name calling, and missing the fact of the substantive contributions that I regularly make.
And I hardly think that “nobody cares” as the good Prof. has indicated that he does care.
Maybe you should try to care too.
Just a little.
For reference, here’s a copy of the “substantive” post that anon is apparently referring to. You can all judge for yourself how substantive it is, and how remarkably germane it is to this “pharmaceutical function” case.
The legal doctrine you allude to is inherency.
While the likes of 6 and basket start flooding the thread with vap1d insults, the point you raise here will not be addressed.
Of course, the same point was raised in the Grand Hall experiment as well as a certain recent case – both of which also are chosen to be ignored in any dialogue on the subject.
But let the insults fly! Serious and deep something…
Thanks for the contribution, anon.
Thanks DanH – wouldn’t it be nice if the concept that NWPA brought up was actually discussed on that thread?
Notice the case cites In re Spormann, 363 F.2d 444, 448, 150 USPQ 449, 452 (CCPA 1966) and In re Rijckart, which are famous for:
“That which may be inherent is not necessarily known. Obviousness cannot be predicated on what is unknown.” In re Spormann, 363 F.2d 444, 448, 150 USPQ 449, 452 (CCPA 1966).
If the arguable inherent limitation is not known at the time, then it cannot be obvious. I think the “natural result” test articulated in this decision must still factor in what is known (whereas in the anticipation context it does not matter whether the inherent limitation was known or not at the time of filing).
The conclusion you draw requires taking that case law out of context. Inherency does not need to be established as of the filing date. This is very well established: There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). MPEP 2112(II).
In the present case, neither the DC nor the CAFC required that TWI present evidence that the property was known at the time of the invention.
But Schering Corp. was a 102 inherency case and is therefore irrelevant.
In order to establish inherency in an obviousness rejection, the examiner must establish that the alleged inherent feature would have been obvious or known to those skilled in the art at the time the invention was made. Kloster Speedsteel, AB v. Crucible, Inc., 793 F.2d 1565, 1576 (Fed. Cir. 1986).
That would be a truly remarkable thing, if the case said what you say it does. But it doesn’t. There is no requirement that an inherent feature was obvious or known at the time the invention was made.
Here is the relevant portion of Kloster Speedsteel:
Stora bases a major argument on the undisputed fact that size change uniformity is an inherent property of the alloy disclosed in the ‘518 patent. That argument is unpersuasive when confronted by Stora’s failure to establish at trial that that inherency would have been obvious to those skilled in the art when the invention of claim 4 was made. Inherency and obviousness are distinct concepts. W.L. Gore & Associates v. Garlock, Inc., 721 F.2d 1540, 1555, 220 USPQ 303, 314 (Fed.Cir.1983) (citing In re Spormann, 363 F.2d 444, 448, 150 USPQ 449, 452 (1966)), cert. deniedI/i>, — U.S. —-, 105 S.Ct. 172, 83 L.Ed.2d 107 (1984).
See also MPEP 2112(IV).
Why are you referring to MPEP 2112(IV)? I don’t see anything about establishing what was known at the time of the invention.
Why do you think that inherency in a 102 case would not be relevant? The issue is the same – does what is disclosed/suggested by the prior art have the property that is recited in the claim?
As for this *** about inherency being obvious… well, all I can say is that case is old and clearly contradicted by many (and newer) others. It’s certainly not what the PTO follows and judging from the CAFC’s citation to Santarus, not what they would follow today either.
See 1.1.1.2.1.2, below. I mistakenly linked to the wrong reply tab — sorry about that.
Note that the Par Pharmaceutical opinion (slip op at 15-16) cites to In re Spormann: “[T]he inherency of an advantage and its obviousness are entirely different questions . . . . Obviousness cannot be predicated on what is unknown.” This line of cases is still very good law.
But the Par Pharamaceutical court did not have to reach that issue, because the predicate requirement of inherency had not been proven. There was therefore no need for the court to address whether the inherent feature was known or obvious at the time of the invention.
Regarding your MPEP question, some of the cases cited in the first paragraph of 2112(IV) are from the Spormann line of cases.
The point is easy to see, Malcolm – my fan base of naysayers and name callers are engaged in
Blablablah.
Again: what’s your point and how is it germane to this thread?
The point?
Asked and answered.
Instead of “blalablah-ing” maybe you should just care enough to read the answer provided.
(and yes, I do notice the attempted goal post shift with the addition of “germane to this thread,” but clearly, my comment is prefaced appropriately indicating that the concept on this thread was identified on the other thread).
Try to care – just a little, and you won’t post such banalities.
Wow.
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